46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224

  
2774 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04585711
(ClinicalTrials.gov)
July 20237/10/2020Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With ArthritisPharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With ArthritisJuvenile Idiopathic Arthritis;Rheumatoid Arthritis;ObesityDrug: Etanercept Optimal dosingDuke UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not yet recruiting2 Years65 YearsAll30Phase 1United States
2NCT05274243
(ClinicalTrials.gov)
September 20221/3/20222-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis2-HOBA Phase 2 Clinical Trial in Rheumatoid ArthritisRheumatoid ArthritisDrug: 2-HOBA;Other: PlaceboVanderbilt University Medical CenterNULLNot yet recruiting18 YearsN/AAll32Phase 2United States
3NCT05267431
(ClinicalTrials.gov)
June 202214/2/2022Outcomes of Biological Therapy on Rheumatoid ArthritisOutcomes of Different Biological Therapy on Rheumatoid ArthritisRheumatoid ArthritisDrug: Biological DrugSohag UniversityNULLNot yet recruiting18 YearsN/AAll200Egypt
4NCT04269993
(ClinicalTrials.gov)
April 1, 202212/2/2020Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic ArthritisImpact of Acute Cannabis Administration on Pain Symptomology and Inflammatory Markers Among Patients With Rheumatoid or Psoriatic ArthritisRheumatoid Arthritis;Psoriatic ArthritisDrug: Cannabis: placebo and medium THC/medium CBDBrown UniversityNULLNot yet recruiting18 Years65 YearsAll76Phase 2NULL
5NCT05166304
(ClinicalTrials.gov)
April 20228/12/2021Rebamipide in Patients With Active Rheumatoid ArthritisRebamipide as an Adjunct to Methotrexate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Rebamipide;Drug: PlaceboOctober 6 UniversityNULLNot yet recruiting18 Years60 YearsAll100Phase 1/Phase 2NULL
6NCT05264025
(ClinicalTrials.gov)
April 202210/1/2022Fexofenadine in Patients With Active Rheumatoid ArthritisFexofenadine as Adjunct to Standard Rheumatoid Therapy in Patients With Active RheumatoidRheumatoid ArthritisDrug: Fexofenadine;Drug: PlaceboOctober 6 UniversityNULLNot yet recruiting18 Years60 YearsAll80Phase 1/Phase 2NULL
7NCT05246293
(ClinicalTrials.gov)
March 2, 202217/1/2022Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease.Safety and Tolerability of Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease (RAILDTo Trial).Rheumatoid Arthritis;Interstitial Lung DiseaseDrug: TofacitinibNational Institute of Respiratory Diseases, MexicoNULLNot yet recruiting18 YearsN/AAll60Phase 2Mexico
8NCT05238896
(ClinicalTrials.gov)
March 1, 20224/1/2022BARIcitinib Cognitive Emotional and Neural signaTuREBARIcitinib Cognitive Emotional and Neural signaTuRE (BARICENTRE)Rheumatoid ArthritisDrug: Baricitinib Oral Tablet [Olumiant];Drug: PlaceboAssistance Publique - Hôpitaux de ParisNULLNot yet recruiting18 Years75 YearsAll80Phase 4France
9NCT05236491
(ClinicalTrials.gov)
March 202210/2/2022COvid-19 Vaccine Booster in Immunocompromised Rheumatic DiseasesCOvid-19 Vaccine Booster in Immunocompromised Rheumatic DiseasesRheumatoid Arthritis;Autoimmune Rheumatologic Disease;Systemic Lupus Erythematosus;Systemic Vasculitis;Systemic Sclerosis;Scleroderma;Undifferentiated Connective Tissue Diseases;Overlap Connective Tissue Disease;ImmunosuppressionBiological: COVID-19 vaccinePaul R FortinCanadian Institutes of Health Research (CIHR)Not yet recruiting18 YearsN/AAll287Phase 2/Phase 3NULL
10NCT05257174
(ClinicalTrials.gov)
March 202228/1/2022The Effects of Jing Si Herbal Tea Liquid Packets on Fatigue in Patients With Inflammatory ArthritisA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Jing Si Herbal Tea Liquid Packets on Fatigue in Patients With Inflammatory ArthritisArthritis;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;FatigueDietary Supplement: Jing Si Herbal Tea LIQUID PACKETS;Dietary Supplement: PlaceboBuddhist Tzu Chi General HospitalNULLNot yet recruiting20 Years99 YearsAll150N/ATaiwan
11NCT05240859
(ClinicalTrials.gov)
February 22, 20226/2/2022Real World Study of a Adalimumab Biosimilar (Geleli) in Rheumatoid ArthritisA Multicenter, Prospective, Observational Real World Study For the Efficacy and Safety of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis.Rheumatoid ArthritisDrug: GeleliPeking University People's HospitalNULLNot yet recruitingN/AN/AAll1600China
12NCT05245448
(ClinicalTrials.gov)
February 22, 202222/1/2022Tetrandrine in the Treatment of Rheumatoid ArthritisComparing the Efficacy of Tetrandrine Combined With Methotrexate and Methotrexate Alone in the Treatment of Rheumatoid arthritis---a Randomized, Double-blinded, Placebo-controlled, Multicenter StudyRheumatoid ArthritisDrug: Tetrandrine;Drug: PlaceboPeking University People's HospitalNULLNot yet recruiting18 Years65 YearsAll240N/AChina
13EUCTR2020-000350-96-DE
(EUCTR)
11/01/202207/07/2021Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexateA Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate 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: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Czechia;Taiwan;Spain;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden
14NCT04688398
(ClinicalTrials.gov)
January 10, 202214/12/2020Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid ArthritisStudy of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid ArthritisPolyarthritisDietary Supplement: Seal oil;Dietary Supplement: ControlLaval UniversityMinistry of Agriculture, Fisheries and Food, Quebec;Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.Not yet recruiting18 YearsN/AAll130N/ANULL
15NCT05090124
(ClinicalTrials.gov)
January 1, 202220/7/2021Experimental Medicine Studies of Brain and Peripheral Immune Mechanisms for Sickness Behaviours in Patients With Rheumatoid ArthritisExperimental Medicine Studies of Brain and Peripheral Immune Mechanisms for Sickness Behaviours in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Adalimumab;Drug: PlaceboNHS Greater Glasgow and ClydeUniversity of GlasgowNot yet recruiting18 Years74 YearsAll50N/ANULL
16NCT05153200
(ClinicalTrials.gov)
January 202229/11/2021Early Changes in Pain, Disease Activity, and Ultrasound Evidence of Inflammatory Synovitis in Patients Receiving JAK-inhibitor vs. TNF-inhibitor Therapy for Active Rheumatoid Arthritis: A Feasibility Study.Early Changes in Pain, Disease Activity, and Ultrasound Evidence of Inflammatory Synovitis in Patients Receiving JAK-inhibitor vs. TNF-inhibitor Therapy for Active Rheumatoid Arthritis: A Feasibility Study.Rheumatoid ArthritisDrug: Upadacitinib;Drug: AdalimumabOttawa Hospital Research InstituteThe Ottawa Hospital;University of OttawaNot yet recruiting18 YearsN/AAll40Phase 4NULL
17NCT05182203
(ClinicalTrials.gov)
January 202218/12/2021Safety and Retention Rate of the JAK Inhibitors in Rheumatoid Arthritis: a Real-life ExperienceSafety and Retention Rate of the JAK Inhibitors in Rheumatoid Arthritis: a Real-life ExperienceRheumatoid Arthritis;Drug UseDrug: biologic/targeted therapyTuen Mun HospitalNULLNot yet recruiting18 YearsN/AAll1800China
18NCT03938701
(ClinicalTrials.gov)
January 202225/2/2019Fluorescence Imaging of Disease Activity in IBD and Rheumatoid Arthritis Using OTL38Fluorescence Imaging for the Evaluation of Disease Activity in IBD and Rheumatoid Arthritis Using the Fluorescent Tracer OTL38 Targeting the Folate ß Receptor: a Single-center Pilot StudyIBD;Rheumatoid ArthritisDrug: OTL38;Device: Fluorescence ImagingUniversity Medical Center GroningenGlaxoSmithKline;On Target Laboratories, LLC;VU University Medical CenterNot yet recruiting18 YearsN/AAll30Phase 1Netherlands
19NCT04924270
(ClinicalTrials.gov)
January 20227/6/2021Safety and Efficacy of Faecal Microbiota Transplantation in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory DiseasesSafety and Clinical Efficacy Associated With Faecal Microbiota Transplantation Performed in Treatment-naïve Patients With Newly Diagnosed Rheumatoid Arthritis, Reactive Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Gouty Arthritis, Psoriasis, Hidradenitis Suppurativa, Pulmonary Sarcoidosis, Crohn's Disease, and Ulcerative Colitis: a 52-week, Double-blind, Randomised, Placebo-controlled, Exploratory TrialRheumatoid Arthritis;Reactive Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Gouty Arthritis;Psoriasis;Hidradenitis Suppurativa;Pulmonary Sarcoidosis;Crohn Disease;Ulcerative ColitisBiological: Faecal microbiota transplantation;Other: PlaceboTorkell EllingsenRegion of Southern Denmark;University of Southern DenmarkNot yet recruiting18 Years70 YearsAll200Phase 2NULL
20NCT04170426
(ClinicalTrials.gov)
December 202118/11/2019Autologous Adipose-derived Stem Cells (AdMSCs) for Rheumatoid ArthritisPhase 1/2a Clinical Study for Subjects With Rheumatoid Arthritis (RA) Using Multiple Dose Intravenous Infusions of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)Rheumatoid ArthritisBiological: autologous adipose derived stem cellsCelltex Therapeutics CorporationNULLNot yet recruiting18 Years75 YearsAll54Phase 1/Phase 2NULL
21NCT05124782
(ClinicalTrials.gov)
November 30, 202122/10/2021Virtual Management of Rheumatoid ArthritisEvaluation of Rheumatoid Arthritis at the Time of TelemedicineRheumatoid ArthritisOther: Rheumatoid Arthritis Impact of Disease questionnaireAssistance Publique - Hôpitaux de ParisNULLRecruitingN/AN/AAll100France
22NCT05152615
(ClinicalTrials.gov)
November 17, 20211/12/2021A Pilot Proof of Concept Study of the Effects of Administration of a Short Chain Fatty Acid (SCFA) in Rheumatoid Arthritis (EASi-RA)A Pilot Proof of Concept Study of the Effects of Administration of a Short Chain Fatty Acid (SCFA) in Rheumatoid Arthritis (EASi-RA)Rheumatoid ArthritisDietary Supplement: Short Chain Fatty Acids (SCFA) Dietary SupplementNYU Langone HealthNULLRecruiting18 YearsN/AAll50N/AUnited States
23NCT05053165
(ClinicalTrials.gov)
November 12, 202116/9/2021A Study to Assess the Safety and Tolerability of LB-P6 and LB-P8 in Healthy ParticipantsA Phase 1, Randomised, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of LB-P6 or LB-P8 in Healthy ParticipantsRheumatoid Arthritis;Non-Alcoholic SteatohepatitisDrug: LB-P6;Drug: LB-P8;Drug: PlaceboLISCure BiosciencesNovotech (Australia) Pty LimitedRecruiting18 Years65 YearsAll30Phase 1Australia
24JPRN-jRCT2071210068
09/11/202128/09/2021Abatacept vs Adalimumab in Early, Seropositive, and SE-positive RAA Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate Rheumatoid ArthritisSingle-blind Treatment Period
Arm A Abatacept+MTX
Arm B Adalimumab+MTX
Open-label Treatment Period
Abatacept+MTX
Maldonado A MichaelNULLRecruiting>= 20age oldNot applicableBoth20Phase 3Australia;France;Germany;USA;Taiwan;Japan
25NCT04876781
(ClinicalTrials.gov)
November 1, 202120/4/2021Korean Post-marketing Surveillance for Xeljanz XRKorean Post-marketing Surveillance for Xeljanz XR (Registered)Active Moderate to Severe Rheumatoid Arthritis;Active Ankylosing SpondylitisDrug: Tofacitinib XRPfizerNULLNot yet recruiting18 YearsN/AAll200NULL
26NCT04680962
(ClinicalTrials.gov)
October 17, 20212/12/2020MabionCD20® Compared to MabThera® and Rituxan® in Patients With Rheumatoid ArthritisA Double-Blind, Randomized, Parallel-Group Study to Investigate the Pharmacokinetic and Clinical Similarity Between MabionCD20, EU-approved MabThera® and US-licensed Rituxan® in Patients With Moderate-to-Severe Rheumatoid ArthritisRheumatoid ArthritisBiological: MabionCD20 (candidate biosimilar to rituximab);Biological: MabThera®;Biological: Rituxan®Mabion SAParexelNot yet recruiting18 Years80 YearsAll280Phase 3NULL
27NCT05080218
(ClinicalTrials.gov)
October 20216/10/2021COVID-19 VaccinE Response in Rheumatology PatientsThe SARS-CoV-2 Vaccine Response and Safety in Rheumatology Patients and the Influence of Temporary Interruptions in Immunomodulatory TherapyRheumatoid Arthritis;Psoriatic Arthritis;SpondylarthritisDrug: Upadacitinib;Drug: Abatacept;Drug: Secukinumab;Drug: Tofacitinib;Drug: TNF Inhibitor;Drug: Canakinumab InjectionJeffrey CurtisUniversity of Alabama at Birmingham;University of Nebraska;University of Pennsylvania;AbbVie;Bristol-Myers Squibb;Novartis;Eli Lilly and Company;PfizerNot yet recruiting18 Years85 YearsAll1000Phase 4United States
28EUCTR2020-000350-96-IT
(EUCTR)
21/09/202122/10/2021Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexateA Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate - - 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]
Product Name: Abatacept
Product Code: [BMS-188667]
INN or Proposed INN: abatacept
Trade Name: Humira
Product Name: ADALIMUMAB
Product Code: [-]
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Czechia;Taiwan;Spain;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden
29NCT05047341
(ClinicalTrials.gov)
September 7, 20218/9/2021A Study of Human Substance Balance and Biotransformation of [14C]SHR0302A Clinical Trial of the Absorption, Metabolism and Excretion of [14C]SHR0302 in Healthy Chinese Adult Male SubjectsRheumatoid Arthritis (RA)Drug: SHR0302?[14C]SHR0302Jiangsu HengRui Medicine Co., Ltd.NULLActive, not recruiting18 Years45 YearsMale6Phase 1China
30EUCTR2020-000350-96-PL
(EUCTR)
24/08/202119/07/2021Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexateA Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate 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]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Czechia;Taiwan;Spain;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden
31NCT05000216
(ClinicalTrials.gov)
August 13, 20216/8/2021COVID-19 Booster Vaccine in Autoimmune Disease Non-RespondersBooster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01)Rheumatoid Arthritis;Systemic Lupus Erythematosus (SLE);Pemphigus Vulgaris;Multiple Sclerosis;Systemic Sclerosis (SSc)Biological: Moderna mRNA-1273;Biological: BNT162b2;Biological: Ad26.COV2.S;Drug: IS (MMF or MPA);Drug: IS (MTX);Biological: IS (B cell depletion therapy)National Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.Recruiting18 YearsN/AAll600Phase 2United States
32EUCTR2020-000350-96-FR
(EUCTR)
09/08/202128/05/2021Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexateA Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate 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: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Czechia;Taiwan;Spain;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden
33EUCTR2020-000350-96-CZ
(EUCTR)
02/08/202110/06/2021Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexateA Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate 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: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Czechia;Taiwan;Spain;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden
34EUCTR2020-000350-96-ES
(EUCTR)
29/07/202123/06/2021Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexateA Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate 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]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Czechia;Taiwan;Spain;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden
35NCT04834557
(ClinicalTrials.gov)
July 20212/4/2021Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid ArthritisEvaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in EgyptRheumatoid ArthritisDrug: Placebo;Drug: Digoxin 0.25 mg;Drug: Ursodeoxycholic acid (UDCA) 500 mgTanta UniversityNULLNot yet recruiting18 Years80 YearsAll90Phase 2NULL
36NCT04885751
(ClinicalTrials.gov)
June 1, 202126/4/2021Compare the Effect of Eupatilin and Rebamipide on the Prevention of GastroenteropathyCompare 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 StudyRheumatoid Arthritis;Osteoarthritis;Ankylosing Spondylitis;Other Musculoskeletal Disorder;Gastric Ulcer;Enteritis;NSAID-Associated Gastropathy;NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced EnteropathyDrug: Eupatilin;Drug: RebamipideSeoul National University Boramae HospitalDong-A ST Co., Ltd.Not yet recruiting19 Years70 YearsAll50Phase 4NULL
37EUCTR2020-005096-12-SE
(EUCTR)
31/05/202109/04/2021Utvärdering av två kortison behandlingsstrategier hos patienter med nydiagnostiserad, tidigare obehandlad ledgångsreumatism: en randomiserad, öppen, non-inferiority klinisk studieUtvärdering 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 UniversitetssjukhusetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
166Phase 4Sweden
38NCT04885829
(ClinicalTrials.gov)
May 31, 20213/5/2021Comparative Study of 3 Tocilizumab Products in Normal Healthy VolunteeersA Single Dose, Double-Blind, Two-Period, Crossover, Comparative Pharmacokinetic Study of Three Tocilizumab Products Administered by the Subcutaneous Route to Normal Healthy VolunteersRheumatoid Arthritis;Giant Cell ArteritisDrug: Tocilizumab Prefilled SyringeSyneos HealthDr. Reddy's Laboratories LimitedRecruiting18 Years50 YearsAll300Phase 1Australia;New Zealand
39JPRN-jRCTs071200107
25/05/202103/03/2021Efficacy 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 trialEfficacy 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 arthritisIn 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 AtsushiNULLRecruiting>= 20age oldNot applicableBoth400N/AJapan
40NCT04884880
(ClinicalTrials.gov)
May 14, 202130/4/2021Efficacy and Safety of Luo-Fu-Shan Plaster in Patients With Rheumatoid ArthritisProspective, Multicentre, Randomized, Double-blind, Placebo-controlled Clinical Trial of Luo-Fu-Shan Plaster in the Treatment of Rheumatoid ArthritisArthritis, RheumatoidDrug: Luo-Fu-Shan Plaster;Drug: The placebo 10gGuang'anmen Hospital of China Academy of Chinese Medical SciencesNULLNot yet recruiting18 Years75 YearsAll180N/AChina
41NCT04947137
(ClinicalTrials.gov)
May 12, 202110/5/2021Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m TilmanoceptDevelopment of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m TilmanoceptRheumatoid ArthritisDrug: Tc99m tilmanoceptNavidea BiopharmaceuticalsNULLActive, not recruiting18 YearsN/AAll135Phase 2United States
42NCT04871919
(ClinicalTrials.gov)
May 11, 202129/4/2021Prospective Observational Study of Filgotinib in Subjects With Rheumatoid ArthritisA Prospective, Non-interventional Study of the Effectiveness, Safety, and Health Related Outcomes in Patients With Moderate to Severe Active Rheumatoid Arthritis Receiving FilgotinibRheumatoid ArthritisDrug: FilgotinibGalapagos NVNULLRecruiting18 YearsN/AAll1500Belgium;Germany;Italy;Netherlands;Spain;United Kingdom
43NCT04815148
(ClinicalTrials.gov)
April 1, 202119/3/2021MH004 Topical Cream in Healthy Adult Volunteers and Participants With Atopic Dermatitis or Rheumatoid ArthritisA Phase Ia/Ib Study to Evaluate the Safety, Tolerability and PK of MH004 Topical Cream in Healthy Adult Volunteers and to Investigate Its Efficacy and Safety Profile in Participants With Atopic Dermatitis or Rheumatoid ArthritisAtopic Dermatitis;Rheumatoid ArthritisDrug: MH004 Ia(0.1%);Drug: MH004 Ia(0.3%);Drug: MH004 Ia(1%);Drug: MH004 Ia(3%);Drug: MH004 Ib-1(0.1%);Drug: MH004 Ib-1(0.3%);Drug: MH004 Ib-1(1%);Drug: MH004 Ib-2(0.3%);Drug: MH004 Ib-2(1%);Drug: MH004 Ib-2(3%)Minghui Pharmaceutical Pty LtdNULLNot yet recruiting18 Years70 YearsAll72Phase 1NULL
44JPRN-jRCTs071200079
22/03/202112/01/2021Discontinuation of methotrexate in rheumatoid arthritis patients achieving clinical remission by treatment with upadacitinib plus methotrexate (DOPPLER study): Study protocol for an interventional, multicenter, open-label and single-arm clinical trial with clinical, ultrasound and biomarker assessmentsDiscontinuation of methotrexate in rheumatoid arthritis patients achieving clinical remission by treatment with upadacitinib plus methotrexate (DOPPLER study): Study protocol for an interventional, multicenter, open-label and single-arm clinical trial with clinical, ultrasound and biomarker assessments Rheumatoid arthritisStarting at baseline (week 0), all patients will receive upadacitinib 15mg/day and continue to receive a stable pre-baseline dosage of MTX until week 24 (Stage I). In addition, if patients achieve a EULAR moderate response or a DAS28-CRP <= 3.2 a week 12, and a DAS28-CRP of < 2.6 at week 24, they will discontinue MTX, and continue upadacitinib monotherapy until week 48 (Stage II).
Patients not achieving a EULAR moderate response or a DAS28-CRP <= 3.2 at week 12 or a DAS28-CRP of < 2.6 at week 24 will be excluded from this study.
Kawakami AtsushiNULLRecruiting>= 20age oldNot applicableBoth155Phase 4Japan
45NCT04806113
(ClinicalTrials.gov)
March 11, 202112/3/2021COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune DiseasesCOVID-19 Vaccine in Immunosuppressed Adults With Autoimmune DiseasesCovid19;Rheumatic Diseases;Rheumatoid Arthritis;SLEBiological: Moderna COVID-19 vaccineMcGill University Health Centre/Research Institute of the McGill University Health CentreCHU de Quebec-Universite Laval;Ministere de la Sante et des Services SociauxActive, not recruiting18 YearsN/AAll220Phase 3Canada
46NCT04798287
(ClinicalTrials.gov)
March 10, 202111/3/2021Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer EndpointsSafety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer EndpointsRheumatoid ArthritisDrug: Tofacitinib;Drug: TNF InhibitorBrigham and Women's HospitalNULLActive, not recruiting18 YearsN/AAll105711United States
47JPRN-UMIN000043547
2021/03/0808/03/2021Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive.Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive. - Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive. Rheumatoid Arthritis60 weeks
Oral administration of 200mg filgotinib daily
DeparShinshu University School of MedicineNULLRecruiting20years-old100years-oldMale and Female100Not selectedJapan
48NCT02903212
(ClinicalTrials.gov)
March 20211/9/2016Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid ArthritisTolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid ArthritisArthritis, RheumatoidBiological: Autologous apoptotic cells injectionCentre Hospitalier Universitaire de BesanconNULLNot yet recruiting18 Years80 YearsAll22Phase 1/Phase 2NULL
49EUCTR2019-004369-42-DE
(EUCTR)
15/02/202127/11/2020A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I Moderately to severely active 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]
Product Code: MSB11456
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: RoActemra(R)
Product Name: RoActemra (R)
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
Fresenius Kabi SwissBioSim GmbHNULLNot RecruitingFemale: yes
Male: yes
542Phase 3Serbia;United States;Czechia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Poland;Bulgaria;Georgia;Germany;Moldova, Republic of
50NCT04740814
(ClinicalTrials.gov)
February 11, 20212/2/2021A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid ArthritisA Multi-Center, Open-Label Study to Evaluate the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis Using an Electrochemiluminescent Immuno-AssayRheumatoid ArthritisDrug: Certolizumab pegolUCB Biopharma SRLNULLActive, not recruiting18 Years69 YearsAll33Phase 1United States
51NCT04757571
(ClinicalTrials.gov)
February 1, 202112/2/2021The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis PatientsThe GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients. A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial.Rheumatoid ArthritisDrug: Paroxetine;Drug: PlaceboSadat City UniversityNULLRecruiting18 Years60 YearsAll120Phase 1/Phase 2Egypt
52JPRN-jRCTs071200007
28/01/202120/04/2020Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessmentsDiscontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments Rheumatoid arthritisRheumatoid arthritis patients who have been treated with infliximab BS during IFX-SIRIUS STUDY I period and persisted with clinical remission or low disease activity discontinue infliximab BS.
If they have relapse after discontinuation of infliximab BS,infliximab BS will be re-administered.
Kawakami AtsushiNULLRecruiting>= 20age oldNot applicableBoth80Phase 4Japan
53ChiCTR2100042440
2021-01-212021-01-21Observation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance geneObservation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance gene difficult-to-treat rheumatoid arthritisThe normal group:No special treatment; Primary untreated group:Do not give any treatment, only before treatment for blood, the group does not consider follow-up treatment, recommended patients to seek medical advice, follow the doctor 's orders;Therapeutic effective group:Continue the original treatment plan;Refractory (trial group):Methotrexate + folic acid tablets + Adalimumab + Qingre Tongluo Prescription;Refractory (control group):Methotrexate + folic acid tablets + adalimumab + simulant;Yunnan Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of traditional Chinese MedicineNULLRecruiting1870BothThe normal group:15; Primary untreated group:15;Therapeutic effective group:15;Refractory (trial group):15;Refractory (control group):15;China
54ChiCTR2100042328
2021-01-192021-01-19Effect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant GeneEffect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant Gene Rheumatoid arthritisThe normal group:No special treatment will be given;Primary untreated group:No treatment was given, only blood was drawn before treatment, and follow-up treatment was not considered in this group. Patients were advised to seek medical treatment by themselves and follow the doctor's advice;Therapeutic effective group:Continue with the original regimen;Observation group:Methotrexate + folic acid tablets + Adamumab + Wenyang Tongluo Recipient;The control group:Methotrexate + folic acid tablets + adamulizumab + simulation agent;Yunnan Hospital of Traditional Chinese Medicine (The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine)NULLRecruiting1870BothThe normal group:15;Primary untreated group:15;Therapeutic effective group:15;Observation group:15;The control group:15;China
55NCT04539964
(ClinicalTrials.gov)
January 11, 202131/8/2020Vagus Nerve Stimulation for Moderate to Severe Rheumatoid ArthritisVagus Nerve Stimulation Using the SetPoint System for Moderate to Severe Rheumatoid Arthritis: The RESET-RA StudyRheumatoid ArthritisProcedure: Implant Procedure;Drug: Conventional Synthetic DMARD;Device: Active stimulation;Device: Non-active stimulationSetPoint Medical CorporationNULLRecruiting22 Years75 YearsAll250Phase 3United States
56NCT04634253
(ClinicalTrials.gov)
January 4, 202117/11/2020A Study of LY3462817 in Participants With Rheumatoid ArthritisA Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants With Moderately to Severely Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Placebo;Drug: LY3462817Eli Lilly and CompanyNULLActive, not recruiting18 YearsN/AAll80Phase 2United States;Czechia;Hungary;Mexico;Poland;Puerto Rico;United Kingdom
57NCT04349046
(ClinicalTrials.gov)
January 1, 202114/4/2020Exception Cementless Hip StemException Cementless Femoral Stem in Total Hip Arthroplasty. A Multicenter, Retrospective and Prospective, Non-controlled Post Market Clinical Follow-up Study (Implants and Instrumentation)Osteoarthritis, Hip;Rheumatoid Arthritis;Inflammatory Arthritis;Congenital Hip Dysplasia;Avascular Necrosis of Hip;Femoral Neck FracturesDevice: Total hip arthoplasty (THA)Zimmer BiometNULLRecruiting18 Years100 YearsAll332Belgium;France
58NCT04535427
(ClinicalTrials.gov)
January 1, 202122/8/2020Role of L-Arginine Supplementation in the Treatment of Rheumatoid ArthritisRole of L-Arginine Supplementation in the Treatment of Rheumatoid ArthritisRheumatoid ArthritisDrug: L-arginine;Drug: PlaceboRenJi HospitalNULLNot yet recruiting18 Years45 YearsAll144Phase 2China
59NCT04586933
(ClinicalTrials.gov)
December 10, 202022/9/2020Nutrition in Rheumatic DiseasesNutritional Intervention in Rheumatic Diseases: Effect of Marine Omega-3 Fatty Acids and Individual Dietary GuidanceSpondyloarthritis;Rheumatoid Arthritis;PolyarthritisDietary Supplement: Omega-3;Dietary Supplement: Placebo (soya);Behavioral: Dietary guidanceHaukeland University HospitalGC Rieber Oils ASRecruiting18 Years75 YearsAll120N/ANorway
60NCT04569890
(ClinicalTrials.gov)
December 1, 202020/9/2020Treatment of Pregnancy RAStudy on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in ChinaRheumatoid Arthritis;Pregnancy RelatedDrug: Certolizumab Pegol 200 MG/ML [Cimzia];Drug: Hydroxychloroquine;Drug: PrednisoneRenJi HospitalNULLNot yet recruiting20 Years40 YearsFemale100N/AChina
61NCT04649697
(ClinicalTrials.gov)
December 1, 202026/10/2020Rebamipide (Regular & Nanoparticulated) vs. Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis PatientsEvaluation of Topical Rebamipide Versus Topical Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients: Randomized-Controlled Clinical TrialRheumatoid ArthritisDrug: Rebamipide;Drug: Nanoparticulated Rebamipide;Drug: Clobetasol PropionateCairo UniversityNULLNot yet recruiting20 Years70 YearsAll39Phase 3NULL
62NCT03828344
(ClinicalTrials.gov)
December 202030/1/2019Safety and Tolerability of a Single Intravenous Infusion of BX-U001 in Refractory Rheumatoid ArthritisA Phase 1 Randomized, Placebo-Controlled, Double-Blind Study of the Safety and Tolerability of a Single Intravenous Infusion of BX-U001, a Human Umbilical Cord Tissue Derived Mesenchymal Stem Cell Product, for Refractory Rheumatoid ArthritisRheumatoid ArthritisBiological: hUC-MSC suspension;Biological: PlaceboBaylx Inc.NULLNot yet recruiting18 Years70 YearsAll16Phase 1NULL
63NCT04292067
(ClinicalTrials.gov)
November 23, 202026/2/2020Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid ArthritisCharacterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid ArthritisSpondyloarthritis;Rheumatoid ArthritisBiological: Faecal samplingAssistance Publique - Hôpitaux de ParisNULLRecruiting18 YearsN/AAll400France
64NCT04758689
(ClinicalTrials.gov)
November 20, 202011/2/2021Laser Acupuncture in Rheumatoid Arthritis Geriatric PatientsLaser Acupuncture in Rheumatoid Arthritis Geriatric PatientsRheumatoid ArthritisCombination Product: Laser, exercise, and methotrexate;Combination Product: Exercise, and methotrexateCairo UniversityNULLCompleted65 Years75 YearsAll60N/AEgypt
65JPRN-jRCTs071200054
18/11/202018/11/2020Effectiveness 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 trialEffectiveness 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 arthritisRheumatoid 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 AtsushiNULLRecruiting>= 20age oldNot applicableBoth40Phase 4Japan
66NCT04311567
(ClinicalTrials.gov)
November 7, 20205/3/2020Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung DiseaseEffects of Tofacitinib vs Methotrexate on Clinical and Molecular Disease Activity Markers in Joints and Lungs in Early Rheumatoid Arthritis (PULMORA) - A Randomized, Controlled, Open-label, Assessor-blinded, Phase IV TrialRheumatoid Arthritis;Interstitial Lung Disease Due to Systemic Disease (Disorder);RA;ILDDrug: Tofacitinib;Drug: MethotrexateVastra Gotaland RegionGöteborg UniversityRecruiting18 Years80 YearsAll48Phase 4Sweden
67NCT04608344
(ClinicalTrials.gov)
November 4, 202023/10/2020Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy ParticipantsA Phase 1 Study to Evaluate OATP Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy ParticipantsRheumatoid ArthritisDrug: Atorvastatin;Drug: Pravastatin;Drug: Rosuvastatin;Drug: FilgotinibGilead SciencesGalapagos NVCompleted18 Years55 YearsAll27Phase 1United States
68EUCTR2020-000658-83-BG
(EUCTR)
21/10/202007/10/2020A study evaluating the effects of GLPG3970 given as an oral treatment for 6 weeks in adults with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexateA randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate 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]
Product Name: GLPG3970
Product Code: G1567970
INN or Proposed INN: Not applicable
Other descriptive name: GLPG3970
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
25Phase 2Poland;Ukraine;Georgia;Bulgaria
69JPRN-jRCTs041200048
02/10/202002/10/2020Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-stateCertolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state - PRIMERA study Rheumatoid arthritis1) MTX*
- Continued group:
Continued at a stable dose and interval throughout the cours of the study.
Folic acid is continued if concomitantly used.
- Withdrawn group:
Week 0 to 12
Reduced after registration.
The dose of MTX is reduced to half, regardless of the initial dose.
Folic acid is continued if concomitantly used.
Week 12 to 52
Discontinued if low disease activity was maintained.
Folic acid is discontinued if concomitantly used.
*The allowable range of adherence is -20% to +20%.

2) CZP and csDMARDs other than MTX
Continued at a stable dose and interval throughout the course of the study in both groups.

3) Glucocorticoids
Continued at a stable dose up to week 36, and allowedto taper after week 36 in both group.

4) Rescue treatment
One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request.
- Restoring, restarting, or increasing doses of MTX
- Increasing doses of or adding csDMARDs other than MTX.
- Increasing doses of or adding glucocorticoids
- Drainage of synovial fluid.
- Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.
Kojima ToshihisaNULLRecruiting>= 20age oldNot applicableBoth114N/AJapan
70EUCTR2019-002810-37-DE
(EUCTR)
23/09/202020/02/2020A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® 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: Reditux
Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg
Product Code: DRL_RI
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera 100mg
INN or Proposed INN: RITUXIMAB
Trade Name: Reditux
Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg
Product Code: DRL_RI
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
Dr. Reddy’s Laboratories S.A.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Germany;Bulgaria;Lithuania;Poland;Czech Republic;Hungary;United States
71EUCTR2020-002507-19-NL
(EUCTR)
07/09/202003/09/2020Research into administration of lower dosed rituximab with an injectionComparison of subcutaneous and intravenous continued treatment with ultra-low dose Rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial - RTX-SC 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: MabThera
Product Name: rituximab
Trade Name: Rixathon
Product Name: rituximab
Sint MaartenskliniekNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 4Netherlands
72EUCTR2019-002676-14-SE
(EUCTR)
26/08/202014/04/2020A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITISA 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation
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: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet
Product Name: tofacitinib (Xeljanz®)
Product Code: CP 690550 MR
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: IRAK 4
Product Code: PF-06650833
INN or Proposed INN: IRAK 4
Other descriptive name: PF-06650833
Product Name: JAK 3
Product Code: PF-06651600
INN or Proposed INN: JAK 3
Other descriptive name: PF-06651600
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
450Phase 2Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Georgia;Bulgaria;Sweden;Bosnia and Herzegovina
73EUCTR2019-002676-14-BG
(EUCTR)
20/08/202027/05/2020A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600 (Ritlecitinib) AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITISA 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation
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: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet
Product Name: tofacitinib (Xeljanz®)
Product Code: CP 690550 MR
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: IRAK 4
Product Code: PF-06650833
INN or Proposed INN: IRAK 4
Other descriptive name: PF-06650833
Product Name: Ritlecitinib/JAK 3
Product Code: PF-06651600
INN or Proposed INN: JAK 3
Other descriptive name: PF-06651600
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
450Phase 2Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
74NCT04973787
(ClinicalTrials.gov)
August 1, 202022/6/2021The Role of Microbiome on Biological Therapy Efficacy in axSpA and RAMicroSpA & MicroRA: The Role of Microbiome on Biological Therapy Efficacy in Axial Spondyloarthritis and Rheumatoid Arthritis - a New ParadigmAxial Spondyloarthritis;Arthritis, RheumatoidBiological: biological disease-modifying antirheumatic drugs (bDMARDs)Universidade Nova de LisboaNOVA Medical School of Universidade NOVA de Lisboa;Centro Hospitalar Lisboa Ocidental Hospital Egas Moniz;Centro Hospitalar Universitário de São João;Centro Hospitalar de Vila Nova de Gaia/Espinho;Centro Hospitalar Universitário de Lisboa Norte - Hospital de Santa Maria;Instituto Português de Reumatologia;Centro Hospitalar Médio Tejo - Hospital Rainha Santa Isabel - Torres Novas;Centro Hospitalar Baixo Vouga - Hospital Infante D. Pedro;CHRC-Comprehensive Health Research Centre, FCM|NMS, UNL;iNOVA4Health - Rheumatic Diseases Lab;Unidade Local de Saúde do Alto Minho, Hospital Conde de Bertiandos;Hospital de Braga E.P.E.;Hospital Sousa Martins - Unidade de Saúde Local da GuardaRecruiting18 Years65 YearsAll90Portugal
75JPRN-jRCTs071190030
28/07/202011/10/2019Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessmentsSwitching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments Rheumatoid arthritisRheumatoid arthritis patients who have been treated with Remicade over 24 weeks and persisted with clinical remission are switched to infliximab BS from Remicade.
The dose and infusion intervals of infliximab BS are kept unchanged from those of Remicade.
Kawakami AtsushiNULLRecruiting>= 20age oldNot applicableBoth80Phase 4Japan
76EUCTR2019-002676-14-SK
(EUCTR)
27/07/202027/04/2020A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITISA 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation
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: Xeljanz® 11mg Prolonged Release Tablet
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: IRAK 4
Product Code: PF-06650833
INN or Proposed INN: IRAK 4
Other descriptive name: PF-06650833
Product Name: JAK 3 Ritlecitinib
Product Code: PF-06651600
INN or Proposed INN: JAK 3
Other descriptive name: PF-06651600
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
450Phase 2Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
77NCT04512001
(ClinicalTrials.gov)
July 27, 202011/8/2020A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union-approved RoActemra® in Patients With Moderately to Severely Active Rheumatoid Arthritis (APTURA I Study)A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union-approved RoActemra® in Patients With Moderately to Severely Active Rheumatoid Arthritis (APTURA I Study)Rheumatoid ArthritisDrug: MSB11456;Drug: EU-approved RoActemraFresenius Kabi SwissBioSim GmbHNULLActive, not recruiting18 YearsN/AAll542Phase 3Bulgaria;Czechia;Georgia;Hungary;Moldova, Republic of;Poland;Russian Federation;Serbia;Slovakia
78NCT04324892
(ClinicalTrials.gov)
July 12, 202025/3/2020Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT StudyEffects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT StudyRheumatoid ArthritisDrug: Treat to targetChinese University of Hong KongNULLNot yet recruiting18 YearsN/AAll110NULL
79EUCTR2019-002676-14-CZ
(EUCTR)
07/07/202011/05/2020A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB), AND TOFACITINIB ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITISA 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation
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: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet
Product Name: tofacitinib (Xeljanz®)
Product Code: CP 690550 MR
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: IRAK 4
Product Code: PF-06650833
INN or Proposed INN: IRAK 4
Other descriptive name: PF-06650833
Product Name: JAK 3
Product Code: PF-06651600
INN or Proposed INN: JAK 3
Other descriptive name: PF-06651600
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
450Phase 2Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Georgia;Bulgaria;Sweden;Bosnia and Herzegovina
80JPRN-UMIN000040094
2020/07/0101/07/2020Development of chronotherapeutics in rheumatoid arthritisDevelopment of chronotherapeutics in rheumatoid arthritis - Development of chronotherapeutics in rheumatoid arthritis rheumatoid arthritisbaricitinib 4mg morning
baricitinib 4mg evening
baricitinib 2mg evening
Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo college of MedicineNULLRecruiting18years-old100years-oldMale and Female90Not applicableJapan
81JPRN-jRCTs071190046
29/06/202020/02/2020Efficacy 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 trialEfficacy 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 arthritisRheumatoid 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 AtsushiNULLRecruiting>= 20age oldNot applicableBoth62Phase 4Japan
82EUCTR2019-002810-37-PL
(EUCTR)
16/06/202011/03/2020A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® 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: Reditux
Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg
Product Code: DRL_RI
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera 100mg
INN or Proposed INN: RITUXIMAB
Trade Name: Reditux
Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg
Product Code: DRL_RI
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
Dr. Reddy’s Laboratories S.A.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany
83EUCTR2019-001185-15-BG
(EUCTR)
29/05/202015/05/2020A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effectA double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 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]
Product Code: AP1189
INN or Proposed INN: Not applicable
SynAct Pharma ApSNULLNot RecruitingFemale: yes
Male: yes
135Phase 2Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden
84EUCTR2018-003418-41-GB
(EUCTR)
18/05/202022/11/2019A comparison of a radioactive imaging method with an existing immunological (involving cells from the Immune System) based method that involves staining of tissues from a patient with a known rheumatoid arthritic joint.A Comparison of Tc 99m Tilmanocept Quantitative Imaging with Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue from Subjects Clinically Diagnosed with Rheumatoid Arthritis (RA) 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: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trade Name: Lymphoseek
Product Name: technetium Tc 99m tilmanocept
INN or Proposed INN: not applicable
Other descriptive name: TILMANOCEPT
Navidea Biopharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2United States;European Union;United Kingdom
85NCT04350216
(ClinicalTrials.gov)
April 30, 20208/4/2020Effect of Sarilumab on Atherosclerotic Disease Assessed by PET/CET in Patients With RA (SARIPET)Effect of Sarilumab Therapy on Atherosclerotic Disease Assessed by Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Rheumatoid ArthritisRheumatoid Arthritis;AtherosclerosisDrug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]Instituto de Investigación Marqués de ValdecillaNULLNot yet recruiting18 Years100 YearsAll20Phase 4NULL
86EUCTR2019-002810-37-LT
(EUCTR)
17/04/202003/03/2020A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® 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: Reditux
Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg
Product Code: DRL_RI
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera 100mg
INN or Proposed INN: RITUXIMAB
Trade Name: Reditux
Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg
Product Code: DRL_RI
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
Dr. Reddy’s Laboratories S.A.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Czechia;Hungary;Poland;Lithuania;Bulgaria;Germany
87NCT04115423
(ClinicalTrials.gov)
April 1, 20202/10/2019A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving TocilizumabA Retrospective Cohort Study to Examine the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab Compared With Tumor Necrosis Factor Inhibitors Using the National Health Insurance DatabaseInfection;Rheumatoid ArthritisDrug: Tocilizumab;Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)Sungkyunkwan UniversityMinistry of Food and Drug Safety, KoreaActive, not recruiting18 YearsN/AAll9508Korea, Republic of
88EUCTR2019-000868-18-DE
(EUCTR)
13/03/202008/07/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, incombination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 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]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Czechia;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan
89JPRN-jRCT1041190125
09/03/202009/03/2020PRECIOUS-B studyPatient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoid arthritis in Stable low disease activity with Baricitinib - PRECIOUS-B study Rheumatoid arthritis1) MTX*
Week 0 to 12
- Reduced after registration.
- The dosing frequency of MTX is decreased from weekly to biweekly without a change in dose, regardless of the initial dose.
- The dosing frequency of folic acid is decreased from weekly to biweekly without a change in dose if concomitantly used.
Week 12 to 52
- Discontinued if low disease activity was maintained.
- Folic acid is discontinued if concomitantly used.
*The allowable range of adherence is -20% to +20%.

2) BAR
- Continued at a stable dose and interval throughout the course of the study.

3) csDMARDs other than MTX
- Continued at a stable dose and interval throughout the course of the study.

4) Glucocorticoids
- Continued at a stable dose up to week 36, and allowed to taper after week 36.

5) Rescue treatments
One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request
- Changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX.
- Increasing doses of or adding csDMARDs other than MTX.
- Increasing doses of or adding glucocorticoids.
- Drainage of synovial fluid.
- Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.
Takahashi NobunoriNULLRecruiting>= 20age oldNot applicableBoth51N/AJapan
90EUCTR2019-002810-37-HU
(EUCTR)
09/03/202020/01/2020A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® 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: Reditux
Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg
Product Code: DRL_RI
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera 100mg
INN or Proposed INN: RITUXIMAB
Trade Name: Reditux
Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg
Product Code: DRL_RI
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
Dr. Reddy’s Laboratories S.A.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Estonia;Czech Republic;Hungary;Poland;Lithuania;Bulgaria;Germany
91NCT03895879
(ClinicalTrials.gov)
March 1, 202026/3/2019Use of Tocilizumab Drug Levels to Optimize Treatment in RAConcentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients: a Randomised, Multicenter, Non-inferiority Trial (TODORA)Rheumatoid ArthritisDrug: TocilizumabReade Rheumatology Research InstituteZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruiting18 YearsN/AAll98Phase 4Netherlands
92NCT04222920
(ClinicalTrials.gov)
March 1, 20207/1/2020Adalimumab Dose Reduction Aiming Low Serum Concentration With Control of Disease ActivityAdalimumab Dose Reduction Aiming Low Serum Concentration With Control of Disease Activity: a Single Blind, Non-inferiority, Randomised Clinical TrialRheumatoid ArthritisOther: Dose reduction to 2mg/L;Other: Dose reduction to 5mg/L;Drug: AdalimumabReade Rheumatology Research InstituteZonMw: The Netherlands Organisation for Health Research and Development;Sint MaartenskliniekRecruiting18 YearsN/AAll89Phase 4Netherlands
93EUCTR2018-003351-37-FR
(EUCTR)
19/02/202028/05/2019A 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 CompanyNULLNot Recruiting Female: yes
Male: yes
2600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesUnited 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
94EUCTR2019-001185-15-NO
(EUCTR)
19/02/202007/11/2019A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effectA double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 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]
Product Code: AP1189
INN or Proposed INN: Not applicable
SynAct Pharma ApSNULLNot RecruitingFemale: yes
Male: yes
135Phase 2Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden
95JPRN-UMIN000039116
2020/01/1515/01/2020Effects of Sleep Management on Postoperative Pain in patients after total knee arthroplasty. A randomized controlled study.Effects of zolpidem tartrate on Postoperative Pain in patients after total knee arthroplasty. A randomized controlled study. - SMAPP Osteoarthritis, Rheumatoid arthritisAdministration of zolpidem tartrate of 5mg for 7 days after surgery
No administration of zolpidem tartrate
Mito medical center, Mito Kyodo General Hospital, University of TsukubaNULLPending20years-oldNot applicableMale and Female84Not selectedJapan
96EUCTR2019-004101-27-NL
(EUCTR)
15/01/202012/12/2019Research into injecting golimumab less frequently by using increased dosesINDIGO: Comparing pharmacokinetic parameters of golimumab 50 mg and golimumab 100 mg with a prolonged dose interval in patients with a rheumatic disease, a within-subject controlled study’ - INDIGO rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB
Sint MaartenskliniekNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
97EUCTR2019-004179-38-SE
(EUCTR)
10/01/202019/11/2019Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritisEffects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis - PULMORA Patients with early active rheumatoid arthritis
MedDRA version: 20.0;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: Xeljanz
Trade Name: Metotrexat Orion
Västra GötalandsregionenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
145 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSweden
98JPRN-UMIN000042632
2020/01/0103/12/2020THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTSTHE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS - laser effectiveness in rheumatoid arthritis Rheumatoid arthritislow level laser therapy. Each patient in group 1 takes 20 sessions of LLLT , in the form of 2 courses, each course contains 10 sessions ,as 3 sessions every week ,10 days free between 2 courses.
The laser apparatuses used for therapy in this study were the following,
1.HeNe Laser wavelength 632,8 nm, continuous emission, output power 7.3 mW.
2.GaAIAs diode laser (830 nm, maximum output power 300 mW).
12 patients
placebo laser and naproxen
Naproxen is given as tablet 500mg twice per day.
12 patients
naproxen
Naproxen is given as tablet 500mg twice per day.
10 patients
Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/IraqNULLComplete: follow-up complete20years-old80years-oldMale and Female34Not applicableAsia(except Japan)
99NCT04115397
(ClinicalTrials.gov)
January 20202/10/2019Bisphosphonates for the Treatment of Seropositive Musculoskeletal ComplaintsTowards Efficient Prediction and Prevention of Rheumatoid ArthritisSeropositive Muskuloskeletal ComplaintsDrug: Zoledronic Acid;Drug: PlaceboKarolinska InstitutetNULLNot yet recruiting18 YearsN/AAll80Phase 4NULL
100EUCTR2019-000284-24-LT
(EUCTR)
18/12/201907/11/2019A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis.A RANDOMIZED COMPARATIVE STUDY ASSESSING THE INTERCHANGEABILITY OF PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS. Moderately to severely active 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] - Skin and Connective Tissue Diseases [C17]
Product Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: Adalimumab
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB HUMIRA
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB HUMIRA
Pfizer IncNULLNot RecruitingFemale: yes
Male: yes
420Phase 3United States;Serbia;Ukraine;Lithuania;Russian Federation;Czech Republic;Mexico;Argentina;Poland;Peru;South Africa;Bulgaria;Bosnia and Herzegovina
101EUCTR2018-004287-56-FR
(EUCTR)
21/11/201931/01/2020Methotrexate and Metformin in rheumatoid arthritis patientsRandomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study - METorMET2 rheumatoid arthritis (RA)
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: METFORMINE ARROW 500mg
Product Name: Metformin
Trade Name: Methotrexate
Product Name: Methotrexate
Trade Name: Methotrexate
Product Name: Methotrexate
Trade Name: Acide folique
Product Name: Acide folique
Product Code: B03BB01
Trade Name: Prednisone
Product Name: Prednisone
Product Code: H02AB07
CHU de BordeauxNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
128 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance
102NCT04227366
(ClinicalTrials.gov)
November 19, 201925/12/2019Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisAn International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-089 (JSC BIOCAD, Russia) in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: BCD-089;Biological: Placebo;Drug: MethotrexatBiocadNULLActive, not recruiting18 YearsN/AAll150Phase 3Russian Federation
103NCT04038970
(ClinicalTrials.gov)
November 8, 201929/7/2019Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to MethotrexateA Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KN019 in Patients With Active Rheumatoid Arthritis While Receiving MethotrexateRheumatoid ArthritisBiological: KN019, 5mg/kg;Biological: KN019, 10 mg/kg;Biological: Placebo;Combination Product: MethotrexateJiangsu Alphamab Biopharmaceuticals Co., LtdNULLRecruiting18 YearsN/AAll141Phase 2China
104EUCTR2019-001185-15-SE
(EUCTR)
06/11/201901/07/2019A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effectA double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 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]
Product Code: AP1189
INN or Proposed INN: Not applicable
SynAct Pharma ApSNULLNot RecruitingFemale: yes
Male: yes
135Phase 2Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden
105EUCTR2019-001793-28-NL
(EUCTR)
05/11/201905/11/2019Adalimumab dose reduction aiming low drug levels with control of disease activity (ADDORA-LOW)Adalimumab dose reduction aiming low serum concentration with control of disease activity (ADDORA-LOW) : a single blind, non-inferiority, randomised clinical trial - ADDORA-Low Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Humira, Hulio, Amgevita, Hyrimoz, Idacio, Imraldi
Product Name: Adalimumab
Product Code: D2E7
INN or Proposed INN: ADALIMUMAB
ReadeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
89Phase 4Netherlands
106NCT04485325
(ClinicalTrials.gov)
November 4, 201930/4/2020Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA PatientsCapability of Tofacitinib or Etanercept to Accelerate Clinical Relevant Tapering of Non-steroidal Anti-inflammatory Drugs (NSAID) and Treat-to-target Guided De-escalation of Corticosteroids in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Previous csDMARD Therapy (AcceleRAte)Rheumatic ArthritisDrug: Tofacitinib;Biological: EtanerceptDr. Frank BehrensPfizerRecruiting18 Years65 YearsAll192Phase 4Germany
107NCT04170504
(ClinicalTrials.gov)
November 201914/11/2019Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid ArthritisEfficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis: A Randomized Controlled TrialRheumatoid ArthritisDrug: Qing Re Huo Xue (QRHX);Drug: Methotrexate;Drug: dummy Qing Re Huo Xue (QRHX)Guang'anmen Hospital of China Academy of Chinese Medical SciencesNULLNot yet recruiting18 YearsN/AAll204Phase 2/Phase 3NULL
108EUCTR2019-000868-18-HU
(EUCTR)
24/10/201928/10/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, incombination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 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]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Spain;Lithuania;United Kingdom;Italy;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan
109NCT04049448
(ClinicalTrials.gov)
October 24, 20196/8/2019Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid ArthritisA Follow-up Phase 2a Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 in Patients With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisDrug: ABX464Abivax S.A.NULLActive, not recruiting18 Years76 YearsAll40Phase 2Belgium;Czechia;France;Hungary;Poland
110EUCTR2019-000867-26-HU
(EUCTR)
24/10/201928/10/2019Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugsA 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs. - contRAst-2 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]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Xeljanz
Product Name: Tofacitinib
INN or Proposed INN: Tofacitinib citrate
Other descriptive name: TOFACITINIB CITRATE
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of
111EUCTR2019-000868-18-LT
(EUCTR)
11/10/201919/07/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 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]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Czechia;Spain;Lithuania;Italy;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan
112EUCTR2018-003351-37-HU
(EUCTR)
07/10/201924/07/2019A 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 CompanyNULLAuthorised-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): yesUnited 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
113NCT04077567
(ClinicalTrials.gov)
October 1, 201929/8/2019An Extension Study of TS-152 in Subjects With Rheumatoid ArthritisAn Extension Study of TS-152 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: TS-152Taisho Pharmaceutical Co., Ltd.NULLActive, not recruiting20 YearsN/AAll401Phase 3Japan
114EUCTR2019-000868-18-CZ
(EUCTR)
20/09/201920/08/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, incombination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 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]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Czechia;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan
115EUCTR2018-004677-27-BE
(EUCTR)
16/09/201925/03/2019Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy. Rheumatoid Arthritis
MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
AbivaxNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Belgium
116EUCTR2018-003351-37-ES
(EUCTR)
05/09/201916/09/2019A Phase 3b/4 Study in Rheumatoid ArthritisA 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.ANULLAuthorised-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): yesGermany;Netherlands;South Africa;Denmark;Australia;Romania;Belgium;Poland;Czech Republic;Hungary;France;United Kingdom;Switzerland;Italy;Israel;Russian Federation;Austria;Turkey;Lithuania;Spain;Greece;Slovakia;United States
117JPRN-jRCTs071190001
29/08/201902/04/2019Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activityContinuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity - CROWN study Rheumatoid arthritisPatients retaining LDA with the combination of CZP and MTX are randomized to two groups consisting of patients who continue MTX at the same doses or discontinue MTX. The effects of both groups are compared 1 year after starting study.

Control group
combination therapy with subcutaneous CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) and oral MTX (at the same dose before starting the protocol treatment) given for 52 weeks of the protocol treatment, or until the time of discontinuation.

Intervention group
monotherapy with CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) given for 52 weeks of the protocol treatment, or until the time of discontinuation.

The discontinuation criteria for the study are as follows:
1) When subjects requested to discontinue the treatment
2) When the principal investigator or subinvestigator considered that the therapy should be discontinued due to adverse (drug) events
3) When a subject turned out not to fulfil the inclusion criteria or meets the exclusion criteria after starting the study
4) When RA relapses, defined as SDAI over 11, were observed at two consecutive visits
5) When the principal investigator or subinvestigator considered continuation of the study is inappropriate for reasons other than above
Miyazaki YusukeTanaka YoshiyaRecruiting>= 16age oldNot applicableBoth150Phase 4Japan
118JPRN-JapicCTI-194928
26/8/201922/08/2019-An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101 Rheumatoid ArthritisIntervention name : methotrexate
INN of the intervention : methotrexate
Dosage And administration of the intervention : Part 1: 7.5 mg MJK101 (SC) or dummy MJK101 (SC) will be administered once a week over a period of 12 weeks. Part 2: All subjects will receive once-weekly MJK101 (SC) for 12 months. At Trial Week 12, the once-weekly dose of MJK101 (SC) will be determined according to the disease activity status of the subject and an assessment of safety. If the subject has not met a low disease activity status at the visits every 4 weeks and has been well tolerated, then the once-weekly MJK101 (SC) dose will be increased by 2.5 mg to a maximum dose of 15 mg.
Control intervention name : methotrexate
INN of the control intervention : methotrexate
Dosage And administration of the control intervention : Part 1: 8 mg MTX (oral) or placebo MTX (oral) will be administered once a week over a period of 12 weeks. The oral administration of MTX or placebo MTX will be divided into 2 doses to be administered approximately within a 12-hour interval.
medac GmbHNULLcomplete2075BOTH100Phase 3Japan
119EUCTR2018-004605-57-NL
(EUCTR)
06/08/201924/07/2019Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patientsConcentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients: a randomised, multicenter, non-inferiority trial (TODORA) - Use of TOcilizumab Drug levels to Optimize treatment in RA (TODORA) Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: RoActemra
Product Name: Tocilizumab
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
ReadeNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
98 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
120NCT04068246
(ClinicalTrials.gov)
August 1, 201921/8/2019The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis PatientsThe AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial.Rheumatoid ArthritisDrug: Metformin;Drug: PlaceboSadat City UniversityNULLCompleted18 YearsN/AAll120Phase 1/Phase 2Egypt
121EUCTR2018-004677-27-HU
(EUCTR)
25/07/201925/07/2019Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy. Rheumatoid Arthritis
MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
AbivaxNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Belgium
122EUCTR2018-003933-14-BE
(EUCTR)
19/07/201924/04/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Galapagos NVNULLNot RecruitingFemale: no
Male: yes
250Phase 2Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
123EUCTR2018-003330-32-PL
(EUCTR)
19/07/201906/05/2019Efficacy and Safety of Oral SKI-O-703 in Refractory Rheumatoid ArthritisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies Rheumatoid Arthritis Despite Treatment With Conventional Therapies
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]
Product Name: Cevidoplenib
Product Code: SKI-O-703
INN or Proposed INN: Cevidoplenib
Oscotec Inc.NULLNot RecruitingFemale: yes
Male: yes
148Phase 2United States;Serbia;Czech Republic;Poland;Ukraine;Russian Federation;Korea, Republic of
124EUCTR2016-003682-26-PL
(EUCTR)
11/07/201917/05/2018Phase 3 trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of patients suffering of Early Rheumatoid ArthritisA Phase 3, Randomized, Double-Blind, Active- and Placebo controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis Early 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]
Product Name: CF101
Product Code: CF101
INN or Proposed INN: Piclidenoson
Other descriptive name: IB-MECA
Product Name: CF101
Product Code: CF101
INN or Proposed INN: Piclidenoson
Other descriptive name: IB-MECA
Product Name: METHOTREXATE
Product Code: METHOTREXATE
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Can-Fite BioPharma, Ltd.NULLNot RecruitingFemale: yes
Male: yes
500Phase 3Serbia;Canada;Poland;Romania;Israel;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
125NCT04464642
(ClinicalTrials.gov)
July 10, 20196/7/2020Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid ArthritisTofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid ArthritisRheumatoid ArthritisDrug: Methotrexate;Drug: TofacitinibDr. Mohammad Mamun KhanNULLActive, not recruiting18 YearsN/AAll110Phase 4Bangladesh
126EUCTR2019-000660-25-PL
(EUCTR)
09/07/201920/05/2019Evaluating Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid ArthritisA Phase III, Open-label, Single-arm, Multiple-dose Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis Moderate to Severe Active 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]
Product Name: CT-P17
Product Code: CT-P17
INN or Proposed INN: ADALIMUMAB
CELLTRION, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3Poland
127EUCTR2018-003053-21-PL
(EUCTR)
27/06/201916/04/2019A Clinical Study Testing the Safety, Properties, and Treatment Effects of an Antibody Drug Conjugate ABBV-3373 in Comparison with the Antibody Adalimumab in Subjects with Moderate to Severe Rheumatoid ArthritisRandomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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]
Product Code: ABBV-3373
INN or Proposed INN: ABBV-3373
Trade Name: Humira (adalimumab)
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2United States;Puerto Rico;Poland;Israel
128NCT03656627
(ClinicalTrials.gov)
June 27, 201931/8/2018Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseSafety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseAutoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative ColitisDrug: NivolumabAlliance Foundation Trials, LLC.Bristol-Myers SquibbActive, not recruiting18 YearsN/AAll7Phase 1United States
129EUCTR2018-003933-14-BG
(EUCTR)
21/06/201927/03/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
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 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
250Phase 2Czechia;Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
130NCT03912428
(ClinicalTrials.gov)
June 14, 201910/4/2019Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and MyositisEvaluation of Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and MyositisMyositisDrug: Celecoxib;Diagnostic Test: 11C-MC1;Diagnostic Test: 11C-ER176National Institute of Mental Health (NIMH)NULLRecruiting18 YearsN/AAll86Phase 1/Phase 2United States
131EUCTR2019-001185-15-DK
(EUCTR)
06/06/201912/04/2019A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 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]
Product Code: AP1189
INN or Proposed INN: Not applicable
SynAct Pharma ApSNULLNot RecruitingFemale: yes
Male: yes
135Phase 2Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden
132NCT03970837
(ClinicalTrials.gov)
June 5, 201916/5/2019Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDsArthritis, RheumatoidBiological: GSK3196165 (Otilimab);Drug: Tofacitinib;Drug: Placebo to GSK3196165 (Otilimab);Drug: Placebo to Tofacitinib;Drug: csDMARDsGlaxoSmithKlineIqvia Pty LtdActive, not recruiting18 YearsN/AAll1764Phase 3United States;Argentina;Australia;Brazil;Bulgaria;China;Colombia;Estonia;France;Germany;Hungary;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Spain;Thailand;United Kingdom
133EUCTR2018-004539-54-DE
(EUCTR)
03/06/201910/04/2019Capability 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 therapyCapability 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 ITMPNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 4Germany
134NCT03926195
(ClinicalTrials.gov)
May 28, 201919/4/2019Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial SpondyloarthritisA Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial SpondyloarthritisRheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Non-Radiographical Axial SpondyloarthritisDrug: Filgotinib;Drug: Placebo;Drug: Standard of CareGalapagos NVGilead SciencesActive, not recruiting21 Years65 YearsMale109Phase 2Belgium;Bosnia and Herzegovina;Bulgaria;Czechia;Estonia;Georgia;Latvia;Poland;Spain;Ukraine
135EUCTR2018-003933-14-CZ
(EUCTR)
28/05/201929/04/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
250Phase 2Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany;Latvia;Moldova, Republic of
136EUCTR2018-003933-14-LV
(EUCTR)
27/05/201907/03/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Galapagos NVNULLAuthorised-recruitment may be ongoing or finished Female: no
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noEstonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Latvia;Germany;Moldova, Republic of
137NCT03980483
(ClinicalTrials.gov)
May 16, 201915/5/2019Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study Comparing GSK3196165 With Placebo and With Tofacitinib, in Combination With Methotrexate in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateArthritis, Rheumatoid;Glycogen Storage Disease Type IIBiological: GSK3196165 (Otilimab);Drug: Tofacitinib 5 mg;Drug: Placebo to GSK3196165;Drug: Placebo to tofacitinib;Drug: Methotrexate;Drug: Folic (or folinic) acidGlaxoSmithKlineIqvia Pty LtdActive, not recruiting18 YearsN/AAll1537Phase 3United States;Argentina;Canada;China;Czechia;Hungary;India;Italy;Latvia;Lithuania;Malaysia;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;United Kingdom
138EUCTR2018-004558-30-ES
(EUCTR)
16/05/201911/04/2019Synovial 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 DíazNULLAuthorised-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): yesSpain
139EUCTR2018-002306-31-GB
(EUCTR)
15/05/201914/02/2019A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599) Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: ABBV-105
Other descriptive name: ABBV-105
Product Code: ABBV-105
Other descriptive name: ABBV-105
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Germany;United Kingdom
140EUCTR2019-000505-72-NL
(EUCTR)
13/05/201918/02/2019Baricitinib in patients suffering from Rheumatoid ArthritisPragmatic trial baricitinib versus First biological in Tight Control” Patients suffering from Rheumatoid Arthritis (PERFECT) Pragmatic trial baricitinib versus First biological in Tight Control” Patients suffering from Rheumatoid Arthritis (PERFECT);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Olumiant
Product Name: baricitinib
Transparency in HealthcareNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
141EUCTR2018-002306-31-BE
(EUCTR)
30/04/201907/02/2019A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599) Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: ABBV-105
Other descriptive name: ABBV-105
Product Code: ABBV-105
Other descriptive name: ABBV-105
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Hungary;Czech Republic;Canada;Spain;Poland;Belgium;United Kingdom
142EUCTR2018-003933-14-ES
(EUCTR)
30/04/201921/05/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Galapagos NVNULLAuthorised-recruitment may be ongoing or finished Female: no
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noEstonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
143NCT03915964
(ClinicalTrials.gov)
April 25, 201912/4/2019A Study of Baricitinib (LY3009104) in Participants With Rheumatoid ArthritisA Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Baricitinib;Drug: TNF InhibitorEli Lilly and CompanyIncyte CorporationActive, not recruiting18 YearsN/AAll2600Phase 4United States;Australia;Austria;Belgium;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Lithuania;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Turkey;United Kingdom
144EUCTR2018-003933-14-EE
(EUCTR)
09/04/201914/03/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
250Phase 2Czech Republic;Estonia;Spain;Poland;Ukraine;Bulgaria;Latvia
145EUCTR2018-002306-31-ES
(EUCTR)
04/04/201912/04/2019A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599) Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: ABBV-105
INN or Proposed INN: ABBV-105
Other descriptive name: ABBV-105
Product Code: ABBV-105
INN or Proposed INN: ABBV-105
Other descriptive name: ABBV-105
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom
146NCT03669367
(ClinicalTrials.gov)
April 1, 201926/7/2018EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)Palindromic Rheumatism, WristDrug: Abatacept Injection;Drug: hydroxycloroquinaFundacion Clinic per a la Recerca BiomédicaNULLNot yet recruiting18 YearsN/AAll98Phase 4NULL
147NCT03700021
(ClinicalTrials.gov)
April 20192/10/2018Response to Treatment With Intravenous Abatacept Adults With Rheumatoid ArthritisSingle-Open Label Study to Assess Changes in the Immune Profile in Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic DrugsRheumatoid ArthritisDrug: Abatacept + csDMARDNew York University School of MedicineNULLNot yet recruiting18 YearsN/AAll25Phase 4United States
148EUCTR2018-002202-31-BG
(EUCTR)
27/03/201930/11/2018A Phase 3 study to compare BAT1806 with RoActemra in patients with Rheumatoid ArthritisA Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
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]
Product Code: BAT1806
INN or Proposed INN: BAT1806
Other descriptive name: TOCILIZUMAB
Trade Name: RoActemra
Product Name: RoActerma
INN or Proposed INN: RoActemra
Other descriptive name: TOCILIZUMAB
Bio-Thera Solutions, Ltd.NULLNot RecruitingFemale: yes
Male: yes
621Phase 3Poland;Ukraine;Georgia;Bulgaria;China
149NCT04057118
(ClinicalTrials.gov)
March 20, 201913/8/2019A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional TherapiesRheumatoid ArthritisDrug: SKI-O-703;Drug: PlaceboOscotec Inc.NULLActive, not recruiting18 YearsN/AAll148Phase 2United States;Czechia;Poland;Russian Federation;Ukraine
150EUCTR2018-002306-31-HU
(EUCTR)
08/03/201911/02/2019A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599) Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: ABBV-105
Other descriptive name: ABBV-105
Product Code: ABBV-105
Other descriptive name: ABBV-105
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Czech Republic;Hungary;Canada;Spain;Poland;Belgium;United Kingdom
151NCT05122117
(ClinicalTrials.gov)
March 4, 20193/11/2021Impact of Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment on Clinical and Biochemical Parameters Among Patients Having Mild Rheumatoid Arthritis With PeriodontitisImpact of Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment on Clinical and Biochemical Parameters Among Patients Having Mild Rheumatoid Arthritis With PeriodontitisRheumatoid Arthritis;Chronic PeriodontitisDevice: Methylene blue mediated Photodynamic therapy;Procedure: Non-surgical periodontal therapyZohaib AkramNULLCompleted25 Years60 YearsAll50N/ASaudi Arabia
152NCT03813771
(ClinicalTrials.gov)
March 201912/9/2018Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell StratificationTargeted Treatment Early With Etanercept Plus Methotrexate Versus T2T Care for DMARD-naïve Early RA Patients. A Prospective, Longitudinal Cohort Study With Embedded Pilot Randomised Controlled Trial to Assess Treatment Rationalisation Based on naïve T-cell Stratification.Rheumatoid ArthritisDrug: Benepali;Drug: Sulfasalazine;Drug: Methotrexate;Drug: HydroxychloroquineUniversity of LeedsSamsung Bioepis Co., Ltd.Not yet recruiting18 YearsN/AAll106Phase 4United Kingdom
153EUCTR2018-000666-10-BE
(EUCTR)
19/02/201916/11/2018A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapyA Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: ABBV-105
Other descriptive name: ABBV-105
Product Code: ABBV-105
Other descriptive name: ABBV-105
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Hungary;Czech Republic;Canada;Poland;Spain;Belgium;Germany;United Kingdom
154EUCTR2018-001690-25-LT
(EUCTR)
08/02/201929/08/2018Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid ArthritisA Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis Moderate to Severe Active 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]
Product Code: CT-P17
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Celltrion, IncNULLNot RecruitingFemale: yes
Male: yes
648Phase 3Hungary;Poland;Ukraine;Lithuania;Peru;Bulgaria
155EUCTR2018-000666-10-ES
(EUCTR)
23/01/201922/01/2019A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapyA Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ABBV-105
Product Code: ABBV-105
INN or Proposed INN: ABBV-105
Other descriptive name: ABBV-105, A-1519938.0
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom
156EUCTR2018-003162-13-IT
(EUCTR)
23/01/201908/11/2018A Study to investigate Bone turnover Markers in patients planned to receive tofacitinibA Study to investigate Bone turnover Markers in patients planned to receive tofacitinib - WI232128 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 5 mg film-coated tablets
Product Name: Xeljanz 5mg
INN or Proposed INN: TOFACITINIB
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesItaly
157EUCTR2017-004543-20-ES
(EUCTR)
22/01/201925/10/2018EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA).EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA). - PALABA PALINDROMIC RHEUMATISM;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: ORENCIA
INN or Proposed INN: ABATACEPT
Trade Name: Dolquine
INN or Proposed INN: HYDROXYCHLOROQUINE
Fundació Clínic per a la Recerca BiomèdicaNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
98 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSpain
158EUCTR2018-000666-10-HU
(EUCTR)
03/01/201929/10/2018A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapyA Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: ABBV-105
Other descriptive name: ABBV-105, A-1519938.0
Product Code: ABBV-105
Other descriptive name: ABBV-105, A-1519938.0
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Spain;Germany;United Kingdom
159NCT03574545
(ClinicalTrials.gov)
December 19, 201821/6/2018Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid ArthritisA Randomized, Open Label, Multiple Dose, Parallel Group Study to Assess the Safety and Pharmacokinetic Comparability of Two VAY736 Drug Products in Patients With Rheumatoid ArthritisRheumatoid ArthritisBiological: ianalumabNovartis PharmaceuticalsNULLRecruiting18 Years65 YearsAll50Phase 1Germany;Jordan
160NCT03784261
(ClinicalTrials.gov)
December 17, 201817/12/2018Usefulness of Non TNF Usage in RA PatientsUsefulness of Non TNF Usage in Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: Drug: Salirumab;Drug: Drug: Tocilizmab;Drug: Drug: AbataceptShinshu UniversityNULLRecruiting20 Years100 YearsAll90Phase 2Japan
161EUCTR2018-000666-10-GB
(EUCTR)
17/12/201824/10/2018A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapyA Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: ABBV-105
Other descriptive name: ABBV-105, A-1519938.0
Product Code: ABBV-105
Other descriptive name: ABBV-105, A-1519938.0
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Hungary;Czech Republic;Puerto Rico;Canada;Spain;Poland;Belgium;Germany;United Kingdom
162EUCTR2018-001690-25-PL
(EUCTR)
11/12/201825/09/2018Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid ArthritisA Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis 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: CT-P17
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Celltrion, IncNULLNot RecruitingFemale: yes
Male: yes
564Phase 3Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Korea, Republic of;Bosnia and Herzegovina
163NCT04204603
(ClinicalTrials.gov)
November 30, 201817/12/2019A Study Evaluating the Efficacy and Safety of CKD-506 in Adult Subjects With Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to MethotrexateA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects With Moderate-to- Severe Rheumatoid Arthritis and Inadequate Response to MethotrexateRheumatoid ArthritisDrug: CKD-506;Drug: PlaceboChong Kun Dang PharmaceuticalNULLCompleted18 Years65 YearsAll122Phase 2Czechia;Georgia;Poland;Russian Federation;Ukraine
164NCT03789292
(ClinicalTrials.gov)
November 26, 201827/12/2018A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid ArthritisA Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisBiological: CT-P17 SC;Biological: Humira SCCelltrionNULLActive, not recruiting18 Years75 YearsAll564Phase 3Bulgaria
165NCT03729674
(ClinicalTrials.gov)
November 26, 201811/10/2018Comparative Effectiveness and Safety of Biosimilar and Legacy DrugsComparative Effectiveness and Safety of Biosimilar and Legacy DrugsRheumatoid Arthritis;Ankylosing Spondylitis;Ulcerative Colitis;Crohn's DiseaseDrug: Biosimilar;Drug: Originator (legacy) drugMcGill University Health Centre/Research Institute of the McGill University Health CentreUniversité de Sherbrooke;Institut de rhumatologie de Montréal;Hospital for Special Surgery, New York;University of Manitoba;University of Toronto;University of Alberta;University of British Columbia;Alberta Health Services;McMaster University;The Arthritis Program Research GroupRecruiting18 YearsN/AAll800Canada
166NCT03755466
(ClinicalTrials.gov)
November 21, 201821/11/2018Examination of Efficacy and Safety of Baricitinib in RA PatientsEfficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or TofacitinibRheumatoid ArthritisDrug: Baricitinib, olumiant®;Drug: Biologics;Drug: Tofacitinib 5 MG [Xeljanz]Shinshu UniversityNULLRecruiting20 YearsN/AAll90Phase 2Japan
167NCT03980639
(ClinicalTrials.gov)
November 20, 201818/1/2019Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBaseAbatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBaseRheumatoid ArthritisDrug: patient treated with DMARDUniversity Hospital, ToulouseNULLRecruiting18 YearsN/AAll594226France
168NCT03852888
(ClinicalTrials.gov)
November 14, 20187/2/2019Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant PatientsKinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant PatientsRheumatoid ArthritisBiological: Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate levelCHU de ReimsNULLCompleted18 YearsN/AAll62N/AFrance
169EUCTR2018-001690-25-HU
(EUCTR)
13/11/201814/08/2018Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid ArthritisA Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis 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: CT-P17
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Celltrion, IncNULLNot RecruitingFemale: yes
Male: yes
564Phase 3Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Bosnia and Herzegovina
170NCT03707535
(ClinicalTrials.gov)
November 12, 201812/10/2018To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid ArthritisA Randomized, Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: CT-P13;Biological: RemicadeCelltrionNULLCompleted18 Years75 YearsAll270Phase 3China
171NCT03714022
(ClinicalTrials.gov)
November 9, 201818/10/2018A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different ProcessesA Randomized, Open-Label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of the Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process Relative to the Current Abatacept Drug Process in Healthy ParticipantsRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbNULLCompleted18 Years55 YearsAll140Phase 1United States
172EUCTR2018-001690-25-BG
(EUCTR)
05/11/201819/09/2018Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid ArthritisA Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis 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: CT-P17
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Celltrion, IncNULLNot RecruitingFemale: yes
Male: yes
648Phase 3Hungary;Poland;Ukraine;Lithuania;Peru;Bulgaria;Korea, Republic of
173NCT04267614
(ClinicalTrials.gov)
November 1, 201811/2/2020This Study is to Investigate the Effect of Etanercept in Early Versus Delayed Referral for Management of Rheumatoid Arthritis Patients.Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Rheumatoid Arthritis With EtanerceptArthritis RheumatoidDrug: EtanerceptPfizerNULLCompletedN/AN/AAll1226Iraq
174EUCTR2017-004226-15-DK
(EUCTR)
26/10/201805/01/2018 Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied. CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Cannabidiol tablet 10 mg
Other descriptive name: CANNABIDIOL
Product Name: Dronabinol capsule 2.5. mg
INN or Proposed INN: DRONABINOL
King Christian 10th Hospital for RheumatologyNULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noDenmark
175EUCTR2018-001377-24-CZ
(EUCTR)
09/10/201814/10/2019Not available.A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects with Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate Rheumatoid arthritis (RA)
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]
Product Code: CKD-506
INN or Proposed INN: Not yet assigned
Chong Kun Dang Pharmaceutical Corporation (CKD)NULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Poland;Ukraine;Russian Federation;Georgia
176NCT03511625
(ClinicalTrials.gov)
October 2, 201810/4/2018The Effects of Acthar on Synovial Inflammation in Rheumatoid ArthritisThe Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot StudyRheumatoid ArthritisDrug: Acthar Injectable Product;Drug: Depo medrolAttune Health Research, Inc.MallinckrodtActive, not recruiting18 YearsN/AAll6Phase 3United States
177ChiCTR1800018637
2018-09-262018-09-30Correlation between Human epididymis protein 4 and interstitial lung disease in patients with rheumatoid arthritisCorrelation between Human epididymis protein 4 and interstitial lung disease in patients with rheumatoid arthritis rheumatoid arthritisGold Standard:Clinical outcome, meet the 2010 ACR/EULAR rheumatoid arthritis classification criteria.;Index test:Human epididymis protein 4,anti-cyclic citrullinated peptide, creatinine, rheumatoid factor;Affiliated Hospital of North Sichuan Medical CollegeNULLRecruitingBothTarget condition:150;Difficult condition:100China
178EUCTR2018-001114-15-NL
(EUCTR)
18/09/201828/05/2018Predicting the risk for rheumatoid arthritis with the help of a PET scan. Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis. - Early diagnostics in RA Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: [18F]PEG-FolateVU Medical Center, department of RheumatologyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
179JPRN-JapicCTI-184229
12/9/201803/12/2018Investigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg SyringeInvestigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg Syringe -Medical Information Database Network-based Cohort Study- Rheumatoid ArthritisIntervention name : PRALIA 60mg Subcutaneous Injection Syringe(denosumab)
INN of the intervention : denosumab
Dosage And administration of the intervention : For adults under normal conditions, 60 mg of denosumab (genetic recombination) is injected subcutaneously every six months. If bone erosion progression occurs when denosumab is injected once every 6 months, denosumab can be injected subcutaneously once every 3 months.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
DAIICHISANKYO Co., Ltd.NULLotherBOTH2000NAJapan
180NCT03701789
(ClinicalTrials.gov)
September 11, 20184/10/2018Effect of Baricitinib Treatment on Peripheral Bone in RAEvaluation of Bone Quality in Patients With Rheumatoid Arthritis Treated With Baricitinib: Single Centre, Mode of Action Study (BARE BONE)Rheumatoid Arthritis;Bone Density;Finger JointsDrug: BaricitinibUniversity of Erlangen-Nürnberg Medical SchoolNULLActive, not recruiting18 Years74 YearsAll15Phase 3Germany
181JPRN-JapicCTI-184029
04/9/201809/07/2018A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) TherapyA Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy Rheumatoid Arthritis (RA)Intervention name : TS-152
INN of the intervention : ozoralizumab
Dosage And administration of the intervention : Subcutaneous injection every 4 weeks
Control intervention name : Placebo
INN of the control intervention : Placebo
Dosage And administration of the control intervention : Usage: Subcutaneous injection every 4 weeks, Dosage: No active ingredients contain
Taisho Pharmaceutical co., LTDNULLcomplete2075BOTH370Phase 2-3Japan
182NCT04999683
(ClinicalTrials.gov)
September 1, 20182/8/2021Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid ArthritisEffect of Anti-inflammatory (ITIS) Diet in Rheumatoid ArthritisRheumatoid Arthritis;OsteoarthritisDietary Supplement: ITIS dietUniversity of California, San DiegoNULLActive, not recruiting18 YearsN/AAll26N/AUnited States
183EUCTR2015-004386-91-PL
(EUCTR)
26/08/201820/07/2016Study to explore and compare the effects of a new drug in combination with methotrexate therapy in people with early and established rheumatoid arthritis.A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs 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: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Poland;Germany
184NCT03636984
(ClinicalTrials.gov)
August 24, 201813/8/2018Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real WorldEfficacy and Safety Study of Anbainuo in Chinese Patients With Rheumatoid Arthritis/ Ankylosing Spondylitis in the Real World: a Prospective, Open-label, Multi-center Observational StudyRheumatoid Arthritis;Ankylosing SpondylitisDrug: recombinant TNF-a receptor: IgG Fc fusion proteinZhejiang Hisun Pharmaceutical Co. Ltd.NULLNot yet recruiting18 YearsN/AAll1000NULL
185NCT03535519
(ClinicalTrials.gov)
August 7, 201814/5/2018Rheumatoid Arthritis Response to MethotrexateRheumatoid Arthritis Ultrasound Response to MethotrexateRheumatoid ArthritisDrug: MethotrexateJuan Carlos NietoNordic Pharma SASRecruiting18 YearsN/AAll50Spain
186EUCTR2017-004079-30-IT
(EUCTR)
06/07/201810/09/2021Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification 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 NOVARANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
207Phase 3Portugal;Spain;Belgium;Italy
187EUCTR2016-002344-16-GB
(EUCTR)
28/06/201829/11/2017Targeted treatment early with etanercept and methotrexate or methotrexate with treat to target (standard) care for treatment-naive early rheumatoid arthritis patients, based on baseline naive T-cell frequency.Targeted treatment early with etanercept (biosimilar) plus methotrexate or methotrexate with T2T care for DMARD-naïve early RA patients. A prospective, longitudinal cohort study with an embedded pilot randomised controlled trial to assess treatment rationalisation based on naïve CD4+ T-cell stratification. - TEEMS Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Benepali
Product Name: Benepali
INN or Proposed INN: ETANERCEPT
University of LeedsNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
106 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
188JPRN-UMIN000033059
2018/06/2020/06/2018The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trialThe impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial - The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial Osteoarthritis of the hip, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fractureA periarticular injection including methylprednisolone, ropivacaine, morphine, bosmin, and ketoprofen for pain after total hip arthroplasty
A periarticular injection including ropivacaine, morphine, bosmin, and ketoprofen for pain after total hip arthroplasty
Hokusuikai Kinen HospitalNULLComplete: follow-up complete18years-oldNot applicableMale and Female120Not selectedJapan
189NCT03649061
(ClinicalTrials.gov)
June 8, 201830/7/2018COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RAEffectiveness of a Combination of Methotrexate and a Step Down Glucocorticoid Regimen (COBRA-Slim) for Remission Induction in Patients With Early Rheumatoid Arthritis (RA), With or Without Fast Access to 24 Weeks of Tumor Necrosis Factor (TNF) Blockade in Insufficient Responders, a Randomized, Multicenter, Pragmatic TrialArthritis, RheumatoidDrug: Etanercept 50 MG/ML;Drug: Leflunomide 10 milligram (MG)P. VerschuerenBelgium Health Care Knowledge CentreActive, not recruiting18 YearsN/AAll284Phase 4Belgium
190NCT03535402
(ClinicalTrials.gov)
June 1, 20189/5/2018Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to BiologicsMeasurement of the Structural Efficacy in Active Rheumatoid Arthritis (RA) Patients Treated With Sarilumab in Combination With Methotrexate (MTX) and Naive to Biologics as Measured by Low-field MRI Using a Modified OMERACT-RAMRIS Score.Rheumatoid ArthritisDrug: SarilumabGaylis, Norman B., M.D.NULLActive, not recruiting18 YearsN/AAll20Phase 3United States
191EUCTR2017-001944-36-ES
(EUCTR)
21/05/201810/10/2017Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid ArthritisA Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: AMG592
INN or Proposed INN: AMG 592
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
137Phase 1;Phase 2United States;Czech Republic;Mexico;Poland;Spain;Romania;Australia;Bulgaria;Germany;United Kingdom;New Zealand
192NCT03492658
(ClinicalTrials.gov)
May 17, 20183/4/2018Abatacept to Silence Anti-citrullinated Protein Antibody-expressing B Cells in Rheumatoid Arthritis (ASCARA)Abatacept to Silence Anti-citrullinated Protein Antibody-expressing B Cells in Rheumatoid Arthritis (ASCARA).Rheumatoid Arthritis;Rheumatic DiseasesDrug: Abatacept;Drug: MethotrexateLeiden University Medical CenterNULLActive, not recruiting18 YearsN/AAll46Phase 4Netherlands
193NCT03508713
(ClinicalTrials.gov)
May 13, 20184/6/2017Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND)Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND): a Multicenter Prospective Observational Study in Southern ChinaRheumatoid ArthritisDrug: disease modified antirheumatic drugs or biological agentsNanfang Hospital of Southern Medical UniversitySouthern Medical University, ChinaNot yet recruiting18 YearsN/AAll200NULL
194EUCTR2017-004054-41-BE
(EUCTR)
07/05/201815/03/2018COBRA-Slim with or without fast access to TNF blockade for remission induction in early RACareRA2020: Effectiveness of a combination of Methotrexate and a step down glucocorticoid regimen (COBRA-Slim) for remission induction in patients with early Rheumatoid Arthritis (RA), with or without fast access to 24 weeks of Tumor Necrosis Factor (TNF) blockade in insufficient responders, a randomized, multicenter, pragmatic trial. - CareRA2020 early active Rheumatoid Arthritis, previously untreated with DMARDs
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 Name: etanercept
INN or Proposed INN: ETANERCEPT
INN or Proposed INN: LEFLUNOMIDE
University Hospitals LeuvenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
440 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesBelgium
195NCT03505008
(ClinicalTrials.gov)
April 18, 201816/4/2018Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and TaiwanMIRACLE (Methotrexate Inadequate Response Patient With Rheumatoid Arthritis Treated by Adalimumab in Combination With Low-dose Methotrexate) StudyRheumatoid ArthritisDrug: Methotrexate;Drug: AdalimumabKeio UniversityEisai Co., Ltd.Active, not recruiting18 YearsN/AAll300Phase 4Japan;Korea, Republic of;Taiwan
196JPRN-jRCT1031180088
18/04/201818/01/2019MIRACLE StudyMIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study Rheumatoid Arthritis
Rheumatoid Arthritis
Subjects meeting all of the inclusion criteria and not applicable to any of the exclusion criteria will start receiving MTX 6 to 8 mg/week after the assessment at Week 0. Also, 10 mg of folic acid will be orally administered once a week 48 hours after the first MTX dosing day of the week to prevent ADRs related to MTX (A daily dosage of 1 mg folic acid is acceptable in South Korea on a condition that the dosage cannot be changed during the study period).
To achieve remission, the dosage of MTX will be promptly escalated to the maximum tolerable dose (MTD) <=25 mg/week (the maximum dose should be set according to the package insert of each country) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an ADR. Weekly dose of MTX will be administered orally at once or twice a day in principle.
If the dosage of MTX is maintained >=10 mg/week and SDAI remission is achieved at Week 24, the MTX therapy will be continued until Week 48 (ARM-1).
If SDAI remission is not achieved despite the maintenance of >=10 mg/week MTX dose at Week 24, ADA 40 mg will be administered subcutaneously every other week until Week 48. Subjects then will be stratified by countries (Japan, South Korea, and Taiwan) as a stratification factor, and for each stratum, subjects will be randomized at a 1:1 ratio to either a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2), and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3).
The MTX dosage shall be either 6 mg/week or 7.5 mg/week in subjects in ARM-3 whose maintenance dose of MTX at Week 24 is 10 mg/week.
Subjects in whom MTX at a dosage >=
Kaneko YukoEisai Co., Ltd.Complete>= 18age oldNot applicableBoth300Phase 4South Korea;Taiwan;Japan
197JPRN-UMIN000030584
2018/04/1827/12/2017MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) StudyMIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study Rheumatoid ArthritisStudy treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR).
If the dosage of MTX is maintained >= 10 mg/week and remission (SDAI <= 3.3) is achieved at Week 24, the MTX therapy will be continued up to Week 48 (ARM-1).
Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR).
If SDAI remission is not achieved despite the dosage of MTX is maintained >= 10 mg/week at Week 24, a bDMARDs will be added to the treatment in line with EULAR Recommendations 2016. Subjects will subcutaneously receive ADA 40 mg as a bDMARDs every other week up to Week 48, and be randomized to a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2) and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3). Then, the efficacy and safety will be evaluated.
Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage
Keio University School of MedicineDivision of Rheumatology, Department of Internal MedicineEisai Co., Ltd.Complete: follow-up continuing18years-oldNot applicableMale and Female300Not selectedJapan,Asia(except Japan)
198JPRN-jRCTs071180018
13/04/201815/02/2019Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. An open label randomized controlled trial by HR-pQCT. Rheumatoid arthritisPatients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6.
Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule.
Kawakami AtsushiNakagaki Hisashi;Daiichi Sankyo co.,LTD.Not Recruiting>= 20age oldNot applicableBoth44Phase 4Japan
199JPRN-UMIN000030575
2018/03/3126/12/2017Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT.Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. - Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. Rheumatoid arthritisPatients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6.
Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule.
Daiichi Sankyo Company, LimitedNULLComplete: follow-up continuing20years-oldNot applicableMale and Female44Not applicableJapan
200EUCTR2017-001944-36-BG
(EUCTR)
13/03/201824/10/2017Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid ArthritisA Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: AMG592
INN or Proposed INN: N/A
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
153Phase 1;Phase 2United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;United Kingdom;New Zealand
201ChiCTR1800014872
2018-03-012018-02-12Role of parecoxib sodium in the multimodal analgesia after total knee arthroplastySafety and efficacy of parecoxib sodium in the multimodal analgesia after total knee arthroplasty: a prospective randomized controlled trial osteoarthritis or rheumatoid arthritisExperimental group:Preoperative intravenous injection of parecoxib sodium and postoperative intravenous patient-controlled analgesia;Control group:Preoperative normal saline injection and postoperative intravenous patient-controlled analgesia;Peking Union Medical College HospitalNULLPendingBothExperimental group:50;Control group:50;China
202JPRN-UMIN000031692
2018/03/0112/03/2018Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplastyEfficacy 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 arthritisStudy 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 UniversityNULLRecruiting20years-oldNot applicableMale and Female60Not selectedJapan
203EUCTR2017-004079-30-BE
(EUCTR)
19/02/201819/02/2018Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification 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)NULLNot RecruitingFemale: yes
Male: yes
219Phase 3Portugal;Spain;Belgium;Italy
204EUCTR2017-004348-39-FR
(EUCTR)
15/02/201816/01/2018Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patientsAssociation between methotrexate erythrocyte polyglutamate concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate - POLYGLU rheumatoid arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: methotrexate
Product Code: 1
CHU Saint-EtienneNULLNot RecruitingFemale: yes
Male: yes
60Phase 4France
205JPRN-UMIN000030760
2018/02/0909/02/2018A pilot study of a simple navigation system for artificial hip joint surgery using augmented reality technology Hip joint disease scheduled for total hip arthroplasty(THA) (Osteoarthritis, Rheumatoid Arthritis, Femoral head necrosis, Femoral neck fracture)Using patient specific guide linked with 3D surgical support software for THANational Hospital Organization Nagoya Medical CenterNULLComplete: follow-up continuing20years-oldNot applicableMale and Female3Not selectedJapan
206EUCTR2016-003630-25-NL
(EUCTR)
08/02/201806/09/2017A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid ArthritisA Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib 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] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
2640 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan
207EUCTR2017-002753-11-FI
(EUCTR)
25/01/201808/11/2017The effect of the new anti-rheumatic drug tofacitinib on cytokine-induced inflammatory pathways in patients with rheumatoid arthritisThe effect of tofacitinib on the activity of JAK-STAT pathways in patients with rheumatoid arthritis (RA) - TofaSTAT17 Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Xeljanz
Product Name: Xeljanz
Product Code: PRD4862257
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Tofacitinib
Product Code: PRD4862257
Tampere University HospitalNULLNot RecruitingFemale: yes
Male: yes
24Phase 4Finland
208JPRN-UMIN000030828
2018/01/1515/01/2018The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis. Rheumatoid ArthritisOsteoporosiszoledronic acid
denosumab
Osaka City University Graduate School of MedicineNULLRecruiting20years-oldNot applicableMale and Female500Not selectedJapan
209EUCTR2017-003259-40-ES
(EUCTR)
04/01/201824/10/2017Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial.Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial. Patients with rheumatoid arthritis with high clinical activity and chronical peirodontitis moderate-severe.
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 Name: amoxicilina
INN or Proposed INN: AMOXICILLIN
Product Name: metronidazol
INN or Proposed INN: METRONIDAZOLE
Other descriptive name: metronidazol
Dra Beatriz Lozano-Hospital Universitario de CanariasNULLNot RecruitingFemale: yes
Male: yes
120Phase 4Spain
210JPRN-UMIN000030237
2018/01/0103/12/2017Additional postoperative intravenous tranexamic acid administration versus placebo administration for patients treated with intraoperative combined intravenous and intra-articular tranexamic acid in total knee arthroplasty: a randomized, double-blind, placebo-controlled trialAdditional postoperative intravenous tranexamic acid administration versus placebo administration for patients treated with intraoperative combined intravenous and intra-articular tranexamic acid in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial - Additional postoperative intravenous tranexamic acid administration versus placebo in total knee arthroplasty Osteoarthritis of the knee, rheumatoid arthritis, avascular necrosisAdditional postoperative intravenous tranexamic acid group: Patients received 1000 mg of tranexamic acid administered intravenously just before skin incision and 1000 mg of tranexamic acid administered intra-articularly after closure of the capsule and retinaculum. In addition, patients received 1000mg/100mL of tranexamic acid administered intravenously 6 hours after the first intravenous administration of tranexamic acid, and 08:00 and 20:00 one day after surgery.
Placebo group: Patients received 1000 mg of tranexamic acid administered intravenously just before skin incision and 1000 mg of tranexamic acid administered intra-articularly after closure of the capsule and retinaculum. Patients received 100 mL of normal saline administered intravenously 6 hours after the first intravenous administration of tranexamic acid, and 08:00 and 20:00 one day after surgery.
Hokusuikai Kinen HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female100Not selectedJapan
211JPRN-jRCTs031180050
26/12/201707/12/2018Hydroxychloroquine for Japanese patients with rheumatoid arthritisEfficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritis Rheumatoid arthritis;D001172Treatment with hydroxychloroquine for 24 weeksKaneko YukoNULLNot Recruiting>= 18age oldNot applicableBoth120Phase 2-3Japan
212EUCTR2017-001970-41-DK
(EUCTR)
21/12/201715/09/2017 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 KristensenNULLAuthorised-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): yesDenmark
213EUCTR2014-000555-93-ES
(EUCTR)
18/12/201710/10/2017Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive ArthralgiaAbatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia Diagnosis of Initial phase of Rheumatoid Arthritis with arthralgia for at least 6 weeks without signs of joints swelling but with presence of ACPA antibodies and signs of joints swelling detected in MRI.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: ORENCIA
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
Universitätsklinikum ErlangenNULLNot RecruitingFemale: yes
Male: yes
98Phase 3Czech Republic;Brazil;Spain;Germany
214EUCTR2017-001717-92-AT
(EUCTR)
11/12/201717/08/2017A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in patients with rheumatoid arthritis who have a high interferon signature (TarIFNiRA)A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in RA patients with a high IFN signature (TarIFNiRA) - TarIFNiRA High IFN siganture in patients with 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: Anifrolumab (MEDI-546)
INN or Proposed INN: ANIFROLUMAB
Other descriptive name: ANIFROLUMAB
Medical University of ViennaNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Italy;Switzerland;Austria
215NCT03254966
(ClinicalTrials.gov)
November 24, 201715/8/2017Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) PatientsRandomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Safety and Efficacy of SHR0302 in Patients With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisDrug: SHR0302;Drug: PlaceboJiangsu HengRui Medicine Co., Ltd.NULLCompleted18 Years70 YearsAll194Phase 2China
216NCT03334851
(ClinicalTrials.gov)
November 17, 20173/11/2017Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid ArthritisA PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITISSystemic Lupus Erythematosus;Rheumatoid ArthritisDrug: PF-06835375;Drug: PlaceboPfizerNULLCompleted18 Years70 YearsAll75Phase 1United States;Puerto Rico
217NCT03911830
(ClinicalTrials.gov)
November 11, 20171/10/2018Aerobic Exercise Program Followed by Cold Water Immersion: Effects on Arthritis Patients Arterial StiffnessEffects of an Aerobic Exercise Program on Cycloergometer Followed by Cold Water Immersion Recovery in Patients With Rheumatoid ArthritisRheumatoid Arthritis;Cryotherapy Effect;Physical ActivityOther: Exercise followed cold water immersionCentre Hospitalier Universitaire de BesanconNULLCompleted20 Years80 YearsAll18N/AFrance
218EUCTR2017-000838-64-NL
(EUCTR)
10/11/201713/06/2017An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisoloneA Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA) 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] - Skin and Connective Tissue Diseases [C17]
Product Code: AZD9567 monohydrate
INN or Proposed INN: AZD9567
Trade Name: PredniHEXAL
INN or Proposed INN: Prednisolone
Other descriptive name: Prednisolone
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Denmark;Netherlands;Sweden
219EUCTR2017-003425-15-DK
(EUCTR)
10/11/201712/09/2017Patients with rheumatoid arthritis and synovitis treated with ultrasound guided intraarticular or intramuscular glucocorticoid injection - A randomised, double-blind, controlled study (Panguian)Patients with rheumatoid arthritis and synovitis treated with ultrasound guided intraarticular or intramuscular glucocorticoid injection - A randomised, double-blind, controlled study (Panguian) Treatment of synovitis among rheumatoid arthritis patients
MedDRA version: 21.0;Level: PT;Classification code 10042868;Term: Synovitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Diprofos Depot
INN or Proposed INN: BETAMETHASONE ACIBUTATE
Other descriptive name: Binyrebsrkhormon
Videncenter for Reumatologi og Rygsygdomme, RigshospitaletNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesDenmark
220NCT04178070
(ClinicalTrials.gov)
November 6, 201724/11/2019Phase ? Clinical Trial of Gerilimzumab Injection in Healthy SubjectsA Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-escalated Phase ? Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Gerilimzumab in Healthy Adult Subjects.Rheumatoid ArthritisBiological: GB224 2mg;Biological: GB224 5mg;Biological: GB224 10mg;Biological: GB224 15mg;Biological: GB224 20mg;Biological: GB224 30mg;Other: Placebo, 2mg;Other: Placebo, 5mg;Other: Placebo, 10mg;Other: Placebo, 15mg;Other: Placebo, 20mg;Other: Placebo, 30mgGenor Biopharma Co., Ltd.NULLRecruiting18 Years45 YearsAll58Phase 1China
221NCT03357471
(ClinicalTrials.gov)
November 3, 201723/11/2017Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Safe and Effective Use of an Electro-Mechanical Injection Device (E-Device) for the Subcutaneous Self-Injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's DiseaseModerate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's DiseaseDrug: e-DeviceUCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll70Phase 3United States
222EUCTR2017-000384-32-BG
(EUCTR)
02/11/201712/07/2017Phase IIb in Rheumatoid ArthritisA Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A 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: Evobrutinib
Product Code: M2951
INN or Proposed INN: Evobrutinib
Other descriptive name: M2951
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
363Phase 2United States;Serbia;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;Bulgaria;South Africa;Germany;Japan
223NCT03387423
(ClinicalTrials.gov)
November 2, 20177/12/2017Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid ArthritisESCALATE-RA A NON-INTERVENTIONAL STUDY OF CRITICAL FACTORS FOR ESCALATING DRUG TREATMENT IN PATIENTS TREATED WITH TOFACITINIB FOR MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITISArthritis, RheumatoidDrug: TofacitinibPfizerNULLRecruiting18 YearsN/AAll1500Germany
224JPRN-UMIN000029797
2017/11/0202/11/2017Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trialIntravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial - Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial Osteoarthritis of the hip, Avascular necrosis of the femoral head, Rheumatoid arthritisThe combined tranexamic acid group received 1000 mg of tranexamic acid administered intravenously just before skin incision of the first hip. After closure of fascia, 1000 mg of tranexamic acid (10 mL of 100 mg/mL tranexamic acid) was administered intra-articularly for each hip. Five hours after the first intravenous administration of tranexamic acid, 1000 mg of tranexamic acid was again given intravenously.
The intravenous tranexamic acid group received 1000 mg of tranexamic acid administered intravenously just before skin incision of the first hip. After closure of the fascia, 10 mL of normal saline was administered intra-articularly for each hip. Five hours after the first intravenous administration of tranexamic acid, 1000 mg of tranexamic acid was again given intravenously.
Hokusuikai Kinen HospitalNULLComplete: follow-up complete18years-oldNot applicableMale and Female40Not selectedJapan
225NCT03329885
(ClinicalTrials.gov)
November 2, 201731/10/2017A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious PsoriasisA Double-Blind Randomized Placebo-Controlled Single and Multiple Ascending Doses Study of the Safety and Tolerability, Pharmacokinetics (Including Bioavailability Comparison and Food Effect) and Pharmacodynamics of Oral BMS-986251 Administration in Healthy Subjects, With Efficacy Assessment of Multiple Doses in Patients With Moderate-to-Severe PsoriasisRheumatoid Arthritis;Psoriasis;Ankylosing Spondylitis;Inflammatory Bowel Diseases;Nonalcoholic SteatohepatitisDrug: BMS-986251;Other: PlaceboBristol-Myers SquibbNULLTerminated18 Years70 YearsAll38Phase 1/Phase 2Netherlands
226JPRN-UMIN000029759
2017/11/0101/11/2017Percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty as a component of multimodal pain management: a randomized control trial Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritisPercutaneous periarticular analgesic injection including methylprednisolone 80 mg [2 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.2 mg [0.2 mL] at one day after simultaneous bilateral total knee arthroplasty
No percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty
Nekoyama Miyao HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female32Not selectedJapan
227NCT03440892
(ClinicalTrials.gov)
November 1, 201714/2/2018Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis PatientsLongitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of SurvivinRheumatoid ArthritisDrug: methotrexate;Drug: sulfasalazine;Drug: abatacept;Drug: tocilizumab;Drug: tofacitinib/baricitinibVastra Gotaland RegionNULLRecruiting20 YearsN/AAll2500Sweden
228JPRN-JapicCTI-173747
01/11/201725/10/2017Specific Use Result Survey of PRALIA 60 mg Subcutaneous Injection Syringe - A Long-term Use Survey in Patients with Rheumatoid Arthritis -Specific Use Result Survey of PRALIA 60 mg Subcutaneous Injection Syringe - A Long-term Use Survey in Patients with Rheumatoid Arthritis - Rheumatoid ArthritisIntervention name : PRALIA 60 mg Subcutaneous Injection Syringe(denosumab)
INN of the intervention : denosumab
Dosage And administration of the intervention : For adults under normal conditions, 60 mg of denosumab (genetic recombination) is injected subcutaneously every six months. If bone erosion progression occurs when denosumab is injected once every 6 months, denosumab can be injected subcutaneously once every 3 months.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
DAIICHISANKYO Co., Ltd.NULLcompleteBOTH1000NAJapan
229NCT02647762
(ClinicalTrials.gov)
October 30, 201716/12/2015CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid ArthritisA Phase 3, Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid ArthritisRheumatoid ArthritisDrug: CF101 1 mg;Drug: CF101 2 mg;Drug: Placebo;Drug: MTXCan-Fite BioPharmaNULLActive, not recruiting18 Years75 YearsAll525Phase 3Bosnia and Herzegovina;Canada;Israel;Moldova, Republic of;Poland;Romania;Serbia
230NCT03324412
(ClinicalTrials.gov)
October 28, 201725/10/2017Efficacy and Safety of TwHF and MTX in Patients With Rheumatoid ArthritisA 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of TwHF and MTX Treating Rheumatoid ArthritisRheumatoid ArthritisDrug: Treatment of MTX;Drug: Treatment of MTX and TwHFGuang'anmen Hospital of China Academy of Chinese Medical SciencesNULLNot yet recruiting45 Years70 YearsAll216Phase 2/Phase 3NULL
231NCT03288584
(ClinicalTrials.gov)
October 27, 201716/9/2017Effects of Interleukin-6 Inhibition on Vascular, Endothelial and Left Ventricular Function in Rheumatoid ArthritisThe Effect of Inhibition of Interleukin-6 Activity on Vascular, Endothelial and Left Ventricular Function in Patients With Rheumatoid ArthritisRheumatoid Arthritis;InflammationDrug: Tocilizumab (Actemra®);Drug: Other biological agent;Drug: Corticosteroid and non-biological agents.University of AthensNULLRecruiting18 Years80 YearsAll60Greece
232EUCTR2017-000149-30-GB
(EUCTR)
25/10/201705/09/2017A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung DiseaseA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease - TRAIL1 Rheumatoid arthritis associated interstitial lung disease (RA-ILD);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Esbriet
Product Name: Esbriet
INN or Proposed INN: Pirfenidone
University Hospitals of Leicester NHS TrustNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
270 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Australia;United Kingdom
233EUCTR2016-004834-11-GB
(EUCTR)
23/10/201716/08/2017A randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritisA randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritis - CR6086-2-02 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 Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: CR6086
Other descriptive name: CR0686
Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: CR6086
Other descriptive name: CR6086
Trade Name: Methotrexate ® 2.5mg Tablets
Product Name: Methotrexate ® 2.5mg Tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE 2.5 mg tablets
Rottapharm Biotech S.r.l.NULLNot RecruitingFemale: yes
Male: yes
240Phase 2Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
234JPRN-UMIN000029003
2017/10/0105/09/2017Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritisPercutaneous periarticular analgesic injection including methylprednisolone 40 mg [1 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.1 mg [0.1 mL] at one day after total knee arthroplasty
No percutaneous periarticular analgesic injection at one day after total knee arthroplasty
Nekoyama Miyao HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female40Not selectedJapan
235NCT03312465
(ClinicalTrials.gov)
September 28, 201712/10/2017Anatomical Shoulder Domelock System StudyAnatomical Shoulder™ Domelock System A Multicenter, Prospective, Non-Controlled Post-Market Clinical Follow-up StudyAdvanced Wear and Tear of the Shoulder Joint;Avascular Necrosis;Conditions Consequent to Earlier Operations;Omarthrosis;Rheumatoid Arthritis;Revision of Shoulder ProsthesisDevice: AS Domelock SystemZimmer BiometNULLRecruiting18 Years80 YearsAll123Belgium;Germany;Switzerland;United Kingdom
236EUCTR2016-005017-45-PL
(EUCTR)
27/09/201719/06/2017A study to explore the effect of a new antibody to treat patients with Rheumatoid ArthritisA Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: NI-0101
Product Code: NI-0101
INN or Proposed INN: N/A
Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody
NovImmune S.A.NULLNot RecruitingFemale: yes
Male: yes
81Phase 2Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina
237EUCTR2017-000384-32-CZ
(EUCTR)
26/09/201726/07/2017Phase IIb in Rheumatoid ArthritisA Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A 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: Evobrutinib
Product Code: M2951
INN or Proposed INN: Evobrutinib
Other descriptive name: M2951
Merck KGaANULLNot Recruiting Female: yes
Male: yes
363 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;South Africa;Bulgaria;Germany;Japan
238EUCTR2012-003655-11-FR
(EUCTR)
18/09/201728/09/2015Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of lifeA multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis moderately to severely 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 Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Galapagos NVNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Guatemala;Ukraine;Austria;Russian Federation;Israel;Chile;Colombia;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany
239NCT03262740
(ClinicalTrials.gov)
September 11, 201724/8/2017The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female PatientsThe Effect of BMS-986195 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female SubjectsRheumatoid ArthritisDrug: BMS-986195;Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol)Bristol-Myers SquibbNULLCompleted18 Years40 YearsFemale58Phase 1United States
240EUCTR2017-000838-64-SE
(EUCTR)
11/09/201719/05/2017An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisoloneA Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA) 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] - Skin and Connective Tissue Diseases [C17]
Product Name: AZD9567
Product Code: AZD9567 monohydrate
INN or Proposed INN: N/A
Trade Name: PredniHEXAL
INN or Proposed INN: Prednisolone
Other descriptive name: -
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Denmark;Netherlands;Sweden
241EUCTR2016-004834-11-PL
(EUCTR)
05/09/201717/07/2017A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritisA randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early 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] - Musculoskeletal Diseases [C05]
Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: see D.3.9.3 'Other descriptive name' below
Other descriptive name: CR6086
Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: see D.3.9.3 'Other descriptive name' below
Other descriptive name: CR6086
Trade Name: Methotrexate® 2.5 mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE 2.5 mg tablets
Rottapharm Biotech S.r.l.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of
242EUCTR2016-004834-11-BG
(EUCTR)
04/09/201701/06/2017A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritisA randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early 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] - Musculoskeletal Diseases [C05]
Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: see D.3.9.3 'Other descriptive name' below
Other descriptive name: CR6086
Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: see D.3.9.3 'Other descriptive name' below
Other descriptive name: CR6086
Trade Name: Methotrexate® 2.5 mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE 2.5 mg tablets
Rottapharm Biotech S.r.l.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of
243EUCTR2016-004834-11-CZ
(EUCTR)
16/08/201702/08/2017A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritisA randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early 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] - Musculoskeletal Diseases [C05]
Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: see D.3.9.3 'Other descriptive name' below
Other descriptive name: CR6086
Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: see D.3.9.3 'Other descriptive name' below
Other descriptive name: CR6086
Trade Name: Methotrexate® 2.5 mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE 2.5 mg tablets
Rottapharm Biotech S.r.l.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
244NCT03327454
(ClinicalTrials.gov)
August 10, 201711/10/2017Benepali® PEN Patient Satisfaction SurveyNon-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled PenRheumatoid Arthritis;SpondyloarthropathiesBiological: BenepaliBiogenNULLCompleted18 YearsN/AAll500Germany
245EUCTR2013-005543-90-EE
(EUCTR)
07/08/201702/06/2017This trial is designed to determine the effects the investigational medicine, ABP 798 on the human body , and what effects investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable 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 Name: ABP 798
Product Code: ABP 798
INN or Proposed INN: rituximab
Other descriptive name: ABP 798 Biosimilar to Rituximab
Trade Name: Rituxan
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituxan
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 1;Phase 3United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
246EUCTR2015-005309-35-LV
(EUCTR)
04/08/201719/05/2017Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid ArthritisA Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 Moderately to Severely 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 Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
R-PharmNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of
247NCT03155347
(ClinicalTrials.gov)
August 2, 201715/5/2017An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) TherapyA Randomized, Multi-Center, Double Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab (TCZ) in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current DMARD TherapyRheumatoid ArthritisDrug: Tocilizumab;Drug: MTX;Drug: Placebo Matched to MTX;Drug: Placebo Matched to TocilizumabHoffmann-La RocheNULLActive, not recruiting18 Years70 YearsAll340Phase 3China
248NCT03215407
(ClinicalTrials.gov)
August 1, 201722/6/2017The Comparative Study of Intra-articular Injection of Tocilizumab and Compound BetamethasoneThe Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the KneeRheumatoid Arthritis of KneeDrug: Intra-articular Tocilizumab;Drug: Intra-articular Compound BetamethasoneChinese PLA General HospitalNULLNot yet recruiting18 Years65 YearsAll60Phase 4NULL
249EUCTR2016-002126-36-ES
(EUCTR)
31/07/201702/06/2017A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a InhibitorsA randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors 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: RO7123520
Product Code: RO7123520/F03-01
INN or Proposed INN: Not available
Other descriptive name: RO7123520
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
204Phase 2United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy
250JPRN-UMIN000028376
2017/07/2601/08/2017Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritisStudy of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis - Study of ultrasound detected residual synovitis in rheumatoid arthritis rheumatoid arthritisCombination of anti-rheumatic therapy and denosumab
Anti-rheumatic therapy alone
Hokkaido Medical Center for Rheumatic DiseasesNULLComplete: follow-up complete20years-old75years-oldMale and Female30Not selectedJapan
251EUCTR2016-000568-41-NL
(EUCTR)
18/07/201729/06/2017Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1650Phase 3Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
252EUCTR2016-001064-11-GB
(EUCTR)
18/07/201731/03/2017Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritisA Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients 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] - Musculoskeletal Diseases [C05]
Product Name: NI-071
Product Code: NI-071
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remicade
Nichi-Iko Pharmaceutical Co., Ltd.NULLNot Recruiting Female: yes
Male: yes
585 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom
253EUCTR2016-000569-21-NL
(EUCTR)
18/07/201729/06/2017Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
423Phase 3United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
254EUCTR2016-004834-11-DK
(EUCTR)
06/07/201711/05/2017A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritisA randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early 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] - Musculoskeletal Diseases [C05]
Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: see D.3.9.3 'Other descriptive name' below
Other descriptive name: CR6086
Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: see D.3.9.3 'Other descriptive name' below
Other descriptive name: CR6086
Trade Name: Methotrexate® 2.5 mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE 2.5 mg tablets
Rottapharm Biotech S.r.l.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
255EUCTR2016-002125-11-ES
(EUCTR)
06/07/201708/05/2017Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid ArthritisA Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis 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: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLNot RecruitingFemale: yes
Male: yes
258Phase 1;Phase 3Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of;Estonia;Slovakia;Spain;Ukraine
256ChiCTR-IPR-17011566
2017-07-012017-06-05The efficacy and safety of sirolimus in refractory rheumatoid arthritis: A multi-center randomized controlled trial in ChinaThe efficacy and safety of sirolimus in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China Rheumatoid Arthritis;M05.901Sirolimus group: Sirolimus; Non-Sirolimus group:Glucocorticoids and Immunosuppressant;the Second Hospital of Shanxi Medical UniversityNULLRecruiting1865BothSirolimus group:200; Non-Sirolimus group:100;China
257EUCTR2016-001825-15-IT
(EUCTR)
28/06/201716/02/2018A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION - A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREAT 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: Tofacitinb
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
PFIZER INCNULLNot RecruitingFemale: yes
Male: yes
580Phase 3Hungary;Czech Republic;Slovakia;Spain;Poland;Bulgaria;Germany;Italy
258EUCTR2016-001825-15-DE
(EUCTR)
26/06/201701/03/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION 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: tofacitinib
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot Recruiting Female: yes
Male: yes
580 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesUnited States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
259EUCTR2015-005309-35-BG
(EUCTR)
22/06/201702/05/2017Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid ArthritisA Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 Moderately to Severely Active 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]
Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
R-Pharm International, LLC.NULLNot RecruitingFemale: yes
Male: yes
1880Phase 3Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of;Belarus;United States;Czechia;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico
260EUCTR2015-002887-17-FR
(EUCTR)
19/06/201716/02/2016Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid ArthritisPhase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors
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: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Bristol-Myers Squibb International CorporationNULLNot Recruiting Female: yes
Male: yes
610 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of
261EUCTR2015-005309-35-GB
(EUCTR)
16/06/201709/06/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid ArthritisA Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 Moderately to Severely 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 Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
R-PharmNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1880 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Belarus;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of
262EUCTR2016-000933-37-SK
(EUCTR)
15/06/201724/04/2017Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
313 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
263EUCTR2016-005017-45-GB
(EUCTR)
15/06/201727/10/2017A study to explore the effect of a new antibody to treat patients with Rheumatoid ArthritisA Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: NI-0101
Product Code: NI-0101
INN or Proposed INN: N/A
Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody
NovImmune S.A.NULLNot Recruiting Female: yes
Male: yes
81 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina
264JPRN-UMIN000027719
2017/06/1212/06/2017Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy. rheumatoid arthritis/remissionadd-on iguratimod
tapering MTX
continuing the treatment
Osaka Medical CollegeNULLRecruiting20years-old100years-oldMale and Female100Not selectedJapan
265EUCTR2016-000569-21-FR
(EUCTR)
08/06/201704/11/2016Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
423 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
266EUCTR2016-002337-30-HR
(EUCTR)
05/06/201712/09/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE 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: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
230 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
267EUCTR2016-002337-30-DE
(EUCTR)
24/05/201706/02/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE 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: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
269 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
268EUCTR2015-005309-35-DE
(EUCTR)
23/05/201724/01/2017Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid ArthritisA Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 Moderately to Severely Active 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]
Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
R-Pharm International LLCNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of;Belarus;United States;Czechia;Taiwan;Estonia;Lithuania;Russian Federation;Colombia
269EUCTR2015-005309-35-PL
(EUCTR)
19/05/201717/03/2017Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid ArthritisA Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 Moderately to Severely Active 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]
Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
R-Pharm International LLCNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3Belarus;United States;Czechia;Estonia;Taiwan;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Georgia;Bulgaria;Latvia;Germany;Korea, Republic of
270JPRN-UMIN000027250
2017/05/1508/05/2017Precision medicine of methotrexate in the patients with rheumatoid arthritisPrecision medicine of methotrexate in the patients with rheumatoid arthritis - Methotrexate precision medicine Rheumatoid arthritisMTX administrationKeio UniversityFukuoka Tokushukai HospitalNULLRecruiting20years-old90years-oldMale and Female50Not selectedJapan
271EUCTR2016-005017-45-HU
(EUCTR)
12/05/201713/03/2017A study to explore the effect of a new antibody to treat patients with Rheumatoid ArthritisA Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 19.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: NI-0101
Product Code: NI-0101
INN or Proposed INN: N/A
Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody
NovImmune S.A.NULLNot RecruitingFemale: yes
Male: yes
81Phase 2Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina
272EUCTR2016-005017-45-BG
(EUCTR)
11/05/201706/04/2017A study to explore the effect of a new antibody to treat patients with Rheumatoid ArthritisA Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: NI-0101
Product Code: NI-0101
INN or Proposed INN: N/A
Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody
NovImmune S.A.NULLNot Recruiting Female: yes
Male: yes
81 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina
273EUCTR2016-000897-39-DE
(EUCTR)
10/05/201727/10/2016An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe 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]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany
274EUCTR2014-005368-13-IT
(EUCTR)
10/05/201716/02/2018A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). - A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA) Severe Rheumatoid Arthritis (RA)
MedDRA version: 20.0;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: SAIT101 (rituximab biosimilar)
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
ARCHIGEN BIOTECH LIMITEDNULLNot RecruitingFemale: yes
Male: yes
282Phase 1;Phase 3United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
275NCT03241108
(ClinicalTrials.gov)
May 10, 201726/6/2017Study of an Anti-TLR4 mAb in Rheumatoid ArthritisRandomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an Anti-Toll Like Receptor 4 Monoclonal Antibody in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: NI-0101;Other: PlaceboNovImmune SANULLCompleted18 YearsN/AAll90Phase 2Bosnia and Herzegovina;Bulgaria;Georgia;Hungary;Moldova, Republic of;Poland;Serbia
276NCT03086343
(ClinicalTrials.gov)
May 9, 201720/3/2017A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDsA Phase 3, Randomized, Active-Controlled, Double-Blind Study Comparing Upadacitinib (ABT-494) to Abatacept in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)Rheumatoid Arthritis (RA)Drug: Abatacept;Drug: Placebo for abatacept;Drug: Upadacitinib;Drug: Placebo for upadacitinibAbbVieNULLActive, not recruiting18 YearsN/AAll613Phase 3United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Czechia;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Chile;Colombia
277EUCTR2016-001825-15-BE
(EUCTR)
08/05/201728/02/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION 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: tofacitinib
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot Recruiting Female: yes
Male: yes
680 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesUnited States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
278EUCTR2016-002337-30-CZ
(EUCTR)
03/05/201706/02/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatmentA 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE 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: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
230Phase 2Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
279EUCTR2016-000569-21-DE
(EUCTR)
02/05/201704/11/2016Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
423Phase 3United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
280EUCTR2016-001825-15-HU
(EUCTR)
01/05/201722/03/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION 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: tofacitinib
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot Recruiting Female: yes
Male: yes
580 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesUnited States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
281EUCTR2016-001064-11-CZ
(EUCTR)
20/04/201731/03/2017Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritisA Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients 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] - Musculoskeletal Diseases [C05]
Product Name: NI-071
Product Code: NI-071
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remicade
Nichi-Iko Pharmaceutical Co., Ltd.NULLNot Recruiting Female: yes
Male: yes
585 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom
282EUCTR2016-000568-41-DE
(EUCTR)
19/04/201724/10/2016Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1650Phase 3United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
283EUCTR2016-000570-37-DE
(EUCTR)
19/04/201724/10/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
284EUCTR2016-002126-36-DE
(EUCTR)
18/04/201723/11/2016A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a InhibitorsA randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors 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: RO7123520
Product Code: RO7123520/F03-01
INN or Proposed INN: Not available
Other descriptive name: RO7123520
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
204Phase 2United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Colombia;Germany;Italy;United Kingdom
285EUCTR2016-001064-11-PL
(EUCTR)
13/04/201712/04/2017Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritisA Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients 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] - Musculoskeletal Diseases [C05]
Product Name: NI-071
Product Code: NI-071
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remicade
Nichi-Iko Pharmaceutical Co., Ltd.NULLNot Recruiting Female: yes
Male: yes
585 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Czech Republic;Puerto Rico;Spain;Poland;Ukraine;Russian Federation;United Kingdom
286EUCTR2016-001825-15-BG
(EUCTR)
11/04/201707/02/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION 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: tofacitinib
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot Recruiting Female: yes
Male: yes
680 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesUnited States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Bulgaria;South Africa;Germany;Korea, Republic of
287EUCTR2016-002337-30-BG
(EUCTR)
11/04/201730/01/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatmentA 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE 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: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
230Phase 2Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
288EUCTR2016-002337-30-SK
(EUCTR)
10/04/201708/02/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE 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]
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.,NULLNot Recruiting Female: yes
Male: yes
230 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
289EUCTR2016-001064-11-ES
(EUCTR)
07/04/201707/04/2017Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritisA Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis 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 Name: NI-071
Product Code: NI-071
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remicade
Nichi-Iko Pharmaceutical Co., Ltd.NULLNot Recruiting Female: yes
Male: yes
585 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom
290EUCTR2016-000897-39-BE
(EUCTR)
03/04/201702/02/2017An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis. 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] - Immune System Diseases [C20]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany
291EUCTR2016-001825-15-GB
(EUCTR)
03/04/201701/03/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION 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: tofacitinib
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot RecruitingFemale: yes
Male: yes
680Phase 3;Phase 4United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Belgium;Poland;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
292NCT03291457
(ClinicalTrials.gov)
March 30, 201720/9/2017A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical PracticeA Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical PracticeRheumatoid ArthritisDrug: Tocilizumab;Drug: Glucocorticoid AgentHoffmann-La RocheNULLCompleted18 YearsN/AAll101Belgium
293EUCTR2016-001825-15-PL
(EUCTR)
29/03/201708/03/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION 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: tofacitinib
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot RecruitingFemale: yes
Male: yes
680Phase 3;Phase 4Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;South Africa;Bulgaria;Germany;Korea, Republic of
294EUCTR2016-002862-30-PL
(EUCTR)
28/03/201703/04/2017A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritisA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE RHEUMATOID ARTHRITIS
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]
Product Code: PF-06651600
INN or Proposed INN: not yet assigned
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
295EUCTR2016-002337-30-ES
(EUCTR)
27/03/201710/03/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatmentA 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE 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: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
230Phase 2Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
296EUCTR2016-002862-30-CZ
(EUCTR)
22/03/201714/12/2016A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritisA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE RHEUMATOID ARTHRITIS
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]
Product Code: PF-06651600
INN or Proposed INN: not yet assigned
Pfizer Inc 235 East 42nd Street, New York, NY10017 USNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
297EUCTR2011-004720-35-NL
(EUCTR)
22/03/201722/02/2017A 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: 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: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
INN or Proposed INN: METHOTREXATE
INN or Proposed INN: METHOTREXATE
INN or Proposed INN: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE
INN or Proposed INN: PREDNISOLONE
The Karolinska Institute, ClinTRIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 4Finland;Denmark;Norway;Iceland;Netherlands;Sweden
298EUCTR2016-000568-41-BG
(EUCTR)
21/03/201724/01/2017Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40mg in 0.4 ml s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1650 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
299EUCTR2016-001825-15-CZ
(EUCTR)
21/03/201721/03/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION 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: tofacitinib
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Pfizer Inc.NULLNot Recruiting Female: yes
Male: yes
680 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesUnited States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
300EUCTR2016-000570-37-BG
(EUCTR)
21/03/201713/02/2017Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
301NCT03245320
(ClinicalTrials.gov)
March 20, 20173/5/2017Clinical Evaluation of the TITAN™ Total Shoulder SystemA Post-Market Observational Study to Evaluate Performance and Safety of the TITAN™ Total Shoulder SystemArthritis;Arthritis, Degenerative;Rheumatoid Arthritis;Post-traumatic Arthrosis of Other Joints, Shoulder Region;Rotator Cuff Syndrome of Shoulder and Allied Disorders;Fracture;Avascular Necrosis;Joint Instability;Joint Trauma;Dislocation, Shoulder;Pain, ShoulderDevice: Integra TITAN™ Total Shoulder Generation 1.0Smith & Nephew, Inc.NULLActive, not recruiting18 YearsN/AAll50United States
302EUCTR2015-005309-35-HU
(EUCTR)
16/03/201702/02/2017Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid ArthritisA Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 Moderately to Severely 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 Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
R-PharmNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;Latvia;Korea, Republic of
303EUCTR2016-002337-30-HU
(EUCTR)
16/03/201706/02/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatmentA 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE 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: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
230Phase 2Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
304EUCTR2015-005309-35-CZ
(EUCTR)
16/03/201731/01/2017Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid ArthritisA Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 Moderately to Severely 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 Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
R-Pharm International LLCNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;Latvia;Korea, Republic of
305EUCTR2016-002862-30-DE
(EUCTR)
15/03/201726/01/2017A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritisA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE RHEUMATOID ARTHRITIS
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]
Product Code: PF-06651600
INN or Proposed INN: not yet assigned
Pfizer Inc 235 East 42nd Street, New York, NY10017 USNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
306EUCTR2016-001825-15-ES
(EUCTR)
09/03/201710/03/2017A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION 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] - Immune System Diseases [C20]
Product Name: tofacitinib
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot Recruiting Female: yes
Male: yes
580 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesUnited States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
307EUCTR2015-003289-97-DE
(EUCTR)
09/03/201730/11/2016A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid ArthritisProtocol I8K-MC-JPDA(c)A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study 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 Name: LY3337641 5 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Product Name: LY3337641 20 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
276Phase 2United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of
308EUCTR2016-002852-26-DE
(EUCTR)
09/03/201706/10/2016MSB11022 in moderately to severely active rheumatoid arthritisA multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA moderately to severely 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 Name: adalimumab
Product Code: MSB11022
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
260Phase 3Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom
309EUCTR2015-005309-35-LT
(EUCTR)
06/03/201731/01/2017Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid ArthritisA Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 Moderately to Severely Active 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]
Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
R-Pharm International LLCNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;Latvia;Korea, Republic of
310EUCTR2015-005307-83-LV
(EUCTR)
03/03/201716/03/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 Moderately to Severely 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 Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
INN or Proposed INN: ADALIMUMAB
R-PharmNULLNot Recruiting Female: yes
Male: yes
1575 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of
311EUCTR2016-002126-36-AT
(EUCTR)
01/03/201711/11/2016A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a InhibitorsA randomized, double-blind, placebo-controlled, multi-center, three-part phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors 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: RO7123520
Product Code: RO7123520/F03-01
INN or Proposed INN: Not available
Other descriptive name: RO7123520
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
204Phase 2United States;Spain;Guatemala;Austria;Chile;Colombia;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;Germany
312NCT03025308
(ClinicalTrials.gov)
February 28, 201717/1/2017Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid ArthritisA Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: Filgotinib;Drug: Placebo to match filgotinibGalapagos NVGilead SciencesActive, not recruiting18 YearsN/AAll2731Phase 3United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Czechia;France;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Netherlands
313EUCTR2014-004868-38-DE
(EUCTR)
23/02/201725/05/2016A 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.NULLNot RecruitingFemale: yes
Male: yes
358Phase 3France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
314EUCTR2015-003289-97-ES
(EUCTR)
20/02/201721/02/2017A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid ArthritisProtocol I8K-MC-JPDA(c)A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study 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 Name: LY3337641 5 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Product Name: LY3337641 20 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Lilly S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
276Phase 2United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of
315EUCTR2016-002862-30-BG
(EUCTR)
16/02/201710/01/2017A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritisA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE RHEUMATOID ARTHRITIS
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06651600
INN or Proposed INN: not yet assigned
Pfizer Inc 235 East 42nd Street, New York, NY10017 USNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
316EUCTR2016-001825-15-SK
(EUCTR)
16/02/201714/12/2016A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MGA PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION 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]
Product Name: tofacitinib
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Pfizer Inc.NULLNot Recruiting Female: yes
Male: yes
680 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesUnited States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
317EUCTR2016-002862-30-SK
(EUCTR)
16/02/201714/12/2016A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritisA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE RHEUMATOID ARTHRITIS
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]
Product Code: PF-06651600
INN or Proposed INN: not yet assigned
Pfizer Inc 235 East 42nd Street, New York, NY10017 USNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
318EUCTR2016-000569-21-PL
(EUCTR)
15/02/201714/02/2017Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
423Phase 3United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
319EUCTR2016-000568-41-PL
(EUCTR)
15/02/201714/02/2017Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40mg in 0.4ml s.c.injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1650 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
320EUCTR2016-000570-37-PL
(EUCTR)
15/02/201713/02/2017Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
321EUCTR2016-000568-41-IT
(EUCTR)
08/02/201717/06/2021Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response toMethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administeredfor 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate - NA Moderately to severely active 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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: Filgotinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: Filgotinib
Trade Name: Methotrexate
INN or Proposed INN: METOTRESSATO SALE SODICO
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
GILEAD SCIENCES INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
1650Phase 3Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico
322EUCTR2016-002862-30-HU
(EUCTR)
31/01/201723/11/2016A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritisA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE RHEUMATOID ARTHRITIS
MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06651600
INN or Proposed INN: not yet assigned
Pfizer Inc 235 East 42nd Street, New York, NY10017 USNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Czech Republic;Hungary;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
323EUCTR2016-000569-21-BE
(EUCTR)
30/01/201728/10/2016Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
423Phase 3United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
324EUCTR2013-003413-18-NL
(EUCTR)
30/01/201728/09/2015Arthritis prevention with abataceptArthritis Prevention In the Pre-clinical Phase of RA with Abatacept. - APIPPRA The target population for therapeutic intervention will be subjects who carry serum autoantibodies (antibodies to citrullinated protein antigens – ACPA; rheumatoid factor – RF) and who have joint pains (arthralgia) but no joint swelling. These subjects are deemed to be at highest risk of developing rheumatoid arthritis.
MedDRA version: 20.0;Level: PT;Classification code 10003239;Term: Arthralgia;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ORENCIA 125 mg solution for injectionLeiden University Medical CenterNULLNot RecruitingFemale: yes
Male: yes
206Phase 2Netherlands;United Kingdom
325EUCTR2016-000570-37-BE
(EUCTR)
30/01/201717/10/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
326EUCTR2016-000568-41-ES
(EUCTR)
13/01/201713/01/2017Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1650 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
327EUCTR2016-000570-37-ES
(EUCTR)
13/01/201713/01/2017Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
328EUCTR2016-000569-21-ES
(EUCTR)
13/01/201713/01/2017Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
423Phase 3United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
329NCT03112213
(ClinicalTrials.gov)
January 12, 201710/4/2017Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) TreatmentCONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis)Rheumatoid ArthritisDrug: Tocilizumab;Drug: NSAIDsHoffmann-La RocheNULLCompleted18 YearsN/AAll135Germany
330EUCTR2016-000897-39-HU
(EUCTR)
09/01/201719/10/2016An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe 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]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Taiwan;Hungary;Mexico;Belgium;Australia;Germany
331NCT02760433
(ClinicalTrials.gov)
January 9, 201729/4/2016Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Have Active DiseaseA Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor TherapyRheumatoid ArthritisDrug: Olokizumab q4w;Drug: Olokizumab q2w;Drug: Placebo q2wR-PharmQuintiles, Inc.;OCT Clinical Trials;Mene ResearchActive, not recruiting18 YearsN/AAll350Phase 3United States;Argentina;Brazil;Colombia;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Russian Federation;Czech Republic;Turkey
332EUCTR2015-003140-39-PL
(EUCTR)
09/01/201711/01/2017A Study to EValuate the Efficacy and Safety of JTE-051 on Subjects with Active Rheumatoid Arthritis (MOVE-RA)A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis (MOVE-RA) - MOVE-RA Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: JTE-051
Product Code: JTE-051
INN or Proposed INN: No proposed INN available
Other descriptive name: JTE-051
Akros Pharma Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Russian Federation;Bulgaria;Colombia
333EUCTR2016-000570-37-CZ
(EUCTR)
05/01/201722/11/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
334EUCTR2016-001532-35-BG
(EUCTR)
05/01/201714/11/2016A Phase II, Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis. Moderate to Severe 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: LNP1955Lupin LimitedNULLNot RecruitingFemale: yes
Male: yes
64Phase 2Hungary;Poland;Bulgaria
335EUCTR2016-000568-41-CZ
(EUCTR)
05/01/201721/10/2016Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40mg in 0.4 ml s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1650Phase 3Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
336EUCTR2016-002852-26-GB
(EUCTR)
05/01/201723/09/2016MSB11022 in moderately to severely active rheumatoid arthritisA multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA moderately to severely 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 Name: adalimumab
Product Code: MSB11022
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Merck KGaANULLNot 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): noUnited States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom
337EUCTR2016-002852-26-BG
(EUCTR)
05/01/201703/01/2017MSB11022 in moderately to severely active rheumatoid arthritisA multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA moderately to severely 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 Name: adalimumab
Product Code: MSB11022
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Merck KGaANULLNot 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): noHungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom
338EUCTR2016-000568-41-BE
(EUCTR)
04/01/201717/10/2016Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1650 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
339NCT03855007
(ClinicalTrials.gov)
January 1, 201715/2/2019The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months TreatmentProspective Clinical Study to Observe the Efficacy and Safety of Iguratimod in Rheumatoid Arthritis and Early Rheumatoid Arthritis Patients for 6 Months Treatment in ChinaArthritis, RheumatoidDrug: Iguratimod;Drug: MTX;Drug: HCQ;Drug: PredQilu Hospital of Shandong UniversityNULLActive, not recruiting16 Years90 YearsAll200Phase 4China
340NCT03016884
(ClinicalTrials.gov)
January 20171/1/2017Safety and Tolerability of Herpes Zoster Vaccine Rheumatologic PatientsSafety and Tolerability of Herpes Zoster Vaccine in Patients With Rheumatoid Arthritis Immunized Prior to Biologics and Tofacitinib Therapy InitiationHerpes ZosterBiological: Zostavax vaccineHaEmek Medical Center, IsraelNULLActive, not recruiting50 YearsN/AAll87Phase 4Israel
341EUCTR2016-000569-21-GB
(EUCTR)
23/12/201601/11/2016Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
423 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
342EUCTR2016-000568-41-GB
(EUCTR)
23/12/201613/10/2016Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1650Phase 3Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;United States;Serbia;Taiwan;Hong Kong;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
343EUCTR2016-001496-75-CZ
(EUCTR)
20/12/201630/09/2016A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate.A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Arthritis on Background Therapy with Methotrexate 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]
Product Name: GS-9876
Product Code: GS-9876
INN or Proposed INN: GS-9876
INN or Proposed INN: GS-9876
Product Name: filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2Serbia;United States;Hungary;Czech Republic;Poland;Ukraine;Bulgaria
344EUCTR2014-004704-29-DE
(EUCTR)
19/12/201623/08/2016 This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable 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 Name: ABP 710
Product Code: ABP 710
INN or Proposed INN: ABP 710
Other descriptive name: ABP 710 - Biosimilar to infliximab
Trade Name: Remicade
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Amgen Inc.NULLNot Recruiting Female: yes
Male: yes
550 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
345EUCTR2014-004704-29-CZ
(EUCTR)
15/12/201602/08/2016This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable 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 Name: ABP 710
Product Code: ABP 710
INN or Proposed INN: ABP 710
Other descriptive name: ABP 710 - Biosimilar to infliximab
Trade Name: Remicade
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
550Phase 3United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
346EUCTR2016-001496-75-PL
(EUCTR)
13/12/201603/11/2016A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate.A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Arthritis on Background Therapy with Methotrexate 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: GS-9876
Product Code: GS-9876
INN or Proposed INN: GS-9876
INN or Proposed INN: GS-9876
Product Name: filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2Serbia;United States;Hungary;Czech Republic;Poland;Ukraine;Bulgaria
347EUCTR2016-000569-21-HU
(EUCTR)
12/12/201607/11/2016Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
423Phase 3United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
348EUCTR2015-003289-97-SK
(EUCTR)
12/12/201611/08/2016A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid ArthritisProtocol I8K-MC-JPDAA Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study 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 Name: LY3337641 5 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Product Name: LY3337641 20 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
276Phase 2United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of
349EUCTR2016-002852-26-LT
(EUCTR)
07/12/201624/10/2016MSB11022 in moderately to severely active rheumatoid arthritisA multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA moderately to severely 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 Name: adalimumab
Product Code: MSB11022
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
260Phase 3United States;Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom
350EUCTR2016-002852-26-CZ
(EUCTR)
07/12/201621/09/2016MSB11022 in moderately to severely active rheumatoid arthritisA multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA moderately to severely 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 Name: adalimumab
Product Code: MSB11022
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Merck KGaANULLNot 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): noHungary;Czech Republic;Poland;Lithuania;Bulgaria;United Kingdom;Germany
351EUCTR2015-003140-39-BG
(EUCTR)
05/12/201623/11/2016A Study to EValuate the Efficacy and Safety of JTE-051 in Subjects with Active Rheumatoid Arthritis (MOVE-RA)A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis (MOVE-RA) - MOVE-RA Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: JTE-051
Product Code: JTE-051
INN or Proposed INN: No proposed INN available
Other descriptive name: JTE-051
Akros Pharma Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Russian Federation;Bulgaria;Colombia
352EUCTR2016-000570-37-HU
(EUCTR)
02/12/201619/10/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Ukraine;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan;Czech Republic;Hungary;United Kingdom;Korea, Republic of;South Africa;Australia;Peru;Malaysia;France;India;Italy;Switzerland;Colombia;Israel;Chile;Russian Federation;Ireland;Spain;Thailand;Slovakia;Hong Kong;Taiwan;United States;Serbia
353EUCTR2016-000568-41-HU
(EUCTR)
02/12/201619/10/2016Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1650 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan;India;Italy;Switzerland;Colombia;Israel;Chile;Russian Federation;Ireland;Ukraine;Spain;Thailand;Slovakia;Hong Kong;Taiwan;United States;Serbia
354NCT02982083
(ClinicalTrials.gov)
December 20161/12/2016Clinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid ArthritisClinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With Rheumatoid ArthritisRheumatoid ArthritisDrug: Raloxifene hydrochloride;Drug: Placebo Oral TabletSara Saeidi ShahriNULLNot yet recruiting50 YearsN/AFemale40N/ANULL
355NCT02983227
(ClinicalTrials.gov)
November 30, 201629/11/2016A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350A 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 ArthritisRheumatoid ArthritisDrug: GDC-0853Genentech, Inc.NULLCompleted18 Years76 YearsAll496Phase 2United States;Argentina;Brazil;Bulgaria;Colombia;Mexico;Poland;Russian Federation;Serbia;Ukraine;Chile;Korea, Republic of
356EUCTR2014-004704-29-BG
(EUCTR)
29/11/201615/09/2016 This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable 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 Name: ABP 710
Product Code: ABP 710
INN or Proposed INN: ABP 710
Other descriptive name: ABP 710 - Biosimilar to infliximab
Trade Name: Remicade
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Amgen Inc.NULLNot Recruiting Female: yes
Male: yes
550 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
357NCT02986139
(ClinicalTrials.gov)
November 29, 20162/11/2016Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic ArthritisA Multicenter, Randomized, Double-blind, Crossover Study to Assess the Injection Site Pain Associated With a Modified Etanercept Formulation in Adult Subjects With Either Rheumatoid Arthritis or Psoriatic ArthritisArthritis, Rheumatoid; Arthritis, PsoriaticDrug: Commercial Formulation Etanercept;Drug: New Formulation EtanerceptAmgenNULLCompleted18 YearsN/AAll111Phase 3United States;Puerto Rico
358EUCTR2016-000570-37-SK
(EUCTR)
29/11/201604/10/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
359NCT02960490
(ClinicalTrials.gov)
November 26, 20163/11/2016A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to BiologicsA Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to BiologicsRheumatoid ArthritisDrug: E6011;Drug: PlaceboEisai Co., Ltd.NULLCompleted18 Years75 YearsAll64Phase 2Japan
360EUCTR2014-004704-29-PL
(EUCTR)
25/11/201604/10/2016This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable 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 Name: ABP 710
Product Code: ABP 710
INN or Proposed INN: ABP 710
Other descriptive name: ABP 710 - Biosimilar to infliximab
Trade Name: Remicade
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
550Phase 3United States;Hungary;Czech Republic;Canada;Spain;Poland;Romania;Australia;Bulgaria;Germany
361EUCTR2014-005368-13-DE
(EUCTR)
22/11/201604/07/2016A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). Severe Rheumatoid Arthritis (RA)
MedDRA version: 20.0;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: SAIT101 (proposed rituximab biosimilar)
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB
Archigen Biotech LimitedNULLNot RecruitingFemale: yes
Male: yes
282Phase 1;Phase 3United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
362JPRN-UMIN000026819
2016/11/2101/04/2017A 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 hipDose:
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 SciencesNULLComplete: follow-up complete20years-oldNot applicableMale and Female80Not selectedJapan
363NCT02874092
(ClinicalTrials.gov)
November 15, 201617/8/2016Ticagrelor in Methotrexate-Resistant Rheumatoid ArthritisTicagrelor in Methotrexate-Resistant Rheumatoid ArthritisRheumatoid ArthritisDrug: Ticagrelor;Drug: MTX therapyNYU Langone HealthNULLCompleted18 YearsN/AAll9Phase 4United States
364EUCTR2016-002852-26-HU
(EUCTR)
15/11/201629/09/2016MSB11022 in moderately to severely active rheumatoid arthritisA multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA moderately to severely 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 Name: adalimumab
Product Code: MSB11022
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
260Phase 3United States;Czech Republic;Hungary;Poland;Lithuania;Bulgaria;Germany;United Kingdom
365EUCTR2016-000570-37-GB
(EUCTR)
14/11/201617/10/2016Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate TreatmentA Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
366NCT02996500
(ClinicalTrials.gov)
November 10, 201613/10/2016Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To MethotrexateA 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATERheumatoid ArthritisDrug: PF-06650833;Drug: Placebo;Drug: TofacitinibPfizerNULLCompleted18 Years75 YearsAll269Phase 2United States;Australia;Bosnia and Herzegovina;Bulgaria;Croatia;Czechia;Georgia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Taiwan;Ukraine
367EUCTR2015-005307-83-DE
(EUCTR)
10/11/201624/03/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 Moderately to Severely 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 Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
INN or Proposed INN: ADALIMUMAB
R-PharmNULLNot Recruiting Female: yes
Male: yes
1575 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of
368EUCTR2015-005308-27-DE
(EUCTR)
08/11/201609/05/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor TherapyA Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 Moderately to Severely 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 Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
R-PharmNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Turkey;Russian Federation;Colombia;Germany;Korea, Republic of
369EUCTR2015-005800-27-PL
(EUCTR)
08/11/201603/10/2016Study of a new drug’s effect in people with severe rheumatoid arthritis who have not responded sufficiently well to treatment with DMARDsA randomised, multi-center, double blind (sponsor open), placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK3117391 in subjects with moderate to severe, active rheumatoid arthritis Rheumatoid Arthritis (RA)
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: GSK3117391
Product Code: GSK3117391
INN or Proposed INN: Not applicable
Other descriptive name: GSK3117391
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Poland;Romania;Russian Federation
370EUCTR2016-002908-15-NL
(EUCTR)
08/11/201623/08/2016REDO study: Research into the effects of lower doses rituximab in patients with rheumatoid arthritisREDO study: RhEumatoid arthritis REtreatment with ultra-low dose Rituximab: Disease Outcome after Dose Optimization - REDO 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: MabThera
INN or Proposed INN: RITUXIMAB
Sint MaartenskliniekNULLNot Recruiting Female: yes
Male: yes
140 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
371NCT02919761
(ClinicalTrials.gov)
November 7, 201626/9/2016Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid ArthritisA Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD TreatmentArthritis, RheumatoidDrug: Acthar Gel;Drug: PlaceboMallinckrodtNULLCompleted18 YearsN/AAll259Phase 4United States;Argentina;Mexico;Peru;Puerto Rico;Colombia
372EUCTR2015-003334-27-FI
(EUCTR)
02/11/201617/06/2016A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
373NCT02960438
(ClinicalTrials.gov)
November 2, 20163/11/2016A Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to MethotrexateA Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to MethotrexateRheumatoid ArthritisDrug: E6011;Drug: PlaceboEisai Co., Ltd.NULLCompleted18 Years75 YearsAll190Phase 2Japan
374NCT03067870
(ClinicalTrials.gov)
November 201625/2/2017Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid ArthritisTransplantation of Autologous Purified Bone Marrow Derived Specific Populations of Stem Cells and Mesenchymal Stem Cells in Patients With Rheumatoid ArthritisRheumatoId Arthritis;Osteoarthritis, Knee;Osteoarthritis, HipBiological: Stem Cell TransplantationStem Cells ArabiaNULLActive, not recruiting17 Years75 YearsAll100Phase 1NULL
375EUCTR2016-002125-11-BG
(EUCTR)
27/10/201613/10/2016Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid ArthritisA Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis 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: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLNot Recruiting Female: yes
Male: yes
258 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;Bulgaria;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of
376EUCTR2015-003334-27-RO
(EUCTR)
27/10/201628/06/2016A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: MTX HEXAL 2,5mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Romania;Kazakhstan;Bulgaria;Japan;New Zealand
377EUCTR2015-003289-97-PL
(EUCTR)
25/10/201617/08/2016A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study 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 Name: LY3337641 5 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Product Name: LY3337641 20 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
276Phase 2United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of
378EUCTR2015-003289-97-AT
(EUCTR)
20/10/201612/08/2016A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid ArthritisProtocol I8K-MC-JPDAA Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study 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 Name: LY3337641 5 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Product Name: LY3337641 20 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
276Phase 2United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of
379EUCTR2016-002125-11-CZ
(EUCTR)
17/10/201621/07/2016Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid ArthritisA Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis 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: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLNot Recruiting Female: yes
Male: yes
258 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;Spain;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Poland;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
380JPRN-jRCTs041180071
13/10/201607/03/2019T-ReX studyTocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study Rheumatoid arthritisAt week 0, the dosing frequency of MTX was decreased from weekly to biweekly without a change in dose, regardless of the initial dose. At week 12, MTX was discontinued if low disease activity was maintained. TCZ and csDMARDs other than MTX were continued at a stable dose and interval throughout the course of the study. Glucocorticoids were continued at a stable dose up to week 36, and allowed to taper after week 36. The use of oral analgesics (non-steroidal anti-inflammatory drugs, acetaminophen, pregabalin, and tramadol) was not prohibited during the study period. One or more of the following rescue treatments were performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request: changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX; increasing doses of or adding csDMARDs other than MTX or glucocorticoids; and administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.Kojima ToshihisaNULLComplete>= 20age oldNot applicableBoth51N/AJapan
381EUCTR2016-002061-54-IT
(EUCTR)
13/10/201615/11/2018Switch 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. GEMELLINULLNot RecruitingFemale: yes
Male: yes
250Phase 4Italy
382EUCTR2016-000498-19-BG
(EUCTR)
13/10/201619/08/2016A 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 ArthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
580Phase 2United States;Serbia;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of
383EUCTR2016-000568-41-SK
(EUCTR)
11/10/201604/10/2016Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Moderately to severely 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 Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1650 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
384EUCTR2015-004858-17-NL
(EUCTR)
05/10/201628/09/2016REMission INDuction in very early Rheumatoid ArthritisREMission INDuction in very early Rheumatoid Arthritis - REMINDRA Very early 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]
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: MTX
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Golimumab
Product Name: Golimumab
Product Code: GOL
INN or Proposed INN: GOLIMUMAB
University Medical Center Utrecht (UMCU)NULLNot Recruiting Female: yes
Male: yes
267 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
385EUCTR2014-004704-29-HU
(EUCTR)
05/10/201608/08/2016This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable 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 Name: ABP 710
Product Code: ABP 710
INN or Proposed INN: ABP 710
Other descriptive name: ABP 710 - Biosimilar to infliximab
Trade Name: Remicade
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
550Phase 3United States;Czech Republic;Hungary;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
386EUCTR2016-000912-13-PL
(EUCTR)
04/10/201626/07/2016A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis.A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis. subjects with moderate to severe rheumatoid arthritis.
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]
Product Name: GSK2982772
Product Code: GSK2982772
INN or Proposed INN: Not Available
Other descriptive name: GSK2982772A, where A denotes the free base
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Spain;Poland;Romania;Germany;Italy;United Kingdom
387EUCTR2014-004704-29-ES
(EUCTR)
03/10/201605/08/2016This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable 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 Name: ABP 710
Product Code: ABP 710
INN or Proposed INN: ABP 710
Other descriptive name: ABP 710 - Biosimilar to infliximab
Trade Name: Remicade
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
550Phase 3United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
388JPRN-UMIN000024025
2016/10/0101/10/2016The clinical impact of methotrexate dose reduction at combination therapy with adalimumab plus methotrexate in rheumatoid arthritis; ALIBABA studyThe clinical impact of methotrexate dose reduction at combination therapy with adalimumab plus methotrexate in rheumatoid arthritis; ALIBABA study - ALIBABA study Rheumatoid Arthritisreceiving 40 mg open-label ADA every other week for 26 weeks with low dose MTX (6mg/week)
receiving 40 mg open-label ADA every other week for 26 weeks with high dose MTX (12mg/week)
Search Institute for Bone and Arthritis Disease (SINBAD), Shirahama Foundation for Health and WelfareNULLRecruiting20years-oldNot applicableMale and Female80Not applicableJapan
389NCT02805010
(ClinicalTrials.gov)
October 201612/6/2016Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered SubcutaneouslyA Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously in Chinese Healthy SubjectsRheumatoid Arthritis (RA)Drug: Abatacept;Other: PlaceboJiangsu Simcere Pharmaceutical Co., Ltd.Bristol-Myers SquibbActive, not recruiting18 Years45 YearsBoth22Phase 1NULL
390NCT02881307
(ClinicalTrials.gov)
October 201619/8/2016Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed DietUltrasound Assessment of Rheumatoid Arthritis Patients Who Changed DietRheumatoid Arthritis;OverweightDietary Supplement: Whey Protein&Prebiotic Supplement;Behavioral: Dietary Counseling;Behavioral: Dietary recommendationsDr. Veena RanganathNULLActive, not recruiting18 YearsN/AAll40N/AUnited States
391EUCTR2014-005368-13-ES
(EUCTR)
23/09/201615/07/2016A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). Severe Rheumatoid Arthritis (RA)
MedDRA version: 19.0;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: SAIT101 (rituximab biosimilar)
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB
Archigen Biotech LimitedNULLNot RecruitingFemale: yes
Male: yes
282Phase 1;Phase 3United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
392NCT02648035
(ClinicalTrials.gov)
September 22, 20165/1/2016EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid ArthritisMulticenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study.Rheumatoid ArthritisBiological: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll200Greece
393EUCTR2014-004904-31-BE
(EUCTR)
21/09/201629/07/2016A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Remsima (infliximab)Mundipharma Pharmaceuticals B.V.NULLNot RecruitingFemale: yes
Male: yes
156Phase 4Belgium;Netherlands
394EUCTR2014-005368-13-HU
(EUCTR)
19/09/201611/07/2016A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). Severe Rheumatoid Arthritis (RA)
MedDRA version: 19.0;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: SAIT101 (rituximab biosimilar)
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB
Archigen Biotech LimitedNULLNot RecruitingFemale: yes
Male: yes
282Phase 1;Phase 3India;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of;United States;Spain;Russian Federation;Italy
395EUCTR2014-005368-13-CZ
(EUCTR)
13/09/201613/09/2016A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). Severe Rheumatoid Arthritis (RA)
MedDRA version: 20.0;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: SAIT101 (proposed rituximab biosimilar)
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB
Archigen Biotech LimitedNULLNot RecruitingFemale: yes
Male: yes
282Phase 1;Phase 3United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
396EUCTR2015-002729-21-PT
(EUCTR)
12/09/201627/04/2016A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritisThe Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria Rheumatoid artritis
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: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
VU University Medical CenterNULLNot RecruitingFemale: yes
Male: yes
800Phase 4Portugal;Hungary;Slovakia;Finland;Germany
397EUCTR2016-002125-11-HU
(EUCTR)
08/09/201611/07/2016Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid ArthritisA Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis 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: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLNot RecruitingFemale: yes
Male: yes
258Phase 1;Phase 3Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Hungary;Czech Republic;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
398EUCTR2015-003334-27-SI
(EUCTR)
07/09/201614/12/2015A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
399EUCTR2016-000912-13-GB
(EUCTR)
05/09/201612/06/2017A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis.A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis. subjects with moderate to severe rheumatoid arthritis.
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]
Product Name: GSK2982772
Product Code: GSK2982772
INN or Proposed INN: Not Available
Other descriptive name: GSK2982772A, where A denotes the free base
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
36 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPoland;Spain;Romania;Germany;Italy;United Kingdom
400NCT02666443
(ClinicalTrials.gov)
September 201624/1/2016Low Dose Dexamethasone in Supraclavicular BlocksLow Dose Dexamethasone as an Adjuvant to Supraclavicular Brachial Plexus Blocks: A Prospective Randomized, Double Blinded, Control StudyRheumatoid Arthritis;Osteoarthritis;Nerve Entrapment;Ligament InjuryDrug: Control intervention (no dexamethasone);Drug: Peri-neural Dexamethasone 1 mg;Drug: Intravenous Dexamethasone 1 mgUniversity of CalgaryNULLRecruiting18 Years80 YearsBoth306N/ACanada
401EUCTR2016-000912-13-DE
(EUCTR)
30/08/201629/06/2016A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis.A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis. subjects with moderate to severe rheumatoid arthritis.
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]
Product Name: GSK2982772
Product Code: GSK2982772
INN or Proposed INN: Not Available
Other descriptive name: GSK2982772A, where A denotes the free base
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
36 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPoland;Spain;Romania;Germany;Italy;United Kingdom
402EUCTR2015-003334-27-LT
(EUCTR)
30/08/201606/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
403EUCTR2015-003335-35-BG
(EUCTR)
29/08/201601/08/2016A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
404EUCTR2016-002125-11-LV
(EUCTR)
23/08/201601/07/2016Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid ArthritisA Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis 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: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLNot Recruiting Female: yes
Male: yes
258 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Korea, Republic of;Bosnia and Herzegovina
405EUCTR2016-000335-40-BG
(EUCTR)
23/08/201608/07/2016A Study examining the treatment effect and Safety of GDC-0853 when compared With Placebo and a biologic therapy (Adalimumab) in Rheumatoid Arthritis Patients who have not responded or intolerance to Previous therapies. A TWO-COHORT RANDOMIZED PHASE II, DOUBLEBLIND, PARALLEL GROUP STUDY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS EVALUATING THE EFFICACY AND SAFETY OF GDC-0853 COMPARED WITH PLACEBO AND ADALIMUMAB IN PATIENTS WITH AN INADEQUATE RESPONSE TO PREVIOUS METHOTREXATE THERAPY (COHORT 1) AND COMPARED WITH PLACEBO IN PATIENTS WITH AN INADEQUATE RESPONSE OR INTOLERANCE TO PREVIOUS TNF THERAPY (COHORT 2) 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
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Genentech, Inc.NULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of
406EUCTR2015-004386-91-DE
(EUCTR)
22/08/201618/05/2016Study to explore and compare the effects of a new drug in combination with methotrexate therapy in people with early and established rheumatoid arthritis.A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs 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: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody
GlaxoSmithKline Research & Development LimitedNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Poland;Germany
407EUCTR2016-002125-11-EE
(EUCTR)
22/08/201605/07/2016Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid ArthritisA Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis 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: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLNot Recruiting Female: yes
Male: yes
258 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
408EUCTR2015-003334-27-BG
(EUCTR)
18/08/201618/07/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Kazakhstan;Bulgaria;Japan;New Zealand;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia
409NCT02705989
(ClinicalTrials.gov)
August 18, 20167/3/2016Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy SubjectsA Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD), and Non-Randomized, Bioavailability(BA) Study of BMS-986195 in Healthy SubjectsRheumatoid ArthritisDrug: BMS-986195;Other: PlaceboBristol-Myers SquibbNULLCompleted18 Years55 YearsAll439Phase 1Australia
410EUCTR2015-003335-35-HU
(EUCTR)
18/08/201618/03/2016A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
411EUCTR2016-000064-42-BG
(EUCTR)
11/08/201628/06/2016 Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A 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: M2951
Product Code: M2951
INN or Proposed INN: N/A
Other descriptive name: M2951
Product Name: M2951
Product Code: M2951
INN or Proposed INN: N/A
Other descriptive name: M2951
Merck KGaANULLNot Recruiting Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;Bulgaria
412EUCTR2015-003333-95-FI
(EUCTR)
10/08/201619/04/2016A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
413EUCTR2016-000393-37-BG
(EUCTR)
08/08/201617/06/2016A study to test the effectiveness of bimekizumab as a treatment for rheumatoid arthritis, to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY/TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE INTRAVENOUS DOSES OF BIMEKIZUMAB (UCB4940) ADMINISTERED TO SUBJECTS WITH MODERATE TO SEVERE 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: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Other descriptive name: UCB4940
UCB Biopharma SprlNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;United Kingdom
414EUCTR2016-001532-35-HU
(EUCTR)
08/08/201615/06/2016A Phase II, Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis. Moderate to Severe 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: LNP1955Lupin LimitedNULLNot RecruitingFemale: yes
Male: yes
64Phase 2Hungary;Bulgaria
415EUCTR2016-000064-42-HU
(EUCTR)
05/08/201606/06/2016Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A 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]
Product Name: M2951
Product Code: M2951
INN or Proposed INN: N/A
Other descriptive name: M2951
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
64Phase 2Estonia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria
416EUCTR2015-005307-83-BG
(EUCTR)
04/08/201617/06/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 Moderately to Severely Active 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]
Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
INN or Proposed INN: ADALIMUMAB
R-Pharm International LLCNULLNot Recruiting Female: yes
Male: yes
1575 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of
417JPRN-JapicCTI-163317
28/7/201613/07/2016Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid ArthritisPhase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors Rheumatoid ArthritisIntervention name : BMS-986142
INN of the intervention : -
Dosage And administration of the intervention : BMS-986142 at dose level 1+ Methotrexate as specified. BMS-986142 at dose level 2 + Methotrexate as specified.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo + Methotrexate dose as specified
Bristol-Myers Squibb K.K.NULLcomplete18120BOTH408Phase 2Japan, Asia except Japan, North America, South America, Europe, Oceania
418EUCTR2015-003334-27-CZ
(EUCTR)
27/07/201606/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
419JPRN-UMIN000021247
2016/07/2222/07/2016Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-stateTocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-state - Tocilizumab treatment with reducing and stopping methotrexate (T-ReX study) Rheumatoid arthritisDouble the time between applications of MTX without changing dose for the first 12 weeks, and then stop MTX if CDAI<=10 is maintained.Nagoya University HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female51Not selectedJapan
420EUCTR2015-003335-35-IT
(EUCTR)
18/07/201628/02/2018A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) - SELECT-BEYOND Moderately to Severely Active Rheumatoid Arthritis (RA)
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: ABT-494
Product Code: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Product Name: ABT-494
Product Code: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
421EUCTR2015-003334-27-HU
(EUCTR)
13/07/201610/06/2016A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
422EUCTR2015-003334-27-ES
(EUCTR)
08/07/201619/01/2016A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 15 mg Once Daily Monotherapy and ABT-494 30 mg Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Egypt;Hungary;Mexico;European Union;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;New Zealand;Japan
423EUCTR2016-001618-18-FR
(EUCTR)
08/07/201609/06/2016Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patientsSTARComparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients in low disease activity or Remission - STAR glucocorticoid withdrawal in 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: Prednisone
Product Name: prednisone 5 mg
Trade Name: Prednisone
Product Name: prednisone 4 mg
Trade Name: Prednisone
Product Name: prednisone 3 mg
Trade Name: Prednisone
Product Name: prednisone 2 mg
Trade Name: Prednisone
Product Name: prednisone 1 mg
Trade Name: Hydrocortisone 10mg
CHU ToulouseNULLNot RecruitingFemale: yes
Male: yes
122Phase 4France
424EUCTR2015-005307-83-PL
(EUCTR)
06/07/201601/06/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 Moderately to Severely 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 Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira)
Product Code: LO4AB04
R-PharmNULLNot RecruitingFemale: yes
Male: yes
1575Phase 3United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of
425EUCTR2015-003335-35-GR
(EUCTR)
05/07/201626/04/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
426EUCTR2015-003433-10-GB
(EUCTR)
05/07/201630/03/2016 ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis GP17-302 A randomized, double-blind, parallel-group, multicenter study to demonstrate similar efficacy and to compare safety and immunogenicity of GP2017 and Humira® in patients with moderate to severe active rheumatoid arthritis - ADMYRA trial 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] - Immune System Diseases [C20]
Product Name: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Hexal, AGNULLNot Recruiting Female: yes
Male: yes
308 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
427NCT03106259
(ClinicalTrials.gov)
June 29, 20163/4/2017Long-term Observational Study to Evaluation the Safety of FURESTEM-RA InjObservational Study to Evaluate the Safety of FURESTEM-RA Inj. in Moderate to Severe Rheumatoid Arthritis Patients Who Participated in Phase 1 Clinical Trial of FURESTEM-RA InjRheumatoid ArthritisDrug: FURESTEM-RA Inj.Kang Stem Biotech Co., Ltd.NULLActive, not recruiting19 Years80 YearsAll9Phase 1Korea, Republic of
428EUCTR2015-003334-27-PL
(EUCTR)
28/06/201608/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand;Korea, Republic of;Bosnia and Herzegovina;China;Latvia;South Africa;Australia;Malaysia;Puerto Rico;Switzerland;Colombia;Russian Federation;Chile;Israel;Ireland;Ukraine;Spain;Greece;Slovakia;Taiwan;Hong Kong;Serbia;Belarus;United States;Portugal
429EUCTR2015-003335-35-NO
(EUCTR)
27/06/201618/03/2016A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
430EUCTR2015-003334-27-GR
(EUCTR)
22/06/201613/05/2016A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;New Zealand;Japan
431EUCTR2015-002729-21-FI
(EUCTR)
21/06/201630/03/2016A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritisThe Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria Rheumatoid artritis
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: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
VU University Medical CenterNULLNot RecruitingFemale: yes
Male: yes
800Phase 4Portugal;Hungary;Slovakia;Finland;Germany
432EUCTR2016-000064-42-CZ
(EUCTR)
21/06/201608/06/2016Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A 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]
Product Name: M2951
Product Code: M2951
INN or Proposed INN: N/A
Other descriptive name: M2951
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
64Phase 2Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria
433EUCTR2015-003334-27-IE
(EUCTR)
17/06/201607/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
434EUCTR2015-003334-27-LV
(EUCTR)
17/06/201608/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
975Phase 3Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
435EUCTR2015-003334-27-PT
(EUCTR)
17/06/201609/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3United States;Belarus;Portugal;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
436EUCTR2015-003332-13-BG
(EUCTR)
15/06/201625/03/2016A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
437EUCTR2015-003334-27-GB
(EUCTR)
15/06/201609/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
438EUCTR2015-005308-27-HU
(EUCTR)
09/06/201628/04/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 Moderately to Severely 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 Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
R-PharmNULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Germany;Colombia;Korea, Republic of
439EUCTR2015-003433-10-CZ
(EUCTR)
08/06/201630/03/2016ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid ArthritisGP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial 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] - Immune System Diseases [C20]
Product Name: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Hexal, AGNULLNot RecruitingFemale: yes
Male: yes
308Phase 3Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
440EUCTR2015-003334-27-HR
(EUCTR)
08/06/201606/07/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;New Zealand;Japan
441EUCTR2015-003433-10-IT
(EUCTR)
08/06/201627/02/2018ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid ArthritisGP17-302 A randomized, double-blind, parallel-group, multicenter study to demonstrate similar efficacy and to compare safety and immunogenicity of GP2017 and Humira® in patients with moderate to severe active rheumatoid arthritis - ADMYRA trial 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: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
HEXAL AGNULLNot RecruitingFemale: yes
Male: yes
308Phase 3Serbia;United States;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
442EUCTR2015-005308-27-CZ
(EUCTR)
07/06/201615/04/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor TherapyA Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 Moderately to Severely Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
R-Pharm International LLCNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Germany;Colombia;Korea, Republic of
443EUCTR2015-002887-17-BE
(EUCTR)
07/06/201616/02/2016Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid ArthritisPhase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors
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]
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
610Phase 2United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Germany;Netherlands;Japan;Korea, Republic of
444EUCTR2015-005307-83-CZ
(EUCTR)
07/06/201618/03/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 Moderately to Severely 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 Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
INN or Proposed INN: ADALIMUMAB
R-Pharm International LLCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1575 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noKorea, Republic of;Germany;Latvia;Georgia;Bulgaria;Romania;Brazil;Poland;Argentina;Mexico;Hungary;Czech Republic;United Kingdom;Colombia;Russian Federation;Lithuania;Estonia;Taiwan;United States
445NCT02758769
(ClinicalTrials.gov)
June 7, 201614/4/2016Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice SettingsLong-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice SettingsRheumatoid ArthritisBiological: ORENCIA Subcutaneous InjectionBristol-Myers SquibbOno Pharmaceutical Co. LtdActive, not recruiting20 YearsN/AAll303Japan
446EUCTR2015-003334-27-BE
(EUCTR)
07/06/201606/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand;Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia
447JPRN-UMIN000021929
2016/06/0115/04/2016Optimization of Infliximab Withdrawal Strategy for Rheumatoid ArthritisOptimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT Study Rheumatoid arthritisDiscontinuation of infliximabChiba UniversityNULLComplete: follow-up continuing18years-oldNot applicableMale and Female200Not selectedJapan
448JPRN-jRCTs031180001
30/05/201612/06/2018Optimization of Infliximab Withdrawal Strategy for Rheumatoid ArthritisOptimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT Rheumatoid arthritisInfliximab WithdrawalIkeda KeiNULLComplete>= 18age oldNot applicableBoth200Phase 4Japan
449EUCTR2015-003433-10-HU
(EUCTR)
26/05/201614/04/2016ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid ArthritisGP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial 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]
Product Name: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Hexal, AGNULLNot RecruitingFemale: yes
Male: yes
308Phase 3Czech Republic;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of;Hungary;France;Italy;United Kingdom;Russian Federation;Turkey;Spain;United States;Serbia
450EUCTR2015-003433-10-DE
(EUCTR)
25/05/201607/04/2016ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid ArthritisGP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial 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]
Product Name: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Hexal, AGNULLNot RecruitingFemale: yes
Male: yes
308Phase 3Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
451NCT02760407
(ClinicalTrials.gov)
May 24, 201629/4/2016Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active DiseaseA Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyRheumatoid ArthritisDrug: Olokizumab 64mg q4w;Drug: Olokizumab 64mg q2w;Drug: Adalimumab 40mg q2w;Drug: Placebo q2wR-PharmQuintiles, Inc.;OCT Clinical TrialsActive, not recruiting18 YearsN/AAll1575Phase 3United States;Argentina;Brazil;Bulgaria;Colombia;Czechia;Estonia;Germany;Hungary;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Romania;Russian Federation;Taiwan;United Kingdom;China;Czech Republic
452EUCTR2015-003335-35-FR
(EUCTR)
24/05/201617/06/2016A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
453EUCTR2016-002035-15-FI
(EUCTR)
20/05/201612/05/2016Outcome after total knee endoprosthesis under general or regional anesthesia, a randomized studyOutcome 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 HospitalNULLNot RecruitingFemale: yes
Male: yes
400Phase 4Finland
454EUCTR2015-003335-35-SK
(EUCTR)
19/05/201622/03/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
455EUCTR2014-004719-36-BG
(EUCTR)
14/05/201605/04/2016Study of the Efficacy and Safety of Olokizumab in Patients withModerately to Severely Active Rheumatoid Arthritis InadequatelyControlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo Controlled,Multicenter Phase III Study of the Efficacy and Safety of Olokizumab inSubjects with Moderately to Severely Active Rheumatoid ArthritisInadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 1 Moderately to Severely 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 Name: Olokizumab
Product Code: CDP6038
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
R-PharmNULLNot RecruitingFemale: yes
Male: yes
420Phase 3Belarus;Turkey;Russian Federation;Bulgaria
456EUCTR2015-003335-35-IE
(EUCTR)
13/05/201610/03/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
457EUCTR2015-003335-35-CZ
(EUCTR)
11/05/201615/03/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
458EUCTR2015-003332-13-HR
(EUCTR)
11/05/201606/07/2016A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
459JPRN-UMIN000022364
2016/05/1020/05/2016Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritisTreatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis - Effectiveness of minodronate in osteoporotic patients with rheumatoid arthritis Osteoprotic patients with rheumatoid arthritisThe selection criteria is based on which treatment each patient wants to take
Minodronate group: oral intake 50mg per month
Minodronate plus active vitamin D group: oral intake 50mg minodronate per month and eldecalcitol 0.75ug per day after breakfast
Department of Orthopaedic Surgery Shinshu University School of MedicineNULLComplete: follow-up complete50years-old100years-oldMale and Female140Not applicableJapan
460EUCTR2015-003335-35-SE
(EUCTR)
10/05/201616/03/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
461EUCTR2015-003433-10-ES
(EUCTR)
09/05/201622/07/2016ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid ArthritisGP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial 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]
Product Name: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Hexal, AGNULLNot RecruitingFemale: yes
Male: yes
308Phase 3Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
462EUCTR2015-002729-21-HU
(EUCTR)
04/05/201611/02/2016A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritisThe Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria Rheumatoid artritis
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: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
VU University Medical CenterNULLNot RecruitingFemale: yes
Male: yes
800Phase 4Portugal;Hungary;Slovakia;Finland;Germany
463EUCTR2015-005307-83-LT
(EUCTR)
04/05/201625/03/2016Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 Moderately to Severely Active 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]
Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
INN or Proposed INN: ADALIMUMAB
R-PharmNULLNot Recruiting Female: yes
Male: yes
1575 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of
464EUCTR2015-003335-35-AT
(EUCTR)
04/05/201614/04/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
465EUCTR2015-003335-35-BE
(EUCTR)
04/05/201610/03/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
466EUCTR2015-003335-35-DK
(EUCTR)
03/05/201614/03/2016A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
467EUCTR2015-003335-35-DE
(EUCTR)
03/05/201609/03/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
468NCT02665910
(ClinicalTrials.gov)
May 201624/1/2016Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) PatientsA Phase I, Randomized, Placebo-Controlled, Multiple Doses Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Patients With RARheumatoid ArthritisDrug: SHR0302;Drug: SHR0302 placebo comparatorJiangsu HengRui Medicine Co., Ltd.NULLNot yet recruiting18 Years70 YearsBoth48Phase 1China
469NCT02538341
(ClinicalTrials.gov)
May 201618/8/2015Safety 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 DiseaseBiological: Herpes Zoster Vaccine;Drug: PlaceboUniversity of Alabama at BirminghamOregon Health and Science UniversityActive, not recruiting50 YearsN/AAll617Phase 2United States
470NCT01815411
(ClinicalTrials.gov)
May 201614/3/2013Effect of Andosan in Patients With Rheumatoid ArthritisEffect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA)Rheumatoid ArthritisDietary Supplement: Mushroom extractEgil JohnsonImmunoPharma ASCompleted19 Years75 YearsAll10N/ANorway
471EUCTR2015-003335-35-ES
(EUCTR)
29/04/201611/03/2016A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
472NCT02603146
(ClinicalTrials.gov)
April 27, 201610/11/2015Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid ArthritisStrategy to Prevent the Onset of Clinically-Apparent Rheumatoid ArthritisHealthy Participants;Rheumatoid Arthritis (RA) PreventionDrug: Hydroxychloroquine;Drug: HCQ PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceActive, not recruiting18 YearsN/AAll144Phase 2United States
473EUCTR2015-002729-21-DE
(EUCTR)
25/04/201602/02/2016A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritisThe Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - GLORIA Rheumatoid artritis
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: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
VU University Medical CenterNULLNot RecruitingFemale: yes
Male: yes
450Phase 4Portugal;Hungary;Slovakia;Finland;Germany
474EUCTR2015-002729-21-SK
(EUCTR)
22/04/201625/02/2016A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritisThe Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria Rheumatoid artritis
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: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
VU University Medical CenterNULLNot RecruitingFemale: yes
Male: yes
450Phase 4Portugal;Hungary;Slovakia;Finland;Germany
475EUCTR2015-003332-13-FI
(EUCTR)
22/04/201619/04/2016A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs Moderately to Severely Active Rheumatoid Arthritis (RA)
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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot 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): noPortugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
476EUCTR2015-003332-13-NO
(EUCTR)
22/04/201621/04/2016A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Egypt;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;New Zealand
477EUCTR2015-003332-13-AT
(EUCTR)
20/04/201601/06/2016A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs Moderately to Severely Active Rheumatoid Arthritis (RA)
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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
478EUCTR2015-002887-17-NL
(EUCTR)
20/04/201622/02/2016Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid ArthritisPhase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors
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]
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
610Phase 2United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of
479EUCTR2015-003333-95-AT
(EUCTR)
20/04/201612/04/2016A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
480EUCTR2015-003332-13-LV
(EUCTR)
20/04/201612/04/2016A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand;Puerto Rico;Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland
481EUCTR2014-004868-38-IT
(EUCTR)
16/04/201606/11/2020A 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.NULLNot RecruitingFemale: yes
Male: yes
358Phase 3France;Portugal;Hungary;Czech Republic;Greece;Spain;Bulgaria;Germany;United Kingdom;Italy
482EUCTR2015-003332-13-IT
(EUCTR)
15/04/201628/02/2018A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs - SELECT-NEXT Moderately to Severely Active Rheumatoid Arthritis (RA)
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: ABT-494
Product Code: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: N.A.
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Italy;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand;Japan;Colombia;Switzerland;Portugal;Serbia;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Barbados;Russian Federation;Chile;Israel
483EUCTR2015-003333-95-DK
(EUCTR)
15/04/201607/04/2016A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) Moderately to Severely Active Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
484EUCTR2015-003332-13-DK
(EUCTR)
15/04/201607/04/2016A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
485NCT02714881
(ClinicalTrials.gov)
April 201614/3/2016Lipids, Inflammation, and CV Risk in RALipids, Inflammation, and Cardiovascular Risk in Rheumatoid ArthritisRheumatoid Arthritis;Cardiovascular DiseaseDrug: certolizumab;Radiation: Stress myocardial perfusion PETBrigham and Women's HospitalNULLActive, not recruiting35 Years90 YearsAll74N/AUnited States
486EUCTR2015-002887-17-AT
(EUCTR)
29/03/201618/01/2016Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid ArthritisPhase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors
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: BMS-986142
Product Code: BMS-986142
INN or Proposed INN: BMS986142
Product Name: BMS-986142
Product Code: BMS-986142
INN or Proposed INN: BMS986142
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
610Phase 2United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of
487EUCTR2015-002887-17-ES
(EUCTR)
28/03/201613/01/2016Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid ArthritisPhase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors
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]
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
610Phase 2United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of
488NCT02706951
(ClinicalTrials.gov)
March 23, 201618/2/2016A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTXRheumatoid ArthritisDrug: Methotrexate;Drug: Upadacitinib;Drug: Placebo Upadacitinib;Drug: Placebo MethotrexateAbbVieNULLActive, not recruiting18 Years99 YearsAll648Phase 3Russian Federation;Serbia;South Africa;Spain;Turkey;Ukraine;Argentina;Australia;Austria;Belgium;Bulgaria;Chile;Czechia;Estonia;Greece;Hungary;Israel;Italy;Japan;Mexico;Poland;Portugal;Puerto Rico;Romania;United States;Colombia;Czech Republic;New Zealand
489NCT02720523
(ClinicalTrials.gov)
March 22, 201622/3/2016A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDsA Phase 2b/3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Japanese Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDsRheumatoid ArthritisDrug: Placebo;Drug: UpadacitinibAbbVieNULLActive, not recruiting18 YearsN/AAll197Phase 2/Phase 3Japan
490EUCTR2014-004868-38-PT
(EUCTR)
07/03/201618/12/2015A 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.NULLNot RecruitingFemale: yes
Male: yes
358Phase 3Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany;Hungary;Portugal;United States;France
491JPRN-UMIN000021157
2016/03/0129/02/2016Clinical trial for efficacy and safety related to weekly dosage regimens of methotrexate Rheumatoid arthritisadministration of weekly MTX dose at once.
administration by dividing three times of weekly MTX dose.
Yokohama Minami Kyousai HospitalAYUMI Pharmaceutical corporationComplete: follow-up completeNot applicableNot applicableMale and Female120Not applicableJapan
492JPRN-UMIN000021492
2016/03/0120/03/2016To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients. Rheumatoid arthritisswitch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.Inoue HospitalNULLComplete: follow-up complete18years-oldNot applicableMale and Female40Not selectedJapan
493EUCTR2015-002634-41-DE
(EUCTR)
25/02/201610/11/2015 Long-term study of BI695501 in patients with active rheumatoid arthritisLong-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab 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 Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Boehringer Ingelheim International GmbHNULLNot 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): noSerbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
494EUCTR2015-002634-41-BG
(EUCTR)
24/02/201621/12/2015Long-term study of BI695501 in patients with active rheumatoid arthritisLong-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab 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 Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
495EUCTR2015-002924-17-BE
(EUCTR)
24/02/201627/01/2016A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid ArthritisA Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Nanocort
INN or Proposed INN: prednisolone
Other descriptive name: PREDNISOLONE
Trade Name: Depo Medrol
Product Name: Depo Medrol
Sun Pharma Global FZENULLNot RecruitingFemale: yes
Male: yes
330Phase 3Belgium;Netherlands
496NCT02706873
(ClinicalTrials.gov)
February 23, 201618/2/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken MethotrexateA Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Placebo to Upadacitinib;Drug: Methotrexate;Drug: Placebo to Methotrexate;Drug: UpadacitinibAbbVieNULLActive, not recruiting18 YearsN/AAll1002Phase 3United States;Argentina;Australia;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Guatemala;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Kazakhstan;Latvia;Lithuania;Mexico;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Slovenia;South Africa;Spain;Switzerland;Taiwan;Tunisia;Turkey;Ukraine;United Kingdom;Czech Republic;Finland;Malaysia;Netherlands
497EUCTR2012-002009-23-DE
(EUCTR)
22/02/201609/10/2015Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
366Phase 3Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
498EUCTR2015-001275-50-RO
(EUCTR)
10/02/201622/02/2016Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early 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]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy
499EUCTR2015-001275-50-HU
(EUCTR)
09/02/201604/12/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early 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] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
500EUCTR2014-004868-38-HU
(EUCTR)
09/02/201611/12/2015A 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.NULLNot RecruitingFemale: yes
Male: yes
358Phase 3France;Portugal;United States;Czech Republic;Hungary;Greece;Canada;Argentina;Spain;Bulgaria;Germany
501EUCTR2014-004868-38-BG
(EUCTR)
02/02/201622/12/2015A 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.NULLNot RecruitingFemale: yes
Male: yes
358Phase 3France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
502NCT02683564
(ClinicalTrials.gov)
February 20169/2/2016BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM StudyA Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM StudyRheumatoid ArthritisDrug: BOW015;Drug: RemicadeEpirus Biopharmaceuticals (Switzerland) GmbHNULLNot yet recruiting18 Years80 YearsBoth548Phase 3NULL
503NCT03332719
(ClinicalTrials.gov)
February 201621/4/2016Efficacy, Safety and Immunogenicity of Enerceptan Compared to Enbrel in Rheumatoid ArthritisMulticentric 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 ArthritisRheumatoid ArthritisBiological: Etanercept;Drug: MethotrexateGema Biotech S.A.QUID-Quality in Drugs and Devices Latin American Consulting SRLCompleted19 Years99 YearsAll168Phase 3Argentina
504EUCTR2015-002809-12-BG
(EUCTR)
27/01/201602/12/2015A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid ArthritisA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Czech Republic;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India
505EUCTR2014-004868-38-GR
(EUCTR)
26/01/201602/12/2015A 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.NULLNot RecruitingFemale: yes
Male: yes
720Phase 3France;Portugal;United States;Hungary;Czech Republic;Canada;Greece;Argentina;Spain;Bulgaria;Germany
506EUCTR2015-002634-41-PL
(EUCTR)
20/01/201616/12/2015Long-term study of BI695501 in patients with active rheumatoid arthritisLong-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab 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 Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Poland;Malaysia;Bulgaria;Germany;Korea, Republic of
507EUCTR2014-004868-38-ES
(EUCTR)
19/01/201613/01/2016A 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.NULLNot 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): noFrance;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
508JPRN-UMIN000018931
2016/01/1707/09/2015Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis1000 mg of intravenous acetaminophen (100 ml) after total knee arthroplasty at 23:00 of day of surgery, 5:00, 11:00, 17:00, and 23:00 of one day after surgery, 5:00, 11:00, 17:00, and 23:00 of two days after surgery, and 5:00 of three days after surgery.
100ml of intravenous normal saline after total knee arthroplasty at 23:00 of day of surgery, 5:00, 11:00, 17:00, and 23:00 of one day after surgery, 5:00, 11:00, 17:00, and 23:00 of two days after surgery, and 5:00 of three days after surgery.
Nekoyama Miyao HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female50Not selectedJapan
509EUCTR2014-000358-13-DE
(EUCTR)
14/01/201631/07/2015A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Trade Name: Zostavax®
Product Name: Zostavax
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
510EUCTR2014-004868-38-FR
(EUCTR)
12/01/201618/01/2016A 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.NULLNot 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): noPortugal;United States;France;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
511EUCTR2014-004673-16-DE
(EUCTR)
12/01/201615/07/2015Randomized, 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 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: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Prednisone Tablets USP, 5 mg
Product Code: RO001-9265/F04
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednisone Tablets USP, 1 mg
Product Code: RO 001-9265/F02-01
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: RoActemra
Product Code: L04AC07
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
226Phase 4Serbia;France;Egypt;Lebanon;Turkey;Russian Federation;Germany;Italy;Switzerland
512NCT02742597
(ClinicalTrials.gov)
January 12, 201621/3/2016Patient-Centred Innovations for Persons With Multimorbidity - OntarioPatient-Centred Innovations for Persons With Multimorbidity - OntarioHypertension;Depression;Anxiety;Musculoskeletal Pain;Arthritis;Rheumatoid Arthritis;Osteoporosis;Chronic Obstructive Pulmonary Disease (COPD);Asthma;Chronic Bronchitis;Cardiovascular Disease;Heart Failure;Stroke;Transient Ischemic Attacks;Ulcer;Gastroesophageal Reflux;Irritable Bowel;Crohn's Disease;Ulcerative Colitis;Diverticulosis;Chronic Hepatitis;Diabetes;Thyroid Disorder;Cancer;Kidney Disease;Urinary Tract Problem;Dementia;Alzheimer's Disease;Hyperlipidemia;HIV;MultimorbidityBehavioral: TIP / IMPACT Plus Care CoordinationLawson Health Research InstituteWestern University, Canada;Université de Sherbrooke;Canadian Institutes of Health Research (CIHR);Sunnybrook Health Sciences Centre;Unity Health Toronto;University Health Network, Toronto;Michael Garron Hospital;Providence Healthcare;Mount Sinai Hospital, Canada;Toronto Central Community Care Access Centre;Women's College HospitalActive, not recruiting18 Years80 YearsAll175N/ACanada
513EUCTR2012-002009-23-HU
(EUCTR)
07/01/201629/09/2015Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
366Phase 3Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Latvia
514EUCTR2015-002634-41-HU
(EUCTR)
07/01/201616/10/2015Long-term study of BI695501 in patients with active rheumatoid arthritisLong-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab 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]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
515NCT02652273
(ClinicalTrials.gov)
January 20168/1/2016Inhibition of Co-Stimulation in Rheumatoid ArthritisInhibition of Co-Stimulation in Rheumatoid ArthritisArthritis, RheumatoidDrug: AbataceptNHS Greater Glasgow and ClydeUniversity of GlasgowNot yet recruiting18 YearsN/ABoth25Phase 4United Kingdom
516NCT02878161
(ClinicalTrials.gov)
January 201612/7/2016Predictability Studies on the Efficacy of TNF-a Inhibitors in Chinese RA From Real WorldScreening Protein Predictive of Response to Tumor Necrosis Factor-a Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal PathwayRheumatoid ArthritisDrug: methotrexate(necessary);Biological: infliximab;Biological: etanercept;Biological: adalimumab;Drug: leflunomide (permitted, not necessary);Drug: NSAIDs (permitted,not necessary);Drug: Glucocorticoids (permitted,not necessary)Fen LiNULLEnrolling by invitation18 Years75 YearsBoth240Phase 4NULL
517NCT02608112
(ClinicalTrials.gov)
December 31, 201516/11/2015Study to Describe Real World Drug Retention Rate of the Tocilizumab at One YearSubcutaneous Tocilizumab in Monotherapy or in Combination With csDMARD in Patients With Moderate to Severe Active Rheumatoid Arthritis and Followed by Hospital and Office Based Rheumatologists: Non Interventional Study to Describe Real-World Drug Retention Rate of the Biotherapy at 1 YearRheumatoid ArthritisDrug: Methotrexate;Drug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll291France
518EUCTR2014-000352-29-HR
(EUCTR)
29/12/201501/02/2016A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02). A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE 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 Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Pfizer Inc.NULLNot Recruiting Female: yes
Male: yes
560 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
519EUCTR2015-002809-12-ES
(EUCTR)
23/12/201530/10/2015A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid ArthritisA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India
520EUCTR2014-004868-38-CZ
(EUCTR)
21/12/201503/12/2015A 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.NULLNot Recruiting Female: yes
Male: yes
358 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
521EUCTR2015-001275-50-AT
(EUCTR)
20/12/201523/11/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early 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: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
522EUCTR2015-004173-32-DK
(EUCTR)
18/12/201520/10/2015Personalized 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 HospitalNULLNot RecruitingFemale: yes
Male: yes
500Phase 4Denmark
523EUCTR2015-000665-30-DE
(EUCTR)
17/12/201514/07/2015Coherus Open-Label Safety Extension StudyAn Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES Rheumatoid arthritisChronic Plaque Psoriasis
MedDRA version: 19.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859
MedDRA version: 19.0;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CHS-0214
INN or Proposed INN: Etanercept
Other descriptive name: BGX-0214
Coherus BioSciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
447Phase 3France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;Italy;United Kingdom
524EUCTR2015-002634-41-ES
(EUCTR)
17/12/201530/10/2015Long-term study of BI695501 in patients with active rheumatoid arthritisLong-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab 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]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
525EUCTR2015-001275-50-IT
(EUCTR)
17/12/201505/11/2020Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis.A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive - ND Early 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]
Product Name: Abatacept
Product Code: [BMS-188667]
INN or Proposed INN: ABATACEPT
Other descriptive name: ND
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
Product Code: [na]
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
Product Code: [na]
INN or Proposed INN: METOTREXATO
Other descriptive name: METHOTREXATE
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Czechia;Finland;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
526NCT02675426
(ClinicalTrials.gov)
December 17, 201511/12/2015A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs AloneA Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDsRheumatoid ArthritisDrug: Placebo;Drug: UpadacitinibAbbVieNULLActive, not recruiting18 Years99 YearsAll661Phase 3United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hong Kong;Hungary;Ireland;Italy;Kazakhstan;Korea, Republic of;Latvia;Lithuania;Mexico;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Netherlands;Norway;Serbia;Singapore;Israel;Denmark;Czech Republic;Colombia;Brazil;Belarus
527EUCTR2015-001275-50-ES
(EUCTR)
15/12/201510/12/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early 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]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot Recruiting Female: yes
Male: yes
1500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
528EUCTR2015-003334-27-SK
(EUCTR)
11/12/201504/11/2015A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
529EUCTR2015-001275-50-SE
(EUCTR)
09/12/201504/12/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early 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: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
530EUCTR2012-002009-23-GB
(EUCTR)
09/12/201507/10/2015Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritisA 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 AGNULLNot 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): noSerbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
531NCT02680067
(ClinicalTrials.gov)
December 8, 20157/12/2015NIR Fluorescence Imaging of Lymphatic Transport Using ICGNear InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine GreenRheumatoid ArthritisDrug: Indocyanine Green;Device: MultiSpectral Imaging SystemUniversity of RochesterNational Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Active, not recruiting18 Years89 YearsAll23Phase 1United States
532EUCTR2015-001275-50-FI
(EUCTR)
08/12/201508/12/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early 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] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
533EUCTR2015-001275-50-GB
(EUCTR)
04/12/201526/11/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early 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: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
534NCT02629159
(ClinicalTrials.gov)
December 1, 201510/12/2015A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to MethotrexateA Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)Rheumatoid ArthritisDrug: Placebo for Adalimumab;Drug: Adalimumab;Drug: Placebo for Upadacitinib;Drug: UpadacitinibAbbVieNULLActive, not recruiting18 YearsN/AAll1629Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Kazakhstan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Czech Republic;Finland;Netherlands
535EUCTR2015-001275-50-DE
(EUCTR)
01/12/201524/11/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early 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: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
536NCT02944799
(ClinicalTrials.gov)
December 201527/6/2016Alendronate Treatment of Osteoporosis in Rheumatoid ArthritisAlendronate Treatment of Osteoporosis in Rheumatoid Arthritis - Indication and Duration: A Randomized, Double-blind, Placebocontrolled Study to Evaluate the Effects of Discontinuation of Alendronate in Patients With Both Rheumatoid Arthritis and Low Bone MassRheumatoid Arthritis;OsteoporosisDrug: Placebo;Drug: Alendronate;Drug: Calcium;Drug: Vitamin DUniversity of AarhusNULLActive, not recruiting18 YearsN/AAll69Phase 2Denmark
537EUCTR2015-001275-50-FR
(EUCTR)
30/11/201504/12/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early 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]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
538EUCTR2015-002809-12-CZ
(EUCTR)
27/11/201502/10/2015A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid ArthritisA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India
539JPRN-JapicCTI-153081
26/11/201526/11/2015Effects of Abatacept in Patients With Early Rheumatoid ArthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive Rheumatoid ArthritisIntervention name : Abatacept + Methotrexate
INN of the intervention : Abatacept + Methotrexate
Dosage And administration of the intervention : Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
Control intervention name : Methotrexate
INN of the control intervention : Methotrexate
Dosage And administration of the control intervention : Methotrexate at least 15mg per week tablet or capsule orally
Control intervention name : Abatacept Placebo
INN of the control intervention : Abatacept Placebo
Dosage And administration of the control intervention : Placebo for Abatacept subcutaneous injection once per week
Control intervention name : Methotrexate Placebo
INN of the control intervention : Methotrexate Placebo
Dosage And administration of the control intervention : Placebo to match Methotrexate capsule orally once per week
Bristol-Myers Squibb K.K.ONO PHARMACEUTICAL CO., LTD.complete18BOTH1000Phase 3Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa
540EUCTR2012-002009-23-BG
(EUCTR)
25/11/201515/10/2015Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
366Phase 3Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
541EUCTR2012-002009-23-ES
(EUCTR)
20/11/201515/10/2015Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
366Phase 3Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
542NCT02557100
(ClinicalTrials.gov)
November 19, 20154/9/2015Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid ArthritisA Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment With Subcutaneous Abatacept in Combination With Methotrexate Versus Subcutaneous Adalimumab in Combination With Methotrexate in Adults With Early Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic DrugsRheumatoid ArthritisDrug: Abatacept;Drug: Adalimumab;Drug: MethotrexateBristol-Myers SquibbNULLCompleted18 YearsN/AAll80Phase 4United States;Canada;Mexico;Algeria
543NCT02512575
(ClinicalTrials.gov)
November 18, 20156/7/2015A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.A Phase I, Randomized, Single-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Ascending Oral Doses Of AZD9567 In Healthy Subjects.Safety;Tolerability;Pharmacokinetics;Pharmacodynamics;Healthy Subjects;Rheumatoid ArthritisDrug: AZD9567 Monohydrat;Drug: Placebo oral suspension/ Placebo capsule;Drug: PrednisoloneAstraZenecaNULLCompleted18 Years55 YearsMale72Phase 1Germany
544NCT03172325
(ClinicalTrials.gov)
November 18, 201524/5/2017Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RAA Phase III, Randomized, Two-armed, Double-blind, Parallel, Active Controlled Clinical Trial to Determine the Non-inferior Efficacy and Safety of CinnoRA® (Adalimumab, CinnaGen Co.) Versus Humira® for Treatment of Active RAActive Rheumatoid ArthritisDrug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid;Drug: PrednisoloneCinnagenNULLCompleted18 Years75 YearsAll136Phase 3Iran, Islamic Republic of
545EUCTR2015-002809-12-HU
(EUCTR)
17/11/201526/08/2015A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid ArthritisA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Czech Republic;Hungary;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India
546EUCTR2015-002809-12-LV
(EUCTR)
17/11/201521/09/2015A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid ArthritisA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India
547EUCTR2014-004673-16-FR
(EUCTR)
16/11/201505/08/2015Randomized, 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 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]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Prednisone Tablets USP, 5 mg
Product Code: RO001-9265/F04
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednisone Tablets USP, 1 mg
Product Code: RO 001-9265/F02-01
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
226Phase 4Serbia;Egypt;France;Slovenia;Lebanon;Turkey;Russian Federation;Germany;Tunisia;Italy;Switzerland
548EUCTR2012-002009-23-CZ
(EUCTR)
13/11/201530/09/2015Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
366Phase 3Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
549EUCTR2013-000337-13-PT
(EUCTR)
13/11/201511/11/2015Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA)Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in RA (PreCePRA) - PreCePRA Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy
MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Universitätsklinikum ErlangenNULLNot RecruitingFemale: yes
Male: yes
156Phase 3United States;Serbia;Portugal;Germany
550EUCTR2015-002924-17-NL
(EUCTR)
12/11/201506/10/2015A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid ArthritisA Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Nanocort
INN or Proposed INN: prednisolone
Other descriptive name: PREDNISOLONE
Trade Name: Depo Medrol
Product Name: Depo Medrol
Sun Pharma Global FZENULLNot Recruiting Female: yes
Male: yes
330 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelgium;Netherlands
551EUCTR2012-003876-38-PL
(EUCTR)
10/11/201516/11/2015Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the pastA randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT Rheumatoid Arthritis
MedDRA version: 19.1;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: GP2013
Product Code: GP2013
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
Product Name: MabThera®
INN or Proposed INN: RITUXIMAB
Hexal AG (a Sandoz company)NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Hungary;Poland;Germany
552EUCTR2012-002009-23-LT
(EUCTR)
06/11/201502/10/2015Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
366Phase 3Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
553NCT02780323
(ClinicalTrials.gov)
November 2, 201519/5/2016Study to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid ArthritisA Multi-center, Double-blind, Active-controlled, Randomized, Parallel-group Clinical Trial to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: CELBESTA®;Drug: CELEBREX®;Drug: CELEBREX® placebo;Drug: CELBESTA® placeboDong-A ST Co., Ltd.NULLCompleted19 YearsN/AAll119Phase 4Korea, Republic of
554JPRN-UMIN000018848
2015/11/0129/08/2015Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritisTapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis - Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis Rheumatoid arthritiscontrol: continue the present treatment
intervention: reduce the dosage of methotrexate by half every 3 months and discontinue
intervention: extend the interval of biologics to one and a half times every 3 months and discontinue
Keio University HospitalNULLComplete: follow-up completeNot applicableNot applicableMale and Female900Not applicableJapan
555NCT02534896
(ClinicalTrials.gov)
November 201525/8/2015To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid ArthritisTo Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid ArthritisActive Rheumatoid ArthritisDrug: Treatment I;Drug: Treatment II;Drug: Treatment IIISun Pharmaceutical Industries LimitedNULLTerminated18 Years90 YearsAll150Phase 3Belgium;Netherlands
556NCT02723760
(ClinicalTrials.gov)
November 201510/3/201699mTc-3PRGD2 SPECT/CT in Rheumatoid Arthritis PatientsClinical Study of 99mTc-3PRGD2 SPECT/CT in Diagnosis and Efficacy Evaluation of Rheumatoid ArthritisRheumatoid ArthritisDrug: 99mTc-3PRGD2First Affiliated Hospital of Fujian Medical UniversityNULLRecruiting20 Years70 YearsBoth40Phase 0China
557NCT02543931
(ClinicalTrials.gov)
November 20156/8/2015Curcuma Longa L in Rheumatoid ArthritisPhase Ib Randomized, Double-Blind, Placebo-Controlled Study of Meriva in Rheumatoid ArthritisRheumatoid ArthritisDrug: Meriva;Drug: placeboUniversity of ArizonaVanderbilt University;National Center for Complementary and Integrative Health (NCCIH);National Institutes of Health (NIH)Terminated18 YearsN/ABoth3Phase 1United States
558NCT02552940
(ClinicalTrials.gov)
October 31, 201516/9/2015An Observational Study to Evaluate the Clinical Effectiveness, Quality of Life, Safety and Tolerability of Tocilizumab (TCZ) in Patients With Rheumatoid Arthritis (RA) in Daily Clinical PracticeA PROSPECTIVE, NON-INTERVENTIONAL STUDY TO EVALUATE THE CLINICAL EFFECTIVENESS, THE CONSISTENCY OF EVALUATION SCORES, QUALITY OF LIFE, SAFETY AND TOLERABILITY OF TOCILIZUMAB SUBCUTANEOUS IN PATIENTS WITH RHEUMATOID ARTHRITIS IN DAILY CLINICAL PRACTICERheumatoid ArthritisDrug: TocilizumabHoffmann-La Rochenv Roche saCompleted18 YearsN/AAll140Belgium;Luxembourg
559EUCTR2012-002009-23-SK
(EUCTR)
27/10/201507/10/2015Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
366Phase 3Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
560EUCTR2014-003453-34-PL
(EUCTR)
26/10/201529/09/2015Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. 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: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Poland;South Africa;Bulgaria;Germany;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina
561EUCTR2012-002009-23-LV
(EUCTR)
23/10/201508/10/2015Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
366Phase 3Germany;Latvia;Bulgaria;Poland;Mexico;Hungary;Czech Republic;France;Italy;United Kingdom;Russian Federation;Lithuania;Spain;Slovakia;Estonia;United States;Serbia
562EUCTR2012-002009-23-PL
(EUCTR)
22/10/201508/10/2015Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
366Phase 3Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
563EUCTR2014-000352-29-BG
(EUCTR)
21/10/201531/08/2015A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02). A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE 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 Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Pfizer Inc.NULLNot Recruiting Female: yes
Male: yes
560 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Peru;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
564EUCTR2015-001275-50-CZ
(EUCTR)
21/10/201529/09/2015Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritisA Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive Early 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: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
565EUCTR2014-003307-30-GB
(EUCTR)
16/10/201525/08/2015Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritisA Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe 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]
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Celltech, UK Registered Branch of UCB Pharma SANULLNot Recruiting Female: yes
Male: yes
102 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Hungary;Slovakia;Russian Federation;United Kingdom
566EUCTR2014-000110-61-DE
(EUCTR)
15/10/201504/05/2015Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE 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 Code: FKB327 PFS
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Code: FKB327 AI
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
567EUCTR2015-000581-58-CZ
(EUCTR)
14/10/201516/06/2015A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of ActionA Randomized, Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: Ro-Actemra
Product Name: Ro Actemra
INN or Proposed INN: tocilizumabum
Other descriptive name: TOCILIZUMAB
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB
Revmatologicky ustav PrahaNULLNot RecruitingFemale: yes
Male: yes
40Phase 4Czech Republic
568EUCTR2012-002009-23-EE
(EUCTR)
12/10/201506/10/2015Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
366Phase 3Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
569JPRN-UMIN000020833
2015/10/0901/02/2016The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an open label multicenter randomized parallel study. Rheumatoid arthritisAdminister MTX 6-16mg/week for 12 weeks to patients with MDA-RA.
If patients can't take MTX, administer IGU 25-50mg/day or Tac 1.5-3.0mg/day for 12 weeks.

Administer ADA 40mg/2weeks for 24weeks additionally, in case of MDA taking MTX or IGU, Tac for 12 weeks.
If patients maintain remission for 24weeks, discontinue ADA by their own will, after 48 weeks administering ADA.
Zenjinkai Shimin-no-mori HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female240Not selectedJapan
570EUCTR2014-003453-34-DE
(EUCTR)
08/10/201526/05/2015Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. - 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: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany
571EUCTR2014-003453-34-IT
(EUCTR)
05/10/201519/01/2021Study of a new drug's effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with MethotrexateA Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. - - 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]
Product Code: GSK3196165
Other descriptive name: Anticorpo monoclonale anti GM-CSF umano
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENTNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Czechia;Taiwan;Estonia;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Bulgaria;Netherlands;Germany
572NCT02778789
(ClinicalTrials.gov)
October 201516/5/2016Comparing the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor BlockersNon Randomized Parallel-group Clinical Study to Compare the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers.Rheumatoid ArthritisDrug: Tocilizumab;Drug: TNF-alpha InhibitorUniversity of Erlangen-Nürnberg Medical SchoolNULLCompleted18 YearsN/AAll66Germany
573EUCTR2015-003638-28-DK
(EUCTR)
30/09/201528/08/2015Treatment of osteoporosis in patients with rheumatoid arthritis.ALOSTRAAlendronate treatment of osteoporosis in rheumatoid arthritis – indication and duration. A randomized, doubleblind, placebocontrolled multi-centre study to evaluate the effects of discontinuation of alendronate in patients with both rheumatoid arthritis and low bone mass. - ALOSTRA Rheumatoid arthritis and osteoporosis
MedDRA version: 20.0;Level: LLT;Classification code 10031289;Term: Osteoporosis, unspecified;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Alendronat Teva
INN or Proposed INN: Alendronic Acid
Other descriptive name: ALENDRONIC ACID
Aarhus University HospitalNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Denmark
574EUCTR2015-002284-42-FI
(EUCTR)
18/09/201528/08/2015The 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 activitINTENT: 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 specifyTrade 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
READENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1650Phase 1Finland
575EUCTR2014-003453-34-CZ
(EUCTR)
16/09/201523/06/2015Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. 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: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany
576NCT02605642
(ClinicalTrials.gov)
September 10, 20152/9/2015Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From RemicadePERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB)Rheumatoid Diseases;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: CT-P13PfizerHospira, now a wholly owned subsidiary of PfizerCompleted18 YearsN/AAll351Bulgaria;Canada;Czechia;Germany;Greece;Spain;United Kingdom;Czech Republic;France;Italy
577EUCTR2014-003453-34-ES
(EUCTR)
03/09/201503/07/2015Study of a new drug's effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. 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: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Taiwan;Estonia;Spain;Ukraine;Russian Federation;Chile;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Bulgaria;Netherlands;Germany
578NCT05116228
(ClinicalTrials.gov)
September 1, 201521/3/2018Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis in Low Disease Activity and RemissionRandomized, Prospective, Active-comparator Controlled, Patient-blinded Study to Demonstrate Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis Patients in Low Disease Activity and Remission - the REDOREM StudyRheumatoid Arthritis;RemissionDrug: 500mg RTX Group;Drug: 1000mg RTX GroupMedical University of ViennaNULLTerminated18 YearsN/AAll21Phase 4Austria
579NCT02553018
(ClinicalTrials.gov)
September 201516/9/2015Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous SyringeA National, Randomized, Open-label Study Comparing Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated With Methotrexate Administered by Auto-injector Versus Administration by Conventional Subcutaneous Injection.Arthritis, RheumatoidDrug: MethotrexateNordic Pharma SASNULLCompleted18 YearsN/AAll278Phase 3France
580JPRN-UMIN000027241
2015/08/3103/05/2017the change of IMT of carotide artery in RA with treatment of tocilizumab rheumatoid arthritistofacitinibhiroshima clinicNULLComplete: follow-up complete18years-old80years-oldMale and Female50Not applicableJapan
581EUCTR2014-003453-34-GB
(EUCTR)
24/08/201513/07/2015Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. 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: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody
GlaxoSmithKline Research & Development LimitedNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noEstonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;South Africa;Bulgaria;Germany
582EUCTR2013-003177-99-AT
(EUCTR)
17/08/201507/05/2015A 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, 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4United 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
583EUCTR2013-003177-99-FI
(EUCTR)
12/08/201512/02/2014A 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, 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4United 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
584EUCTR2014-004887-39-PL
(EUCTR)
08/08/201507/07/2015A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid ArthritisAn Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC).
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: SB5
INN or Proposed INN: ADALIMUMAB
Product Code: SB5
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., LtdNULLNot RecruitingFemale: yes
Male: yes
Poland
585NCT02797769
(ClinicalTrials.gov)
August 20158/6/2016A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA)Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare DatabasesRheumatoid ArthritisDrug: Other Biologics;Drug: TocilizumabHoffmann-La RocheNULLNot yet recruiting18 YearsN/ABoth75000N/ANULL
586EUCTR2015-000665-30-GB
(EUCTR)
30/07/201520/05/2015Coherus Open-Label Safety Extension StudyAn Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES Rheumatoid arthritisChronic Plaque Psoriasis
MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859
MedDRA version: 18.0;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CHS-0214
INN or Proposed INN: Etanercept
Other descriptive name: BGX-0214
Coherus BioSciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
447Phase 3France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;Italy;United Kingdom
587EUCTR2012-003876-38-HU
(EUCTR)
28/07/201522/05/2015Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the pastA randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT Rheumatoid Arthritis
MedDRA version: 18.1;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: GP2013
Product Code: GP2013
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
Product Name: MabThera®
INN or Proposed INN: RITUXIMAB
Hexal AG (a Sandoz company)NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Hungary;Poland;Germany
588EUCTR2015-000665-30-IT
(EUCTR)
27/07/201528/02/2018Coherus Open-Label Safety Extension StudyAn Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES Rheumatoid arthritisChronic Plaque Psoriasis
MedDRA version: 20.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: etanercept
Product Code: CHS-0214
INN or Proposed INN: ETANERCEPT
Other descriptive name: ETANERCEPT
COHERUS BIOSCIENCES, INC.NULLNot RecruitingFemale: yes
Male: yes
447Phase 3France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;United Kingdom;Italy
589EUCTR2015-000665-30-ES
(EUCTR)
24/07/201501/06/2015Coherus Open-Label Safety Extension StudyAn Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES Rheumatoid arthritisChronic Plaque Psoriasis
MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859
MedDRA version: 18.0;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CHS-0214
INN or Proposed INN: Etanercept
Other descriptive name: BGX-0214
Coherus BioSciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
447Phase 3France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;Italy;United Kingdom
590EUCTR2014-003453-34-HU
(EUCTR)
23/07/201527/05/2015Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. 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: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany
591EUCTR2012-002535-28-ES
(EUCTR)
22/07/201510/07/2015A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA Rheumatoid Arthritis
MedDRA version: 18.0;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: MabThera
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)NULLNot RecruitingFemale: yes
Male: yes
180Phase 4Portugal;Belgium;Spain;Netherlands;Italy;United Kingdom
592EUCTR2012-003876-38-DE
(EUCTR)
21/07/201529/04/2015Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the pastA randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT Rheumatoid Arthritis
MedDRA version: 19.0;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: GP2013
Product Code: GP2013
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
Product Name: MabThera®
INN or Proposed INN: RITUXIMAB
Hexal AG (a Sandoz company)NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Hungary;Poland;Germany
593EUCTR2015-000833-64-FR
(EUCTR)
17/07/201502/07/2015N/AN/A Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: ORENCIA
Trade Name: MABTHERA
Trade Name: ROACTEMRA
CHU Amiens-PicardieNULLNot RecruitingFemale: yes
Male: yes
110Phase 4France
594EUCTR2014-003034-42-BG
(EUCTR)
15/07/201511/05/2015An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid ArthritisA Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061 Rheumatoid Arthritis (RA)
MedDRA version: 20.0;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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061
Ablynx NVNULLNot Recruiting Female: yes
Male: yes
501 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
595EUCTR2014-003034-42-BE
(EUCTR)
13/07/201518/05/2015An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid ArthritisA Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061 Rheumatoid Arthritis (RA)
MedDRA version: 18.0;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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
501Phase 2Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
596EUCTR2014-003033-26-CZ
(EUCTR)
08/07/201505/12/2014A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid ArthritisA Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid Arthritis (RA)
MedDRA version: 18.1;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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
330Phase 2Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
597EUCTR2014-000110-61-ES
(EUCTR)
06/07/201501/06/2015Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE 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]
Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
598EUCTR2014-003034-42-DE
(EUCTR)
29/06/201518/03/2015An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid ArthritisA Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061 Rheumatoid Arthritis (RA)
MedDRA version: 18.1;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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
501Phase 2Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
599EUCTR2014-003012-36-BG
(EUCTR)
19/06/201512/03/2015A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid ArthritisA Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis Rheumatoid Arthritis (RA)
MedDRA version: 18.1;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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: not available
Other descriptive name: ALX-0061
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
228Phase 2Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
600EUCTR2014-003034-42-ES
(EUCTR)
19/06/201514/04/2015An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid ArthritisA Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061 Rheumatoid Arthritis (RA)
MedDRA version: 18.0;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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
501Phase 2Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
601EUCTR2014-003453-34-EE
(EUCTR)
18/06/201514/05/2015Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. 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: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany
602EUCTR2014-003012-36-CZ
(EUCTR)
10/06/201505/01/2015A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid ArthritisA Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis Rheumatoid Arthritis (RA)
MedDRA version: 18.0;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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: not available
Other descriptive name: ALX-0061
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
228Phase 2Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
603EUCTR2014-000358-13-HR
(EUCTR)
08/06/201510/11/2015A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
604EUCTR2014-001471-31-DE
(EUCTR)
02/06/201504/02/2015This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT) 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]
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand
605JPRN-UMIN000017495
2015/06/0126/11/2015Establish the suitable strategy of maintenance therapy for rheumatoid arthritis patient with methotrexate and adalimumab rheumatoid arthritis(RA)dose maintain group: no change of treatment

MTX reducing group: reduce 2mg/week of MTX at ever 8 weeks. If remission is maintained at MTX 2mg/week, MTX will be stopped.

ADA spacing group: space the intervals of ADA for 1week at ever 8 weeks. If remission is maitained at the 6 weeks-intervals of ADA, ADA is stopped.
Keio University School of Medicine, Japan.NULLRecruitingNot applicableNot applicableMale and Female75Not selectedJapan
606EUCTR2015-000538-31-DE
(EUCTR)
01/06/201507/04/2015Application into the joint of opioids in chronic arthritis of the knee jointNEUORIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the knee joint - Neuroimpa - knee joint chronic arthritis of the knee joint effusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA.
MedDRA version: 18.0;Level: LLT;Classification code 10067624;Term: Knee arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Morphine Hexal
INN or Proposed INN: Morphinsulfat
Other descriptive name: MORPHINE SULFATE
Trade Name: Triam 40 mg Lichtenstein
INN or Proposed INN: TRIAMCINOLONACETONID
Other descriptive name: TRIAMCINOLONACETONID EP
Charité University medicine BerlinNULLNot RecruitingFemale: yes
Male: yes
Phase 2Germany
607NCT02552082
(ClinicalTrials.gov)
June 201510/8/2015Scorpio Non Restricted Geometry (NRG) Study in JapanThe Verification Study on the Effectiveness of Rotational Tolerance of Scorpio NRG Study in TKAOsteoarthritis;Rheumatoid ArthritisDevice: Scorpio NRG posterior stabilized (PS)Stryker Japan K.K.NULLCompleted20 YearsN/AAll150Japan
608EUCTR2010-021184-32-BG
(EUCTR)
27/05/201514/04/2015GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies Refractory 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 Name: NA
Product Code: GP2013
INN or Proposed INN: rituximab
Other descriptive name: NA
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
124Phase 1;Phase 2United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
609EUCTR2014-003012-36-ES
(EUCTR)
27/05/201502/02/2015A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid ArthritisA Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis Rheumatoid Arthritis (RA)
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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: not available
Other descriptive name: ALX-0061
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
228Phase 2Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
610EUCTR2014-003033-26-DE
(EUCTR)
21/05/201518/12/2014A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid ArthritisA Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid Arthritis (RA)
MedDRA version: 18.1;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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
330Phase 2Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
611EUCTR2014-003012-36-DE
(EUCTR)
21/05/201529/12/2014A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid ArthritisA Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis Rheumatoid Arthritis (RA)
MedDRA version: 18.1;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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: not available
Other descriptive name: ALX-0061
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
228Phase 2Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
612NCT02402686
(ClinicalTrials.gov)
May 20, 201525/3/2015Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)Open-Label, Multi-Center, Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab SC Monotherapy in Daily Clinical Practice (SIMPACT)Rheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll353Hungary
613JPRN-UMIN000017440
2015/05/1807/05/2015In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study.In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study. - RAXEL study Rheumatoid arthritisfor 3 months Tofacitinib 5mg BID everyday
for 3 months Tofacitinib 5mg BID everyday
for 3 months Methotrexate6mg-16mg/week
Graduate School of Medicine and School of Medicine, Chiba Universitythe department of allergy and clinical immunologyNULLComplete: follow-up complete18years-old90years-oldMale and Female134Phase 4Japan
614EUCTR2013-004019-37-DK
(EUCTR)
13/05/201524/02/2015A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate 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] - Immune System Diseases [C20]
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Czech Republic;Canada;Poland;Romania;Turkey;Australia;Denmark;Bulgaria;Germany;New Zealand
615EUCTR2014-000110-61-CZ
(EUCTR)
11/05/201504/05/2015Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE 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]
Product Code: FKB327 PFS
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Code: FKB327 AI
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
680Phase 3Bulgaria;Germany;United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru
616EUCTR2014-003034-42-HU
(EUCTR)
08/05/201503/03/2015An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid ArthritisA Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061 Rheumatoid Arthritis (RA)
MedDRA version: 18.1;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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
501Phase 2Serbia;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
617EUCTR2013-004569-16-DE
(EUCTR)
07/05/201526/11/2014A 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 ArthritisA 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 10017NULLNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany;Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy
618EUCTR2011-004720-35-NO
(EUCTR)
04/05/201526/01/2015A 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 InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 4Finland;Denmark;Norway;Sweden
619EUCTR2014-005418-45-SE
(EUCTR)
04/05/201518/03/2015Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE Rheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Plaquenil
INN or Proposed INN: HYDROXYCHLOROQUINE
Christine BengtssonSolveig Wållberg-JonssonNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
620NCT02566967
(ClinicalTrials.gov)
May 20151/10/2015An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve Low Disease Activity (LDA) or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural PerspectiveAn Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve LDA or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective When Treating to TargetRheumatoid ArthritisDrug: tofacitinibNorman B. Gaylis, MDNULLCompleted18 YearsN/AAll20Phase 3United States
621EUCTR2013-004569-16-GR
(EUCTR)
30/04/201529/01/2015A 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 ArthritisA 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]Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
180Phase 3Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa;Germany
622EUCTR2014-002945-23-ES
(EUCTR)
30/04/201509/02/2015A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who?s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI.A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. 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]
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
36Phase 2Estonia;Czech Republic;Spain;Russian Federation;Latvia;United Kingdom
623EUCTR2014-001471-31-BG
(EUCTR)
29/04/201521/04/2015Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT) 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]
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand
624EUCTR2014-003033-26-BG
(EUCTR)
29/04/201519/02/2015A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid ArthritisA Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid Arthritis (RA)
MedDRA version: 18.1;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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
330Phase 2Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Serbia;United States;Spain;Czech Republic;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
625EUCTR2010-021184-32-PL
(EUCTR)
21/04/201506/02/2015GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies Refractory 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 Name: NA
Product Code: GP2013
INN or Proposed INN: rituximab
Other descriptive name: NA
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
124Phase 1;Phase 2United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
626EUCTR2014-003307-30-HU
(EUCTR)
16/04/201522/01/2015Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritisA Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe 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]
Product Name: BIMEKIZUMAB
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Celltech, UK Registered Branch of UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
180Phase 2Czech Republic;Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Moldova, Republic of
627EUCTR2014-001471-31-RO
(EUCTR)
08/04/201505/10/2015Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT) 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]
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Czech Republic;Canada;Poland;Turkey;Romania;Australia;Bulgaria;Germany;New Zealand
628EUCTR2014-002541-22-DE
(EUCTR)
02/04/201509/12/2014Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid ArthritisA randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH 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 Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Humira, 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
540Phase 3United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;Puerto Rico;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
629JPRN-UMIN000016606
2015/04/0101/04/2015Efficacy and safety of electroporation and MTX combination therapy for the patients with RA rheumatoid arthritis* Evaluate the articular synovitis by gray and power dopplar scale using ultrasound (US).
* Injection MTX (5mg/ml, 1ml) into MP or PIP joint using guide of US. After three minutes, perform electroporation for four angles with US gel.
* Condition of electroporation is 50V/cm 250ms 4puluse.
* Single intervention of injection MTX or combination of MTX and electroporation. Evaluation is performed at 2, 4, 12, and 26 weeks after baseline.
* Evaluate the articular synovitis by gray and power dopplar scale using ultrasound (US).
* Injection MTX (5mg/ml, 1ml) into MP or PIP joint using guide of US.
* Single intervention of injection MTX or combination of MTX and electroporation. Evaluation is performed at 2, 4, 12, and 26 weeks after baseline.
Osaka City University Medical School, Department of Orthopedic SurgeryNULLComplete: follow-up complete20years-oldNot applicableMale and Female60Phase 2Japan
630NCT02423538
(ClinicalTrials.gov)
April 20157/4/2015First-in-Human Single Ascending Dose of SHR0302A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy VolunteersRheumatoid ArthritisDrug: SHR0302;Drug: SHR0302 placebo comparatorJiangsu HengRui Medicine Co., Ltd.NULLActive, not recruiting18 Years45 YearsBoth64Phase 1China
631EUCTR2014-003307-30-CZ
(EUCTR)
31/03/201503/02/2015Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritisA Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe 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]
Product Name: BIMEKIZUMAB
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Celltech, UK Registered Branch of UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
180Phase 2Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Czech Republic;Moldova, Republic of
632JPRN-UMIN000016950
2015/03/2703/04/2015Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept rheumatoid arthritisInfliximab or adalimumab or golimumabOsaka Medical CollegeNULLComplete: follow-up complete20years-oldNot applicableMale and Female50Not selectedJapan
633EUCTR2015-000089-72-IT
(EUCTR)
26/03/201506/02/2015abatacept in obese and overweight RA patiensFAT GENE EXPRESSION IN OVERWEIGHT AND OBESE PATIENTS WITH PERSISTENTLY ACTIVE RHEUMATOID ARTHRITIS TREATED WITH ABATACEPT AND CLINICAL RESPONSE
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] - Immune System Diseases [C20]
Trade Name: ORENCIA
Product Name: Orencia abatacept
Policlinico Gemelli-CIC- UCSCNULLNot RecruitingFemale: yes
Male: yes
40Phase 4Italy
634EUCTR2010-021184-32-GB
(EUCTR)
25/03/201512/06/2015GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies Refractory 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 Name: NA
Product Code: GP2013
INN or Proposed INN: rituximab
Other descriptive name: NA
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot Recruiting Female: yes
Male: yes
124 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
635NCT02486302
(ClinicalTrials.gov)
March 24, 201528/6/2015A 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 TREATMENTRheumatoid Arthritis;Psoriatic Arthritis;Axial Spondyloarthritis;Plaque PsoriasisDrug: EtanerceptPfizerNULLCompleted18 YearsN/AAll1534Germany
636EUCTR2014-003033-26-BE
(EUCTR)
23/03/201525/11/2014A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid ArthritisA Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid Arthritis (RA)
MedDRA version: 18.0;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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
330Phase 2Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
637EUCTR2014-003012-36-BE
(EUCTR)
23/03/201518/12/2014A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid ArthritisA Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis Rheumatoid Arthritis (RA)
MedDRA version: 18.0;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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: not available
Other descriptive name: ALX-0061
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
228Phase 2Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
638EUCTR2014-001471-31-HU
(EUCTR)
23/03/201523/01/2015This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT) 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]
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;New Zealand
639EUCTR2014-004419-35-GB
(EUCTR)
18/03/201502/02/2015Inhibition of Co-Stimulation in Rheumatoid ArthritisInhibition of Co-Stimulation in Rheumatoid Arthritis - Inhibition of Co-Stimulation in Rheumatoid Arthritis (ICoSRA) Rheumatoid Arthritis: patients who are dual ACPA and HLA-DR4 positive
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: Abatacept
Product Name: Abatacept
INN or Proposed INN: Abatacept
NHS Greater Glasgow and ClydeUniversity of GlasgowAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
25 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
640EUCTR2013-004569-16-BG
(EUCTR)
18/03/201505/01/2015A 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 ArthritisA 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]Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
180Phase 3Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa;Germany
641EUCTR2012-001176-10-BG
(EUCTR)
16/03/201504/11/2014Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
2165Phase 3United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;New Zealand
642EUCTR2014-000352-29-FR
(EUCTR)
16/03/201518/06/2015A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE 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 Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
560Phase 3Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
643EUCTR2013-004569-16-HR
(EUCTR)
16/03/201529/04/2015A 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 ArthritisA 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]Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
180Phase 3Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany
644EUCTR2014-003012-36-HU
(EUCTR)
10/03/201530/12/2014A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid ArthritisA Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis Rheumatoid Arthritis (RA)
MedDRA version: 18.1;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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: not available
Other descriptive name: ALX-0061
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
228Phase 2Serbia;United States;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
645EUCTR2013-005524-42-NL
(EUCTR)
10/03/201527/03/2014STAtins to Prevent Rheumatoid Arthritis (STAPRA)Prevention of rheumatoid arthritis by atorvastatin in seropositive arthralgia patients: a multi-center doubleblind randomized placebo-controlled trial - STAtins to Prevent Rheumatoid Arthritis (STAPRA) Rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039080;Term: Rheumatoid factor positive;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Atorvastatin
Product Name: Atorvastatin
Product Code: C10AA05
INN or Proposed INN: ATORVASTATIN
ReadeNULLNot RecruitingFemale: yes
Male: yes
220Phase 4Netherlands
646EUCTR2014-001471-31-CZ
(EUCTR)
04/03/201527/01/2015This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT) 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]
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand
647JPRN-UMIN000015433
2015/03/0101/11/2014Safety study of methotrexate low-dose once daily administration in rheumatoid arthritis patients rheumatoid arthritismethotrexateDepartment of Medical Pharmaceutics , Graduate School of Medicine and Pharmaceutical Sciences for Research, University of ToyamaNULLRecruiting20years-oldNot applicableMale and Female35Not selectedJapan
648EUCTR2013-004148-49-FR
(EUCTR)
23/02/201518/06/2015RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITISA PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE 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 Name: Infliximab-Pfizer
Product Code: PF-06438179
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-Pfizer
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-EU
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
614Phase 3United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
649EUCTR2013-002805-76-BG
(EUCTR)
20/02/201510/10/2014A 24-week placebo-controlled clinical study to evaluate the adequate dose,efficacy and safety of 3 doses of namilumab combined with methotrexatein subjects with moderate to severe rheumatoid arthritis.A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) NEXUS. Rheumatoid Arthritis (RA)
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 Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
108Phase 2Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Japan;United Kingdom
650EUCTR2014-003033-26-ES
(EUCTR)
20/02/201507/01/2015A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid ArthritisA Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid Arthritis (RA)
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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
330Phase 2Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
651EUCTR2014-002945-23-GB
(EUCTR)
18/02/201504/11/2014 A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI.A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. 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]
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Takeda Development Centre Europe Ltd.NULLNot Recruiting Female: yes
Male: yes
36 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noEstonia;Czech Republic;Spain;Russian Federation;United Kingdom
652EUCTR2014-001114-26-SE
(EUCTR)
18/02/201526/08/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab doseA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 4United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
653EUCTR2014-002945-23-CZ
(EUCTR)
18/02/201521/11/2014A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI.A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. 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]
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
36Phase 2Estonia;Czech Republic;Spain;Russian Federation;United Kingdom
654EUCTR2014-003033-26-HU
(EUCTR)
17/02/201526/11/2014A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid ArthritisA Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid Arthritis (RA)
MedDRA version: 18.1;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: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
330Phase 2Serbia;United States;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
655EUCTR2014-002541-22-ES
(EUCTR)
16/02/201522/12/2014Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid ArthritisA randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH 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
Trade Name: Humira, 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
340 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
656EUCTR2014-001114-26-NL
(EUCTR)
13/02/201524/09/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab doseA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 4United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Netherlands;Germany;Sweden
657EUCTR2014-002541-22-HU
(EUCTR)
11/02/201515/12/2014Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid ArthritisA randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH 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
Trade Name: Humira, 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
340Phase 3United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
658NCT02466581
(ClinicalTrials.gov)
February 3, 201529/5/2015Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease ActivityA Multicenter, Randomized, Open-label, Blinded-assessor, Follow-up, Phase 4 Study in Patients With Rheumatoid Arthritis Who Have Completed the Initial Treatment Part in the NORD-STAR Study and Have Reached Stable Low Disease ActivityRheumatoid ArthritisDrug: Sulphasalazine + Hydroxychloroquine OR Prednisolone;Biological: Cimzia;Biological: Orencia;Biological: RoActemraKarolinska InstitutetNULLActive, not recruiting18 YearsN/AAll25Phase 4Sweden
659EUCTR2013-004569-16-HU
(EUCTR)
03/02/201518/11/2014A 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 ArthritisA 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]Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
180Phase 3Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany
660EUCTR2013-003530-33-GB
(EUCTR)
02/02/201522/05/2014Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib 3mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 12mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 30mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 15mg
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
494Phase 2United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;Bulgaria;South Africa;Latvia;Netherlands;New Zealand
661NCT02330445
(ClinicalTrials.gov)
February 201518/12/20146-Month Phase I/II Open Label PRTX-100 in Previous Rheumatoid Arthritis Study Participants and Sera CollectionPhase I/II Open Label Evaluation of Safety and Feasibility of 6 Months IV PRTX-100 Administrations in Previous Rheumatoid Arthritis Study Participants and Development of Immunological Samples for Assay Development From Normal VolunteersArthritis, RheumatoidDrug: PRTX-100Protalex, Inc.NULLCompleted18 YearsN/AAll13Phase 1/Phase 2United States
662NCT02373202
(ClinicalTrials.gov)
February 201512/2/2015A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Sarilumab;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Bucillamine;Drug: Tacrolimus;Drug: MizoribineSanofiRegeneron PharmaceuticalsCompleted20 YearsN/AAll91Phase 3Japan
663NCT02633332
(ClinicalTrials.gov)
February 201530/11/2015Use of Well Known Drugs for New Destination - RA Improvement (RANT)Observational Retrospective Study About the Use of Well Known Drugs in Combination to Obtain a New Drug to Improve Quality of Life/Health in Patient With Diagnosed Rheumatoid Arthritis Not Responding to Commonly Used TreatmentsRheumatoid Arthritis;Autoimmune Diseases;Disorder of Synovium;Sjogren's Syndrome;Acute and Chronic Inflammation;Disorder of Pleura and Pleural Cavity;Felty's Syndrome;Rheumatoid NodulesDrug: Vitamin D3;Drug: Lipitor®;Drug: Acycloguanosine;Drug: Tetracycline;Drug: methotrexate;Drug: etanerceptUniversità Popolare Homo & NaturaNULLCompleted18 Years75 YearsBoth15Phase 1Italy
664NCT02357069
(ClinicalTrials.gov)
February 201529/1/2015A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate TherapyMulti-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 MTXArthritis, RheumatoidDrug: Enbrel;Drug: LBEC0101LG Life SciencesMochida Pharmaceutical Company, Ltd.Active, not recruiting20 Years75 YearsBoth372Phase 3Japan;Korea, Republic of
665NCT02332590
(ClinicalTrials.gov)
February 20155/1/2015Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)A Randomized, Double-blind, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Sarilumab;Drug: Adalimumab;Drug: Placebo (for sarilumab);Drug: Placebo (for adalimumab)SanofiRegeneron PharmaceuticalsActive, not recruiting18 YearsN/AAll369Phase 3United States;Chile;Czechia;Germany;Hungary;Israel;Korea, Republic of;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic;France
666EUCTR2014-002541-22-CZ
(EUCTR)
26/01/201509/12/2014Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid ArthritisA randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH 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 Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Humira, 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
540Phase 3Romania;Peru;South Africa;Germany;Korea, Republic of;Czech Republic;Hungary;Puerto Rico;Poland;United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom
667EUCTR2013-004019-37-BG
(EUCTR)
26/01/201502/09/2014A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate 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]
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
225Phase 2Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand
668EUCTR2014-000109-11-DE
(EUCTR)
22/01/201508/10/2014Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC 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]
Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
730Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
669EUCTR2014-003255-54-CZ
(EUCTR)
21/01/201524/10/2014A study evaluating the effects of RGB-03 and MabThera combined with Methotrexate in patients with Rheumatoid ArthritisA Double-blind, Randomised, Comparative Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Evaluation of RGB-03 and MabThera® Combined with Methotrexate in Rheumatoid Arthritis Patients 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]
Product Name: RGB-03
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Gedeon Richter PlcNULLNot RecruitingFemale: yes
Male: yes
142Phase 1;Phase 3Hungary;Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Romania;Austria;Russian Federation;Israel;Germany
670EUCTR2014-000109-11-BG
(EUCTR)
21/01/201510/10/2014Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC 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]
Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
730Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
671NCT03719469
(ClinicalTrials.gov)
January 20, 20156/9/2018Circulating microRNAs as Novel Prognosis Biomarkers for Rheumatoid ArthritisCirculating microRNAs Expression as Predictors of Clinical Response in Rheumatoid Arthritis Patients Treated With Green TeaRh DiseaseDietary Supplement: Green tea groupKing Saud UniversityNULLCompleted18 Years85 YearsAll150NULL
672EUCTR2013-004019-37-DE
(EUCTR)
19/01/201524/07/2014A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate 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]
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
225Phase 2Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand
673EUCTR2012-002535-28-IT
(EUCTR)
16/01/201504/11/2014A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA Rheumatoid Arthritis
MedDRA version: 17.1;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
INN or Proposed INN: RITUXIMAB
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University LondonNULLNot RecruitingFemale: yes
Male: yes
180Phase 4Portugal;Spain;Belgium;Netherlands;United Kingdom;Italy
674EUCTR2013-003530-33-BE
(EUCTR)
15/01/201519/09/2014Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib 3mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 12mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 30mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 15mg
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
494Phase 2United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Puerto Rico;Belgium;South Africa;Bulgaria;Latvia;Netherlands;New Zealand
675EUCTR2013-004569-16-SK
(EUCTR)
14/01/201521/11/2014A 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 ArthritisA 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
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]
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
180Phase 3Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany
676EUCTR2011-002067-20-FR
(EUCTR)
13/01/201523/08/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892United States;Portugal;Greece;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany
677EUCTR2014-000358-13-ES
(EUCTR)
13/01/201522/09/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
678EUCTR2010-021184-32-HU
(EUCTR)
09/01/201527/10/2014GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies Refractory 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: NA
Product Code: GP2013
INN or Proposed INN: rituximab
Other descriptive name: NA
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
124Phase 1;Phase 2United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
679EUCTR2013-003530-33-BG
(EUCTR)
09/01/201506/11/2014Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib 3mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 12mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 30mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 15mg
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
494Phase 2United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Puerto Rico;Belgium;Bulgaria;South Africa;Latvia;Netherlands;New Zealand
680EUCTR2013-005543-90-BG
(EUCTR)
06/01/201522/10/2014This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable 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 Name: ABP 798
Product Code: ABP 798
INN or Proposed INN: rituximab
Other descriptive name: ABP 798 - Biosimilar to rituximab
Trade Name: Rituxan
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituxan
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 1;Phase 3United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
681EUCTR2014-000352-29-EE
(EUCTR)
05/01/201507/08/2014A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE 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 Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
560Phase 3Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand;Colombia
682ChiCTR-INR-16009274
2015-01-012016-09-25The multi-center clinical research in TCM diagnosis and treatment norms on Rheumatoid arthritis of piweikuixu-shirezuluo symptomsThe multi-center clinical research in TCM diagnosis and treatment norms on Rheumatoid arthritis of piweikuixu-shirezuluo symptoms Rheumatoid arthritisRA No.1+fengshi mud:RA No.1+fengshi mud;MTX+LEF Group:MTX+LEF;RA No.1+fengshi mud+MTX+LEF Group:RA No.1+fengshi mud+MTX+LEF;Zhejiang Chinese Medical UniversityNULLRecruiting1865BothRA No.1+fengshi mud:150;MTX+LEF Group:150;RA No.1+fengshi mud+MTX+LEF Group:150;China
683NCT02371096
(ClinicalTrials.gov)
January 20155/2/2015Comparative Pharmacokinetic Trial of RGB-03 and MabTheraRheumatoid ArthritisDrug: MabThera (rituximab);Drug: RGB-03Gedeon Richter Plc.NULLNot yet recruiting18 Years75 YearsBothPhase 1NULL
684JPRN-UMIN000012650
2014/12/3121/12/2013In vivo kinematic analysis of total knee arthroplasty with 3-dimensional registration technique. osteoarthritis or rheumatoid arthritis of the knee jointFluoroscopy was performed to continuously
capture the knee from the lateral direction in a weight-bearing
position and knee bending position.
Dept. of orthopedic surgery, Osaka Medical CollegeNULLRecruiting20years-old90years-oldMale and Female60Not selectedJapan
685EUCTR2014-000109-11-CZ
(EUCTR)
18/12/201409/10/2014Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC 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]
Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
686EUCTR2014-000443-33-DE
(EUCTR)
18/12/201407/07/2014Coherus RA StudyA 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, IncNULLNot RecruitingFemale: yes
Male: yes
620Phase 3United States;Belarus;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;South Africa;Germany;Japan
687JPRN-UMIN000020663
2014/12/1621/01/2016A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib. Rheumatoid arthritisPeriod :12 months
Patients take Tofacitinib 5mg twice a day.
Kyusyu University Hospital Medicine and biosystemic scienceNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not applicableJapan
688EUCTR2014-002945-23-EE
(EUCTR)
16/12/201427/11/2014A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI.A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. Rheumatoid Arthritis (RA)
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 Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
9Phase 2Czech Republic;Estonia;Spain;Russian Federation;United Kingdom
689JPRN-UMIN000015794
2014/12/1510/12/2014Efficacy 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 ) osteoporosis, rheumatoid arthritismonthly risedronate sodium 75mg for 6 months
monthly placebo for 6 months
Division of rheumatology, endcrinology and nephrology, Hokkaido University Graduate School of MedicineNULLComplete: follow-up continuing20years-oldNot applicableMale and Female165Phase 4Japan
690EUCTR2014-001114-26-GR
(EUCTR)
12/12/201402/12/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaringA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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] - Immune System Diseases [C20]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
334Phase 4Hungary;Canada;Greece;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
691EUCTR2014-001114-26-IE
(EUCTR)
11/12/201414/08/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab doseA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 4United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
692EUCTR2013-003530-33-NL
(EUCTR)
11/12/201422/05/2014Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494 Moderately to Severely Active Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
520Phase 2United States;Serbia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Puerto Rico;Belgium;Australia;Bulgaria;South Africa;Latvia;Netherlands;Moldova, Republic of
693EUCTR2014-000352-29-DE
(EUCTR)
11/12/201413/10/2014A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE 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 Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Product Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
560Phase 3Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
694EUCTR2014-000109-11-ES
(EUCTR)
09/12/201404/11/2014Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. 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] - Immune System Diseases [C20]
Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
695EUCTR2014-000352-29-HU
(EUCTR)
05/12/201409/10/2014A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE 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 Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
560Phase 3Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
696EUCTR2014-000993-20-SE
(EUCTR)
04/12/201402/09/2014Dosing of glucocorticoid (triamcinolone hexacetonid) when injecting knee joints of rheumatic diseasesDosing of intraarticular triamcinolone hexacetonid for knee synovitis in chronic polyarthritis Psoriatic arthritis and rheumatoid arthritis with synovitis of the knee;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: triamcinolone hexacetonide (Lederspan)
Product Name: triamcinolone hexacetonid (Lederspan)
Product Code: 9512
Trade Name: triamcinolone hexacetonide (Lederspan)
Product Name: triamcinolone hexacetonid (Lederspan)
Product Code: 9512
Center for Research and Development Uppsala University/County Council of GävleborgNULLNot RecruitingFemale: yes
Male: yes
160Phase 4Sweden
697EUCTR2014-000358-13-CZ
(EUCTR)
04/12/201404/08/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
698EUCTR2014-000358-13-PL
(EUCTR)
03/12/201424/09/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
699NCT02876874
(ClinicalTrials.gov)
December 20143/2/2015Relationship Between the Activity of Rheumatoid Arthritis and Lymph Node Morphology and Lymphatics Drainagethe Relationship Between the Activity of Rheumatoid Arthritis(RA) and Popliteal/Epitrochlear Lymph Node Morphology and the Drainage of Hand/Foot Superficial Lymphatic VesselsRheumatoid Arthritis;Lymph Node Mass;Lymphatic Vessel; DilatationDrug: indocyanine green(ICG)Shanghai University of Traditional Chinese MedicineNULLRecruiting18 Years65 YearsBoth21N/AChina
700EUCTR2013-001417-32-BG
(EUCTR)
27/11/201416/09/2014A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid ArthritisA Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Germany;Moldova, Republic of
701EUCTR2014-001114-26-GB
(EUCTR)
25/11/201414/08/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab doseA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
702EUCTR2013-003984-72-CZ
(EUCTR)
24/11/201414/04/2014A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone. Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
270Phase 2United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;South Africa;Latvia
703EUCTR2013-003530-33-CZ
(EUCTR)
24/11/201409/05/2014Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib 3mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 12mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 30mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 15mg
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
494Phase 2United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Puerto Rico;Belgium;South Africa;Bulgaria;Latvia;Netherlands;New Zealand
704EUCTR2013-002622-23-GR
(EUCTR)
20/11/201423/10/2014Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trialSafety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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] - Immune System Diseases [C20]
Product Code: Bi 695500Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
250Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
705EUCTR2014-002374-36-SE
(EUCTR)
19/11/201427/08/2014A study with dose de-escalation of coventional or biologic treatments in early rheeumatoid arthritis in patients with low disease activity.A multicenter, randomized, open-label, blinded-assessor, follow-up, phase 4 study in patients with rheumatoid arthritis who have completed the initial treatment part (active conventional therapy versus three biologic treatments) in the NORD-STAR study and have reached stable low disease activity - CO-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
Trade Name: Orencia
Trade Name: RoActemra
Trade Name: Methotrexate
Trade Name: Metoject
Trade Name: Azathioprine
Trade Name: Leflunomide
The Karolinska Institutet, ClinTRIDNULLNot RecruitingFemale: yes
Male: yes
500Phase 4Sweden
706EUCTR2013-005543-90-DE
(EUCTR)
19/11/201416/06/2014This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable 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 Name: ABP 798
Product Code: ABP 798
INN or Proposed INN: RITUXIMAB
Other descriptive name: ABP 798 - Biosimilar to rituximab
Trade Name: Rituxan
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituxan
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 1;Phase 3United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
707NCT02281552
(ClinicalTrials.gov)
November 18, 201430/10/2014A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid ArthritisA Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Study To Demonstrate Non-inferiority For The Efficacy Of A Once Daily Dose Of Tofacitinib Modified Release Tablet To A Twice Daily Dose Of The Immediate Release Tablet In Adult Patients With Rheumatoid Arthritis On Background MethotrexateRheumatoid ArthritisDrug: TofacitinibPfizerNULLCompleted20 YearsN/AAll209Phase 3Japan
708EUCTR2014-001114-26-ES
(EUCTR)
17/11/201401/09/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaringA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
334Phase 4Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
709EUCTR2014-001114-26-FR
(EUCTR)
13/11/201418/06/2015A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaringA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
334Phase 4Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Australia;Germany;Netherlands;Sweden
710EUCTR2014-000358-13-EE
(EUCTR)
13/11/201407/08/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
711EUCTR2014-000358-13-GB
(EUCTR)
12/11/201412/09/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
712EUCTR2014-001114-26-DE
(EUCTR)
10/11/201408/08/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab doseA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 4Sweden;Netherlands;Germany;Australia;Canada;Hungary;Italy;United Kingdom;Austria;Ireland;Spain;Greece;United States
713EUCTR2014-000358-13-RO
(EUCTR)
10/11/201410/03/2015A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
714EUCTR2014-000358-13-BG
(EUCTR)
06/11/201428/10/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
715EUCTR2014-000352-29-LT
(EUCTR)
06/11/201408/10/2014A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE 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 Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Product Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
560Phase 3Serbia;United States;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Peru;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
716EUCTR2013-002805-76-ES
(EUCTR)
06/11/201419/08/2014A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis followed by a 48-week active extension study.A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) followed by a 48-week active extension study. 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]
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
324Phase 2United States;Spain;Russian Federation;Colombia;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Korea, Republic of
717EUCTR2014-001114-26-AT
(EUCTR)
05/11/201410/10/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab doseA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 4United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
718EUCTR2013-004019-37-HU
(EUCTR)
04/11/201431/07/2014A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate 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]
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
225Phase 2Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand;Poland;Czech Republic;Hungary;Canada
719JPRN-UMIN000015616
2014/11/0410/11/2014Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction rheumatoid arthritisAdalimumab plus Methotrexate
Tocilizumab plus Methotrexate
Biologic Mate Study GroupNULLComplete: follow-up complete20years-old75years-oldMale and Female300Not selectedJapan
720EUCTR2014-001114-26-HU
(EUCTR)
04/11/201410/09/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab doseA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
200Phase 4United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
721NCT02342977
(ClinicalTrials.gov)
November 201418/12/2014Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty:Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty: A Randomized Double -Blinded, Placebo-controlled Pilot Study.Osteoarthritis;Rheumatoid Arthritis;Avascular NecrosisDrug: Placebo;Drug: LacosamideIndiana University School of MedicineVA Office of Research and DevelopmentWithdrawn18 Years70 YearsBoth0Phase 2United States
722NCT02293902
(ClinicalTrials.gov)
November 201413/11/2014A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX TherapyRheumatoid ArthritisDrug: Sarilumab SAR153191 (REGN88);Other: Placebo (for sarilumab);Drug: Methotrexate;Drug: Folic acidSanofiRegeneron PharmaceuticalsCompleted20 Years75 YearsAll243Phase 3Japan
723NCT02551575
(ClinicalTrials.gov)
November 201426/8/2015Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid ArthritisEfficacy and Safety of Qingre Huoxue Comprehensive Therapy in the Treatment of Rheumatoid Arthritis (RA): A Randomized, Double-blind, Double-dummy, Multi-center TrialRheumatoid ArthritisDrug: Treatment of MTX and HCQ;Drug: Treatment of TCM;Drug: Integrative MedicineGuang'anmen Hospital of China Academy of Chinese Medical SciencesNULLActive, not recruiting18 Years65 YearsBoth468Phase 2/Phase 3China
724NCT02030028
(ClinicalTrials.gov)
November 20146/1/2014ACTH Gel Therapy in Rheumatoid ArthritisOpen Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid ArthritisRheumatoid ArthritisDrug: ACTHAR gelDana AschermanMallinckrodtRecruiting18 Years100 YearsAll20N/AUnited States
725NCT02287610
(ClinicalTrials.gov)
November 20146/11/2014A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid ArthritisA Non-Interventional Study to Evaluate the Effectiveness of Delayed-Release Prednisone (RAYOS) on Clinical Assessments and Serologic Disease Activity in Patients With Active Rheumatoid Arthritis in the Clinical Practice SettingRheumatoid ArthritisDrug: RAYOS (delayed-release prednisone)Horizon Pharma Ireland, Ltd., Dublin IrelandNULLCompleted18 YearsN/AAll75N/ANULL
726NCT02319642
(ClinicalTrials.gov)
November 201415/12/2014An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044A 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 ArthritisDrug: Certolizumab PegolUCB Pharma SAParexelCompleted18 YearsN/AAll347Phase 3China
727NCT02296775
(ClinicalTrials.gov)
November 201418/11/2014Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisBiological: DRL_RI;Biological: Rituxan;Biological: MabTheraDr. Reddy's Laboratories LimitedNULLCompleted18 Years65 YearsAll276Phase 1/Phase 2India;Ukraine
728EUCTR2014-000443-33-PL
(EUCTR)
29/10/201421/07/2014Coherus RA StudyA 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, IncNULLNot RecruitingFemale: yes
Male: yes
620Phase 3United States;Belarus;Spain;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;South Africa;Germany;Japan
729EUCTR2014-000352-29-GB
(EUCTR)
29/10/201409/10/2014A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE 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 Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Product Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Pfizer Inc.NULLNot Recruiting Female: yes
Male: yes
560 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
730EUCTR2014-000352-29-CZ
(EUCTR)
27/10/201405/08/2014A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02). A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE 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 Name: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Product Name: Adalimumab-Pfizer
Product Code: PR-06410293
INN or Proposed INN: ADALIMUMAB
Pfizer Inc.NULLNot Recruiting Female: yes
Male: yes
560 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
731EUCTR2014-000443-33-IT
(EUCTR)
24/10/201424/06/2014Coherus RA StudyA 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, IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Belarus;Spain;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Argentina;Poland;Brazil;South Africa;Germany;Japan
732EUCTR2014-000443-33-ES
(EUCTR)
24/10/201404/07/2014Coherus RA StudyA 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, IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Belarus;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Brazil;South Africa;Germany;Japan
733EUCTR2014-000352-29-ES
(EUCTR)
23/10/201429/10/2014A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE 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: Adalimumab-Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB-EU
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
560Phase 3Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
734EUCTR2013-004019-37-RO
(EUCTR)
22/10/201405/03/2015A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate 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] - Immune System Diseases [C20]
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Czech Republic;Canada;Poland;Turkey;Romania;Denmark;Australia;Bulgaria;Germany;New Zealand
735EUCTR2013-004148-49-PL
(EUCTR)
21/10/201427/08/2014RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITISA PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE 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 Name: Infliximab-Pfizer
Product Code: PF-06438179
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-Pfizer
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-EU
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
614Phase 3United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Georgia;Germany;Japan
736EUCTR2013-004148-49-BG
(EUCTR)
20/10/201401/09/2014RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITISA PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE 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 Name: Infliximab-Pfizer
Product Code: PF-06438179
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-Pfizer
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-EU
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
614Phase 3Japan;Bulgaria;Germany;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Georgia
737EUCTR2014-000443-33-GB
(EUCTR)
20/10/201426/06/2014Coherus RA StudyA 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, IncNULLNot RecruitingFemale: yes
Male: yes
620Phase 3United States;Belarus;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;South Africa;Germany;Japan
738EUCTR2014-001114-26-IT
(EUCTR)
20/10/201416/09/2014A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaringA Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) 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: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
334Phase 4Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
739EUCTR2013-004019-37-CZ
(EUCTR)
15/10/201405/09/2014A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate 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]
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Czech Republic;Canada;Poland;Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand
740EUCTR2013-002805-76-GB
(EUCTR)
09/10/201430/12/2013 A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis.A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) NEXUS. Rheumatoid Arthritis (RA)
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 Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Takeda Development Centre Europe Ltd.NULLNot Recruiting Female: yes
Male: yes
108 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Poland;Spain;Russian Federation;Bulgaria;Germany;Japan;United Kingdom
741EUCTR2014-000706-34-GB
(EUCTR)
06/10/201418/07/2014A Study to Determine the Body's Immune Response To a Vaccination for Herpes Zoster In Subjects Who Have Rheumatoid Arthritis and Receive Tofacitinib (CP-690,550) (the drug being tested) or PlaceboA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS THE IMMUNE RESPONSE FOLLOWING ADMINISTRATION OF ZOSTER VACCINE TO SUBJECTS WITH RHEUMATOID ARTHRITIS RECEIVING TOFACITINIB (CP-690,550) OR PLACEBO WITH BACKGROUND METHOTREXATE TREATMENT 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] - Immune System Diseases [C20]
Product Name: tofacitinib citrate
Product Code: CP-690,550 – 10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
140Phase 2United States;Hungary;Germany;United Kingdom
742EUCTR2013-002805-76-DE
(EUCTR)
06/10/201427/01/2014A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis followed by a 48-week active extension study.A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) followed by a 48-week active extension study. 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]
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
324Phase 2Czech Republic;Mexico;Argentina;Poland;Brazil;Spain;Russian Federation;Bulgaria;Colombia;Germany;United Kingdom;Korea, Republic of
743EUCTR2014-001299-79-DK
(EUCTR)
06/10/201407/07/2014Pnemococcal vaccination of rheumatoid arthritis patients in biological treatmentPneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy - Immunovax_RA Immunoresponse on pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy
MedDRA version: 18.0;Level: LLT;Classification code 10069594;Term: Pneumococcal immunization;System Organ Class: 100000004865;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Prevenar 13
INN or Proposed INN: pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE
Trade Name: Pneumovax
INN or Proposed INN: pneumococcal polysaccharide serotype 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT)
Department of Infectious Diseases, Odense University HospitalNULLNot RecruitingFemale: yes
Male: yes
Phase 3Denmark
744EUCTR2014-000358-13-LT
(EUCTR)
03/10/201411/09/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Germany
745EUCTR2014-000859-91-FR
(EUCTR)
03/10/201418/06/2015Relation 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 TOURSNULLNot RecruitingFemale: yes
Male: yes
100Phase 4France
746JPRN-UMIN000015217
2014/10/0101/10/2014Identification of Antibodies Involved in Atherosclerosis Progression and Evaluation of Orencia`s Efficacy on Antibodies, Atherosclerosis Biomarkers and Structural Markers in Orencia-Treated Patients with Rheumatoid Arthritis Complicated by AtherosclerosisIdentification of Antibodies Involved in Atherosclerosis Progression and Evaluation of Orencia`s Efficacy on Antibodies, Atherosclerosis Biomarkers and Structural Markers in Orencia-Treated Patients with Rheumatoid Arthritis Complicated by Atherosclerosis - Orencia Atherosclerosis And Rheumatoid Arthritis Study(ORACLE Arthritis Study) RA patients aged 20 years or older and have never been treated with biological products or molecular targeted drug therapy.AbataceptYokohama City University Graduate School of MedicineNULLRecruiting20years-oldNot applicableMale and Female40Not applicableJapan
747JPRN-UMIN000015462
2014/10/0117/10/2014Clinical study on drug holiday with regulated rheumatoid arthritis activity after treatment with tofacitinib (Xanadu study) Rheumatoid arthritisContinue current treatment
Tofacitinib discontinuation
MTX discontinuation
School of Medicine, University of Occupational and Environmental Health, JapanNULLRecruiting18years-oldNot applicableMale and Female400Not selectedJapan
748NCT02148640
(ClinicalTrials.gov)
October 201423/5/2014The NOR-SWITCH StudyA RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDYRheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis ChronicDrug: Innovator infliximab;Drug: Biosimilar infliximabDiakonhjemmet HospitalSouth-Eastern Norway Regional Health AuthorityCompleted18 YearsN/AAll482Phase 4Norway
749EUCTR2014-000358-13-LV
(EUCTR)
26/09/201411/09/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
750EUCTR2011-005689-39-SK
(EUCTR)
24/09/201407/07/2014A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
208Phase 2United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of
751EUCTR2013-004555-21-GR
(EUCTR)
22/09/201421/03/2014This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid ArthritisA Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis 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: CT- P10
Product Code: CT- P10
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera
Product Code: L01XC02
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
CELLTRION, Inc.NULLNot RecruitingFemale: yes
Male: yes
361Phase 3Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina
752EUCTR2012-002945-40-DE
(EUCTR)
22/09/201401/04/2014BI695501 compared to adalimumab in patients with active rheumatoid arthritisEfficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial 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]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
650Phase 3United States;Serbia;Estonia;Thailand;Spain;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of
753EUCTR2013-002358-57-BE
(EUCTR)
18/09/201415/07/2014A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic TherapyA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy Moderately to Severely Active Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Spain;Belgium;Australia;Netherlands;United Kingdom
754EUCTR2013-002805-76-CZ
(EUCTR)
11/09/201417/07/2014A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis.A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) NEXUS. Rheumatoid Arthritis (RA)
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 Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
108Phase 2Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Japan;United Kingdom
755EUCTR2011-004720-35-FI
(EUCTR)
10/09/201409/09/2014A 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 InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Finland;Denmark;Sweden
756EUCTR2013-003177-99-NL
(EUCTR)
09/09/201425/02/2014A 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, 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4United 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
757EUCTR2014-000443-33-HU
(EUCTR)
09/09/201406/06/2014Coherus RA StudyA 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, IncNULLNot RecruitingFemale: yes
Male: yes
620Phase 3United States;Belarus;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;South Africa;Germany;Japan
758EUCTR2013-005543-90-PL
(EUCTR)
09/09/201411/07/2014This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable 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 Name: ABP 798
Product Code: ABP 798
INN or Proposed INN: rituximab
Other descriptive name: ABP 798 - Biosimilar to rituximab
Trade Name: Rituxan
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituxan
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 1;Phase 3United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
759EUCTR2012-003654-86-BG
(EUCTR)
04/09/201421/05/2014Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate aloneRandomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone moderately to severely active 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: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Propsoed INN - FILGOTINIB
Other descriptive name: GLPG0634
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
760JPRN-UMIN000014624
2014/09/0123/07/2014Effects of postoperative administration of celecoxib on postoperative pain management in patients after total knee arthroplasty. A randomized controlled study. Osteoarthritis, Rheumatoid arthritisAdministration of celecoxib from 2 hours after TKA surgery
Administration of celecoxib from 2 days after TKA surgery
Mito medical center, Mito Kyodo General Hospital, University of TsukubaNULLComplete: follow-up complete20years-oldNot applicableMale and Female120Phase 4Japan
761NCT02097264
(ClinicalTrials.gov)
September 201424/3/2014A Trial Investigating the Mechanism of Action of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to MethotrexateA Randomised, Active Comparator, Double-blind, Multi Centre, Parallel, Phase 2a Trial, Investigating the Mechanism of Action, of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to MethotrexateInflammation;Rheumatoid ArthritisDrug: NNC0109-0012;Drug: Adalimumab;Drug: placeboNovo Nordisk A/SNULLWithdrawn18 Years75 YearsBoth0Phase 2Ireland;Portugal;Spain;United Kingdom
762EUCTR2013-005543-90-HU
(EUCTR)
26/08/201413/05/2014This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body, and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable 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 Name: ABP 798
Product Code: ABP 798
INN or Proposed INN: rituximab
Other descriptive name: ABP 798 - Biosimilar to rituximab
Trade Name: Rituxan
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituxan
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 1;Phase 3United States;Estonia;Hungary;Canada;Poland;Bulgaria;Germany
763EUCTR2012-002945-40-BG
(EUCTR)
21/08/201405/08/2014BI695501 compared to adalimumab in patients with active rheumatoid arthritisEfficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial 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]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
650Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Russian Federation;Chile;Hungary;Poland;Malaysia;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of
764EUCTR2013-004148-49-HU
(EUCTR)
13/08/201406/06/2014RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITISA PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE 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 Name: Infliximab-Pfizer
Product Code: PF-06438179
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-Pfizer
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-EU
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
614Phase 3United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
765EUCTR2014-002056-40-NO
(EUCTR)
12/08/201413/06/2014A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasisA RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858
MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Diakonhjemmet Hospital ASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Norway
766EUCTR2013-004604-19-DE
(EUCTR)
06/08/201403/06/2014Effect of Adalimumab plus Methortrexat (MTX) versus Placebo plus MTX on cartilage in early RA patientsDelayed 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 DüsseldorfNULLNot RecruitingFemale: yes
Male: yes
30Phase 3Germany
767EUCTR2013-002622-23-DE
(EUCTR)
06/08/201427/03/2014Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trialSafety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial moderately to severely active rheumatoid arthritis
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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]
Product Code: Bi 695500Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
250United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
768JPRN-UMIN000014737
2014/08/0101/08/2014The effects of denosumab compared with oral bisphosphonates (BP) in patients with RA complicated with osteoporosis on the progression of structural damage, BMD and disease activity. rheumatoid arthritisDenosumab group: Denosumab 60mg is administered by subcutaneous injections every 6 months (at baseline, at 6 months and at 12 months). All patients are to take vitamin D.
BP group: Patients take BP continuously. All patients are to take vitamin D.
Yokohama City University Medical CenterNULLComplete: follow-up complete50years-old90years-oldMale and Female286Not selectedJapan
769NCT02219191
(ClinicalTrials.gov)
August 201416/7/2014Puerarin Versus Atorvastatin in Treating Metabolism Syndrome in Patients With Chronic Rheumatic DiseasesThe Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic DiseasesRheumatoid ArthritisDrug: puerarin tablet 50 mg;Drug: Atorvastatin tablet 20 mgChengdu PLA General HospitalNULLActive, not recruiting18 Years75 YearsAll150N/AChina
770NCT02234960
(ClinicalTrials.gov)
August 20145/9/2014Local, Non-Interventional Study of RoActemra (Tocilizumab) in Poland (ACT-POL): First-Line Treatment in Routine Clinical Practice of Participants With Rheumatoid Arthritis (RA)TOCILIZUMAB IN FIRST LINE BIOLOGIC TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS IN ROUTINE CLINICAL PRACTICE IN POLAND - MULTICENTER, NON-INTERVENTIONAL, PROSPECTIVE, OBSERVATIONAL STUDY (ACT-POL)Rheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/ABoth102N/APoland
771EUCTR2013-002358-57-NL
(EUCTR)
30/07/201424/02/2014A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic TherapyA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy Moderately to Severely Active Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Spain;Australia;Netherlands;United Kingdom
772EUCTR2013-002622-23-ES
(EUCTR)
29/07/201425/04/2014Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trialSafety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial moderately to severely active rheumatoid arthritis
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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]
Product Code: Bi 695500
INN or Proposed INN: Not applicable
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
250United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
773EUCTR2013-004148-49-DE
(EUCTR)
28/07/201406/06/2014RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITISA PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE 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 Name: Infliximab-Pfizer
Product Code: PF-06438179
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-Pfizer
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-EU
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
614Phase 3Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany
774EUCTR2013-003530-33-LV
(EUCTR)
28/07/201417/06/2014Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494 Moderately to Severely Active Rheumatoid Arthritis (RA)
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: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494
Product Name: ABT-494 30mg
INN or Proposed INN: ABT-494
Product Name: ABT-494 15mg
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
494Phase 2United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;Bulgaria;South Africa;Netherlands;Latvia;New Zealand
775EUCTR2013-003177-99-GB
(EUCTR)
17/07/201411/03/2014A 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.NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4United 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
776EUCTR2013-004148-49-LT
(EUCTR)
14/07/201423/05/2014RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITISA PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE 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 Name: Infliximab-Pfizer
Product Code: PF-06438179
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-Pfizer
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-EU
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
614Phase 3Poland;Brazil;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina
777EUCTR2013-003177-99-CZ
(EUCTR)
10/07/201405/02/2014A 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.NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4Mexico;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
778EUCTR2012-002945-40-ES
(EUCTR)
07/07/201429/04/2014BI695501 compared to adalimumab in patients with active rheumatoid arthritisEfficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial 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]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Colombia;France;Hungary;Mexico;Argentina;Poland;Malaysia;Belgium;South Africa;Bulgaria;Germany;New Zealand;Korea, Republic of
779JPRN-UMIN000016928
2014/07/0326/03/2015Targeted Ultrasound in Rheumatoid Arthritis Rheumatoid arthritisIf DAS28 increased by >0.6 from baseline, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week.
If DAS28 increased by >0.6 from baseline or total PD score is 4 or greater, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week.
Leeds UniversityNULLRecruiting18years-oldNot applicableMale and Female400Not selectedJapan,Europe
780EUCTR2013-004148-49-GB
(EUCTR)
03/07/201406/06/2014 RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITISA PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE 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 Name: Infliximab-Pfizer
Product Code: PF-06438179
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-Pfizer
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-EU
Pfizer Inc.NULLNot Recruiting Female: yes
Male: yes
614 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
781JPRN-UMIN000015175
2014/07/0117/09/2014Head-to-head comparison of Subcutaneous Tocilizumab versus Abatacept for Rheumatoid arthritis : prospective, randomized trial. Rheumatoid ArthritisSubcutaneous Tocilizumab 162mg every other week.
Subcutaneous Abatacept 125mg every week.
St.Marianna University School of MedicineNULLRecruiting20years-oldNot applicableMale and Female120Not selectedJapan
782NCT02011334
(ClinicalTrials.gov)
July 20144/12/2013A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs.A MULTICENTER, OPEN LABEL STUDY TO EVALUATE EFFICACY AND SAFETY OF TOCILIZUMAB GIVEN SUBCUTANEOUSLY IN MONOTHERAPY AND IN COMBINATION WITH NON-BIOLOGIC DMARDS IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS IN LATIN AMERICARheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/ABoth285Phase 3Argentina;Brazil;Colombia;Dominican Republic;Mexico;Venezuela;Ecuador;Uruguay
783EUCTR2013-003984-72-ES
(EUCTR)
30/06/201409/05/2014A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone. 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] - Immune System Diseases [C20]
Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494
AbbVie Inc.NULLNot RecruitingFemale: yes
Male: yes
270Phase 2United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia
784EUCTR2013-001417-32-ES
(EUCTR)
30/06/201422/05/2014A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid ArthritisA Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Chile;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of;Sweden
785EUCTR2013-004654-13-RO
(EUCTR)
27/06/201430/05/2014The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritisAn Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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: ABP 501
Product Code: ABP 501
Other descriptive name: ABP 501
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
425Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
786EUCTR2013-003530-33-ES
(EUCTR)
26/06/201417/03/2014Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494 Moderately to Severely Active 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] - Immune System Diseases [C20]
Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
520Phase 2United States;Serbia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Puerto Rico;Belgium;Australia;Bulgaria;South Africa;Latvia;Netherlands;Moldova, Republic of
787EUCTR2013-005013-13-PL
(EUCTR)
25/06/201431/03/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® 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 SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
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]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of
788JPRN-UMIN000014311
2014/06/2424/06/2014Examination of the clinical remission and functional remission in Infliximab using the increase-in-quantity protocol to TNF-alpha inhibitory drug resistance rheumatoid arthritis rheumatoid arthritisThe quantity of Infliximab is increased.Institute of Health Biosciences,The University of Tokushima Graduate SchoolNULLPending20years-old75years-oldMale and Female10Not selectedJapan
789EUCTR2013-002622-23-NL
(EUCTR)
24/06/201417/02/2014Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trialSafety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial moderately to severely active rheumatoid arthritis
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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]
Product Code: Bi 695500
INN or Proposed INN: Rituximab
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
250United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
790EUCTR2013-003984-72-SK
(EUCTR)
23/06/201415/04/2014A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone. 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] - Immune System Diseases [C20]
Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
270Phase 2Latvia;South Africa;Puerto Rico;Mexico;European Union;Hungary;Czech Republic;Russian Federation;Israel;Chile;Turkey;Ukraine;Spain;Slovakia;Serbia;United States
791EUCTR2013-004148-49-CZ
(EUCTR)
20/06/201405/06/2014RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITISA PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE 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 Name: Infliximab-Pfizer
Product Code: PF-06438179
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-Pfizer
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-EU
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
614Phase 3United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
792EUCTR2010-019262-86-BE
(EUCTR)
20/06/201404/03/2014Long term evaluation of sarilumab in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND 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 Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
2000Phase 3United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden
793EUCTR2013-001417-32-LT
(EUCTR)
19/06/201407/04/2014A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid ArthritisA Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of
794EUCTR2013-003530-33-HU
(EUCTR)
18/06/201426/03/2014Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494) Moderately to Severely Active Rheumatoid Arthritis (RA)
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]
Product Name: Upadacitinib 3mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 12mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 30mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 15mg
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
494Phase 2United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;Bulgaria;South Africa;Latvia;Netherlands;New Zealand
795EUCTR2012-003686-17-SI
(EUCTR)
17/06/201403/04/2014A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
796EUCTR2012-002535-28-PT
(EUCTR)
06/06/201425/02/2014Not applicableA Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA 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
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University LondonNULLNot RecruitingFemale: yes
Male: yes
160Phase 4Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
797EUCTR2013-002622-23-HU
(EUCTR)
03/06/201402/04/2014Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trialSafety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial moderately to severely active rheumatoid arthritis
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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]
Product Code: Bi 695500Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
250United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
798EUCTR2013-002790-22-HU
(EUCTR)
02/06/201403/04/2014To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE 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]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
120United States;Estonia;Czech Republic;Hungary;Argentina;Poland;Russian Federation;Chile
799EUCTR2013-001417-32-DE
(EUCTR)
02/06/201418/02/2014A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid ArthritisA Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H 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] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Chile;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of;Sweden
800JPRN-UMIN000013546
2014/06/0131/03/2014The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitistake a glass of grapefruit juice every day
do not take grapefruit juice
Department of Rheumatology and Clinical Immunology, Kyoto University HospitalNULLPending16years-old80years-oldMale and Female20Not applicableJapan
801EUCTR2012-001176-10-PL
(EUCTR)
31/05/201428/04/2014Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE 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] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
2165Phase 3Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
802EUCTR2013-002790-22-EE
(EUCTR)
30/05/201407/05/2014To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE 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
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
120United States;Hungary;Czech Republic;Estonia;Argentina;Poland;Russian Federation;Chile
803EUCTR2013-003984-72-LV
(EUCTR)
30/05/201428/03/2014A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone. Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
270 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia
804NCT02046616
(ClinicalTrials.gov)
May 28, 201424/1/2014A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)Tocilizumab SC in Patients With Active Rheumatoid Arthritis and Inadequate Response to DMARDs. A Single-Arm, Open-Label Study to Evaluate Safety, Tolerability and Efficacy. In a Subgroup of Patients Inflammation Will Be Measured by Ultrasound.Rheumatoid ArthritisDrug: Tocilizumab;Drug: Methotrexate;Drug: Non-Biologic DMARDsHoffmann-La RocheNULLCompleted18 YearsN/AAll133Phase 3Denmark;Finland;Norway;Sweden
805EUCTR2011-004720-35-DK
(EUCTR)
28/05/201424/02/2014A 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: 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: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
INN or Proposed INN: METHOTREXATE
Trade Name: Metoject
Other descriptive name: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 4Finland;Denmark;Netherlands;Norway;Iceland;Sweden
806EUCTR2012-002945-40-HU
(EUCTR)
27/05/201404/04/2014BI695501 compared to adalimumab in patients with active rheumatoid arthritisEfficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial 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] - Immune System Diseases [C20]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
650Phase 3United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Malaysia;Poland;South Africa;Bulgaria;Germany;New Zealand;Korea, Republic of
807EUCTR2013-001417-32-HU
(EUCTR)
27/05/201417/03/2014A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid ArthritisA Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of
808EUCTR2013-003493-27-GR
(EUCTR)
27/05/201416/04/2014Study with the aim to evaluate the safety, tolerability and efficacy of QAL964 in patients with Rheumatoid Arthritis who are treated with anti-rheumatic drug methotrexate but where the treatment does not sufficiently work.A randomized, double-blind, placebo-controlled study toinvestigate the safety, tolerability and efficacy of orallyadministered QAL964 in patients with active rheumatoidarthritis on stable doses of methotrexate and withinadequate response to methotrexate - CQAL964B2201 Rheumatoid Arthritis
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: QAL964
Other descriptive name: QAL964
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
42Hungary;Greece;Ukraine;Romania;Russian Federation
809EUCTR2012-003654-86-LV
(EUCTR)
26/05/201424/04/2014Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone.Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone moderately to severely active 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]
Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Propsoed INN - FILGOTINIB
Other descriptive name: GLPG0634
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Serbia;Spain;Ukraine;Guatemala;Lithuania;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Australia;Peru;Bulgaria;Germany;Latvia;New Zealand
810EUCTR2012-004339-21-PL
(EUCTR)
25/05/201423/04/2014To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid ArthritisA Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy - SARIL-RA-EASY 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 Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: sarilumab
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Mexico;Poland;Russian Federation;Chile;South Africa
811EUCTR2013-004654-13-DE
(EUCTR)
22/05/201403/02/2014The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritisAn Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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: ABP 501
Product Code: ABP 501
INN or Proposed INN: N/A
Other descriptive name: ABP 501
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
425Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
812EUCTR2013-002790-22-CZ
(EUCTR)
21/05/201408/04/2014To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE 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]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
120Phase 3United States;Hungary;Estonia;Czech Republic;Argentina;Poland;Russian Federation;Chile
813EUCTR2013-003984-72-HU
(EUCTR)
20/05/201404/04/2014A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone. Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494
AbbVie Deutschland GmbH & Co.KGNULLNot RecruitingFemale: yes
Male: yes
270Phase 2United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia
814EUCTR2013-003413-18-GB
(EUCTR)
13/05/201404/04/2014Arthritis prevention with abataceptArthritis Prevention In the Pre-clinical Phase of RA with Abatacept. - APIPPRA The target population for therapeutic intervention will be subjects who carry serum autoantibodies (antibodies to citrullinated protein antigens – ACPA; rheumatoid factor – RF) and who have joint pains (arthralgia) but no joint swelling. These subjects are deemed to be at highest risk of developing rheumatoid arthritis.
MedDRA version: 20.0;Level: PT;Classification code 10003239;Term: Arthralgia;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ORENCIA 125 mg solution for injectionKing’s College LondonGuy's and St. Thomas' NHS Foundation Trust;Leiden University Medical CenterAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
206 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noNetherlands;United Kingdom
815EUCTR2012-002945-40-EE
(EUCTR)
09/05/201410/04/2014BI695501 compared to adalimumab in patients with active rheumatoid arthritisEfficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial 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]
Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
650Phase 3United States;Serbia;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;New Zealand;Korea, Republic of
816EUCTR2013-002622-23-PT
(EUCTR)
09/05/201428/02/2014Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trialSafety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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] - Immune System Diseases [C20]
Product Code: Bi 695500Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
817EUCTR2010-019262-86-SE
(EUCTR)
09/05/201424/03/2014Long term evaluation of sarilumab in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND 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 Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
2000Phase 3United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden
818EUCTR2012-001176-10-HR
(EUCTR)
08/05/201405/09/2014Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
2165 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
819EUCTR2013-003177-99-ES
(EUCTR)
07/05/201417/03/2014A 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, 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4United 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
820EUCTR2013-005013-13-BG
(EUCTR)
28/04/201423/04/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® 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 SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
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] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Phase 3Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
821EUCTR2013-003177-99-SK
(EUCTR)
28/04/201410/03/2014A 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.NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4United 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
822EUCTR2012-002535-28-BE
(EUCTR)
28/04/201428/03/2014A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RAA Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA 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: RoActemra
Product Name: RoActemra
Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)NULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesPortugal;Spain;Belgium;Netherlands;Italy;United Kingdom
823EUCTR2012-001176-10-NL
(EUCTR)
18/04/201428/12/2013Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE 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] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
2165Phase 3Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China
824EUCTR2013-004654-13-BG
(EUCTR)
14/04/201418/03/2014An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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: ABP 501
Product Code: ABP 501
Other descriptive name: ABP 501
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
425Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
825EUCTR2013-004654-13-PL
(EUCTR)
13/04/201403/04/2014The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritisAn Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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 Name: ABP 501
Product Code: ABP 501
Other descriptive name: ABP 501
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
425Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
826EUCTR2013-003177-99-SE
(EUCTR)
11/04/201405/02/2014A 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, 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4United 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
827EUCTR2013-005013-13-LT
(EUCTR)
08/04/201413/02/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® 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 SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
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]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
828EUCTR2013-003493-27-HU
(EUCTR)
08/04/201430/01/2014Study with the aim to evaluate the safety, tolerability and efficacy of QAL964 in patients with Rheumatoid Arthritis who are treated with anti-rheumatic drug methotrexate but where the treatment does not sufficiently work.A randomized, double-blind, placebo-controlled study toinvestigate the safety, tolerability and efficacy of orallyadministered QAL964 in patients with active rheumatoidarthritis on stable doses of methotrexate and withinadequate response to methotrexate - CQAL964B2201 Rheumatoid Arthritis
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: QAL964
Other descriptive name: QAL964
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Hungary;Ukraine;Russian Federation
829EUCTR2013-004555-21-SK
(EUCTR)
07/04/201423/01/2014This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid ArthritisA Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis 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: CT- P10
Product Code: CT- P10
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera
Product Code: L01XC02
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
CELLTRION, Inc.NULLNot RecruitingFemale: yes
Male: yes
361Phase 3Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina
830EUCTR2013-004555-21-AT
(EUCTR)
07/04/201402/01/2014This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid ArthritisA Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 19.0;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: CT- P10
Product Code: CT- P10
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera
Product Code: L01XC02
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
CELLTRION, Inc.NULLNot RecruitingFemale: yes
Male: yes
361Phase 3Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of
831EUCTR2013-002358-57-CZ
(EUCTR)
04/04/201411/12/2013A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic TherapyA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy Moderately to Severely Active Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Spain;Australia;Netherlands;United Kingdom
832EUCTR2013-005013-13-CZ
(EUCTR)
03/04/201413/02/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® 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 SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
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]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
833EUCTR2013-002622-23-BE
(EUCTR)
02/04/201426/03/2014Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trialSafety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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]
Product Code: Bi 695500Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
834EUCTR2013-004555-21-HU
(EUCTR)
02/04/201423/01/2014This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid ArthritisA Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 18.0;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: CT- P10
Product Code: CT- P10
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera
Product Code: L01XC02
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
CELLTRION, Inc.NULLNot RecruitingFemale: yes
Male: yes
361Phase 3Korea, Republic of;Bosnia and Herzegovina;Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Latvia;Germany
835JPRN-UMIN000013440
2014/04/0118/03/2014To evaluate the efficacy and safety of subcutaneous and intravenous abatacept. Rheumatoid arthritisSC abatacept
IV abatacept
Extension of SC abatacept
Osaka Medical CollegeNULLComplete: follow-up complete20years-old80years-oldMale and Female50Not selectedJapan
836EUCTR2013-004555-21-DE
(EUCTR)
31/03/201417/01/2014This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid ArthritisA Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 20.0;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: CT- P10
Product Code: CT- P10
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera
Product Code: L01XC02
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
CELLTRION, Inc.NULLNot RecruitingFemale: yes
Male: yes
361Phase 3Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany;Latvia;Bosnia and Herzegovina;Korea, Republic of
837EUCTR2012-003655-11-BG
(EUCTR)
27/03/201419/02/2014Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of lifeA multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis moderately to severely active 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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
739Phase 2United States;Czechia;Spain;Guatemala;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of
838EUCTR2013-002622-23-BG
(EUCTR)
27/03/201421/03/2014Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trialSafety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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]
Product Code: Bi 695500Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
250Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
839EUCTR2010-020992-21-DE
(EUCTR)
25/03/201408/07/2011Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritisA 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, Phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis. 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] - Immune System Diseases [C20]
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
INN or Proposed INN: METHOTREXATE
Other descriptive name: not applicable
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
140Phase 2Serbia;United States;Philippines;Taiwan;Morocco;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Monaco;India;Czech Republic;Mexico;Argentina;Poland;Romania;South Africa;Germany;Tunisia;Bosnia and Herzegovina
840EUCTR2013-005001-31-ES
(EUCTR)
25/03/201407/02/2014Study on the ability of zoledronic acid to prevent worsening of radiographs of hands and feet of patients with rheumatoid arthritis diagnosed less than 2 years ago and who have few symptoms in their joints by making treatment with the drugs commonly used for the management of disease.Randomized clinical trial on the prevention of radiographic progression with zoledronic acid in patients with early rheumatoid arthritis and low disease activity - Prevention of radiographic progression in rheumatoid arthritis with zoledronic acid 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: Zoledronic acid
Product Name: Zoledronic acid
INN or Proposed INN: ZOLEDRONIC ACID
Dra. Carmen Gómez Vaquero (Servicio de Reumatología del Hospital Universiari de Bellvitge - Idibell)NULLNot RecruitingFemale: yes
Male: yes
Phase 3Spain
841EUCTR2013-004654-13-ES
(EUCTR)
25/03/201428/01/2014The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritisAn Open-Label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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]
Product Name: ABP 501
Product Code: ABP 501
INN or Proposed INN: ABP 501
Other descriptive name: ABP 501
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
425Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
842EUCTR2013-000525-31-RO
(EUCTR)
24/03/201412/02/2015The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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: ABP 501
Product Code: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
843EUCTR2010-019262-86-NO
(EUCTR)
24/03/201408/10/2010Long term evaluation of SAR153191 (REGN88, sarilumab) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating safety and efficacy of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND 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]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1940United States;Portugal;Belarus;Philippines;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Norway;Germany;New Zealand
844EUCTR2013-003780-65-IT
(EUCTR)
24/03/201403/12/2013Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid ArthritisA Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects with Moderate to Severe Active Rheumatoid Arthritis who have Experienced an Inadequate Response to TNF inhibitors Rheumatoid Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859
MedDRA version: 14.1;Classification code 10060732;Term: Rheumatoid arthritis flare up;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
240Phase 2France;United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Australia;South Africa;Japan;Italy
845EUCTR2013-004555-21-PT
(EUCTR)
24/03/201407/01/2014This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid ArthritisA Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 20.0;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: CT- P10
Product Code: CT- P10
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera
Product Code: L01XC02
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
CELLTRION, Inc.NULLNot RecruitingFemale: yes
Male: yes
361Phase 3Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina
846EUCTR2013-003780-65-HU
(EUCTR)
19/03/201421/01/2014Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid ArthritisA Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects with Moderate to Severe Active Rheumatoid Arthritis who have Experienced an Inadequate Response to TNF inhibitorsRevised Protocol Number 02 incorporating Amendment 06 andAdministrative Letter 02 Rheumatoid Arthritis
MedDRA version: 17.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859
MedDRA version: 17.1;Classification code 10060732;Term: Rheumatoid arthritis flare up;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
230Phase 2France;United States;Hungary;Mexico;Canada;Argentina;Australia;South Africa;Japan;Italy
847EUCTR2012-003686-17-GR
(EUCTR)
18/03/201416/01/2014A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
848EUCTR2012-003194-25-HR
(EUCTR)
17/03/201403/09/2014Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid ArthritisRandomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis Active 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: MabionCD20
INN or Proposed INN: Rituximab
Trade Name: MabThera®
Product Name: MabThera®
INN or Proposed INN: RITUXIMAB
Mabion S.A.NULLNot Recruiting Female: yes
Male: yes
863 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Poland;Ukraine;Romania;Lithuania;Croatia;Russian Federation;Georgia
849JPRN-UMIN000013362
2014/03/1506/03/2014Examination of the remission maintenance effect by low dose etanercept after clinical remission in the rheumatoid arthritis. Rheumatoid ArthritisMethotrexate
Etanercept
Takarazuka city hospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female60Not selectedJapan
850EUCTR2013-002358-57-ES
(EUCTR)
11/03/201405/12/2013A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic TherapyA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy Moderately to Severely Active 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] - Immune System Diseases [C20]
Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494
AbbVie Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Spain;Australia;Netherlands;United Kingdom
851EUCTR2013-001492-20-PT
(EUCTR)
05/03/201424/01/2014A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to MethotrexateA randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to 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] - Skin and Connective Tissue Diseases [C17]
Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Other descriptive name: NNC0109-0012
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
42Phase 2Portugal;Spain;Ireland;United Kingdom
852ChiCTR-TCS-14004252
2014-03-042014-02-12A multicenter study for the evaluation of efficacy & safety of buprenorphine transdermal patch (Norspan or Sovenor transdermal patch) in patients with non-malignant pain of moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain and joint/muscle pain, when an opioidA multicenter study for the evaluation of efficacy & safety of buprenorphine transdermal patch (Norspan or Sovenor transdermal patch) in patients with non-malignant pain of moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain and joint/muscle pain, when an opioid osteoarthritis, rheumatoid arthritis, lower back pain, joint/muscle paincase series:Norspan 5mg patch (1 patch per week), and the dose can be titrated up to maximum 40mg patch in the titration period (maximun 42 days). Patient will then be using the optimum dosage for 11 weeks, and follow-up for another 2 weeks after treatment period, maximum 19 weeks;The Chinese University of Hong KongNULLPending1880Bothcase series:15;I (Phase 1 study)NULL
853NCT02046603
(ClinicalTrials.gov)
March 4, 201424/1/2014A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic AgentOpen-Label, Phase IIIb Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab Monotherapy or Combination Therapy With Methotrexate (MTX) or Other Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Patients With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-Tumour Necrosis Factor (Anti-TNF) Biologic AgentRheumatoid ArthritisDrug: Tocilizumab;Drug: DMARDs;Drug: Oral Corticosteroids;Drug: MethotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll162Phase 3United Kingdom
854EUCTR2013-004555-21-LV
(EUCTR)
03/03/201402/01/2014This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid ArthritisA Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis 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: CT- P10
Product Code: CT- P10
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera
Product Code: L01XC02
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
CELLTRION, Inc.NULLNot RecruitingFemale: yes
Male: yes
361Phase 3Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Germany;Latvia;Korea, Republic of;Bosnia and Herzegovina
855EUCTR2012-003635-31-AT
(EUCTR)
26/02/201402/07/2013Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate aloneRandomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. moderately to severely active 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: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: GLPG0634
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
595Phase 2United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
856EUCTR2013-004051-20-ES
(EUCTR)
26/02/201427/12/2013NOT CONTROLLED STUDY TO ASSESS THE EFFICACY OF TOCILIZUMAB IN PATIENTS WITH MODERATE OR SEVERE RHEUMATOID ARTHRITIS WHO ARE CANDIDATES TO BE TREATED WITH A BIOLOGICAL THERAPY AS MONOTHERAPYNOT CONTROLLED STUDY TO ASSESS THE EFFICACY OF TOCILIZUMAB IN PATIENTS WITH MODERATE OR SEVERE RHEUMATOID ARTHRITIS WHO ARE CANDIDATES TO BE TREATED WITH A BIOLOGICAL THERAPY AS MONOTHERAPY RHEUMATOID ARTHRITIS;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: ROACTEMRA
FUNDACIÓN ESPAÑOLA DE REUMATOLOGIANULLNot RecruitingFemale: yes
Male: yes
122Phase 4Spain
857EUCTR2012-003654-86-AT
(EUCTR)
26/02/201408/07/2013Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate aloneRandomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone moderately to severely active 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: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Propsoed INN - FILGOTINIB
Other descriptive name: GLPG0634
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
280Phase 2Serbia;United States;Spain;Guatemala;Ukraine;Lithuania;Austria;Israel;Chile;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany;New Zealand
858NCT02065700
(ClinicalTrials.gov)
February 25, 201414/2/2014Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis PatientsA Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid ArthritisRheumatoid ArthritisDrug: FilgotinibGalapagos NVGilead SciencesActive, not recruiting18 YearsN/AAll739Phase 2United States;Argentina;Australia;Belgium;Bulgaria;Chile;Colombia;Czechia;France;Germany;Guatemala;Hungary;Israel;Latvia;Mexico;Moldova, Republic of;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine;Czech Republic
859EUCTR2013-004654-13-HU
(EUCTR)
24/02/201414/01/2014The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritisAn Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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: ABP 501
Product Code: ABP 501
INN or Proposed INN: N/A
Other descriptive name: ABP 501
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
425Bulgaria;Germany;United States;Spain;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania
860EUCTR2012-001176-10-DE
(EUCTR)
24/02/201405/12/2013Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE 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: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
2165Phase 3Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
861EUCTR2013-002007-34-SE
(EUCTR)
20/02/201423/01/2014Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound - TOZULTRA 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: RoActemra
Product Name: Tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
Roche a/sNULLNot RecruitingFemale: yes
Male: yes
137Phase 3Finland;Denmark;Sweden
862EUCTR2012-001176-10-PT
(EUCTR)
18/02/201409/12/2013Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE 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: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
2165 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
863EUCTR2013-004654-13-GB
(EUCTR)
12/02/201417/01/2014The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritisAn Open-Label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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]
Product Name: ABP 501
Product Code: ABP 501
Other descriptive name: ABP 501
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
425Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
864EUCTR2013-004654-13-CZ
(EUCTR)
12/02/201403/01/2014The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritisAn Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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 Name: ABP 501
Product Code: ABP 501
INN or Proposed INN: N/A
Other descriptive name: ABP 501
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
425Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
865EUCTR2013-002007-34-FI
(EUCTR)
10/02/201414/11/2013Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound. - TOZULTRA 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]
Product Name: Tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
Roche a/sNULLNot RecruitingFemale: yes
Male: yes
137Phase 3Finland;Denmark;Sweden
866JPRN-UMIN000016844
2014/02/0720/03/2015The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF InhibitorsThe clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors - The aggressive clinical tight control study(TACTICS trial) Rheumatoid arthritisinfliximab: standard strategy
infliximab: aggressive strategy
golimumab: standard strategy
golimumab: aggressive strategy
Takarazuka city hospitalNULLRecruiting20years-old90years-oldMale and Female80Not applicableJapan
867EUCTR2013-002358-57-HU
(EUCTR)
05/02/201421/12/2013A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic TherapyA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy Moderately to Severely Active Rheumatoid Arthritis (RA)
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] - Immune System Diseases [C20]
Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Spain;Australia;Netherlands;United Kingdom
868NCT02173587
(ClinicalTrials.gov)
February 201422/6/2014Study Evaluating the Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid ArthritisEfficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid ArthritisRheumatoid ArthritisDietary Supplement: Mussel oil capsules;Dietary Supplement: Corn oil capsulesZhejiang UniversitySir Run Run Shaw HospitalActive, not recruiting18 Years75 YearsBoth56N/AChina
869EUCTR2013-001492-20-ES
(EUCTR)
31/01/201416/01/2014A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to MethotrexateA randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to 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] - Skin and Connective Tissue Diseases [C17]
Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Other descriptive name: NNC0109-0012
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
42Phase 2Portugal;Spain;Ireland;United Kingdom
870EUCTR2013-002777-22-DK
(EUCTR)
31/01/201411/12/2013Targeted Ultrasound in Rheumatoid Arthritis (TURA)Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA 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: Body processes [G] - Immune system processes [G12]
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular MedicineNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
230 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom
871EUCTR2013-002777-22-ES
(EUCTR)
31/01/201402/12/2013Targeted Ultrasound in Rheumatoid Arthritis (TURA)Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA 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: Body processes [G] - Immune system processes [G12]
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular MedicineNULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom
872NCT01987479
(ClinicalTrials.gov)
January 30, 20148/11/2013A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid ArthritisMulti-Center, Open Label, Single Arm Phase IIIB Study on Safety and Efficacy of Subcutaneous Tocilizumab in Monotherapy or in Combination With Methotrexate or Other Non-Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis Patients With an Inadequate Response to Non-Biologic DMARDs - OSCARRheumatoid ArthritisDrug: Non-Biologic DMARDs;Drug: Tocilizumab;Drug: MethotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll150Phase 3Netherlands
873EUCTR2013-002777-22-HU
(EUCTR)
28/01/201428/11/2013Targeted Ultrasound in Rheumatoid Arthritis (TURA)Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA 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: Body processes [G] - Immune system processes [G12]
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular MedicineNULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom
874EUCTR2012-001176-10-IT
(EUCTR)
22/01/201428/10/2013A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE 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: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
2165Phase 3United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
875EUCTR2011-005689-39-DE
(EUCTR)
20/01/201424/05/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
208Phase 2United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of
876EUCTR2012-001176-10-BE
(EUCTR)
14/01/201423/12/2013Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
2165Phase 3Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
877EUCTR2012-001176-10-AT
(EUCTR)
13/01/201413/12/2013Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
2165Phase 3South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia
878JPRN-UMIN000012364
2014/01/1025/11/2013Drug registry study to evaluate the effectiveness of tramadol / acetaminophen combination tablets as pain management for patient with rheumatoid arthritis. rheumatoid arthritisTramadol / acetaminophen combination tablets will be administrated by 1 tablets / time/ qid and every 4 hours for pain relief.
Step by step dose up administration schedule over 4weeks will be applied at beginning of treatment as bellows;
*Day1-Day7(1 tablet/day, after night meal)
*Day8-Day14(1 tabletX2 times /day, after morning and night meal)
*Day15-Day21(1 tabletX3 times /day, after morning, afternoon and night meal
*Day22-Day30(1 tabletX4 times /day, after morning, night meal and before bedtime)
Once dose reached to 1 tabletX4 times /day, then treatment will be continue up to 24 weeks.
Osaka City University Medical School, Department of Orthopedic SurgeryNULLComplete: follow-up complete25years-old75years-oldMale and Female31Not applicableJapan
879EUCTR2013-000525-31-DE
(EUCTR)
10/01/201406/08/2013The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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: ABP 501
Product Code: ABP 501
INN or Proposed INN: N/A
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
880EUCTR2012-001176-10-GB
(EUCTR)
10/01/201420/12/2013Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
2165 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
881NCT02001987
(ClinicalTrials.gov)
January 201429/11/2013A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic TherapyA Multi-Center Open-Label Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Tocilizumab in Tocilizumab-Naive Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARD and/or Biologic TherapyRheumatoid ArthritisDrug: Tocilizumab;Drug: Methotrexate;Drug: csDMARDsHoffmann-La RocheNULLCompleted18 YearsN/AAll139Phase 3France
882EUCTR2012-003686-17-LT
(EUCTR)
31/12/201321/11/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
883JPRN-UMIN000012690
2013/12/2827/12/2013Study of Actemura Remission induction of RAand Sequential Maintenance of Remission by Reasonable cost Treatment Rheumatoid Arthritistocilizumab+tacrolimus+Bucillamine
tocilizumab
National hospital organization Chiba east national hospital Clinical Research CenterNULLComplete: follow-up complete20years-old99years-oldMale and Female60Not applicableJapan
884EUCTR2013-001492-20-GB
(EUCTR)
24/12/201318/10/2013A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to MethotrexateA randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to 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] - Skin and Connective Tissue Diseases [C17]
Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Other descriptive name: NNC0109-0012
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
42Phase 2Portugal;Hungary;Czech Republic;Spain;Belgium;Poland;Ireland;Germany;Netherlands;Italy;United Kingdom
885EUCTR2013-004006-26-DK
(EUCTR)
18/12/201318/12/2013OPALOptical images for monitoring treatment changes in rheumatoid arthritis – a longitudinal study with Rheumascan Detection of synovitis and tenosynovitis in the hands of patients with rheumatoid arthritis; Diagnostic performance of optical imaging in comparison with ultrasound and magnetic resonance imaging.
MedDRA version: 16.1;Level: LLT;Classification code 10067132;Term: Synovitis wrist;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ICG-Pulsion
INN or Proposed INN: 2-{7-[1,1-dimethyl-3-(4-sulfobutyl)-benz[e]indolin-2-ylidene]-1,3,5-heptatrienyl}-1,1-dimethyl-3-(sulfobutyl)-1H-benz[e]-indolium hydroxide,inner salt
Other descriptive name: INDOCYANINE GREEN
Knowledge Centre for Rheumatology and Back DiseasesNULLNot RecruitingFemale: yes
Male: yes
Phase 4Denmark
886EUCTR2013-002777-22-DE
(EUCTR)
17/12/201322/11/2013Targeted Ultrasound in Rheumatoid Arthritis (TURA)Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA 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: Body processes [G] - Immune system processes [G12]
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular MedicineNULLNot RecruitingFemale: yes
Male: yes
230Phase 4France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom
887EUCTR2013-002150-79-BE
(EUCTR)
16/12/201324/10/2013A study to evaluate the efficacy and safety of tocilizumab subcutaneous in RA patientsTOSCARA: An open-label, single-arm study to evaluate the efficacy, safety and tolerability of tocilizumab (TCZ) subcutaneous in TCZ-naïve patients with active rheumatoid arthritis - TOSCARA 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: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-02
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
N.V. Roche S.A.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3Belgium
888EUCTR2013-000525-31-BG
(EUCTR)
13/12/201321/11/2013The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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]
Product Name: ABP 501
Product Code: ABP 501
INN or Proposed INN: N/A
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
889EUCTR2011-004720-35-IS
(EUCTR)
13/12/201306/12/2013NORD-STARA multicenter, randomized, single-blinded, phase 4 study in patients with early rheumatoid arthritis to compare 1) active conventional therapy versus three biologic treatments, and 2) two de-escalation strategies in patients who respond to treatment. - NORD-STAR 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: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
Trade Name: Metoject
The Karolinska Instutute, ClinTRIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Finland;Denmark;Norway;Iceland;Sweden
890EUCTR2013-002007-34-DK
(EUCTR)
09/12/201309/12/2013Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound - TOZULTRA 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: RoActemra
Product Name: Tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
Roche a/sNULLNot RecruitingFemale: yes
Male: yes
137Phase 3Finland;Denmark;Sweden
891JPRN-UMIN000018816
2013/12/0526/08/2015Study on the relationship between arthritis and sleep disturbanceStudy on the relationship between arthritis and sleep disturbance - Sleep study in arthritis Rheumatoid ArthritisTreatment with melatonin-mimetics, ramelteon.
Treatment with biological disease-modifying anti-rheumatic drugs.
Shunichi ShiozawaRheumatic Diseases Center, Kohnan Kakogawa HospitalComplete: follow-up complete20years-oldNot applicableMale and Female200Not applicableJapan
892JPRN-UMIN000012473
2013/12/0304/12/2013Study for variations of safety and efficacy profile caused by division of weekly dose of methotrexate(preliminary study) Rheumatoid arthritisadministration of weekly MTX dose at once
administration by dividing three times of weekly MTX dose
Yokohama Minami Kyousai HospitalSanten Pharmaceutical CO.,Ltd.Santen Pharmaceutical CO.,Ltd.Complete: follow-up completeNot applicableNot applicableMale and Female40Not applicableJapan
893EUCTR2012-003686-17-SE
(EUCTR)
02/12/201305/06/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
894EUCTR2013-000114-38-DE
(EUCTR)
29/11/201329/05/2013A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b) Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses
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: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Other descriptive name: A
INN or Proposed INN: Tregalizumab
Other descriptive name: B
INN or Proposed INN: Tregalizumab
Other descriptive name: C
INN or Proposed INN: Tregalizumab
Other descriptive name: D
INN or Proposed INN: Tregalizumab
Other descriptive name: E
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
304Phase 2Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden
895NCT03736044
(ClinicalTrials.gov)
November 25, 201311/10/2018Reconstitution of CD4+CD25highCD127low/-TcellAnalysis of T Cell Population to Obtain a Free-drug Remission in Patients Affected by Rheumatoid Athritis in Remission Phase Induced by TNF-blocker TherapyRheumatoid ArthritisDrug: TNF-blockers suspension in patients with rheumatoid arthritisUniversity Hospital of FerraraNULLCompleted18 YearsN/AAll48Phase 1NULL
896NCT01941095
(ClinicalTrials.gov)
November 20, 201330/8/2013A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid ArthritisMulticenter, Open Label, Phase IIIb Study to Evaluate the Safety and Tolerability of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Methotrexate or Other Non-Biologic Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine;Drug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll100Phase 3Greece
897EUCTR2013-000525-31-PL
(EUCTR)
17/11/201310/10/2013The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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: ABP 501
Product Code: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
898EUCTR2013-001999-38-PL
(EUCTR)
17/11/201311/10/2013A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymoreA Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy - Phase II study of TNF-K in Rheumatoid Arthritis Active 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]
Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: not assigned yet
Other descriptive name: TNF-Kinoid
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
140Phase 2Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of
899EUCTR2013-002777-22-GB
(EUCTR)
14/11/201307/10/2013Targeted Ultrasound in Rheumatoid Arthritis (TURA)Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA 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]
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular MedicineNULLNot RecruitingFemale: yes
Male: yes
310Phase 4France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom
900EUCTR2013-003658-26-NL
(EUCTR)
13/11/201318/10/2013Individualised treatment strategy based on disease activity for early RA patients in usual clinical practice: The COBRA Cohort Study Treat-to-target strategy for early RA patients in usual clinical practice: The COBRA Cohort Study - COBRA Cohort Study Early Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Prednison
Product Name: Prednison
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Plaquenil
Product Name: hydroxycholoquine
INN or Proposed INN: hydroxychloroquine sulfate
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Trade Name: Sulfasalazine
Product Name: Sulfasalazine
INN or Proposed INN: Sulfasalazine
Other descriptive name: SULFASALAZINE
VU University Medical CenterNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
901JPRN-UMIN000012257
2013/11/1211/11/2013Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial osteoarthritis, rheumatoid arthritis, avascular necrosis of femoral condyleA periarticular injection including methylprednisolone, ropivacaine, morphine, bosmin, and ketoprofen for pain after total knee arthroplasty
A periarticular injection including ropivacaine, morphine, bosmin, and ketoprofen for pain after total knee arthroplasty
Nekoyama Miyao HospitalNULLComplete: follow-up complete18years-oldNot applicableMale and Female74Not selectedJapan
902EUCTR2013-003486-34-DK
(EUCTR)
04/11/201304/11/2013Treatment of Tenosynovitis among rheumatoid arthritis patientsSystemic versus ultrasound-guided local glucocorticoid treatment, among rheumatoid arthritis patients with tenosynovitis - a randomized double blind study - SULTAN
MedDRA version: 16.0;Level: LLT;Classification code 10042869;Term: Synovitis and tenosynovitis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Diprofos Depot
INN or Proposed INN: BETAMETHASONE ACIBUTATE
Other descriptive name: Binyrebarkhormon
Trade Name: Natriumklorid 9mg/ml
INN or Proposed INN: SODIUM CHLORIDE
Other descriptive name: SODIUM CHLORIDE
Knowledge Centre for Rheumatology and Back DiseasesNULLNot RecruitingFemale: yes
Male: yes
Denmark
903NCT02254655
(ClinicalTrials.gov)
November 201318/11/2013The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid ArthritisThe Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis, a Controlled and Randomized TrialRheumatoid ArthritisDrug: Puerarin injection 400 mg;Drug: ControlChengdu PLA General HospitalNULLCompleted18 Years75 YearsAll119Phase 2China
904NCT02027298
(ClinicalTrials.gov)
November 201318/11/2013Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II StudyAbatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II StudyPrimary Sjogren's Syndrome;Secondary Sjogren's Syndrome;Inflammatory Arthritis;Rheumatoid ArthritisDrug: AbataceptThe Cleveland ClinicBristol-Myers SquibbWithdrawn18 YearsN/AAll0Phase 2United States
905NCT01980836
(ClinicalTrials.gov)
November 20134/11/2013Effect of Tocilizumab to the Cellular Immune Response to Influenza VaccineThe Effect of Tocilizumab on the Cellular Immune Response to Seasonal Influnza Vaccine in Patients With Rheumatoid ArthritisRheumatoid Arthritis;Cellular Immune ResponseBiological: Seasonal influenza vaccineTel-Aviv Sourasky Medical CenterNULLNot yet recruiting18 YearsN/ABoth40Phase 4Israel
906NCT01951170
(ClinicalTrials.gov)
November 201323/9/2013An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid ArthritisAn Open-Label Study to Evaluate Non-Progression Of Structural Joint Damage Of Subcutaneous Tocilizumab In Patients With Moderate To Severe Active Rheumatoid Arthritis (Ac-Cute)Rheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll52Phase 3Australia
907NCT02005757
(ClinicalTrials.gov)
November 20134/12/2013Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED)Open Label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Mizoribine in Active Rheumatoid Arthritis Patients Unsuccessfully Treated With Disease-modifying Antirheumatic DrugRheumatoid ArthritisDrug: Bredinin tablet 150mg;Drug: Bredinin tablet 50mgChong Kun Dang PharmaceuticalNULLRecruiting20 Years80 YearsBoth60Phase 2Korea, Republic of
908NCT02293590
(ClinicalTrials.gov)
November 201330/10/2014RICE: Remission by Intra-articular Injection Plus CErtolizumabAn Open Label, Randomised Study to Compare the Efficacy of Certolizumab Pegol (CZP) Plus a Dynamic or Fixed Dose Treatment Strategy in Patients With Rheumatoid Arthritis, a Phase II StudyRheumatoid ArthritisDrug: Certolizumab PegolRüdiger B. MüllerUCB PharmaCompleted18 YearsN/AAll43Phase 2Switzerland
909NCT01855789
(ClinicalTrials.gov)
November 201314/5/2013A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous Tocilizumab With Methotrexate in Participants With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Placebo;Drug: Tocilizumab;Drug: methotrexateHoffmann-La RocheNULLCompleted18 YearsN/ABoth718Phase 3United States
910NCT01990157
(ClinicalTrials.gov)
November 20135/11/2013Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid ArthritisSafety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis in Which Methotrexate (MTX) Treatment is Not EffectiveRheumatoid ArthritisDrug: TAB08Theramab LLCNULLCompleted18 Years65 YearsAll18Phase 1/Phase 2Russian Federation
911EUCTR2012-001176-10-ES
(EUCTR)
31/10/201305/09/2013Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE 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: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
2165Phase 3United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
912EUCTR2013-001999-38-CZ
(EUCTR)
30/10/201324/07/2013A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymoreA Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy - Phase II study of TNF-K in Rheumatoid Arthritis Active 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]
Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: not assigned yet
Other descriptive name: TNF-Kinoid
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
140Phase 2Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of
913EUCTR2012-004074-25-DE
(EUCTR)
30/10/201329/07/2013Comparison of the effectiveness and safety of two different starting dosages of cortisone, compared to each other and to placebo, in early active rheumatoid arthritisComparison of the efficacy and safety of two different starting dosages of prednisolone in early active rheumatoid arthritis: a randomized, placebo controlled trial - CORRA Early 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]
Trade Name: PredniHEXAL® 5mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Trade Name: PredniHEXAL® 5mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Trade Name: PredniHEXAL® 10mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 10mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Trade Name: PredniHEXAL® 20mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 20mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Ruhr-Universität BochumNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Germany
914EUCTR2013-001999-38-HU
(EUCTR)
30/10/201316/07/2013A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymoreA Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy - Phase II study of TNF-K in Rheumatoid Arthritis Active 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]
Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: not assigned yet
Other descriptive name: TNF-Kinoid
Neovacs SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2Serbia;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of
915EUCTR2013-002341-11-GB
(EUCTR)
25/10/201326/07/2013This is a study in healthy subjects to look at the effect of tocilizumab (RoActemra) on a type of white blood cellA SINGLE BLIND PHASE IV PHARMACODYNAMIC STUDY TO EVALUATE NEUTROPHIL DISTRIBUTION KINETICS AND FUNCTION FOLLOWING SINGLE-DOSE TOCILIZUMAB TREATMENT IN HEALTHY SUBJECTS healthy volunteers (intended indication: 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: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: no
Male: yes
Phase 4United Kingdom
916EUCTR2013-000342-19-NL
(EUCTR)
24/10/201308/10/2013A clinical trial where patients with Rheumatoid Arthritis are treated with the study drug tocilizumab, subcutaneous (injection in the skin), with or without other non-biological anti-rhematic drugs, to study the safety and efficacy of the drug.MULTI-CENTER, OPEN LABEL, SINGLE ARM PHASE IIIB STUDY ON SAFETY AND EFFICACY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO NON-BIOLOGIC DMARDS - OSCAR Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Roche Nederland B.V.NULLNot RecruitingFemale: yes
Male: yes
Phase 3Netherlands
917EUCTR2012-003686-17-GB
(EUCTR)
24/10/201306/06/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
918EUCTR2013-002429-52-IE
(EUCTR)
23/10/201315/08/2013STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITISA PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs 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] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab SC
Other descriptive name: TOCILIZUMAB SC
Roche Farma S.ANULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;Spain;Ireland
919EUCTR2013-000114-38-BG
(EUCTR)
23/10/201309/09/2013A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b) Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses
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] - Immune System Diseases [C20]
Product Name: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Other descriptive name: A
INN or Proposed INN: Tregalizumab
Other descriptive name: B
INN or Proposed INN: Tregalizumab
Other descriptive name: C
INN or Proposed INN: Tregalizumab
Other descriptive name: D
INN or Proposed INN: Tregalizumab
Other descriptive name: E
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
304Phase 2Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden
920EUCTR2013-002429-52-PT
(EUCTR)
21/10/201308/08/2013STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITISA PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Roche Farma S.A.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;Spain;Ireland
921EUCTR2013-000525-31-CZ
(EUCTR)
21/10/201317/07/2013The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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: ABP 501
Product Code: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
922JPRN-UMIN000012399
2013/10/1626/11/2013Performance of Rheumascan in healthy subjects and patients with active rheumatoid arthritis Rheumatoid arthritisPatients 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 UniversityDiagnostic Imaging Center, Ochanomizu Surugadai ClinicComplete: follow-up complete20years-oldNot applicableMale and Female9Not applicableJapan
923EUCTR2012-003724-20-RO
(EUCTR)
14/10/201328/07/2014A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate.A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone Rheumatoid Arthritis
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 Code: IPI 145
INN or Proposed INN: -
Other descriptive name: IPI-145
Product Code: IPI 145
INN or Proposed INN: -
Other descriptive name: IPI-145
Product Code: IPI 145
INN or Proposed INN: -
Other descriptive name: IPI-145
Infinity Pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
316Phase 2Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;Colombia;New Zealand
924EUCTR2013-000525-31-ES
(EUCTR)
12/10/201301/08/2013The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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: ABP 501
Product Code: ABP 501
INN or Proposed INN: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
925EUCTR2013-001999-38-BE
(EUCTR)
07/10/201311/07/2013A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymoreA Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy - Phase II study of TNF-K in Rheumatoid Arthritis Active 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]
Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: not assigned yet
Other descriptive name: TNF-Kinoid
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
140Phase 2Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of
926JPRN-UMIN000011891
2013/10/0101/10/2013Multicenter study of the effect of GoLimumab On the Remission Induction rate and bio-free remission maintenance rate in early rheumatoid Arthritis. Rheumatoid ArthritisGolimumabSt.Marianna University School of MedicineNULLComplete: follow-up complete20years-old70years-oldMale and Female50Not selectedJapan
927EUCTR2013-000054-22-GB
(EUCTR)
01/10/201307/08/2013OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENTOPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENT - ACT-MOVE Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanised anti-human monoclonal antibody directed against the IL-6R
Roche Products LimitedNULLNot RecruitingFemale: yes
Male: yes
Phase 3United Kingdom
928NCT01773681
(ClinicalTrials.gov)
October 201316/1/2013Novel Imaging Markers for Rheumatoid ArthritisNovel Imaging Markers for Rheumatoid ArthritisRheumatoid ArthritisDrug: Cimzia;Device: Magnetic Resonance Imaging (MRI);Device: High-resolution peripheral quantitative computed tomography (HR-pQCT)University of California, San FranciscoNULLCompleted18 YearsN/AAll30United States
929NCT02538757
(ClinicalTrials.gov)
October 201318/8/2015Safety 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 ArthritisBiological: Herpes Zoster Vaccine;Drug: PlaceboUniversity of Alabama at BirminghamOregon Health and Science UniversityActive, not recruiting50 YearsN/AAll125Phase 2United States
930EUCTR2012-003635-31-BG
(EUCTR)
27/09/201325/09/2013Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate aloneRandomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. moderately to severely active 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: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Propsoed INN - FILGOTINIB
Other descriptive name: GLPG0634
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
595Phase 2United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
931EUCTR2012-003654-86-DE
(EUCTR)
26/09/201303/06/2013Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate aloneRandomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone moderately to severely active 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: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Propsoed INN - FILGOTINIB
Other descriptive name: GLPG0634
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Serbia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
932EUCTR2013-000525-31-HU
(EUCTR)
26/09/201330/09/2013The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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: ABP 501
Product Code: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
933EUCTR2013-000114-38-SK
(EUCTR)
25/09/201303/07/2013A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b) Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses
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: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Other descriptive name: A
INN or Proposed INN: Tregalizumab
Other descriptive name: B
INN or Proposed INN: Tregalizumab
Other descriptive name: C
INN or Proposed INN: Tregalizumab
Other descriptive name: D
INN or Proposed INN: Tregalizumab
Other descriptive name: E
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
304Phase 2Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden
934EUCTR2013-000114-38-HU
(EUCTR)
19/09/201312/06/2013A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b) Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses
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: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Other descriptive name: A
INN or Proposed INN: Tregalizumab
Other descriptive name: B
INN or Proposed INN: Tregalizumab
Other descriptive name: C
INN or Proposed INN: Tregalizumab
Other descriptive name: D
INN or Proposed INN: Tregalizumab
Other descriptive name: E
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
304Phase 2Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Sweden
935EUCTR2013-000944-25-HU
(EUCTR)
19/09/201316/07/2013Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with rheumatoid arthritisA three year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in subjects with active rheumatoid arthritis - REASSURE-1 Extension 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: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
454Panama;United States;Thailand;Guatemala;Colombia;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Japan
936EUCTR2012-005733-37-GB
(EUCTR)
18/09/201323/07/2013A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy 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: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
584Phase 3Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
937EUCTR2012-005674-61-LV
(EUCTR)
13/09/201313/09/2013Mesenchymal Precursor Cells (MPCs) for treatment of rheumatoid arthritisA double-blind, randomized, placebo-controlled, multi-center, dose escalation study of a single intravenous infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in the treatment of biologic-naïve patients with rheumatoid arthritis Rheumatoid arthritis
MedDRA version: 16.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Allogeneic Mesenchymal Precursor Cells
Other descriptive name: ALLOGENEIC MESENCHYMAL PRECURSOR CELLS
Mesoblast, IncNULLNot RecruitingFemale: yes
Male: yes
90Serbia;Hungary;Estonia;Czech Republic;Belgium;Poland;Croatia;Latvia
938EUCTR2013-000359-42-GR
(EUCTR)
12/09/201327/08/2013Not applicableMulticenter, open label, phase IIIb study to evaluate the safety and tolerability of subcutaneous tocilizumab as monotherapy and/or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs in patients with 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] - Musculoskeletal Diseases [C05]
Product Name: Tocilizumab SC
Product Code: Ro 487-7533/F10-04
ROCHE HELLAS S.A.NULLNot RecruitingFemale: yes
Male: yes
Phase 3Greece
939EUCTR2012-005674-61-EE
(EUCTR)
12/09/201302/09/2013Mesenchymal Precursor Cells (MPCs) for treatment of rheumatoid arthritisA double-blind, randomized, placebo-controlled, multi-center, dose escalation study of a single intravenous infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in the treatment of biologic-naïve patients with rheumatoid arthritis Rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Allogeneic Mesenchymal Precursor Cells
Other descriptive name: ALLOGENEIC MESENCHYMAL PRECURSOR CELLS
Mesoblast, IncNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Serbia;Hungary;Czech Republic;Estonia;Belgium;Poland;Croatia;Latvia
940EUCTR2012-001984-66-NO
(EUCTR)
11/09/201317/10/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA 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 & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910Phase 3United 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
941EUCTR2012-005674-61-BE
(EUCTR)
11/09/201330/08/2013Mesenchymal Precursor Cells (MPCs) for treatment of rheumatoid arthritisA double-blind, randomized, placebo-controlled, multi-center, dose escalation study of a single intravenous infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in the treatment of biologic-naïve patients with rheumatoid arthritis Rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Allogeneic Mesenchymal Precursor Cells
Other descriptive name: ALLOGENEIC MESENCHYMAL PRECURSOR CELLS
Mesoblast, IncNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Serbia;Hungary;Estonia;Czech Republic;Poland;Belgium;Croatia;Latvia
942NCT01907230
(ClinicalTrials.gov)
September 10, 201314/7/2013Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis PatientsPropylactic Use of Entecavir for Biological Agents Associated Hepatitis B Virus Reactivation in Inflammatory Arthritis Patients: a Randomized Controlled TrialRheumatoid Arthritis;Hepatitis B Reactivation;Exposure to Hepatitis B VirusDrug: EntecavirTaipei Veterans General Hospital, TaiwanNULLActive, not recruiting20 Years90 YearsAll115Phase 4Taiwan
943EUCTR2012-001176-10-LT
(EUCTR)
09/09/201320/06/2013Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE 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] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
2165Phase 3Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
944EUCTR2013-000114-38-LT
(EUCTR)
09/09/201302/07/2013A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b) Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses
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]
Product Name: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Product Name: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Product Name: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Product Name: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Product Name: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
304Phase 2United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden
945EUCTR2012-003635-31-DE
(EUCTR)
05/09/201330/04/2013Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate aloneRandomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. moderately to severely 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 Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Propsoed INN - FILGOTINIB
Other descriptive name: GLPG0634
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
595Phase 2United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
946EUCTR2013-000114-38-CZ
(EUCTR)
04/09/201312/06/2013A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b) Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses
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] - Immune System Diseases [C20]
Product Name: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Other descriptive name: A
INN or Proposed INN: Tregalizumab
Other descriptive name: B
INN or Proposed INN: Tregalizumab
Other descriptive name: C
INN or Proposed INN: Tregalizumab
Other descriptive name: D
INN or Proposed INN: Tregalizumab
Other descriptive name: E
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
304Phase 2United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden
947EUCTR2012-003654-86-ES
(EUCTR)
03/09/201312/07/2013Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate aloneRandomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone moderately to severely active 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: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Propsoed INN - FILGOTINIB
Other descriptive name: GLPG0634
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Serbia;Spain;Ukraine;Guatemala;Lithuania;Austria;Russian Federation;Chile;Israel;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Germany;Latvia;New Zealand
948EUCTR2012-003635-31-LV
(EUCTR)
02/09/201306/08/2013Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate aloneRandomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. moderately to severely active 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: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Propsoed INN - FILGOTINIB
Other descriptive name: GLPG0634
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
595Phase 2United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
949JPRN-JapicCTI-132209
01/9/2013Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA (REASSURE-E)A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Subjects With Active Rheumatoid Arthritis Rheumatoid ArthritisIntervention name : AIN457
INN of the intervention : Secukinumab
Dosage And administration of the intervention : Subjects will receive 150 mg secukinumab s.c.
Control intervention name : null
Novartis Pharma K.K.NULL18BOTH454Phase 3NULL
950NCT01955603
(ClinicalTrials.gov)
September 201324/9/2013A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid ArthritisA Randomised, Placebo-controlled, Double-blind Within Cohort, Dose Escalation, Multiple-dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered Subcutaneously to Subjects With Moderate to Severe Rheumatoid ArthritisInflammation;Rheumatoid ArthritisDrug: NNC0215-0384;Drug: placeboNovo Nordisk A/SNULLCompleted18 Years75 YearsBoth24Phase 1Germany;Hungary;Poland;Russian Federation
951NCT01948388
(ClinicalTrials.gov)
September 20139/9/2013The Effect of Corticotrophin (ACTH) in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis PatientsStudy of The Effect of Corticotrophin in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients From a Clinical and Structural Perspective As Measured by a Clinical Disease Activity Index Score and Bone Edema, Synovitis and Erosions on Magnetic Resonance ImagingRheumatoid ArthritisDrug: corticotrophin 80 unitsGaylis, Norman B., M.D.NULLCompleted18 YearsN/AAll20Phase 4United States
952NCT01995201
(ClinicalTrials.gov)
September 20131/11/2013A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid ArthritisA Phase IIIb Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous (SC) Tocilizumab (TCZ) Given as Monotherapy or in Combination With Methotrexate (MTX) or Other Non Biologics DMARDs in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: DMARD;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLActive, not recruiting18 YearsN/ABoth401Phase 3Ireland;Portugal;Spain
953NCT01901900
(ClinicalTrials.gov)
September 201310/7/2013Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA.A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: Secukinumab (AIN457)Novartis PharmaceuticalsNULLCompleted18 YearsN/ABoth196Phase 3United States;Argentina;Canada;Guatemala;Hungary;India;Italy;Japan;Mexico;Thailand;Colombia;Panama;Puerto Rico
954EUCTR2012-003635-31-CZ
(EUCTR)
28/08/201331/05/2013Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate aloneRandomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. moderately to severely active 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: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Propsoed INN - FILGOTINIB
Other descriptive name: GLPG0634
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
595Phase 2United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
955EUCTR2013-000525-31-GB
(EUCTR)
27/08/201302/07/2013The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritisA Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis Moderate to Severe 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: ABP 501
Product Code: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
956EUCTR2012-004342-14-DK
(EUCTR)
27/08/201319/04/2013A Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic DrugsA Phase 2/3 Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs 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: VX-509
Product Code: VX-509
INN or Proposed INN: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 2;Phase 3United States;Estonia;Lithuania;Denmark;South Africa;Netherlands
957EUCTR2013-002429-52-ES
(EUCTR)
23/08/201312/07/2013STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITISA PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Roche Farma S.ANULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;Spain;Ireland
958EUCTR2012-004090-16-NL
(EUCTR)
20/08/201302/05/2013Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy.A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: BI 655064Boehringer Ingelheim B.VNULLNot RecruitingFemale: yes
Male: yes
106Czech Republic;Poland;Spain;Germany;Netherlands;New Zealand
959EUCTR2011-005649-10-DE
(EUCTR)
19/08/201318/07/2012An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with 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] - Musculoskeletal Diseases [C05]
Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Trade Name: Simponi
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Germany;Brazil;Argentina;Mexico;Czech Republic;Hungary;France;United Kingdom;Israel;Russian Federation;Spain;Greece;Slovakia;Portugal
960EUCTR2012-002181-12-SE
(EUCTR)
19/08/201309/07/2012A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RAA Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA Active 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: MK-8457
Product Code: MK-8457
INN or Proposed INN: None
Other descriptive name: MK-8457
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to asNULLNot RecruitingFemale: yes
Male: yes
178Phase 2United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden
961EUCTR2012-005733-37-CZ
(EUCTR)
16/08/201315/05/2013A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy 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: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
584Phase 3Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
962EUCTR2012-003654-86-HU
(EUCTR)
15/08/201317/05/2013Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate aloneRandomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone moderately to severely active 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: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Propsoed INN - FILGOTINIB
Other descriptive name: GLPG0634
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Serbia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
963EUCTR2012-005026-30-HU
(EUCTR)
15/08/201320/02/2013A 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.NULLNot RecruitingFemale: yes
Male: yes
498Phase 3Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
964EUCTR2012-002181-12-AT
(EUCTR)
08/08/201325/06/2013A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RAA Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA Active 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: MK-8457
Product Code: MK-8457
Other descriptive name: MK-8457
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as the SPONSOR or Merck)NULLNot RecruitingFemale: yes
Male: yes
178Phase 2United States;Greece;Spain;Austria;Colombia;United Kingdom;Italy;France;Hungary;Brazil;Poland;Australia;Denmark;Peru;South Africa;New Zealand;Sweden
965EUCTR2011-005689-39-CZ
(EUCTR)
07/08/201323/05/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Hungary;Taiwan;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
966EUCTR2013-000114-38-EE
(EUCTR)
06/08/201313/06/2013A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b) Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses
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: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Other descriptive name: A
INN or Proposed INN: Tregalizumab
Other descriptive name: B
INN or Proposed INN: Tregalizumab
Other descriptive name: C
INN or Proposed INN: Tregalizumab
Other descriptive name: D
INN or Proposed INN: Tregalizumab
Other descriptive name: E
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
304Phase 2Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Sweden
967EUCTR2010-020892-22-NL
(EUCTR)
03/08/201310/08/2011Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X 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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
2000United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Latvia;Netherlands;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
968EUCTR2012-005733-37-LV
(EUCTR)
02/08/201322/05/2013A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy 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: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
584Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
969EUCTR2013-001569-17-IT
(EUCTR)
02/08/201304/06/2013A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with other non-biological medicinal products in rheumatoid arthritis (RA) patients.A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with methotrexate and/or other DMARDS in rheumatoid arthritis (RA) patients. 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: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Roche S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3Italy
970EUCTR2012-000439-17-LV
(EUCTR)
02/08/201305/06/2013A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate TherapyA Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis active 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 Code: MK-8457
Product Code: MK-8457
MERCK SHARP & DOHME CORP.NULLNot RecruitingFemale: yes
Male: yes
434Phase 2United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Peru;Denmark;South Africa;Latvia;Germany;Moldova, Republic of;Japan
971EUCTR2013-000944-25-IT
(EUCTR)
02/08/201306/06/2013Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with rheumatoid arthritisA three year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in subjects with active rheumatoid arthritis - REASSURE-1 Extension 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: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Farma S.p.A.NULLNot RecruitingFemale: yes
Male: yes
454Panama;United States;Thailand;Guatemala;Colombia;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Japan
972NCT01915537
(ClinicalTrials.gov)
August 201330/7/2013Infliximab and Classic DMARDs in the Rheumatoid Arthritis PatientsA Prospective Cohort Study to Observe the Difference of Efficacy Between Infliximab With Methotrexate and Classic DMARDs in the Severe Rheumatoid Arthritis Patients With Poor PrognosisRheumatoid Arthritis(RA)Drug: Infliximab group;Drug: Classic DMARDs treatment groupZhang, Xiao, M.D.Central South University;Tianjin Medical University General Hospital;Xijing HospitalNot yet recruiting18 Years70 YearsBoth170N/AChina
973EUCTR2012-003686-17-LV
(EUCTR)
24/07/201305/07/2013A Phase 3 Study in Rheumatoid Arthritis A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
3350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
974EUCTR2012-003635-31-ES
(EUCTR)
23/07/201310/06/2013Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate aloneRandomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. moderately to severely active 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: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Propsoed INN - FILGOTINIB
Other descriptive name: GLPG0634
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
595Phase 2Latvia;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand;Serbia;United States;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru
975EUCTR2012-003686-17-BE
(EUCTR)
18/07/201331/05/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden;United States;Portugal;Taiwan;Slovakia
976EUCTR2012-002323-15-HR
(EUCTR)
17/07/201330/03/2015A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active 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: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
977EUCTR2011-005648-93-GB
(EUCTR)
12/07/201330/05/2013A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis Protocol Ref: CD-IA-CAM-3001-1109 - An Open-label of Mavrilimumab in 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] - Musculoskeletal Diseases [C05]
Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
MedImmune LtdNULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany
978EUCTR2012-005733-37-LT
(EUCTR)
11/07/201320/05/2013A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy 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: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
584Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
979EUCTR2012-003686-17-HU
(EUCTR)
11/07/201307/06/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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 Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
980EUCTR2012-005733-37-BG
(EUCTR)
10/07/201321/05/2013A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy 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: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
584Phase 3Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
981EUCTR2012-003635-31-HU
(EUCTR)
09/07/201322/04/2013Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate aloneRandomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. moderately to severely active 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: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
595Phase 2United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
982EUCTR2012-003644-71-BE
(EUCTR)
08/07/201306/02/2013Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failureA 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.NULLNot RecruitingFemale: yes
Male: yes
120Phase 4France;Hong Kong;Spain;Poland;Belgium;Australia;Russian Federation;Israel;Chile;Netherlands;Colombia;New Zealand
983EUCTR2011-005648-93-PT
(EUCTR)
05/07/201303/04/2013A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult 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] - Musculoskeletal Diseases [C05]
Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
400Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;South Africa;Bulgaria;Germany
984EUCTR2011-005649-10-GB
(EUCTR)
05/07/201311/03/2013 An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis Protocol:CD-IA-CAM-3001-1107 - Mavrilimumab versus Anti tumor Necrosis Factor in Rheumatoid Arthritis 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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Trade Name: Simponi
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB
MedImmune LimitedNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany
985EUCTR2012-003686-17-DK
(EUCTR)
04/07/201307/06/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
986EUCTR2012-003686-17-DE
(EUCTR)
04/07/201313/06/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
987EUCTR2012-001984-66-LV
(EUCTR)
03/07/201325/04/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA 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 & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United 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
988EUCTR2012-001984-66-IT
(EUCTR)
02/07/201307/05/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA 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 & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United 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
989EUCTR2012-003223-38-DE
(EUCTR)
01/07/201308/04/2013Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04 RHEUMATOID ARTHRITIS
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Rituximab-Pfizer
Product Code: PF-05280586
INN or Proposed INN: Not Applicable
Other descriptive name: Not Applicable
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
157Phase 2United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
990NCT02519387
(ClinicalTrials.gov)
July 201315/7/2015Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate IntensityMulticentre Study for Evaluation of the Efficacy and Safety of Buprenorphine Transdermal Patch (SOVENOR®) 5mg and 10mg in Patients With Non-malignant Pain of Moderate Intensity Due to Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain and Joint/Muscle Pain, When an Opioid is Necessary for Obtaining Adequate AnalgesiaOsteoarthritis;Rheumatoid Arthritis;Lower Back Pain;Joint Pain;Muscle PainDrug: Buprenorphine Transdermal PatchMundipharma Pharmaceuticals Sdn. Bhd.NULLCompleted40 YearsN/AAll78Phase 4Malaysia
991NCT02236481
(ClinicalTrials.gov)
July 20138/9/2014Clinical Study to Evaluate the Efficacy of Anakinra in Patients With Rheumatoid Arthritis and DiabetesNo-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 StudyDiabetes Mellitus, Type 2;Arthritis, RheumatoidDrug: Anakinra;Drug: TNF alpha inhibitorsProf. Roberto GiacomelliNULLTerminated18 YearsN/AAll41Phase 4Italy
992NCT01851070
(ClinicalTrials.gov)
July 201319/4/2013A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFa InhibitorA Double-blind, Randomized, Placebo-controlled, Dose-escalation, Multi-center Study a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFa InhibitorRheumatoid ArthritisDrug: Allogeneic Mesenchymal Precursor Cells;Drug: Normal SalineMesoblast, Ltd.PPDCompleted18 Years80 YearsAll48Phase 2United States;Australia
993EUCTR2011-005689-39-HU
(EUCTR)
27/06/201322/05/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc, 235 East 42nd Street, New York 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
994EUCTR2012-004090-16-CZ
(EUCTR)
27/06/201314/02/2013Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy.A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: BI 655064
INN or Proposed INN: BI 655064
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
106Phase 1;Phase 2Czech Republic;Poland;Spain;Netherlands;Germany;New Zealand
995EUCTR2012-003635-31-BE
(EUCTR)
26/06/201303/04/2013Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate aloneRandomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. moderately to severely active 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: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Propsoed INN - FILGOTINIB
Other descriptive name: GLPG0634
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
595Phase 2United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
996EUCTR2012-001984-66-DE
(EUCTR)
26/06/201306/03/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA 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 & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United 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
997EUCTR2012-003686-17-NL
(EUCTR)
26/06/201325/06/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3000Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden
998EUCTR2011-005689-39-ES
(EUCTR)
26/06/201324/06/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Taiwan;Hungary;Czech Republic;Slovakia;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
999EUCTR2012-001984-66-LT
(EUCTR)
20/06/201323/04/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA 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 & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United 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
1000NCT01881308
(ClinicalTrials.gov)
June 17, 201317/6/2013Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid ArthritisREmission in Rheumatoid Arthritis - Assessing WIthrawal of Disease-modifying Antirheumatic Drugs in a Non-inferiority DesignRheumatoid ArthritisDrug: TNF inhibitors;Drug: Synthetic DMARD(s);Drug: Co-medication: Synthetic DMARDsDiakonhjemmet HospitalThe Research Council of Norway;South-Eastern Norway Regional Health AuthorityActive, not recruiting18 Years80 YearsAll360Phase 4Norway
1001EUCTR2012-003686-17-CZ
(EUCTR)
17/06/201331/05/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
1002EUCTR2012-003724-20-DE
(EUCTR)
13/06/201304/02/2013A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate.A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone Rheumatoid Arthritis
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 Code: IPI 145
Other descriptive name: IPI-145
Product Code: IPI 145
Other descriptive name: IPI-145
Product Code: IPI 145
Other descriptive name: IPI-145
Infinity Pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
316Phase 2Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Colombia;Germany;New Zealand
1003EUCTR2012-003686-17-PT
(EUCTR)
12/06/201314/06/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden
1004EUCTR2012-003686-17-AT
(EUCTR)
11/06/201307/06/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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 Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
1005EUCTR2012-003686-17-FR
(EUCTR)
07/06/201321/09/2015A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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 Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3000Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
1006EUCTR2012-001984-66-HU
(EUCTR)
06/06/201314/03/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA 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 & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United 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
1007EUCTR2012-003536-23-PL
(EUCTR)
05/06/201322/04/2013To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN 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]
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: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden
1008EUCTR2012-003686-17-SK
(EUCTR)
05/06/201302/05/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND 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
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3000Phase 3Croatia;Germany;Japan;Sweden;Canada;Argentina;Brazil;Belgium;Poland;Romania;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico
1009NCT01861782
(ClinicalTrials.gov)
June 201312/5/2013Comparison Between Dead Sea Solar and Water Treatment to Sulfur Pool and Medicinal Mud Treatment in Patients With RAComparison Between Dead Sea Solar and Water Treatment to Sulfur Pool and Medicinal Mud Treatment in Patients With Rheumatoid ArthritisRheumatoid ArthritisOther: Dead Sea Solar and Water Treatment;Other: Sulfur Pool & Medicinal MudSoroka University Medical CenterNULLActive, not recruiting18 YearsN/ABoth30N/AIsrael
1010NCT01885819
(ClinicalTrials.gov)
June 201318/6/2013Autologous Adipose Tissue Stromal Vascular Fraction Cells for Rheumatoid ArthritisFeasibility Study of Non-Expanded Autologous Adipose Tissue Derived Stromal Vascular Fraction Cells in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid ArthritisRheumatoid ArthritisBiological: Autologous stromal vascular fraction cellsTranslational BiosciencesNULLWithdrawn18 YearsN/AAll0Phase 1/Phase 2Panama
1011NCT01878318
(ClinicalTrials.gov)
June 20136/6/2013A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDsOpen Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in the Hand of Patients With Moderate to Severe Rheumatoid Arthritis (RA) and Inadequate Response to Non-biological DMARDsRheumatoid ArthritisDrug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLWithdrawn18 YearsN/ABoth0Phase 4Venezuela
1012NCT01961271
(ClinicalTrials.gov)
June 20137/10/2013Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle PainMulticentre Study To Evaluate Efficacy And Safety Of Buprenorphine Transdermal Patch (Norspan) In Chronic Non-Malignant Pain Of Moderate To Severe Intensity Due To Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain And Joint / Muscle Pain, When Opioid Is Needed For AnalgesiaOsteoarthritis;Rheumatoid Arthritis;Lower Back Pain;Joint Pain;Muscle PainDrug: Buprenorphine transdermal patchMundipharma Pte Ltd.Mundipharma Korea Ltd;Mundipharma (Hong Kong) Ltd;Mundipharma Distribution GmBH (Philippine Branch)Completed18 Years80 YearsAll114Phase 4Hong Kong;Korea, Republic of;Philippines
1013JPRN-UMIN000014485
2013/05/2401/12/2014Golimumab study for development of tight control and biologics-free condition.Golimumab study for development of tight control and biologics-free condition. - Go-sunrising study rheumatoid arthritisTreatment with Golimumab for patients with rheumatoid arthritisRheumatology, Internal MedicineJuntendo University School of Medicine, Juntendo Koshigaya HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female40Not selectedJapan
1014EUCTR2012-000610-11-CZ
(EUCTR)
22/05/201320/06/2012A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to MethotrexateA randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate 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 Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 50 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 25 mg/ml
INN or Proposed INN: N/A
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
298Phase 2United States;Spain;Ukraine;Russian Federation;Italy;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany
1015EUCTR2012-000609-58-CZ
(EUCTR)
22/05/201321/06/2012A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologicsA randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics 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 Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 50 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 25 mg/ml
INN or Proposed INN: N/A
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
268Phase 2United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1016EUCTR2012-003536-23-GB
(EUCTR)
21/05/201315/03/2013To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN 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: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra
sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden
1017EUCTR2012-003724-20-BG
(EUCTR)
20/05/201320/03/2013A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate.A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone Rheumatoid Arthritis
MedDRA version: 17.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: IPI 145
Other descriptive name: IPI-145
Product Code: IPI 145
Other descriptive name: IPI-145
Product Code: IPI 145
Other descriptive name: IPI-145
Infinity Pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
316Phase 2Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;Colombia;New Zealand
1018EUCTR2012-001984-66-FI
(EUCTR)
17/05/201324/04/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA 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 & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United 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
1019EUCTR2012-005026-30-PL
(EUCTR)
17/05/201308/03/2013A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA 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.NULLNot RecruitingFemale: yes
Male: yes
596Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
1020EUCTR2012-002339-27-ES
(EUCTR)
16/05/201316/05/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active 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: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Lilly S.A.NULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
1021EUCTR2012-001984-66-GR
(EUCTR)
15/05/201323/04/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA 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 & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United 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
1022EUCTR2012-005026-30-CZ
(EUCTR)
15/05/201322/02/2013A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA 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.NULLNot RecruitingFemale: yes
Male: yes
596Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
1023EUCTR2012-003223-38-GB
(EUCTR)
14/05/201312/02/2013Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04 RHEUMATOID ARTHRITIS
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Rituximab-Pfizer
Product Code: PF-05280586
INN or Proposed INN: Not Applicable
Other descriptive name: Not Applicable
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
157 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
1024EUCTR2012-003439-41-NL
(EUCTR)
14/05/201327/03/2013A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 InhibitorA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs 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: VX-509
Product Code: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Estonia;Lithuania;Denmark;South Africa;Netherlands
1025EUCTR2013-000337-13-DE
(EUCTR)
13/05/201312/02/2013Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA)Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in RA (PreCePRA) Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy
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: Cimzia
Product Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Universitätsklinikum ErlangenNULLNot RecruitingFemale: yes
Male: yes
156Phase 3Serbia;Portugal;Germany
1026EUCTR2012-001984-66-CZ
(EUCTR)
13/05/201327/03/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA 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 & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United 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
1027EUCTR2012-005026-30-LT
(EUCTR)
10/05/201321/02/2013A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA 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.NULLNot RecruitingFemale: yes
Male: yes
498Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
1028EUCTR2010-019262-86-SK
(EUCTR)
02/05/201304/03/2013Long term evaluation of SAR153191 (REGN88, sarilumab) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating safety and efficacy of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND 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
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
2100Phase 3Portugal;United States;Belarus;Philippines;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Germany;Norway;New Zealand;Sweden
1029EUCTR2012-003536-23-NL
(EUCTR)
01/05/201322/02/2013To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN 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]
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: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
200Mexico;Argentina;Poland;Belgium;Brazil;Romania;Norway;Netherlands;Sweden;United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary
1030EUCTR2012-001984-66-ES
(EUCTR)
25/04/201309/04/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA 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 & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
5910United 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
1031EUCTR2012-001984-66-GB
(EUCTR)
25/04/201304/03/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA 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 & DéveloppementNULLNot 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): noHungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand;Czech Republic;United Kingdom;Lithuania;Guatemala;Finland;Korea, Republic of;Latvia;South Africa;Australia;Peru;Malaysia;France;India;Italy;Colombia;Chile;Russian Federation;Israel;Ukraine;Spain;Greece;Ecuador;Taiwan;United States
1032EUCTR2011-003538-16-PL
(EUCTR)
23/04/201308/03/2013To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET 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 Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand;Austria;Turkey;Lithuania;Guatemala;Korea, Republic of;Australia;Peru;India;Switzerland;Italy;Colombia;Israel;Chile;Russian Federation;Ukraine;Spain;Greece;Ecuador;Slovakia;Hong Kong;Estonia;Taiwan;United States;Portugal
1033EUCTR2012-004090-16-DE
(EUCTR)
23/04/201306/11/2012Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy.A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: BI 655064Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
106Czech Republic;Poland;Spain;Netherlands;Germany;New Zealand
1034EUCTR2010-022243-38-NL
(EUCTR)
23/04/201313/12/2012A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy - SIRROUND-T 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
840United States;Serbia;Portugal;Taiwan;Spain;Lithuania;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of
1035EUCTR2012-002322-73-LT
(EUCTR)
16/04/201328/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1036EUCTR2012-002323-15-GR
(EUCTR)
15/04/201329/03/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3Study Evaluating the Efficacy and Safety of Baricitinib(LY3009104) in Patients with Moderately to Severely ActiveRheumatoid Arthritis Who Have Had an InadequateResponse to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Japan;Korea, Republic of
1037EUCTR2011-002894-48-NO
(EUCTR)
11/04/201306/09/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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 Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 1;Phase 3United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
1038EUCTR2012-003439-41-LT
(EUCTR)
11/04/201331/12/2012A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 InhibitorA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs 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]
Product Name: VX-509
Product Code: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Estonia;Lithuania;Denmark;South Africa;Netherlands
1039EUCTR2012-004342-14-LT
(EUCTR)
11/04/201329/01/2013A Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic DrugsA Phase 2/3 Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs 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]
Product Name: VX-509
Product Code: VX-509
INN or Proposed INN: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 2/3United States;Estonia;Lithuania;Denmark;South Africa;Netherlands
1040EUCTR2012-005026-30-BG
(EUCTR)
10/04/201305/03/2013A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA 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.NULLNot RecruitingFemale: yes
Male: yes
596Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
1041EUCTR2012-003881-42-RO
(EUCTR)
09/04/201323/07/2014A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with AdalimumabA Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab 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: Body processes [G] - Immune system processes [G12]
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Puerto Rico;Romania;Germany
1042EUCTR2012-003536-23-NO
(EUCTR)
09/04/201312/02/2013To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN 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: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Germany;Sweden
1043EUCTR2012-003536-23-SE
(EUCTR)
08/04/201307/02/2013To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN 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: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden
1044EUCTR2011-004017-17-GB
(EUCTR)
08/04/201311/01/2013Tocilizumab and Remission in early rheumatoid arthritisProspective, Single-centre, Open-Label, Randomised, Pilot Study Assessing the changes in expression of JAK-STAT and Speed & Depth of Remission Induced by Tocilizumab & Methotrexate Combination and Tocilizumab Monotherapy in Patients with Early Rheumatoid Arthritis (TREMERA). - TREMERA Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: RoActemra
Product Name: Tocilizumab
Product Code: RoActemra
The University of LeedsNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
1045EUCTR2012-003536-23-BE
(EUCTR)
04/04/201307/01/2013To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN 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: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Netherlands;Germany;Norway;Sweden
1046EUCTR2012-003439-41-DK
(EUCTR)
04/04/201322/03/2013A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 InhibitorA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs 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: VX-509
Product Code: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Estonia;Lithuania;Denmark;South Africa;Netherlands
1047EUCTR2012-003057-29-CZ
(EUCTR)
02/04/201312/09/2012A 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.NULLNot RecruitingFemale: yes
Male: yes
58Phase 2Hungary;Czech Republic;Slovakia
1048JPRN-UMIN000009887
2013/04/0101/04/2013Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6 Rheumatoid ArthritisWhen 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha.
If the initial concentration of serum TNF alpha is less than 1.1 pg/ml, we will raise the dose of infliximab to 6 mg/kg.
When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha.
If the initial concentration of serum TNF alpha is more than 1.1 pg/ml, we will raise the dose of infliximab to 10 mg/kg.
Department of Orthopaedic surgery, Tohoku University HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female100Not applicableJapan
1049EUCTR2012-003536-23-ES
(EUCTR)
01/04/201304/02/2013To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN 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: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden
1050NCT01764997
(ClinicalTrials.gov)
April 20138/1/2013An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus MethotrexateA 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 MTXRheumatoid ArthritisDrug: Sarilumab;Drug: Etanercept;Drug: Methotrexate;Drug: Placebo (for sarilumab);Drug: Placebo (for etanercept);Drug: AdalimumabSanofiRegeneron PharmaceuticalsTerminated18 YearsN/AAll776Phase 3United States;Argentina;Australia;Brazil;Chile;Colombia;Czechia;Ecuador;Finland;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;New Zealand;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic
1051EUCTR2011-002896-40-PL
(EUCTR)
29/03/201311/02/2013A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritisA RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01 RHEUMATOID ARTHRITIS
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Rituximab-Pfizer
Product Code: PF-05280586
INN or Proposed INN: Not Applicable
Other descriptive name: Not Applicable
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
195United States;Taiwan;Spain;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
1052EUCTR2012-003536-23-IT
(EUCTR)
29/03/201305/02/2013To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN 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: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden
1053EUCTR2011-003538-16-CZ
(EUCTR)
29/03/201308/11/2012To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET 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
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
1054EUCTR2012-002324-32-SE
(EUCTR)
27/03/201320/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
1055EUCTR2010-019262-86-CZ
(EUCTR)
26/03/201330/03/2011Long term evaluation of sarilumab in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND 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 Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
2025Phase 3United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden
1056EUCTR2012-002322-73-SI
(EUCTR)
26/03/201319/03/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1057EUCTR2011-003538-16-DE
(EUCTR)
26/03/201310/12/2012To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET 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 Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522Phase 3Czech Republic;Hungary;United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Australia;Peru;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand
1058EUCTR2011-002840-29-RO
(EUCTR)
25/03/201316/06/2016A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexateA Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available 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]
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of
1059JPRN-UMIN000010286
2013/03/2121/03/2013Maintenance Trial by Orencia in Rheumatoid Arthritis Rheumatoid ArthritisPatients whose RA status is in low disease activity after 24 weeks of treatment with abatacept receive the reduced dosage of abatacept.Hokkaido University HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female150Not selectedJapan
1060EUCTR2012-002339-27-GB
(EUCTR)
21/03/201304/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active 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]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot Recruiting Female: yes
Male: yes
660 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Romania;Germany;Japan;Korea, Republic of
1061EUCTR2012-002322-73-DE
(EUCTR)
21/03/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1062EUCTR2012-002323-15-GB
(EUCTR)
21/03/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot Recruiting Female: yes
Male: yes
525 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noKorea, Republic of;Japan;Germany;Netherlands;Denmark;Australia;Croatia;Belgium;Poland;Argentina;Canada;Mexico;France;India;Switzerland;United Kingdom;Italy;Israel;Austria;Turkey;Spain;Greece;United States
1063EUCTR2012-002339-27-DE
(EUCTR)
21/03/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
1064EUCTR2012-005275-14-NO
(EUCTR)
19/03/201304/02/2013Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugsRemission 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 ASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Norway
1065EUCTR2011-003538-16-PT
(EUCTR)
14/03/201313/12/2012To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET 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
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522United States;Portugal;Taiwan;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
1066EUCTR2012-003536-23-EE
(EUCTR)
13/03/201312/02/2013To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN 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]
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: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Netherlands;Norway;Sweden
1067EUCTR2012-003536-23-FI
(EUCTR)
13/03/201319/02/2013To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN 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: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden
1068EUCTR2012-003881-42-DE
(EUCTR)
13/03/201309/01/2013A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with AdalimumabA Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab 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: Body processes [G] - Immune system processes [G12]
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Romania;Germany
1069EUCTR2012-002324-32-GR
(EUCTR)
12/03/201326/02/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3United States;Portugal;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Sweden;Korea, Republic of
1070EUCTR2012-003644-71-ES
(EUCTR)
12/03/201321/12/2012Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failureA 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.NULLNot RecruitingFemale: yes
Male: yes
168France;Hong Kong;Czech Republic;Spain;Australia;Israel;Chile;Russian Federation;Netherlands;Germany;Colombia
1071EUCTR2012-002339-27-BE
(EUCTR)
11/03/201319/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Germany;Japan;Korea, Republic of
1072EUCTR2011-005648-93-SK
(EUCTR)
11/03/201306/02/2013A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with 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] - Musculoskeletal Diseases [C05]
Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Bulgaria;South Africa;Germany
1073EUCTR2012-003629-40-CZ
(EUCTR)
11/03/201323/11/2012An Efficacy And Safety Study of CNTO6785 In Patients With Active Rheumatoid Arthritis Despite Methotrexate TherapyA Randomized, Placebo-controlled Double-blind, Multicenter, Phase 2 Dose Ranging Study To Assess The Efficacy And Safety of CNTO6785 In Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid Arthritis
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: CNTO6785
Product Code: CNTO6785
INN or Proposed INN: CNTO6785
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Philippines;Czech Republic;Argentina;Thailand;Poland;Russian Federation;Colombia;China;India
1074EUCTR2011-005649-10-SK
(EUCTR)
11/03/201306/02/2013An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis 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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Trade Name: Simponi
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany
1075EUCTR2011-003538-16-IT
(EUCTR)
08/03/201314/01/2013To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET 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
INN or Proposed INN: sarilumab
Product Name: SARILUMAB
Product Code: SAR153191
INN or Proposed INN: sarilumab
SANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENTNULLNot RecruitingFemale: yes
Male: yes
522Portugal;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Colombia;Italy;Switzerland;India;Australia;Peru;Korea, Republic of;Korea, Democratic People's Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Germany;New Zealand
1076EUCTR2012-003536-23-HU
(EUCTR)
07/03/201316/01/2013To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN 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: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Sweden;Norway;Germany;Netherlands;Romania;Brazil;Belgium;Poland;Argentina
1077EUCTR2011-006021-23-PL
(EUCTR)
05/03/201304/01/2013.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)NULLNot RecruitingFemale: yes
Male: yes
650Phase 2Hungary;Czech Republic;Mexico;Belgium;Poland;Bulgaria;Germany
1078EUCTR2011-006020-20-PL
(EUCTR)
05/03/201319/11/2012A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis SubjectsA Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Rheumatoid Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 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)NULLNot RecruitingFemale: yes
Male: yes
275Phase 2United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria
1079EUCTR2011-006058-94-DE
(EUCTR)
04/03/201327/08/2012Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agentsA Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - REASSURE 2 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]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
234Phase 3United States;Portugal;Panama;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of
1080NCT02036931
(ClinicalTrials.gov)
March 201314/1/2014A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular SystemA Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular SystemNoninflammatory Degenerative Joint Disease;Rheumatoid ArthritisDevice: Metal on Polyethylene articulation;Drug: Ceramic on Polyethylene articulation;Device: Ceramic on Ceramic articulationZimmer BiometNULLActive, not recruiting18 YearsN/AAll315United States;France;Germany;Ireland;Netherlands;Spain
1081NCT01768572
(ClinicalTrials.gov)
March 201311/1/2013To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF AntagonistsRheumatoid ArthritisDrug: sarilumab SAR153191 (REGN88);Drug: tocilizumab;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide;Drug: subcutaneous placebo;Drug: intravenous placeboSanofiRegeneron PharmaceuticalsCompleted18 YearsN/AAll202Phase 3United States;Argentina;Belgium;Brazil;Czechia;Estonia;Finland;Hungary;Israel;Italy;Mexico;Netherlands;Norway;Poland;Romania;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic
1082EUCTR2012-003223-38-ES
(EUCTR)
27/02/201304/03/2013Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04 RHEUMATOID ARTHRITIS
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Rituximab-Pfizer
Product Code: PF-05280586
INN or Proposed INN: Not Applicable
Other descriptive name: Not Applicable
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
157United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
1083EUCTR2012-004342-14-EE
(EUCTR)
26/02/201331/01/2013A Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic DrugsA Phase 2/3 Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs 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]
Product Name: VX-509
Product Code: VX-509
INN or Proposed INN: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 2/3United States;Estonia;Lithuania;Denmark;South Africa;Netherlands
1084JPRN-UMIN000010126
2013/02/2526/02/2013Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung diseaseEfficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease - Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD Interstitial lung disease related to rheumatoid arthritisIn cases with UIP/NSIP pattern ILD, treatment is started with prednisolone and tacrolimus. For safety concern, the doses of tacrolimus should not exceed the dose approved in Japan and are adjusted to maintain blood trough levels less than 10 ng/ml. Prednisolone is started at the dose of 0.5 mg/kg/day and continued at the initial dose through 2-4 weeks, then reduced by 5 mg every 2-4 weeks. After the dose of prednisolone reaches 15 mg/day, it is reduced by 2.5 mg. After the dose of prednisolone reaches 10 mg, it is reduced by 1 mg every 4 weeks. The dose of prednisolone should be tapered to achieve 0.2 mg/kg/day at week 24. Prednisolone should be maintained at least 5 mg/day until month 12. Then prednisolone can be either continued, reduced or stopped later on.
In cases with OP pattern ILD, prednisolone is started, tapered and maintained as mentioned in cases with UIP/NSIP pattern ILD. Methotrexate is started after the dose of prednisolone reaches 0.3 to 0.4 mg/kg/day. Methotrexate is increased to the maximal tolerable dose, but should not exceed 16 mg/week. Methotrexate should be used following the guideline published by Japan College of Rheumatology. If methotrexate is not feasible by any reason, it can be substituted by tacrolimus and tacrolimus should be used as mentioned in UIP/NSIP pattern ILD cases.
Department of Lifetime Clinical Immunology, Tokyo Medical and Dental UniversityNULLComplete: follow-up complete20years-oldNot applicableMale and Female34Not applicableJapan
1085EUCTR2012-002324-32-BE
(EUCTR)
25/02/201319/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
1086EUCTR2012-000609-58-BE
(EUCTR)
20/02/201314/06/2012A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologicsA randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics 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 Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 50 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 25 mg/ml
INN or Proposed INN: N/A
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
268Phase 2United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Germany
1087EUCTR2012-002322-73-ES
(EUCTR)
20/02/201306/03/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active 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: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Lilly S.A.NULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;France;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
1088EUCTR2012-000610-11-BE
(EUCTR)
20/02/201314/06/2012A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to MethotrexateA randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to 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] - Musculoskeletal Diseases [C05]
Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 50 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 25 mg/ml
INN or Proposed INN: N/A
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
268Phase 2United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Germany
1089EUCTR2012-003536-23-CZ
(EUCTR)
20/02/201303/01/2013To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN 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]
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: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden
1090EUCTR2011-003538-16-AT
(EUCTR)
19/02/201314/01/2013To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET 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
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
1091EUCTR2012-004090-16-ES
(EUCTR)
19/02/201329/11/2012Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy.A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: BI 655064
INN or Proposed INN: BI 655064
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
130Czech Republic;Spain;Australia;Netherlands;Germany;New Zealand
1092EUCTR2012-003724-20-HU
(EUCTR)
19/02/201320/12/2012A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate.A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone Rheumatoid Arthritis
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 Code: IPI 145
Other descriptive name: IPI-145
Product Code: IPI 145
Other descriptive name: IPI-145
Product Code: IPI 145
Other descriptive name: IPI-145
Infinity Pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
316Phase 2Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;Colombia;New Zealand
1093EUCTR2011-005649-10-CZ
(EUCTR)
18/02/201311/12/2012An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis 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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Trade Name: Simponi
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Brazil;Germany
1094EUCTR2012-005370-62-IT
(EUCTR)
18/02/201311/01/2013clinical study to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes.No-profit” clinical study for the improvement of 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. rheumatoid arthritis and type 2 diabetes mellitus as comorbidity.
MedDRA version: 14.1;Level: LLT;Classification code 10037740;Term: RA;System Organ Class: 100000004859
MedDRA version: 14.1;Level: PT;Classification code 10012601;Term: Diabetes mellitus;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: KINERET*SC 7SIR 100MG 0,67ML
INN or Proposed INN: ANAKINRA
OSPEDALE CIVILE SAN SALVATORE, ASL 04, L'AQUILANULLNot RecruitingFemale: yes
Male: yes
200Phase 4Italy
1095EUCTR2011-003538-16-GR
(EUCTR)
18/02/201314/01/2013To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET 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
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;Japan;New Zealand
1096EUCTR2012-002322-73-GB
(EUCTR)
15/02/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active 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]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot Recruiting Female: yes
Male: yes
1280 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPoland;Belgium;Romania;Croatia;Germany;Japan;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Lithuania;Slovenia;Korea, Republic of;China;Netherlands;Latvia;South Africa;Australia;France;Switzerland;Israel;Russian Federation;Spain;Greece;Slovakia;Taiwan;Portugal;United States
1097EUCTR2011-003538-16-HU
(EUCTR)
14/02/201314/11/2012To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET 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
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522Portugal;United States;Taiwan;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
1098JPRN-UMIN000010033
2013/02/1414/02/2013To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy Rheumatoid ArthritisTocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks.Daihei KidaNULLComplete: follow-up complete20years-old75years-oldMale and Female20Not selectedJapan
1099EUCTR2012-002339-27-CZ
(EUCTR)
13/02/201304/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
1100EUCTR2012-002339-27-SK
(EUCTR)
12/02/201305/02/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
1101EUCTR2012-002322-73-SK
(EUCTR)
12/02/201305/02/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1102EUCTR2011-006344-71-DE
(EUCTR)
08/02/201325/04/2012Treatment with eggs of pig whipworm for patients with rheumatoid arthritis, who are insufficiently treated with methotrexateTrichuris suis ova (TSO) as a additional therapy for rheumatoid arthritis patients with insufficient response to methotrexate. A prospective, double-blind, randomized, controlled monocenter study. 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: Trichuris suis ova
Product Name: Trichuris suis ova
Product Code: TSO
INN or Proposed INN: Trichuris suis ova
Other descriptive name: Pig whipworm eggs
Immanuel Krankenhaus BerlinNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Germany
1103EUCTR2012-002323-15-DK
(EUCTR)
08/02/201308/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Japan;Korea, Republic of
1104EUCTR2010-022242-24-BG
(EUCTR)
07/02/201311/12/2012A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite DMARD Therapy 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
1650Phase 3Serbia;United States;Taiwan;Ukraine;Lithuania;Russian Federation;Chile;Colombia;India;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;Romania;Croatia;Peru;Bulgaria;South Africa;Japan;Korea, Republic of
1105EUCTR2011-006018-15-HU
(EUCTR)
06/02/201330/11/2012A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate Rheumatoid Arthritis
MedDRA version: 16.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 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)NULLNot RecruitingFemale: yes
Male: yes
375Phase 2United States;Czech Republic;Hungary;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia
1106EUCTR2011-002894-48-BG
(EUCTR)
06/02/201320/11/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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] - Immune System Diseases [C20]
Product Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 1;Phase 3United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
1107EUCTR2012-002324-32-IT
(EUCTR)
06/02/201311/01/2013A phase 3 study in moderate to severe rheumatoid arthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
Trade Name: Maxtrex
INN or Proposed INN: METHOTREXATE
Product Name: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
Trade Name: Maxtrex
INN or Proposed INN: METHOTREXATE
ELI LILLY AND COMPANYNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
1108EUCTR2011-005649-10-HU
(EUCTR)
05/02/201327/11/2012An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis 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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Trade Name: Simponi
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany
1109EUCTR2012-000439-17-HU
(EUCTR)
05/02/201320/11/2012A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate TherapyA Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: MK-8457
Product Code: MK-8457
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc.NULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Denmark;Peru;South Africa;Latvia;Germany;Japan;Moldova, Republic of
1110EUCTR2011-003538-16-LT
(EUCTR)
04/02/201305/11/2012To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET 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]
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522United States;Portugal;Hong Kong;Taiwan;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand
1111EUCTR2012-003194-25-LT
(EUCTR)
04/02/201324/09/2012Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid ArthritisRandomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis Active 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: MabionCD20
INN or Proposed INN: Rituximab
Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Mabion S.A.NULLNot RecruitingFemale: yes
Male: yes
863Serbia;Poland;Ukraine;Croatia;Romania;Lithuania;Russian Federation;Georgia
1112EUCTR2012-002339-27-PT
(EUCTR)
01/02/201302/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active 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: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
1113EUCTR2011-006021-23-CZ
(EUCTR)
01/02/201306/12/2012.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 DevelopmentNULLNot RecruitingFemale: yes
Male: yes
650Phase 2Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany
1114NCT02087449
(ClinicalTrials.gov)
February 20135/3/2014Evaluate E1 Wear, Clinical Performance of E1 Liner in THA in Korean Patient PopulationA Prospective Multi-center Study on E1 Acetabular Liner in THAOsteoarthritis;Avascular Necrosis;Traumatic Arthritis;Rheumatoid Arthritis;Legg-perthes DiseaseDevice: E1-Hip BearingZimmer BiometNULLActive, not recruiting20 Years65 YearsAll100Korea, Republic of
1115EUCTR2012-002324-32-GB
(EUCTR)
31/01/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active 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]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot Recruiting Female: yes
Male: yes
550 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Brazil;Belgium;South Africa;Germany;Japan;Korea, Republic of;Sweden
1116EUCTR2011-003538-16-SK
(EUCTR)
29/01/201308/03/2013To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET 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
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
1117EUCTR2012-002323-15-BE
(EUCTR)
28/01/201320/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
1118EUCTR2012-002323-15-PL
(EUCTR)
25/01/201319/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active 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]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
1119EUCTR2011-006021-23-BG
(EUCTR)
25/01/201313/12/2012A two-year, open-label clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA) who completed a previous study of ASP015KA 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 DevelopmentNULLNot RecruitingFemale: yes
Male: yes
650Phase 2Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany;Colombia
1120EUCTR2011-002894-48-DE
(EUCTR)
25/01/201324/07/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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]
Product Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
459Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
1121EUCTR2012-003439-41-EE
(EUCTR)
24/01/201302/01/2013A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 InhibitorA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs 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]
Product Name: VX-509
Product Code: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Estonia;Lithuania;Denmark;South Africa;Netherlands
1122EUCTR2012-003881-42-BE
(EUCTR)
24/01/201318/12/2012A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with AdalimumabA Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab 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: Body processes [G] - Immune system processes [G12]
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Slovakia;Puerto Rico;Belgium;Romania;Germany
1123EUCTR2012-002322-73-GR
(EUCTR)
24/01/201313/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Switzerland;France;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1124EUCTR2012-003881-42-SK
(EUCTR)
23/01/201327/04/2016A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with AdalimumabA Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab 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: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Slovakia;Puerto Rico;Belgium;Romania;Germany
1125EUCTR2012-002324-32-DE
(EUCTR)
23/01/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
1126EUCTR2012-002322-73-CZ
(EUCTR)
22/01/201304/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1127EUCTR2012-002760-27-BG
(EUCTR)
21/01/201309/11/2012Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritisA four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active 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] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
345United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1128EUCTR2012-002535-28-GB
(EUCTR)
21/01/201314/12/2012A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RAA Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA 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: RoActemra
Product Name: RoActemra
Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)NULLNot RecruitingFemale: yes
Male: yes
160Phase 4Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
1129EUCTR2012-002322-73-BE
(EUCTR)
21/01/201319/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1130EUCTR2011-002894-48-ES
(EUCTR)
18/01/201329/10/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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 Code: BI 695500
INN or Proposed INN: Not applicable
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
300United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden
1131EUCTR2011-001122-18-BG
(EUCTR)
18/01/201328/08/2012A Study of the Effectiveness and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Under the Skin of Patients with Active Rheumatoid Arthritis, Despite Existing Methotrexate TherapyA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy Rheumatoid Arthritis
MedDRA version: 15.0;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 Code: CNTO 1959
Other descriptive name: CNTO 1959 IgG
Product Code: CNTO 1959
Other descriptive name: CNTO 1959 IgG
Product Name: Ustekinumab
Product Code: CNTO1275
Other descriptive name: Ustekinumab
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Colombia;Hungary;Czech Republic;Mexico;Argentina;Singapore;Peru;Bulgaria
1132EUCTR2012-002324-32-PT
(EUCTR)
18/01/201302/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
1133EUCTR2012-002322-73-PT
(EUCTR)
18/01/201302/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active 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: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1134EUCTR2012-002322-73-NL
(EUCTR)
17/01/201317/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active 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: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1135EUCTR2012-002323-15-NL
(EUCTR)
17/01/201317/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active 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: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of
1136EUCTR2011-003538-16-ES
(EUCTR)
16/01/201329/11/2012To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-? Antagonists - SARIL-RA-TARGET 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
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
522Phase 3United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Australia;Peru;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand
1137EUCTR2012-002323-15-AT
(EUCTR)
14/01/201308/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
1138EUCTR2012-002339-27-HU
(EUCTR)
14/01/201322/11/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
1139EUCTR2012-002181-12-HU
(EUCTR)
14/01/201328/11/2012A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RAA Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA Active 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: MK-8457
Product Code: MK-8457
Other descriptive name: MK-8457
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
178Phase 2United States;Greece;Spain;Austria;Colombia;United Kingdom;Italy;France;Hungary;Brazil;Poland;Australia;Denmark;Peru;South Africa;New Zealand;Sweden
1140EUCTR2012-002322-73-HU
(EUCTR)
14/01/201327/11/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1141EUCTR2012-002324-32-AT
(EUCTR)
14/01/201309/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
1142EUCTR2012-002322-73-LV
(EUCTR)
11/01/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active 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: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;France;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
1143EUCTR2011-006020-20-BG
(EUCTR)
11/01/201304/01/2013A clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA)A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Rheumatoid Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 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)NULLNot RecruitingFemale: yes
Male: yes
275Phase 2United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria
1144EUCTR2012-002181-12-IT
(EUCTR)
10/01/201306/11/2012A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RAA Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti- TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA Active 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: MK-8457
Product Code: MK-8457
INN or Proposed INN: MK-8457
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
178Phase 2United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;Hungary;Brazil;Australia;Peru;Denmark;South Africa;New Zealand;Sweden
1145EUCTR2011-002067-20-GR
(EUCTR)
10/01/201313/12/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892United States;Portugal;Greece;Spain;Ireland;Austria;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1146EUCTR2012-000439-17-PL
(EUCTR)
10/01/201313/11/2012A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate TherapyA Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis active 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: MK-8457
Product Code: MK-8457
INN or Proposed INN: MK-8457 (free acid)
Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: MK-8457 (free acid)
Merck Sharpe & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Peru;Denmark;South Africa;Latvia;Germany;Moldova, Republic of;Japan
1147EUCTR2011-006018-15-BG
(EUCTR)
10/01/201328/12/2012A clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA) who are having insufficient relief from methotrexateA Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate Rheumatoid Arthritis
MedDRA version: 16.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 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)NULLNot RecruitingFemale: yes
Male: yes
375Phase 2United States;Hungary;Czech Republic;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia
1148EUCTR2012-002323-15-ES
(EUCTR)
09/01/201309/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active 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: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Lilly S.A.NULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
1149EUCTR2012-000609-58-IT
(EUCTR)
07/01/201325/09/2012A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologicsA randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics - NN8226-3612 Rheumatoid arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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: NA
Product Code: 0109-0012A 100 mg/ml
Product Name: NA
Product Code: 0109-0012A 50 mg/ml
Product Name: NA
Product Code: 0109-0012A 25 mg/ml
NOVO NORDISKNULLNot RecruitingFemale: yes
Male: yes
268Phase 2United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1150EUCTR2012-002339-27-IT
(EUCTR)
07/01/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
Product Name: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
ELI LILLY AND COMPANYNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Korea, Democratic People's Republic of;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Croatia;Germany;Japan;Korea, Republic of
1151NCT02089087
(ClinicalTrials.gov)
January 7, 201313/3/2014Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis PatientsA Randomized, Double-blind, Placebo-controlled, Single Ascending Dose First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CFZ533 in Healthy Subjects and Rheumatoid Arthritis PatientsRheumatoid ArthritisBiological: CFZ533;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll75Phase 1United States;Taiwan
1152EUCTR2012-000610-11-IT
(EUCTR)
07/01/201325/09/2012A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to MethotrexateA randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate Rheumatoid arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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: NA
Product Code: 0109-0012A 100 mg/ml
Product Name: NA
Product Code: 0109-0012A 50 mg/ml
Product Name: NA
Product Code: 0109-0012A 25 mg/ml
NOVO NORDISKNULLNot RecruitingFemale: yes
Male: yes
268Phase 2United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1153EUCTR2012-001618-40-PL
(EUCTR)
04/01/201331/10/2012Evaluation of the blood concentration of Tabalumab after the administration of Tabalumab using prefilled syringe or auto-injector in patients with Rheumathoid Arthritis that have not responded correctly to treatment with Methotrexate.Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled syringe or Auto-Injector in Patients with Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate. Rheumatoid Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: tabalumab
Product Code: LY2127399
Other descriptive name: TABALUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
180United States;Czech Republic;Argentina;Poland;Russian Federation
1154EUCTR2011-005649-10-PT
(EUCTR)
04/01/201310/09/2012An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis 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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Trade Name: Simponi
Product Name: Golimumab
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany
1155EUCTR2011-006021-23-HU
(EUCTR)
04/01/201324/10/2012.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 DevelopmentNULLNot RecruitingFemale: yes
Male: yes
650Phase 2Czech Republic;Hungary;Mexico;Poland;Belgium;Bulgaria;Germany
1156ChiCTR-TRC-13003948
2013-01-012013-12-05The evaluation of clinical curative effect of 'supplying of shen and nourishing sui' law of electroacupuncture combined with ZeLing joint swelling mixture in the treatment of rheumatoid arthritis with yin-deficiency of liver and kidney patternThe evaluation of clinical curative effect of 'supplying of shen and nourishing sui' law of electroacupuncture combined with ZeLing joint swelling mixture in the treatment of rheumatoid arthritis with yin-deficiency of liver and kidney pattern rheumatoid arthritisControl:Methotrexate 10mg qw PO + Leflunomide 10mg qd PO ;EA combined with medicine group:M+L+SEA+ZJSM ;Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese MedicineNULLCompleted1870BothControl:60;EA combined with medicine group:60;China
1157JPRN-UMIN000007404
2013/01/0101/03/2012Open-label, multicenter, randomized controlled trials, for comparing remission induction rate of a dose-escalation therapy of methotrexate and an additional combination therapy with bucillamine for naive patients to over 8 mg/weekly of methotrexate. Rheumatoid arthritisDose escalation of methotrexate
Concomitant therapy of methotrexate and bucillamine
KONAMON Study GroupNULLRecruitingNot applicableNot applicableMale and Female90Not applicableJapan
1158NCT01767844
(ClinicalTrials.gov)
January 20138/1/2013Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients?Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients? A Randomised Controlled Pilot TrialRheumatoid ArthritisDietary Supplement: Creatine;Dietary Supplement: PlaceboBangor UniversityNULLActive, not recruiting18 YearsN/ABoth43N/AUnited Kingdom
1159NCT01389388
(ClinicalTrials.gov)
January 201316/4/2010Effects of Rosuvastatin on Carotid Artery Plaques in Patients With Inflammatory Joint DiseaseCholesterol Plaques in Carotid and Coronary Arteries and the Effect of Rosuvastatin in Rheumatoid Arthritis, Ankylosing Spondylitis and Other Inflammatory Joint DiseasesCarotid Artery Plaque;Ankylosing Spondylitis;Rheumatoid ArthritisDrug: RosuvastatinDiakonhjemmet HospitalNULLCompleted35 Years80 YearsBoth114N/ANorway
1160NCT01793519
(ClinicalTrials.gov)
January 201314/2/2013Stopping TNF Alpha Inhibitors in Rheumatoid ArthritisStopping Tumor Necrosis Factor-Alpha Inhibitors in Rheumatoid Arthritis (STARA) Clinical TrialRheumatoid ArthritisDrug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: PlaceboGeorgetown UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);University of Maryland, College Park;Washington D.C. Veterans Affairs Medical Center;Medstar Health Research Institute;Patient-Centered Outcomes Research Institute;Arthritis and Pain Associates of PG County;Arthritis & Rheumatism Associates, P.C.;Rheumatology Associates of Baltimore, L.L.C.;The Arthritis Clinic of Northern Virginia, P.C.;Arthritis and Rheumatic Disease Associates, P.C.Recruiting18 YearsN/AAll290Phase 4United States
1161EUCTR2012-002323-15-IT
(EUCTR)
18/12/201219/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
Product Name: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
ELI LILLY AND COMPANYNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Australia;Netherlands;Japan;Korea, Republic of
1162NCT01491815
(ClinicalTrials.gov)
December 14, 20128/12/2011Active Conventional Therapy Compared to Three Different Biologic Treatments in Early Rheumatoid Arthritis With Subsequent Dose ReductionA 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 TreatmentRheumatoid ArthritisDrug: Non-biological DMARD's;Biological: Cimzia;Biological: Orencia;Biological: RoActemraKarolinska InstitutetNULLActive, not recruiting18 YearsN/AAll812Phase 4Denmark;Finland;Iceland;Netherlands;Norway;Sweden
1163EUCTR2011-006020-20-CZ
(EUCTR)
12/12/201203/08/2012A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis SubjectsA Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Rheumatoid Arthritis
MedDRA version: 16.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 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)NULLNot RecruitingFemale: yes
Male: yes
275Phase 2United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria
1164EUCTR2011-006018-15-CZ
(EUCTR)
12/12/201203/08/2012A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate Rheumatoid Arthritis
MedDRA version: 16.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 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)NULLNot RecruitingFemale: yes
Male: yes
375Phase 2United States;Hungary;Czech Republic;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia
1165EUCTR2010-020992-21-GR
(EUCTR)
11/12/201206/12/2012Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritisA 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4,5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis. 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] - Immune System Diseases [C20]
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
INN or Proposed INN: METHOTREXATE
Other descriptive name: not applicable
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;Slovakia;Greece;Thailand;Spain;Poland;Turkey;Romania;Monaco;Germany;India
1166EUCTR2011-006058-94-PT
(EUCTR)
11/12/201223/10/2012Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agentsA Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - REASSURE 2 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 Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
234Phase 3Panama;Portugal;United States;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of
1167JPRN-UMIN000009425
2012/12/0601/12/2012A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient Rheumatoid ArthritisThe dose of golimumab should be fixed as 50 mg/month for all period. Treat-to-target strategy might be achieved by MTX or other DMARDs for one year. The goal of treatment is low disease activity.
Treat-to-target strategy will be started with 50 mg of golimumab for first 3 months and then 100 mg golimumab can be used for tight control of rheumatoid arthritis to achieve low disease activity (LDA). Also MTX or other DMARDs might be used for tight control. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is allowed. Total period is one year.
Treat-to-target strategy will be started with 100 mg of golimumab for first 3 months. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is performed. If not, physicians should control the disease activity using MTX or other DMARDs. Total period is one year.
Osaka City University Medical SchoolNULLRecruiting20years-oldNot applicableMale and Female150Phase 4Japan
1168EUCTR2010-022243-38-BE
(EUCTR)
04/12/201206/09/2012A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy 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] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
840Portugal;Serbia;United States;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand
1169EUCTR2011-006058-94-GR
(EUCTR)
04/12/201223/10/2012Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agentsA Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents 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: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
234Phase 3Panama;Portugal;United States;Greece;Ecuador;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Korea, Republic of
1170EUCTR2011-005376-42-BG
(EUCTR)
03/12/201228/08/2012A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritisA randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with 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] - Musculoskeletal Diseases [C05]
Product Code: 0114-0006B
INN or Proposed INN: N/A
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
60Serbia;Hungary;Spain;Poland;Russian Federation;Bulgaria;Latvia
1171JPRN-UMIN000013885
2012/12/0105/05/2014Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study rheumatoid arthiritisRA patients were scheduled to receive TCZ once a month after 24 weeks. Serum NT-pro BNP concentrations were measured simultaneously on stored baseline and 24 week samples.Itabashi Chuo Medical CenterNULLComplete: follow-up complete20years-oldNot applicableMale and Female100Not applicableJapan
1172EUCTR2012-002181-12-ES
(EUCTR)
27/11/201223/08/2012A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RAA Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-alpha Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA Active 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: MK-8457
Product Code: MK-8457
INN or Proposed INN: MK8457
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
178Phase 2United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden
1173EUCTR2010-022243-38-GB
(EUCTR)
21/11/201229/06/2012A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
840 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand
1174JPRN-UMIN000011181
2012/11/1912/07/2013Continuous epidural infusion versus periarticular multimodal drug injection in bilateral simultaneous total knee arthroplasty: a randomized controlled trial Osteoarthritis of knee, rheumatoid arthritisA continuous epidural infusion containing ropivacaine and morphine for pain after simultaneous bilateral total knee arthroplasty
A periarticular multimodal drug injection including ropivacaine, morphine, bosmin, methylprednisolone, and ketoprofen for pain after simultaneous bilateral total knee arthroplasty
Nekoyama miyao hospitalNULLComplete: follow-up complete18years-oldNot applicableMale and Female60Not selectedJapan
1175EUCTR2011-006021-23-BE
(EUCTR)
19/11/201225/10/2012.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 DevelopmentNULLNot RecruitingFemale: yes
Male: yes
650Phase 2Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany
1176EUCTR2011-002894-48-GR
(EUCTR)
16/11/201219/10/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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 Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 1;Phase 3United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
1177EUCTR2012-002181-12-GR
(EUCTR)
16/11/201208/10/2012A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RAA Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA Active rheumatoid arthritis
MedDRA version: 15.0;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: MK-8457
Product Code: MK-8457
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
178Phase 2United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden
1178EUCTR2011-001122-18-CZ
(EUCTR)
15/11/201210/07/2012A Study of the Effectiveness and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Under the Skin of Patients with Active Rheumatoid Arthritis, Despite Existing Methotrexate TherapyA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy 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 Code: CNTO 1959
Other descriptive name: CNTO 1959 IgG
Product Code: CNTO 1959
Other descriptive name: CNTO 1959 IgG
Product Name: Ustekinumab
Product Code: CNTO1275
Other descriptive name: Ustekinumab
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Korea, Democratic People's Republic of;Turkey;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Argentina;Singapore;Peru;Bulgaria
1179EUCTR2012-002760-27-ES
(EUCTR)
14/11/201223/01/2013Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritisA four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis 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: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Farmaceutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
345United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1180EUCTR2010-022243-38-IT
(EUCTR)
14/11/201211/12/2012A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy 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: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
JANSSEN-CILAG INTERNATIONAL N.V.NULLNot RecruitingFemale: yes
Male: yes
990Portugal;United States;Taiwan;Spain;Lithuania;Austria;United Kingdom;Italy;Canada;Argentina;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China;Japan;Korea, Republic of
1181EUCTR2012-003057-29-HU
(EUCTR)
13/11/201219/09/2012A 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.NULLNot RecruitingFemale: yes
Male: yes
58Phase 2Czech Republic;Hungary;Slovakia
1182EUCTR2012-002181-12-GB
(EUCTR)
12/11/201221/08/2012A Phase IIa Proof Of Concept study to evaluate Safety, Tolerability and Efficacy in Subjects with Rheumatoid ArthritisA Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA Active 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: MK-8457
Product Code: MK-8457
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
178Phase 2United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden
1183EUCTR2012-002760-27-SK
(EUCTR)
12/11/201211/10/2012Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritisA four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis Rheumatoid arthritis
MedDRA version: 15.0;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
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
345United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1184EUCTR2012-003057-29-SK
(EUCTR)
12/11/201219/09/2012A 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.NULLNot RecruitingFemale: yes
Male: yes
58Phase 2Hungary;Czech Republic;Slovakia
1185EUCTR2011-005648-93-BG
(EUCTR)
09/11/201216/08/2012A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis 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]
Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Bulgaria;South Africa;Germany
1186EUCTR2010-019262-86-PT
(EUCTR)
09/11/201209/08/2012Long term evaluation of sarilumab in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND 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]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
2000Phase 3Poland;Belgium;Brazil;Belarus;Portugal;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Greece;Ecuador;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Czechia;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Romania;Norway;Germany;New Zealand;Sweden
1187EUCTR2011-002894-48-PT
(EUCTR)
09/11/201209/12/2011Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 15.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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] - Immune System Diseases [C20]
Product Code: BI 695500
INN or Proposed INN: No Active Name Specified
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
1188EUCTR2012-002760-27-IT
(EUCTR)
08/11/201230/10/2012A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis.A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 15.0;Level: LLT;Classification code 10037738;Term: R 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
Product Name: secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
345United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany
1189EUCTR2012-002760-27-DE
(EUCTR)
06/11/201225/09/2012Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritisA four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis Rheumatoid arthritis
MedDRA version: 15.0;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
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
345Romania;Bulgaria;Germany;United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil
1190EUCTR2012-001618-40-CZ
(EUCTR)
05/11/201203/08/2012Evaluation of the blood concentration of Tabalumab after the administration of Tabalumab using prefilled syringe or auto-injector in patients with Rheumathoid Arthritis that have not responded correctly to treatment with Methotrexate.Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled syringe or Auto-Injector in Patients with Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate. Rheumatoid Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: tabalumab
Product Code: LY2127399
Other descriptive name: TABALUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
180United States;Czech Republic;Argentina;Poland;Russian Federation
1191EUCTR2012-001760-30-IT
(EUCTR)
05/11/201225/07/2012Evaluation effects of treatment with an inhibitor of the receptor of a protein (interleukin-6 IL-6)involved in inflammatory process, on the clinical response and on the changes from baseline in the biomarkers in patients with rheumatoid arthritis (RA)not responding adequately to Disease-modifying antirheumatic drugs (DMARDs) and/or to a first biological agent.Evaluation effects of treatment with IL-6R inhibitor on clinical response and biomarkers in patients with rheumatoid arthritis (RA) not responding to DMARDs and/or a first biological agent. 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: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
OSSERVATORIO EPIDEMIOLOGICO GISEANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
1192EUCTR2012-000609-58-GB
(EUCTR)
01/11/201220/06/2012A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologicsA randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics 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: 0109-0012A 100 mg/ml
Product Code: 0109-0012A 50 mg/ml
Product Code: 0109-0012A 25 mg/ml
Novo Nordisk A/SNULLNot Recruiting Female: yes
Male: yes
268 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany
1193JPRN-UMIN000009088
2012/11/0112/10/2012Bio Logic MateTM clinical performance test for IFX Efficacy prediction rheumatoid arthritisIFX plus methotrexateBio Logic Mate Study GroupNULLComplete: follow-up complete20years-old75years-oldMale and Female150Not selectedJapan
1194NCT01741493
(ClinicalTrials.gov)
November 20123/12/2012A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494A Study in Healthy Adult Volunteers and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Dosing of ABT-494Rheumatoid ArthritisDrug: ABT-494;Drug: Placebo;Drug: TofacitinibAbbVie (prior sponsor, Abbott)NULLCompleted18 Years75 YearsAll67Phase 1United States
1195NCT01709760
(ClinicalTrials.gov)
November 201216/10/2012A Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With RAA 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 ArthritisRheumatoid ArthritisDrug: Methotrexate;Drug: ENIA11;Drug: PlaceboMycenax Biotech Inc.NULLUnknown status20 YearsN/AAll91Phase 3Taiwan
1196NCT01725230
(ClinicalTrials.gov)
November 20127/11/2012Assess the Pharmacokinetics of Rosuvastatin and Simvastatin When Administered Alone or in Combination With FostamatinibAn Open-label, Non-randomized, 2-Period, Fixed Sequence, Single-center Study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice DailyRheumatoid ArthritisDrug: Fostamatinib;Drug: Rosuvastatin;Drug: SimvastatinAstraZenecaNULLCompleted18 Years55 YearsBoth42Phase 1United States
1197NCT01689532
(ClinicalTrials.gov)
November 201218/9/2012A Study of CNTO 136 (Sirukumab) Administered Subcutaneously in Japanese Patients With Active Rheumatoid Arthritis Unresponsive to Methotrexate or SulfasalazineA Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously as Monotherapy, in Japanese Subjects With Active Rheumatoid Arthritis Unresponsive to Methotrexate or SulfasalazineArthritis, RheumatoidDrug: Sirukumab 100 mg;Drug: Sirukumab 50 mg;Drug: PlaceboJanssen Pharmaceutical K.K.GlaxoSmithKlineCompleted20 YearsN/AAll122Phase 3Japan
1198NCT01711359
(ClinicalTrials.gov)
November 201218/10/2012A Study in Participants With Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic DrugsRheumatoid ArthritisDrug: Baricitinib;Drug: Methotrexate;Drug: Baricitinib Placebo;Drug: MTX Placebo;Drug: Folic AcidEli Lilly and CompanyNULLCompleted18 YearsN/AAll588Phase 3United States;Argentina;Austria;Belgium;Brazil;Canada;Germany;Greece;India;Italy;Japan;Korea, Republic of;Mexico;Portugal;Puerto Rico;Russian Federation;South Africa;Sweden;United Kingdom
1199NCT01749787
(ClinicalTrials.gov)
November 20126/12/2012Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid ArthritisA Phase Ib Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation, Safety and Tolerability Study of PRTX-100 in Combination With Methotrexate or Leflunomide in Patients With Active Rheumatoid ArthritisArthritis, RheumatoidDrug: PRTX-100 at 1.5 mcg/kg;Drug: PRTX-100 at 3.0 mcg/kg;Drug: PRTX-100 at 6.0 mcg/kg;Drug: PRTX-100 at 12.0 mcg/kg;Drug: PRTX-100 at 240 mcg;Drug: Placebo;Drug: PRTX-100 at 420 mcgProtalex, Inc.NULLCompleted18 YearsN/ABoth61Phase 1United States
1200EUCTR2011-002840-29-CZ
(EUCTR)
31/10/201205/09/2012A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexateA Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available 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: JNJ-38518168-ZBQ - film-coated tablet - 3 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of
1201NCT01636843
(ClinicalTrials.gov)
October 30, 20126/7/2012A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MethotrexateA Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MethotrexateInflammation;Rheumatoid ArthritisDrug: NNC0109-0012;Drug: placeboNovo Nordisk A/SNULLTerminated18 Years75 YearsAll298Phase 2United States;Argentina;Belgium;Brazil;Czechia;France;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;Spain;Ukraine;Czech Republic
1202NCT01741688
(ClinicalTrials.gov)
October 26, 201230/11/2012An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid ArthritisA Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With TocilizumabRheumatoid ArthritisBiological: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll16N/APeru
1203EUCTR2011-002840-29-HU
(EUCTR)
25/10/201204/09/2012A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexateA Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available 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: JNJ-38518168-ZBQ - film-coated tablet - 3 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of
1204EUCTR2011-005634-19-BG
(EUCTR)
24/10/201219/10/2012A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis. 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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
280Phase 2Germany;South Africa;Bulgaria;Poland;Argentina;Mexico;Hungary;Czech Republic;France;Chile;Russian Federation;Ukraine;Spain;Estonia;Serbia
1205EUCTR2010-021146-22-GB
(EUCTR)
23/10/201225/10/2012Alemtuzumab and rheumatoid arthritis - a study to look at the function of the immune systemAlemtuzumab and rheumatoid arthritis - an immunisation study - Alemtuzumab and rheumatoid arthritis - an immunisation study 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: Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994; manufacturerd by Cambridge Therapeutic Antibody Centre, Burroughs Wellcome, Glaxo Wellcome)
Product Name: Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994)
The Newcastle upon Tyne Hospitals NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
40Phase 4United Kingdom
1206EUCTR2011-002896-40-DE
(EUCTR)
23/10/201202/07/2012A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritisA RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01 RHEUMATOID ARTHRITIS
MedDRA version: 16.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Rituximab-Pfizer
Product Code: PF-05280586
INN or Proposed INN: Not Applicable
Other descriptive name: Not Applicable
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017 USNULLNot RecruitingFemale: yes
Male: yes
195United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany
1207EUCTR2011-005649-10-ES
(EUCTR)
22/10/201219/07/2012An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 15.0;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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Trade Name: Simponi
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany
1208EUCTR2011-002840-29-LV
(EUCTR)
22/10/201225/10/2012A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexateA Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available 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: JNJ-38518168-ZBQ - film-coated tablet - 3 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of
1209EUCTR2010-022243-38-ES
(EUCTR)
22/10/201221/08/2012A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy 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: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
990United States;Serbia;Portugal;Taiwan;Spain;Lithuania;Austria;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China;Japan;Sweden;Korea, Republic of
1210EUCTR2012-000535-36-PL
(EUCTR)
18/10/201213/09/2012A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis. 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: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany
1211EUCTR2012-000610-11-ES
(EUCTR)
17/10/201209/07/2012A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to MethotrexateA randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to 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] - Musculoskeletal Diseases [C05]
Product Code: 0109-0012A 100 mg/ml
Product Code: 0109-0012A 50 mg/ml
Product Code: 0109-0012A 25 mg/ml
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
268Phase 2United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1212EUCTR2011-002894-48-HU
(EUCTR)
16/10/201216/08/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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] - Immune System Diseases [C20]
Product Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
459Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
1213EUCTR2010-022243-38-PT
(EUCTR)
15/10/201227/08/2012A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
840United States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand
1214EUCTR2012-002573-62-SE
(EUCTR)
12/10/201214/08/2012Doppler quantitative evaluation and follow-up over 12 months in RA patients with moderate and high disease activity who are candidates for biologic add-on therapy with AdalimumabDoppler quantitative evaluation and follow-up over 12 months in RA patients with moderate and high disease activity who are candidates for biologic add-on therapy with Adalimumab Rheumatoid arthritis (RA)
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: HumiraThe Karolinska Institute, ClinTRIDNULLNot RecruitingFemale: yes
Male: yes
120Phase 4Sweden
1215EUCTR2007-002066-35-SK
(EUCTR)
10/10/201215/04/2008A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Trade Name: Humira® 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: Humira®
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Czech Republic;Hungary;Slovakia;Greece;Bulgaria;Germany;Italy
1216EUCTR2011-005648-93-HU
(EUCTR)
09/10/201217/04/2012A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis 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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany
1217EUCTR2012-002760-27-HU
(EUCTR)
09/10/201203/09/2012Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritisA four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis 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: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
345United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1218EUCTR2011-002894-48-EE
(EUCTR)
08/10/201208/12/2011Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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 Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 1;Phase 3United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
1219EUCTR2011-005649-10-GR
(EUCTR)
03/10/201205/10/2012An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 15.0;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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Trade Name: Simponi
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Czech Republic;Mexico;Argentina;Brazil;Germany;Hungary;Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France
1220EUCTR2011-005648-93-GR
(EUCTR)
03/10/201205/10/2012A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 15.0;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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany
1221JPRN-UMIN000018101
2012/10/0126/06/2015Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study Osteoarthritis, rheumatoid arthritis, osteonecrosisTo determine whether postoperative VTE is present and to evaluate the efficacy and safety of edoxaban for the prevention of patients undergoing TKA, OWHTO, or CWHTO, angiography of the pulmonary artery and deep veins of the lower limbs is performed in all patients on postoperative day 7.
Levels of coagulation and fibrinolysis markers are evaluated on the preoperative day and on postoperative days 1, 3, 7, and 14.
Yokohama City University School of MedicineNULLRecruitingNot applicableNot applicableMale and Female100Not selectedJapan
1222JPRN-UMIN000010315
2012/10/0126/03/2013Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessmentPrediction of the recurrence after adalimumab discontinuation by using ultrasound assessment - PROUD study rheumatoid arthritisIn patients with clinical remission by adalimumab (DAS28-CRP <2.6) maintained over 24 weeks, to stop the Adalimumab.Osaka City University Medical SchoolMetabolism, 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 complete20years-oldNot applicableMale and Female50Not selectedJapan
1223JPRN-JapicCTI-132091
01/10/2012A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFalpha AgentsA Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFalpha Agents Rheumatoid ArthritisIntervention name : AIN457
INN of the intervention : secukinumab
Dosage And administration of the intervention : subcutaneously 75mg, 150mg
Control intervention name : null
Novartis Pharma K.K.NULL18BOTH234Phase 3NULL
1224JPRN-UMIN000008812
2012/10/0101/10/2012Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) Rheumatoid arthritistocilizumab monotherapyDepartment of Rheumatology & Clinical ImmunologySaitama Medical Center, Saitama Medical UniversitityNULLComplete: follow-up complete16years-old80years-oldMale and Female40Not selectedJapan
1225NCT01709578
(ClinicalTrials.gov)
October 201215/10/2012To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-a AntagonistsRheumatoid ArthritisDrug: Sarilumab;Drug: placebo;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomideSanofiRegeneron PharmaceuticalsCompleted18 YearsN/AAll546Phase 3United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Ecuador;Germany;Greece;Guatemala;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic;Hong Kong
1226NCT01789151
(ClinicalTrials.gov)
October 20127/2/201399m-Technetium- Glucosamine in Arthritis99mTc-labelled D-Glucosamine in the Evaluation of Disease Activity in Patients With Degenerative and Inflammatory Rheumatic ConditionsRheumatoid Arthritis;Ankylosing SpondylitisDevice: Technetium labelled glucosamineUniversity of SydneyAbbVieNo longer available18 Years90 YearsBothN/AAustralia
1227NCT01770379
(ClinicalTrials.gov)
October 201216/10/2012Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFa Agents.A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa AgentsRheumatoid ArthritisBiological: Secukinumab (AIN457);Biological: PlaceboNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll242Phase 3United States;Argentina;Brazil;Colombia;Czech Republic;Dominican Republic;Germany;Greece;Guatemala;India;Italy;Japan;Korea, Republic of;Panama;Portugal;South Africa;Ecuador;Puerto Rico
1228NCT01619176
(ClinicalTrials.gov)
October 20125/6/2012Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and BloodNon Inferiority Trial for the Study of Acupuncture on Rheumatoid ArthritisRheumatoid ArthritisDrug: methotrexate;Drug: non-steroidal anti-inflammatory drug (NSAID);Drug: leflunomide;Procedure: AcupunctureChinese Academy of SciencesShanghai GuangHua Hospital of integrated traditional and western medicineCompleted18 Years65 YearsFemale15N/AChina
1229EUCTR2011-004419-22-BG
(EUCTR)
29/09/201222/06/2012Study of VX-509 in Rheumatoid Arthritis Subjects taking MethotrexateA 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension 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]
Product Name: VX-509
Product Code: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Serbia;Estonia;Slovakia;Ukraine;Russian Federation;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany
1230JPRN-jRCTs032180245
28/09/201212/03/2019Wear of 32mm OXINIUM head on XLPE: Multicenter RCT StudyWear of 32mm Oxidized Zirconium (OXINIUM) head on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study - 32mmOX multicenter study Hip osteoarthritis, Rheumatoid arthritis
Hip osteoarthritis, Rheumatoid arthritis
Arm A: Oxidized zirconium alloy (OXINIUM) femoral head
Arm B: Standard cobalt chromium alloy head
Random allocation is registered automatically at the UMIN Internet Medical Research Data Center (INDICE)
Kume ShinichiroNULLNot Recruiting>= 20age old<= 75age oldBoth352Phase 4Japan
1231EUCTR2012-002760-27-CZ
(EUCTR)
27/09/201213/08/2012Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritisA four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis 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: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
345United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1232EUCTR2011-006058-94-CZ
(EUCTR)
26/09/201219/07/2012Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agentsA Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - REASSURE 2 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: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
234Phase 3Portugal;Panama;United States;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of
1233NCT01711814
(ClinicalTrials.gov)
September 26, 201219/10/2012A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis StudyA 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 StudyArthritis, RheumatoidDrug: peficitinibAstellas Pharma Global Development, Inc.Janssen Biotech, Inc.Completed18 YearsN/AAll611Phase 2United States;Belgium;Bulgaria;Colombia;Czechia;Hungary;Mexico;Poland;Czech Republic
1234EUCTR2012-000610-11-DE
(EUCTR)
25/09/201203/07/2012A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to MethotrexateA randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate 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 Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 50 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 25 mg/ml
INN or Proposed INN: N/A
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
268Phase 2United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1235EUCTR2012-000609-58-DE
(EUCTR)
25/09/201227/06/2012A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologicsA randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics 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 Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 50 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 25 mg/ml
INN or Proposed INN: N/A
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
268Phase 2United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1236EUCTR2012-002181-12-DK
(EUCTR)
24/09/201224/09/2012A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RAA Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - RADIUS-010 Active rheumatoid arthritis
MedDRA version: 15.0;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: MK-8457
Product Code: MK-8457
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to asNULLNot RecruitingFemale: yes
Male: yes
178Phase 2United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Denmark;Peru;Australia;South Africa;New Zealand;Sweden
1237EUCTR2011-005634-19-DE
(EUCTR)
19/09/201202/05/2012A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis. 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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
280Phase 2Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany
1238EUCTR2011-005648-93-DE
(EUCTR)
19/09/201211/05/2012A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis 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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;South Africa;Bulgaria;Germany
1239EUCTR2011-002894-48-GB
(EUCTR)
14/09/201206/12/2011Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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]
Product Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
1240EUCTR2011-002894-48-NL
(EUCTR)
10/09/201214/12/2011Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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] - Immune System Diseases [C20]
Product Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
459Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
1241EUCTR2011-005648-93-ES
(EUCTR)
10/09/201224/05/2012A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis 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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Bulgaria;South Africa;Germany
1242EUCTR2011-006020-20-HU
(EUCTR)
07/09/201229/06/2012A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis SubjectsA Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Rheumatoid Arthritis
MedDRA version: 15.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ASP015K
Product Code: ASP015K
INN or Proposed INN: ASP015K hydrobromide
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Product Code: ASP015K
INN or Proposed INN: ASP015K hydrobromide
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Product Code: ASP015K
INN or Proposed INN: ASP015K hydrobromide
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 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)NULLNot RecruitingFemale: yes
Male: yes
275Phase 2United States;Czech Republic;Hungary;Mexico;Poland;Ukraine;Bulgaria
1243EUCTR2012-000535-36-DE
(EUCTR)
05/09/201215/06/2012A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis. 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: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany
1244EUCTR2010-022243-38-DE
(EUCTR)
05/09/201221/06/2012A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy 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] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
840United States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand
1245EUCTR2010-022243-38-AT
(EUCTR)
04/09/201201/08/2012A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
840United States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand
1246EUCTR2011-006058-94-IT
(EUCTR)
04/09/201213/09/2012Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agentsA Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents Rheumatoid arthritis
MedDRA version: 15.0;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: AIN457F
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457F
INN or Proposed INN: SECUKINUMAB
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
234Phase 3Portugal;Panama;United States;Greece;Ecuador;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Korea, Republic of
1247NCT01647451
(ClinicalTrials.gov)
September 201219/7/2012A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid ArthritisA Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid ArthritisInflammation;Rheumatoid ArthritisDrug: NNC0114-0006;Drug: placeboNovo Nordisk A/SNULLCompleted18 Years75 YearsAll62Phase 2Bulgaria;Hungary;Latvia;Poland;Russian Federation;Serbia;Spain
1248NCT01640938
(ClinicalTrials.gov)
September 201212/7/2012Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid ArthritisA Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: Secukinumab (AIN457)Novartis PharmaceuticalsNULLCompleted18 YearsN/ABoth259Phase 3United States;Brazil;Bulgaria;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Mexico;Russian Federation;Slovakia;Spain;Romania
1249NCT01635686
(ClinicalTrials.gov)
September 20124/7/2012Comparison the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male VolunteersA 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 VolunteersRheumatoid ArthritisDrug: DWP422 25mg;Drug: ENBREL 25MG PFS INJ.Daewoong Pharmaceutical Co. LTD.NULLNot yet recruiting20 Years45 YearsMale38Phase 1Korea, Republic of
1250EUCTR2011-006070-73-DE
(EUCTR)
28/08/201224/02/2012Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid ArthritisA Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM Rheumatoid arthritis
MedDRA version: 15.0;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: Fostamatinib 50 mg blue film-coated tablet
Product Code: R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
130United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Bulgaria;South Africa;Germany
1251EUCTR2012-000535-36-BE
(EUCTR)
28/08/201205/06/2012A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.A multicenter, randomized, double-blind, double dummy, parallel design study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation compared to the currently approved adalimumab formulation in subjects with active rheumatoid arthritis. 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: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Czech Republic;Slovakia;Puerto Rico;Poland;Belgium;Romania;Germany
1252EUCTR2011-002067-20-IT
(EUCTR)
23/08/201213/09/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the EU and a n. of other countries worldwideA multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate Moderate to severe rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;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: Humira
INN or Proposed INN: ADALIMUMAB
UCB PHARMA SA/NV.NULLNot RecruitingFemale: yes
Male: yes
892United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1253EUCTR2012-000535-36-SK
(EUCTR)
23/08/201214/06/2012A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.A multicenter, randomized, double-blind, double dummy, parallel design study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation compared to the currently approved adalimumab formulation in subjects with active rheumatoid arthritis. 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: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany
1254EUCTR2012-000439-17-DE
(EUCTR)
15/08/201210/04/2012A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients with Active Rheumatoid Arthritis Despite Methotrexate TherapyA Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: NA
Other descriptive name: MK-8457
Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: NA
Other descriptive name: MK-8457
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
434Phase 2United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Peru;Denmark;South Africa;Latvia;Germany;Moldova, Republic of;Japan
1255EUCTR2011-002896-40-GB
(EUCTR)
14/08/201211/06/2012A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritisA RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES 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]
Product Code: PF-05280586
INN or Proposed INN: Not Applicable
Other descriptive name: Not Applicable
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
195 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Israel;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany
1256EUCTR2012-000609-58-HU
(EUCTR)
13/08/201218/06/2012A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologicsA randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics 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 Code: 0109-0012A 100 mg/ml
Product Code: 0109-0012A 50 mg/ml
Product Code: 0109-0012A 25 mg/ml
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
268Phase 2United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1257EUCTR2012-000610-11-HU
(EUCTR)
13/08/201218/06/2012A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to MethotrexateA randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to 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] - Musculoskeletal Diseases [C05]
Product Code: 0109-0012A 100 mg/ml
Product Code: 0109-0012A 50 mg/ml
Product Code: 0109-0012A 25 mg/ml
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
268Phase 2United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1258EUCTR2012-000535-36-CZ
(EUCTR)
02/08/201218/06/2012A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis. 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: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany
1259EUCTR2011-002894-48-BE
(EUCTR)
02/08/201218/07/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
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] - Immune System Diseases [C20]
Product Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
459Phase 1;Phase 3United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
1260EUCTR2011-005634-19-CZ
(EUCTR)
01/08/201224/04/2012A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis. 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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
280Phase 2Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany
1261EUCTR2011-005648-93-CZ
(EUCTR)
01/08/201224/04/2012A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis 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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;South Africa;Bulgaria;Germany
1262NCT01636817
(ClinicalTrials.gov)
August 20126/7/2012A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa BiologicsA Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa BiologicsInflammation;Rheumatoid ArthritisDrug: NNC0109-0012;Drug: placeboNovo Nordisk A/SNULLTerminated18 Years75 YearsAll239Phase 2United States;Argentina;Belgium;Brazil;Czechia;France;Germany;Hungary;Italy;Mexico;Poland;Spain;United Kingdom;Czech Republic
1263JPRN-UMIN000008572
2012/07/3131/07/2012The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients Rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX)Tacrolimus group patients receive daily the optimal dosage of tacrolimus within the range between 1.5-3.0 mg/day for 52 weeks.
Etanercept group patient receive weekly subcutaneous injection of etanercept 50mg for 52 weeks.
Department of Rheumatology and infectious disease, Kitasato university school of medicine1)Kitasato institute medical center hospital2)Kitasato institute hospital3)Ishikawa internal medicine clinicRecruiting20years-old70years-oldMale and Female80Not applicableJapan
1264NCT01705730
(ClinicalTrials.gov)
July 31, 201210/10/2012A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in MonotherapyMon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in MonotherapyRheumatoid ArthritisDrug: tocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll71Belgium
1265EUCTR2011-006018-15-BE
(EUCTR)
28/07/201202/07/2012A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to MethotrexateA Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate Rheumatoid Arthritis
MedDRA version: 16.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 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)NULLNot RecruitingFemale: yes
Male: yes
375Phase 2United States;Hungary;Czech Republic;Mexico;Poland;Belgium;Ukraine;Bulgaria;Colombia
1266EUCTR2011-005634-19-ES
(EUCTR)
27/07/201224/04/2012A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis. 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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
280Phase 2Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany
1267EUCTR2011-004529-28-CZ
(EUCTR)
25/07/201203/04/2012A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid ArthritisA Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available Rheumatoid Arthritis
MedDRA version: 15.0;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-40346527-AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Czech Republic;Argentina;Poland;Malaysia;Bulgaria;Chile;Russian Federation;Korea, Republic of
1268EUCTR2011-002067-20-GB
(EUCTR)
23/07/201213/03/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot Recruiting Female: yes
Male: yes
892 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Portugal;Greece;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany
1269EUCTR2011-005648-93-EE
(EUCTR)
19/07/201216/04/2012A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis 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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany
1270EUCTR2012-000439-17-GB
(EUCTR)
17/07/201216/04/2012A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate TherapyA Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: MK-8457
Product Code: MK-8457
Merck, Sharpe & Dohme Corp., a subsidiary of Merck & Co. Inc (hereafter referred to as Merck)NULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Peru;Denmark;South Africa;Latvia;Germany;Moldova, Republic of;Japan
1271EUCTR2010-019262-86-AT
(EUCTR)
12/07/201206/06/2012Long term evaluation of sarilumab in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - SARIL-RA-EXTEND 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 Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Other descriptive name: SAR153191
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
2000Phase 3United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden
1272EUCTR2010-022242-24-LT
(EUCTR)
11/07/201229/05/2012A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite DMARD Therapy 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
1650Phase 3Serbia;United States;Taiwan;Ukraine;Lithuania;Russian Federation;Chile;Colombia;India;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;Romania;Croatia;Peru;South Africa;Bulgaria;Japan;Korea, Republic of
1273JPRN-UMIN000010902
2012/07/1107/06/2013A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty Osteoarthritis of knee, rheumatoid arthritis, avascular necrosisAn epidural anesthesia containing 2mg/ml ropivacaine 100ml and 10mg/ml morphine 0.8ml for pain after total knee arthroplasty
A periarticular multimodal drug injection including 7.5mg/ml ropivacaine, 10mg/ml morphine 0.8ml, bosmin 0.3mg, methylprednisolone 40mg, and ketoprofen 50mg for pain after total knee arthroplasty
Nekoyama miyao hospitalNULLComplete: follow-up complete18years-oldNot applicableMale and Female100Not selectedJapan
1274EUCTR2010-022243-38-LT
(EUCTR)
11/07/201229/05/2012A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy 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]
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
840United States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand
1275EUCTR2011-002067-20-PT
(EUCTR)
06/07/201221/03/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892Phase 4Portugal;United States;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1276EUCTR2011-005376-42-LV
(EUCTR)
06/07/201213/03/2012A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritisA randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis 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 Code: 0114-0006BNovo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
60Serbia;Hungary;Spain;Poland;Bulgaria;Russian Federation;Latvia
1277JPRN-UMIN000033222
2012/07/0102/07/2018Clinical Results of Prophylactic Iodine-supported Primary TKA for Compromised Cases Osteoarthritis, Rheumatoid arthritis of knee jointprophylactic iodine-suported primaru TKAFukui General HospitalNULLComplete: follow-up complete50years-old90years-oldMale and Female30Not selectedJapan
1278JPRN-UMIN000008404
2012/07/0112/07/2012Extension of Tocilizumab Dose Intervals in Patients with Low to Moderate Disease Activity Rheumatoid Arthritis using IL-6 Serum Level as Starting Criteria. rheumatoid arthritisExtension of Tocilizumab Dose IntervalsJapan Labour Health and Welfare Organization,Yokohama Rosai HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female50Not selectedJapan
1279NCT01578850
(ClinicalTrials.gov)
July 201212/4/2012Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to ScreeningA 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 ArthritisDrug: Etanercept;Drug: placeboPfizerNULLCompleted18 Years70 YearsAll491Phase 4Brazil;China;Colombia;Czech Republic;Egypt;Hungary;Jordan;Lebanon;Malaysia;Mexico;Philippines;Qatar;Romania;Russian Federation;South Africa;Taiwan;Thailand;Ukraine;United Arab Emirates;Saudi Arabia
1280EUCTR2010-018485-24-HU
(EUCTR)
29/06/201202/05/2012To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritisA multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.
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: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
216Czech Republic;Hungary;Spain;Latvia;Germany
1281EUCTR2011-002067-20-BG
(EUCTR)
28/06/201211/05/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892Phase 4United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1282EUCTR2011-005260-20-GB
(EUCTR)
28/06/201210/05/2012RoActemra® (tocilizumab) plus methotrexate (MTX) in stable dosage in comparison with RoActemra® plus reducing (tapering) MTX dosages in patients with severe rheumatoid arthritis (RA) that have inadequate responded to a trial of two disease modifying anti-rheumatic drugs (DMARDs), including MTX and have not been previously treated with a biologic agent, such as a TNF inhibitor.Randomised, Phase IV, placebo-controlled, comparative study to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rheumatoid arthritis (RA) who have demonstrated an inadequate response to prior conventional disease-modifying anti-rheumatic drugs (DMARDs) treatment and have initiated RoActemra® (tocilizumab, TCZ) in combination with MTX. - ACT-TAPER Adult Rheumatoid Arthritis (RA)
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: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
Roche Products LimitedNULLNot Recruiting Female: yes
Male: yes
618 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
1283EUCTR2011-002067-20-AT
(EUCTR)
26/06/201227/03/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1284EUCTR2011-002067-20-ES
(EUCTR)
26/06/201210/05/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1285EUCTR2011-005204-15-AT
(EUCTR)
20/06/201215/05/2012Could 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 ImmunologieNULLNot RecruitingFemale: yes
Male: yes
110Phase 4Austria
1286EUCTR2011-002067-20-CZ
(EUCTR)
19/06/201225/04/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892Phase 4United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany
1287EUCTR2011-005376-42-ES
(EUCTR)
18/06/201229/03/2012A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritisA randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis 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 Code: 0114-0006BNovo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;Hungary;Poland;Spain;Russian Federation;Bulgaria;Latvia
1288EUCTR2012-000439-17-DK
(EUCTR)
15/06/201215/06/2012A Study to Evaluate Safety, Tolerability and Effecacy of MK-8457 plus Methotrexate in Patients with Active Rheumatoid Arthritis Despite Methotrexate TherapyA Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis active 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: MK-8457
Product Code: MK-8457
Product Name: MK-8457
Product Code: MK-8457
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,NULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Denmark;Peru;South Africa;Latvia;Germany;Moldova, Republic of;Japan
1289EUCTR2011-001122-18-HU
(EUCTR)
13/06/201202/05/2012A Study of the Effectiveness and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Under the Skin of Patients with Active Rheumatoid Arthritis, Despite Existing Methotrexate TherapyA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy Rheumatoid Arthritis
MedDRA version: 15.0;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 Code: CNTO 1959
Other descriptive name: CNTO 1959 IgG
Product Code: CNTO 1959
Other descriptive name: CNTO 1959 IgG
Product Name: Ustekinumab
Product Code: CNTO1275
Other descriptive name: Ustekinumab
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Colombia;Hungary;Czech Republic;Mexico;Argentina;Singapore;Peru;Bulgaria
1290EUCTR2011-002067-20-DE
(EUCTR)
13/06/201216/02/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 18.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892Phase 4Ireland;Austria;Italy;United States;Portugal;Greece;Spain;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1291EUCTR2011-005634-19-EE
(EUCTR)
13/06/201216/04/2012A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis. 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: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
280Phase 2Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany
1292EUCTR2011-001729-25-NL
(EUCTR)
11/06/201205/03/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active rheumatoid arthritis
MedDRA version: 15.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1293EUCTR2011-005448-87-CZ
(EUCTR)
11/06/201212/04/2012A 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 10017NULLNot RecruitingFemale: yes
Male: yes
320United 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
1294EUCTR2009-017998-37-BE
(EUCTR)
08/06/201211/04/2012Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy. Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis. Patients with an active Crohn's disease.
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: HLT;Classification code 10052775;Term: Spondyloarthropathies;System Organ Class: 100000004859
MedDRA version: 19.0;Classification code 10039078;Term: Rheumatoid arthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab pegol
INN or Proposed INN: CERTOLIZUMAB PEGOL
Product Name: 99mTc-S-HYNIC Certolizumab pegol
INN or Proposed INN: CERTOLIZUMAB PEGOL
Ghent University HospitalNULLNot Recruiting Female: yes
Male: yes
36 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelgium
1295EUCTR2011-005021-48-NL
(EUCTR)
07/06/201205/06/2012A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX)
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: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Teva Pharmaceutical IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
1296EUCTR2011-004419-22-SK
(EUCTR)
06/06/201212/04/2012Study of VX-509 in Rheumatoid Arthritis Subjects taking MethotrexateA 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension 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: VX-509
Product Code: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
350Phase 2Serbia;United States;Estonia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany
1297EUCTR2011-004419-22-HU
(EUCTR)
06/06/201221/03/2012Study of VX-509 in Rheumatoid Arthritis Subjects taking MethotrexateA 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension 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: VX-509
Product Code: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
350Phase 2Serbia;United States;Estonia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany
1298EUCTR2011-004419-22-CZ
(EUCTR)
06/06/201213/03/2012Study of VX-509 in Rheumatoid Arthritis Subjects taking MethotrexateA 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension 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]
Product Name: VX-509
Product Code: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Serbia;Estonia;Slovakia;Ukraine;Russian Federation;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany
1299NCT01611688
(ClinicalTrials.gov)
June 4, 20121/6/2012First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid ArthritisFirst Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid ArthritisInflammation;Rheumatoid ArthritisDrug: NNC0215-0384;Drug: placeboNovo Nordisk A/SNULLCompleted18 Years75 YearsAll36Phase 1Germany
1300JPRN-UMIN000008281
2012/06/0128/06/2012Dose-escalation study of infliximab or methotrexate based on the disease activity in patients with rheumatoid arthritis treated with infliximab rheumatoid arthritisDose-escalation of MTX or IFXDepartment of Internal Medicien and Rheumatology, Juntendo University School of MedicineNULLRecruiting20years-oldNot applicableMale and Female30Not selectedJapan
1301EUCTR2011-004529-28-BG
(EUCTR)
01/06/201207/05/2012A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid ArthritisA Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available 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: JNJ-40346527-AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Poland;Bulgaria
1302JPRN-UMIN000007806
2012/06/0101/05/2012The feasibility study of accelated infliximab infusion during maintenance phase patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.Chiba University HospitalNULLComplete: follow-up completeNot applicableNot applicableMale and Female54Phase 2Japan
1303EUCTR2011-001729-25-GB
(EUCTR)
01/06/201219/04/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot Recruiting Female: yes
Male: yes
800 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Colombia;Italy;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1304EUCTR2011-002067-20-IE
(EUCTR)
01/06/201210/04/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892Phase 4United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany
1305NCT01559103
(ClinicalTrials.gov)
May 31, 201219/3/2012Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis PatientsA Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (Anti-IL-6)Rheumatoid ArthritisBiological: MEDI5117;Biological: MEDI5117 PlaceboNovo Nordisk A/SNULLTerminated20 Years75 YearsAll39Phase 1United States;Germany;United Kingdom
1306EUCTR2012-000222-21-DE
(EUCTR)
31/05/201216/03/2012Comparison of the patient's experience with the methotrexate pre-filled syringe and with the methrotexate pre-filled pen and preference of the patient for subcutaneous methotrexate injection.An open-label, randomized, two-period cross-over study of repeated subcutaneous injections of methotrexate 50mg/ml solution either by a pre-filled syringe (reference) or by a disposable pre-filled pen (test) to assess patient’s preference and self-injection experience and to compare the local tolerability in patients with active rheumatoid arthritis - Preference MTX pre-filled syringe vs pre-filled pen in RA 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] - Immune System Diseases [C20]
Trade Name: metex® 50 mg/ml Injektionslösung, Fertigspritze
Product Name: metex® 50 mg/ml Injektionslösung, Fertigspritze
Product Code: 70930.00.00
INN or Proposed INN: Methotrexate disodium
Product Name: methotrexate pre-filled pen
INN or Proposed INN: Methotrexate disodium
medac Gesellschaft für klinische Spezialpräparate mbHNULLNot RecruitingFemale: yes
Male: yes
Germany
1307EUCTR2011-005376-42-HU
(EUCTR)
30/05/201211/04/2012A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritisA randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis 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 Code: 0114-0006BNovo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
60Serbia;Hungary;Spain;Poland;Bulgaria;Russian Federation;Latvia
1308EUCTR2011-002067-20-HU
(EUCTR)
30/05/201220/03/2012Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
892United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1309EUCTR2011-004720-35-SE
(EUCTR)
28/05/201222/12/2011A 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: 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: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
INN or Proposed INN: METHOTREXATE
Trade Name: Metoject
Other descriptive name: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE
The Karolinska Institute, ClinTRIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Sweden
1310EUCTR2011-006040-79-DK
(EUCTR)
25/05/201225/05/2012A clinical trial with the aim to explore the efficacy and safety of adding tocilizumab to standard of care in patients withearly rheumatoid arthThe efficacy and safety of adding tocilizumab to methotrexate and intra-articular glucocorticosteroid treatment in early rheumatoid arthritis.A randomized, double-blinded, placebo-controlled trial. - DanACT Early Adult 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®Aarhus University Hospital, Department of Rheumatology UNULLNot RecruitingFemale: yes
Male: yes
180Phase 4Denmark
1311EUCTR2011-005021-48-CZ
(EUCTR)
23/05/201215/02/2012A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX)
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: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Teva Pharmaceutical IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Netherlands;Germany;Georgia;Bulgaria;Romania;Poland;Macedonia, the former Yugoslav Republic of;Hungary;Czech Republic;Russian Federation;Ukraine;Spain;Serbia
1312EUCTR2011-004419-22-DE
(EUCTR)
23/05/201201/03/2012Study of VX-509 in Rheumatoid Arthritis Subjects taking MethotrexateA 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension 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: VX-509
Product Code: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
350Phase 2Serbia;United States;Estonia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany
1313EUCTR2011-001729-25-IT
(EUCTR)
23/05/201219/03/2012Study designed to demonstrate the efficacy and safety of certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritisA multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. Early active rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;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: Trexan
INN or Proposed INN: METHOTREXATE
UCB PHARMA SA/NV.NULLNot RecruitingFemale: yes
Male: yes
800United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1314EUCTR2011-006070-73-BG
(EUCTR)
22/05/201207/05/2012Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid ArthritisA Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM 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: Fostamatinib 50 mg blue film-coated tablet
Product Code: R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
130United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;South Africa;Bulgaria;Germany
1315EUCTR2011-001729-25-SE
(EUCTR)
22/05/201222/02/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800Phase 3United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1316EUCTR2011-006070-73-CZ
(EUCTR)
16/05/201229/02/2012Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid ArthritisA Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM 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: Fostamatinib 50 mg blue film-coated tablet
Product Code: R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
130United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Bulgaria;South Africa;Germany
1317EUCTR2012-000139-21-AT
(EUCTR)
14/05/201223/04/2012Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: Ro-Actemra
Product Name: Ro Actemra
Other descriptive name: TOCILIZUMAB
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: Ro-Actemra
Product Name: Ro Actemra
Other descriptive name: TOCILIZUMAB
Medizinische Universität Wien, Universitätsklinik für Innere Medizin IIINULLNot RecruitingFemale: yes
Male: yes
Phase 4Czech Republic;Slovakia;Austria;Russian Federation;Switzerland
1318EUCTR2011-005021-48-ES
(EUCTR)
14/05/201221/02/2012A study to investigate and compare the efficacy, safety, tolerability andpharmacodynamic (biochemical and physiological effects of the drug) ofTL011 and MabThera® (rituximab) in patients with severe, activerheumatoid arthritis treated with methotrexate (MTX)A multicenter, double-blind, randomized, active controlled, parallelgroupstudy to evaluate the efficacy, safety, tolerability andpharmacodynamic profiles of TL011 infusions compared with MabThera®(rituximab) in subjects with severe, active rheumatoid arthritis treatedwith methotrexate (MTX) - ALTO Sujetos adultos con artritis reumatoide (AR) activa de grado severo tratados con MTX
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: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg Concentrado para solución para perfusión
INN or Proposed INN: RITUXIMAB
Teva Pharmaceutical IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
1319EUCTR2011-005448-87-HU
(EUCTR)
14/05/201221/03/2012A 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 10017NULLNot RecruitingFemale: yes
Male: yes
320United 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
1320EUCTR2011-004529-28-PL
(EUCTR)
14/05/201228/03/2012A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid ArthritisA Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available 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: JNJ-40346527-AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Poland;Bulgaria
1321EUCTR2012-000439-17-LT
(EUCTR)
11/05/201215/03/2012A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate TherapyA Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: None
Other descriptive name: MK-8457
Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: None
Other descriptive name: MK-8457
MERCK SHARP & DOHME CORP.NULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Denmark;Peru;South Africa;Latvia;Germany;Japan;Moldova, Republic of
1322EUCTR2011-005008-14-HU
(EUCTR)
10/05/201228/02/2012Not applicableRandomized, Double blind, Placebo-controlled, Multicenter, Phase II Study to Compare Four Dose Regimens of GLPG0634 Versus Placebo, in Combination With Methotrexate, Administered for 4 Weeks in the Treatment of Subjects With Active Rheumatoid Arthritis who have an Inadequate Response to Methotrexate Alone 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: GLPG0634
Product Name: GLPG0634
Product Name: GLPG0634
Product Name: GLPG0634
Galapagos SASUNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;European Union;Ukraine;Russian Federation;Moldova, Republic of
1323EUCTR2011-005021-48-BG
(EUCTR)
09/05/201220/04/2012A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX)
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: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Teva Pharmaceutical IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands
1324EUCTR2011-005021-48-HU
(EUCTR)
04/05/201215/02/2012A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX)
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: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Teva Pharmaceutical IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
1325EUCTR2011-006125-14-HU
(EUCTR)
04/05/201208/03/2012A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS - FUNCTION LTEA MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS - FUNCTION LTE Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: RoActemra
Product Code: RO4877533
Roche (Magyarország) Kft.NULLNot RecruitingFemale: yes
Male: yes
241Hungary
1326EUCTR2011-004419-22-EE
(EUCTR)
02/05/201221/03/2012Study of VX-509 in Rheumatoid Arthritis Subjects taking MethotrexateA 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension 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]
Product Name: VX-509
Product Code: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Serbia;Estonia;Slovakia;Ukraine;Russian Federation;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany
1327JPRN-UMIN000014484
2012/05/0101/12/2014Saitama Actemra study for QOL in patients with Rheumatoid arthritis rheumatoid arthritisTreatment with TocilizumabJuntendo University, Juntendo Koshigaya HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female40Not selectedJapan
1328JPRN-UMIN000007786
2012/05/0119/04/2012"Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis " Rheumatoid Arthritisinfliximab plus methotrexateSaitama Medical Center. Saitama Medical UniversityNULLComplete: follow-up complete20years-old75years-oldMale and Female40Not applicableJapan
1329NCT01617005
(ClinicalTrials.gov)
May 20128/6/2012A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARDRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll50N/AMontenegro
1330NCT01548001
(ClinicalTrials.gov)
May 20125/3/2012Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid ArthritisA Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod Alone or Iguratimod in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Iguratimod;Drug: MethotrexateJiangsu Simcere Pharmaceutical Co., Ltd.NULLActive, not recruiting18 Years65 YearsBoth910Phase 4China
1331NCT01579006
(ClinicalTrials.gov)
May 201216/4/2012Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid ArthritisA Multi National, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (Actemra)Rheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheClalit Health ServicesCompleted18 YearsN/AAll184N/AIsrael
1332JPRN-UMIN000009535
2012/04/2512/12/2012Suppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexateSuppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexate - SCRUM study rheumatoid arthritisWe randomly assigned patients who have the positive joint of power Doppler signal by ultrasonography even in clinical remission to increase or stable the dose of MTX and observation .
MTX increase group was increased to 16mg, it will continue to increase as much as possible.
We randomly assigned patients who have the positive joint of power Doppler signal by ultrasonography even in clinical remission to increase or stable the dose of MTX and observation .
MTX increase group was increased to 16mg, it will continue to increase as much as possible.
We observe the patients if there is no positive joint power Doppler signal.
Osaka City University Medical SchoolNULLComplete: follow-up complete20years-old100years-oldMale and Female120Not selectedJapan
1333JPRN-UMIN000018017
2012/04/2322/06/2015Analysis 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 rheumatoid arthritis or psoriasis patients with past hepatitis B virus infectionThe effect of preventive lamivudine, adefovir or entecavir on de novo HBV hepatitis.Department of general internal medicine, Kyushu-University hospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female70Not selectedJapan
1334EUCTR2011-004529-28-HU
(EUCTR)
18/04/201201/03/2012A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid ArthritisA Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available 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: JNJ-40346527-AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Czech Republic;Hungary;Argentina;Poland;Ukraine;Singapore;Chile;Bulgaria;Russian Federation;Korea, Republic of
1335JPRN-UMIN000011087
2012/04/1101/07/2013Efficacy of monthly minodronate for the treatment of osteoporosis associated with rheumatoid arthritis after previous treatment with bisphosphonates OsteoporosisMinodronic acid (50mg/month or 1mg/day)Osaka University Graduate School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female100Not applicableJapan
1336EUCTR2011-001729-25-DE
(EUCTR)
11/04/201210/01/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active rheumatoid arthritis
MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800Argentina;Brazil;Australia;Netherlands;Germany;Sweden;Canada;Mexico;Czech Republic;Hungary;Switzerland;Italy;United Kingdom;Colombia;Austria;Ireland;Spain;United States
1337EUCTR2011-005021-48-PL
(EUCTR)
10/04/201214/03/2012A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX)
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: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Teva Pharmaceutical IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Poland;Macedonia, the former Yugoslav Republic of
1338EUCTR2011-002392-41-BG
(EUCTR)
09/04/201207/02/2012A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis.A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS Treatment of patients with moderate to severe rheumatoid arthritis (RA)
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Z102
Product Code: Z102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Trade Name: Dacortin ®
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Zalicus, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 2Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria
1339EUCTR2011-001729-25-CZ
(EUCTR)
03/04/201203/02/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1340JPRN-UMIN000007380
2012/04/0101/05/2012Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis rheumatoid arthritistocilizumab + methotrexate (10mg/week)
high-dose methotrexate (stepwisely increased to 16mg/week)
Kinki University Faculty of Medicine, Division of Hematology and RheumatologyNULLComplete: follow-up complete20years-old80years-oldMale and Female40Not selectedJapan
1341JPRN-UMIN000007432
2012/04/0102/03/2012Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody. rheumatoid arthritisInfliximab and Methotrexate.
Patient is treated with IFX 3mg/kg for 0, 2, or 6 weeks, and henceforth every 8 weeks till 46weeks. Disease activity is assessed every 4weeks (suitable) or every 8 weeks (indispensable), and if SDAI Score 3.3 or more, it will change into of 3mg/kg 4week or 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks. If not remission(SDAI Score 3.3 or more), after change into of 3mg/kg 4week interval medication, it will change into of 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks.
Keio UniversityNULLComplete: follow-up continuing20years-old75years-oldMale and Female100Not selectedJapan
1342NCT01579890
(ClinicalTrials.gov)
April 201216/4/2012Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid ArthritisA 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 ArthritisOsteoarthritis of the HandDrug: DiclofenacMallinckrodtNuvo Research Inc.Approved for marketingN/AN/ABothN/ANULL
1343EUCTR2011-004171-36-ES
(EUCTR)
30/03/201230/01/2012A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) Severe 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]
Product Name: SAIT101
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody
Trade Name: MabThera®
Product Name: MabThera®
INN or Proposed INN: RITUXIMAB
Samsung Electronics Co. Ltd.NULLNot RecruitingFemale: yes
Male: yes
616Taiwan;Spain;Turkey;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Korea, Republic of
1344EUCTR2011-002392-41-HU
(EUCTR)
28/03/201216/12/2011A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis.A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS Treatment of patients with moderate to severe rheumatoid arthritis (RA)
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Z102
Product Code: Z102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Trade Name: Dacortin ®
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Zalicus, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 2Bulgaria;Peru;Poland;Brazil;Argentina;Canada;Mexico;Hungary;Russian Federation;Chile;Ukraine;United States;Serbia
1345EUCTR2010-021184-32-EE
(EUCTR)
23/03/201208/03/2012GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies Refractory 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 Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
164Phase 2Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1346EUCTR2011-001729-25-HU
(EUCTR)
22/03/201226/01/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1347EUCTR2011-001729-25-ES
(EUCTR)
16/03/201227/01/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1348EUCTR2011-002275-41-CZ
(EUCTR)
15/03/201228/12/2011A Study of Two Different Adalimumab Formulations in Adults withRheumatoid Arthritis.A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis. 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: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
60Czech Republic;Belgium
1349EUCTR2011-004468-31-LT
(EUCTR)
14/03/201205/01/2012Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritisAn Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 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: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
CELLTRION, IncNULLNot RecruitingFemale: yes
Male: yes
617Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina
1350EUCTR2009-011791-30-HU
(EUCTR)
14/03/201219/01/2012A multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritisA randomised, double-blind, placebo-controlled, multiple dose trial of NNC0151-0000-0000 in subjects with rheumatoid arthritis 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: NNC151-0000
Product Code: NNC0151-0000-0000
Other descriptive name: Anti-C5aR
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
48Czech Republic;Hungary;Poland;Ukraine;Romania;Denmark;Russian Federation;Germany;United Kingdom
1351EUCTR2011-003953-25-DE
(EUCTR)
13/03/201204/01/2012A Study of Two Different Adalimumab Formulations in Adults with Rheumatoid Arthritis.A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis. 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: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
Product Code: L04 AB04
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
60Canada;Australia;Germany
1352EUCTR2011-001729-25-IE
(EUCTR)
09/03/201212/01/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800Phase 3United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1353EUCTR2011-001729-25-AT
(EUCTR)
08/03/201208/02/2012Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - Early active rheumatoid arthritis
MedDRA version: 16.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
800United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1354JPRN-UMIN000017230
2012/03/0122/04/2015Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies) Rheumatoid arthritisBiologic treatment (tocilizumab)Kyushu UniversityNULLRecruiting20years-oldNot applicableMale and Female60Not selectedJapan
1355NCT01565408
(ClinicalTrials.gov)
March 201221/3/2012Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid ArthritisSafety and Tolerability of NNC0114-0006 Following Multiple s.c. Dosing at Escalating Dose Levels in Subjects With Rheumatoid ArthritisInflammation;Rheumatoid ArthritisDrug: NNC0114-0006;Drug: placeboNovo Nordisk A/SNULLCompleted18 Years75 YearsAll32Phase 1Germany;Russian Federation
1356NCT01670045
(ClinicalTrials.gov)
March 201217/8/2012A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid ArthritisA Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With TocilizumabRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll43N/AIndonesia;Greece
1357EUCTR2011-004171-36-CZ
(EUCTR)
15/02/201230/11/2011A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) Severe Rheumatoid Arthritis (RA)
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: SAIT101
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody
Trade Name: MabThera®
Product Name: MabThera®
INN or Proposed INN: RITUXIMAB
Samsung Electronics Co. Ltd.NULLNot RecruitingFemale: yes
Male: yes
616Hungary;Switzerland;Turkey;South Africa;Brazil;Czech Republic;Russian Federation;United Kingdom;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
1358EUCTR2011-004468-31-ES
(EUCTR)
10/02/201207/12/2011Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritisAn Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 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: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
CELLTRION, IncNULLNot RecruitingFemale: yes
Male: yes
522Phase 3Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;United Kingdom;Italy;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina
1359EUCTR2011-004468-31-PL
(EUCTR)
07/02/201210/02/2012Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritisAn Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 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: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
CELLTRION, IncNULLNot RecruitingFemale: yes
Male: yes
617Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina
1360EUCTR2011-004468-31-LV
(EUCTR)
06/02/201230/12/2011Long-term safety and effectivenss CT-P13 together with methotrexate in patients with arthritisAn Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 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: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
CELLTRION, IncNULLNot RecruitingFemale: yes
Male: yes
617Portugal;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;United Kingdom;Italy;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
1361EUCTR2011-000311-34-IT
(EUCTR)
03/02/201206/12/2011GO-AHEADA Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects with Active Axial Spondyloarthritis (Phase 3b, Protocol No. P07642, also known as MK-8259-006-00). - GO-AHEAD Active Axial Spondyloarthritis (SpA)
MedDRA version: 14.0;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]
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB
SCHERING PLOUGH RESEARCH INSTITUTE, A DIVISION OF SCHERING CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Greece;Canada;Finland;Spain;Turkey;Russian Federation;Germany;United Kingdom;Italy
1362EUCTR2011-004468-31-IT
(EUCTR)
02/02/201202/03/2012Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritisAn Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13-3.1 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: CT-P13
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Other descriptive name: NA
CELLTRION, INC.NULLNot RecruitingFemale: yes
Male: yes
617Korea, Republic of;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Peru;Latvia;Bosnia and Herzegovina
1363JPRN-UMIN000007019
2012/02/0101/02/2012Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's disease Rheumatoid arthritistocilizumab monotherapyDepartment of Rheumatology & Clinical Immunology,Saitama Medical Center, Saitama Medical UniversitityNULLComplete: follow-up complete16years-old70years-oldMale and Female40Not selectedJapan
1364JPRN-UMIN000006702
2012/02/0111/11/2011A parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid Arthritis rheumatoid arthritisIntensive treatment group
Period: 24 weeks
In the intensive treatment group, a patient starts treatment with MTX at 8mg/week. Dosage is increased to 0.25mg/kg/week by week 8 and is further increased to his or her maximum tolerable dosage by week 12. The maximum tolerable dosage is maintained until week 24. If a patient shows inadequate response to MTX and does not achieve SDAI(simplified disease activity index)emission or CDAI (linical disease activity index)remission by week 16, additional treatment with tacrolimus, bucillamine, sarazosulfapyridine, or biologics will be started as scheduled in the protocol.
After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72.
Conventional treatment group
Period: 24 weeks
In the control group, a patient starts treatment with MTX, tacrolimus, bucillamine, sarazosulfapyridine, or biologics by attending rheumatologists' discretion by week 24. Biologics are allowed on and after week 12. After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72.
Tokyo Medical and Dental UniversityDepartment of PharmacovigilanceComplete: follow-up continuing20years-old70years-oldMale and Female290Not applicableJapan
1365JPRN-UMIN000007205
2012/02/0102/02/2012The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis Rheumatoid arthritis1) Tacrolimus
Oral administration of tacrolimus is started usually at a dose of 1.5 mg/day immediately after informed consent is obtained.
The dose can be increased or decreased within the limits of 3 mg/day with taking into account symptoms, adverse reactions and so on.
However, the administration of tacrolimus can be started at a dose of 0.5 or 1.0 mg/day in order to reduce adverse effects.
Juntendo UniversityNULLPending65years-oldNot applicableMale and Female30Not selectedJapan
1366NCT01646385
(ClinicalTrials.gov)
February 201212/4/2012Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics RegistryLong-term Safety and Efficacy of Etanercept in a UK Observational Cohort Study - a Retrospective Database Analysis of British Society of Rheumatology Biologics Registry (BSRBR) DataRheumatoid ArthritisDrug: etanercept;Drug: non-biologic anti-rheumatic drugsPfizerNULLCompleted18 YearsN/AAll6393N/ANULL
1367NCT01562327
(ClinicalTrials.gov)
February 201221/3/2012A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid ArthritisA Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab ActemraRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll50N/AArgentina
1368EUCTR2011-002275-41-BE
(EUCTR)
31/01/201206/01/2012A Study of Two Different Adalimumab Formulations in Adults withRheumatoid Arthritis.A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis. 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: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
60Czech Republic;Belgium
1369EUCTR2011-004468-31-AT
(EUCTR)
26/01/201230/11/2011Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritisAn Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 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: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
CELLTRION, IncNULLNot RecruitingFemale: yes
Male: yes
522Portugal;Colombia;Bulgaria;Chile;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Jordan;Poland
1370EUCTR2010-023782-22-SK
(EUCTR)
25/01/201207/10/2011A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUGA PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG Rheumatoid Arthritis
MedDRA version: 16.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-04171327
INN or Proposed INN: Not available
Product Code: PF-04171327
INN or Proposed INN: Not available
Product Code: PF-04171327
INN or Proposed INN: Not available
Trade Name: Decortin
INN or Proposed INN: PREDNISONE
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
315Phase 2Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Hungary;Czech Republic;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of
1371EUCTR2011-002849-36-LV
(EUCTR)
12/01/201222/11/2011A study of multiple different dosages of JNJ 39758979 and placebo in patients with active Rheumatoid ArthritisA 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 NVNULLNot RecruitingFemale: yes
Male: yes
325Phase 2United States;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Mexico;Argentina;Poland;Malaysia;Singapore;Romania;Latvia;Japan
1372EUCTR2011-004468-31-GB
(EUCTR)
06/01/201225/11/2011Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritisAn Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 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: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
CELLTRION, IncNULLNot RecruitingFemale: yes
Male: yes
617Phase 3Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina
1373JPRN-UMIN000012613
2012/01/0120/12/2013Reduction or withdrawal of etanercept after remission with etanerceptin patients with rheumatoid arthritis patients. rheumatoid arthritisetanercept50mg/wk or25mg twice/wk
reduction of etanercept to 25mg/wk arfter 3 months from remission
Dept. of orthopedic surgery, Osaka Medical CollegeNULLComplete: follow-up complete20years-old70years-oldMale and Female30Not selectedJapan
1374NCT02922192
(ClinicalTrials.gov)
January 1, 201228/9/2016Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive AnalysisIncidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive AnalysisRheumatoid Arthritis;Inflammatory Bowel Disease;Psoriasis;Psoriatic Arthritis;Ankylosing SpondylitisDrug: TNF-a antagonists, non-TNFs, DMARD non-biologicsBiologics & Biosimilars Collective Intelligence ConsortiumHealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Kaiser Permanente;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta Pharmaceuticals, Inc.;Pfizer;University of PittsburghCompleted18 YearsN/AAll90360NULL
1375EUCTR2011-004468-31-SK
(EUCTR)
30/12/201104/01/2012Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritisAn Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 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: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
CELLTRION, IncNULLNot RecruitingFemale: yes
Male: yes
Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina
1376EUCTR2010-023782-22-BG
(EUCTR)
21/12/201121/05/2012A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUGA PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG Rheumatoid Arthritis
MedDRA version: 15.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-04171327
Product Code: PF-04171327
Product Code: PF-04171327
Trade Name: Decortin
INN or Proposed INN: PREDNISONE
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
315Phase 2Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Hungary;Czech Republic;Mexico;Canada;Malaysia;Poland;Romania;Bulgaria;South Africa;Germany;Korea, Republic of
1377EUCTR2010-023782-22-DE
(EUCTR)
13/12/201116/09/2011A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUGA PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG Rheumatoid Arthritis
MedDRA version: 16.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-04171327
INN or Proposed INN: na
Product Code: PF-04171327
INN or Proposed INN: na
Product Code: PF-04171327
INN or Proposed INN: na
Trade Name: Decortin
INN or Proposed INN: PREDNISONE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USANULLNot RecruitingFemale: yes
Male: yes
315Phase 2United States;Serbia;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of
1378EUCTR2009-016266-90-PT
(EUCTR)
09/12/201129/01/2010Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patientsA 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 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]
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
1740Belarus;United States;Portugal;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Austria;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand
1379EUCTR2011-000436-28-PL
(EUCTR)
07/12/201120/06/2011A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS Treatment of patients with moderate to severe rheumatoid arthritis (RA)
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Z102
Product Code: Z102
INN or Proposed INN: Z102 (Prednisolone and Dipyridamole).
Product Name: Prednisolone
Product Code: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Dipyridamole
Product Code: Dipyridamole
INN or Proposed INN: Dipyridamole
Trade Name: Dacortin ®
INN or Proposed INN: PREDNISONE
Zalicus, Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Serbia;Hungary;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Chile;Bulgaria;Russian Federation
1380EUCTR2010-020065-24-GR
(EUCTR)
05/12/201104/11/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
2800Phase 4United 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
1381EUCTR2011-001220-38-DE
(EUCTR)
30/11/201121/07/2011A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid ArthritisA multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension 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]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350United Kingdom;Germany;Russian Federation;Belgium;United States
1382NCT01326962
(ClinicalTrials.gov)
November 30, 20117/3/2011A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNFTocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNFRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll28Phase 3Saudi Arabia
1383EUCTR2011-000275-13-BE
(EUCTR)
29/11/201120/10/2011Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugsA randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents 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: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
630Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Japan;Peru;Belgium;Argentina
1384EUCTR2010-023956-99-CZ
(EUCTR)
29/11/201117/06/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 (v1.0, dated 09-Oct-2014) RHEUMATOID ARTHRITIS,NOS
MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
677Phase 2Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of;United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil
1385EUCTR2011-005036-26-GB
(EUCTR)
29/11/201131/10/2011A study to investigate what effects FX125L (taken by mouth) has on adults with chronic inflammatory diseasesAn Exploratory Phase IIa Study to Investigate the Biological Activity of Oral FX125L in Adult Patients with Chronic Inflammatory Disease AsthmaChronic obstructive pulmonary diseaseRheumatoid arthritisPsoriasis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0;Classification code 10003553;Term: Asthma;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0;Level: LLT;Classification code 10010952;Term: COPD;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: FX125LFunxional Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
Phase 2United Kingdom
1386EUCTR2010-023782-22-HU
(EUCTR)
22/11/201127/09/2011A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUGA PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG Rheumatoid Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-04171327
Product Code: PF-04171327
Product Code: PF-04171327
Trade Name: Decortin
INN or Proposed INN: PREDNISONE
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
315Phase 2Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of
1387EUCTR2011-000102-21-BG
(EUCTR)
09/11/201101/09/2011Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agentsA randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1 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 Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
548United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1388EUCTR2010-024516-34-BG
(EUCTR)
09/11/201107/09/2011Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexateA randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with 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] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
215United States;Hungary;Slovakia;Canada;Bulgaria;Italy
1389JPRN-UMIN000006653
2011/11/0104/11/2011Trabecular Metal Primary Hip Prosthesis Registry Study -Multicenter clinical research in Japan and US-Trabecular Metal Primary Hip Prosthesis Registry Study -Multicenter clinical research in Japan and US- - TM Stem Registry Study -Multicenter clinical research in Japan and US Patients who have been diagnosed Osteoarthritis, Rheumatoid Arthritis and Avascular Necrosis, etc.Trabecular Metal Primary Hip Prosthesis by THAShonan Kamakura Joint Reconstruction CenterNULLComplete: follow-up continuing18years-oldNot applicableMale and Female100Not applicableJapan,North America
1390NCT01408602
(ClinicalTrials.gov)
November 20112/8/2011A Study of Two Doses of MRC375 in Moderate to Severe Rheumatoid Arthritis PatientsA 24-week, Phase 2, Double-blind, Placebo-controlled, Randomized Study to Assess the Safety and Efficacy of 2 Doses of MRC375 in Patients With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisDrug: MRC375;Drug: Matching Placebo;Drug: MRC375 150mgMolecular Research Center, Inc.Camargo Pharmaceutical Services;Clin Data Services;Harrison Clinical Research;BARC Global Central Laboratory;Bilcare Global Clinical SuppliesActive, not recruiting18 YearsN/ABoth300Phase 2United States
1391NCT01592292
(ClinicalTrials.gov)
November 201111/4/2012An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha TherapyA Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF AgentRheumatoid ArthritisDrug: Rituximab;Drug: Adalimumab;Drug: Etanercept;Drug: InfliximabHoffmann-La RocheNULLCompleted20 YearsN/AAll90N/AKorea, Republic of
1392NCT02243800
(ClinicalTrials.gov)
November 201116/9/2014Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D DeficiencyStudy of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D DeficiencyRheumatoid Arthritis;Vitamin D DeficiencyOther: cholecalciferol versus placeboUniversity Hospital, Clermont-FerrandCRINEX Laboratory;BP 337 - 3 rue de Gentilly;92541 MONTROUGE Cedex FRANCERecruiting18 YearsN/ABoth164Phase 3France
1393NCT01251120
(ClinicalTrials.gov)
November 201130/11/2010A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: DMARDHoffmann-La RocheNULLTerminated18 YearsN/AAll2Phase 4Finland
1394NCT01469013
(ClinicalTrials.gov)
November 20118/11/2011Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate TherapyA Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of Baricitinib (LY3009104) in Japanese Patients With Active Rheumatoid Arthritis on Background Methotrexate TherapyArthritis, RheumatoidDrug: Placebo;Drug: Baricitinib;Drug: MethotrexateEli Lilly and CompanyNULLCompleted20 Years75 YearsAll145Phase 2Japan
1395NCT01468077
(ClinicalTrials.gov)
November 20117/11/2011A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) TreatmentMulticenter, Randomized, Parallel Group Study to Compare the Incidence of Tocilizumab Related Infusion Reactions in Patients With Moderate to Severe Active RA, When Infusion is Given Over 31 Minutes Compared to 1 HourRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll47Phase 2Denmark;Iceland
1396EUCTR2010-020992-21-SK
(EUCTR)
26/10/201106/12/2011Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritisA 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to methotrexate, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide 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: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
INN or Proposed INN: METHOTREXATE
Other descriptive name: not applicable
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Slovakia;Greece;Spain;Thailand;Turkey;India;France;Czech Republic;Poland;Romania;Tunisia;Germany
1397EUCTR2009-016266-90-BE
(EUCTR)
25/10/201122/08/2011Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patientsA 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 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]
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
1594Phase 2;Phase 3Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Austria;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Romania;Germany;New Zealand
1398EUCTR2011-000102-21-DE
(EUCTR)
20/10/201109/08/2011Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agentsA randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NARTURE-1 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]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
548United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1399EUCTR2010-020992-21-ES
(EUCTR)
17/10/201128/05/2012Comparación de la eficacia de masitinib frente a metotrexato en el tratamiento de la artritis reumatoideEstudio 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 ScienceNULLNot RecruitingFemale: yes
Male: yes
140Slovakia;Greece;Thailand;Spain;Turkey;Germany;India;United States;Czech Republic
1400EUCTR2010-020992-21-CZ
(EUCTR)
12/10/201118/07/2011Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritisA 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis. 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]
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
INN or Proposed INN: METHOTREXATE
Other descriptive name: not applicable
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
140Phase 2United States;Czech Republic;Slovakia;Greece;Spain;Thailand;Turkey;Germany;India
1401EUCTR2010-019912-18-BG
(EUCTR)
03/10/201125/08/2011A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid ArthritisA 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 - BrevActa 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]
Product Name: tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS)
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody
Product Name: tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI)
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
600United States;Philippines;Greece;Thailand;Costa Rica;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Panama;Guatemala;Hungary;Mexico;Canada;Argentina;Brazil;Dominican Republic;Bulgaria;New Zealand
1402NCT01359943
(ClinicalTrials.gov)
October 201119/5/2011Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking MethotrexateA Randomized, Double-blind, Placebo-controlled Study of Efficacy, Safety and Tolerability of Secukinumab at 12 Weeks Administered With an Intravenous (i.v.) or Subcutaneous (s.c.) Loading Regimen Compared to Placebo in Patients With Active Rheumatoid Arthritis Despite Treatment With MethotrexateRheumatoid ArthritisBiological: secukinumab (AIN457);Drug: placeboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll221Phase 2United States;Bulgaria;Canada;Hungary;Italy;Poland;Puerto Rico;Slovakia
1403NCT01641952
(ClinicalTrials.gov)
October 201113/7/2012An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) AgentNon-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH ProgramRheumatoid ArthritisDrug: RituximabHoffmann-La RocheNULLCompleted18 YearsN/AAll505N/ARomania
1404EUCTR2010-024516-34-SK
(EUCTR)
29/09/201113/04/2012Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexateA randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with 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] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
215United States;Hungary;Slovakia;Canada;Bulgaria;Italy
1405NCT04169100
(ClinicalTrials.gov)
September 28, 201114/11/2019Novel Form of Acquired Long QT SyndromeNovel Form of Acquired Long QT SyndromeLong QT Syndrome;Connective Tissue Diseases;Rheumatoid ArthritisDrug: PrednisoneNarrows Institute for Biomedical ResearchVA New York Harbor Healthcare SystemRecruiting18 Years89 YearsAll25Phase 4United States
1406EUCTR2010-020065-24-BE
(EUCTR)
26/09/201116/05/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
3080United States;Serbia;Philippines;Ecuador;Greece;Spain;Russian Federation;Israel;Chile;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
1407EUCTR2011-000102-21-SK
(EUCTR)
22/09/201128/06/2011Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agentsA randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents 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]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
548United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany
1408EUCTR2010-023956-99-DE
(EUCTR)
22/09/201101/06/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 RHEUMATOID ARTHRITIS,NOS
MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
677Phase 2United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of
1409EUCTR2010-023782-22-CZ
(EUCTR)
21/09/201101/08/2011A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUGA PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG Rheumatoid Arthritis
MedDRA version: 16.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-04171327
Product Code: PF-04171327
Product Code: PF-04171327
Trade Name: Decortin
INN or Proposed INN: PREDNISONE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
315Phase 2United States;Serbia;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of
1410EUCTR2011-001220-38-BE
(EUCTR)
19/09/201130/08/2011A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid ArthritisA multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension 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: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Belgium;Russian Federation;Germany;United Kingdom
1411EUCTR2010-023692-26-SK
(EUCTR)
09/09/201113/09/2011Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 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: Fostamatinib disodium
Product Code: previously known as R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands
1412EUCTR2010-023587-40-NL
(EUCTR)
06/09/201111/05/2011A 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.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. Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
700Germany;Netherlands;Italy;Sweden;Greece;Finland;Spain
1413EUCTR2010-020065-24-DE
(EUCTR)
06/09/201130/05/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
2800Phase 4United 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
1414NCT01245439
(ClinicalTrials.gov)
September 201117/11/2010A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid ArthritisLocal 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 DMARDRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll65Phase 3Turkey
1415NCT01446978
(ClinicalTrials.gov)
September 20113/10/2011Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating DrugsHepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or MethotrexateVaccine Response ImpairedBiological: hepatitis A vaccineSormland County Council, SwedenNULLActive, not recruiting18 YearsN/ABoth150Phase 2Sweden
1416NCT01350804
(ClinicalTrials.gov)
September 20119/5/2011Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor a (Anti-TNFa) Agents (CAIN457F2309 and CAIN457F2309E1)A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents (CAIN457F2309) and A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2309E1)Rheumatoid ArthritisBiological: AIN457;Biological: Placebo;Biological: AbataceptNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll551Phase 3United States;Brazil;Bulgaria;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Mexico;Romania;Russian Federation;Slovakia;Spain
1417EUCTR2010-019912-18-HU
(EUCTR)
31/08/201108/06/2011A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid ArthritisA 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 - BrevActa Adult Rheumatoid Arthritis (RA)
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]
Product Name: tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS)
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody
Product Name: tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI)
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
600United States;Philippines;Greece;Thailand;Costa Rica;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Panama;Guatemala;Hungary;Mexico;Canada;Argentina;Brazil;Dominican Republic;Bulgaria;New Zealand
1418EUCTR2010-024516-34-HU
(EUCTR)
31/08/201129/06/2011Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexateA randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with methotrexate 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]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
215United States;Hungary;Canada;Bulgaria;Italy
1419EUCTR2010-020745-27-HU
(EUCTR)
31/08/201111/07/2011Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (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 antagonist - OSKIRA - 3 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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany
1420EUCTR2010-020065-24-NL
(EUCTR)
31/08/201106/07/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
3080Phase 4Serbia;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
1421NCT01377012
(ClinicalTrials.gov)
August 30, 201117/6/2011Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFa AgentsA Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents (CAIN457F2302) and a Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2302E1)Rheumatoid ArthritisBiological: Secukinumab (AIN457);Biological: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll637Phase 3United States;Argentina;Belgium;Canada;Colombia;Guatemala;Hungary;India;Italy;Japan;Mexico;Panama;Puerto Rico;Thailand;Turkey;United Kingdom;Peru;Romania
1422EUCTR2010-020065-24-ES
(EUCTR)
25/08/201101/07/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
2800Phase 4United 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
1423EUCTR2011-000385-35-IT
(EUCTR)
19/08/201127/02/2012MULTICENTER, OPEN LABEL STUDY TO EVALUATE THE PREDICTABILITY OF EARLY RESPONSE TO CERTOLIZUMAB PEGOL (IN COMBINATION WITH METHOTREXATE) AS CONFIRMED AT WEEK 52 IN SUBJECTS WITH MODERATE-SEVERE RHEUMATOID ARTHRITIS (RA): THE CZP-SPEED STUDYMULTICENTER, OPEN LABEL STUDY TO EVALUATE THE PREDICTABILITY OF EARLY RESPONSE TO CERTOLIZUMAB PEGOL (IN COMBINATION WITH METHOTREXATE) AS CONFIRMED AT WEEK 52 IN SUBJECTS WITH MODERATE-SEVERE RHEUMATOID ARTHRITIS (RA): THE CZP-SPEED STUDY - CZP-SPEED 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: CIMZIA
INN or Proposed INN: CERTOLUZIMAB PEGOL
Other descriptive name: NA
UCB PHARMANULLNot RecruitingFemale: yes
Male: yes
Italy
1424EUCTR2011-000102-21-CZ
(EUCTR)
19/08/201127/05/2011Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agentsA randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1 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]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
548United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1425EUCTR2010-022378-15-GB
(EUCTR)
18/08/201110/02/2011A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis.VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET 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]
Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (IMMU-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody
Nycomed GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom
1426EUCTR2010-023956-99-HU
(EUCTR)
17/08/201118/05/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 RHEUMATOID ARTHRITIS,NOS
MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
677Phase 2United States;Taiwan;Spain;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of
1427EUCTR2011-002363-15-IS
(EUCTR)
17/08/201122/06/2011A clinical trial with the aim to explore infusion reactions from Tocilizumab given either in 31 or 60 minutes to patients with moderate to severe rheumatoid arthritis.Multicenter, randomized, parallel group study to compare the incidence of Tocilizumab related infusion reactions in patients with moderate to severe active RA, when infusion is given over 31 minutes compared to 1 hour. - ACT FAST Adult 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®Roche a/sNULLNot RecruitingFemale: yes
Male: yes
56Denmark;Iceland
1428EUCTR2011-000102-21-ES
(EUCTR)
17/08/201104/07/2011Seguridad y Eficacia de secukinumab comparado con placebo y abatacept in pacientes con artritis reumatoide activa que no respodieron a agentes anti- TNFalfaEstudio 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.NULLNot RecruitingFemale: yes
Male: yes
548United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany
1429EUCTR2011-002363-15-DK
(EUCTR)
16/08/201127/07/2011A clinical trial with the aim to explore infusion reactions from Tocilizumab given either in 31 or 60 minutes to patients with moderate to severe rheumatoid arthritis.Multicenter, randomized, parallel group study to compare the incidence of Tocilizumab related infusion reactions in patients with moderate to severe active RA, when infusion is given over 31 minutes compared to 1 hour. - ACT FAST Adult 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: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Roche a/sNULLNot RecruitingFemale: yes
Male: yes
56Denmark;Iceland
1430EUCTR2010-020065-24-GB
(EUCTR)
15/08/201108/04/2011A 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.NULLNot 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): yesSerbia;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
1431EUCTR2010-021184-32-IT
(EUCTR)
03/08/201102/02/2011GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies Refractory 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]
Product Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
164Phase 2Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany
1432EUCTR2011-000436-28-HU
(EUCTR)
02/08/201110/08/2011A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS Treatment of patients with moderate to severe rheumatoid arthritis (RA)
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Z102
Product Code: Z102
INN or Proposed INN: Z102 (Prednisolone and Dipyridamole).
Product Name: Prednisolone
Product Code: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Dipyridamole
Product Code: Dipyridamole
INN or Proposed INN: Dipyridamole
Trade Name: Dacortin ®
INN or Proposed INN: PREDNISONE
Zalicus, Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria
1433NCT01426789
(ClinicalTrials.gov)
August 201112/8/2011A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) PatientsA Multicenter, 12 Week, Randomized, Double-blind, Placebo-controlled Biomarker Study of Secukinumab (AIN457) in Rheumatoid Arthritis Patients Followed by an Open Label ExtensionRheumatoid ArthritisDrug: Placebo;Drug: SecukinumabNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll100Phase 2United States;Belgium;Germany;Russian Federation;United Kingdom
1434JPRN-UMIN000013750
2011/07/3121/04/2014Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis Rheumatoid arthritis, PeriodontitisIL-6 receptor inhibition group:
Tocilizumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later.

TNF inhibition group:
Infliximab, Etanercept, and Adalimumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later.
Division of Periodontology, Niigata University Graduate School of Medical and Dental SciencesNULLComplete: follow-up completeNot applicableNot applicableMale and Female80Not selectedJapan
1435EUCTR2011-000275-13-HU
(EUCTR)
29/07/201110/06/2011Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugsA randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents 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: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
630Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan
1436EUCTR2010-020065-24-AT
(EUCTR)
28/07/201117/05/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
3080Phase 4Serbia;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
1437EUCTR2010-023956-99-NL
(EUCTR)
28/07/201130/05/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Protocol Amendment 03 (v1.0, dated 08-Mar-2011) RHEUMATOID ARTHRITIS,NOS
MedDRA version: 13.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: BMS-945429
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
677Phase 2United States;Taiwan;Spain;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Germany;Netherlands;Japan;Korea, Republic of
1438EUCTR2011-001863-39-AT
(EUCTR)
28/07/201115/06/2011A study of saftey and efficacy of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab Monotherapy in patients with mild to moderate rheumatoid arthritis, who have not adequately responded to their current treatment with MTX.A multi-center study of the safety and effect on disease activity of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab monotheraphy in patients with mild to moderate rheumatoid arthritis, with inadequate response to MTX (defined as DAS 28 = 4,5 and > 2,6) - OPTIMISE Mild to moderate 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
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexat Lederle 2.5mg tablets
Product Name: Methotrexat
Product Code: RO0029893
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
Roche Austria GmbHNULLNot RecruitingFemale: yes
Male: yes
Austria
1439EUCTR2010-020065-24-CZ
(EUCTR)
26/07/201127/05/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
3080Phase 4Serbia;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
1440EUCTR2010-022206-40-PL
(EUCTR)
26/07/201111/04/2011A Rheumatoid Arthritis Study in Patients (FLEX-O)A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O) 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: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1002Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Peru;Australia;South Africa;Bulgaria;New Zealand;Japan;Korea, Republic of
1441EUCTR2010-024516-34-IT
(EUCTR)
25/07/201129/12/2011Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexateA randomized, double-blind, placebo-controlled study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active rheumatoid arthritis despite treatment with 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] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457F
Other descriptive name: Secukinumab
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
215United States;Hungary;Canada;Bulgaria;Italy
1442EUCTR2010-020065-24-LT
(EUCTR)
25/07/201125/05/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
3080Serbia;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
1443EUCTR2010-023956-99-BE
(EUCTR)
20/07/201124/05/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 RHEUMATOID ARTHRITIS,NOS
MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
677Phase 2United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of
1444EUCTR2010-023956-99-ES
(EUCTR)
20/07/201103/11/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - Site Specific (v1.0, dated 11-Jan-2011);Protocol Amendment 03 (v1.0, dated 08-Mar-2011) - RHEUMATOID ARTHRITIS,NOS
MedDRA version: 14.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: BMS-945429
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
677Phase 2Hungary;Germany;Netherlands;France;Italy;South Africa;Brazil;Russian Federation;Czech Republic;Canada;Peru;Taiwan;Argentina;Belgium;Mexico;Korea, Republic of;Spain;Japan;United States
1445EUCTR2011-000275-13-GB
(EUCTR)
20/07/201118/07/2011Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugsA randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents 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]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
630Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan
1446EUCTR2011-000102-21-HU
(EUCTR)
14/07/201108/06/2011Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agentsA randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1 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]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
548United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1447EUCTR2011-001220-38-GB
(EUCTR)
12/07/201117/05/2011A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid ArthritisA multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension 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]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Belgium;Russian Federation;Germany;United Kingdom
1448EUCTR2010-023956-99-IT
(EUCTR)
11/07/201101/03/2012A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to Methotrexate RHEUMATOID ARTHRITIS,NOS
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Anti-Interleukin-6 Monoclonal
Product Code: BMS-945429
INN or Proposed INN: NA
Other descriptive name: anti IL 6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: NA
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
BRISTOL-M.SQUIBBNULLNot RecruitingFemale: yes
Male: yes
677Phase 2United States;Taiwan;Spain;Korea, Democratic People's Republic of;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Germany;Netherlands;Japan;Korea, Republic of
1449JPRN-jRCTs032180273
11/07/201114/03/2019Wear of OXINIUM on XLPE: Multicenter RCT StudyWear of Oxidized Zirconium (OXINIUM) on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study - 28mmOX multicenter study Hip osteoarthritis, Rheumatoid arthritis
Hip osteoarthritis, Rheumatoid arthritis
Arm A: Oxidized zirconium alloy (OXINIUM) femoral head
Arm B: Standard cobalt chromium alloy head
Random allocation is registered automatically at the UMIN Internet Medical Research Data Center (INDICE)
Akiyama HaruhikoNULLNot Recruiting>= 20age old<= 75age oldBoth1308Phase 4Japan
1450EUCTR2009-016266-90-AT
(EUCTR)
06/07/201131/05/2011Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patientsA 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 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]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
1594Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand
1451JPRN-JapicCTI-111628
01/7/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for Clazakizumab in Subjects Who Are Not Responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of Clazakizumab Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate. Rheumatoid ArthritisIntervention name : Clazakizumab
Dosage And administration of the intervention : Injection, 25 mg, 100 mg, 200 mg
Control intervention name : Methotrexate,Adalimumab
Dosage And administration of the control intervention : Methotrexate:Oral,7.5 mg, Adalimumab:Injection,40mg
Bristol-Myers K.K.NULL18BOTH406Phase 2NULL
1452EUCTR2010-021283-14-HU
(EUCTR)
29/06/201127/04/2011A randomised, double blind, placebo-controlled trial with multiple doses of Anti-IL-20 in subjects with rheumatoid arthritisA randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis 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]
Product Name: Anti-IL-20 (109-0012)
Product Code: NNC 0109-0000-0012
Other descriptive name: Anti-IL-20
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
66Portugal;Hungary;United Kingdom;Spain;Italy
1453EUCTR2011-000102-21-IT
(EUCTR)
28/06/201109/01/2012Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti- TNFa agentsA randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents 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: Secukinumab
Product Code: AIN457F
INN or Proposed INN: Secukinumab
Trade Name: ORENCIA*IV 2FL 250MG+2SIR
INN or Proposed INN: ABATACEPT
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
548United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany
1454EUCTR2011-000275-13-IT
(EUCTR)
28/06/201123/02/2012Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs.A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents. 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: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
630Panama;United States;Thailand;Guatemala;Turkey;Colombia;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan
1455EUCTR2010-019262-86-ES
(EUCTR)
22/06/201121/04/2010Estudio 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: SAR153191sanofi-aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Hungary;Finland;Germany;Netherlands;Estonia;Spain;Greece;Austria;Lithuania
1456EUCTR2010-022208-36-GR
(EUCTR)
21/06/201116/05/2011An Open Label Study for Patients With Rheumatoid Arthritis A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) 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]
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1505Phase 3United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Colombia;Sri Lanka;Italy;India;Malaysia;Australia;Peru;South Africa;Korea, Republic of;Lithuania;Hungary;Mexico;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;New Zealand;Japan
1457EUCTR2010-019262-86-IT
(EUCTR)
17/06/201106/09/2011Long term evaluation of SAR153191 (REGN88) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA 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]
Product Code: SAR153191SANOFI-AVENTIS S.P.ANULLNot RecruitingFemale: yes
Male: yes
1696Phase 3Portugal;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;Malaysia;Australia;Peru;South Africa;Netherlands;Finland;Korea, Democratic People's Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Norway;Germany;New Zealand;Sweden
1458EUCTR2011-000107-40-GB
(EUCTR)
16/06/201110/03/2011A 12 weeks study to evaluate effect of revamilst in addition tomethotrexate in rheumatiod arthritis patients.A Phase IIb, 12 week Randomized, Double-Blind, Parallel Group, Placebo-Controlled study to evaluate Efficacy, Safety and Tolerability of 2, 4 and 6 mg of Revamilast in patients with Active Rheumatoid Arthritis who have had an inadequate response to Methotrexate. Rheumatoid Arthritis
MedDRA version: 15.0;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: Revamilast
Product Code: GRC 4039
INN or Proposed INN: Revamilast
Product Name: Revamilast
Product Code: GRC 4039
INN or Proposed INN: Revamilast
Product Name: Revamilast
Product Code: GRC 4039
INN or Proposed INN: Revamilast
Glenmark Pharmaceuticals SANULLNot RecruitingFemale: yes
Male: yes
406Phase 2Philippines;Poland;Sri Lanka;United Kingdom;India
1459EUCTR2010-020065-24-HU
(EUCTR)
15/06/201102/05/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
3080Phase 4Serbia;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
1460EUCTR2010-023587-40-DE
(EUCTR)
14/06/201102/03/2011A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-InhibitorA 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. Adult Rheumatoid Arthritis (RA)
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®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
700United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden
1461EUCTR2008-001523-57-NO
(EUCTR)
10/06/201123/09/2008Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to MethotrexateMulticenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Denmark;Germany;Norway;France;Hungary;Spain;Italy;United Kingdom
1462EUCTR2010-022207-22-DE
(EUCTR)
08/06/201103/12/2010A Study in Patients With Rheumatoid Arthritis (FLEX-V)A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors (FLEX-V) 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]
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: not available
Other descriptive name: not available
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: not available
Other descriptive name: not available
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
555Phase 3United States;Taiwan;Greece;Spain;Russian Federation;Colombia;Italy;Mexico;Argentina;Poland;Brazil;Malaysia;Australia;Germany;New Zealand;Japan;Korea, Republic of
1463EUCTR2010-021184-32-BE
(EUCTR)
08/06/201114/04/2011GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti- TNF therapies Refractory 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]
Product Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan (INN: Rituximab), brand name in the US
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
164Phase 2Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1464EUCTR2010-020065-24-LV
(EUCTR)
08/06/201111/05/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
3080Phase 4Serbia;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
1465EUCTR2010-022208-36-DE
(EUCTR)
08/06/201103/12/2010A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) Rheumatoid Arthritis
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 CompanyNULLNot RecruitingFemale: yes
Male: yes
1505Phase 3Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
1466EUCTR2011-000215-79-FR
(EUCTR)
07/06/201124/02/2011Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRATociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRA Polyarthrite rhumatoïdeTrade Name: Roactemra
Other descriptive name: TOCILIZUMAB
CHU de Clermont FerrandNULLNot 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): noFrance
1467EUCTR2010-022504-42-GB
(EUCTR)
07/06/201116/11/2010A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients with Active Rheumatoid Arthritis on background Methotrexate TherapyA Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients with Active Rheumatoid Arthritis on background Methotrexate Therapy Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY3009104
Product Code: LY3009104
INN or Proposed INN: Not available
Other descriptive name: JAK1 / JAK2 Inhibtor
Product Name: LY3009104
Product Code: LY3009104
INN or Proposed INN: Not available
Other descriptive name: JAK1 / JAK2 Inhibtor
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
270Phase 2Hungary;United Kingdom
1468JPRN-UMIN000005590
2011/06/0112/05/2011Maintenance of remission by tocilizumab mono-therapy after remission obtained by combination with methotrexate in patients with rheumatoid arthritis Rheumatoid arthritisCessation of MTX (tocilizumab monotherapy)
Continue MTX with tocilizumab
Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical UniversityNULLComplete: follow-up complete20years-old75years-oldMale and Female40Not selectedJapan
1469JPRN-UMIN000005773
2011/06/0114/06/2011Magnetic resonance image analysis for quantification of knee articular cartilage verified response to etanercept(ETN) in subjects with active rheumatoid arthritis rheumatoid arthritisETN+MTX
MTX
22nd Century Medical & Research Center, the University of TokyoNULLComplete: follow-up complete20years-old80years-oldMale and Female20Not selectedJapan
1470EUCTR2007-000012-90-NL
(EUCTR)
01/06/201118/10/2010The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT TrialThe Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamlined safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Anti-Inflammatory Drug (NSAID) therapy when used to treat pain and inflammation in osteoarthritis or rheumatoid arthritis patients who are free from ischaemic heart disease, cerebrovascular disease, peripheral arterial disease, and moderate or severe heart failure.
MedDRA version: 9.1;Level: LLT;Classification code 10041591;Term: Spinal osteoarthritis
MedDRA version: 9.1;Classification code 10003268;Term: Arthritis rheumatoid
Trade Name: Celebrex
Trade Name: Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses
University of DundeeNULLNot RecruitingFemale: yes
Male: yes
Denmark;Netherlands;United Kingdom
1471NCT01373151
(ClinicalTrials.gov)
June 201113/6/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.Rheumatoid ArthritisDrug: BMS-945429 Placebo;Biological: BMS-945429;Drug: Methotrexate;Drug: Methotrexate Placebo;Drug: Adalimumab Placebo;Drug: AdalimumabCSL BehringNULLCompleted18 YearsN/AAll418Phase 2United States;Argentina;Belgium;Brazil;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;South Africa;Spain;Taiwan;Czech Republic;Peru
1472NCT01355354
(ClinicalTrials.gov)
June 201117/5/2011Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy SubjectsAn Open-Label, Non-Randomised, 2-Period, Single Centre Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice DailyHealthy Volunteers;Rheumatoid ArthritisDrug: Digoxin;Drug: FostamatinibAstraZenecaNULLCompleted18 Years45 YearsBoth21Phase 1United Kingdom
1473EUCTR2010-022378-15-DE
(EUCTR)
25/05/201109/02/2011A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis.VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET 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]
Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (Immu-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody
Nycomed GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom
1474EUCTR2010-022378-15-ES
(EUCTR)
19/05/201121/02/2011A clinical study to explore the therapeutic effects of different doses ofthe new drug veltuzumab, a drug of biologic origin, and placebo, inpatients with rheumatoid arthritis.VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET 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]
Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (Immu-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody
Nycomed GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom
1475EUCTR2010-018485-24-DE
(EUCTR)
18/05/201128/01/2011To investigate the efficacy and safety of SC BT061 in patients with activerheumatoid arthritisA multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.
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: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
176Hungary;Czech Republic;Spain;Latvia;Germany
1476EUCTR2010-021283-14-PT
(EUCTR)
13/05/201107/12/2010A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritisA randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis Rheumatoid arthritis
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/SNULLNot RecruitingFemale: yes
Male: yes
66Phase 2Portugal;Hungary;Czech Republic;Spain;Italy;United Kingdom
1477JPRN-UMIN000024507
2011/05/1221/10/2016Drug interaction between methotrexate and salazosulfapyridine in Japanese patients with rheumatoid arthritis rheumatoid arthritisIn these patients, who had received SASP/MTX combination therapy for at least 12 weeks, SASP was discontinued, and the patients received MTX monotherapy for the next 24 weeks.Japan Community Healthcare OrganizationNULLComplete: follow-up complete20years-old100years-oldMale and Female10Not selectedJapan
1478EUCTR2010-022224-77-BE
(EUCTR)
10/05/201114/01/2011Open-label study to assess the safety and efficacy of CDP6038 inpatients who completed RA0056A PHASE 2 MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0056 - RA0057 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]
Product Name: CDP6038
Product Code: CDP6038
INN or Proposed INN: Olokizumab
Other descriptive name: Recombinant human Mab of IgG4 subtype
UCB Biosciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
190Phase 2United States;Belgium;United Kingdom
1479EUCTR2009-013758-33-NL
(EUCTR)
10/05/201116/09/2010MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITISMULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS 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: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
36Denmark;Netherlands;Sweden
1480EUCTR2010-019871-31-CZ
(EUCTR)
10/05/201101/03/2011Etoricoxib and placebo in patients with rheumatoid arthritisA 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 ArthritisRandomizovaná dvojite zaslepená placebem kontrolovaná multicentrická studie fáze III složená ze dvou cástí hodnotící relativní úcinnost a toleranci dvou dávek MK-0663/Etoricoxibu u pacientu s revmatoidní artritidou Rheumatoid Arthritis (RA)
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: 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.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
1481EUCTR2010-023587-40-GR
(EUCTR)
10/05/201116/05/2011A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-InhibitorA 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. Adult Rheumatoid Arthritis (RA)
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®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
700United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden
1482EUCTR2010-020839-39-BE
(EUCTR)
10/05/201125/11/2010Efficacy and safety of CDP6038 in patients with rheumatoid arthritis withan unsuccessful response to anti-TNF therapyA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056 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]
Product Name: CDP6038
Product Code: CDP6038
Other descriptive name: Recombinant human Mab of IgG4 subtype
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: Tocilizumab
INN or Proposed INN: RoActemra®
Other descriptive name: TOCILIZUMAB
UCB Biosciences, Inc. A Member of the UCB Group of CompaniesNULLNot RecruitingFemale: yes
Male: yes
220Phase 2United States;Belgium;United Kingdom
1483EUCTR2009-015019-42-DE
(EUCTR)
10/05/201120/08/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
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: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Peru;Germany;Netherlands
1484EUCTR2010-023587-40-SE
(EUCTR)
04/05/201114/03/2011A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-InhibitorA randomized, open-label, 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. 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®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
96United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden
1485EUCTR2009-016266-90-ES
(EUCTR)
03/05/201116/12/2009Estudio 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 - MOBILITYEstudio 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 & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
1740Phase 2Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Czech Republic;Hungary;Belgium;Romania;Germany;Netherlands
1486EUCTR2010-019871-31-SK
(EUCTR)
02/05/201128/02/2011A 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 ArthritisA 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:
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.NULLNot RecruitingFemale: yes
Male: yes
1800Phase 3Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
1487EUCTR2010-020065-24-IT
(EUCTR)
29/04/201120/03/2012A 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
ROCHENULLNot RecruitingFemale: yes
Male: yes
2800Phase 4United 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
1488EUCTR2010-023587-40-DK
(EUCTR)
28/04/201112/04/2011A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-InhibitorA 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. Adult Rheumatoid Arthritis (RA)
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®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
700Phase 4United States;European Union;Greece;Finland;Spain;Denmark;Russian Federation;Netherlands;Germany;Italy;Sweden
1489EUCTR2010-022224-77-GB
(EUCTR)
27/04/201121/12/2010Open-label study to assess the safety and efficacy of CDP6038 in patients who completed RA0056A PHASE 2 MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0056 - RA0057 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: CDP6038
Product Code: CDP6038
INN or Proposed INN: Olokizumab
Other descriptive name: Recombinant human Mab of IgG4 subtype
UCB Biosciences IncNULLNot RecruitingFemale: yes
Male: yes
190Phase 2United States;Belgium;United Kingdom
1490EUCTR2010-019262-86-DE
(EUCTR)
26/04/201120/08/2010Long term evaluation of sarilumab in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND 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]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
2025Phase 3Philippines;Taiwan;Estonia;United States;Portugal;Belarus;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden
1491EUCTR2010-019514-24-CZ
(EUCTR)
21/04/201106/12/2010Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)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.
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: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX Goldshield Tablets
INN or Proposed INN: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
380United States;Czech Republic;Canada;Puerto Rico;Argentina;Spain;Belgium;Austria;Germany
1492EUCTR2010-019912-18-GR
(EUCTR)
18/04/201101/04/2011A 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 arthritisA 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 Rheumatoid arthritis (RA)
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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.NULLNot RecruitingFemale: yes
Male: yes
600Hungary;Greece;Spain;Bulgaria
1493EUCTR2010-023587-40-FI
(EUCTR)
15/04/201124/02/2011A randomized, open-label 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.A randomized, open-label 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. 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®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
96Greece;Finland;Spain;Netherlands;Germany;Italy;Sweden
1494EUCTR2010-023587-40-ES
(EUCTR)
13/04/201117/02/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
700Phase 4Greece;Finland;Spain;Denmark;Netherlands;Germany;Italy;Sweden
1495EUCTR2010-022378-15-HU
(EUCTR)
08/04/201121/02/2011VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVETVELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (Immu-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody
Nycomed GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Czech Republic;Hungary;Spain;Germany;United Kingdom
1496EUCTR2010-021020-94-HU
(EUCTR)
08/04/201105/10/2010A 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-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-aA 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-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a active rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: SAR153191
Product Code: SAR153191
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB
Sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
250Hungary;Czech Republic;Germany;Spain;Italy
1497EUCTR2010-023692-26-GB
(EUCTR)
07/04/201118/11/2010Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 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] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: previously known as R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Germany
1498EUCTR2008-007346-63-GB
(EUCTR)
05/04/201111/10/2010Reumap: An Open Label phase II study of Bovine Intestinal Alkaline Phosphatase (bIAP), An Inflammation modulating moiety, in RA patients - REUMAPReumap: An Open Label phase II study of Bovine Intestinal Alkaline Phosphatase (bIAP), An Inflammation modulating moiety, in RA patients - REUMAP Rheumatoid ArthritisProduct Name: bIAP
Product Code: EC 3.1.3.1
INN or Proposed INN: bovine intesastinal alkaline phosphatase (bIAP)
Other descriptive name: bIAP
Alloksys Life Sciences B.V.NULLNot RecruitingFemale: yes
Male: yes
Phase 2United Kingdom
1499EUCTR2009-015019-42-BE
(EUCTR)
04/04/201106/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.0;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: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170Phase 3Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Netherlands;Germany
1500EUCTR2010-019514-24-DE
(EUCTR)
04/04/201108/11/2010Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)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.
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
380United States;Czech Republic;Puerto Rico;Canada;Argentina;Spain;Austria;Germany
1501JPRN-UMIN000005362
2011/04/0101/04/2011Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs). Patients with rheumatoid arthritis with anemia taking NSAIDsTreatment with mesalazineDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of MedicineNULLComplete: follow-up complete20years-old70years-oldMale and Female13Not selectedJapan
1502EUCTR2010-022206-40-LT
(EUCTR)
01/04/201128/12/2010A Rheumatoid Arthritis Study in Patients(FLEX-O)A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O) 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]
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: not available
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1002Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Australia;Peru;South Africa;Bulgaria;Japan;New Zealand
1503EUCTR2010-022205-17-LT
(EUCTR)
01/04/201128/12/2010A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate(FLEX-M)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy (FLEX-M) 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]
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: Not available
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
990Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Croatia;Romania;Australia;Peru;Bulgaria;South Africa;Japan;New Zealand;Korea, Republic of
1504EUCTR2010-022208-36-LT
(EUCTR)
01/04/201128/12/2010A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) Rheumatoid Arthritis
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 CompanyNULLNot RecruitingFemale: yes
Male: yes
1505Phase 3Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
1505NCT01336218
(ClinicalTrials.gov)
April 201114/4/2011Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With RifampicinRheumatoid Arthritis;Healthy VolunteersDrug: fostamatinib;Drug: rifampicinAstraZenecaNULLCompleted18 Years55 YearsBoth15Phase 1United States
1506EUCTR2010-023880-17-GB
(EUCTR)
31/03/201125/02/2011SWITCH Clinical Trial for Patients with Rheumatoid Arthritis who have failed an initial TNF-blocking drugSWITCH: 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 LeedsNULLNot 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): yesUnited Kingdom
1507EUCTR2010-022206-40-BG
(EUCTR)
30/03/201124/02/2011A Rheumatoid Arthritis Study in Patients (FLEX-O)A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O) 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]
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1002Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Malaysia;Poland;Croatia;Romania;Australia;Peru;Bulgaria;South Africa;Japan;New Zealand;Korea, Republic of
1508EUCTR2010-022205-17-BG
(EUCTR)
29/03/201124/02/2011A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate (FLEX-M)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy (FLEX-M) 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]
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Trade Name: Boostrix®
Product Name: Boostrix®
Product Code: -
Other descriptive name: DIPHTHERIA TOXOID
Other descriptive name: TETANUS TOXOID
Other descriptive name: PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE
Other descriptive name: PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ADSORBED ON ALUMINIUM HYDROXIDE
Other descriptive name: PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE
Trade Name: PNEUMOVAX® 23
Product Name: PNEUMOVAX® 23
Product Code: -
Other descriptive name: pneumococcal serotypes
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
990Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Croatia;Romania;Australia;Peru;Bulgaria;South Africa;Japan;New Zealand;Korea, Republic of
1509EUCTR2010-021558-21-GB
(EUCTR)
28/03/201108/10/2010A Clinical Study of AK106-001616 in Patients With Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis 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]
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Hungary;Slovakia;Czech Republic;Germany;United Kingdom;Ukraine
1510EUCTR2010-022208-36-BG
(EUCTR)
24/03/201124/02/2011An Open Label Study for Patients With Rheumatoid Arthritis (FLEX-P) A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) (FLEX-P) 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: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: Not available
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: Not available
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1505Phase 3United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Sri Lanka;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;Lithuania;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
1511EUCTR2010-021577-37-BG
(EUCTR)
24/03/201104/02/2011A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid ArthritisA 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 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: Anti Lymphotoxin Alpha
Product Code: MLTA3698A
Other descriptive name: Anti lymphotoxin alpha
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
GENENTECH, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Hungary;Mexico;Spain;Peru;Chile;Bulgaria;Germany
1512EUCTR2010-023910-30-GB
(EUCTR)
23/03/201128/02/2011A 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 LeedsNULLNot RecruitingFemale: yes
Male: yes
120Phase 4United Kingdom
1513EUCTR2010-021558-21-SK
(EUCTR)
23/03/201126/10/2010A Clinical Study of AK106-001616 in Patients With Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis 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]
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Hungary;Czech Republic;Germany;United Kingdom;Slovakia;Ukraine
1514EUCTR2010-022207-22-ES
(EUCTR)
21/03/201129/12/2010A 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-alfaA 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 CompanyNULLNot RecruitingFemale: yes
Male: yes
555Phase 3Greece;Poland;Spain;Germany;Italy
1515EUCTR2010-022208-36-ES
(EUCTR)
21/03/201129/12/2010A 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 CompanyNULLNot RecruitingFemale: yes
Male: yes
1505Phase 3Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
1516EUCTR2010-023692-26-BG
(EUCTR)
17/03/201124/02/2011Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 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: Fostamatinib disodium
Product Code: previously known as R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
370Phase 2Netherlands;United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;Bulgaria;South Africa;Germany
1517EUCTR2010-021577-37-DE
(EUCTR)
17/03/201129/10/2010A 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 ARTHRITISA 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 Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: N/A
Product Code: MLTA3698A
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
GENENTECH, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Spain;Bulgaria;Germany
1518EUCTR2010-022378-15-CZ
(EUCTR)
16/03/201121/02/2011A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis.VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET 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]
Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (IMMU-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody
Nycomed GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom
1519EUCTR2010-022207-22-GR
(EUCTR)
15/03/201120/01/2011A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a InhibitorsA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors Rheumatoid Arthritis
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 CompanyNULLNot RecruitingFemale: yes
Male: yes
555Phase 3Greece;Poland;Spain;Germany;Italy
1520EUCTR2010-023587-40-IT
(EUCTR)
10/03/201127/04/2011A 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. - NDA 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. - ND 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: RoActemra
INN or Proposed INN: tocilizumab
Trade Name: Humira
INN or Proposed INN: Adalimumab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
700Greece;Finland;Spain;Netherlands;Germany;Italy;Sweden
1521EUCTR2010-021020-94-DE
(EUCTR)
10/03/201115/09/2010A 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-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-aA 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-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a active rheumatoid arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Code: SAR153191
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB
Sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
250Hungary;Czech Republic;Germany;Spain;Italy
1522EUCTR2010-022865-81-CZ
(EUCTR)
02/03/201122/12/2010Clinical trial to investigate the safety, efficacy, and absorption, distribution, and elimination of ALX-0061 compared to placebo in patients with rheumatoid arthritisA phase I/II, multi-center, randomized, double-blind, placebo controlled study, with a single ascending dose part followed by a multiple ascending dose part, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of intravenous ALX-0061 in patients with rheumatoid arthritis - ALX-0061 phase I/II, single ascending dose and multiple ascending dose study in rheumatoid arthritis 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: ALX-0061
Product Code: ALX-0061
Other descriptive name: ALX-0061 Nanobody
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
72Phase 1/2Hungary;Czech Republic
1523NCT01313520
(ClinicalTrials.gov)
March 1, 201125/2/2011A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136)A Randomized Clinical Trial to Study the Effects of Infliximab on Clinical Efficacy and Hand and Wrist Magnetic Resonance Imaging (MRI) in Patients With Active Rheumatoid Arthritis (RA)(Protocol No. P08136)Arthritis, RheumatoidDrug: Infliximab;Drug: PlaceboMerck Sharp & Dohme Corp.NULLCompleted18 YearsN/AAll61Phase 2Moldova, Republic of;Romania
1524NCT01301703
(ClinicalTrials.gov)
March 201121/2/2011Vaccination Against Pertussis, Tetanus and Diphtheria in Patients Suffering From Rheumatoid ArthritisThe Efficacy and Safety of Vaccination Against Pertussis. Tetanus and Diphtheria in Patients Suffering From Rheumatoid ArthritisRheumatoid ArthritisBiological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)Tel-Aviv Sourasky Medical CenterNULLNot yet recruiting18 Years64 YearsBoth100Phase 4Israel
1525NCT01353859
(ClinicalTrials.gov)
March 201113/5/2011A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDsAn Open Label, Local, Multicenter , Phase IIIb Interventional Study to Assess the Efficacy of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) in Indonesian Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDsRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: methotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll39Phase 3Indonesia;Greece
1526EUCTR2010-020890-18-CZ
(EUCTR)
25/02/201102/11/2010AN 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 ARTHRITISAN 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.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Czech Republic
1527EUCTR2010-020839-39-GB
(EUCTR)
25/02/201112/10/2010Efficacy and safety of CDP6038 in patients with rheumatoid arthritis with an unsuccessful response to anti-TNF therapyA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056 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: Olikizumab
Product Code: CDP6038
INN or Proposed INN: Olokizumab
Other descriptive name: Recombinant human Mab of IgG4 subtype
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: Tocilizumab
INN or Proposed INN: RoActemra®
Other descriptive name: TOCILIZUMAB
UCB Biosciences, IncNULLNot RecruitingFemale: yes
Male: yes
220United Kingdom;United States
1528EUCTR2010-022207-22-IT
(EUCTR)
24/02/201103/02/2011A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors - NDA Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors - ND Rheumatoid Arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
555Phase 3Greece;Poland;Spain;Germany;Italy
1529EUCTR2010-022206-40-HU
(EUCTR)
23/02/201126/11/2010A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) TherapyA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy Rheumatoid Arthritis
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 CompanyNULLNot RecruitingFemale: yes
Male: yes
1002Phase 3Hungary;Poland;Lithuania;Bulgaria
1530EUCTR2010-022205-17-HU
(EUCTR)
18/02/201115/12/2010A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate TherapyA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy Rheumatoid Arthritis
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 CompanyNULLNot RecruitingFemale: yes
Male: yes
990Phase 3Hungary;Poland;Lithuania;Bulgaria
1531EUCTR2010-020890-18-HU
(EUCTR)
18/02/201116/11/2010Tofacitinib MRI in Early Rheumatoid ArthritisAN 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 10017NULLNot RecruitingFemale: yes
Male: yes
90Phase 2Czech Republic;Hungary
1532EUCTR2010-022208-36-HU
(EUCTR)
18/02/201126/11/2010A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) Rheumatoid Arthritis
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 CompanyNULLNot RecruitingFemale: yes
Male: yes
1505Phase 3Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
1533EUCTR2010-020744-35-IT
(EUCTR)
18/02/201122/12/2010A 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 DMARDs. D4300C00002 - OSKIRA-2A 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 DMARDs. D4300C00002 - OSKIRA-2 Patients with active Rheumatoid Arthritis despite current treatment with a DMARD.
MedDRA version: 9.1;Level: PT;Classification code 10039073
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib
ASTRAZENECANULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;United Kingdom;Italy
1534EUCTR2010-020745-27-IT
(EUCTR)
18/02/201122/12/2010A 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 antagonist. D4300C00003 - OSKIRA-3A 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 antagonist. D4300C00003 - OSKIRA-3 Patients with active Rheumatoid Arthritis (RA), despite treatment with methotrexate, who have had an inadequate response to a single TNF-alfa antagonist.
MedDRA version: 9.1;Level: PT;Classification code 10039073
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib
ASTRAZENECANULLNot RecruitingFemale: yes
Male: yes
450Phase 3France;Portugal;Hungary;Czech Republic;Spain;Germany;United Kingdom;Italy
1535EUCTR2010-020745-27-DE
(EUCTR)
17/02/201121/07/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (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 antagonist - OSKIRA - 3 Rheumatoid Arthritis
MedDRA version: 15.0;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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany
1536EUCTR2010-020744-35-DE
(EUCTR)
17/02/201121/07/2010Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Disease Modifying Anti-rheumatic Drug (DMARD) But NotResponding. (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 DMARDs - OSKIRA - 2 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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Serbia;United States;Spain;Ukraine;Lithuania;Israel;Italy;United Kingdom;India;Czech Republic;Canada;Romania;South Africa;Latvia;Germany
1537EUCTR2010-020892-22-DE
(EUCTR)
17/02/201121/07/2010Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X 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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
2000Serbia;Portugal;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1538EUCTR2009-012615-18-FR
(EUCTR)
16/02/201105/11/2010Efficacy and safety of cholecalciferol on rheumatoid arthritis activity in patients with vitamin D deficiency - SCORPIONEfficacy and safety of cholecalciferol on rheumatoid arthritis activity in patients with vitamin D deficiency - SCORPION Rheumatoid arthritis (RA)
MedDRA version: 12.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions
Trade Name: UVEDOSE
INN or Proposed INN: COLECALCIFEROL
CHU de Clermont-FerrandNULLNot RecruitingFemale: yes
Male: yes
France
1539EUCTR2010-023692-26-CZ
(EUCTR)
16/02/201122/12/2010Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 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: Fostamatinib disodium
Product Code: previously known as R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands
1540EUCTR2010-020743-12-DE
(EUCTR)
15/02/201121/07/2010Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Methotrexate But Not Responding. (OSKIRA - 1)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 Methotrexate - OSKIRA - 1 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] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Ukraine;Chile;Russian Federation;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany
1541EUCTR2010-021558-21-DE
(EUCTR)
15/02/201119/10/2010A Clinical Study of AK106-001616 in Patients With Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Czech Republic;Hungary;Slovakia;Germany;United Kingdom
1542EUCTR2010-022865-81-HU
(EUCTR)
11/02/201115/02/2011Clinical trial to investigate the safety, efficacy, and absorption, distribution, and elimination of ALX-0061 compared to placebo in patients with rheumatoid arthritisA phase I/II, multi-center, randomized, double-blind, placebo controlled study, with a single ascending dose part followed by a multiple ascending dose part, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of intravenous ALX-0061 in patients with rheumatoid arthritis - ALX-0061 phase I/II, single ascending dose and multiple ascending dose study in rheumatoid arthritis 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: ALX-0061
Product Code: ALX-0061
Other descriptive name: ALX-0061 Nanobody
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
72Phase 1/2Czech Republic;Hungary
1543EUCTR2010-020892-22-IT
(EUCTR)
08/02/201122/12/2010A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA-XA Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA-X Patients with active Rheumatoid Arthritis (RA) who have participated in a qualifying study.
MedDRA version: 9.1;Level: PT;Classification code 10039073
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib
ASTRAZENECANULLNot RecruitingFemale: yes
Male: yes
2000Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Latvia;Germany;United Kingdom;Italy
1544EUCTR2010-021558-21-HU
(EUCTR)
08/02/201107/10/2010A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Hungary;Slovakia;Czech Republic;Germany;United Kingdom
1545EUCTR2010-020499-50-GB
(EUCTR)
07/02/201131/12/2010Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody.An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial. - Effects of B cell depletion on bone turnover in rheumatoid arthritis.Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody.An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial. - Effects of B cell depletion on bone turnover in rheumatoid arthritis. rheumatoid arthritis
MedDRA version: 13;Level: PT;Classification code 10039073;Term: rheumatoid arthritis
Trade Name: MabThera
Product Name: rituximab
South Tees Hospitals NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
46Phase 4United Kingdom
1546EUCTR2010-023692-26-HU
(EUCTR)
04/02/201108/02/2011Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 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: Fostamatinib disodium
Product Code: previously known as R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Hungary;Czech Republic;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands
1547EUCTR2010-022504-42-HU
(EUCTR)
04/02/201123/11/2010A study to evaluate the efficacy of different doses of LY3009104 therapy compared to placebo in patients with Rheumatoid Arthritis who are on ongoing methotrexate background therapy.A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients with Active Rheumatoid Arthritis on background Methotrexate Therapy 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: LY3009104
Product Code: LY3009104
INN or Proposed INN: Not available
Other descriptive name: JAK1 / JAK2 Inhibitor
Product Name: LY3009104
Product Code: LY3009104
INN or Proposed INN: Not available
Other descriptive name: JAK1 / JAK2 Inhibtor
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
270Phase 2United States;Czech Republic;Hungary;Mexico;Argentina;Poland;Ukraine;Croatia;Romania;Peru;United Kingdom;India
1548EUCTR2010-019262-86-NL
(EUCTR)
02/02/201124/06/2010Long term evaluation of sarilumab in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND 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 Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
2000Phase 3United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile
1549JPRN-UMIN000008164
2011/02/0113/06/2012Restart for sustaining remission of rheumatoid arthritis in use of etanercept Rheumatoid ArthritisAfter the administration of etanercept (50mg/week), the dosage of etanercept will be discontinued when the low disease activity (DAS28-ESR<3.2) is achieved. If patients recur from low disease activity, same dose of etanercept will be administered again by the observation of every two months. This strategy will be maintained for two years. We must control the disease activity below the low disease activity using combined medicine except glucocorticoid if patients could not reach low disease activity after the administration of etanercept in three months. It will be considered to be a dropout if patients cannot reach low disease activity within six months.Osaka City University Medical SchoolNULLRecruiting20years-oldNot applicableMale and Female50Phase 4Japan
1550EUCTR2010-021283-14-IT
(EUCTR)
01/02/201123/12/2010A randomised, double blind, placebo-controlled, multiple dose trial of NNC109-0012 (Anti-IL-20) in subjects with rheumatoid arthritis - NN8226-3875A randomised, double blind, placebo-controlled, multiple dose trial of NNC109-0012 (Anti-IL-20) in subjects with rheumatoid arthritis - NN8226-3875 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073
Product Name: Anti-IL-20 (109-0012)
Product Code: NNC 0109-0000-0012
NOVO NORDISKNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Portugal;United Kingdom;Spain;Italy
1551NCT01282255
(ClinicalTrials.gov)
February 201121/1/2011Efficacy of NNC109-0012 in Subjects With Active Rheumatoid ArthritisA Randomised, Double Blind, Placebo-controlled, Multiple Dose Trial of Anti-IL-20 (109-0012) in Subjects With Rheumatoid ArthritisInflammation;Rheumatoid ArthritisDrug: NNC109-0012;Drug: placeboNovo Nordisk A/SNULLCompleted18 Years75 YearsAll67Phase 2Czech Republic;Germany;Italy;Poland;Portugal;Romania;Spain;United Kingdom
1552NCT01254331
(ClinicalTrials.gov)
February 20113/12/2010An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local EnvironmentOpen 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 DMARDsRheumatoid ArthritisDrug: tocilizumab [RoActemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll51Phase 3Tunisia
1553EUCTR2010-019514-24-AT
(EUCTR)
27/01/201121/12/2010Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)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.
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
380United States;Czech Republic;Canada;Puerto Rico;Argentina;Spain;Austria;Germany
1554EUCTR2010-019514-24-ES
(EUCTR)
27/01/201130/11/2010Estudio 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. - CONCERTOEstudio 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. KGNULLNot RecruitingFemale: yes
Male: yes
380Czech Republic;Spain;Austria;Germany
1555EUCTR2010-021577-37-ES
(EUCTR)
27/01/201123/11/2010ESTUDIO 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 ARTHRITISESTUDIO 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, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Germany;Bulgaria;Spain
1556EUCTR2010-019926-15-CZ
(EUCTR)
27/01/201101/12/2010A Phase 2 placebo-controlled study to compare the effectiveness and safety of two doses of apremilast (CC-10004) in subjects with active rheumatoid arthritis, who have not responded to methotrexate treatmentA PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY, TO COMPARE THE EFFICACY AND SAFETY OF TWO DOSES OF APREMILAST (CC-10004) IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid arthritis, a chronic systemic autoimmune inflammatory disease characterized by persisten synovial inflammations.
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: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Czech Republic
1557EUCTR2010-019514-24-BE
(EUCTR)
25/01/201125/11/2010Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)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.
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
380Phase 3United States;Czech Republic;Canada;Puerto Rico;Argentina;Spain;Belgium;Austria;Germany
1558EUCTR2010-019912-18-ES
(EUCTR)
17/01/201119/01/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Hungary;Greece;Spain;Bulgaria
1559EUCTR2010-021283-14-GB
(EUCTR)
14/01/201108/10/2010A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritisA randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis Rheumatoid arthritis
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/SNULLNot RecruitingFemale: yes
Male: yes
66Portugal;Hungary;Spain;Italy;United Kingdom
1560EUCTR2010-020892-22-BG
(EUCTR)
13/01/201109/11/2010Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X 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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
2000Serbia;Portugal;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1561EUCTR2010-020743-12-PL
(EUCTR)
11/01/201101/10/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding. (OSKIRA - 1)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 Methotrexate - OSKIRA - 1 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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany
1562EUCTR2010-019871-31-BE
(EUCTR)
11/01/201131/08/2010A 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 ArthritisA 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:
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.NULLNot RecruitingFemale: yes
Male: yes
1800Phase 3Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
1563EUCTR2010-022208-36-IT
(EUCTR)
10/01/201108/02/2011A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis(RA) - NDA Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis(RA) - ND Rheumatoid Arthritis.
MedDRA version: 9.1;Level: PT;Classification code 10039073
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1505Phase 3Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
1564EUCTR2010-021283-14-ES
(EUCTR)
07/01/201105/11/2010A 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/SNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Portugal;United Kingdom;Spain;Italy
1565EUCTR2010-022049-88-DE
(EUCTR)
05/01/201111/11/2010Efficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAIEfficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAI Rheumatoid Arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: RoActemra 20 mg/ml Concentrate for solution for infusion
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: Tocilizumab
Trade Name: Mabthera 500 mg Concentrate for solution for infusion
Product Name: Rituximab
Product Code: RO045-2294
INN or Proposed INN: RITUXIMAB
Roche Pharma AGNULLNot RecruitingFemale: yes
Male: yes
Germany
1566NCT01223911
(ClinicalTrials.gov)
January 201114/10/2010A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid ArthritisA Randomised, Double-blind, Placebo-controlled, Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid ArthritisInflammation;Rheumatoid ArthritisDrug: NNC 0151-0000-0000;Drug: placeboNovo Nordisk A/SNULLCompleted18 Years75 YearsAll34Phase 2Czech Republic;Denmark;Hungary;Poland;Romania;United Kingdom
1567NCT01411215
(ClinicalTrials.gov)
January 201113/5/2011A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient DepartmentA Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology DepartmentRheumatoid Arthritis;Ankylosing SpondylitisDrug: EnbrelPfizerNULLTerminated18 YearsN/AAll160N/AChina
1568NCT01207453
(ClinicalTrials.gov)
January 201121/9/2010Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid ArthritisMilnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid ArthritisArthritis, RheumatoidDrug: Milnacipran;Drug: PlaceboBrigham and Women's HospitalForest Laboratories;National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed24 YearsN/AAll49Phase 4United States
1569NCT01351805
(ClinicalTrials.gov)
January 20114/5/2011Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee PainVitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee PainAutoimmune Diseases;Systemic Inflammatory Process;Knee Pain Chronic;Osteoarthritis;Rheumatoid ArthritisDrug: Fish Oil;Dietary Supplement: Vitamin D;Other: placebo pillBrigham and Women's HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Active, not recruiting50 YearsN/AAll25876N/AUnited States
1570NCT01274182
(ClinicalTrials.gov)
January 201110/1/2011GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.Rheumatoid ArthritisBiological: GP2013;Biological: MabThera;Biological: RituxanSandozNovartis PharmaceuticalsCompleted18 YearsN/AAll312Phase 1/Phase 2United States;Argentina;Austria;Belgium;Brazil;Estonia;France;Germany;Hungary;India;Italy;Romania;Spain;Turkey
1571EUCTR2010-019134-27-BG
(EUCTR)
23/12/201018/10/2010A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPYA PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY Rhuematoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Trade Name: Methotrexate 10 mg tablets
Product Name: Methotrextate
INN or Proposed INN: Methotrexate
Trade Name: Folimet
Product Name: Folic Acid
INN or Proposed INN: Folic Acid
Chelsea Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Czech Republic;Mexico;Argentina;Poland;Bulgaria
1572EUCTR2010-021558-21-CZ
(EUCTR)
23/12/201021/10/2010A Clinical Study of AK106-001616 in Patients With Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis 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]
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Hungary;Czech Republic;Slovakia;Ukraine;Germany;United Kingdom
1573EUCTR2010-021020-94-ES
(EUCTR)
21/12/201021/10/2010Estudio 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 & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
250Hungary;Czech Republic;Germany;Spain;Italy
1574NCT02675803
(ClinicalTrials.gov)
December 20, 20109/7/2015Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of VAY736 in Rheumatoid Arthritis PatientsA Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VAY736 in Rheumatoid Arthritis PatientsRheumatoid ArthritisBiological: VAY736;Biological: VAY736 placeboNovartis PharmaceuticalsNULLCompleted18 Years65 YearsAll65Phase 1Germany
1575EUCTR2010-020892-22-PT
(EUCTR)
17/12/201017/09/2010A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - XA Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
2000Portugal;Estonia;Spain;Lithuania;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands
1576EUCTR2010-020745-27-PT
(EUCTR)
17/12/201016/09/2010A 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 antagonist - OSKIRA - 3A 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 antagonist - OSKIRA - 3 Rheumatoid Arthritis
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 ABNULLNot RecruitingFemale: yes
Male: yes
450Phase 3France;Portugal;Hungary;Czech Republic;Spain;Germany;Italy;United Kingdom
1577EUCTR2010-021020-94-CZ
(EUCTR)
17/12/201005/10/2010A 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-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-aA 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-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a active rheumatoid arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Code: SAR153191
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB
Sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
250Hungary;Germany;Czech Republic;Spain;Italy
1578EUCTR2010-020744-35-PT
(EUCTR)
17/12/201016/09/2010A 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 DMARDs - OSKIRA - 2A 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 DMARDs - OSKIRA - 2 Rheumatoid Arthritis
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 ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;Italy;United Kingdom
1579EUCTR2010-021577-37-HU
(EUCTR)
16/12/201027/10/2010A 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 ARTHRITISA 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 Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: N/A
Product Code: MLTA3698A
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
GENENTECH, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Spain;Bulgaria;Germany
1580EUCTR2010-021283-14-CZ
(EUCTR)
15/12/201027/09/2010A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritisA randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis Rheumatoid arthritis
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/SNULLNot RecruitingFemale: yes
Male: yes
66Portugal;Hungary;Czech Republic;Spain;Italy;United Kingdom
1581EUCTR2010-020743-12-FR
(EUCTR)
14/12/201005/10/2010A 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 Methotrexate - OSKIRA - 1A 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 Methotrexate - OSKIRA - 1 Rheumatoid arthritis
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 ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3France;Estonia;Hungary;Slovakia;Poland;Belgium;Bulgaria;Germany;United Kingdom
1582EUCTR2010-020745-27-FR
(EUCTR)
14/12/201005/10/2010A 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 antagonist - OSKIRA - 3A 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 antagonist - OSKIRA - 3 Rheumatoid Arthritis
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 ABNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;France;Hungary;Czech Republic;Spain;Belgium;Germany;Italy;United Kingdom
1583EUCTR2010-020745-27-ES
(EUCTR)
13/12/201030/09/2010A 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 - 3A 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 ABNULLNot RecruitingFemale: yes
Male: yes
450Phase 3France;Portugal;Hungary;Czech Republic;Belgium;Spain;Germany;Italy;United Kingdom
1584EUCTR2010-020744-35-ES
(EUCTR)
13/12/201023/09/2010A 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 - 2A 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 ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;Italy;United Kingdom
1585EUCTR2010-022206-40-SK
(EUCTR)
13/12/201027/04/2016A Rheumatoid Arthritis Study in Patients (FLEX-O)A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O) 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 Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1002Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Peru;Australia;South Africa;Bulgaria;New Zealand;Japan;Korea, Republic of
1586EUCTR2010-020892-22-ES
(EUCTR)
13/12/201005/10/2010A 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 - XA 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 ABNULLNot RecruitingFemale: yes
Male: yes
2000Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Netherlands;Latvia;Germany;Italy;United Kingdom
1587EUCTR2009-015898-12-NL
(EUCTR)
10/12/201010/06/2010Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination with Methotrexate, Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis and an Inadequate Response to MethotrexateRandomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination with Methotrexate, Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Patients with active rheumatoid arthritis and an inadequate response to Methotrexate
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: GLPG0259
Product Code: GLPG0259
Product Name: GLPG0259
Product Code: GLPG0259
Product Name: GLPG0259
Product Code: GLPG0259
Product Name: GLPG0259
Product Code: GLPG0259
Galápagos NVNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Netherlands;Belgium
1588EUCTR2009-016266-90-RO
(EUCTR)
03/12/201026/07/2010A 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 - MOBILITYA 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 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 & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
1740Phase 2;Phase 3Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Czech Republic;Hungary;Belgium;Romania;Germany;Netherlands
1589EUCTR2010-019871-31-GB
(EUCTR)
01/12/201008/10/2010A 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 ArthritisA 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: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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.,NULLNot Recruiting Female: yes
Male: yes
1800 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
1590EUCTR2010-019262-86-LT
(EUCTR)
01/12/201026/10/2010Long term evaluation of sarilumab in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND 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]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
2000Phase 3United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden
1591EUCTR2010-018646-31-LT
(EUCTR)
30/11/201006/08/2010CT-P13 Compared With Remicade When Co-Administered With MethotrexateA 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 - 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]
Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
CELLTRION, IncNULLNot RecruitingFemale: yes
Male: yes
584Phase 3Portugal;Colombia;Bulgaria;Chile;Indonesia;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Russian Federation;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Poland;Jordan
1592EUCTR2010-021184-32-DE
(EUCTR)
30/11/201030/08/2010GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies Refractory 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 Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
164Phase 2Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1593EUCTR2010-018375-22-BG
(EUCTR)
25/11/201023/09/2010A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.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-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA 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: tocilizumab 162mg/0.9ml syringe SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200United States;Philippines;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Italy;France;Peru;Australia;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Bulgaria;Germany;New Zealand
1594EUCTR2010-020743-12-BE
(EUCTR)
23/11/201007/07/2010A 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 Methotrexate - OSKIRA - 1A 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 Methotrexate - OSKIRA - 1 Rheumatoid arthritis
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 ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3France;Estonia;Hungary;Slovakia;Poland;Belgium;Bulgaria;Germany;United Kingdom
1595EUCTR2010-020892-22-BE
(EUCTR)
23/11/201001/07/2010Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X 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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
2000Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1596EUCTR2010-020745-27-BE
(EUCTR)
23/11/201001/07/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (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 antagonist - OSKIRA - 3 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] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany
1597EUCTR2009-011791-30-CZ
(EUCTR)
18/11/201002/08/2010A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritisA randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis Rheumatoid arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: NNC151-0000
Product Code: NNC0151-0000-0000
Other descriptive name: Anti-C5aR
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
48Hungary;Czech Republic;Poland;Ukraine;Romania;Denmark;Russian Federation;Germany;United Kingdom
1598EUCTR2009-015019-42-FI
(EUCTR)
17/11/201027/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
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: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170United States;Serbia;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;Netherlands
1599EUCTR2010-021184-32-AT
(EUCTR)
11/11/201019/10/2010GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies Refractory 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: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
288Phase 2Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1600EUCTR2009-012041-35-BG
(EUCTR)
10/11/201018/08/2010A phase II, randomized, double-blind, controlled study to evaluate the immune responses, safety and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis who have relapsed despite anti-TNFa biological therapyA phase II, randomized, double-blind, controlled study to evaluate the immune responses, safety and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis who have relapsed despite anti-TNFa biological therapy - TNF-K-003 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: TNF-Kinoid
Product Code: TNF-K
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
48Phase 2France;Argentina;Belgium;Croatia;Romania;Chile;Bulgaria
1601EUCTR2010-020743-12-BG
(EUCTR)
10/11/201009/11/2010A 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 Methotrexate - OSKIRA - 1 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 Methotrexate - OSKIRA - 1 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] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Peru;Bulgaria;Germany
1602EUCTR2010-018674-20-DK
(EUCTR)
05/11/201021/09/2010Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination WithMethotrexate in Adults With Very Early Rheumatoid Arthritis (RA)A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA.Revised protocol 01 incorporating protocol amendment 01 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: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety
INN or Proposed INN: METHOTREXATE
Other descriptive name: MTX
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
470Phase 3United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Denmark;Australia;South Africa;Germany;Korea, Republic of;Sweden
1603EUCTR2010-018674-20-DE
(EUCTR)
05/11/201017/08/2010Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination With Methotrexate in Adults With Very Early Rheumatoid Arthritis (RA)A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA.Revised protocol 01 incorporating protocol amendment 01 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]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety
INN or Proposed INN: METHOTREXATE
Other descriptive name: MTX
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
470Phase 3United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Australia;Denmark;South Africa;Germany;Korea, Republic of;Sweden
1604EUCTR2010-018646-31-ES
(EUCTR)
05/11/201012/08/2010Estudio 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 ArthritisEstudio 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, IncNULLNot RecruitingFemale: yes
Male: yes
584Phase 3Portugal;Slovakia;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom
1605EUCTR2010-019871-31-AT
(EUCTR)
03/11/201001/09/2010Etoricoxib and placebo in patients with rheumatoid arthritisA 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: 15.1;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: 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.NULLNot RecruitingFemale: yes
Male: yes
1800Phase 3United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
1606EUCTR2010-019871-31-LT
(EUCTR)
02/11/201017/09/2010Etoricoxib and placebo in patients with rheumatoid arthritisA 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: 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: 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.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
1607EUCTR2009-015019-42-LT
(EUCTR)
02/11/201017/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.0;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: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany
1608JPRN-UMIN000004412
2010/11/0120/10/2010Corticosteroid-sparing effect of Actemra in patients with Rheumatoid Arthritis refractory to anti-TNF agents, methotrexate and corticosteroid rheumatoid arthritistocilizumabGeneral Internal Medicine, Tenri HospitalNULLRecruiting16years-old80years-oldMale and Female25Not applicableJapan
1609JPRN-UMIN000008756
2010/11/0130/08/2012Abatacept-based approach to cure of RA Rheumatoid ArthritisAbatacept treatmentat month 12
MTX treatment at month 12
University of Occupational and Environmental Health, JapanNULLRecruiting15years-oldNot applicableFemale40Not selectedJapan
1610NCT01255761
(ClinicalTrials.gov)
November 20106/12/2010A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis SubjectsPhase 4, Randomized, 52-Week Study To Evaluate Two Assessment Tools To Predict Treatment Success At 52 Weeks Based On A Treatment Decision At Week 12 In Subjects With Moderate To Severe Rheumatoid Arthritis Receiving CimziaRheumatoid ArthritisBiological: Certolizumab Pegol (CZP)UCB PharmaNULLCompleted18 YearsN/AAll736Phase 4United States
1611NCT01245790
(ClinicalTrials.gov)
November 201019/11/2010A Study of Fostamatinib in Subjects With Impaired Kidney FunctionAn Open-label, Phase I Study to Assess the Pharmacokinetics of R406 in Subjects With Renal Impairment Compared to Healthy Subjects Following Administration of a Single Dose of Fostamatinib 150 mgRheumatoid Arthritis;Renal ImpairmentDrug: fostamatinibAstraZenecaNULLCompleted18 YearsN/ABoth24Phase 1United States
1612NCT01225393
(ClinicalTrials.gov)
November 201018/10/2010A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid ArthritisA Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: MLTA3698A;Drug: adalimumab;Drug: leflunomide;Drug: methotrexate;Drug: placeboGenentech, Inc.NULLCompleted18 Years75 YearsBoth211Phase 2Romania;Spain;Bulgaria;Chile;Germany;Hungary;Mexico;Peru;Poland;United States
1613NCT01618019
(ClinicalTrials.gov)
November 20108/6/2012N-3 PUFA and Rheumatoid Arthritis in KoreaEffect of n-3 Polyunsaturated Fatty Acid Supplementation on Patients With Rheumatoid ArthritisRheumatoid ArthritisDietary Supplement: Omega-3 fatty acid;Dietary Supplement: PlaceboHanyang UniversityNULLCompleted18 Years80 YearsAll109N/AKorea, Republic of
1614NCT01225991
(ClinicalTrials.gov)
November 201020/10/2010Milnacipran for Treatment of Pain in Older Adults With Rheumatoid ArthritisAn Open-label Trial of Milnacipran for the Treatment of Pain in Rheumatoid Arthritis (RA) in Older AdultsRheumatoid ArthritisDrug: MilnacipranUniversity of California, Los AngelesForest LaboratoriesCompleted50 YearsN/AAll18Phase 4United States
1615NCT01287858
(ClinicalTrials.gov)
November 201012/1/2011Study to Assess Safety, Tolerability, and Pharmacokinetics of Oral Doses for AC430 in Healthy SubjectsA Phase 1, Randomized, Double Blind, Placebo Controlled, Sequential, Ascending Single-Dose and Multiple-Dose First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AC430 in Healthy SubjectsRheumatoid ArthritisDrug: AC430Daiichi Sankyo Inc.NULLCompleted18 Years45 YearsBoth88Phase 1United States
1616NCT01217814
(ClinicalTrials.gov)
November 20107/10/2010Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-a BlockersA Randomized, Double-blind, Parallel-group, Placebo- and Active Calibrator-controlled Study Assessing the Clinical Benefit of SAR153191 Subcutaneous (SC) on Top of MTX in Patients With Active RA Who Have Failed Previous TNF-a AntagonistsRheumatoid ArthritisDrug: Sarilumab;Drug: Placebo;Drug: Golimumab;Drug: methotrexate (MTX);Drug: Folic/folinic acidSanofiRegeneron PharmaceuticalsTerminated18 Years75 YearsAll16Phase 2United States;Colombia;Czechia;Italy;Mexico;Spain;Brazil;Canada;Czech Republic;Germany;Hungary;Norway
1617NCT01242488
(ClinicalTrials.gov)
November 201015/11/2010Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) TherapyRandomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker TherapyRheumatoid ArthritisBiological: CDP6038;Biological: Tocilizumab (Actemra or RoActemra);Other: Placebo sc;Other: Placebo ivUCB PharmaNULLCompleted18 YearsN/ABoth221Phase 2United States;Belgium;United Kingdom
1618EUCTR2008-006924-68-AT
(EUCTR)
28/10/201012/01/2009Extension 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. - this is an extension study to MA21573Extension 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. - this is an extension study to MA21573 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3France;Portugal;Hungary;Czech Republic;Spain;Austria;Netherlands;United Kingdom;Italy
1619EUCTR2010-021184-32-FR
(EUCTR)
28/10/201013/09/2010A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or two anti- TNF therapiesA randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or two anti- TNF therapies Refractory rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
164Phase 2France;Hungary;Estonia;Poland;Belgium;Spain;Austria;Bulgaria;Germany;United Kingdom;Italy
1620EUCTR2010-020892-22-GB
(EUCTR)
26/10/201005/07/2010Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X 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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
2000 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1621EUCTR2010-020743-12-GB
(EUCTR)
26/10/201005/07/2010A 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 Methotrexate - OSKIRA - 1A 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 Methotrexate - OSKIRA - 1 Rheumatoid arthritis
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 ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3France;Estonia;Hungary;Slovakia;Poland;Belgium;Bulgaria;Germany;United Kingdom
1622NCT01362062
(ClinicalTrials.gov)
October 26, 201026/5/2011Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) TherapyA Study to Observe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti TNF Therapy.Rheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll110N/AIndia
1623EUCTR2010-020744-35-GB
(EUCTR)
26/10/201005/07/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (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 DMARDs - OSKIRA - 2 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] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia
1624EUCTR2010-020745-27-GB
(EUCTR)
26/10/201005/07/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (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 antagonist - OSKIRA - 3 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] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
450Phase 3France;Portugal;United States;Spain;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany
1625EUCTR2010-019871-31-DE
(EUCTR)
25/10/201009/12/2010Etoricoxib and placebo in patients with rheumatoid arthritisA 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: 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: 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.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
1626EUCTR2010-020744-35-LV
(EUCTR)
22/10/201013/08/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (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 DMARDs - OSKIRA - 2 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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;Czech Republic;Canada;Romania;South Africa;Latvia;Germany
1627EUCTR2010-020892-22-LV
(EUCTR)
22/10/201013/08/2010Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X 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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
2000Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Mexico;Czech Republic;Hungary;United Kingdom;Lithuania;Netherlands;Latvia;South Africa;Peru;Australia;France;India;Italy;Russian Federation;Israel;Chile;Ukraine;Spain;Slovakia;Estonia;Serbia;Portugal;United States
1628EUCTR2010-018674-20-IT
(EUCTR)
21/10/201017/12/2010A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA - NDA Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA - ND Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073
Product Name: Abatacept
Product Code: BMS188667
Trade Name: METHOTREXATE HOSPIRA 2.5 mg tablety
INN or Proposed INN: Methotrexate
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
470Phase 3France;Finland;Denmark;Germany;Italy;Sweden
1629EUCTR2010-018485-24-CZ
(EUCTR)
20/10/201024/08/2010To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritisA multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.
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]
Product Name: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
128Hungary;Czech Republic;Spain;Latvia;Germany
1630EUCTR2010-019134-27-CZ
(EUCTR)
19/10/201028/06/2010A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPYA PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY Rhuematoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Trade Name: Methotrexate
Product Name: Methotrextate
INN or Proposed INN: Methotrexate
Trade Name: Folic Acid
Product Name: Folic Acid
INN or Proposed INN: Folic Acid
Chelsea Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Czech Republic;Bulgaria
1631EUCTR2010-019871-31-FI
(EUCTR)
18/10/201030/08/2010Etoricoxib and placebo in patients with rheumatoid arthritisA 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: 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: 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.NULLNot RecruitingFemale: yes
Male: yes
1800Phase 3United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
1632EUCTR2010-020892-22-HU
(EUCTR)
15/10/201011/08/2010A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - XA Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X Rheumatoid Arthritis
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 ABNULLNot RecruitingFemale: yes
Male: yes
2000Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Latvia;Germany;Italy;United Kingdom
1633EUCTR2010-021020-94-IT
(EUCTR)
15/10/201028/09/2010A randomized, double-blind, parallel-group, placebo- and active calibrator-controlled study 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-alpha) antagonists. - NDA randomized, double-blind, parallel-group, placebo- and active calibrator-controlled study 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-alpha) antagonists. - ND active rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073
Product Code: SAR153191
Trade Name: SIMPONI
INN or Proposed INN: GOLIMUMAB
Sanofi-aventis Recherche & D?veloppementNULLNot RecruitingFemale: yes
Male: yes
250Hungary;Czech Republic;Germany;Spain;Italy
1634EUCTR2010-019964-36-DE
(EUCTR)
14/10/201009/06/2010A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2 Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CCX354-C
Product Code: CCX354-C
Other descriptive name: CCX354
Product Name: CCX354-C
Product Code: CCX354-C
Other descriptive name: CCX354
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Czech Republic;Hungary;Belgium;Germany
1635EUCTR2008-001523-57-DE
(EUCTR)
14/10/201010/06/2010Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate - IM101179Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate - IM101179 Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
100Hungary;United Kingdom;Germany;Denmark;France;Norway;Spain;Italy
1636EUCTR2007-006129-29-PL
(EUCTR)
14/10/201021/04/2010A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritisA multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis - MOR103 Rheumatoid Arthritis PoC Study Rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: MOR103
Product Code: MOR103
Other descriptive name: Human Recombinant IgG1, lambda
MorphoSys AGNULLNot RecruitingFemale: yes
Male: yes
89Germany;Ukraine;Netherlands;Belarus;Bulgaria;Poland
1637EUCTR2010-020743-12-HU
(EUCTR)
14/10/201011/08/2010A 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 Methotrexate - OSKIRA - 1A 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 Methotrexate - OSKIRA - 1 Rheumatoid arthritis
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 ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3France;Estonia;Hungary;Poland;Bulgaria;Germany;United Kingdom
1638EUCTR2010-018674-20-FI
(EUCTR)
13/10/201023/08/2010Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination WithMethotrexate in Adults With Very Early Rheumatoid Arthritis (RA)A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA.Revised Protocol 01 incorporating amendment 01. 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: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety
INN or Proposed INN: METHOTREXATE
Other descriptive name: MTX
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
470Phase 3United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Australia;Denmark;South Africa;Germany;Korea, Republic of;Sweden
1639EUCTR2010-020738-24-GB
(EUCTR)
12/10/201017/08/2010To 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 LondonNULLNot 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): yesUnited Kingdom
1640EUCTR2010-020744-35-LT
(EUCTR)
11/10/201018/08/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (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 DMARDs - OSKIRA - 2 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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia
1641EUCTR2010-020743-12-SK
(EUCTR)
11/10/201005/08/2010Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Methotrexate But Not Responding. (OSKIRA - 1)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 Methotrexate - OSKIRA - 1 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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany
1642EUCTR2010-020745-27-CZ
(EUCTR)
11/10/201030/08/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (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 antagonist - OSKIRA - 3 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] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany
1643EUCTR2010-020744-35-CZ
(EUCTR)
11/10/201030/08/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (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 DMARDs - OSKIRA - 2 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] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia
1644EUCTR2010-018646-31-SK
(EUCTR)
11/10/201023/06/2010A 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 ArthritisA 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 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
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
CELLTRION, IncNULLNot RecruitingFemale: yes
Male: yes
584Phase 3Portugal;Slovakia;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom
1645EUCTR2010-020892-22-SK
(EUCTR)
11/10/201005/08/2010Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X 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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
2000United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1646EUCTR2010-020892-22-CZ
(EUCTR)
11/10/201030/08/2010Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X 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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
2000Serbia;Portugal;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1647EUCTR2010-018646-31-LV
(EUCTR)
11/10/201029/06/2010A 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 - 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
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
CELLTRION, IncNULLNot RecruitingFemale: yes
Male: yes
633Phase 3Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania
1648EUCTR2010-018375-22-LT
(EUCTR)
11/10/201016/08/2010A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.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-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA 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: tocilizumab 162mg/0.9ml syringe SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200United States;Philippines;Hong Kong;Spain;Thailand;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;New Zealand
1649EUCTR2010-020892-22-LT
(EUCTR)
11/10/201018/08/2010Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X 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: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
2000United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1650EUCTR2010-018646-31-BG
(EUCTR)
07/10/201007/09/2010A 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 ArthritisA 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 Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
CELLTRION, IncNULLNot RecruitingFemale: yes
Male: yes
584Phase 3Portugal;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom
1651EUCTR2009-015019-42-AT
(EUCTR)
05/10/201001/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.0;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: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany
1652EUCTR2009-016119-38-BG
(EUCTR)
05/10/201018/08/2010A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
220United Kingdom;Bulgaria;Latvia;Poland
1653EUCTR2010-018375-22-DE
(EUCTR)
05/10/201014/07/2010A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.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-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA 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]
Product Name: tocilizumab 162mg/0.9ml syringe SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1200United States;Philippines;Hong Kong;Spain;Thailand;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;New Zealand
1654EUCTR2009-015845-21-GR
(EUCTR)
04/10/201004/10/2010A 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 arthritisA 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: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
1655EUCTR2009-015845-21-PT
(EUCTR)
01/10/201022/07/2010A 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 arthritisA 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: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Finland;Portugal;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
1656EUCTR2010-018646-31-PT
(EUCTR)
01/10/201023/07/2010A 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 ArthritisA 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 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
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
CELLTRION, IncNULLNot RecruitingFemale: yes
Male: yes
584Phase 3Portugal;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom
1657EUCTR2006-005035-19-HU
(EUCTR)
01/10/201019/09/2007A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TASOCITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TASOCITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Product Code: CP-690,550
Product Name: CP-690,550
Product Code: CP-690,550
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 2;Phase 3Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Sweden
1658NCT01149057
(ClinicalTrials.gov)
October 201022/6/2010A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDSAn Open-Label Study to Evaluate the Efficacy and Safety Of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARDs and/or Biologic DMARDsRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheClalit Health ServicesCompleted18 YearsN/AAll145Phase 4Israel
1659NCT02528292
(ClinicalTrials.gov)
October 20105/8/2011Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Rheumatoid ArthritisPhase 4 Study of Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Patients With Rheumatoid Arthritis Undergoing Treatment With Anti-TNF TherapyRheumatoid ArthritisProcedure: Synovial biopsy;Drug: Anti-TNF therapyBarts & The London NHS TrustNULLActive, not recruiting18 YearsN/ABoth24Phase 4United Kingdom
1660EUCTR2010-018646-31-AT
(EUCTR)
29/09/201003/08/2010A 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 - Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
CELLTRION, IncNULLNot RecruitingFemale: yes
Male: yes
584Phase 3Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania
1661EUCTR2010-019694-15-BE
(EUCTR)
28/09/201028/07/2010Act-Alone : An open-label, single-arm study to describe glucocorticoid use in rheumatoid arthritis patients treated with Tocilizumab in daily clinical practice and to evaluate systematic glucocorticoid dose reduction once low disease activity is reached - ACT-AloneAct-Alone : An open-label, single-arm study to describe glucocorticoid use in rheumatoid arthritis patients treated with Tocilizumab in daily clinical practice and to evaluate systematic glucocorticoid dose reduction once low disease activity is reached - ACT-Alone Rheumatoid Arthritis in adult
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Medrol 4 mg tablets
Other descriptive name: METHYLPREDNISOLONE
Trade Name: Medrol A 16 mg tablets
Other descriptive name: METHYLPREDNISOLONE
N.V. Roche S.A.NULLNot RecruitingFemale: yes
Male: yes
Phase 4Belgium
1662EUCTR2010-019262-86-GR
(EUCTR)
28/09/201023/09/2010A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: N/A
Product Code: SAR153191
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Belgium;Netherlands;Germany;Norway;Sweden
1663EUCTR2010-020892-22-EE
(EUCTR)
27/09/201016/08/2010Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X 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] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
2000United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1664EUCTR2010-020743-12-EE
(EUCTR)
24/09/201016/08/2010Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Methotrexate But Not Responding. (OSKIRA - 1)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 Methotrexate - OSKIRA - 1 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] - Immune System Diseases [C20]
Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
Astra Zeneca ABNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Germany;Bulgaria;Peru;Australia;Brazil;Belgium;Poland;Argentina;Mexico;Hungary;France;India;United Kingdom;Chile;Russian Federation;Ukraine;Slovakia;Estonia;United States
1665EUCTR2010-018674-20-BE
(EUCTR)
23/09/201019/08/2010Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination with Methotrexate in Adults with very early Rheumatoid Arthritis (RA)A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA.Revised Protocol 01 incorporating protocol amendment 01 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]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety
INN or Proposed INN: METHOTREXATE
Other descriptive name: MTX
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
470Phase 3United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;South Africa;Germany;Korea, Republic of;Sweden
1666EUCTR2009-011791-30-DK
(EUCTR)
22/09/201012/11/2009A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritisA randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: NNC151-0000
Product Code: NNC0151-0000-0000
Other descriptive name: Anti-C5aR
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
48Hungary;Czech Republic;Poland;Ukraine;Romania;Denmark;Russian Federation;Germany;United Kingdom
1667JPRN-UMIN000011789
2010/09/2120/09/2013Usefulness of intravenous abatacept at an increased dose in rheumatoid arthritis patients with a poor prognosis Rheumatoid arthritisAdministration of increased dose of abatacept to patients with rheumatoid arthritis previously treated with abatacept.National Health Organization Nagoya Medical CenterNULLComplete: follow-up completeNot applicableNot applicableMale and Female20Not applicableJapan
1668EUCTR2009-015898-12-BE
(EUCTR)
20/09/201014/06/2010Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination with Methotrexate, Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis and an Inadequate Response to MethotrexateRandomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination with Methotrexate, Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Patients with active rheumatoid arthritis and an inadequate response to Methotrexate
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: GLPG0259
Product Code: GLPG0259
Product Name: GLPG0259
Product Code: GLPG0259
Product Name: GLPG0259
Product Code: GLPG0259
Product Name: GLPG0259
Product Code: GLPG0259
Galápagos NVNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Netherlands;Belgium
1669EUCTR2010-018674-20-SE
(EUCTR)
16/09/201020/08/2010Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination WithMethotrexate in Adults With Very Early Rheumatoid Arthritis (RA)A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA.Revised Protocol 01 incorporating amendment 01 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: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety
INN or Proposed INN: METHOTREXATE
Other descriptive name: MTX
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
470Phase 3France;United States;Mexico;Canada;Finland;Denmark;Australia;Russian Federation;Germany;Italy;Korea, Republic of;Sweden
1670EUCTR2010-019935-37-FI
(EUCTR)
15/09/201002/07/2010A 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 ArthritisA 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:
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
Other descriptive name: TOCILIZUMAB
Roche OyNULLNot RecruitingFemale: yes
Male: yes
160Finland
1671EUCTR2010-018646-31-IT
(EUCTR)
14/09/201026/07/2010A 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 - ND Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073
Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
INN or Proposed INN: Infliximab
CELLTRION, IncNULLNot RecruitingFemale: yes
Male: yes
584Phase 3Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania
1672EUCTR2010-018375-22-GB
(EUCTR)
14/09/201029/06/2010A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.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-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA 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: tocilizumab 162mg/0.9ml syringe SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
1200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Philippines;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Italy;France;Peru;Australia;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Bulgaria;Germany;New Zealand
1673EUCTR2010-018674-20-FR
(EUCTR)
10/09/201016/08/2010A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA.A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA. Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety
INN or Proposed INN: METHOTREXATE
Other descriptive name: MTX
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
470Phase 3Sweden;Italy;Germany;Denmark;Belgium;Finland;France
1674EUCTR2009-013758-33-DK
(EUCTR)
09/09/201009/06/2010MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITISMULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS 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: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
36Denmark;Netherlands;Sweden
1675EUCTR2010-018646-31-GB
(EUCTR)
09/09/201022/07/2010A 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 - 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
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
CELLTRION, IncNULLNot RecruitingFemale: yes
Male: yes
633Phase 3Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania
1676EUCTR2010-019964-36-CZ
(EUCTR)
08/09/201009/06/2010A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2 Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CCX354-C
Product Code: CCX354-C
Other descriptive name: CCX354
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Hungary;Czech Republic;Belgium;Germany
1677EUCTR2009-016266-90-LT
(EUCTR)
06/09/201025/01/2010A 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 - MOBILITYA 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 Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: not applicable
Product Code: SAR153191
Product Name: not applicable
Product Code: SAR153191
Product Name: not applicable
Product Code: SAR153191
Sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
1740Portugal;Estonia;Hungary;Czech Republic;Greece;Finland;Spain;Romania;Lithuania;Austria;Netherlands;Germany
1678NCT01208506
(ClinicalTrials.gov)
September 201023/9/2010First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid ArthritisFirst Human Dose Trial of NNC0114-0000-0005 in Healthy Subjects and Subjects With Rheumatoid ArthritisInflammation;Rheumatoid Arthritis;HealthyDrug: NNC0114-0000-0005;Drug: placeboNovo Nordisk A/SNULLCompleted18 Years75 YearsAll64Phase 1Germany
1679NCT01197534
(ClinicalTrials.gov)
September 20108/9/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.(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 DMARDsRheumatoid ArthritisDrug: fostamatinib;Drug: placebo, fostamatinibAstraZenecaNULLCompleted18 YearsN/AAll913Phase 3United States;Canada;Czech Republic;Germany;India;Israel;Italy;Latvia;Lithuania;Portugal;Romania;Serbia;South Africa;Spain;Ukraine;United Kingdom
1680NCT01154647
(ClinicalTrials.gov)
September 201028/6/2010Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity SyndromesUnraveling Impaired Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes: a Series of Experiments Targeting Brain NeurotransmissionFatigue Syndrome, Chronic;Fibromyalgia;Arthritis, RheumatoidDrug: citalopram;Drug: 1 ml 0.9 % NaClVrije Universiteit BrusselResearch Foundation Flanders;Universiteit Antwerpen;University Hospital, Antwerp;Artesis University College, AntwerpNot yet recruiting18 Years65 YearsFemale70N/ABelgium
1681NCT01197521
(ClinicalTrials.gov)
September 20108/9/2010Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.(OSKIRA-1): 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 MethotrexateRheumatoid ArthritisDrug: fostamatinib;Drug: placebo, fostamatinibAstraZenecaNULLCompleted18 YearsN/AAll923Phase 3United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Chile;Estonia;France;Hungary;India;Mexico;Peru;Poland;Slovakia;Ukraine;United Kingdom;Germany;Russian Federation
1682EUCTR2010-019964-36-BE
(EUCTR)
26/08/201020/05/2010A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2 Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CCX354-C
Product Code: CCX354-C
Other descriptive name: CCX354
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Czech Republic;Hungary;Belgium;Germany
1683EUCTR2009-016119-38-LV
(EUCTR)
13/08/201028/05/2010A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
220United Kingdom;Bulgaria;Latvia;Poland
1684EUCTR2010-018375-22-ES
(EUCTR)
03/08/201004/06/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
1685NCT01195272
(ClinicalTrials.gov)
August 20102/9/2010A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.A 52 Week, Single Center, Open-label Study to Evaluate Neutrophil Function and Survival Effects of Tocilizumab (TCZ) in Patients With Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll21Phase 4United Kingdom
1686EUCTR2010-018375-22-IT
(EUCTR)
29/07/201005/07/2010A randomized, double-blind, parallel group study of the safety and effect onclinical outcome of tocilizumab SC versus tocilizumab IV, in combination withtraditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), inpatients with moderate to severe active rheumatoid arthritis - NDA randomized, double-blind, parallel group study of the safety and effect onclinical outcome of tocilizumab SC versus tocilizumab IV, in combination withtraditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), inpatients with moderate to severe active rheumatoid arthritis - ND Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: tocilizumab 162mg/0.9ml syringe SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Trade Name: RoActemra
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1200Spain;Lithuania;Bulgaria;Germany;United Kingdom;Italy
1687EUCTR2010-019261-28-DE
(EUCTR)
26/07/201016/06/2010A randomised, single-dose, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC 0142-0000-0002 in subjects with active rheumatoid arthritisA randomised, single-dose, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC 0142-0000-0002 in subjects with active rheumatoid arthritis Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: NNC 0142-0000-0002
Product Code: NNC 142-0002
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
160Germany
1688EUCTR2009-015845-21-DE
(EUCTR)
22/07/201018/03/2010A 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 arthritisA 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: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Portugal;Finland;Czech Republic;United Kingdom;Germany;Belgium;Spain;Greece;Sweden
1689EUCTR2009-016987-34-HU
(EUCTR)
21/07/201026/02/2010PHASE 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 ARTHRITISPHASE 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 Moderate to severe active Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3Czech Republic;Hungary;Poland;Spain;Bulgaria;Germany;Sweden
1690EUCTR2010-019262-86-HU
(EUCTR)
21/07/201027/05/2010Long term evaluation of sarilumab in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND 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 Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
2025Phase 3United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden;New Zealand
1691EUCTR2009-012759-12-CZ
(EUCTR)
16/07/201022/02/2010A 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.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. Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Denmark;Germany;Sweden
1692EUCTR2009-015845-21-CZ
(EUCTR)
16/07/201026/03/2010A 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 arthritisA 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: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
1693EUCTR2009-016987-34-BG
(EUCTR)
15/07/201009/07/2010Phase 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 ArthritisPHASE 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 Moderate to severe active 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: Not applicable
Product Code: CP-690,550
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM
Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USANULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Philippines;Taiwan;Slovakia;Thailand;Spain;Costa Rica;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden
1694EUCTR2010-019964-36-HU
(EUCTR)
14/07/201007/06/2010A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2 Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CCX354-C
Product Code: CCX354-C
Other descriptive name: CCX354
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Hungary;Czech Republic;Belgium
1695EUCTR2009-016266-90-GR
(EUCTR)
13/07/201001/07/2010A 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 - MOBILITYA 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 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 & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
1740Portugal;Estonia;Hungary;Czech Republic;Greece;Finland;Spain;Romania;Lithuania;Austria;Netherlands;Germany
1696EUCTR2009-010516-15-GR
(EUCTR)
13/07/201021/04/2010Randomized, 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 MethotrexateRandomized, 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)
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.NULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Greece;Poland;Spain
1697EUCTR2009-015845-21-SE
(EUCTR)
06/07/201010/05/2010A 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 arthritisA 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: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
1698EUCTR2009-017438-32-PL
(EUCTR)
06/07/201026/04/2010A 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritisA 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritis active rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: VX-509
Product Code: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Hungary;Germany;Poland
1699EUCTR2009-012041-35-BE
(EUCTR)
02/07/201030/09/2009A phase II, randomized, double-blind, controlled study to evaluate the immune responses, safety and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis who have relapsed despite anti-TNFa biological therapyA phase II, randomized, double-blind, controlled study to evaluate the immune responses, safety and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis who have relapsed despite anti-TNFa biological therapy - TNF-K-003 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: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet
Other descriptive name: N.A.
Neovacs SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2France;Argentina;Belgium;Croatia;Romania;Chile;Bulgaria
1700EUCTR2010-019262-86-FI
(EUCTR)
01/07/201019/05/2010Long term evaluation of sarilumab in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND 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 Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
2000Phase 3United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden
1701JPRN-UMIN000003880
2010/07/0107/07/2010Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area Rheumatoid arthritisDAS28>3.2 at 24 weeks
Switching to another biologics
DAS28>3.2 at 24 weeks
Dose up of MTX or addition of other DMARDs
DAS28<=3.2 at 24 weeks
40 mg of Adalimumab every two week
DAS28<=3.2 at 24 weeks
40 mg of Adalimumab every four week
Osaka City University Medical SchoolHigashi Sumiyoshi Morimoto Hospital, Yodogawa Christian Hospital, Kitade Hospital, Shirahama Hamayu HospitalRecruiting20years-oldNot applicableMale and Female100Not applicableJapan
1702JPRN-UMIN000003807
2010/07/0101/07/2010A study for comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis Rheumatoid ArthritisCombination therapy of three DMARDs (bucillamine, salazosulphapyridine and methotrexate)
Combination therapy of TNF-bloking biologics and methotrexate
Japan Association of Rheumatologists in Private PracticeNULLComplete: follow-up completeNot applicableNot applicableMale and Female160Not applicableJapan
1703EUCTR2009-016119-38-CZ
(EUCTR)
01/07/201002/07/2010A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
220Czech Republic;Poland;Bulgaria;Latvia;United Kingdom
1704EUCTR2009-012055-19-FR
(EUCTR)
24/06/201026/04/2010A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritisA randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: GSK315234 Injection 100mg/mL
Product Code: GSK315234
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
45Phase 2France;Belgium;Ireland;United Kingdom
1705EUCTR2009-012055-19-GB
(EUCTR)
24/06/201015/03/2010A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritisA randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: GSK315234 Injection 100mg/mL
Product Code: GSK315234
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
45United Kingdom;Belgium;France;Ireland
1706EUCTR2009-016266-90-DE
(EUCTR)
24/06/201012/01/2010Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patientsA 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 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]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
1594Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand
1707EUCTR2009-016119-38-PL
(EUCTR)
23/06/201030/04/2010A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
220United Kingdom;Bulgaria;Latvia;Poland
1708EUCTR2010-019262-86-EE
(EUCTR)
18/06/201021/05/2010Long term evaluation of sarilumab in rheumatoid arthritis patientsA multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND 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 Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
2000Phase 3Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden;United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru
1709EUCTR2009-013758-33-SE
(EUCTR)
17/06/201022/03/2010MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITISMULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS 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: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
36Denmark;Netherlands;Sweden
1710EUCTR2009-015845-21-FI
(EUCTR)
16/06/201030/04/2010A 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 arthritisA 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: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
1711EUCTR2009-012055-19-IE
(EUCTR)
16/06/201012/02/2010A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritisA randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: GSK315234 Injection 100mg/mL
Product Code: GSK315234
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
45United Kingdom;Belgium;France;Ireland
1712EUCTR2009-012759-12-GR
(EUCTR)
15/06/201013/11/2009A 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.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. Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1128Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
1713EUCTR2009-010582-23-GR
(EUCTR)
15/06/201030/12/2009A 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 BVNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
1714EUCTR2008-001523-57-HU
(EUCTR)
14/06/201027/04/2010Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to MethotrexateMulticenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
100Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;Italy
1715EUCTR2009-014296-40-IT
(EUCTR)
08/06/201008/02/2010PHASE 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 - NDPHASE 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 - ND Rheumatoid arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073
Product Code: CP-690,550Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
396Phase 3United Kingdom;Germany;Belgium;France;Ireland;Spain;Italy;Austria
1716EUCTR2009-015845-21-BE
(EUCTR)
08/06/201004/05/2010A 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 arthritisA 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: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Phase 4Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
1717EUCTR2010-019873-13-BE
(EUCTR)
07/06/201014/04/2010Comparative 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 - TOMERAComparative 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 LucNULLNot RecruitingFemale: yes
Male: yes
Phase 2Belgium
1718EUCTR2008-005708-18-GB
(EUCTR)
04/06/201014/04/2010Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excessPrevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excess Rheumatoid arthritis, SLE, Polymyalgia rheumatica, Disthyroid eye disease, Cushing's syndromeTrade Name: Glucophage (metformin)
Product Name: Metformin
Queen Mary University of LondonNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
1719EUCTR2009-016119-38-GB
(EUCTR)
19/05/201017/03/2010Safety and Efficacy of AMG 827 in Subjects With RAA Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. 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: Body processes [G] - Immune system processes [G12]
Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
220Czech Republic;United Kingdom;Bulgaria;Latvia;Poland;Australia
1720EUCTR2009-014735-20-BG
(EUCTR)
18/05/201023/02/2010A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid ArthritisA Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: CAM-3001
Product Code: CAM-3001
Other descriptive name: anti-GM-CSF receptor alpha
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Czech Republic;Hungary;Estonia;Poland;Lithuania;Bulgaria;Latvia
1721EUCTR2009-017163-42-SE
(EUCTR)
18/05/201023/03/2010Pain modulation in RA – Influence of adalimumab. A randomized, placebo-controlled study using functional magnetic resonance imaging - PARADEPain modulation in RA – Influence of adalimumab. A randomized, placebo-controlled study using functional magnetic resonance imaging - PARADE Rheumatoid arthritis (RA)The overall aim with this project is to investigate central pain mechanisms in RA and healthy controls, and in RA how these are influenced by autonomic neural regulation and TNF-blockade with Humira.Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Karolinska InstituteNULLNot RecruitingFemale: yes
Male: yes
Phase 4Sweden
1722EUCTR2009-016987-34-PL
(EUCTR)
17/05/201019/03/2010PHASE 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 ARTHRITISPHASE 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 Moderate to severe active Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Code: CP-690,550
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3Czech Republic;Hungary;Spain;Poland;Bulgaria;Germany;Sweden
1723EUCTR2009-015845-21-GB
(EUCTR)
13/05/201017/03/2010A 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 arthritisA 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: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche Ltd.NULLNot 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): yesPortugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
1724EUCTR2009-015740-42-DE
(EUCTR)
12/05/201012/01/2010A 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 - RETROA 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 ErlangenNULLNot RecruitingFemale: yes
Male: yes
318Phase 3Germany
1725EUCTR2009-015845-21-ES
(EUCTR)
12/05/201012/01/2012A 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 4United States;Portugal;Greece;Finland;Spain;Turkey;United Kingdom;Switzerland;Czech Republic;Mexico;Belgium;Brazil;Australia;Germany;Sweden
1726EUCTR2009-015950-39-DE
(EUCTR)
12/05/201028/12/2009Rituximab-Treatment in Addition to Leflunomide in Patients with active rheumatoid arthritisAddition of Rituximab to Leflunomide in patients with active rheumatoid arthritis - AMARA Active rheumatoid arthritis (RA) Patients who have had an inadequate response to disease modifying anti-rheumatic drugs (not more than 3 DMARDs including leflunomide, not more than one anti-TNF failure) and currently have active disease despite at least 3-month treatment with leflunomide. Active disease is defined as DAS 28 > 3.2 and at least swollen joint count (SJC) = 3 and tender joint count (TJC) = 3 included in the 28 joint count.
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: MabThera®
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB
Johann Wolfgang Goethe-Universität Frankfurt/M.NULLNot RecruitingFemale: yes
Male: yes
Germany
1727EUCTR2010-018331-18-GB
(EUCTR)
12/05/201018/03/2010A 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyA 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
United Kingdom
1728EUCTR2009-010516-15-ES
(EUCTR)
11/05/201029/07/2009Ensayo 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 MethotrexateEnsayo 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.NULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Greece;Poland;Spain
1729EUCTR2007-000896-41-AT
(EUCTR)
06/05/201013/05/2008A 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 methotrexateA 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 arthritisTrade 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,USANULLNot RecruitingFemale: yes
Male: yes
900Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
1730EUCTR2009-016987-34-SK
(EUCTR)
05/05/201028/04/2010Phase 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 ArthritisPHASE 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 Moderate to severe active 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: Not applicable
Product Code: CP-690,550
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM
Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USANULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Philippines;Taiwan;Slovakia;Thailand;Spain;Costa Rica;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden
1731EUCTR2009-012566-32-BG
(EUCTR)
05/05/201027/04/2010A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
240Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland
1732EUCTR2009-016987-34-DE
(EUCTR)
03/05/201017/02/2010Phase 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 ArthritisPHASE 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 Moderate to severe active 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: Not applicable
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM
Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USANULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Philippines;Taiwan;Slovakia;Thailand;Costa Rica;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Denmark;Australia;Peru;Korea, Republic of;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden
1733JPRN-UMIN000003615
2010/05/0114/05/2010Evaluation of the effectiveness of three nonbiologic DMARDs [salazosulfapyridine(SSZ), bucillamine(BUC), methotrexate(MTX)] combination therapy for early RA RA(Rheumatoid Arthritis)Using 3 DMARDs(Salazosulfapyridine, Bucillamine, and Methotrexate) for 24 monthsSt Luke's International HospitalNULLRecruiting20years-old80years-oldMale and Female20Not selectedJapan
1734EUCTR2008-002623-85-SE
(EUCTR)
28/04/201004/03/2010A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATEA 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
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
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,USANULLNot RecruitingFemale: yes
Male: yes
300Phase 4France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
1735EUCTR2009-017438-32-BE
(EUCTR)
27/04/201024/02/2010A 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritisA 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritis active rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: N/A
Product Code: VX-509
Product Name: N/A
Product Code: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Poland;Belgium;Germany
1736EUCTR2009-017379-90-IT
(EUCTR)
27/04/201031/03/2010Characterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - NDCharacterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - ND RA patients fulfilling the 1987 ACR criteria who discontinued a first antibody TNF-i (Infliximab or Adalimumab) because of secondary inefficacy
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
INN or Proposed INN: ETANERCEPTAZIENDA OSPEDALIERA SENESENULLNot RecruitingFemale: yes
Male: yes
Italy
1737EUCTR2009-014735-20-CZ
(EUCTR)
23/04/201012/11/2009A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH 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]
Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Hungary;Estonia;Czech Republic;Poland;Ukraine;Lithuania;Romania;Bulgaria;Russian Federation;Latvia;Japan
1738EUCTR2009-016987-34-CZ
(EUCTR)
23/04/201004/03/2010Phase 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 ArthritisPHASE 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 Moderate to severe active 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: Not applicable
Product Code: CP-690,550
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM
Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USANULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Philippines;Taiwan;Slovakia;Thailand;Spain;Costa Rica;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden
1739EUCTR2009-016987-34-ES
(EUCTR)
19/04/201012/02/2010Estudio 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 ARTHRITISEstudio 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
PFIZERNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Czech Republic;Hungary;Slovakia;Poland;Belgium;Spain;Bulgaria;Germany;Sweden
1740EUCTR2009-017438-32-HU
(EUCTR)
16/04/201024/02/2010A 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritisA 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritis active rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: VX-509
Product Code: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Hungary;Germany;Poland
1741EUCTR2009-011791-30-GB
(EUCTR)
14/04/201014/10/2009 A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: NNC151-0000
Product Code: NNC0151-0000-0000
Other descriptive name: Anti-C5aR
Novo Nordisk A/SNULLNot 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): noHungary;Czech Republic;Poland;Ukraine;Romania;Denmark;Russian Federation;Germany;United Kingdom
1742EUCTR2009-012118-27-BE
(EUCTR)
13/04/201023/02/2010A 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/AA 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 NVNULLNot RecruitingFemale: yes
Male: yes
95Phase 2Czech Republic;Spain;Belgium;Netherlands;United Kingdom
1743EUCTR2009-015835-34-IT
(EUCTR)
09/04/201029/03/2010VITAMIN D EFFECT ON T LYMPHOCYTES AND OSTEOCLASTOGENESIS IN RHEUMAOID ARTHRITIS - NDVITAMIN D EFFECT ON T LYMPHOCYTES AND OSTEOCLASTOGENESIS IN RHEUMAOID ARTHRITIS - ND Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid
Trade Name: DIBASE*IM OS 2F 1ML 300000UI/M
INN or Proposed INN: Colecalciferol
AZIENDA OSPEDALIERA ORDINE MAURIZIANONULLNot RecruitingFemale: yes
Male: no
Phase 3Italy
1744EUCTR2009-014296-40-AT
(EUCTR)
07/04/201029/12/2009PHASE 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 INHIBITORSPHASE 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 Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: tasocitinib (proposed INN)
Product Code: CP-690,550
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
396Phase 3United Kingdom;Germany;Belgium;France;Ireland;Spain;Italy;Austria
1745EUCTR2009-012055-19-BE
(EUCTR)
06/04/201002/03/2010A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritisA randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: GSK315234 Injection 100mg/mL
Product Code: GSK315234
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
45United Kingdom;Belgium;France;Ireland
1746EUCTR2009-016266-90-CZ
(EUCTR)
06/04/201022/12/2009A 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 - MOBILITYA 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 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 & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
1740Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Czech Republic;Hungary;Belgium;Romania;Germany;Netherlands
1747EUCTR2009-016987-34-BE
(EUCTR)
01/04/201011/02/2010Phase 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 ArthritisPHASE 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 Moderate to severe active 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: Not applicable
Product Code: CP-690,550
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM
Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USANULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Philippines;Taiwan;Slovakia;Thailand;Spain;Costa Rica;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden
1748EUCTR2009-011137-26-PL
(EUCTR)
01/04/201025/01/2010An 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). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Simponi
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece;Poland
1749NCT01067430
(ClinicalTrials.gov)
April 201010/2/2010Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA)Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis.Rheumatoid ArthritisDrug: Etoricoxib;Drug: DiclofenacNorthumbria Healthcare NHS Foundation TrustNULLWithdrawn18 YearsN/AAll0Phase 4United Kingdom
1750NCT01151644
(ClinicalTrials.gov)
April 201025/6/2010Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic DiseasesSafety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic DiseasesRheumatoid Arthritis;Spondyloarthritis;Systemic Lupus Erythematosus (SLE);Dermatomyositis (DM);DMixed Connective Tissue Disease;Systemic Vasculitis;Systemic Sclerosis (SSc);Sjögren's Syndrome;Antiphospholipid Syndrome;Juvenile Idiopathic Arthritis;Juvenile SLE;Juvenile DMBiological: Anti-pandemic H1N1 influenza vaccineUniversity of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloActive, not recruitingN/AN/ABoth5000Phase 4Brazil
1751NCT01313858
(ClinicalTrials.gov)
April 201010/3/2011A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing SpondylitisArthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, AnkylosingDrug: Simponi®;Drug: MethotrexateMerck Sharp & Dohme Corp.NULLCompleted18 YearsN/AAll1613N/AGermany
1752EUCTR2009-012566-32-HU
(EUCTR)
31/03/201020/11/2009A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Czech Republic;Hungary;Poland;Bulgaria;Latvia;United Kingdom
1753EUCTR2007-006657-63-HU
(EUCTR)
26/03/201015/02/2010Dose 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 FranceNULLNot RecruitingFemale: yes
Male: yes
186Phase 4Hungary;Finland;Denmark;Iceland;Sweden
1754EUCTR2009-015636-15-HU
(EUCTR)
25/03/201008/02/2010Rheumatoid arthritisAn Open-label Extension Study to Assess the Long-term Safety and Tolerability of ATN-103 in Subjects With Rheumatoid Arthritis 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]
Product Name: ATN-103
Product Code: ATN-103
Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer CompanyNULLNot RecruitingFemale: yes
Male: yes
260Hungary;Russian Federation;Germany;Canada;Switzerland;Belgium;Japan;United States;South Africa
1755EUCTR2009-014735-20-PL
(EUCTR)
23/03/201021/12/2009A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH 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]
Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Hungary;Estonia;Czech Republic;Poland;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Japan
1756EUCTR2009-016266-90-FI
(EUCTR)
23/03/201029/12/2009Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patientsA 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 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
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sar
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
1594Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand
1757EUCTR2009-011137-26-GR
(EUCTR)
22/03/201020/10/2009An 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). - GO-MORE Active Rheumatoid Arthritis
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
1758EUCTR2009-012759-12-HU
(EUCTR)
17/03/201025/01/2010A 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.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. Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1128Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
1759EUCTR2009-010582-23-IT
(EUCTR)
10/03/201008/01/2010A 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) - NDA 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
CENTOCORNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
1760EUCTR2007-006657-63-IS
(EUCTR)
10/03/201018/02/2010Study 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 KingdomNULLNot RecruitingFemale: yes
Male: yes
72Hungary;Finland;Iceland;Denmark;Norway;Sweden
1761EUCTR2009-015653-20-NL
(EUCTR)
08/03/201010/03/2010Prospective study on the effects of etanercept treatment in patients with rheumatoid arthritis who are naïve for TNF-alpha blocking therapy and patients who do not respond (anymore) to prior treatment with other anti-TNF-alpha medication - Not applicableProspective study on the effects of etanercept treatment in patients with rheumatoid arthritis who are naïve for TNF-alpha blocking therapy and patients who do not respond (anymore) to prior treatment with other anti-TNF-alpha medication - Not applicable rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: etanercept
Product Name: Etanercept
INN or Proposed INN: METHOTREXATE
Other descriptive name: methotrexate
NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
1762EUCTR2009-010516-15-PL
(EUCTR)
03/03/201021/08/2009Randomized, 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 MethotrexateRandomized, 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)
MedDRA version: 13.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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 Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer CompanyNULLNot RecruitingFemale: yes
Male: yes
200Hungary;Greece;Spain;Poland
1763EUCTR2009-016266-90-HU
(EUCTR)
03/03/201030/12/2009Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patientsA 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 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
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
1594Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand
1764EUCTR2009-016266-90-EE
(EUCTR)
02/03/201005/01/2010Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patientsA 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 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
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sar
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
1594Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Romania;Germany;New Zealand
1765EUCTR2009-011137-26-PT
(EUCTR)
01/03/201009/12/2009An 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). - GO-MOREAn 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). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1766NCT01034397
(ClinicalTrials.gov)
March 201016/12/2009A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDsA Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy of Tocilizumab+Non-biological DMARD in Reducing Synovitis as Measured by MRI at 12 Weeks After Initiation of Treatment in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Non-biological DMARDsRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: placebo;Drug: non-biological DMARDsHoffmann-La RocheNULLCompleted18 YearsN/AAll54Phase 4Portugal
1767NCT02010216
(ClinicalTrials.gov)
March 20104/12/2013A Study of RoActemra/Actemra (Tocilizumab) in Adult Patients With Rheumatoid Arthritis (SVOBODA Programme)Non-Randomized Phase IV Trial on Efficacy and Safety of Actemra in the Treatment of Adult Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll23Phase 4Kazakhstan
1768NCT01063062
(ClinicalTrials.gov)
February 28, 20103/2/2010A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)A Single-arm, Open-label, Multicenter Study of Tocilizumab Monotherapy or in Combination With Methotrexate to Assess Safety and the Efficacy in Reducing Disease Activity in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs (PICTURE)Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: MethotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll107Phase 3Egypt
1769EUCTR2009-011137-26-CZ
(EUCTR)
26/02/201013/10/2009An 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). - GO-MORE Active 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: Simponi
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
1770EUCTR2009-011137-26-AT
(EUCTR)
25/02/201004/09/2009An 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). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Simponi
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
1771EUCTR2006-005330-20-CZ
(EUCTR)
19/02/201019/04/2007anti TNF-IR phase IIIA randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. Rheumatoid arthritis
MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3France;Hungary;Czech Republic;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
1772EUCTR2009-014735-20-LT
(EUCTR)
18/02/201025/11/2009A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH 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]
Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Hungary;Estonia;Czech Republic;Poland;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Japan
1773EUCTR2009-011137-26-IT
(EUCTR)
15/02/201002/10/2009An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-na?ve 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). - GO -MORE Active Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073
Product Name: Golimumab
Product Code: SCH900259
Product Name: Golimumab
Product Code: SCH 900259
Shering Plough Research Institute, A division of Schering Plough CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
1774EUCTR2009-010582-23-BE
(EUCTR)
10/02/201023/09/2009Golimumab 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.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
1775EUCTR2009-014296-40-BE
(EUCTR)
10/02/201008/10/2009PHASE 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 INHIBITORSPHASE 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 Rheumatoid arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Code: CP-690,550Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
396Phase 3United States;Tanzania, United Republic of;Taiwan;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Brazil;Australia;Germany;Korea, Republic of;Sweden
1776EUCTR2007-006129-29-NL
(EUCTR)
10/02/201018/08/2009A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritisA multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis - MOR103 Rheumatoid Arthritis PoC Study Rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: MOR103
Product Code: MOR103
Other descriptive name: Human Recombinant IgG1, lambda
MorphoSys AGNULLNot RecruitingFemale: yes
Male: yes
89Germany;Ukraine;Belarus;Netherlands;Bulgaria;Poland
1777EUCTR2009-016987-34-SE
(EUCTR)
09/02/201023/12/2009.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 Moderate to severe active 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 Code: CP-690,550
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Philippines;Taiwan;Slovakia;Thailand;Costa Rica;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Australia;Peru;Korea, Republic of;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden
1778EUCTR2007-000830-38-PL
(EUCTR)
08/02/201005/01/2010A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Cimzia®
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3France;Poland;Austria;Germany;Italy
1779EUCTR2009-012566-32-CZ
(EUCTR)
05/02/201001/10/2009A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
240Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland
1780EUCTR2008-007185-33-BE
(EUCTR)
01/02/201010/09/2009A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexateA Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ATN-103
Product Code: ATN-103
Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer CompanyNULLNot RecruitingFemale: yes
Male: yes
240Phase 1/2Hungary;United Kingdom;Germany;Netherlands;Belgium
1781NCT01038674
(ClinicalTrials.gov)
February 201022/12/2009Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid ArthritisA Randomised, Double Blind, Placebo-controlled, Multiple Dose, Dose-escalation, Phase 1 Trial of Anti-IL-20 in Subjects With Rheumatoid ArthritisInflammation;Rheumatoid ArthritisDrug: anti-IL-20;Drug: placeboNovo Nordisk A/SNULLCompleted18 Years75 YearsAll16Phase 1Belgium;Poland
1782EUCTR2009-012759-12-IE
(EUCTR)
26/01/201005/11/2009A 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.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. 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: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1128Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
1783EUCTR2009-014735-20-HU
(EUCTR)
25/01/201002/11/2009A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid ArthritisA Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CAM-3001
Product Code: CAM-3001
Other descriptive name: anti-GM-CSF receptor alpha
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
216Phase 2Czech Republic;Estonia;Hungary;Poland;Lithuania;Bulgaria
1784EUCTR2007-006129-29-BG
(EUCTR)
21/01/201026/10/2009A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritisA multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis - MOR103 Rheumatoid Arthritis PoC Study Rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: MOR103
Product Code: MOR103
Other descriptive name: Human Recombinant IgG1, lambda
MorphoSys AGNULLNot RecruitingFemale: yes
Male: yes
89Belarus;Poland;Ukraine;Bulgaria;Netherlands;Germany
1785EUCTR2008-006064-11-HU
(EUCTR)
20/01/201027/10/2009A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
564Hungary;Lithuania
1786EUCTR2009-011137-26-BE
(EUCTR)
18/01/201019/10/2009An 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). - GO-MOREAn 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). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Simponi
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Phase 3Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1787EUCTR2009-012759-12-SE
(EUCTR)
12/01/201017/11/2009A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.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. - FUNCTION 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®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3Portugal;United States;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Peru;Australia;Denmark;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Germany;New Zealand;Sweden
1788EUCTR2009-012759-12-PT
(EUCTR)
12/01/201021/10/2009A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.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. - FUNCTION 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®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3Portugal;United States;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Peru;Australia;Denmark;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Germany;New Zealand;Sweden
1789EUCTR2008-007185-33-DE
(EUCTR)
12/01/201002/09/2009A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexateA Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ATN-103
Product Code: ATN-103
Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer CompanyNULLNot RecruitingFemale: yes
Male: yes
240Phase 1/2Hungary;United Kingdom;Germany;Netherlands;Belgium
1790EUCTR2009-014296-40-FR
(EUCTR)
11/01/201019/11/2009PHASE 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 INHIBITORSPHASE 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 Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
396Phase 3France;Belgium;Spain;Ireland;Austria;Germany;United Kingdom;Italy
1791EUCTR2006-005035-19-IE
(EUCTR)
06/01/201007/10/2009A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4500Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
1792EUCTR2009-014296-40-IE
(EUCTR)
06/01/201006/10/2009PHASE 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 INHIBITORSPHASE 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 Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
396Phase 3United Kingdom;Germany;Belgium;France;Spain;Ireland;Italy;Austria
1793EUCTR2009-014296-40-GB
(EUCTR)
05/01/201020/10/2010PHASE 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 INHIBITORSPHASE 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 Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
396Phase 3Germany;United Kingdom;Belgium;France;Ireland;Spain;Italy;Austria
1794EUCTR2009-010582-23-DE
(EUCTR)
04/01/201022/09/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
1795NCT02731560
(ClinicalTrials.gov)
January 20106/3/2016Rituximab (RTX) for Disease Modifying Anti Rheumatic Drug (DMARD) Non-responders in Pakistan: The Pakistan Rituximab Study (PARIS)Efficacy and Safety of Rituximab in Pakistani Patients With Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: RituximabProf. Abid Z. FarooqiAga Khan University;Fatima Memorial Hospital;Fauji Foundation Hospital, RawalpindiCompleted18 Years80 YearsBoth74Phase 4NULL
1796NCT01039688
(ClinicalTrials.gov)
January 201023/12/2009Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTXPhase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid ArthritisArthritis, RheumatoidDrug: CP-690,550;Drug: Disease-modifying antirheumatic drugPfizerNULLCompleted18 Years99 YearsAll956Phase 3United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;Colombia;Costa Rica;Czechia;Dominican Republic;Germany;Hungary;India;Korea, Republic of;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Puerto Rico;Russian Federation;Slovakia;Spain;Sweden;Taiwan;Thailand;Ukraine;Czech Republic
1797NCT01071798
(ClinicalTrials.gov)
January 201018/2/2010An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid ArthritisA Prospective, Multi-center, Non-interventional Observational Study to Evaluate the Safety and Effectiveness of MabThera® (Rituximab) Within the First 6 Months (in Case of Re-therapy the First 12 Months) of Treatment in Patients With Severe Active Rheumatoid Arthritis in Routine CareRheumatoid ArthritisDrug: RituximabHoffmann-La RocheNULLCompleted18 YearsN/AAll1653N/AGermany;United States
1798NCT01089023
(ClinicalTrials.gov)
January 20108/3/2010A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid ArthritisMulticenter, Open-Label Study to Evaluate the Safety, Tolerability and the Effect on Disease Activity 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.Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll95Phase 4Bahrain;Iran, Islamic Republic of;Kuwait;Qatar;United Arab Emirates
1799EUCTR2009-010582-23-GB
(EUCTR)
31/12/200928/06/2010Golimumab 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.NULLNot 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): noGreece;Belgium;Austria;Germany;Italy;United Kingdom;Sweden
1800EUCTR2009-011268-13-GB
(EUCTR)
31/12/200915/03/2010Optimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT studyOptimal 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 ClydeUniversity of GlasgowNot RecruitingFemale: yes
Male: yes
United Kingdom
1801EUCTR2008-006064-11-LT
(EUCTR)
30/12/200919/10/2009An Efficacy and Safety Study of intravenous Golimumab in patients with Active Rheumatoid Arthritis (RA) despite treatment with methotrexate, non steroidal pain medications and/or corticosteroidsA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy 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] - Immune System Diseases [C20]
Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
564United States;Ukraine;Lithuania;Korea, Republic of;New Zealand;Australia;Poland;Malaysia;Argentina;Mexico;Hungary;Colombia;Russian Federation
1802EUCTR2009-014735-20-LV
(EUCTR)
29/12/200921/10/2009A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH 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]
Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Hungary;Estonia;Czech Republic;Poland;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Japan
1803EUCTR2009-012566-32-LV
(EUCTR)
29/12/200930/10/2009A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
240Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland
1804EUCTR2009-014735-20-EE
(EUCTR)
29/12/200927/10/2009A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH 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]
Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha
MedImmune LtdNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Hungary;Czech Republic;Estonia;Poland;Ukraine;Lithuania;Romania;Bulgaria;Russian Federation;Latvia;Japan
1805EUCTR2009-012759-12-FI
(EUCTR)
21/12/200928/09/2009A 2 year, global, randomized, phase III clinical trial stuying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with methotrexate and methotrexate only, in patients with early, moderate to severe rheumatoid arthritis.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. - FUNCTION 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®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3United States;Portugal;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Peru;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Germany;New Zealand;Sweden
1806EUCTR2009-011137-26-IE
(EUCTR)
21/12/200915/09/2009An 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). - GO-MOREAn 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). - GO-MORE Active Rheumatoid Arthritis
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1807EUCTR2009-012566-32-PL
(EUCTR)
17/12/200909/11/2009A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
240Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland
1808EUCTR2009-010582-23-SE
(EUCTR)
16/12/200923/10/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
1809EUCTR2008-002623-85-DE
(EUCTR)
16/12/200912/06/2009Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid ArthritisA 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,USANULLNot RecruitingFemale: yes
Male: yes
300Poland;Romania;Germany;Netherlands;Sweden;Qatar;Spain;Ireland;Russian Federation;Switzerland;United Kingdom;Italy;France
1810EUCTR2009-012204-42-BE
(EUCTR)
16/12/200928/09/2009A 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 arthritisA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
50Belgium;Ireland
1811EUCTR2009-011137-26-FR
(EUCTR)
15/12/200910/09/2009An 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). - GO-MOREAn 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). - GO-MORE Active Rheumatoid Arthritis
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 CorporationNULLNot 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): noPortugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1812EUCTR2009-012759-12-DK
(EUCTR)
07/12/200903/11/2009A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.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. - FUNCTION 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®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3Portugal;United States;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Peru;Denmark;Australia;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Germany;New Zealand;Sweden
1813EUCTR2009-011137-26-DK
(EUCTR)
07/12/200902/11/2009An 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). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Simponi
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece;Poland
1814EUCTR2008-004894-16-HU
(EUCTR)
03/12/200917/11/2008Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and Company limitedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Czech Republic;Hungary;Poland;Germany
1815EUCTR2009-012566-32-GB
(EUCTR)
02/12/200902/08/2010A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
240Hungary;Czech Republic;United Kingdom;Bulgaria;Latvia;Poland
1816EUCTR2009-011137-26-NL
(EUCTR)
02/12/200931/08/2009An 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). - GO-MORE Active Rheumatoid Arthritis
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
1817EUCTR2009-012759-12-ES
(EUCTR)
01/12/200923/09/2009Estudio 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.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
1818NCT01044498
(ClinicalTrials.gov)
December 20097/1/2010A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid ArthritisAn Open-label, Multi-center, One Sequence Cross-over Drug Interaction Study to Investigate the Effect of Tocilizumab (TCZ, RO4877533) on the Pharmacokinetics and Pharmacodynamics of an Oral Contraceptive (OC) in Female Patients With Active Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: Tocilizumab;Drug: Ortho-Novum® 1/35Hoffmann-La RocheNULLCompleted18 Years44 YearsFemale46Phase 3United States
1819EUCTR2009-016055-22-FI
(EUCTR)
27/11/200909/10/2009Immuunipuutteisten matkailijoiden A-hepatiittisuojausImmuunipuutteisten matkailijoiden A-hepatiittisuojaus Terveet vapaaehtoiset ja vapaaehtoiset potilaat, joilla on diagnosoitu nivelreuma.
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Epaxal
Product Name: Epaxal
HY, HUSNULLNot RecruitingFemale: yes
Male: yes
Finland;Sweden
1820EUCTR2009-012424-87-GB
(EUCTR)
26/11/200914/10/2009T 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 TNFT 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 LondonNULLNot 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): yesUnited Kingdom
1821EUCTR2009-010582-23-AT
(EUCTR)
26/11/200912/10/2009Golimumab 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.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
1822EUCTR2008-007185-33-GB
(EUCTR)
26/11/200928/07/2010A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexateA Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ATN-103
Product Code: ATN-103
Wyeth Pharmaceuticals Inc., Acting through its division Wyeth Research, a Pfizer CompanyNULLNot RecruitingFemale: yes
Male: yes
240Phase 1/2Hungary;Germany;United Kingdom;Netherlands;Belgium
1823EUCTR2009-013223-37-ES
(EUCTR)
25/11/200917/09/2009Estudio 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 ARTHRITISEstudio 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.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2Hungary;Czech Republic;Spain
1824EUCTR2009-009696-34-DE
(EUCTR)
23/11/200914/05/2009A Study in Patients with Rheumatoid ArthritisA Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients with Active Rheumatoid Arthritis on Concomitant DMARD Therapy 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: LY2439821
Product Code: LY2439821
INN or Proposed INN: N.A.
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
648Phase 2India;Russian Federation;Germany;Peru;Taiwan;Argentina;Romania;Korea, Republic of;Chile;Poland
1825EUCTR2009-012185-32-IT
(EUCTR)
23/11/200925/06/2009Open label, multicentric phase IIIb study to evaluate the effect of tocilizumab in combination with DMARDs in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by dedicated magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis (RA) - NDOpen label, multicentric phase IIIb study to evaluate the effect of tocilizumab in combination with DMARDs in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by dedicated magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis (RA) - ND Moderate to severe active rheumatoid arthritis (RA), who are inadequate responders to DMARDs.
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Tocilizumab
Product Code: Ro487-7533
INN or Proposed INN: RoActemra
ROCHENULLNot RecruitingFemale: yes
Male: yes
Phase 3Italy
1826EUCTR2009-014296-40-ES
(EUCTR)
20/11/200924/09/2009PHASE 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-690,550Pfizer S.A.NULLNot RecruitingFemale: yes
Male: yes
396Phase 3France;Belgium;Spain;Ireland;Austria;Germany;United Kingdom;Italy
1827EUCTR2009-012204-42-IE
(EUCTR)
13/11/200909/09/2009A 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 arthritisA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
50Belgium;Ireland
1828EUCTR2009-012759-12-DE
(EUCTR)
13/11/200925/08/2009A 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.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. Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1128Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
1829EUCTR2009-012759-12-FR
(EUCTR)
13/11/200909/10/2009A 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.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. Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
1830EUCTR2009-012759-12-IT
(EUCTR)
12/11/200917/11/2009A 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. - ND 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. - ND Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
Trade Name: Methotrexate ``Lederle`` 2.5mg tablets
INN or Proposed INN: Methotrexate
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Denmark;Germany;Sweden
1831EUCTR2009-014296-40-DE
(EUCTR)
12/11/200927/08/2009PHASE 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 INHIBITORSPHASE 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 Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: not applicable
Product Code: CP-690,550
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
396Phase 3France;Belgium;Spain;Ireland;Austria;Germany;United Kingdom;Italy
1832EUCTR2008-006924-68-HU
(EUCTR)
11/11/200902/09/2009Extension 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. - this is an extension study to MA21573Extension 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. - this is an extension study to MA21573 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200Portugal;Hungary;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
1833EUCTR2009-011137-26-SK
(EUCTR)
11/11/200919/11/2009An 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). - GO-MOREAn 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). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Phase 3Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1834EUCTR2009-013223-37-CZ
(EUCTR)
10/11/200917/08/2009A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITISA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS Rheumatoid Arthritis
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
INN or Proposed INN: Prednisone
Other descriptive name: Decortin®
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2Hungary;Czech Republic;Spain
1835EUCTR2009-013316-12-NL
(EUCTR)
10/11/200921/10/2009A multi-center, randomized, double blind, placebo controlled study to evaluate remission in DMARD and biological naïve early reumatoid arthritis (RA) subjects treated with tocilizumab (TCZ) plus tight control methotrexate (MTX) treatment, TCZ monotherapy or tight control MTX monotherapy. - U-Act-EarlyA multi-center, randomized, double blind, placebo controlled study to evaluate remission in DMARD and biological naïve early reumatoid arthritis (RA) subjects treated with tocilizumab (TCZ) plus tight control methotrexate (MTX) treatment, TCZ monotherapy or tight control MTX monotherapy. - U-Act-Early Rheumatoid Arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: RoActemra
Trade Name: Methotrexate 'Lederle' 2,5mg tablets
Roche Nederland B.V.NULLNot RecruitingFemale: yes
Male: yes
Netherlands
1836EUCTR2008-002623-85-IE
(EUCTR)
06/11/200915/09/2009Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid ArthritisA 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,USANULLNot RecruitingFemale: yes
Male: yes
300Qatar;Spain;Ireland;Russian Federation;Switzerland;United Kingdom;Italy;France;Poland;Romania;Germany;Netherlands;Sweden
1837EUCTR2007-003288-36-GB
(EUCTR)
04/11/200903/10/2008A 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) - RESTARTA 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 BVNULLNot 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): yesFrance;Finland;Spain;Austria;Germany;Netherlands;United Kingdom
1838EUCTR2009-014824-40-CZ
(EUCTR)
03/11/200903/09/2009An open label follow on study to evaluate the long-term safety, tolerability and efficacy of ART621 following fortnightly administration for 48 weeks in patients with rheumatoid arthritis concomitantly taking methotrexate.An open label follow on study to evaluate the long-term safety, tolerability and efficacy of ART621 following fortnightly administration for 48 weeks in patients with rheumatoid arthritis concomitantly taking methotrexate. Rheumatoid arthritisProduct Code: ART621Arana Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic
1839EUCTR2007-006129-29-DE
(EUCTR)
03/11/200916/06/2009A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritisA multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis - MOR103 Rheumatoid Arthritis PoC Study Rheumatoid arthritis
MedDRA version: 13.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: MOR103
Product Code: MOR103
Other descriptive name: Human Recombinant IgG1, lambda
MorphoSys AGNULLNot RecruitingFemale: yes
Male: yes
89Poland;Ukraine;Bulgaria;Netherlands;Germany
1840JPRN-UMIN000002687
2009/11/0116/11/2009ENBREL Clinical Outcome in RA patients for Growing Evidence rheumatoid arthritisMTX/MTX+DMARDs group
MTX+ETN group
ETN continuation group
ETN discontinuation group
TAP CorporationNULLComplete: follow-up complete20years-oldNot applicableMale and Female330Not applicableJapan,Asia(except Japan)
1841JPRN-UMIN000002744
2009/11/0110/11/2009Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuation rheumatoid arthritistocilizumab plus methotrexate
tocilizumab
Keio UniversityNULLComplete: follow-up complete20years-old75years-oldMale and Female300Not selectedJapan
1842NCT00976599
(ClinicalTrials.gov)
November 200911/9/2009A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid ArthritisAn Exploratory Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Pharmacodynamics Of CP-690,550, Administered Orally Twice Daily (BID) For 4 Weeks, In Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: CP-690,550 + methotrexate;Drug: Placebo + MethotrexatePfizerNULLCompleted18 YearsN/AAll29Phase 2United States
1843NCT01006681
(ClinicalTrials.gov)
November 200931/10/2009Vaccination Against Influenza H1N1 in Rheumatic DiseasesEfficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Immunomodulatory DrugsInfluenza;Rheumatic DiseasesBiological: Focetria (Monovalent MF59-Adjuvanted vaccine)Tel-Aviv Sourasky Medical CenterNULLNot yet recruiting18 Years65 YearsBoth400Phase 2NULL
1844NCT01010581
(ClinicalTrials.gov)
November 20099/11/2009SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid ArthritisA Randomized, Double Blind, Placebo-Controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: SC12267 (4SC-101);Drug: Placebo;Drug: Methotrexate;Drug: Folic Acid4SC AGNULLCompleted18 YearsN/ABoth266Phase 2Bulgaria;Czech Republic;Poland;Romania
1845NCT01007175
(ClinicalTrials.gov)
November 20092/11/2009Study Evaluating Multiple Ascending Doses Of ATN-103 In Japanese Subjects With Rheumatoid ArthritisA Randomized, Multicenter, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Clinical Efficacy Of ATN-103 Administered To Japanese Subjects With Active Rheumatoid Arthritis On A Background Of MethotrexateRheumatoid ArthritisBiological: ATN-103 10 mg q4wks;Biological: ATN-103 30 mg q4wks;Biological: ATN-103 80 mg q4wks;Biological: ATN-103 10 mg q8wks;Biological: ATN-103 80 mg q8wksAblynxNULLCompleted20 Years75 YearsBoth60Phase 1/Phase 2Japan
1846NCT00844714
(ClinicalTrials.gov)
November 200912/2/2009Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab TherapyCardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab TherapyEndothelial Function;Rheumatoid Arthritis;InflammationDrug: RituxanUniversity of California, San FranciscoGenentech, Inc.Completed18 YearsN/AAll20N/AUnited States
1847NCT01009879
(ClinicalTrials.gov)
November 20095/11/2009Human Tumor Necrosis Factor Alpha (TNFa)-Induced Pre-B Cell Bone Marrow EmigrantsHuman TNFa-Induced Pre-B Cell Bone Marrow EmigrantsRheumatoid ArthritisDrug: EtanerceptUniversity of PittsburghAmgenWithdrawn18 YearsN/ABoth0Phase 4United States
1848NCT01173120
(ClinicalTrials.gov)
November 200928/7/2010Methotrexate - Inadequate Response Device Sub-StudySub-study-A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to MethotrexateRheumatoid Arthritis (RA)Device: Abatacept combination product (ACP)Bristol-Myers SquibbNULLCompleted18 YearsN/AAll62Phase 3NULL
1849EUCTR2009-012118-27-NL
(EUCTR)
27/10/200927/05/2009A 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 SubstudyA 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 NVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Czech Republic;United Kingdom;Netherlands;Spain
1850EUCTR2009-011137-26-ES
(EUCTR)
23/10/200906/08/2009 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 CorporationNULLNot 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): noPortugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1851EUCTR2009-011137-26-FI
(EUCTR)
22/10/200925/08/2009An 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). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Simponi
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
1852EUCTR2009-011137-26-HU
(EUCTR)
19/10/200902/09/2009An 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). - GO-MORE Active Rheumatoid Arthritis
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
1853EUCTR2009-011137-26-GB
(EUCTR)
19/10/200918/10/2010An 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). - GO-MOREAn 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). - GO-MORE Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Simponi
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 CorporationNULLNot 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): noPortugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1854EUCTR2009-012953-39-PL
(EUCTR)
19/10/200931/07/2009A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid ArthritisA Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: SC12267
Product Code: SC12267
Trade Name: Metex 2,5mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Metex 7,5mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Metex 10mg Tabletten
INN or Proposed INN: METHOTREXATE
4SC AGNULLNot RecruitingFemale: yes
Male: yes
244Phase 2Czech Republic;Bulgaria;Poland
1855EUCTR2009-012705-19-CZ
(EUCTR)
16/10/200917/07/2009A 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 - LX3305.201A 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:
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.NULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Czech Republic;Bulgaria
1856EUCTR2008-007185-33-HU
(EUCTR)
16/10/200909/09/2009A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexateA Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ATN-103
Product Code: ATN-103
Wyeth Research Division of Wyeth Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 1/2Hungary;United Kingdom;Germany;Netherlands;Belgium
1857EUCTR2009-013223-37-HU
(EUCTR)
16/10/200902/09/2009A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITISA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS Rheumatoid Arthritis
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
INN or Proposed INN: Prednisone
Other descriptive name: Decortin®
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
119Phase 2Hungary;Spain
1858EUCTR2009-012759-12-GB
(EUCTR)
14/10/200917/08/2009A 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.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. Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
F. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
1128 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
1859EUCTR2009-014394-41-DK
(EUCTR)
12/10/200923/09/2009Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers.Whole-Body MRI in Rheumatoid Arthritis Protocol (WRAP)Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers.Whole-Body MRI in Rheumatoid Arthritis Protocol (WRAP) Reumatoid artritis
MedDRA version: 12.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid
Trade Name: Humira
Product Name: Humira
Product Code: Adalimummab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Adalimumab
Hvidovre HospitalNULLNot RecruitingFemale: yes
Male: yes
Phase 4Denmark
1860EUCTR2009-012218-30-PT
(EUCTR)
06/10/200912/08/2009A randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 weeks after initiation of treatment in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to non-biological DMARDs - PORTRAITA randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 weeks after initiation of treatment in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to non-biological DMARDs - PORTRAIT Men and women > 18 years of age with RA who are currently experiencing an inadequate clinical response to a stable dose of non-biologic DMARDs (at least 12 weeks) and with MRI documented synovitis of dominant hand.Trade Name: RoActemraRoche Farmacêutica Química, Lda.NULLNot RecruitingFemale: yes
Male: yes
Portugal
1861EUCTR2009-011137-26-DE
(EUCTR)
05/10/200903/08/2009An 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). - GO-MOREAn 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). - GO-MORE Active 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: Simponi
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
3150Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1862EUCTR2008-002623-85-GB
(EUCTR)
01/10/200917/08/2009Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid ArthritisA 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)NULLNot 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): yesQatar;Spain;Ireland;Russian Federation;United Kingdom;Switzerland;Italy;France;Poland;Romania;Germany;Netherlands;Sweden
1863EUCTR2009-011000-34-DE
(EUCTR)
30/09/200909/06/2009A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexateA 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate Moderate to severe Rheumatoid Arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: AIN457
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200Hungary;Slovakia;Czech Republic;Germany
1864EUCTR2009-012705-19-BG
(EUCTR)
29/09/200906/10/2009A 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 - LX3305.201A 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:
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.NULLNot RecruitingFemale: yes
Male: yes
104Phase 2Hungary;Czech Republic;Bulgaria
1865EUCTR2009-012118-27-ES
(EUCTR)
28/09/200903/07/2009A 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 sinovialA 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 NVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Czech Republic;United Kingdom;Netherlands;Spain
1866EUCTR2006-006373-25-FI
(EUCTR)
21/09/200916/06/2009A 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-690,550Pfizer Inc. 235 East 42nd Street, New York, NY10017NULLNot RecruitingFemale: yes
Male: yes
300Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
1867EUCTR2006-005035-19-FI
(EUCTR)
21/09/200915/06/2009A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4500Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
1868EUCTR2009-012759-12-AT
(EUCTR)
14/09/200921/08/2009A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.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. - FUNCTION 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®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3United States;Portugal;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Peru;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Germany;New Zealand;Sweden
1869EUCTR2009-012953-39-BG
(EUCTR)
11/09/200918/09/2009A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid ArthritisA Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: SC12267
Product Code: SC12267
INN or Proposed INN: Vidofludimus
Trade Name: Metex 2,5mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Metex 7,5mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Metex 10mg Tabletten
INN or Proposed INN: METHOTREXATE
4SC AGNULLNot RecruitingFemale: yes
Male: yes
244Phase 2Czech Republic;Bulgaria;Poland
1870EUCTR2008-001847-20-DE
(EUCTR)
08/09/200903/06/2009Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexateRandomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY 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: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
F Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
470United States;Serbia;Estonia;Greece;Thailand;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Brazil;Croatia;Romania;Denmark;Germany;Latvia;Netherlands;Norway;Sweden
1871EUCTR2009-012118-27-GB
(EUCTR)
04/09/200918/06/2009A 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 SubstudyA 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 NVNULLNot RecruitingFemale: yes
Male: yes
95Phase 2Czech Republic;United Kingdom;Netherlands;Spain
1872EUCTR2009-012118-27-CZ
(EUCTR)
04/09/200925/06/2009A 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 SubstudyA 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 NVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2United Kingdom;Czech Republic;Netherlands;Spain
1873EUCTR2006-006373-25-GB
(EUCTR)
03/09/200916/11/2010A 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/AA 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-690,550Pfizer Inc. 235 East 42nd Street, New York, NY10017NULLNot 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): noCzech Republic;Slovakia;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden
1874EUCTR2006-005035-19-GB
(EUCTR)
03/09/200927/04/2009 A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
4500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
1875EUCTR2009-012953-39-CZ
(EUCTR)
02/09/200903/07/2009A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid ArthritisA Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: SC12267
Product Code: SC12267
Trade Name: Metex 2,5mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Metex 7,5mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Metex 10mg Tabletten
INN or Proposed INN: METHOTREXATE
4SC AGNULLNot RecruitingFemale: yes
Male: yes
244Phase 2Czech Republic;Bulgaria;Poland
1876EUCTR2009-011000-34-SK
(EUCTR)
02/09/200909/09/2009A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201 Moderate to severe Rheumatoid Arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AIN457
Product Code: AIN457
INN or Proposed INN: not available
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200Hungary;Czech Republic;Germany;Slovakia
1877NCT00984815
(ClinicalTrials.gov)
September 200923/9/2009Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug TreatmentOpen-Label Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-Steroidal Anti-Inflammatory Drug TreatmentOsteoarthritis;Rheumatoid Arthritis;Chronic Low Back Pain;Chronic Regional Pain Syndrome;Chronic Soft Tissue PainDrug: HZT-501Horizon Pharma Ireland, Ltd., Dublin IrelandNULLCompleted40 Years80 YearsAll86Phase 3United States
1878NCT01075477
(ClinicalTrials.gov)
September 200924/2/2010An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment GuidelinesRheumatoid ArthritisDrug: rituximab [Mabthera/Rituxan]Hoffmann-La RocheNULLCompleted18 YearsN/ABoth151N/AFinland;United States
1879EUCTR2009-010813-57-DE
(EUCTR)
28/08/200924/06/2009A multicenter, randomized, double-blind, placebo-controlled, single dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of intravenous and subcutaneous CDP6038 in male and female subjects with rheumatoid arthritis on a stable dose of methotrexate.A multicenter, randomized, double-blind, placebo-controlled, single dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of intravenous and subcutaneous CDP6038 in male and female subjects with rheumatoid arthritis on a stable dose of methotrexate. Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CDP6038
Product Code: CDP6038
Other descriptive name: recombinant human Mab of IgG4 subtype
Product Name: CDP6038
Product Code: CDP6038
Other descriptive name: recombinant human Mab of IgG4 subtype
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
72Germany
1880EUCTR2009-011000-34-HU
(EUCTR)
27/08/200920/07/2009A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201 Moderate to severe Rheumatoid Arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AIN457
Product Code: AIN457
INN or Proposed INN: not available
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200Hungary;Slovakia;Czech Republic;Germany
1881EUCTR2008-006936-37-BE
(EUCTR)
24/08/200908/04/2009A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of MethotrexateA Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate Rheumatoid Arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ILV-094
Product Code: ILV-094
Other descriptive name: Recombinant human anti IL-22 monoclonal antibody IgG1
Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and DevelopmentNULLNot RecruitingFemale: yes
Male: yes
180Phase 2Hungary;Belgium;Netherlands;Germany
1882EUCTR2009-011206-42-CZ
(EUCTR)
18/08/200905/06/2009A Randomized, Double Blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients with Active Rheumatoid Arthritis with Inadequate Response to Any Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy including BiologicsA Randomized, Double Blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients with Active Rheumatoid Arthritis with Inadequate Response to Any Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy including Biologics Active Rheumatoid Arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: INCB028050 phosphate
Product Code: INCB028050
Other descriptive name: INCB028050 phosphate salt
Product Name: INCB028050 phosphate
Product Code: INCB028050
Other descriptive name: INCB028050 phosphate salt
Product Name: INCB028050 phosphate
Product Code: INCB028050
Other descriptive name: INCB028050 phosphate salt
Incyte CorporationNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Czech Republic
1883EUCTR2009-011000-34-CZ
(EUCTR)
18/08/200915/06/2009A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201 Moderate to severe Rheumatoid Arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AIN457
Product Code: AIN457
INN or Proposed INN: not available
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200Hungary;Slovakia;Germany;Czech Republic
1884EUCTR2008-002623-85-FR
(EUCTR)
18/08/200904/06/2009A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATEA 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
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
Trade Name: Methotrexate Sodium tablets 2.5mg
Product Name: Methotrexate
INN or Proposed INN: methotrexate
Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and DevelopmentNULLNot RecruitingFemale: yes
Male: yes
300Phase 4France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
1885EUCTR2009-012705-19-HU
(EUCTR)
17/08/200916/07/2009A 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 - LX3305.201A 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:
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.NULLNot RecruitingFemale: yes
Male: yes
104Phase 2Hungary;Czech Republic;Bulgaria
1886EUCTR2009-010516-15-HU
(EUCTR)
14/08/200914/07/2009Randomized, 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 MethotrexateRandomized, 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)
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.NULLNot RecruitingFemale: yes
Male: yes
200Hungary;Greece;Poland;Spain
1887EUCTR2009-011000-34-BE
(EUCTR)
14/08/200922/07/2009A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201 Moderate to severe Rheumatoid Arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AIN457
Product Code: AIN457
INN or Proposed INN: not available
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200Hungary;Czech Republic;Slovakia;Belgium;Germany
1888EUCTR2008-008338-35-FI
(EUCTR)
13/08/200914/05/2009PHASE 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 METHOTREXATEPHASE 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 METHOTREXATE CP 690,550 is 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
Product Name: Humira
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain
1889EUCTR2006-005035-19-DK
(EUCTR)
11/08/200923/06/2009A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate( Phase III formulation)
Product Code: CP-690,550-10
Product Name: Tofacitinib citrate (Proposed commercial formulation debossed)
Product Code: CP-690,550-10
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4500Phase 2;Phase 3Portugal;United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
1890EUCTR2008-006936-37-DE
(EUCTR)
03/08/200916/04/2009A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of MethotrexateA Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate Rheumatoid Arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ILV-094
Product Code: ILV-094
Other descriptive name: Recombinant human anti IL-22 monoclonal antibody IgG1
Wyeth Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer companyNULLNot RecruitingFemale: yes
Male: yes
180Hungary;Germany;Netherlands;Belgium
1891NCT03681639
(ClinicalTrials.gov)
August 1, 200913/9/2018Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral ComponentA Multi-Centre, Prospective Study to Obtain Survival and Clinical Outcome Data on the Zimmer Hip Resurfacing System Utilising the Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral ComponentAvascular Necrosis of Hip;Osteoarthritis, Hip;Rheumatoid Arthritis;Inflammatory Arthritis;Post-traumatic; ArthrosisDiagnostic Test: Serum Metal ion levels determined to monitor changes in chromium and cobalt levelsZimmer BiometNULLActive, not recruiting18 Years65 YearsAll225N/AGermany
1892JPRN-UMIN000002340
2009/08/0120/08/2009Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET) Rheumatoid ArthritisTreatment with higher dosages of infliximab (3-10 mg/Kg)
Every 2 months
Follow-up to 54 weeks
Treatment with one of other biologics (etanercept, adalimumab, tocilizumab) in standard protocol
Follow-up to 54 weeks
Department of Rheumatosurgery, Osaka City University Medical SchoolNULLComplete: follow-up complete20years-oldNot applicableMale and Female60Phase 4Japan
1893NCT01224041
(ClinicalTrials.gov)
August 200918/10/2010Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to MethotrexateClinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 StudyRheumatoid ArthritisDrug: TacrolimusAstellas Pharma IncAstellas Pharma Korea, Inc.Completed18 Years75 YearsBoth78Phase 4Korea, Republic of
1894EUCTR2008-006075-75-CZ
(EUCTR)
29/07/200928/07/2009A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
130Phase 2Hungary;United Kingdom;Germany;Czech Republic
1895EUCTR2007-006603-20-HU
(EUCTR)
29/07/200914/05/2009A Phase 2, 2-Part, Multicenter, Randomized, Double-blind,Parallel-group, Placebo-controlled, Proof-of-concept, dose-findingStudy Evaluating the Efficacy and Safety of CNTO 136Administered Subcutaneously in Subjects with Active RheumatoidArthritis Despite Methotrexate Therapy - Not availableA Phase 2, 2-Part, Multicenter, Randomized, Double-blind,Parallel-group, Placebo-controlled, Proof-of-concept, dose-findingStudy Evaluating the Efficacy and Safety of CNTO 136Administered Subcutaneously in Subjects with Active RheumatoidArthritis Despite Methotrexate Therapy - Not available Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CNTO136
Product Code: CNTO136
INN or Proposed INN: not available
Other descriptive name: CNTO 136 IgG
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
190Phase 2Hungary
1896EUCTR2008-006936-37-NL
(EUCTR)
27/07/200929/04/2009A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of MethotrexateA Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate Rheumatoid Arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ILV-094
Other descriptive name: Recombinant human anti IL-22 monoclonal antibody IgG1
Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and DevelopmentNULLNot RecruitingFemale: yes
Male: yes
120Hungary;Germany;Netherlands;Belgium
1897EUCTR2008-002623-85-ES
(EUCTR)
27/07/200919/02/2010A 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 DevelopmentNULLNot RecruitingFemale: yes
Male: yes
300Phase 4France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
1898EUCTR2008-002623-85-NL
(EUCTR)
27/07/200901/05/2009A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATEA 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 DevelopmentNULLNot RecruitingFemale: yes
Male: yes
300France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
1899EUCTR2008-005525-11-GR
(EUCTR)
20/07/200917/11/2009A 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.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. Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: rituximab
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
81Phase 2France;Greece;Spain;Netherlands;Germany;United Kingdom
1900EUCTR2008-002623-85-IT
(EUCTR)
14/07/200930/06/2009A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate - PRIZEA 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 DevelopmentNULLNot RecruitingFemale: yes
Male: yes
300France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
1901EUCTR2008-008338-35-DE
(EUCTR)
14/07/200904/05/2009PHASE 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 METHOTREXATEPHASE 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 METHOTREXATE CP 690,550 is 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
Product Name: Humira
INN or Proposed INN: Adalimumab
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Finland;United Kingdom;Czech Republic;Germany;Denmark;Bulgaria;Spain
1902EUCTR2008-004875-23-HU
(EUCTR)
08/07/200911/05/2009An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid ArthritisAn Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
198Hungary;Germany;Belgium;France;Austria;Poland
1903NCT00928512
(ClinicalTrials.gov)
July 200925/6/2009Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)A 16-week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab (AIN457) Followed by an Extension Phase up to a Total of 60 Weeks in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With MethotrexateRheumatoid ArthritisDrug: Secukinmab;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll237Phase 2United States;Belgium;Czech Republic;Germany;Hungary;Japan;Korea, Republic of;Poland;Russian Federation;Slovakia;Taiwan;Puerto Rico
1904EUCTR2009-012141-34-GB
(EUCTR)
29/06/200915/05/2009Randomised Controlled Trial of the Use of Topical Application of Tranexamic Acid in Primary Total Hip Replacement. - (TRANX-H)Randomised Controlled Trial of the Use of Topical Application of Tranexamic Acid in Primary Total Hip Replacement. - (TRANX-H) Blood loss in total hip replacement in patient with ostoearthritis and rheumatoid arthritis.Trade Name: Cyklokapron®
Product Name: Cyklokapron®
Product Code: NA
University Hospital of North Tees and HartlepoolNULLNot RecruitingFemale: yes
Male: yes
150United Kingdom
1905EUCTR2008-004875-23-AT
(EUCTR)
26/06/200930/04/2009An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid ArthritisAn Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Product Code: NA
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
236Hungary;Germany;Belgium;France;Poland;Austria
1906EUCTR2008-008337-11-GR
(EUCTR)
25/06/200920/10/2009PHASE 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 DMARDSPHASE 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 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
1907EUCTR2008-006917-25-PL
(EUCTR)
24/06/200910/03/2009A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). Patients with active rheumatoid arthritis who are on a stable dose of methotrexateProduct Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: Tranilast
INN or Proposed INN: Tranilast
Nuon Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2United Kingdom;Czech Republic;Germany;Bulgaria;Poland
1908EUCTR2008-007788-17-DE
(EUCTR)
24/06/200908/04/2009PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITISPHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS CP 690,550 is 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 Name: CP-690,550
Product Code: CP-690,550
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
611Phase 3Czech Republic;Bulgaria;Germany
1909EUCTR2007-000828-40-PL
(EUCTR)
24/06/200912/05/2009A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis.A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3Germany;France;Italy;Austria;Poland
1910EUCTR2008-008337-11-SK
(EUCTR)
22/06/200909/09/2009PHASE 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 DMARDSPHASE 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 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
795Phase 3Slovakia;Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden
1911EUCTR2008-008337-11-ES
(EUCTR)
19/06/200927/03/2009Estudio 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 DMARDSEstudio 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-690,550Pfizer, S.A.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
1912EUCTR2008-008338-35-ES
(EUCTR)
19/06/200927/03/2009PHASE 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 metotrexatoPHASE 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.ANULLNot RecruitingFemale: yes
Male: yes
700Phase 3Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom
1913EUCTR2008-008337-11-DK
(EUCTR)
18/06/200915/05/2009PHASE 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 DMARDSPHASE 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 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
1914EUCTR2008-008337-11-FI
(EUCTR)
17/06/200924/04/2009PHASE 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 DMARDSPHASE 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 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
795Phase 3Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
1915EUCTR2008-007023-26-BG
(EUCTR)
16/06/200922/05/2009PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEPHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE CP 690,550 is being studied as a disease modifying antirheumatic drug for the treatment of moderate to severe active rheumatoid arthritis in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Poland;Bulgaria
1916EUCTR2008-008337-11-DE
(EUCTR)
16/06/200907/04/2009PHASE 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 DMARDSPHASE 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 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USANULLNot RecruitingFemale: yes
Male: yes
795Phase 3Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden
1917EUCTR2008-002381-55-ES
(EUCTR)
16/06/200901/08/2008Evaluación 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.NULLNot RecruitingFemale: yes
Male: yes
Spain
1918EUCTR2008-008338-35-BG
(EUCTR)
16/06/200922/05/2009PHASE 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 METHOTREXATEPHASE 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 METHOTREXATE CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Code: CP-690,550
Trade Name: Humira
Product Name: Humira
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain
1919EUCTR2008-008338-35-GB
(EUCTR)
11/06/200909/04/2009PHASE 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 METHOTREXATEPHASE 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 METHOTREXATE CP 690,550 is 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
Product Name: Humira
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Bulgaria;Spain
1920EUCTR2008-008337-11-GB
(EUCTR)
10/06/200909/04/2009PHASE 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 DMARDSPHASE 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 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Finland;Germany;United Kingdom;Denmark;Spain;Greece;Poland;Sweden
1921EUCTR2008-008337-11-PL
(EUCTR)
09/06/200930/04/2009PHASE 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 DMARDSPHASE 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 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
795Phase 3Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
1922EUCTR2008-006917-25-BG
(EUCTR)
09/06/200910/06/2009A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). Patients with active rheumatoid arthritis who are on a stable dose of methotrexateProduct Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Nuon Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2United Kingdom;Czech Republic;Germany;Bulgaria;Poland
1923EUCTR2008-001105-42-PL
(EUCTR)
03/06/200917/04/2009A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDGA Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Germany;Belgium;France;Austria;Poland
1924EUCTR2008-007023-26-PL
(EUCTR)
03/06/200905/06/2009PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEPHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE CP 690,550 is being studied as a disease modifying antirheumatic drug for the treatment of moderate to severe active rheumatoid arthritis in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Bulgaria;Poland
1925EUCTR2008-008338-35-DK
(EUCTR)
03/06/200929/04/2009PHASE 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 METHOTREXATEPHASE 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 METHOTREXATE CP 690,550 is 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
Product Name: Humira
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom
1926EUCTR2008-006924-68-GR
(EUCTR)
03/06/200919/11/2009Extension 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. - this is an extension study to MA21573Extension 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. - this is an extension study to MA21573 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3France;Portugal;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;United Kingdom;Italy
1927JPRN-UMIN000002175
2009/06/0110/07/2009Comparison of the clinical responses by the dosage of once or triple a week of MTX in patients with rheumatoid Arthritis Rheumatoid ArthritisMTX, once a week
MTX, triple a week
POEM study groupNULLComplete: follow-up continuing16years-old80years-oldMale and Female60Not applicableJapan
1928EUCTR2008-007788-17-BG
(EUCTR)
01/06/200922/05/2009PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS - CP 690,550 is 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 Name: CP-690,550
Product Code: CP-690,550
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
611Phase 3Germany;Czech Republic;Bulgaria
1929NCT00947492
(ClinicalTrials.gov)
June 200927/7/2009Monitoring Epstein-Barr Virus (EBV) Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive DrugsMonitoring EBV Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs ; Orencia* (Abatacept) and RoActemra* (Tocilizumab).Rheumatoid ArthritisBiological: Venous blood sampleAssistance Publique Hopitaux De MarseilleNULLActive, not recruiting18 YearsN/ABoth60N/AFrance
1930EUCTR2008-008337-11-SE
(EUCTR)
27/05/200923/03/2009PHASE 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 DMARDSPHASE 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 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden
1931EUCTR2008-004875-23-DE
(EUCTR)
26/05/200909/03/2009An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid ArthritisAn Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Product Code: NA
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
236Poland;Austria;France;Belgium;Germany;Hungary
1932EUCTR2008-008338-35-SK
(EUCTR)
25/05/200909/09/2009PHASE 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 METHOTREXATEPHASE 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 METHOTREXATE CP 690,550 is 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
Product Name: Humira
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom
1933EUCTR2008-007788-17-CZ
(EUCTR)
20/05/200918/03/2009PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS - CP 690,550 is 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 Name: CP-690,550
Product Code: CP-690,550
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
611Phase 3Germany;Czech Republic;Bulgaria
1934EUCTR2008-008338-35-CZ
(EUCTR)
20/05/200918/03/2009PHASE 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 METHOTREXATEPHASE 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 METHOTREXATE CP 690,550 is 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
Product Name: Humira
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom
1935EUCTR2008-007023-26-CZ
(EUCTR)
18/05/200910/03/2009PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEPHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE CP 690,550 is being studied as a disease modifying antirheumatic drug for the treatment of moderate to severe active rheumatoid arthritis in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Bulgaria;Poland
1936EUCTR2008-006924-68-PT
(EUCTR)
18/05/200917/03/2009Extension 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. - this is an extension study to MA21573Extension 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. - this is an extension study to MA21573 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200France;Portugal;Hungary;Czech Republic;Spain;Netherlands;United Kingdom;Italy
1937EUCTR2008-004875-23-BE
(EUCTR)
18/05/200907/01/2009An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid ArthritisAn Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
236France;Hungary;Poland;Belgium;Austria;Germany
1938EUCTR2009-011105-17-IT
(EUCTR)
17/05/200927/03/2009A single-arm, open-label study of early improvement of anemia and fatigue during treatment with tocilizumab (TCZ) in combination with non biologic DMARDs, in adult patients with moderate to severe active rheumatoid arthritis. - Anemia FatigueA single-arm, open-label study of early improvement of anemia and fatigue during treatment with tocilizumab (TCZ) in combination with non biologic DMARDs, in adult patients with moderate to severe active rheumatoid arthritis. - Anemia Fatigue Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Tocilizumab
Product Code: Ro 487-7533
INN or Proposed INN: RoActemra
ROCHENULLNot RecruitingFemale: yes
Male: yes
Italy
1939EUCTR2007-006657-63-FI
(EUCTR)
08/05/200927/01/2009Study 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 KingdomNULLNot RecruitingFemale: yes
Male: yes
72Hungary;Finland;Iceland;Denmark;Norway;Sweden
1940EUCTR2009-011520-53-SK
(EUCTR)
04/05/200917/03/2009Evaluation of Adherence and Persistence to Tocilizumab in combination with Methotrexate or Tocilizumab Monotherapy in patients with moderate to severe active rheumatoid arthritis in local environmentEvaluation 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 arthritisTrade Name: RoActemra®
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra
Roche Slovensko s.r.o.NULLNot RecruitingFemale: yes
Male: yes
Slovakia
1941NCT00891020
(ClinicalTrials.gov)
May 200929/4/2009A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDsRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: Nonbiologic DMARDs of investigator's choiceHoffmann-La RocheNULLCompleted18 YearsN/AAll886Phase 3United States;Puerto Rico;United Kingdom
1942EUCTR2008-007023-26-GR
(EUCTR)
29/04/200903/04/2009PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEPHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE CP 690,550 is being studied as a disease modifying antirheumatic drug for the treatment of moderate to severe active rheumatoid arthritis in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CP-690,550Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Greece;Poland;Bulgaria
1943EUCTR2007-001625-10-GR
(EUCTR)
29/04/200906/03/2009An 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. - ExtraAn 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 ARTHRITISTrade Name: Etanercept
INN or Proposed INN: ETANERCEPT
Wyeth Pharmaceuticals FranceNULLNot RecruitingFemale: yes
Male: yes
700Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
1944EUCTR2008-006924-68-CZ
(EUCTR)
28/04/200912/02/2009Extension 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. - this is an extension study to MA21573Extension 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. - this is an extension study to MA21573 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
1945EUCTR2008-005525-11-DE
(EUCTR)
24/04/200909/12/2008A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate. 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: MabThera 500mg
Product Name: rituximab
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
81United Kingdom;Germany;Netherlands;France;Spain
1946EUCTR2008-006917-25-DE
(EUCTR)
24/04/200922/01/2009A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). Patients with active rheumatoid arthritis who are on a stable dose of methotrexateTrade Name: Ribazen
Product Name: Tranilast
INN or Proposed INN: Tranilast
Trade Name: Ribazen
Product Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Nuon Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2United Kingdom;Czech Republic;Germany;Bulgaria;Poland
1947EUCTR2008-006917-25-GB
(EUCTR)
22/04/200909/04/2009A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). - Tranilast plus Methotrexate vs MTX Alone in Patients with Active RAA Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). - Tranilast plus Methotrexate vs MTX Alone in Patients with Active RA Patients with active rheumatoid arthritis who are on a stable dose of methotrexateProduct Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: methotrexate
Nuon Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2Czech Republic;Germany;United Kingdom;Bulgaria;Poland
1948EUCTR2008-004875-23-PL
(EUCTR)
22/04/200925/02/2009An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid ArthritisAn Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Product Code: NA
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
236Hungary;Germany;Belgium;France;Austria;Poland
1949EUCTR2008-006075-75-DE
(EUCTR)
22/04/200917/02/2009A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
130Phase 2Hungary;Czech Republic;United Kingdom;Germany
1950EUCTR2008-005427-28-NL
(EUCTR)
22/04/200909/12/2008A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - RealisticA Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
1048Phase 3Germany;Netherlands;France;Spain;Italy
1951EUCTR2007-006657-63-DK
(EUCTR)
16/04/200920/02/2009Study 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 KingdomNULLNot RecruitingFemale: yes
Male: yes
72Hungary;Finland;Denmark;Iceland;Norway;Sweden
1952NCT01081717
(ClinicalTrials.gov)
April 14, 20094/3/2010Golimumab Safety and Surveillance Program Using the Ingenix NHI DatabaseA Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis Treated With Golimumab and Other Types of Biological and Systemic Non Biological TreatmentsRheumatoid Arthritis;Arthritis, Psoriatic;Ankylosing SpondylitisDrug: systemic non-biological treatments;Biological: anti-TNF biologics;Biological: golimumab;Biological: non-anti-TNF biologics;Other: general populationJanssen Biotech, Inc.NULLCompletedN/A99 YearsAll1064United States
1953EUCTR2008-006075-75-GB
(EUCTR)
14/04/200928/04/2009A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
130Phase 2Hungary;Czech Republic;Germany;United Kingdom
1954EUCTR2008-004894-16-CZ
(EUCTR)
14/04/200926/11/2008Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate TherapyPhase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and Company limitedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Hungary;Germany;Czech Republic;Poland
1955EUCTR2009-011044-20-GB
(EUCTR)
08/04/200914/04/2009A Single-Centre, Double-blind, Double-dummy, Randomised, Placebo Controlled, Four Period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600mg and 150mg) on QT/QTc Interval, Compared to Placebo, using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male VolunteersA Single-Centre, Double-blind, Double-dummy, Randomised, Placebo Controlled, Four Period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600mg and 150mg) on QT/QTc Interval, Compared to Placebo, using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers rheumatoid arthritis
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions
Product Code: AZD5672
Trade Name: Avelox®
Product Name: Avelox- Moxifloxacin
AstraZeneca ABNULLNot RecruitingFemale: no
Male: yes
64United Kingdom
1956EUCTR2008-006924-68-FR
(EUCTR)
06/04/200919/03/2009Extension 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 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. Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
Product Code: RO4877533/F04-F05
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Portugal;France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;United Kingdom;Italy
1957EUCTR2008-006924-68-IT
(EUCTR)
03/04/200923/03/2009Extension 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 to study MA21573Extension 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 to study MA21573 Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF therapies.
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 RocheNULLNot RecruitingFemale: yes
Male: yes
1200Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
1958EUCTR2008-005427-28-ES
(EUCTR)
03/04/200926/01/2009Estudio fase IIIb, multicéntrico, con un período doble ciego controlado con placebo y aleatorizado de 12 semanas, seguido de una fase de extensión abierta para evaluar la seguridad y la eficacia de certolizumab pegol administrado a pacientes con artritis reumatoide activa. (A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis). - RealisticEstudio fase IIIb, multicéntrico, con un período doble ciego controlado con placebo y aleatorizado de 12 semanas, seguido de una fase de extensión abierta para evaluar la seguridad y la eficacia de certolizumab pegol administrado a pacientes con artritis reumatoide activa. (A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis). - Realistic Artritis reumatoide (Rheumatoid arthritis)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
1048Phase 3Germany;Netherlands;France;Spain;Italy
1959EUCTR2008-005427-28-FR
(EUCTR)
02/04/200919/03/2009A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - RealisticA Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
1048Phase 3France;Spain;Germany;Netherlands;Italy
1960EUCTR2008-006924-68-NL
(EUCTR)
02/04/200909/02/2009Extension 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. - this is an extension study to MA21573Extension 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. - this is an extension study to MA21573 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1200Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
1961JPRN-UMIN000004271
2009/04/0127/09/2010Upper 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 Rheumatoid arthritis (RA)NSAIDs-induced gastrointestinal mucosal injuryJapanese 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 HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female100Not applicableJapan
1962NCT00931086
(ClinicalTrials.gov)
April 200930/6/2009Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99An Expanded Access Trial of Belimumab Antibody (Monoclonal Anti-BLyS Antibody) in Patients With Rheumatoid Arthritis (RA) Who Were Previously Treated Under HGS Protocol LBRA99Rheumatoid ArthritisDrug: belimumabHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineNo longer available18 YearsN/ABothPhase 4United States
1963NCT01075711
(ClinicalTrials.gov)
April 200924/2/2010Determine the Improvement in Activity Status/Quality of Life (QoL) of Patients With Rheumatoid Arthritis (RA) During Treatment With Lodotra (Prednisone)Non-interventional Study for Determining the Improvement in the Activity Status / Life Quality of Patients With Rheumatoid Arthritis Being Treated With the Tempus TabletArthritis, RheumatoidDrug: PrednisoneMerck KGaAMerck Serono GmbH, GermanyCompleted18 YearsN/ABoth2728N/AGermany
1964EUCTR2008-005525-11-NL
(EUCTR)
31/03/200912/12/2008A 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.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. Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: rituximab
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
81France;Spain;Germany;Netherlands;United Kingdom
1965EUCTR2008-004875-23-FR
(EUCTR)
31/03/200916/04/2009An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid ArthritisAn Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
236Phase 2France;Hungary;Poland;Belgium;Austria;Germany
1966EUCTR2008-006930-92-CZ
(EUCTR)
31/03/200906/01/2009A multi-centre randomised, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of ART621 following multiple dose administration for 3 months in patients with rheumatoid arthritis concomitantly taking methotrexateA multi-centre randomised, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of ART621 following multiple dose administration for 3 months in patients with rheumatoid arthritis concomitantly taking methotrexate Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: ART621Arana Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic
1967EUCTR2008-003011-12-GB
(EUCTR)
30/03/200927/04/2009Prospective Randomised Double-Blind Placebo Controlled Study Assessing the Efficacy of Tocilizumab with Synovial Analysis in Patients with Rheumatoid Arthritis - TOCRAProspective Randomised Double-Blind Placebo Controlled Study Assessing the Efficacy of Tocilizumab with Synovial Analysis in Patients with Rheumatoid Arthritis - TOCRA Rheumatoid ArthritisTrade Name: RoActemra®EV Product Code: PRD82321
Product Name: Tocilizumab
Product Code: RO4877533
University of LeedsNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
1968EUCTR2008-000587-17-DE
(EUCTR)
26/03/200917/12/2008Multi-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 TherapyMulti-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 Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
1969EUCTR2007-006657-63-SE
(EUCTR)
25/03/200906/02/2009Study 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 KingdomNULLNot RecruitingFemale: yes
Male: yes
72Hungary;Finland;Denmark;Norway;Iceland;Sweden
1970EUCTR2008-006936-37-HU
(EUCTR)
25/03/200902/03/2009A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of MethotrexateA Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate Rheumatoid Arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ILV-094
Product Code: ILV-094
Other descriptive name: Recombinant human anti IL-22 monoclonal antibody IgG1
Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and DevelopmentNULLNot RecruitingFemale: yes
Male: yes
180Hungary;Germany;Netherlands;Belgium
1971EUCTR2008-006075-75-HU
(EUCTR)
24/03/200918/02/2009A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
130Phase 2Hungary;Czech Republic;United Kingdom;Germany
1972EUCTR2008-000744-13-BG
(EUCTR)
19/03/200926/01/2009Long Term Follow On Safety Study of Fostamatinib in Patients Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 StudyAn Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study 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: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
800France;United States;Mexico;Belgium;Poland;Romania;Peru;Bulgaria;Germany;Colombia;Italy
1973EUCTR2008-004754-33-CZ
(EUCTR)
17/03/200918/03/2009A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug TherapyA Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug Therapy Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: BG00012
Other descriptive name: Dimeythl Fumarate
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Czech Republic;Poland
1974EUCTR2008-000587-17-IT
(EUCTR)
12/03/200920/03/2009Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background No-Biologic DMARDs who have an Inadequate Response to Current Non-Biologic DMARD and/or Anti-TNF Therapy - NDMulti-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background No-Biologic DMARDs who have an Inadequate Response to Current Non-Biologic DMARD and/or Anti-TNF Therapy - ND Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to DMARDs or anti-TNF therapies
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533
INN or Proposed INN: tocilizumab
ROCHENULLNot RecruitingFemale: yes
Male: yes
1500Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
1975EUCTR2008-006924-68-GB
(EUCTR)
06/03/200929/04/2009Extension 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. - this is an extension study to MA21573Extension 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. - this is an extension study to MA21573 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
1200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Portugal;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Italy;United Kingdom
1976NCT00883753
(ClinicalTrials.gov)
March 200917/4/2009An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) TherapyAn Extension Phase of the Multi-National Open-Label Study (MA21573) 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.Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll934Phase 3Australia;Canada;Czech Republic;France;Greece;Hungary;Italy;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;United Kingdom;Austria;Turkey
1977EUCTR2008-000587-17-HU
(EUCTR)
27/02/200928/11/2008Multi-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 TherapyMulti-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 Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
1978EUCTR2008-005427-28-DE
(EUCTR)
27/02/200910/12/2008A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - RealisticA Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
1048Phase 3Germany;Netherlands;France;Spain;Italy
1979EUCTR2008-004754-33-PL
(EUCTR)
25/02/200924/11/2008A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug TherapyA Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug Therapy Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: BG00012
Other descriptive name: Dimeythl Fumarate
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Czech Republic;Poland
1980EUCTR2008-006443-39-ES
(EUCTR)
23/02/200909/12/2008Estudio 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.NULLNot RecruitingFemale: yes
Male: yes
Spain
1981EUCTR2008-005320-81-ES
(EUCTR)
18/02/200920/01/2009Segundo 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 - A2201E2Segundo 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.NULLNot RecruitingFemale: yes
Male: yes
160Phase 2Belgium;Spain;Austria;Germany
1982EUCTR2008-001847-20-GR
(EUCTR)
17/02/200906/03/2009Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. Rheumatoid ArthritisTrade Name: RoActemra®
Product Code: L04AC07
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
F Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
470France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
1983EUCTR2007-001625-10-GB
(EUCTR)
17/02/200902/05/2008An 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. - ExtraAn 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 FranceNULLNot Recruiting Female: yes
Male: yes
700 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yesFrance;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;Italy;United Kingdom
1984EUCTR2008-005320-81-BE
(EUCTR)
16/02/200920/02/2009A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2 Rheumatoid Arthritis
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 Pharma Services AGNovartis Pharma BelgiumNot RecruitingFemale: yes
Male: yes
Spain;Belgium;Austria;Germany
1985EUCTR2008-006924-68-ES
(EUCTR)
13/02/200919/01/2009Fase 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 MA21573Fase 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1200Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
1986EUCTR2008-004894-16-DE
(EUCTR)
12/02/200911/11/2008Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate TherapyPhase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and Company limitedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Hungary;Czech Republic;Germany;Poland
1987EUCTR2008-001523-57-ES
(EUCTR)
09/02/200922/10/2008Estudio 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 MethotrexateEstudio 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
100Phase 3France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom
1988EUCTR2008-005320-81-DE
(EUCTR)
06/02/200917/11/2008A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2 Rheumatoid Arthritis
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 interleukin-1beta of the IgG1-Kappa-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
213Germany;Spain;Austria
1989EUCTR2008-005525-11-FR
(EUCTR)
06/02/200913/03/2009A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate. Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera
Product Code: RO452294/V02
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533/F01
INN or Proposed INN: tocilizumab
F Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
81Phase 2France;Greece;Spain;Netherlands;Germany;United Kingdom
1990EUCTR2008-001847-20-SE
(EUCTR)
02/02/200923/10/2008Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexateRandomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY 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: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
F Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
470Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
1991EUCTR2008-005525-11-ES
(EUCTR)
29/01/200909/12/2008Estudio 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 LtdNULLNot RecruitingFemale: yes
Male: yes
81Phase 2France;Greece;Spain;Netherlands;Germany;United Kingdom
1992EUCTR2008-004754-33-SK
(EUCTR)
29/01/200914/11/2008A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug TherapyA Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug Therapy Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: BG00012
Other descriptive name: Dimeythl Fumarate
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Czech Republic;Slovakia;Poland
1993EUCTR2008-005427-28-IT
(EUCTR)
28/01/200911/03/2009A phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled,randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis - RealisticA phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled,randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis - Realistic rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
1048Phase 3Germany;Netherlands;France;Spain;Italy
1994EUCTR2008-000744-13-IT
(EUCTR)
28/01/200909/01/2009An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study - NDAn Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study - ND Reumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: R935788
INN or Proposed INN: Fosfamatinib Disodium
Product Name: R935788
INN or Proposed INN: Fosfamatinib Disodium
RIGEL PHARMACEUTICALS INCNULLNot RecruitingFemale: yes
Male: yes
800France;Bulgaria;Germany;Italy
1995EUCTR2008-001847-20-IT
(EUCTR)
18/01/200918/12/2008Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo-controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - NDRandomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo-controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ND Adult patients with active moderate to severe (DAS28 > 4.4) rheumatoid arthritis (RA) who have inadequately responded to prior conventional MTX treatment and have not been treated with any biologic agent before.
MedDRA version: 9.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid
Product Name: Tocilizumab
Product Code: RO04877533
Trade Name: Methotrexate Lederle 2.5 mg Tablets
INN or Proposed INN: Methotrexate
Product Name: Tocilizumab
Product Code: RO04877533
ROCHENULLNot RecruitingFemale: yes
Male: yes
470France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;United Kingdom;Italy;Sweden
1996EUCTR2008-004894-16-PL
(EUCTR)
15/01/200918/12/2008Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate TherapyPhase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and Company limitedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Hungary;Czech Republic;Germany;Poland
1997EUCTR2008-000587-17-GR
(EUCTR)
13/01/200930/01/2009Multi-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 TherapyMulti-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 Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to DMARDs or anti- TNF therapies
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: Tocilizumab
F. Hoffmann- La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
1998EUCTR2007-000896-41-GB
(EUCTR)
12/01/200919/01/2009 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 arthritisTrade 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,USANULLNot 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): yesFrance;Czech Republic;Hungary;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
1999EUCTR2007-001377-28-PT
(EUCTR)
09/01/200925/08/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
2000EUCTR2007-006150-25-DE
(EUCTR)
09/01/200926/05/2008A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects with Active Seropositive Rheumatoid Arthritis on a Stable Background of MethotrexateA Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate - TRU-015 Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: Prednisone
Trade Name: Solu-Medrone 125mg
INN or Proposed INN: Methylprednisolone Sodium Succinate
Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: Prednisone
Trade Name: Solu-Medrone 125mg
INN or Proposed INN: Methylprednisolone Sodium Succinate
Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
216Hungary;Germany;Serbia;Netherlands;Belgium;Mexico;France;Romania;Austria
2001EUCTR2007-003288-36-ES
(EUCTR)
08/01/200909/03/2010Ensayo 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®). - RESTARTEnsayo 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 BVNULLNot RecruitingFemale: yes
Male: yes
200Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
2002EUCTR2008-001523-57-DK
(EUCTR)
07/01/200914/10/2008Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to MethotrexateMulticenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
100France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom
2003EUCTR2008-007225-39-BE
(EUCTR)
06/01/200912/02/2009A 2 year follow up to assess the effectiveness in daily practice of different treatment strategies for early Rheumatoid Arthritis patients.A 2 year prospective multicentre randomised controlled trial comparing effectiveness in daily practice of different treatment strategies for early RA - CareRA early active Rheumatoid Arthritis, previously untreated with DMARDS
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: Ledertrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Salazopyrine
INN or Proposed INN: SULFASALAZINE
Trade Name: Arava
INN or Proposed INN: LEFLUNOMIDE
University Hospitals LeuvenNULLNot RecruitingFemale: yes
Male: yes
400Phase 4Belgium
2004EUCTR2008-001523-57-GB
(EUCTR)
06/01/200922/10/2008Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to MethotrexateMulticenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate
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 CorporationNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom
2005NCT00838058
(ClinicalTrials.gov)
January 20092/2/2009A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy VolunteersRheumatoid Arthritis;Healthy VolunteersDrug: CE-224,535;Drug: CE 224,535PfizerNULLCompleted18 Years55 YearsBoth11Phase 1United States
2006EUCTR2008-005525-11-GB
(EUCTR)
29/12/200816/12/2008A 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.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. Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: rituximab
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
81 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Greece;Spain;Netherlands;Germany;United Kingdom
2007EUCTR2008-001523-57-IT
(EUCTR)
23/12/200817/03/2009Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate - NDMulticenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate - ND active rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid
Trade Name: ORENCIA
INN or Proposed INN: ABATACEPT
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
100Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;Italy
2008EUCTR2008-001847-20-GB
(EUCTR)
19/12/200809/09/2008Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexate.Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY 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: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
F Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
470 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
2009EUCTR2008-001847-20-LV
(EUCTR)
19/12/200829/12/2008Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexateRandomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY 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: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
F Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
470United States;Serbia;Estonia;Greece;Thailand;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Brazil;Croatia;Romania;Denmark;Latvia;Germany;Netherlands;Norway;Sweden
2010EUCTR2007-001625-10-IE
(EUCTR)
12/12/200807/10/2008AN 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 ACTIVITYAN 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 ARTHRITISTrade Name: Etanercept
INN or Proposed INN: ETANERCEPT
Wyeth Pharmaceuticals FranceNULLNot RecruitingFemale: yes
Male: yes
700Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Spain;Ireland;Italy;Greece;Poland;Austria
2011EUCTR2008-001847-20-NL
(EUCTR)
10/12/200823/10/2008Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT-RAYRandomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT-RAY Rheumatoid ArthritisProduct Name: Tocilizumab
Product Code: RO04877533
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
F Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
470France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
2012EUCTR2008-001847-20-DK
(EUCTR)
10/12/200821/10/2008Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexateRandomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY 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: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium
F Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
470Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
2013EUCTR2008-000744-13-BE
(EUCTR)
09/12/200808/10/2008An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 StudyAn Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
800Phase 2France;Belgium;Bulgaria;Germany;Italy
2014EUCTR2007-003288-36-FR
(EUCTR)
08/12/200821/10/2008A 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) - RESTARTA 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 BVNULLNot RecruitingFemale: yes
Male: yes
200Phase 4France;Finland;Spain;Austria;Germany;Netherlands;United Kingdom
2015EUCTR2008-004931-39-PL
(EUCTR)
08/12/200804/11/2008A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80 mg, 160 mg, and 320 mg ALD518 versus Placebo Administered as Multiple Intravenous Infusions to Patients with Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate.A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80 mg, 160 mg, and 320 mg ALD518 versus Placebo Administered as Multiple Intravenous Infusions to Patients with Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate. Active Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ALD518
Product Code: ALD518
Other descriptive name: ALD518 monoclonal antibody (anti IL-6 mAb)
Alder Biopharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
120Poland
2016EUCTR2008-002046-27-DE
(EUCTR)
08/12/200808/07/2008Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose MethotrexateClinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Ofatumumab
Product Code: GSK1841157
Other descriptive name: HuMax-CD20
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 1/2Germany;Belgium;France;Spain
2017EUCTR2007-000830-38-DE
(EUCTR)
05/12/200829/09/2008A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3France;Poland;Austria;Germany;Italy
2018EUCTR2007-006150-25-AT
(EUCTR)
03/12/200807/10/2008A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of MethotrexateA Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: PREDNISONE
Trade Name: Solu-Medrone 125mg
INN or Proposed INN: METHYLPREDNISOLONE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: PREDNISONE
Trade Name: Solu-Medrone 125mg
INN or Proposed INN: METHYLPREDNISOLONE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Wyeth Research Division of Wyeth Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
216Hungary;Germany;Netherlands;Belgium;France;Austria
2019EUCTR2007-006150-25-NL
(EUCTR)
01/12/200802/06/2008A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of MethotrexateA Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: PREDNISONE
Trade Name: Solu-Medrone 125mg
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: PREDNISONE
Trade Name: Solu-Medrone 125mg
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Wyeth Research Division of Wyeth Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
216Hungary;Germany;Netherlands;Belgium;France;Austria
2020NCT00805116
(ClinicalTrials.gov)
December 20088/12/2008Marine Oils and ArthritisWhale Oil Versus Cod Liver Oil in Rheumatoid ArthritisRheumatoid ArthritisDietary Supplement: Whale blubber oil;Dietary Supplement: Cod liver oilNational Institute of Nutrition and Seafood Research, NorwayNULLTerminated18 YearsN/ABoth7N/ANorway
2021NCT00818064
(ClinicalTrials.gov)
December 200830/12/2008Safety and Tolerability of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid ArthritisA Randomised, Double-blind, Placebo-controlled, Single- Dose, Dose-escalation Trial of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid ArthritisInflammation;Rheumatoid Arthritis;HealthyDrug: anti-IL-20;Drug: placeboNovo Nordisk A/SNULLCompleted18 Years75 YearsAll32Phase 1Netherlands
2022NCT00810277
(ClinicalTrials.gov)
November 30, 200816/12/2008A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDsAn Open Label Study to Evaluate the Safety and Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARDs.Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll14Phase 3Finland
2023EUCTR2008-001847-20-EE
(EUCTR)
28/11/200813/10/2008Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. Rheumatoid ArthritisTrade Name: RoActemra®
Product Code: L04AC07
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
F Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
470France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
2024EUCTR2007-003288-36-FI
(EUCTR)
28/11/200830/09/2008A 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) - RESTARTA 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 BVNULLNot RecruitingFemale: yes
Male: yes
200Phase 4Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
2025EUCTR2007-001625-10-IT
(EUCTR)
26/11/200801/04/2009An 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. - EXTRAAn 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 FranceNULLNot RecruitingFemale: yes
Male: yes
700France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;United Kingdom;Italy
2026EUCTR2008-001847-20-FR
(EUCTR)
17/11/200821/10/2008Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Tocilizumab
Product Code: RO04877533/F05/F04
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate
F Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
470Phase 3France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
2027EUCTR2008-001105-42-AT
(EUCTR)
11/11/200806/08/2008A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDGA Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: NA
Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Austria;Poland;France;Belgium;Germany
2028EUCTR2007-003288-36-DE
(EUCTR)
10/11/200803/09/2008A 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) - RESTARTA 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 BVNULLNot RecruitingFemale: yes
Male: yes
200Phase 4Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
2029EUCTR2007-005434-37-GB
(EUCTR)
07/11/200828/05/2008A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study) Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008), Amendment 08-Site Specific (v1.0, date 11-May-2009) & Amendment 15-Site Specific - UK sites only (v1.0, date 07-OCt-2010). And Pharmacogenetics Blood Sample Protocol Amendment 01 - Site-specific (v1.0, Date 07-Sep-2007). - MTX-IR Study RHEUMATOID ARTHRITIS, NOS
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: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Product Name: Abatacept (SC)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot Recruiting Female: yes
Male: yes
2400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2030EUCTR2008-002046-27-BE
(EUCTR)
05/11/200817/09/2008Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose MethotrexateClinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Ofatumumab
Product Code: GSK1841157
Other descriptive name: HuMax-CD20
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
35Phase 1/2Germany;Belgium;France;Spain
2031EUCTR2006-005353-30-GB
(EUCTR)
04/11/200801/04/2008A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis.A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis. Rheumatoid arthritis
MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot 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): noSpain;Lithuania;Austria;Italy;United Kingdom
2032EUCTR2007-005434-37-GR
(EUCTR)
04/11/200806/02/2009A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). - MTX-IR StudyA Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). - MTX-IR Study RHEUMATOID ARTHRITIS, NOS
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
Product Name: Abatacept (SC)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
2400Phase 3France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2033EUCTR2008-001523-57-FR
(EUCTR)
04/11/200821/10/2008Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to MethotrexateMulticenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
100Phase 3France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom
2034NCT00791999
(ClinicalTrials.gov)
November 200814/11/2008Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Pharmacokinetics and Safety of CDP870 as add-on Medication to MTX in Japanese Active RA Patients Who Have an Incomplete Response to MTX.Rheumatoid ArthritisDrug: CDP870 400mg;Drug: CDP870 200mg;Drug: CDP870 100mg;Drug: Placebo of CDP870Otsuka Pharmaceutical Co., Ltd.UCB Japan Co. Ltd.Completed20 Years74 YearsAll316Phase 2/Phase 3Japan
2035NCT00791921
(ClinicalTrials.gov)
November 200814/11/2008Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.Rheumatoid ArthritisDrug: CDP870;Drug: Placebo of CDP870Otsuka Pharmaceutical Co., Ltd.UCB Japan Co. Ltd.Completed20 Years74 YearsAll230Phase 3Japan
2036NCT00948610
(ClinicalTrials.gov)
November 200828/7/2009Sleep and Immunity in Rheumatoid Arthritis : Remicade SubstudySleep & Immune Mechanisms in Rheumatoid Arthritis: Remicade SubstudyRheumatoid ArthritisDrug: RemicadeUniversity of California, Los AngelesNational Heart, Lung, and Blood Institute (NHLBI)Completed18 Years85 YearsAll20N/AUnited States
2037NCT00901550
(ClinicalTrials.gov)
November 200813/5/2009The Chinese University of Hong Kong Early Arthritis StudyThe Chinese University of Hong Kong Early Arthritis StudyRheumatoid ArthritisDrug: Methotrexate;Drug: InfliximabChinese University of Hong KongNULLCompleted18 Years80 YearsBoth40N/AChina
2038NCT00783536
(ClinicalTrials.gov)
November 200829/10/2008A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid ArthritisAn Randomized, Open Label, Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate With DMARD Therapy in Subjects With Active Early Rheumatoid ArthritisRheumatoid ArthritisDrug: Etanercept + Methotrexate;Drug: DMARDSWyeth is now a wholly owned subsidiary of PfizerNULLWithdrawn18 Years80 YearsBoth402Phase 4Mexico
2039NCT00771030
(ClinicalTrials.gov)
November 20089/10/2008Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid ArthritisA Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: AMG 827;Other: PlaceboAmgenNULLCompleted18 Years70 YearsBoth40Phase 1/Phase 2Canada;Mexico;United States
2040NCT00796705
(ClinicalTrials.gov)
November 200820/11/2008Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA)Switching Anti-TNF-alpha Agents in Patients With RA With An Inadequate Response to TNF-alpha InhibitionRheumatoid ArthritisDrug: Adalimumab;Drug: Adalimumab placebo;Drug: EtanerceptNational Institute of Allergy and Infectious Diseases (NIAID)NULLTerminated18 YearsN/AAll13Phase 4United States
2041EUCTR2007-002950-42-GB
(EUCTR)
27/10/200820/03/2008A 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 therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTXA 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 therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab
GlaxoSmithKline Research & DevelopmentNULLNot RecruitingFemale: yes
Male: yes
248Phase 3Czech Republic;Hungary;Belgium;Spain;Poland;Lithuania;United Kingdom
2042EUCTR2008-005320-81-AT
(EUCTR)
21/10/200822/09/2008A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2 Rheumatoid Arthritis
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 Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200Germany;Spain;Austria
2043EUCTR2008-000742-30-HU
(EUCTR)
18/10/200824/04/2008A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to MethotrexateA Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Rigel Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
420Phase 2Hungary;Bulgaria;Poland
2044EUCTR2008-001847-20-ES
(EUCTR)
17/10/200811/08/2008Estudio 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 LtdNULLNot RecruitingFemale: yes
Male: yes
470France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
2045EUCTR2007-002536-29-BG
(EUCTR)
16/10/200801/10/2008A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - August IIA randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - August II Rheumatoid 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Portugal;Finland;Germany;Czech Republic;France;Bulgaria;Spain;Italy;Greece;Poland;Austria;Sweden
2046EUCTR2008-001105-42-DE
(EUCTR)
16/10/200804/08/2008A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDGA Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Germany;Belgium;France;Poland;Austria
2047EUCTR2007-003288-36-NL
(EUCTR)
15/10/200811/07/2008A 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) - RESTARTA 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 BVNULLNot RecruitingFemale: yes
Male: yes
200Phase 4Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
2048EUCTR2008-000742-30-BG
(EUCTR)
15/10/200814/08/2008A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to MethotrexateA Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Rigel Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
420Phase 2Hungary;Bulgaria;Poland
2049EUCTR2008-002046-27-ES
(EUCTR)
14/10/200806/05/2010Clinical 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.NULLNot RecruitingFemale: yes
Male: yes
70Phase 1/2Germany;Belgium;France;Spain
2050EUCTR2006-004139-31-GR
(EUCTR)
14/10/200806/11/2009A 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. - OPTIMAA 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. - OPTIMA Rheumatoid Arthritis.
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metotab®
INN or Proposed INN: methotrexate
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden
2051EUCTR2008-005212-40-SE
(EUCTR)
14/10/200814/08/2008Pain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSINGPain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSING Rheumatoid arthritis (RA)The overall aim with this project is to investigate central pain mechanisms in RA and healthy controls, and in RA how these are influenced by autonomic neural regulation and TNF-blockade with Remicade.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10060016;Term: Alpha tumor necrosis factor
MedDRA version: 9.1;Classification code 10029817;Term: Nuclear magnetic resonance imaging brain
MedDRA version: 9.1;Classification code 10053689;Term: Cardiovascular autonomic function test
Trade Name: Remicade
INN or Proposed INN: Infliximab
Karolinska InstituteNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
Sweden
2052EUCTR2008-000587-17-BE
(EUCTR)
13/10/200819/08/2008Multi-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 - ACT-SureMulti-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 - ACT-Sure Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece
2053EUCTR2008-001105-42-FR
(EUCTR)
10/10/200828/08/2008A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDGA Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;Poland;Belgium;Austria;Germany
2054EUCTR2007-000830-38-AT
(EUCTR)
09/10/200809/09/2008A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3France;Poland;Austria;Germany;Italy
2055EUCTR2007-001625-10-AT
(EUCTR)
09/10/200804/06/2008An 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. - ExtraAn 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 FranceNULLNot RecruitingFemale: yes
Male: yes
700Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
2056EUCTR2008-004398-16-SE
(EUCTR)
08/10/200812/08/2008A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable RA Patients in Clinical remission - ADMIREA Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable RA Patients in Clinical remission - ADMIRE Adalimumab has the indication for life-long treatment of RA but can adalimumab be discontinued in patients who are in stable clinical remission (DAS28<2.6) with retained low disease activity or will the RA symptoms relapse? If relapse occurs, how is the response if adalimumab is reinstituted?
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott Scandinavia ABNULLNot RecruitingFemale: yes
Male: yes
50Sweden
2057EUCTR2007-003288-36-AT
(EUCTR)
01/10/200818/08/2008A 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) - RESTARTA 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 BVNULLNot RecruitingFemale: yes
Male: yes
200Phase 4Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
2058EUCTR2007-001625-10-DE
(EUCTR)
01/10/200805/05/2008An 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. - ExtraAn 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 FranceNULLNot RecruitingFemale: yes
Male: yes
700Hungary;Czech Republic;United Kingdom;Germany;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
2059NCT00768053
(ClinicalTrials.gov)
October 20083/10/2008Evaluation of EULAR-RAID Score in Rheumatoid Arthritis PatientsOpen-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 EtanerceptRheumatoid ArthritisDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerLincoln Medical and Mental Health Center;Umanis;SODIA;depolaboCompleted18 YearsN/AAll108Phase 4France;Monaco
2060NCT00771329
(ClinicalTrials.gov)
October 200810/10/2008BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB023 (Anti-TWEAK) Administered to Subjects With Rheumatoid Arthritis.Rheumatoid ArthritisDrug: BIIB023;Other: Placebo (sterile normal saline)Biogen IdecNULLCompleted18 Years65 YearsBoth53Phase 1United States;Russian Federation;Ukraine
2061EUCTR2008-000587-17-DK
(EUCTR)
22/09/200804/07/2008Multi-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 TherapyMulti-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 Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2062EUCTR2008-001241-26-HU
(EUCTR)
18/09/200802/06/2008A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate - n.a.A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate - n.a. Active rheumatoid arthritis, functional class II-III
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: BT061 (CD4 monoclonal antibody)
Product Code: BT971
INN or Proposed INN: BT061 (CD4 monoclonal antibody)
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
110Hungary;Bulgaria
2063EUCTR2008-000742-30-PL
(EUCTR)
17/09/200830/09/2008A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to MethotrexateA Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Rigel Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
420Phase 2Hungary;Bulgaria;Poland
2064EUCTR2008-001105-42-BE
(EUCTR)
16/09/200814/07/2008A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDGA Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;Poland;Belgium;Austria;Germany
2065EUCTR2006-004139-31-NO
(EUCTR)
16/09/200819/12/2007A 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. - OPTIMAA 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. - OPTIMA Rheumatoid Arthritis.
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. KGNULLNot RecruitingFemale: yes
Male: yes
1000France;Hungary;Czech Republic;Greece;Spain;Belgium;Austria;Netherlands;Germany;Norway;United Kingdom;Sweden
2066EUCTR2008-000587-17-CZ
(EUCTR)
15/09/200820/06/2008Multi-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 TherapyMulti-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 Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Belgium;Spain;Greece
2067EUCTR2007-005434-37-IT
(EUCTR)
12/09/200811/06/2008Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate.(Short title: MTX-IR Study) Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008) - MTX-IR StudyPhase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate.(Short title: MTX-IR Study) Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008) - MTX-IR Study RHEUMATOID ARTHRITIS, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Orencia
INN or Proposed INN: ABATACEPT
Product Name: abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
2400Phase 3France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;United Kingdom;Italy
2068EUCTR2008-000743-34-IT
(EUCTR)
11/09/200801/10/2008Studio di Fase II multicentrico, randomizzato, in doppio cieco, controllato verso placebo, parallel-dose di R935788 in pazienti affetti da artrite reumatoide che hanno sperimentato fallimento di almeno un biologico - NDStudio di Fase II multicentrico, randomizzato, in doppio cieco, controllato verso placebo, parallel-dose di R935788 in pazienti affetti da artrite reumatoide che hanno sperimentato fallimento di almeno un biologico - ND Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: R935788RIGEL PHARMACEUTICALS INCNULLNot RecruitingFemale: yes
Male: yes
195Germany;France;Italy
2069EUCTR2008-000587-17-IE
(EUCTR)
11/09/200805/06/2008Multi-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 TherapyMulti-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 Rheumatoid Arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Tocilizumab (Actemra)
Product Code: RO4877533 (TCZ)
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2070EUCTR2007-001625-10-PL
(EUCTR)
10/09/200809/06/2008An 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. - ExtraAn 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 FranceNULLNot RecruitingFemale: yes
Male: yes
700Greece;Austria;Poland;Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy
2071EUCTR2008-000743-34-DE
(EUCTR)
10/09/200810/06/2008A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One BiologicA Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Rigel Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2Germany;France;Italy
2072EUCTR2008-004126-16-FI
(EUCTR)
05/09/200815/07/2008Local Open-Label Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARDsLocal Open-Label Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARDs Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: tocilizumab
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
Roche OyNULLNot RecruitingFemale: yes
Male: yes
Finland
2073EUCTR2007-006150-25-BE
(EUCTR)
05/09/200824/06/2008A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of MethotrexateA Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: PREDNISONE
Trade Name: Solu-Medrone 125mg
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Wyeth Research Division of Wyeth Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
216Phase 2France;Hungary;Belgium;Austria;Netherlands;Germany
2074EUCTR2008-002046-27-FR
(EUCTR)
05/09/200815/07/2008OFA110867 : Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose MethotrexateOFA110867 : Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Ofatumumab
Product Code: GSK1841157
Other descriptive name: HuMax-CD20
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 1;Phase 2France;Spain;Belgium;Germany
2075EUCTR2007-001377-28-DE
(EUCTR)
01/09/200815/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
2076NCT00706797
(ClinicalTrials.gov)
September 200825/6/2008Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA SubjectsAn 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 ActivityRheumatoid ArthritisDrug: etanercept (EnbrelTM);Drug: methotrexateWyeth is now a wholly owned subsidiary of PfizerNULLTerminated18 YearsN/AAll141Phase 4Czech Republic;France;Germany;Hungary;Italy;Poland;Spain;Turkey;United Kingdom;Austria;Croatia;United States
2077NCT00750880
(ClinicalTrials.gov)
September 200810/9/2008An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.International Multi-Center 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 or Anti-TNF Therapy.Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll1681Phase 3Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Luxembourg;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;Sweden;Switzerland;Turkey;United Kingdom;United States
2078EUCTR2008-000170-20-ES
(EUCTR)
26/08/200803/06/2008A 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-582949Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
240Phase 2France;Czech Republic;Spain
2079EUCTR2008-000587-17-FI
(EUCTR)
20/08/200805/06/2008Multi-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 TherapyMulti-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 Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2080EUCTR2007-001585-33-DE
(EUCTR)
19/08/200814/04/2008A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCOREA randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Netherlands;Latvia;Germany
2081EUCTR2008-000105-11-DE
(EUCTR)
19/08/200816/05/2008Effectiveness after 4 and 24 weeks and safety of tocilizumab in patients with active RA - TAMARA - Tocilizumab And DMARDs: Achievements in Rheumatoid ArthritisEffectiveness after 4 and 24 weeks and safety of tocilizumab in patients with active RA - TAMARA - Tocilizumab And DMARDs: Achievements in Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: RoActemra
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Roche Pharma AGNULLNot RecruitingFemale: yes
Male: yes
Germany
2082EUCTR2007-002951-18-DE
(EUCTR)
16/08/200830/06/2008A 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 therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonistA 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 therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab
GlaxoSmithKline Research & DevelopmentNULLNot RecruitingFemale: yes
Male: yes
236Phase 3France;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
2083EUCTR2007-007539-14-HU
(EUCTR)
15/08/200826/08/2008A 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 - ESCAPEA 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 ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
2084EUCTR2008-000170-20-CZ
(EUCTR)
14/08/200830/04/2008A 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.Pharmacogenetics Blood Sample Amendment 01 (version 1.0, dated 19-Dec-2007);Revised Protocol 02, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008) and Amendment 07 (version 1.0 dated on 01-Jul-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.Pharmacogenetics Blood Sample Amendment 01 (version 1.0, dated 19-Dec-2007);Revised Protocol 02, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008) and Amendment 07 (version 1.0 dated on 01-Jul-2008). subjects with rheumatoid arthritis (RA) who are on background therapy with methotrexate (MTX)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: BMS-582949Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
240Czech Republic;France;Spain
2085EUCTR2008-001241-26-BG
(EUCTR)
14/08/200827/09/2008A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant MethotrexateA randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate Active rheumatoid arthritis, functional class II-III.
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: BT061 (CD4 monoclonal antibody)
Product Code: BT971
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
110Hungary;Bulgaria
2086EUCTR2007-007539-14-BG
(EUCTR)
14/08/200806/08/2008A 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 - ESCAPEA 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 ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
2087EUCTR2006-000923-32-GB
(EUCTR)
13/08/200815/10/2007A randomised, double-blind, placebo-controlled, Bayesian adaptive dose finding study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat intravenous infusions GSK315234A in patients with active rheumatoid arthritis (RA)A randomised, double-blind, placebo-controlled, Bayesian adaptive dose finding study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat intravenous infusions GSK315234A in patients with active rheumatoid arthritis (RA) Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: GSK315234
Product Code: GSK315234
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
112United Kingdom
2088EUCTR2008-000587-17-NL
(EUCTR)
12/08/200810/09/2008Multi-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 TherapyMulti-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 Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: RoActemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2089EUCTR2008-000587-17-FR
(EUCTR)
12/08/200816/07/2008Multi-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 TherapyMulti-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 Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Tolicizumab Roche
Product Code: RO4877533/F04-F05
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden
2090EUCTR2007-005434-37-IE
(EUCTR)
08/08/200822/05/2008A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR StudyA Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study RHEUMATOID ARTHRITIS, NOS
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
Product Name: Abatacept (SC)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
2400Phase 3France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2091EUCTR2007-005434-37-BE
(EUCTR)
08/08/200828/05/2008A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010), and Administrative Letter 01. And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008) & Amendment 08-Site Specific (v1.0, date 11-May-2009). - MTX-IR StudyA Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010), and Administrative Letter 01. And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008) & Amendment 08-Site Specific (v1.0, date 11-May-2009). - MTX-IR Study RHEUMATOID ARTHRITIS, NOS
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
Product Name: Abatacept (SC)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
2400Phase 3France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2092EUCTR2008-000587-17-PT
(EUCTR)
08/08/200806/06/2008Multi-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 - ACT-SUREMulti-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 - ACT-SURE Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2093EUCTR2007-002951-18-GB
(EUCTR)
07/08/200814/03/2008A 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 therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonistA 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 therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab
GlaxoSmithKline Research & DevelopmentNULLNot Recruiting Female: yes
Male: yes
236 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noDenmark;Germany;Netherlands;Italy;United Kingdom;Sweden;Spain;France
2094EUCTR2007-005434-37-DE
(EUCTR)
05/08/200829/05/2008A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study).Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR StudyA Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study).Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study RHEUMATOID ARTHRITIS, NOS
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
Product Name: Abatacept (SC)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
2400Phase 3France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2095EUCTR2007-007539-14-PL
(EUCTR)
05/08/200830/06/2008A 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 - ESCAPEA 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 ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
2096EUCTR2006-005035-19-BG
(EUCTR)
04/08/200810/06/2009A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A 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]
Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: Tofacitinib citrate (Proposed commercial formulation- debossed)
Product Code: CP-690,550-10
INN or Proposed INN: NA
Other descriptive name: NA
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
2097EUCTR2006-006373-25-BG
(EUCTR)
04/08/200814/09/2009A 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/AA 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-690,550Pfizer Inc. 235 East 42nd Street, New York, NY10017NULLNot RecruitingFemale: yes
Male: yes
300Czech Republic;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden
2098EUCTR2007-005434-37-AT
(EUCTR)
30/07/200820/06/2008A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 02 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007), Protocol amendment 03 (v1.0, date 25-Apr-2008), and Protocol Amendment 06 (v1.0, date 25-Sep-2008). And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008). - MTX-IR StudyA Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 02 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007), Protocol amendment 03 (v1.0, date 25-Apr-2008), and Protocol Amendment 06 (v1.0, date 25-Sep-2008). And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008). - MTX-IR Study RHEUMATOID ARTHRITIS, NOS
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
Product Name: Abatacept (SC)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
2400Phase 3France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2099EUCTR2007-002950-42-BE
(EUCTR)
25/07/200824/06/2008A 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 therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTXA 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 therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX Rheumatoid Arthritis
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/SNULLNot RecruitingFemale: yes
Male: yes
248Phase 3Czech Republic;Hungary;Spain;Poland;Belgium;Lithuania;United Kingdom
2100EUCTR2007-005434-37-FR
(EUCTR)
24/07/200819/05/2008A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). - MTX-IR StudyA Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). - MTX-IR Study RHEUMATOID ARTHRITIS, NOS
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
Product Name: Abatacept (SC)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
2400Phase 3France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2101EUCTR2008-000587-17-ES
(EUCTR)
22/07/200826/05/2008Estudio 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 TherapyEstudio 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden
2102EUCTR2007-005434-37-NL
(EUCTR)
16/07/200830/05/2008A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR StudyA Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study RHEUMATOID ARTHRITIS, NOS
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
Product Name: Abatacept (SC)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
2400Phase 3France;Hungary;Greece;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom
2103EUCTR2007-000896-41-IT
(EUCTR)
15/07/200830/07/2008A 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 - NDA 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 DivisionNULLNot RecruitingFemale: yes
Male: yes
900Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
2104EUCTR2007-001377-28-NL
(EUCTR)
15/07/200829/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
2105EUCTR2007-005434-37-HU
(EUCTR)
09/07/200826/05/2008A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR StudyA Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study RHEUMATOID ARTHRITIS, NOS
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
Product Name: Abatacept (SC)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
2400Phase 3France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2106EUCTR2007-001625-10-DK
(EUCTR)
08/07/200818/06/2008An 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. - ExtraAn 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 FranceNULLNot RecruitingFemale: yes
Male: yes
700Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
2107EUCTR2007-006150-25-HU
(EUCTR)
04/07/200801/04/2009A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects with Active Seropositive Rheumatoid Arthritis on a Stable Background of MethotrexateA Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate - TRU-015 Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: Prednisone
Trade Name: Solu-Medrone 125mg
INN or Proposed INN: Methylprednisolone Sodium Succinate
Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
216France;Serbia;Hungary;Mexico;Belgium;Romania;Austria;Netherlands;Germany
2108EUCTR2008-000587-17-SE
(EUCTR)
03/07/200821/05/2008Multi-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 TherapyMulti-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 Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2109EUCTR2007-003508-36-GB
(EUCTR)
02/07/200829/02/2008A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Lodotra®
INN or Proposed INN: Prednisone
Nitec Pharma AGNULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noHungary;Germany;United Kingdom
2110JPRN-UMIN000001798
2008/07/0125/03/2009Prevention of cartilage destruction in rheumatoid arthritis by etanercept (PRECEPT study) Rheumatoid arthritisInjection of etanercept by 50 mg/week for one year
Injection of etanercept by 25 mg/week for one year
Team RA, Rheumatosurgery, Osaka City University Medical SchoolNULLComplete: follow-up complete20years-old80years-oldMale and Female100Not applicableJapan
2111JPRN-UMIN000001281
2008/07/0131/07/2008Strategic reduction of joint destruction in rheumatoid arthritis Rheumatoid arthritisTNF-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, JapanNULLNot applicableNot applicableMale and Female120Not selectedJapan
2112JPRN-UMIN000001240
2008/07/0110/07/2008The efficacy of tocilizumab to patients with rheumatoid arthritis refractory to anti-TNF agents: the open trial rheumatoid arthritisTocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks for 3 yearsDivision of Rheumatology & Clinical Immunology, Jichi Medical UniversityNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not selectedJapan
2113JPRN-UMIN000002421
2008/07/0104/09/2009Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis rheumatoid arthritistocilizumab
Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab
AA amyloidosis clinical research conferenceNULLRecruiting20years-oldNot applicableMale and Female40Not selectedJapan
2114NCT00729209
(ClinicalTrials.gov)
July 20084/8/2008A Study of ARRY-371797 in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: ARRY-371797, p38 inhibitor; oral;Drug: PlaceboArray Biopharma, now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/AAll28Phase 1United States
2115NCT00782600
(ClinicalTrials.gov)
July 200827/10/2008Study of Controlled Release Formulations of CE-224,535 Against the Immediate Release Formulation in Normal VolunteersA Phase 1, Randomized, 4-Period, 4-Sequence Cross-Over Study Of The Pharmacokinetics Of 3 Durations Of Release Of A Controlled Release Formulation And A Single Dose Of An Immediate Release Oral Suspension Of CE-224,535 In Normal Healthy VolunteersRheumatoid ArthritisDrug: suspension IR;Drug: CR 1;Drug: CR 2;Drug: CR 3PfizerNULLCompleted18 Years55 YearsBoth16Phase 1United States
2116EUCTR2007-000830-38-IT
(EUCTR)
30/06/200821/07/2008A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. - NDA Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. - ND rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Level: PT;Term: Rheumatoid arthritis
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A. (Casa Madre)NULLNot RecruitingFemale: yes
Male: yes
132Phase 3Germany;France;Italy;Poland;Austria
2117EUCTR2007-001377-28-AT
(EUCTR)
26/06/200827/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
2118EUCTR2007-004399-38-LT
(EUCTR)
26/06/200823/04/2008A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITISA RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS RHEUMATOID ARTHRITIS (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
CombinatoRx, IncorporatedNULLNot RecruitingFemale: yes
Male: yes
616United Kingdom;Estonia;Lithuania
2119EUCTR2007-006150-25-FR
(EUCTR)
24/06/200805/05/2008A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of MethotrexateA Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: PREDNISONE
Trade Name: Solu-Medrone 125mg
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Wyeth Research Division of Wyeth Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
216Phase 2France;Hungary;Belgium;Austria;Netherlands;Germany
2120EUCTR2008-000327-25-PL
(EUCTR)
24/06/200820/05/2008A 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 A 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 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CE-224,535Pfizer Inc. 235 East 42nd Street NY10017NULLNot RecruitingFemale: yes
Male: yes
78Phase 2Czech Republic;Spain;Poland
2121EUCTR2007-000896-41-DE
(EUCTR)
20/06/200821/04/2008A 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 methotrexateA 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, USANULLNot RecruitingFemale: yes
Male: yes
900France;Czech Republic;Hungary;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
2122EUCTR2007-001625-10-CZ
(EUCTR)
19/06/200821/05/2008An 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. - ExtraAn 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.NULLNot RecruitingFemale: yes
Male: yes
700Hungary;Germany;United Kingdom;Czech Republic;Denmark;France;Ireland;Austria;Poland;Greece;Italy;Spain
2123EUCTR2008-000587-17-AT
(EUCTR)
19/06/200809/05/2008Multi-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 - ACT-SUREMulti-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 - ACT-SURE Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2124EUCTR2007-006527-13-BG
(EUCTR)
18/06/200814/06/2008A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients with Active Rheumatoid ArthritisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients with Active Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Level: PT;Term: Rheumatoid arthritis
Product Name: CF101
INN or Proposed INN: methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-ß-Dribofuronamide
Other descriptive name: IB-MECA
INN or Proposed INN: methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-ß-Dribofuronamide
Other descriptive name: IB-MECA
Can-Fite BioPharma Ltd.NULLNot RecruitingFemale: yes
Male: yes
228Phase 2Bulgaria
2125EUCTR2008-000743-34-BE
(EUCTR)
18/06/200809/04/2008A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One BiologicA Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Rigel Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2France;Belgium;Germany;Italy
2126EUCTR2008-000587-17-GB
(EUCTR)
18/06/200818/04/2008Multi-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 TherapyMulti-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 Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Greece;Spain;Belgium;Denmark;Czech Republic;United Kingdom
2127EUCTR2007-003508-36-HU
(EUCTR)
17/06/200818/02/2008A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Lodotra®
INN or Proposed INN: Prednisone
Nitec Pharma AGNULLNot RecruitingFemale: yes
Male: yes
350Hungary;Germany;United Kingdom
2128EUCTR2007-007539-14-IT
(EUCTR)
17/06/200806/06/2008A 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 - EscapeA 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 Male and female patients over 18 years of age, with active RA despite current treatment with methotrexate. All patients will continue with background methotrexate therapy.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AZD5672
Product Code: AZD5672
Product Name: AZD5672
Product Code: AZD5672
INN or Proposed INN: ETANERCEPT
ASTRAZENECANULLNot RecruitingFemale: yes
Male: yes
360Phase 2Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
2129EUCTR2007-001625-10-HU
(EUCTR)
16/06/200818/03/2008An 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. - ExtraAn 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 FranceNULLNot RecruitingFemale: yes
Male: yes
700Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
2130EUCTR2007-007539-14-CZ
(EUCTR)
12/06/200818/04/2008A 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 - ESCAPEA 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 ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
2131EUCTR2007-002951-18-SE
(EUCTR)
11/06/200825/03/2008A 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 therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonistA 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 therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist Rheumatoid Arthritis
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/SNULLNot RecruitingFemale: yes
Male: yes
236Phase 3Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden
2132EUCTR2007-001377-28-FR
(EUCTR)
11/06/200829/02/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
2133EUCTR2007-007859-14-PL
(EUCTR)
11/06/200809/05/2008A 12-WEEK, PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF ARRY-438162, ADMINISTERED ORALLY DAILY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS INCOMPLETELY RESPONSIVE TO METHOTREXATEA 12-WEEK, PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF ARRY-438162, ADMINISTERED ORALLY DAILY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS INCOMPLETELY RESPONSIVE TO METHOTREXATE Active Rheumatoid Arthritis incompletely responsive to methotrexate
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ARRY-438162
Product Name: ARRY-438162
Array BioPharma Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Poland
2134EUCTR2006-004834-33-PL
(EUCTR)
09/06/200806/05/2008A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - RobustA Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Rob 803
Product Code: Rob 803 6.25mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
Product Name: Rob 803
Product Code: Rob 803 12.5mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
Product Name: Rob 803
Product Code: Rob 803 15mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
Product Name: Rob 803
Product Code: Rob 803 25mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
OxyPharma ABNULLNot RecruitingFemale: yes
Male: yes
224Phase 2United Kingdom;Bulgaria;Latvia;Poland
2135EUCTR2007-005464-26-GB
(EUCTR)
05/06/200811/04/2008Devlopment 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 LondonGuys and St Thomas'NHS Foundation TrustNot 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): yesUnited Kingdom
2136EUCTR2007-000886-40-IT
(EUCTR)
04/06/200821/03/2008Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADERAssessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADER Patients with a diagnosis of early active rhematoid arthritis in the previous 6 months, naive of previous treatment by DMARD and who need to be treated by DMARD.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: ARAVA
INN or Proposed INN: Leflunomide
Trade Name: ARAVA
INN or Proposed INN: Leflunomide
Trade Name: ARAVA
INN or Proposed INN: Leflunomide
sanofi-aventis GroupeNULLNot RecruitingFemale: yes
Male: yes
200Portugal;Italy
2137EUCTR2007-002951-18-DK
(EUCTR)
03/06/200823/04/2008A 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 therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonistA 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 therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist Rheumatoid Arthritis
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/SNULLNot RecruitingFemale: yes
Male: yes
236Phase 3France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
2138EUCTR2007-002536-29-GR
(EUCTR)
03/06/200812/02/2008A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RAA randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA Rheumatoid 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden
2139EUCTR2007-001625-10-FR
(EUCTR)
03/06/200813/05/2008An 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. - ExtraAn 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 ARTHRITISTrade Name: Etanercept
INN or Proposed INN: ETANERCEPT
Wyeth Pharmaceuticals FranceNULLNot RecruitingFemale: yes
Male: yes
700Phase 4France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;Italy;United Kingdom
2140EUCTR2008-000170-20-FR
(EUCTR)
03/06/200815/04/2008A 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.Pharmacogenetics Blood Sample Amendment 01 (version 1.0, dated 19-Dec-2007);Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 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.Pharmacogenetics Blood Sample Amendment 01 (version 1.0, dated 19-Dec-2007);Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008) subjects with rheumatoid arthritis (RA) who are on background therapy with methotrexate (MTX)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: BMS-582949Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
240Phase 2France;Czech Republic;Spain
2141NCT00654368
(ClinicalTrials.gov)
June 20083/4/2008CAMEO: Canadian Methotrexate and Etanercept Outcome StudyCanadian Methotrexate and Etanercept Outcome Study: An Open Label Randomized Trial of Etanercept and Methotrexate Versus Etanercept Alone in the Treatment of Rheumatoid Arthritis (CAMEO)Rheumatoid ArthritisBiological: Etanercept;Drug: MethotrexateAmgenWyeth is now a wholly owned subsidiary of PfizerCompleted18 YearsN/AAll258Phase 4Canada
2142NCT02151409
(ClinicalTrials.gov)
June 200828/5/2014Dose-escalation Trial of Anti-C5aR Antibody in Healthy SubjectsA Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Trial of Anti-C5aR Antibody (NNC 0151-0000-0000) Administered by i.v. Infusion or s.c. Injection in Healthy Subjects.Inflammation;Systemic Lupus Erythematosus;Rheumatoid Arthritis;HealthyDrug: NNC 0151-0000-0000;Drug: placeboNovo Nordisk A/SNULLCompleted18 Years55 YearsMale60Phase 1Netherlands
2143EUCTR2007-001625-10-ES
(EUCTR)
28/05/200824/03/2008Estudio 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. - ExtraEstudio 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 FranceNULLNot RecruitingFemale: yes
Male: yes
700Phase 4France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;Italy;United Kingdom
2144EUCTR2008-000327-25-CZ
(EUCTR)
27/05/200802/04/2008A 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 METHOTREXATEA 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 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CE-224,535Pfizer Inc. 235 East 42nd Street NY10017NULLNot RecruitingFemale: yes
Male: yes
78Phase 2Czech Republic;Spain;Poland
2145EUCTR2007-000828-40-DE
(EUCTR)
27/05/200810/01/2008A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
170Phase 3Germany;France;Italy;Poland;Austria
2146EUCTR2007-007859-14-HU
(EUCTR)
22/05/200822/01/2008A 12-WEEK, PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF ARRY-438162, ADMINISTERED ORALLY DAILY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS INCOMPLETELY RESPONSIVE TO METHOTREXATEA 12-WEEK, PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF ARRY-438162, ADMINISTERED ORALLY DAILY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS INCOMPLETELY RESPONSIVE TO METHOTREXATE Active Rheumatoid Arthritis incompletely responsive to methotrexate
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ARRY-438162
Product Name: ARRY-438162
Array BioPharma Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Poland
2147EUCTR2006-003054-26-HU
(EUCTR)
22/05/200814/12/2007A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: TAK-783Takeda Global R&D (Europe) LtdNULLNot RecruitingFemale: yes
Male: yes
230Hungary;Czech Republic;Latvia
2148EUCTR2007-005759-41-DE
(EUCTR)
21/05/200821/02/2008A 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 - FEATURE: Ocrelizumab in MTX-IR RA-patients; mono- vs. dual infusionA 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 - FEATURE: Ocrelizumab in MTX-IR RA-patients; mono- vs. dual infusion Rheumatoid arthritis
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 LtdNULLNot RecruitingFemale: yes
Male: yes
300United Kingdom;Germany;France;Spain;Italy
2149EUCTR2008-000327-25-ES
(EUCTR)
19/05/200818/03/2008ESTUDIO 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 METHOTREXATEESTUDIO 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-224,535PFIZER S.A.NULLNot RecruitingFemale: yes
Male: yes
78Phase 2Czech Republic;Poland;Spain
2150EUCTR2007-000896-41-BE
(EUCTR)
16/05/200827/02/2008A 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 methotrexateA 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 arthritisTrade 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,USANULLNot RecruitingFemale: yes
Male: yes
900Phase 4France;Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
2151EUCTR2007-007539-14-SK
(EUCTR)
16/05/200816/04/2008A 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 - ESCAPEA 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 ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2Hungary;Czech Republic;Slovakia;Poland;Bulgaria;Latvia;Malta;Italy
2152EUCTR2007-000828-40-IT
(EUCTR)
15/05/200814/07/2008A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab' fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis - NDA Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab' fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis - ND Rheumatoid arthritis with moderate to low disease activity
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB S.A. (Casa Madre)NULLNot RecruitingFemale: yes
Male: yes
170Phase 3Germany;France;Italy;Poland;Austria
2153EUCTR2007-002951-18-FR
(EUCTR)
14/05/200818/03/2008A 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 therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonistA 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 therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist Rheumatoid Arthritis
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/SNULLNot RecruitingFemale: yes
Male: yes
236Phase 3France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
2154EUCTR2007-006288-56-AT
(EUCTR)
14/05/200814/04/2008Methotrexat-Polyglutamate als Marker fuer das klinische Outcome in der Therapie der rheumatoiden ArthritisMethotrexat-Polyglutamate als Marker fuer das klinische Outcome in der Therapie der rheumatoiden Arthritis Rheumatoid ArthritisTrade Name: Ebetrexat
INN or Proposed INN: METHOTREXATE
Ludwig Boltzmann Cluster für Rheumatologie, Balneologie und RehabilitationNULLNot RecruitingFemale: yes
Male: yes
Austria
2155EUCTR2007-005905-23-DE
(EUCTR)
13/05/200829/01/2008A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week DosingA Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
424United Kingdom;Germany
2156EUCTR2007-002536-29-DE
(EUCTR)
08/05/200805/12/2007A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RAA randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA Rheumatoid 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
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: Adalimumab
Merck Serono InternationalNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Portugal;France;Czech Republic;Greece;Finland;Spain;Poland;Austria;Bulgaria;Germany;Italy;Sweden
2157EUCTR2007-000896-41-FR
(EUCTR)
07/05/200829/02/2008A 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 methotrexateA 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 arthritisTrade 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 FranceNULLNot RecruitingFemale: yes
Male: yes
900Phase 4France;Czech Republic;Hungary;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
2158EUCTR2007-007539-14-LV
(EUCTR)
07/05/200812/05/2008A 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 - ESCAPEA 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 ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
2159EUCTR2007-005759-41-IT
(EUCTR)
06/05/200810/10/2008A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy. - NDA Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy. - ND Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Ocrelizumab
Product Code: RO-496-4913
ROCHENULLNot RecruitingFemale: yes
Male: yes
300France;Spain;Germany;United Kingdom;Italy
2160NCT01224418
(ClinicalTrials.gov)
May 200814/10/2010A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to MethotrexateClinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 StudyRheumatoid ArthritisDrug: TacrolimusAstellas Pharma IncAstellas Pharma Korea, Inc.Completed18 Years75 YearsBoth50Phase 4Korea, Republic of
2161NCT00667758
(ClinicalTrials.gov)
May 200824/4/2008Gonadotropin-Releasing Hormone (GnRH)-Antagonist Therapy in Rheumatoid ArthritisAntagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled TrialRheumatoid ArthritisDrug: Cetrorelix;Drug: PlaceboBetanien HospitalNorwegian Foundation for Health and Rehabilitation;University of OsloCompleted18 YearsN/ABoth104Phase 2Norway
2162EUCTR2007-000896-41-SE
(EUCTR)
29/04/200806/02/2008A 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 methotrexateA 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 arthritisTrade 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,USANULLNot RecruitingFemale: yes
Male: yes
900Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
2163EUCTR2007-005759-41-GB
(EUCTR)
29/04/200829/02/2008 A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy - FEATURE A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy - FEATURE Rheumatoid arthritis
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 LtdNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Spain;Germany;Italy;United Kingdom
2164EUCTR2007-007539-14-MT
(EUCTR)
25/04/200812/05/2008A 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 - ESCAPEA 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 ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
2165EUCTR2007-003508-36-DE
(EUCTR)
25/04/200828/03/2008A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
INN or Proposed INN: PrednisoneNitec Pharma AGNULLNot RecruitingFemale: yes
Male: yes
350Hungary;Germany;United Kingdom
2166EUCTR2007-005759-41-ES
(EUCTR)
23/04/200819/02/2008Estudio 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 TherapyEstudio 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 LtdNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;Spain;Germany;Italy;United Kingdom
2167EUCTR2007-005905-23-GB
(EUCTR)
22/04/200815/02/2008A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing - M10-261, FINAL 30Nov07A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing - M10-261, FINAL 30Nov07 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
424Germany;United Kingdom
2168EUCTR2007-004399-38-EE
(EUCTR)
18/04/200829/02/2008A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITISA RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS RHEUMATOID ARTHRITIS (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
CombinatoRx, IncorporatedNULLNot RecruitingFemale: yes
Male: yes
616United Kingdom;Estonia;Lithuania
2169EUCTR2007-000896-41-CZ
(EUCTR)
14/04/200804/03/2008A 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 methotrexateA 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 arthritisTrade 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,USANULLNot RecruitingFemale: yes
Male: yes
900Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
2170EUCTR2007-004878-31-HU
(EUCTR)
09/04/200820/12/2007An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab
GlaxoSmithKline Research & Development Ltd.NULLNot RecruitingFemale: yes
Male: yes
264Phase 2Hungary;Denmark;United Kingdom
2171EUCTR2006-004834-33-BG
(EUCTR)
03/04/200824/03/2008A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - RobustA Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust Rheumatiod Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Rob 803 (capsules 6.25 mg)
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803 (capsules 12.5 mg)
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803 (capsules 15 mg)
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803 (capsules 25 mg)
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
OxyPharma ABNULLNot RecruitingFemale: yes
Male: yes
224Phase 2United Kingdom;Bulgaria;Latvia;Poland
2172EUCTR2007-003647-75-FR
(EUCTR)
01/04/200807/02/2008A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritisA randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: rituximab
Merck Serono InternationalNULLNot RecruitingFemale: yes
Male: yes
90Phase 2France;Finland;Netherlands;United Kingdom;Sweden
2173EUCTR2007-003069-42-LT
(EUCTR)
01/04/200805/02/2008A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA) RHEUMATOID ARTHRITIS (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Dipyridamole
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
CombinatoRx, IncorporatedNULLNot RecruitingFemale: yes
Male: yes
616Hungary;United Kingdom;Estonia;Lithuania
2174EUCTR2007-000593-24-GB
(EUCTR)
28/03/200801/08/2007An 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 LtdNULLNot 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): yesUnited Kingdom;Sweden
2175EUCTR2007-002066-35-HU
(EUCTR)
28/03/200823/07/2007A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Trade Name: Humira® 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: Humira®
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece
2176EUCTR2007-003069-42-HU
(EUCTR)
27/03/200818/09/2007A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA) RHEUMATOID ARTHRITIS (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Dipyridamole
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
CombinatoRx, IncorporatedNULLNot RecruitingFemale: yes
Male: yes
616Hungary;United Kingdom;Estonia;Lithuania
2177EUCTR2007-000896-41-HU
(EUCTR)
27/03/200816/10/2007A 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 ethotrexateA 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 arthritisTrade 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 FranceNULLNot RecruitingFemale: yes
Male: yes
900Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
2178EUCTR2007-005759-41-FR
(EUCTR)
19/03/200812/02/2008A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an inadequate Response to Methotrexate TherapyA Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an inadequate Response to Methotrexate Therapy Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ocrelizumab
Product Code: RO 496-4913/F03
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;Spain;Germany;Italy;United Kingdom
2179EUCTR2007-000760-24-SK
(EUCTR)
05/03/200810/04/2008Activity and safety of oral administration of SSR150106XB for the reduction of inflammation in patients with active rheumatoid arthritis (RA): A 4-week, multi-center, randomized, double-blind, placebo-controlled parallel group study of 90 µg administrered once daily and 90µg once every other day - ACCORD-RAActivity and safety of oral administration of SSR150106XB for the reduction of inflammation in patients with active rheumatoid arthritis (RA): A 4-week, multi-center, randomized, double-blind, placebo-controlled parallel group study of 90 µg administrered once daily and 90µg once every other day - ACCORD-RA Patients with active rheumatoid arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: SSR150106XB
Product Code: SSR150106XB
INN or Proposed INN: NA
Other descriptive name: NA
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
75Phase 2Czech Republic;Slovakia
2180EUCTR2007-004241-15-IT
(EUCTR)
04/03/200827/06/2008A Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis. - NDA Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis. - ND Psoriatic arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10032451;Term: Other rheumatoid arthritis with visceral or systemic involvement
Trade Name: ORENCIA
INN or Proposed INN: abatacept
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
220Phase 2United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy
2181EUCTR2007-002536-29-FR
(EUCTR)
03/03/200804/10/2007A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RAA randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Atacicept
Trade Name: Humira
Product Name: Adalimumab
Merck Serono InternationalNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Portugal;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Sweden
2182EUCTR2007-004399-38-GB
(EUCTR)
03/03/200820/03/2008A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITISA RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS RHEUMATOID ARTHRITIS (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CRx-102
INN or Proposed INN: Dipyridamole
INN or Proposed INN: Prednisolone
Product Code: CRx-102
INN or Proposed INN: Dipyridamole
INN or Proposed INN: Prednisolone
CombinatoRx, IncorporatedNULLNot RecruitingFemale: yes
Male: yes
616United Kingdom;Estonia;Lithuania
2183EUCTR2007-002536-29-CZ
(EUCTR)
03/03/200816/11/2007A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RAA randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA Rheumatoid 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden
2184NCT00628095
(ClinicalTrials.gov)
March 200825/2/2008Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With MethotrexateA Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of CE-224,535, An Antagonist Of The P2x7 Receptor, In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis In Subjects Who Are Inadequately Controlled On MethotrexateArthritis, RheumatoidDrug: CE-224,535;Drug: PlaceboPfizerNULLCompleted18 YearsN/ABoth100Phase 2/Phase 3United States;Chile;Czech Republic;Korea, Republic of;Mexico;Poland;Spain
2185NCT00605735
(ClinicalTrials.gov)
March 200818/1/2008PoC in Rheumatoid Arthritis With MethotrexateA Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects With Rheumatoid Arthritis Having an Inadequate Response to MethotrexateRheumatoid Arthritis, NOSDrug: BMS-582949;Drug: PlaceboBristol-Myers SquibbNULLCompleted18 YearsN/ABoth121Phase 2United States;Argentina;Czech Republic;France;Korea, Republic of;Mexico;Spain;Taiwan;Brazil
2186NCT00650767
(ClinicalTrials.gov)
March 200831/3/2008A Study of ARRY-438162 in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: ARRY-438162, MEK inhibitor; oral;Drug: PlaceboArray Biopharma, now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/AAll201Phase 2United States;Argentina;Brazil;Hungary;Peru;Poland;Romania
2187EUCTR2007-001585-33-GR
(EUCTR)
26/02/200809/08/2007A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - SCOREA randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - SCORE Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffman- La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2188EUCTR2006-005035-19-GR
(EUCTR)
26/02/200820/09/2007A LONG TERM, OPEN LABEL FOLLOW UP STUDY OF CP 690,550, A MODERATELY SELECTIVE JANUS KINASE 3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS. - N/AA LONG TERM, OPEN LABEL FOLLOW UP STUDY OF CP 690,550, A MODERATELY SELECTIVE JANUS KINASE 3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS. - N/A Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-
Product Name: CP-690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-
Pfizer Inc. 235 East 42nd Street, New York, NY10017NULLNot RecruitingFemale: yes
Male: yes
550Phase 2;Phase 3Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Sweden
2189EUCTR2007-000828-40-FR
(EUCTR)
26/02/200811/12/2007A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
170Phase 3France;Poland;Austria;Germany;Italy
2190EUCTR2006-006373-25-GR
(EUCTR)
26/02/200820/09/2007A 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-690,550Pfizer Inc. 235 East 42nd Street, New York, NY10017NULLNot RecruitingFemale: yes
Male: yes
300Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
2191EUCTR2006-006591-37-GR
(EUCTR)
26/02/200820/09/2007A 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 ArthritisA 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 ArthritisTrade Name: Enbrel
Product Name: Pre-filled syringe
INN or Proposed INN: ETANERCEPT
Product Name: Enbrel Auto Injector
INN or Proposed INN: ETANERCEPT
Wyeth Pharmaceuticals FranceNULLNot RecruitingFemale: yes
Male: yes
264Greece;Austria
2192EUCTR2006-006562-42-GB
(EUCTR)
21/02/200813/01/2009An Observational and Exploratory Study to determine the effect of anti TNF Biologic Treatment in Rheumatoid CachexiaAn 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 TrustNULLNot 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): yesUnited Kingdom
2193EUCTR2007-000828-40-AT
(EUCTR)
21/02/200831/03/2008A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076 Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
170Phase 3Germany;France;Italy;Poland;Austria
2194EUCTR2004-002132-26-GB
(EUCTR)
19/02/200811/03/2005A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of ocrelizumab (Ro 496-4913, PRO70769, rhuMAb 2H7) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/AA randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of ocrelizumab (Ro 496-4913, PRO70769, rhuMAb 2H7) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/A Rheumatoid ArthritisProduct Name: Ocrelizumab / rhuMAb 2H7
Product Code: Ro 496-4913
INN or Proposed INN: Ocrelizumab
Other descriptive name: rhuMAb 2H7
F. Hoffmann-La Roche LimitedNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;United Kingdom
2195EUCTR2007-003647-75-GB
(EUCTR)
15/02/200810/12/2007A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritisA randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: MabThera 500 mg (10 mg/ml) concentrate for solution for infusion
Product Name: Rituximab
INN or Proposed INN: rituximab
Merck Serono SA - GenevaNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Finland;Netherlands;United Kingdom;Sweden
2196EUCTR2007-002066-35-IT
(EUCTR)
13/02/200807/09/2007A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - NDA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - ND CP-690,550 is being developed as a disease-modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 6.1;Level: PT;Classification code 10039073
Product Name: CP-690,550
Product Name: CP-690,550
Trade Name: Humira
INN or Proposed INN: Adalimumab
PFIZERNULLNot RecruitingFemale: yes
Male: yes
350Phase 2Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece
2197EUCTR2007-002066-35-GR
(EUCTR)
11/02/200820/09/2007A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Trade Name: Humira® 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: Humira®
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Czech Republic;Hungary;Slovakia;Greece;Bulgaria;Germany;Italy
2198EUCTR2006-005036-24-BG
(EUCTR)
08/02/200807/02/2008A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/AA PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-
Product Name: CP-690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-
Pfizer Inc. 235 East 42nd Street, New York, NY10017NULLNot RecruitingFemale: yes
Male: yes
483Phase 2Hungary;Czech Republic;Bulgaria;Sweden
2199EUCTR2007-003647-75-SE
(EUCTR)
06/02/200804/12/2007A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritisA randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: MabThera 500 mg (10 mg/ml) concentrate for solution for infusion
Product Name: Rituximab
INN or Proposed INN: rituximab
Merck Serono InternationalNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Finland;United Kingdom;Netherlands;France;Sweden
2200EUCTR2007-000896-41-ES
(EUCTR)
06/02/200818/12/2007Estudio 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 ethotrexateEstudio 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 arthritisTrade 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 FranceNULLNot RecruitingFemale: yes
Male: yes
900Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
2201EUCTR2006-004140-23-GB
(EUCTR)
04/02/200807/11/2007A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RAA randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA Rheumatoid arthritis
MedDRA version: 8.1;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
Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Finland;Portugal;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2202EUCTR2007-002536-29-BE
(EUCTR)
01/02/200820/11/2007A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RAA randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA Rheumatoid 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Portugal;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Sweden
2203EUCTR2007-002536-29-PT
(EUCTR)
01/02/200821/11/2007A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RAA randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA Rheumatoid 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Finland;Portugal;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden
2204EUCTR2006-005035-19-DE
(EUCTR)
01/02/200804/10/2007A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A 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: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
2205EUCTR2007-002066-35-DE
(EUCTR)
01/02/200817/02/2009A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Trade Name: Humira® 40 mg Injektionslösung in Fertigspritze
INN or Proposed INN: Adalimumab
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Hungary;Czech Republic;Germany;Bulgaria;Italy;Greece
2206NCT01072058
(ClinicalTrials.gov)
February 200818/2/2010Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF BlockerProspective Evaluation of Heart Function by Echocardiographic Study, Pro-brain Natriuretic Peptide Type B and Troponin T in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF BlockerArthritis, Rheumatoid;Spondylitis, AnkylosingDrug: TNF blockers (infliximab, adalimumab, etanercept)University of Sao PauloNULLActive, not recruiting18 Years70 YearsBoth100Phase 4Brazil
2207EUCTR2007-002066-35-BG
(EUCTR)
31/01/200815/02/2008A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Trade Name: Humira® 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: Humira®
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Czech Republic;Hungary;Greece;Bulgaria;Germany;Italy
2208EUCTR2007-003647-75-FI
(EUCTR)
31/01/200819/12/2007A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritisA randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: rituximab
Merck Serono InternationalNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Finland;United Kingdom;Netherlands;France;Sweden
2209EUCTR2007-002536-29-IT
(EUCTR)
30/01/200809/01/2008A RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED MULTICENTRE PHASE II STUDY OF ATACICEPT IN ANTI-TNFA NAIVE PATIENTS WITH MODERATE TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO METHOTREXATE - ATACICEPT IN ANTI TNF-a NAIVE SUBJECTS WITH RAA RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED MULTICENTRE PHASE II STUDY OF ATACICEPT IN ANTI-TNFA NAIVE PATIENTS WITH MODERATE TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO METHOTREXATE - ATACICEPT IN ANTI TNF-a NAIVE SUBJECTS WITH RA RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Atacicept
INN or Proposed INN: Atacicept
Trade Name: HUMIRA
INN or Proposed INN: Adalimumab
MERCK SERONO INTERNATIONAL SANULLNot RecruitingFemale: yes
Male: yes
264Phase 2Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden
2210EUCTR2006-006591-37-AT
(EUCTR)
25/01/200804/01/2008A 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 ArthritisA 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 ArthritisTrade Name: Enbrel
Product Name: Pre-filled syringe
INN or Proposed INN: ETANERCEPT
Product Name: Enbrel Auto Injector
INN or Proposed INN: ETANERCEPT
Wyeth Pharmaceuticals FranceNULLNot RecruitingFemale: yes
Male: yes
264Greece;Austria
2211EUCTR2007-006729-28-GB
(EUCTR)
25/01/200804/12/2007Is a single dose intramuscular (IM) triamcinolone acetonide injection more effective in treating symptomatic flare in established rheumatoid arthritis than equivalent dose of oral prednisolone? - Treatment comparison for symptomatic flare in RAIs a single dose intramuscular (IM) triamcinolone acetonide injection more effective in treating symptomatic flare in established rheumatoid arthritis than equivalent dose of oral prednisolone? - Treatment comparison for symptomatic flare in RA The objective of this study is to compare the efficacy of equivalent doses of IM triamcinolone acetonide and oral prednisolone in controlling a symptomatic flare in patients with established RA.
MedDRA version: 9.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up
Trade Name: Kenalog
Product Name: Triamcinolone acetonide
INN or Proposed INN: TRIAMCINOLONE ACETONIDE
Trade Name: Prednisolone
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Trafford NHS TrustNULLNot RecruitingFemale: yes
Male: yes
58United Kingdom
2212EUCTR2007-003069-42-GB
(EUCTR)
24/01/200815/08/2007A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA) RHEUMATOID ARTHRITIS (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Dipyridamole
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
CombinatoRx, IncorporatedNULLNot RecruitingFemale: yes
Male: yes
616Hungary;United Kingdom;Estonia;Lithuania
2213EUCTR2007-000012-90-GB
(EUCTR)
23/01/200828/03/2007The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT TrialThe Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamlined safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Anti-Inflammatory Drug (NSAID) therapy when used to treat pain and inflammation in osteoarthritis or rheumatoid arthritis patients who are free from ischaemic heart disease, cerebrovascular disease, peripheral arterial disease, and moderate or severe heart failure.
MedDRA version: 13.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 13.1;Level: PT;Classification code 10041591;Term: Spinal osteoarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Celebrex
Trade Name: Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses
University of DundeeNULLNot RecruitingFemale: yes
Male: yes
Phase 4Denmark;Netherlands;United Kingdom
2214EUCTR2007-002536-29-ES
(EUCTR)
18/01/200814/02/2008Estudio 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-TNFaEstudio 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Portugal;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Sweden
2215EUCTR2007-000593-24-SE
(EUCTR)
16/01/200821/11/2007An 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 LtdNULLNot RecruitingFemale: yes
Male: yes
52United Kingdom;Sweden
2216EUCTR2007-001420-12-CZ
(EUCTR)
16/01/200813/11/2007A 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 SulphasalazineA 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 ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2Czech Republic;France;Poland;Sweden
2217EUCTR2007-002066-35-CZ
(EUCTR)
09/01/200823/10/2007A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Trade Name: Humira® 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: Humira®
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece
2218EUCTR2007-002950-42-PL
(EUCTR)
09/01/200824/08/2007A 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 therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTXA 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 therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab
GlaxoSmithKline Research and DevelopmentNULLNot RecruitingFemale: yes
Male: yes
248Phase 3Czech Republic;Hungary;Spain;Poland;Lithuania;United Kingdom
2219EUCTR2006-005137-38-GB
(EUCTR)
21/12/200714/08/2007A 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:
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 FranceNULLNot 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): noFrance;Finland;Denmark;Germany;United Kingdom;Sweden
2220EUCTR2006-003577-27-ES
(EUCTR)
21/12/200709/10/2007ESTUDIO 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/aESTUDIO 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.NULLNot RecruitingFemale: yes
Male: yes
290Phase 2Czech Republic;Estonia;Spain
2221EUCTR2007-001420-12-PL
(EUCTR)
20/12/200717/10/2007A 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 SulphasalazineA 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 ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2Czech Republic;France;Poland;Sweden
2222EUCTR2006-005353-30-AT
(EUCTR)
19/12/200723/05/2007A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis.A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis. Rheumatoid arthritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
600Spain;Lithuania;Austria;United Kingdom;Italy
2223EUCTR2007-001035-58-PT
(EUCTR)
14/12/200716/08/2007A 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 METHOTREXATE - N/AA 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 METHOTREXATE - N/A RHEUMATOID 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 Inc, 235 East 42nd Street,New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
114Phase 2Portugal;Spain;Italy
2224EUCTR2007-002536-29-SE
(EUCTR)
12/12/200726/10/2007A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RAA randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA Rheumatoid 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden
2225EUCTR2007-001114-17-GB
(EUCTR)
12/12/200713/02/2008A Mechanism of Action study to evaluate the effects of IL-6receptor blockade with tocilizumab (TCZ) on lipids, arterialstiffness, and markers of atherogenic risk in patients withmoderate to severe active rheumatoid arthritis (RA).A Mechanism of Action study to evaluate the effects of IL-6receptor blockade with tocilizumab (TCZ) on lipids, arterialstiffness, and markers of atherogenic risk in patients withmoderate to severe active rheumatoid arthritis (RA). Rheumatoid Arthritis (RA)Product Name: Actemra
Product Code: RO4877533 (TCZ)
F. Hoffmann-La Roche LimitedNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom
2226EUCTR2007-001665-15-IT
(EUCTR)
10/12/200705/10/2007A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 monoclonal antibody) in patients with rheumatoid arthritis - NDA 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 monoclonal antibody) in patients with rheumatoid arthritis - ND rheumatoid arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073
Product Name: Canakinumab
Product Code: ACZ885
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
179Phase 2Germany;Netherlands;Spain;Italy
2227EUCTR2007-004878-31-DK
(EUCTR)
10/12/200709/10/2007An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Hungary;Denmark;United Kingdom
2228EUCTR2006-005137-38-DK
(EUCTR)
10/12/200708/06/2007A 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:
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 FranceNULLNot RecruitingFemale: yes
Male: yes
534France;Finland;Denmark;Germany;United Kingdom;Sweden
2229EUCTR2007-002951-18-NL
(EUCTR)
10/12/200709/08/2007A 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 therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonistA 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 therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist Rheumatoid Arthritis
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/SNULLNot RecruitingFemale: yes
Male: yes
236Phase 3Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden
2230EUCTR2007-004878-31-GB
(EUCTR)
07/12/200716/10/2007An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
264 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Denmark;United Kingdom
2231EUCTR2007-000491-16-AT
(EUCTR)
06/12/200705/04/2007A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not availableA 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available Rheumatoid Arthritis
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 Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
260Germany;Spain;Austria
2232EUCTR2006-004139-31-NL
(EUCTR)
02/12/200726/04/2007A 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. - OPTIMAA 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. - OPTIMA Rheumatoid Arthritis.
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. KGNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden
2233NCT00647270
(ClinicalTrials.gov)
December 200727/3/2008Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week DosingA Multi-center, Randomized, Double-blind,Placebo-controlled Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week DosingRheumatoid ArthritisDrug: adalimumab;Drug: PlaceboAbbottNULLCompleted18 YearsN/AAll420Phase 3United States;Australia;Canada;Germany;Puerto Rico;United Kingdom
2234EUCTR2007-002950-42-ES
(EUCTR)
27/11/200711/10/2007A 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 MTXA 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/SNULLNot RecruitingFemale: yes
Male: yes
248Phase 3Czech Republic;Hungary;Belgium;Poland;Spain;Lithuania;United Kingdom
2235EUCTR2007-002951-18-ES
(EUCTR)
27/11/200711/10/2007A 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 antagonistA 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/SNULLNot RecruitingFemale: yes
Male: yes
236Phase 3France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
2236EUCTR2007-001035-58-IT
(EUCTR)
21/11/200705/10/2007A 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 METHOTREXATE - NDA 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 METHOTREXATE - ND Treatment of rheumatoid arthritis (RA).
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Maraviroc
Product Code: UK-427,857
PFIZERNULLNot RecruitingFemale: yes
Male: yes
114Phase 2Portugal;Spain;Italy
2237EUCTR2007-002536-29-FI
(EUCTR)
19/11/200715/10/2007A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RAA randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA Rheumatoid 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Portugal;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Sweden
2238EUCTR2007-001585-33-ES
(EUCTR)
15/11/200713/09/2007Estudio 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. - SCOREEstudio 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.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2239EUCTR2006-006373-25-CZ
(EUCTR)
14/11/200720/09/2007A 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-690,550Pfizer Inc. 235 East 42nd Street, New York, NY10017NULLNot RecruitingFemale: yes
Male: yes
300Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
2240EUCTR2006-005035-19-CZ
(EUCTR)
14/11/200720/09/2007A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citate (Phase III formulation)
Product Code: CP-690,550-10
Product Name: Tofacitinib citrate (Proposed commercial formulation - debossed)
Product Code: CP-690,550-10
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4500Phase 2;Phase 3Portugal;United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
2241EUCTR2007-001585-33-LT
(EUCTR)
13/11/200705/07/2007A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCOREA randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE Rheumatoid arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffman-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2242EUCTR2007-000886-40-PT
(EUCTR)
09/11/200707/08/2007Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADERAssessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER patients with a diagnosis of early active rheumatoid arthritis in the previous 6 months, naïves of previous treatment by a DMARD and who need to be treated by a DMARD
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
sanofi-aventis groupeNULLNot RecruitingFemale: yes
Male: yes
200Portugal;Italy
2243EUCTR2007-002536-29-AT
(EUCTR)
09/11/200715/10/2007A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RAA randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA Rheumatoid 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden
2244EUCTR2007-001665-15-NL
(EUCTR)
09/11/200717/10/2007A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritisA 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis Rheumatoid Arthritis
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 Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
179Phase 2Germany;Netherlands;Spain;Italy
2245NCT00302952
(ClinicalTrials.gov)
November 6, 200713/3/2006Lovastatin for the Treatment of Mildly Active Rheumatoid ArthritisA Double Blind, Placebo Controlled, Phase II, Randomized Study of Lovastatin Therapy in the Treatment of Mildly Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Lovastatin;Drug: PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceTerminated18 Years70 YearsAll64Phase 2United States
2246EUCTR2007-000896-41-NL
(EUCTR)
05/11/200717/10/2007A 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 ethotrexateA 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 arthritisTrade 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 FranceNULLNot RecruitingFemale: yes
Male: yes
900Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
2247EUCTR2007-000012-90-DK
(EUCTR)
02/11/200725/09/2007The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety StudyDansk:Klinisk forsøg med standardbehandling versus celecoxib (SCOT-forsøget)Et stort, strømlinet forsøg i lægemiddelsikkerhed - SCOT TrialThe Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety StudyDansk:Klinisk forsøg med standardbehandling versus celecoxib (SCOT-forsøget)Et stort, strømlinet forsøg i lægemiddelsikkerhed - SCOT Trial The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamlined safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Anti-Inflammatory Drug (NSAID) therapy when used to treat pain and inflammation in osteoarthritis or rheumatoid arthritis patients who are free from ischaemic heart disease, cerebrovascular disease, peripheral arterial disease, and moderate or severe heart failure.
MedDRA version: 9.1;Level: LLT;Classification code 10041591;Term: Spinal osteoarthritis
MedDRA version: 9.1;Classification code 10003268;Term: Arthritis rheumatoid
Trade Name: Celebra (celecoxib)
INN or Proposed INN: CELECOXIB
Trade Name: Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses
University of DundeeNULLNot RecruitingFemale: yes
Male: yes
13682Phase 4Denmark;Netherlands;United Kingdom
2248NCT00533897
(ClinicalTrials.gov)
November 200720/9/2007Phase IIIB Subcutaneous Missed Dose StudyA Phase IIIb, Multi-Center, Randomized, Withdrawal Study to Evaluate the Immunogenicity and Safety of Subcutaneous Administered Abatacept in Adults With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Abatacept;Drug: PlaceboBristol-Myers SquibbNULLCompleted18 YearsN/AAll270Phase 3United States;Argentina;Canada;Mexico;South Africa;Brazil
2249NCT01245361
(ClinicalTrials.gov)
November 200719/11/2010A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial BenefitA Comparative Study Of A 6-Month Infliximab (Remicade®) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis (RA) : Clinical, Radiological (MRI) And Synovial Benefit P1200/001.Undifferentiated ArthritisDrug: Infliximab;Drug: sodium chloridePatrick DurezNULLCompletedN/AN/ABoth30N/ABelgium
2250NCT00554853
(ClinicalTrials.gov)
November 20076/11/2007PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular DiseasePeroxisome Proliferator-activated Receptor-gamma Agonists, Rheumatoid Arthritis and Cardiovascular DiseaseRheumatoid ArthritisDrug: pioglitazone;Drug: Sublingual nitroglycerineUniversity of MichiganNational Heart, Lung, and Blood Institute (NHLBI)Completed21 Years100 YearsAll143Phase 3United States
2251NCT00664573
(ClinicalTrials.gov)
November 200721/4/2008Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) PatientsAssessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202.Rheumatoid ArthritisBiological: Baminercept alfa (BG9924)Biogen IdecNULLTerminated18 Years75 YearsBoth339Phase 2Argentina;Brazil;Hungary;Mexico;Poland;Romania;Russian Federation;United Kingdom
2252NCT00840957
(ClinicalTrials.gov)
November 200710/2/2009Pharmaco Kinetic Variability of Infliximab in Rheumatoid ArthritisPharmaco Kinetic and Pharmacokinetic-Pharmacodynamic Variability of InfliximabRheumatoid ArthritisBiological: infliximabUniversity Hospital, ToursNULLCompleted18 YearsN/ABoth84N/AFrance
2253NCT00578305
(ClinicalTrials.gov)
November 200719/12/2007A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to MethotrexateA Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to MethotrexateRheumatoid ArthritisBiological: Rituximab;Drug: Placebo;Drug: Methylprednisolone;Drug: Methotrexate;Drug: Folic acid or folateHoffmann-La RocheNULLCompleted18 Years80 YearsAll185Phase 3Argentina;Brazil;Canada;Czech Republic;Denmark;Estonia;France;Germany;Greece;Latvia;Lithuania;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Switzerland;Turkey;Former Serbia and Montenegro;United Kingdom
2254EUCTR2007-003069-42-EE
(EUCTR)
31/10/200710/08/2007A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA) RHEUMATOID ARTHRITIS (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Dipyridamole
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
CombinatoRx, IncorporatedNULLNot RecruitingFemale: yes
Male: yes
616Hungary;United Kingdom;Estonia;Lithuania
2255EUCTR2007-001035-58-ES
(EUCTR)
30/10/200726/07/2007A 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/AA 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.NULLNot RecruitingFemale: yes
Male: yes
114Phase 2Portugal;Spain;Italy
2256EUCTR2007-001585-33-DK
(EUCTR)
26/10/200712/07/2007A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCOREA randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffman-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2257EUCTR2006-006591-37-BE
(EUCTR)
25/10/200712/06/2007A 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 ArthritisA 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 ArthritisTrade Name: Enbrel
Product Name: Pre-filled syringe
INN or Proposed INN: ETANERCEPT
Product Name: Enbrel Auto Injector
INN or Proposed INN: ETANERCEPT
Wyeth Pharmaceuticals FranceNULLNot RecruitingFemale: yes
Male: yes
264Greece;Belgium;Austria
2258EUCTR2006-005137-38-DE
(EUCTR)
23/10/200723/08/2007A 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:
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 FranceNULLNot RecruitingFemale: yes
Male: yes
534France;Finland;Denmark;Germany;United Kingdom;Sweden
2259EUCTR2007-002945-18-IT
(EUCTR)
22/10/200707/02/2008A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - NDA double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - ND Rheumatoid arthritis
MedDRA version: 9.1;Level: HLT;Classification code 10039078;Term: Rheumatoid arthropathies
Product Name: Ofatumumab
Product Code: HuMax-CD20
GENMAB A/SNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Czech Republic;Italy
2260EUCTR2006-005330-20-SE
(EUCTR)
22/10/200727/08/2007A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy.A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. Rheumatoid arthritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
800France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2261EUCTR2006-003768-67-ES
(EUCTR)
19/10/200710/09/2007A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
58Phase 3Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden
2262EUCTR2007-002950-42-HU
(EUCTR)
18/10/200731/07/2007A 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 therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTXA 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 therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX Rheumatoid Arthritis
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/SNULLNot RecruitingFemale: yes
Male: yes
248Phase 3Czech Republic;Hungary;Belgium;Spain;Poland;Lithuania;United Kingdom
2263EUCTR2007-001420-12-FR
(EUCTR)
17/10/200723/07/2007A 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 SulphasalazineA 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 ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2France;Czech Republic;Slovakia;Poland;Belgium;Sweden
2264EUCTR2007-001665-15-DE
(EUCTR)
16/10/200730/07/2007A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritisA 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
179Phase 2Germany;Netherlands;Spain;Italy
2265EUCTR2007-001420-12-SK
(EUCTR)
15/10/200718/04/2008A 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 SulphasalazineA 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 ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2France;Czech Republic;Slovakia;Poland;Belgium;Sweden
2266EUCTR2007-002950-42-CZ
(EUCTR)
15/10/200715/08/2007A 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 therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTXA 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 therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab
GlaxoSmithKline Research and DevelopmentNULLNot RecruitingFemale: yes
Male: yes
248Phase 3Hungary;Czech Republic;Spain;Poland;Lithuania;United Kingdom
2267EUCTR2007-002945-18-CZ
(EUCTR)
15/10/200727/08/2007A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - Clinical efficacy and safety of ofatumumab in RA patients receiving background nonbiologic DMARDsA double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - Clinical efficacy and safety of ofatumumab in RA patients receiving background nonbiologic DMARDs Rheumatoid Arthritis
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/SNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Czech Republic
2268EUCTR2007-001420-12-SE
(EUCTR)
12/10/200720/07/2007A 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 SulphasalazineA 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 ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2Czech Republic;France;Poland;Sweden
2269EUCTR2006-003698-29-EE
(EUCTR)
12/10/200724/08/2007A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid ArthritisA Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Hungary;United Kingdom;Czech Republic;Netherlands;France;Estonia;Ireland;Italy;Latvia;Austria;Sweden
2270EUCTR2006-005330-20-IT
(EUCTR)
10/10/200715/10/2007A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-α therapy. - NDA randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-α therapy. - ND Rheumatoid Arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073
Product Name: Ocrelizumab
Product Code: RO 496-4913
ROCHENULLNot RecruitingFemale: yes
Male: yes
1000France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2271EUCTR2006-005353-30-LT
(EUCTR)
10/10/200728/06/2007A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM) FILM.A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis. - FILM 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: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
600United States;Panama;Philippines;Taiwan;Thailand;Spain;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;Mexico;Argentina;Brazil;Poland;Australia;Peru;South Africa;New Zealand;Korea, Republic of
2272EUCTR2007-001585-33-EE
(EUCTR)
10/10/200718/07/2007A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis andinadequate response to methotrexate - the R.A. SCORE study. - R.A. SCOREA randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis andinadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffman-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2273EUCTR2007-001585-33-FR
(EUCTR)
09/10/200723/07/2007A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCOREA randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE 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.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3France;Czech Republic;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2274EUCTR2006-003698-29-IT
(EUCTR)
05/10/200703/04/2007A long term assessment of safety and physical function with AMG 108 subcutaneous monthly treatment in subjects with Rheumatoid Arthritis - AMG 108 20060119A long term assessment of safety and physical function with AMG 108 subcutaneous monthly treatment in subjects with Rheumatoid Arthritis - AMG 108 20060119 Rheumatoid Arthritis AR
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: AMG 108
Product Code: AMG 108
AMGEN S.P.A.NULLNot RecruitingFemale: yes
Male: yes
784Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2275EUCTR2007-000733-19-HU
(EUCTR)
04/10/200709/08/2007A Phase 2B, Blinded Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA202A Phase 2B, Blinded Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA202 Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: BG9924Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
380Phase 2Hungary;United Kingdom
2276EUCTR2007-000734-38-GB
(EUCTR)
02/10/200726/06/2007An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA203An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA203 Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: BG9924Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom
2277EUCTR2007-000733-19-GB
(EUCTR)
02/10/200726/06/2007A Phase 2B, Blinded Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA202A Phase 2B, Blinded Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA202 Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: BG9924Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
380Phase 2Hungary;United Kingdom
2278EUCTR2006-005353-30-IT
(EUCTR)
01/10/200719/07/2007A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab in combinationwith methotrexate (MTX) compared to MTX alone inmethotrexate- naïve patients with active rheumatoid arthritis. - NDA randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab in combinationwith methotrexate (MTX) compared to MTX alone inmethotrexate- naïve patients with active rheumatoid arthritis. - ND Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ocrelizumab
Product Code: RO496-4913
ROCHENULLNot RecruitingFemale: yes
Male: yes
600Spain;Lithuania;Austria;United Kingdom;Italy
2279JPRN-UMIN000000837
2007/10/0101/10/2007Combination effect of bucillamine and salazosulphapyridine on rheumatoid arthritis; Prospective randomized controlled study Rheumatoid arthritisBucillamine mono-therapy(It's possible to choose the combination therapy with salazosulphapyridine at 6 months after the start of the treatment)
Salazosulphapyridine mono-therapy(It's possible to choose the combination therapy with bucillamineat 6 months after the start of the treatment)
Combination therapy of bucillamine and salazosulphapyridine (over the study period)
BASIC study groupNULLRecruiting20years-old75years-oldMale and Female180Not applicableJapan
2280NCT00554606
(ClinicalTrials.gov)
October 20075/11/2007Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid ArthritisA 54-week, Phase II, Multi-center, Open-label Extension Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1B Monoclonal Antibody) in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: ACZ885NovartisNULLCompleted18 Years75 YearsAll115Phase 2United States;Belgium;Germany;Italy;Netherlands;Russian Federation;Spain;Switzerland;Turkey
2281NCT02699892
(ClinicalTrials.gov)
October 200725/2/2016Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid ArthritisPost Marketing Non Interventional Clinical Research of Administration of Rituximab in Rheumatoid ArthritisRheumatoid ArthritisDrug: RituximabHoffmann-La RocheNULLCompleted18 Years80 YearsAll130N/ASerbia
2282NCT00595517
(ClinicalTrials.gov)
October 20077/1/2008Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced UlcerA Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) UseGastric Ulcer;Duodenal Ulcer;Rheumatoid Arthritis;Osteoarthritis;LumbagoDrug: Esomeprazole 20 mgAstraZenecaNULLCompleted20 YearsN/AAll395Phase 3Japan
2283EUCTR2007-001984-31-IT
(EUCTR)
28/09/200717/12/2007A PHASE 2 RANDOMIZED, MULTICENTER, ACTIVE COMPARATOR-CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF COADMINISTRATION OF CP-690,550 AND MYCOPHENOLATE MOFETIL / MYCOPHENOLATE SODIUM IN DE NOVO KIDNEY ALLOGRAFT RECIPIENTS - NDA PHASE 2 RANDOMIZED, MULTICENTER, ACTIVE COMPARATOR-CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF COADMINISTRATION OF CP-690,550 AND MYCOPHENOLATE MOFETIL / MYCOPHENOLATE SODIUM IN DE NOVO KIDNEY ALLOGRAFT RECIPIENTS - ND CP-690,550 is an immunosuppressive agent being developed for the prevention of kidney allograft rejection, and for the treatment of rheumatoid arthritis as a disease-modifying anti-rheumatic drug.
MedDRA version: 9.1;Level: LLT;Classification code 10023439;Term: Kidney transplant rejection
Product Name: CP-690,550
Product Name: CP-690,550
Trade Name: SANDIMMUN NEORAL*50CPS 25MG
INN or Proposed INN: Ciclosporin
Trade Name: SANDIMMUN NEORAL*30CPS 100MG
INN or Proposed INN: Ciclosporin
PFIZERNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy
2284EUCTR2007-002951-18-IT
(EUCTR)
28/09/200705/10/2007A 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-alfa; antagonist therapy - ND 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-alfa; antagonist therapy - ND Rheumatoid arthritis
MedDRA version: 9.1;Level: HLT;Classification code 10039078;Term: Rheumatoid arthropathies
Product Name: Ofatumumab
Product Code: HuMax-CD20
Genmab A/SNULLNot RecruitingFemale: yes
Male: yes
236Phase 3France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
2285EUCTR2006-005147-28-GB
(EUCTR)
25/09/200718/12/2008MTX-IR Phase IIIA randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. Rheumatoid Arthritis (RA)
MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot 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): noFrance;Greece;Spain;Belgium;Austria;Germany;United Kingdom
2286EUCTR2007-001585-33-NL
(EUCTR)
20/09/200709/08/2007A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCOREA randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffman-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Latvia;Netherlands
2287EUCTR2006-003768-67-AT
(EUCTR)
20/09/200726/04/2007A 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 MethotrexateAnd Protocol Amendment 01 (Version 1.0, Date 16-May-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 MethotrexateAnd Protocol Amendment 01 (Version 1.0, Date 16-May-2007) RHEUMATOID ARTHRITIS,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
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
58Phase 3Germany;United Kingdom;Netherlands;Spain;Austria;Sweden
2288EUCTR2006-006127-40-GB
(EUCTR)
16/09/200707/12/2006Cerebral Blood Flow following TNF-alpha Antagonism in Rheumatoid Arthritis - a Pilot Study - TNF/CBF in RACerebral Blood Flow following TNF-alpha Antagonism in Rheumatoid Arthritis - a Pilot Study - TNF/CBF in RA Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Humira
Product Name: Humira 40mg solution for injection in pre-filled syringe (adalimumab)
INN or Proposed INN: recombinant human monoclonal antibody
Newcastle-upon-Tyne Hospitals NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
15Phase 4United Kingdom
2289EUCTR2007-001665-15-ES
(EUCTR)
14/09/200727/06/2007Estudio 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.NULLNot RecruitingFemale: yes
Male: yes
179Belgium;Spain;Netherlands;Germany;Italy
2290EUCTR2007-002950-42-LT
(EUCTR)
13/09/200731/07/2007A 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 therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTXA 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 therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX Rheumatoid Arthritis
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/SNULLNot RecruitingFemale: yes
Male: yes
248Phase 3Hungary;United Kingdom;Czech Republic;Spain;Poland;Lithuania
2291EUCTR2006-004140-23-FI
(EUCTR)
13/09/200723/05/2007A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RAA randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA Rheumatoid arthritis
MedDRA version: 8.1;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
Merck Serono Int, a branch of Laboratoires Serono SA, an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Portugal;Finland;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2292EUCTR2006-004834-33-GB
(EUCTR)
13/09/200714/06/2007A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - RobustA Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: Rob 803 6.5mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
Product Code: Rob 803 12.5mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
Product Code: Rob 803 15mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
Product Code: Rob 803 25mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
OxyPharma ABNULLNot RecruitingFemale: yes
Male: yes
224Phase 2Poland;Belgium;Lithuania;Bulgaria;Latvia;United Kingdom
2293EUCTR2006-005147-28-GR
(EUCTR)
11/09/200704/05/2007A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. Rheumatoid Arthritis (RA) Lower Lever Term (LLT) code number 10039073Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1000United Kingdom;Germany;France;Spain;Greece;Austria
2294EUCTR2006-005036-24-HU
(EUCTR)
11/09/200705/07/2007A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/AA PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-
Product Name: CP-690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-
Pfizer Inc. 235 East 42nd Street, New York, NY10017NULLNot RecruitingFemale: yes
Male: yes
483Phase 2Hungary;Czech Republic;Bulgaria;Sweden
2295EUCTR2006-005330-20-SK
(EUCTR)
07/09/200710/04/2008A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy.A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. Rheumatoid arthritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3France;Czech Republic;Hungary;Slovenia;Slovakia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2296EUCTR2006-004139-31-HU
(EUCTR)
05/09/200717/05/2007A 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. - 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. - OPTIMA Rheumatoid Arthritis.
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. KGNULLNot RecruitingFemale: yes
Male: yes
1000Phase 4Slovakia;Greece;Spain;Austria;United Kingdom;France;Hungary;Czech Republic;Belgium;Germany;Netherlands;Norway;Sweden
2297EUCTR2007-001665-15-BE
(EUCTR)
05/09/200702/08/2007A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritisA 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis Rheumatoid Arthritis
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 Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
179Phase 2Spain;Belgium;Netherlands;Germany;Italy
2298EUCTR2006-005640-81-GB
(EUCTR)
04/09/200727/07/2007A PLACEBO CONTROLLED STUDY OF THE EFFECT OF EXTENDED TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: - EXXTRAA PLACEBO CONTROLLED STUDY OF THE EFFECT OF EXTENDED TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: - EXXTRA Rheumatoid arthritisTrade Name: Mabthera
Product Name: Mabthera
Product Code: Rituximab
Trade Name: Methylprednisolone
Product Name: Methylprednisolone
Other descriptive name: Methylprednisolone
University of LeedsNULLNot 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): noUnited Kingdom
2299EUCTR2006-003698-29-LV
(EUCTR)
03/09/200704/09/2007A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid ArthritisA Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2300NCT00523692
(ClinicalTrials.gov)
September 200730/8/2007Remission Induction in Very Early Rheumatoid ArthritisRemission Induction in Very Early Rheumatoid Arthritis: a Comparison of Etanercept Plus Methotrexate Plus Steroid With Standard TherapyRheumatoid ArthritisDrug: Etanercept, methotrexate and depomedrone;Drug: depemedroneUniversity Hospital BirminghamWyeth is now a wholly owned subsidiary of PfizerNot yet recruiting18 YearsN/ABoth20Phase 4United Kingdom
2301EUCTR2006-003054-26-CZ
(EUCTR)
31/08/200706/08/2007A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid Arthritis - NAA Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid Arthritis - NA Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: TAK-783Takeda Global R&D (Europe) LtdNULLNot RecruitingFemale: yes
Male: yes
230Hungary;Czech Republic;Latvia
2302EUCTR2006-005330-20-SI
(EUCTR)
30/08/200722/06/2007anti-TNF-IR phase IIIA randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. Rheumatoid arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2303EUCTR2006-004139-31-DE
(EUCTR)
30/08/200724/04/2007A 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. - OPTIMAA 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. - OPTIMA Rheumatoid Arthritis.
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. KGNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Czech Republic;United Kingdom;Germany;Netherlands;France;Spain;Greece;Austria;Sweden
2304EUCTR2006-005036-24-CZ
(EUCTR)
27/08/200704/07/2007A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/AA PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-
Product Name: CP-690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-
Pfizer Inc. 235 East 42nd Street, New York, NY10017NULLNot RecruitingFemale: yes
Male: yes
483Phase 2Hungary;Czech Republic;Bulgaria;Sweden
2305EUCTR2006-004834-33-BE
(EUCTR)
25/08/200721/06/2007A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - RobustA Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: Rob 803 6.5mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
Product Code: Rob 803 12.5mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
Product Code: Rob 803 15mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
Product Code: Rob 803 25mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
OxyPharma ABNULLNot RecruitingFemale: yes
Male: yes
224Phase 2Poland;Belgium;Bulgaria;Latvia;United Kingdom
2306EUCTR2007-001420-12-BE
(EUCTR)
23/08/200709/07/2007A 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 SulphasalazineA 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 ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2France;Czech Republic;Poland;Belgium;Sweden
2307EUCTR2007-001585-33-CZ
(EUCTR)
22/08/200704/09/2007A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCOREA randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffman-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3France;Estonia;Czech Republic;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2308EUCTR2007-000734-38-BE
(EUCTR)
17/08/200725/06/2007An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA203An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA203 Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: BG9924Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
120Belgium;United Kingdom
2309EUCTR2006-005330-20-NL
(EUCTR)
15/08/200713/06/2007A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. - SCRIPTA randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. - SCRIPT Rheumatoid arthritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1000France;Hungary;Slovenia;Spain;Belgium;Germany;Netherlands;Italy;Sweden
2310EUCTR2006-003698-29-IE
(EUCTR)
08/08/200712/01/2007A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid ArthritisA Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Estonia;France;Ireland;Italy;Latvia;Austria;Sweden;Hungary;United Kingdom;Czech Republic;Netherlands
2311EUCTR2006-004139-31-CZ
(EUCTR)
08/08/200715/02/2007A 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. - OPTIMAA 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. - OPTIMA Rheumatoid Arthritis.
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. KGNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Germany;United Kingdom;Czech Republic;Netherlands;France;Spain;Greece;Austria;Sweden
2312EUCTR2007-001754-11-IT
(EUCTR)
03/08/200702/07/2007Pilot study to evaluate the effect of Rituximab in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis. - NDPilot study to evaluate the effect of Rituximab in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis. - ND Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Mabthera
INN or Proposed INN: Rituximab
ROCHENULLNot RecruitingFemale: yes
Male: yes
Italy
2313NCT00597818
(ClinicalTrials.gov)
August 200710/1/2008Cobiprostone Prevention of NSAID-induced Gastroduodenal InjuryA Multi-center, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone for the Prevention of NSAID-induced Gastroduodenal Injury in Patients With Osteoarthritis and/or Rheumatoid Arthritis PatientsNSAID-induced Gastroduodenal Injury;Ulcers;Rheumatoid Arthritis;OsteoarthritisDrug: Cobiprostone;Drug: Placebo;Drug: Non-steroidal anti-inflammatory drugSucampo Pharma Americas, LLCNULLCompleted40 Years70 YearsAll121Phase 2United States
2314NCT00542789
(ClinicalTrials.gov)
August 200711/10/2007Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAIDA Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) UseGastric Ulcer;Duodenal Ulcer;Rheumatoid Arthritis;Osteoarthritis;LumbagoDrug: Esomeprazole;Drug: PlaceboAstraZenecaNULLCompleted20 YearsN/AAll343Phase 3Japan
2315NCT00505089
(ClinicalTrials.gov)
August 200719/7/2007Efficacy and Safety of Subcutaneous Versus Intravenous ACZ885 in Adult Patients With Established Rheumatoid ArthritisAn Exploratory, Open Label Pharmacokinetic - Pharmacodynamic Study to Compare Subcutaneous Versus Intravenous Administration of ACZ885 in Adult Patients With Established Rheumatoid ArthritisRheumatoid ArthritisDrug: ACZ885NovartisNULLTerminated18 Years75 YearsBoth11Phase 1/Phase 2Belgium;Germany;Netherlands;Poland
2316EUCTR2006-004834-33-LV
(EUCTR)
26/07/200708/06/2007A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - RobustA Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust Rheumatiod Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Rob 803
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
OxyPharma ABNULLNot RecruitingFemale: yes
Male: yes
224Phase 2United Kingdom;Bulgaria;Latvia;Poland
2317EUCTR2007-001585-33-LV
(EUCTR)
26/07/200730/07/2007A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCOREA randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffman-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2318EUCTR2006-005147-28-DE
(EUCTR)
25/07/200705/02/2007MTX-IR Phase IIIA randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. Rheumatoid Arthritis (RA)
MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3France;Greece;Spain;Belgium;Austria;Germany;United Kingdom
2319EUCTR2006-005330-20-DE
(EUCTR)
18/07/200709/03/2007anti TNF-IR phase IIIA randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. Rheumatoid arthritis
MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2320EUCTR2006-003698-29-AT
(EUCTR)
18/07/200716/08/2006A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid ArthritisA Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2321EUCTR2006-004666-14-DE
(EUCTR)
17/07/200702/04/2007An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not availableAn exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available Rheumatoid Arthritis
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 Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
32Germany
2322EUCTR2007-000886-40-CZ
(EUCTR)
17/07/200730/05/2007Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADERAssessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER patients with a diagnosis of early active rheumatoid arthritis in the previous 6 months, naïves of previous treatment by a DMARD and who need to be treated by a DMARD
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
sanofi-aventis groupeNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Czech Republic;Italy
2323EUCTR2006-003698-29-HU
(EUCTR)
16/07/200729/05/2007A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid ArthritisA Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
700Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2324EUCTR2006-005330-20-FR
(EUCTR)
16/07/200726/03/2007A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-a therapy.A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-a therapy. Rheumatoid arthritis
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 LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3France;Czech Republic;Hungary;Slovakia;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2325EUCTR2006-005035-19-SK
(EUCTR)
10/07/200709/04/2008A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A 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]
Product Name: CP-690,550
Product Code: CP-690,550-10
Product Name: CP-690,550
Product Code: CP-690,550-10
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
2326EUCTR2006-004140-23-PT
(EUCTR)
09/07/200705/03/2007A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RAA randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA Rheumatoid arthritis
MedDRA version: 8.1;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
Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2327EUCTR2005-001889-13-DE
(EUCTR)
09/07/200721/12/2006Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3 Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab
Schering-Plough Research Institute (SPRI)NULLNot RecruitingFemale: yes
Male: yes
315Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden
2328EUCTR2006-004834-33-LT
(EUCTR)
05/07/200705/06/2007A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - RobustA Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust Rheumatiod Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Rob 803
Product Code: Rob 803 6.25mg capsule
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803
Product Code: Rob 803 12.5mg capsule
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803
Product Code: Rob 803 15mg capsule
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803
Product Code: Rob 803 25mg capsule
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
OxyPharma ABNULLNot RecruitingFemale: yes
Male: yes
224Phase 2Poland;Belgium;Lithuania;Bulgaria;Latvia;United Kingdom
2329EUCTR2006-004140-23-GR
(EUCTR)
03/07/200704/04/2007A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RAA randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA Rheumatoid arthritis
MedDRA version: 8.1;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
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
288Phase 2Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2330EUCTR2006-006746-33-DE
(EUCTR)
28/06/200712/03/2007Re-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IRRe-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IR Rheumatoid arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
Roche Pharma AGNULLNot RecruitingFemale: yes
Male: yes
240Germany
2331EUCTR2006-005466-39-HU
(EUCTR)
25/06/200722/03/2007A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD TherapyA Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: BG9924Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
380Phase 2Hungary;United Kingdom
2332EUCTR2007-000491-16-BE
(EUCTR)
22/06/200704/05/2007A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not availableA 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available Rheumatoid Arthritis
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 Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
Spain;Belgium;Austria;Germany
2333EUCTR2007-000760-24-CZ
(EUCTR)
21/06/200709/05/2007Activity and safety of oral administration of SSR150106XB for the reduction of inflammation in patients with active rheumatoid arthritis (RA): A 4-week, multi-center, randomized, double-blind, placebo-controlled parallel group study of 90 µg administrered once daily and 90µg once every other day - ACCORD-RAActivity and safety of oral administration of SSR150106XB for the reduction of inflammation in patients with active rheumatoid arthritis (RA): A 4-week, multi-center, randomized, double-blind, placebo-controlled parallel group study of 90 µg administrered once daily and 90µg once every other day - ACCORD-RA Patients with active rheumatoid arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: SSR150106XB
Product Code: SSR150106XB
INN or Proposed INN: NA
Other descriptive name: NA
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
75Phase 2Czech Republic
2334EUCTR2006-005137-38-FR
(EUCTR)
19/06/200710/04/2007A 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:
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 FranceNULLNot RecruitingFemale: yes
Male: yes
724Phase 3France;Finland;Denmark;Germany;United Kingdom;Sweden
2335EUCTR2006-001553-10-DE
(EUCTR)
19/06/200721/02/2007A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204 Early Rheumatoid Arthritis in adults
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ACZ885
Product Code: ACZ885
Trade Name: Methotrexat 2,5 mg Tabletten medac
Product Name: Methotrexate (MTX)
INN or Proposed INN: Methotrexate
Other descriptive name: MTX
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
92Phase 2Germany;Netherlands;Italy
2336EUCTR2006-005137-38-FI
(EUCTR)
18/06/200715/05/2007A 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:
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 FranceNULLNot RecruitingFemale: yes
Male: yes
534Finland;Germany;United Kingdom;Denmark;France;Sweden
2337EUCTR2007-000491-16-DE
(EUCTR)
08/06/200722/03/2007A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not availableA 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200Germany;Spain;Austria
2338EUCTR2006-005330-20-BE
(EUCTR)
07/06/200728/02/2007anti TNF-IR phase IIIA randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. Rheumatoid arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3France;Czech Republic;Hungary;Slovakia;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2339EUCTR2006-004140-23-CZ
(EUCTR)
06/06/200718/12/2006A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RAA randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA Rheumatoid arthritis
MedDRA version: 8.1;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
Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Bulgaria;Germany;Netherlands;United Kingdom;Italy;Sweden
2340EUCTR2006-004140-23-SE
(EUCTR)
04/06/200703/05/2007A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RAA randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA Rheumatoid arthritis
MedDRA version: 8.1;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
Merck Serono Int, a branch ofLaboratories Serono S.A. an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2341EUCTR2006-004666-14-BE
(EUCTR)
04/06/200729/03/2007An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not availableAn exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available Rheumatoid Arthritis
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 Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
32Belgium;Germany
2342EUCTR2006-003054-26-LV
(EUCTR)
01/06/200712/09/2007A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: TAK-783Takeda Global R&D (Europe) LtdNULLNot RecruitingFemale: yes
Male: yes
230Hungary;Czech Republic;Latvia
2343EUCTR2006-005330-20-HU
(EUCTR)
01/06/200710/04/2007A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy.A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. Rheumatoid arthritis
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 LtdNULLNot RecruitingFemale: yes
Male: yes
1000France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2344EUCTR2006-003768-67-GB
(EUCTR)
01/06/200712/02/2007A 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 MethotrexateRevised Protocol 02, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), and Administrative Letter 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 MethotrexateRevised Protocol 02, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), and Administrative Letter dated 13-Jun-2007. RHEUMATOID ARTHRITIS,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 CorporationNULLNot RecruitingFemale: yes
Male: yes
58Phase 3Spain;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden
2345EUCTR2006-005035-19-IT
(EUCTR)
01/06/200704/07/2007A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550, A MODERATELY SELECTIVE JANUS-KINASE-3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS - NDA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550, A MODERATELY SELECTIVE JANUS-KINASE-3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS - ND Relief of signs and symptoms, improvement of physical function, and structure preservation in rheumatoid arthritis RA .
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Product Name: CP-690,550
PFIZERNULLNot RecruitingFemale: yes
Male: yes
550Phase 2Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Sweden
2346NCT00447759
(ClinicalTrials.gov)
June 200714/3/2007The Standard Care Versus Celecoxib Outcome TrialPhase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID'sOsteoarthritis;Rheumatoid ArthritisDrug: Celecoxib;Drug: DiclofenacUniversity of DundeeUniversity of Glasgow;University of NottinghamCompleted60 YearsN/AAll7297Phase 4Denmark;Netherlands;United Kingdom
2347NCT00422227
(ClinicalTrials.gov)
June 200711/1/2007Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific RegionA Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: Etanercept , Methotrexate;Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomideWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsAll300Phase 4Hong Kong;India;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand
2348EUCTR2006-004140-23-DE
(EUCTR)
31/05/200714/08/2007A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RAA randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA Rheumatoid arthritis
MedDRA version: 8.1;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
Merck Serono Int, a branch of Laboratoires Seron SA an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Portugal;Greece;Finland;Spain;Belgium;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Sweden
2349EUCTR2006-005137-38-SE
(EUCTR)
29/05/200730/04/2007A 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:
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 FranceNULLNot RecruitingFemale: yes
Male: yes
534Finland;Germany;United Kingdom;Denmark;France;Sweden
2350EUCTR2007-000082-38-DK
(EUCTR)
24/05/200726/03/2007The OPERA Study. Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis. A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development. - The OPERA StudyThe OPERA Study. Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis. A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development. - The OPERA Study In early RA methotrexate and intra-articular glucocorticoid in combination with adalimumab is better than methotrexate and intra-articular glucocorticoid in achieving control of the disease as assessed by DAS28 < 3.2.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Humira (adalimumab)
Product Name: Humira® (adalimumab)
Product Code: 2593
INN or Proposed INN: Adalimumab
Aarhus University Hospital, DenmarkNULLNot RecruitingFemale: yes
Male: yes
180Phase 4Denmark
2351EUCTR2006-005147-28-BE
(EUCTR)
24/05/200721/02/2007A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. Rheumatoid Arthritis (RA)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3France;Greece;Spain;Belgium;Austria;Germany;United Kingdom
2352EUCTR2006-001553-10-NL
(EUCTR)
23/05/200702/04/2007A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204 Early Rheumatoid Arthritis in adults
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: ACZ885
INN or Proposed INN: ACZ885 Drug Substance
Other descriptive name: ACZ885 Drug Substance
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
92Phase 2Germany;Netherlands;Italy
2353EUCTR2006-005036-24-SK
(EUCTR)
21/05/200703/04/2007A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/AA PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-
Product Name: CP-690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-
Pfizer Ltd - Ramsgate Road, Sandwich CT139NJ, UK.NULLNot RecruitingFemale: yes
Male: yes
483Phase 2Hungary;Czech Republic;Slovakia;Bulgaria;Sweden
2354EUCTR2006-003768-67-NL
(EUCTR)
16/05/200727/03/2007A 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 MethotrexateA 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 RHEUMATOID ARTHRITIS,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 CorporationNULLNot RecruitingFemale: yes
Male: yes
58Phase 3Germany;United Kingdom;Netherlands;Spain;Austria;Sweden
2355EUCTR2007-001190-28-GB
(EUCTR)
09/05/200717/04/2007Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACITRandomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Methotrexate
Product Code: Methotrexate
INN or Proposed INN: METHOTREXATE
Product Name: Sulfasalazine
Product Code: Sulfasalazine
INN or Proposed INN: SULFASALAZINE
Product Name: Hydroxychloroquine
Product Code: Hydroxychloroquine
INN or Proposed INN: Hydroxychloroquine
Product Name: Ciclosporin
Product Code: Ciclosporin
INN or Proposed INN: Ciclosporin
Product Name: Leflunomide
Product Code: Leflunomide
INN or Proposed INN: Leflunomide
Product Name: Sodium aurothiomalate (intramuscular gold)
Product Code: Sodium aurothiomalate (intramuscular gold)
INN or Proposed INN: Sodium aurothiomalate
Product Name: methylprednisolone
Product Code: methylprednisolone
INN or Proposed INN: Methylprednisolone
Product Name: Prednisolone
Product Code: Predniso
King's College LondonNULLNot RecruitingFemale: yes
Male: yes
190Phase 4United Kingdom
2356EUCTR2006-005467-26-BE
(EUCTR)
08/05/200714/02/2007A phase 2b, randomised, double-blind, placebo-controlled, multi-centre, dose-finding study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of BG9924 when given in combination with methotrexate to subjects with active Rheumatoid Arthritis who have had an inadequate response to anti-TNF therapyA phase 2b, randomised, double-blind, placebo-controlled, multi-centre, dose-finding study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of BG9924 when given in combination with methotrexate to subjects with active Rheumatoid Arthritis who have had an inadequate response to anti-TNF therapy Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: BG9924Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;United Kingdom
2357EUCTR2006-005147-28-FR
(EUCTR)
07/05/200706/03/2007A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. Rheumatoid Arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ocrelizumab
Product Code: RO 496-4913/F03
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3France;Greece;Spain;Belgium;Austria;Germany;United Kingdom
2358EUCTR2006-006373-25-SE
(EUCTR)
04/05/200716/03/2007A 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-690,550Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UKNULLNot RecruitingFemale: yes
Male: yes
300Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
2359EUCTR2006-005036-24-SE
(EUCTR)
04/05/200716/03/2007A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/AA PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-
Product Name: CP-690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-
Pfizer Ltd - Ramsgate Road, Sandwich CT139NJ, UK.NULLNot RecruitingFemale: yes
Male: yes
483Phase 2Hungary;Czech Republic;Bulgaria;Sweden
2360EUCTR2006-005035-19-SE
(EUCTR)
04/05/200716/03/2007A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4500Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
2361EUCTR2006-004139-31-SE
(EUCTR)
02/05/200712/02/2007A 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. - OPTIMAA 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. - OPTIMA Rheumatoid Arthritis.
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. KGNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden
2362NCT00504595
(ClinicalTrials.gov)
May 200719/7/2007Safety and Efficacy of ACZ885 in Adult Patients With Established Rheumatoid ArthritisA 12-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR20) and to Determine a Biomarker Profile in Adult Patients With Established Rheumatoid Arthritis Responding to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) as Compared to Healthy Subjects Exposed to ACZ885Rheumatoid ArthritisDrug: ACZ885 (investigational);Drug: PlaceboNovartisNULLCompleted18 Years75 YearsAll80Phase 2Russian Federation;Spain;Switzerland;Turkey
2363NCT00455208
(ClinicalTrials.gov)
May 200730/3/2007A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and OsteoarthritisStudy Evaluating Cura-100 in Rheumatoid Arthritis and OsteoarthritisRheumatoid Arthritis;OsteoarthritisDrug: Cura-100Cura Biotech LLCNULLNot yet recruiting20 Years50 YearsBoth20Phase 1/Phase 2United States
2364EUCTR2007-000491-16-ES
(EUCTR)
30/04/200705/03/2007Estudio 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 availableEstudio 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.NULLNot RecruitingFemale: yes
Male: yes
Belgium;Spain;Austria;Germany
2365EUCTR2006-003768-67-BE
(EUCTR)
27/04/200723/04/2007A 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 MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter 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 MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007. RHEUMATOID ARTHRITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
58Phase 3Spain;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden
2366EUCTR2006-004140-23-ES
(EUCTR)
24/04/200705/03/2007Estudio 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 IIEstudio 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.NULLNot RecruitingFemale: yes
Male: yes
288Phase 2Portugal;Slovakia;Greece;Finland;Spain;Italy;United Kingdom;Czech Republic;Belgium;Bulgaria;Netherlands;Germany;Sweden
2367EUCTR2006-004139-31-ES
(EUCTR)
23/04/200725/01/2007A 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. - OPTIMAA 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. KGNULLNot RecruitingFemale: yes
Male: yes
1000France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden
2368EUCTR2005-002660-29-HU
(EUCTR)
20/04/200708/11/2005A Phase 1b/2 Multiple-Dose Safety and Pharmacokinetic/Pharmacodynamic Study of LY2189102 in Patients with Rheumatoid ArthritisA Phase 1b/2 Multiple-Dose Safety and Pharmacokinetic/Pharmacodynamic Study of LY2189102 in Patients with Rheumatoid Arthritis Rheumatoid ArthritisProduct Name: Anti IL-1ß antibody
Product Code: LY2189102
Other descriptive name: Anti IL-1ß antibody, subclass IgG4
Eli Lilly and Company LimitedNULLNot RecruitingFemale: yes
Male: yes
135Phase 1Hungary;Spain
2369EUCTR2006-002216-10-NL
(EUCTR)
20/04/200702/11/2006A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACERA Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: PG-760564
Product Code: PG-760564
Procter & Gamble PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
270Hungary;United Kingdom;Czech Republic;Netherlands
2370EUCTR2006-006373-25-SK
(EUCTR)
20/04/200703/04/2007A 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/AA 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-690,550Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UKNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden
2371EUCTR2006-005035-19-BE
(EUCTR)
17/04/200709/01/2007A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A 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]
Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4500Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
2372EUCTR2006-005147-28-AT
(EUCTR)
16/04/200723/03/2007A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. - STAGEA randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. - STAGE Rheumatoid Arthritis (RA)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3France;Greece;Spain;Belgium;Austria;Germany;United Kingdom
2373EUCTR2006-005467-26-GB
(EUCTR)
12/04/200716/01/2007A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF TherapyA Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapy Rheumatoid Arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: BG9924Biogen Idec LtdNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelgium;United Kingdom
2374EUCTR2006-005466-39-GB
(EUCTR)
12/04/200707/01/2007A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD TherapyA Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: BG9924Biogen Idec LtdNULLNot Recruiting Female: yes
Male: yes
380 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;United Kingdom
2375EUCTR2006-004140-23-BE
(EUCTR)
10/04/200707/02/2007A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RAA randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA Rheumatoid arthritis
MedDRA version: 8.1;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
Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2376EUCTR2006-004669-32-ES
(EUCTR)
09/04/200706/02/2007Estudio 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 availableEstudio 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.ANULLNot RecruitingFemale: yes
Male: yes
80Spain
2377EUCTR2006-006032-22-GB
(EUCTR)
04/04/200726/02/2007TRial of Atorvastatin for the primary prevention of Cardiovascular Events in Rheumatoid Arthritis - TRACE RATRial of Atorvastatin for the primary prevention of Cardiovascular Events in Rheumatoid Arthritis - TRACE RA Rheumatoid arthritis is associated with increased mortality from cardiovascular disease (CVD). Statins have a proven effect in reducing CVD events in at-risk populations, mostly due to their cholesterol-lowering properties, but possibly through anti-inflammatory and immunomodulatory effects. This trial will assess the hypothesis that atorvastatin is more effective than placebo in the primary prevention of cardiovascular events in patients with RA.Product Name: Atorvastatin
INN or Proposed INN: ATORVASTATIN
University of ManchesterDudley Group of Hospitals NHS Trust Not Recruiting Female: yes
Male: yes
5350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom
2378EUCTR2006-004139-31-BE
(EUCTR)
03/04/200719/12/2006A 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. - OPTIMAA 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. - OPTIMA Rheumatoid Arthritis.
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. KGNULLNot RecruitingFemale: yes
Male: yes
1000France;Hungary;Czech Republic;Greece;Spain;Belgium;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
2379EUCTR2005-003558-83-EE
(EUCTR)
02/04/200707/02/2007A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Sweden;Austria;Latvia;Italy;Spain;Ireland;Estonia;Netherlands;United Kingdom;Czech Republic
2380EUCTR2006-004140-23-SK
(EUCTR)
02/04/200719/01/2007A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RAA randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA Rheumatoid arthritis
MedDRA version: 8.1;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
Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Portugal;Slovakia;Greece;Finland;Spain;Italy;United Kingdom;Czech Republic;Belgium;Bulgaria;Netherlands;Germany;Sweden
2381NCT00484237
(ClinicalTrials.gov)
April 20077/6/2007A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid ArthritisA Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Safety and Efficacy of Etanercept 10 mg Twice Weekly and 25 mg Once Weekly in Japanese Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: etanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted20 Years75 YearsBoth80Phase 3Japan
2382EUCTR2006-005035-19-ES
(EUCTR)
26/03/200723/01/2007ESTUDIO ABIERTO DE SEGUIMIENTO A LARGO PLAZO DE CP-690,550, UN INHIBIDOR DE LA JANUS QUINASA 3 MODERADAMENTE SELECTIVO, PARA EL TRATAMIENTO DE LA ARTRITIS REUMATOIDEA LONG TERM, OPEN LABEL FOLLOW UP STUDY OF CP 690,550, A MODERATELY SELECTIVE JANUS KINASE 3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS. - N/AESTUDIO ABIERTO DE SEGUIMIENTO A LARGO PLAZO DE CP-690,550, UN INHIBIDOR DE LA JANUS QUINASA 3 MODERADAMENTE SELECTIVO, PARA EL TRATAMIENTO DE LA ARTRITIS REUMATOIDEA LONG TERM, OPEN LABEL FOLLOW UP STUDY OF CP 690,550, A MODERATELY SELECTIVE JANUS KINASE 3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS. - N/A Artritis reumatoide (AR)Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: (3R,4R)-4-metil-3-(metil-1H-pirrolo [2,3-d]pirimidin-4-ilamino)-ß-oxo-1-
Product Name: CP-690,550
Other descriptive name: (3R,4R)-4-metil-3-(metil-1H-pirrolo [2,3-d]pirimidin-4-ilamino)-ß-oxo-1-
Pfizer S.A.NULLNot RecruitingFemale: yes
Male: yes
550Phase 2Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Sweden
2383EUCTR2006-006373-25-ES
(EUCTR)
23/03/200724/01/2007ESTUDIO 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-690,550Pfizer, S.A.NULLNot RecruitingFemale: yes
Male: yes
300Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
2384EUCTR2006-003768-67-SE
(EUCTR)
23/03/200707/02/2007A 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 MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter 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 MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007. RHEUMATOID ARTHRITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
58Phase 3Germany;United Kingdom;Netherlands;Spain;Austria;Sweden
2385EUCTR2006-001553-10-BE
(EUCTR)
20/03/200721/02/2007A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204 Early Rheumatoid Arthritis in adults
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: ACZ885
INN or Proposed INN: ACZ885 Drug Substance
Other descriptive name: ACZ885 Drug Substance
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
92 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelgium;Netherlands;Germany;Italy
2386EUCTR2006-003768-67-DE
(EUCTR)
19/03/200719/02/2007A 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 MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007. And Protocol Amemdment 02 - Site specific (Version 1.0, Dated 16-May-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 MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007. And Protocol Amemdment 02 - Site specific (Version 1.0, Dated 16-May-2007) RHEUMATOID ARTHRITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
58Phase 3United Kingdom;Germany;Netherlands;Spain;Austria;Sweden
2387EUCTR2006-004139-31-FR
(EUCTR)
12/03/200712/02/2007A 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. - OPTIMAA 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. - OPTIMA Rheumatoid Arthritis.
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. KGNULLNot RecruitingFemale: yes
Male: yes
1000Phase 4Slovakia;Greece;Spain;Austria;United Kingdom;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Norway;Sweden
2388EUCTR2006-004140-23-BG
(EUCTR)
09/03/200701/03/2007A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RAA randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA Rheumatoid arthritis
MedDRA version: 8.1;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.NULLNot RecruitingFemale: yes
Male: yes
288Phase 2Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2389EUCTR2005-002909-23-PT
(EUCTR)
08/03/200703/01/2007Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NALong-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA Rheumatoid arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;Italy;United Kingdom;Sweden
2390EUCTR2006-003146-41-DE
(EUCTR)
08/03/200723/11/2006A CONTROLLED RANDOMIZED DOUBLE-BLIND MULTICENTER STUDY COMPARING TWO THERAPY STRATEGIES IN DMARD-NAIVE EARLY RHEUMATOID ARTHRITIS PATIENTS OVER 48 WEEKS: INDUCTION THERAPY WITH ADALIMUMAB AND METHOTREXATE OVER 24 WEEKS FOLLOWED BY METHOTREXATE MONOTHERAPY UP TO WEEK 48 VS. METHOTREXATE MONOTHERAPY - HIT HARDA CONTROLLED RANDOMIZED DOUBLE-BLIND MULTICENTER STUDY COMPARING TWO THERAPY STRATEGIES IN DMARD-NAIVE EARLY RHEUMATOID ARTHRITIS PATIENTS OVER 48 WEEKS: INDUCTION THERAPY WITH ADALIMUMAB AND METHOTREXATE OVER 24 WEEKS FOLLOWED BY METHOTREXATE MONOTHERAPY UP TO WEEK 48 VS. METHOTREXATE MONOTHERAPY - HIT HARD Musculoskeletal disorders
MedDRA version: 8.1;Level: LLT;Classification code 10048592;Term: Musculoskeletal disorder
Trade Name: Humira
Product Name: HUMIRA
INN or Proposed INN: Adalimumab
Trade Name: Metex
Product Name: Metex
Charité-Universitätsmedizin Berlin; Department of Rheumatology and Clinical ImmunologyNULLNot RecruitingFemale: yes
Male: yes
Germany
2391EUCTR2006-004139-31-GB
(EUCTR)
06/03/200702/01/2007A 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. - OPTIMAA 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. - OPTIMA Rheumatoid Arthritis.
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. KGNULLNot RecruitingFemale: yes
Male: yes
1000France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden
2392EUCTR2005-003558-83-LV
(EUCTR)
02/03/200712/02/2007A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden
2393NCT00487825
(ClinicalTrials.gov)
March 200718/6/2007Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid ArthritisA 26-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR50) and to Determine a Biomarker Profile in Responders to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) Plus MTX as Compared to MTX Alone in Early Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: Canakinumab (investigational);Drug: Placebo;Drug: Methotrexate (MTX)NovartisNULLCompleted18 Years75 YearsAll78Phase 2United States;Belgium;Germany;Italy;Netherlands;Spain
2394EUCTR2006-004140-23-IT
(EUCTR)
26/02/200711/04/2007A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A phase II dose-finding study of atacicept in RAA randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A phase II dose-finding study of atacicept in RA RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ATACICEPT
Product Code: TACI - FC5
SERONO INTERNATIONAL SANULLNot RecruitingFemale: yes
Male: yes
288Phase 2Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2395EUCTR2006-006380-22-DE
(EUCTR)
22/02/200728/12/2006Biological dosimetry in radiation synovectomy of small finger joints with Erbium [169Er] citrate - ER-MM1 biological dosimetryBiological dosimetry in radiation synovectomy of small finger joints with Erbium [169Er] citrate - ER-MM1 biological dosimetry Patients with rheumatoid arthritis or seronegative spondylarthropathy with at least one inflamed finger joint (MCP, PIP, DIP) referred for RSO with with Erbium [169Er]citrate
MedDRA version: 8.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions
Trade Name: ERMM-1
INN or Proposed INN: erbium citrate
CIS bio internationalNULLNot RecruitingFemale: yes
Male: yes
10Phase 4Germany
2396EUCTR2006-002216-10-HU
(EUCTR)
15/02/200725/10/2006A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACERA Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: PG-760564
Product Code: PG-760564
Procter & Gamble PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
270Hungary;United Kingdom;Czech Republic;Netherlands
2397EUCTR2006-004139-31-SK
(EUCTR)
15/02/200719/01/2007A 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. - OPTIMAA 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. - OPTIMA Rheumatoid Arthritis.
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. KGNULLNot RecruitingFemale: yes
Male: yes
1000Phase 4Slovakia;Greece;Spain;Austria;United Kingdom;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Norway;Sweden
2398EUCTR2006-005035-19-AT
(EUCTR)
15/02/200712/02/2007A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A 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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
2399EUCTR2006-006373-25-AT
(EUCTR)
15/02/200712/02/2007A 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-690,550Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UKNULLNot RecruitingFemale: yes
Male: yes
300Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
2400EUCTR2006-001550-27-DE
(EUCTR)
13/02/200719/10/2006A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexateA 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate Active Rheumatoid ArthritisProduct Name: ACZ885
Product Code: ACZ885
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
293Finland;Spain;Austria;Germany
2401EUCTR2006-004139-31-AT
(EUCTR)
13/02/200706/02/2007A 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. - OPTIMAA 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. - OPTIMA Rheumatoid Arthritis.
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. KGNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden
2402EUCTR2006-001550-27-FI
(EUCTR)
13/02/200710/10/2006A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not availableA 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available Active Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: N/A
Other descriptive name: N/A
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
260Finland;Germany;Spain;Austria
2403EUCTR2004-002993-49-EE
(EUCTR)
02/02/200723/02/2005A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study Rheumatoid Arthritis
Classification code 10039073
Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
950Phase 3Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania
2404EUCTR2005-003558-83-IE
(EUCTR)
01/02/200713/03/2006A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)Product Code: AMG 108Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Czech Republic;United Kingdom;Netherlands;Estonia;Spain;Ireland;Italy;Latvia;Austria;Sweden
2405NCT00418717
(ClinicalTrials.gov)
February 20072/1/2007Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RAAn Open-label, Multicenter, Dose-regimen Study Evaluating the Efficacy and Safety of Etanercept 50 mg Once-weekly Dose in Japanese Subjects With Rheumatoid ArthritisArthritis, RheumatoidDrug: etanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted20 Years75 YearsAll42Phase 3Japan
2406NCT00425932
(ClinicalTrials.gov)
February 200722/1/2007Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid ArthritisImpact of Rituximab on Magnetic Resonance Imaging Evidence of Synovitis and Bone Lesions in Patients With Moderate or Severe Rheumatoid ArthritisRheumatoid ArthritisBiological: RituximabGaylis, Norman B., M.D.Oklahoma Medical Research Foundation;Genentech, Inc.Completed18 Years80 YearsBoth60Phase 2United States
2407EUCTR2004-001234-17-GR
(EUCTR)
30/01/200718/09/2006Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not ApplicableDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Trade Name: Celebrex
Product Name: Celebrex
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltrarol SR
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer HellasNot RecruitingFemale: yes
Male: yes
4402Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
2408EUCTR2006-001553-10-IT
(EUCTR)
26/01/200715/05/2007A 26-week, phase II, multi-center, randomized, doubleblind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - NDA 26-week, phase II, multi-center, randomized, doubleblind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - ND Early rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ACZ885
Product Code: ACZ885
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
87Phase 2Germany;Netherlands;Italy
2409EUCTR2006-002216-10-GB
(EUCTR)
22/01/200716/02/2012A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACERA Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: PG-760564
Product Code: PG-760564
Procter & Gamble PharmaceuticalsNULLNot Recruiting Female: yes
Male: yes
270 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Czech Republic;Netherlands;United Kingdom
2410EUCTR2004-001234-17-EE
(EUCTR)
22/01/200729/12/2005Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - N/ADouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - N/A Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Trade Name: Celebrex
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltarol SR (generics also available in the EU)
Product Name: Voltarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer Inc. New YorkNot RecruitingFemale: yes
Male: yes
4402Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
2411EUCTR2006-003983-73-CZ
(EUCTR)
17/01/200722/11/2006A Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients with Active Rheumatoid Arthritis Despite Methotrexate TherapyA Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: RWJ-445380 Capsules 50 mg
Product Code: RWJ-445380-002
Other descriptive name: JNJ-16240159-AAC
Product Name: RWJ-445380 capsule 100 mg
Product Code: RWJ-445380-002
Other descriptive name: JNJ-16240159-AAC
Product Name: RWJ-445380 capsules 150 mg
Product Code: RWJ-445380-002
Other descriptive name: JNJ-16240159-AAC
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
240Phase 2Germany;Czech Republic
2412EUCTR2006-006275-21-GB
(EUCTR)
10/01/200718/10/2011A Randomised, Pragmatic, Open-label study of Adalimumab versus Etanercept for Rheumatoid Arthritis. - Adalimumab versus Etanercept for RAA 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 TrustNULLNot 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): yesUnited Kingdom
2413NCT00716248
(ClinicalTrials.gov)
January 20078/7/2008Bucillamine Study of Holding Remission After Infliximab Dose-offThe Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving MethotrexateRheumatoid ArthritisDrug: bucillamine;Drug: methotrexateSaitama Medical UniversityKeio UniversityActive, not recruiting20 YearsN/ABoth40Phase 4Japan
2414EUCTR2005-001889-13-FR
(EUCTR)
27/12/200630/11/2006Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3 Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab.
MedDRA version: 8.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up
Trade Name: Remicade
INN or Proposed INN: Infliximab
Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.NULLNot Recruiting Female: yes
Male: yes
315 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Portugal;France;Belgium;Denmark;Austria;Germany;Netherlands;Sweden
2415EUCTR2006-003698-29-BE
(EUCTR)
18/12/200613/11/2006A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid ArthritisA Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784France;Estonia;Hungary;Czech Republic;Belgium;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden
2416EUCTR2006-003698-29-GB
(EUCTR)
14/12/200629/09/2006A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid ArthritisA Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Hungary;Czech Republic;United Kingdom;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2417EUCTR2006-004140-23-NL
(EUCTR)
13/12/200626/04/2007A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RAA randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA Rheumatoid arthritis
MedDRA version: 8.1;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
Merck Serono Int.a branch of Laboratoires Serono SA an affiliate of Merck KgaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2418EUCTR2005-003232-21-DE
(EUCTR)
11/12/200604/09/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid Arthritis (RA)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
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium tablets 2.5 mg
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
625Hungary;Germany;Malta;Latvia;Lithuania
2419EUCTR2005-003232-21-MT
(EUCTR)
07/12/200618/01/2007A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid Arthritis (RA)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
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium tablets 2.5 mg
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
625Hungary;Germany;Malta;Latvia;Lithuania
2420EUCTR2006-003577-27-EE
(EUCTR)
01/12/200629/09/2006A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOIDARTHRITIS. - naA 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOIDARTHRITIS. - na Treatment of rheumatoid arthritis (RA)
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 Luxembourg SARL Branch Office EstoniaNULLNot RecruitingFemale: yes
Male: yes
290Phase 2Czech Republic;Estonia;Spain
2421NCT00413452
(ClinicalTrials.gov)
December 200615/12/2006Etanercept SFP in RA PatientsOpen-Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis.Rheumatoid ArthritisDrug: EtanerceptAmgenWyeth is now a wholly owned subsidiary of PfizerCompleted18 YearsN/ABoth224Phase 3United States;Canada
2422NCT00440492
(ClinicalTrials.gov)
December 200623/2/2007Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid ArthritisAn Open-Label Study To Evaluate The Potential Pharmacokinetic Interaction Between PLA-695 And Methotrexate When Coadministered Orally To Adult Subjects With Rheumatoid ArthritisArthritis, RheumatoidDrug: PLA-695Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years75 YearsBothPhase 1United States;Canada
2423EUCTR2006-003142-42-DE
(EUCTR)
30/11/200602/02/2007A Randomized, Double Blind, Placebo-controlled, Proof of Concept Study to evaluate Efficacy, Safety and Pharmacokinetics of two Different Doses of SC12267 (20mg, 35 mg) in Patients with Rheumatoid ArthritisA Randomized, Double Blind, Placebo-controlled, Proof of Concept Study to evaluate Efficacy, Safety and Pharmacokinetics of two Different Doses of SC12267 (20mg, 35 mg) in Patients with Rheumatoid Arthritis Active Rheumatoid Arthritis
MedDRA version: 8.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: SC122674SC AGNULLNot RecruitingFemale: yes
Male: yes
120Germany
2424EUCTR2005-003232-21-LT
(EUCTR)
30/11/200610/10/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid Arthritis (RA)
MedDRA version: 8.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
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 Liquid in Vial
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
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Product Name: Golimumab pre-filled syringe
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.NULLNot RecruitingFemale: yes
Male: yes
625Hungary;Germany;Malta;Latvia;Lithuania
2425EUCTR2006-003577-27-CZ
(EUCTR)
29/11/200611/10/2006A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOIDARTHRITIS. - naA 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOIDARTHRITIS. - na Treatment of rheumatoid arthritis (RA)
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 LtdNULLNot RecruitingFemale: yes
Male: yes
290Phase 2Czech Republic;Estonia;Spain
2426EUCTR2006-002216-10-CZ
(EUCTR)
27/11/200612/10/2006A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACERA Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: PG-760564
Product Code: PG-760564
Procter & Gamble PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
270Hungary;United Kingdom;Czech Republic;Netherlands
2427EUCTR2005-003232-21-HU
(EUCTR)
22/11/200606/09/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid Arthritis (RA)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 Liquid in Vial
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
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Product Name: Golimumab Pre-Filled Syringe
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.NULLNot RecruitingFemale: yes
Male: yes
625Hungary;Germany;Malta;Latvia;Lithuania
2428NCT00072982
(ClinicalTrials.gov)
November 200613/11/2003Treatment of Rheumatoid Arthritis With Marine and Botanical OilsTreatment of Rheumatoid Arthritis With Marine and Botanical OilsRheumatoid ArthritisDrug: fish oil;Drug: borage seed oil;Drug: combination fish oil and borage seed oilNational Center for Complementary and Integrative Health (NCCIH)NULLActive, not recruiting18 Years85 YearsBoth156Phase 3United States
2429NCT00396812
(ClinicalTrials.gov)
November 20066/11/2006Rituximab for the Treatment of Early Rheumatoid Arthritis (RA)An Open Label, Single Arm, Single Center, Phase I/II Trial of Rituximab (a Monoclonal Antibody to CD20) for the Treatment of Early Rheumatoid ArthritisRheumatoid ArthritisDrug: RituximabNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceTerminated18 YearsN/AAll4Phase 1/Phase 2United States
2430NCT00589485
(ClinicalTrials.gov)
November 200621/12/2007Total Knee Replacement Using Simplex® or Cobalt™ Bone CementTotal Knee Replacement Using Simplex® or Cobalt™ Bone CementOsteoarthritis;Rheumatoid Arthritis;Traumatic Arthritis;Knee ArthritisDevice: Simplex® Bone Cement;Device: Cobalt™ Bone CementZimmer BiometNew Lexington ClinicWithdrawn18 YearsN/AAll0N/AUnited States
2431NCT00395577
(ClinicalTrials.gov)
November 20061/11/2006A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 When Administered Concomitantly With MethotrexateRheumatoid ArthritisDrug: VX-702Vertex Pharmaceuticals IncorporatedNULLCompleted18 Years75 YearsBoth120Phase 2Bulgaria;Croatia;Former Serbia and Montenegro;Poland;Russian Federation;Slovenia
2432NCT00424346
(ClinicalTrials.gov)
November 200617/1/2007Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid ArthritisA 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) With Three Different Dose Regimens in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate Including 76-week and 96-week ExtensionsRheumatoid ArthritisDrug: Canakinumab;Drug: PlaceboNovartisNULLCompleted18 YearsN/AAll274Phase 2United States;Austria;Belgium;Canada;Germany;Spain;Finland
2433NCT00761514
(ClinicalTrials.gov)
November 200625/9/2008Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With HumiraEvaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira as Their First Anti-TNF Monoclonal Antibody (VIVIR)Rheumatoid ArthritisDrug: Humira (adalimumab)AbbottNULLTerminated18 YearsN/AAll14Phase 4Puerto Rico
2434NCT02079532
(ClinicalTrials.gov)
November 20064/3/2014A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF InhibitorAn Open-label Study to Evaluate the Safety of MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF AgentRheumatoid ArthritisDrug: rituximab [MabThera]Hoffmann-La RocheNULLCompleted18 Years75 YearsAll302Phase 3Germany
2435EUCTR2006-003698-29-NL
(EUCTR)
26/10/200614/06/2007A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid ArthritisA Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2436EUCTR2006-004715-22-SI
(EUCTR)
26/10/200617/10/2006A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 when Administered Concomitantly with MethotrexateA Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 when Administered Concomitantly with Methotrexate Rheumatoid ArthritisProduct Code: VX-702Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Slovenia
2437EUCTR2005-002219-26-HU
(EUCTR)
25/10/200619/04/2006 A randomized, parallel group, placebo-controlled, double blind study to asses the safety and tolerability of SB 681323 at 7.5 mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatois arthritis” A randomized, parallel group, placebo-controlled, double blind study to asses the safety and tolerability of SB 681323 at 7.5 mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatois arthritis” Rheumatoid Arthritis patients with CRP higher than 10 mg/LProduct Code: SB 681323GlaxoSmithKlineNULLNot RecruitingFemale: yes
Male: yes
82Phase 2Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
2438EUCTR2006-001550-27-BE
(EUCTR)
23/10/200617/08/2006A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not availableA 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available Active Rheumatoid ArthritisProduct Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: N/A
Other descriptive name: N/A
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
260Finland;Spain;Belgium;Austria;Germany
2439EUCTR2006-003698-29-CZ
(EUCTR)
20/10/200629/08/2006A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid ArthritisA Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2440EUCTR2006-003698-29-SK
(EUCTR)
19/10/200629/09/2006A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid ArthritisA Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Phase 2Estonia;Slovakia;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Netherlands;Latvia;Sweden
2441EUCTR2006-004673-98-HU
(EUCTR)
16/10/200608/09/2006Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blockerEfficacy 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 infusionRoche (Hungary) Ltd.NULLNot RecruitingFemale: yes
Male: yes
20Hungary
2442EUCTR2006-003698-29-FR
(EUCTR)
05/10/200614/09/2006A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid ArthritisA Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Phase 2Estonia;Slovakia;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Netherlands;Latvia;Sweden
2443EUCTR2006-000363-28-GB
(EUCTR)
03/10/200628/04/2006DIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA StudyDIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA Study Rheumatoid arthritis and Psoriatic arthritisTrade Name: Remicade
Product Name: Infliximab
INN or Proposed INN: Infliximab
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: Etanercept
Greater Glasgow Health BoardGlasgow UniversityNot 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): yesUnited Kingdom
2444EUCTR2006-003698-29-SE
(EUCTR)
03/10/200617/08/2006A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid ArthritisA Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2445EUCTR2005-003232-21-LV
(EUCTR)
02/10/200629/09/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid Arthritis (RA)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
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium tablets 2.5 mg
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
625Hungary;Germany;Malta;Latvia;Lithuania
2446JPRN-UMIN000000512
2006/10/0103/11/2006Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate Rheumatoid ArthritisIf the score of DAS28 is under 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, doses of methotrexate will reduced to 2mg/w. When the score of DAS28 increses, tacrolimus will be administered instead of methotrexate. Period of observation is 32 weeks.
If the score of DAS28 is over 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, tacrolimus will be administered. Period of observation is 32 weeks.
Rheumatosurgery, Osaka City University Medical SchoolNULLComplete: follow-up completeNot applicableNot applicableMale and Female30Not applicableJapan
2447EUCTR2005-002396-33-HU
(EUCTR)
26/09/200607/07/2006A 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.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. Rheumatoid arthritisTrade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
375Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
2448EUCTR2006-005391-40-IT
(EUCTR)
25/09/200605/06/2007Study on the effect of intra-articular infiltrations of aulogous platelet gel as inhibitor of erosion in rheumatoid arthritis patients - NDStudy on the effect of intra-articular infiltrations of aulogous platelet gel as inhibitor of erosion in rheumatoid arthritis patients - ND Patients with Rheumatoid Arthritis
Level: PTClassification code 10039073
Product Name: Platelet Rich Plasma
INN or Proposed INN: Triamcinolone
AZIENDA OSPEDALIERA SENESENULLNot RecruitingFemale: yes
Male: yes
Italy
2449EUCTR2006-001000-37-DE
(EUCTR)
19/09/200616/06/2006Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRSTEfficacy and safety of rituximab in patients with rheumatoid arthritis - FIRST Rheumatoid arthritis
MedDRA version: 8.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
Roche Pharma AGNULLNot RecruitingFemale: yes
Male: yes
300Germany
2450EUCTR2006-001428-38-GB
(EUCTR)
18/09/200629/09/2006Remission Induction in Very Early Rheumatoid Arthritis (RIVERA):a comparison of etanercept plus methotrexate plus steroid with standard therapy - RIVERARemission 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 TrustNULLNot RecruitingFemale: yes
Male: yes
20Phase 4United Kingdom
2451EUCTR2006-001550-27-AT
(EUCTR)
18/09/200625/07/2006A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not availableA 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available Active Rheumatoid ArthritisProduct Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: N/A
Other descriptive name: N/A
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
260Finland;Germany;Spain;Austria
2452EUCTR2005-002396-33-SK
(EUCTR)
14/09/200615/06/2006A 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.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. Rheumatoid arthritisTrade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
375Hungary;Finland;United Kingdom;Germany;Slovakia;Spain;Italy
2453EUCTR2005-001742-16-NL
(EUCTR)
06/09/200622/03/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - NA Active rheumatoid arthritis (RA)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.NULLNot RecruitingFemale: yes
Male: yes
420Germany;United Kingdom;Netherlands;Spain;Austria
2454EUCTR2005-002219-26-NO
(EUCTR)
05/09/200618/07/2005A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA) Rheumatoid arthritis (RA)Product Name: SB-681323 Tablets
Product Code: SB-681323
GlaxoSmithKline R&D LtdNULLNot Recruiting Female: yes
Male: yes
82 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
2455EUCTR2004-001490-26-EE
(EUCTR)
01/09/200608/03/2006A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RAA MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA RHEUMATOID ARTHRITISTrade Name: Persantin 100 mg
Product Name: N/A
Product Code: CRx-150
INN or Proposed INN: Dipyridamole and Amoxapine
Trade Name: Defanyl 50 and 100 mg
Product Name: N/A
Product Code: CRx-150
CombinatoRx, IncNULLNot RecruitingFemale: yes
Male: yes
72United Kingdom;Estonia
2456EUCTR2005-006165-14-CZ
(EUCTR)
18/08/200624/08/2006A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NAA Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NA Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: MLN3897
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: AVE9897
Trade Name: Methotrexate(MTX) administration is at the discretion of the rheumatologist and no tradename is fixed by the protocol.
Product Name: Methotrexate
Product Code: N/A
INN or Proposed INN: Methotrexate
Other descriptive name: N/A
Millennium Pharmaceuticals Inc,NULLNot RecruitingFemale: yes
Male: yes
186Phase 2United Kingdom;Czech Republic;Netherlands
2457EUCTR2005-006165-14-NL
(EUCTR)
16/08/200601/06/2006A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NAA Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NA Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: MLN3897
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: AVE9897
Trade Name: Methotrexate(MTX) administration is at the discretion of the rheumatologist and no tradename is fixed by the protocol
Product Name: Methotrexate
Product Code: N/A
INN or Proposed INN: Methotrexate
Other descriptive name: N/A
Millennium Pharmaceuticals Inc,NULLNot RecruitingFemale: yes
Male: yes
186Phase 2Czech Republic;United Kingdom;Netherlands
2458EUCTR2005-002326-63-EE
(EUCTR)
09/08/200626/08/2005A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. Rheumatoid Arthritis
Classification code 10039073
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
590Phase 3Czech Republic;Estonia;Latvia;Lithuania
2459EUCTR2005-006165-14-GB
(EUCTR)
03/08/200611/05/2006A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NAA Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NA Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: MLN3897
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: AVE9897
Trade Name: Methotrexate(MTX) administration is at the discretion of the rheumatologist and no tradename is fixed by the protocol.
Product Name: Methotrexate
Product Code: N/A
INN or Proposed INN: Methotrexate
Other descriptive name: N/A
Millennium Pharmaceuticals Inc,NULLNot Recruiting Female: yes
Male: yes
186 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Netherlands;United Kingdom
2460JPRN-C000000452
2006/08/0101/08/2006Remission Induction of Very Early Rheumatoid Arthritis with Methotrexate and Etanercept rheumatoid arthritismethotrexate 8mg/week
methotrexate 8mg/week and
etanercept(25mg x1-2/week) for 3 months
methotrexate 8mg/week and
etanercept(25mgx1-2/week) for 6 months
Johoku Biological SummitNULLPendingNot applicableNot applicableMale and Female50Phase 4Japan
2461EUCTR2006-004062-13-IT
(EUCTR)
18/07/200630/08/2006Randomised, open label, no profit, clinical, multicenter study of phase II and IIIB to assess efficacy and tolerability of oxycodone/paracetamol compared to anti-inflammatory non-steroidal drugs FANS and corticosteroid, in patients suffering moderate to severe chronic pain due to rheumatoid arthritis. - Do.R.A.Randomised, open label, no profit, clinical, multicenter study of phase II and IIIB to assess efficacy and tolerability of oxycodone/paracetamol compared to anti-inflammatory non-steroidal drugs FANS and corticosteroid, in patients suffering moderate to severe chronic pain due to rheumatoid arthritis. - Do.R.A. RHEUMATOID ARTHRITIS
MedDRA version: 6.1;Level: PT;Classification code 10039073
Trade Name: DEPALGOS*20+325MG 28CPR RP
INN or Proposed INN: OXICODONE DC.IT
INN or Proposed INN: PARACETAMOLO DC.IT FU
A.U.S.L. RIMININULLNot RecruitingFemale: yes
Male: yes
149Phase 2Italy
2462EUCTR2005-001889-13-NL
(EUCTR)
13/07/200620/04/2006Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3 Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab.
MedDRA version: 8.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up
Trade Name: RemicadeIntegrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.NULLNot Recruiting Female: yes
Male: yes
315 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):France;Portugal;Belgium;Denmark;Austria;Germany;Netherlands;Sweden
2463EUCTR2005-003558-83-NL
(EUCTR)
13/07/200620/04/2006A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - Not availableA Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - Not available Rheumatoid arthritis (RA)Product Code: AMG 108Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden
2464EUCTR2004-003296-36-HU
(EUCTR)
10/07/200614/06/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy - NA Active rheumatoid arthritis (RA) despite methotrexate (MTX) therapyProduct 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
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
400Hungary;Germany
2465EUCTR2004-003295-10-HU
(EUCTR)
04/07/200630/12/2005A 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 Arthritis - NAA 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 Arthritis - NA Active Rheumatoid Arthritis (methotrexate [MTX]-naïve)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
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
600Hungary;United Kingdom;Spain;Italy
2466EUCTR2004-001234-17-GB
(EUCTR)
15/06/200615/09/2005Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not ApplicableDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Trade Name: Celebrex
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltrarol SR
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer LimitedNULLNot Recruiting Female: yes
Male: yes
4402 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yesPortugal;Estonia;Czech Republic;Greece;Belgium;Spain;Ireland;Lithuania;Latvia;Germany;United Kingdom;Sweden
2467EUCTR2005-003558-83-BE
(EUCTR)
09/06/200617/05/2006A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)Product Code: AMG 108Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Estonia;Czech Republic;Spain;Belgium;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden
2468EUCTR2005-001742-16-DE
(EUCTR)
07/06/200623/03/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTERA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER Active rheumatoid arthritis (RA)Product Name: Golimumab Liquid in Vial
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 Pre-Filled Syringe
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 Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
420United Kingdom;Germany;Netherlands;Spain;Austria
2469EUCTR2005-001742-16-ES
(EUCTR)
02/06/200619/04/2006Estudio 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 activaProduct 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.NULLNot RecruitingFemale: yes
Male: yes
420Germany;United Kingdom;Netherlands;Spain;Austria
2470NCT00443950
(ClinicalTrials.gov)
June 20065/3/2007Study Evaluating the Efficacy and Safety of Etanercept in Chinese Subjects With Rheumatoid ArthritisA Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Etanercept in Chinese Subjects With Active Rheumatoid Arthritis Receiving MethotrexateArthritis, RheumatoidDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/ABoth150Phase 3China
2471EUCTR2006-000854-32-AT
(EUCTR)
29/05/200619/05/2006Rituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-BlockersRituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-Blockers Rheumatoid ArthritisTrade Name: Rituximab - MabThera
Product Name: Rituximab MabThera
Product Code: no
Vienna Medical UniversityNULLNot RecruitingFemale: yes
Male: yes
20Austria
2472EUCTR2005-001742-16-GB
(EUCTR)
26/05/200603/03/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTERA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER Active rheumatoid arthritis (RA)Product Name: Golimumab Liquid in Vial
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 Pre-Filled Syringe
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.NULLNot Recruiting Female: yes
Male: yes
420 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFinland;Spain;Austria;Germany;Netherlands;United Kingdom
2473EUCTR2004-001234-17-SE
(EUCTR)
22/05/200627/10/2005Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not ApplicableDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Trade Name: celebra
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer ABNULLNot RecruitingFemale: yes
Male: yes
4402Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
2474EUCTR2005-001742-16-FI
(EUCTR)
17/05/200604/04/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTERA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER Active rheumatoid arthritis (RA)Product Name: Golimumab Liquid in Vial
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 Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
420Finland;Spain;Austria;Germany;Netherlands;United Kingdom
2475EUCTR2004-003295-10-GB
(EUCTR)
17/05/200608/12/2005A 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 Arthritis - NAA 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 Arthritis - NA Active Rheumatoid Arthritis (methotrexate [MTX]-naïve)Product Name: Golimumab Liquid in Vial
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: Methotrexate sodium tablets 2.5 mg
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Hungary;Spain;Austria;Italy;United Kingdom
2476EUCTR2005-002909-23-IS
(EUCTR)
08/05/200625/04/2006Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. Rheumatoid arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Germany;Iceland;Italy;United Kingdom;Sweden
2477EUCTR2005-001889-13-DK
(EUCTR)
04/05/200616/03/2006Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3 Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab.
MedDRA version: 8.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up
Trade Name: RemicadeIntegrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.NULLNot RecruitingFemale: yes
Male: yes
315Portugal;Germany;Netherlands;Belgium;Denmark;France;Greece;Sweden
2478EUCTR2005-000158-61-LT
(EUCTR)
03/05/200606/01/2006A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Trade Name: CELEBREX
Product Name: Celebrex
INN or Proposed INN: Celecoxib
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
2210Phase 3Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2479EUCTR2005-001889-13-GR
(EUCTR)
02/05/200623/05/2006Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3 Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab.Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Remicade
Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.NULLNot Recruiting Female: yes
Male: yes
315 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):France;Portugal;Greece;Belgium;Denmark;Austria;Germany;Netherlands;Sweden
2480EUCTR2005-001742-16-AT
(EUCTR)
01/05/200630/03/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTERA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER Active rheumatoid arthritis (RA)Product Name: Golimumab Liquid in Vial
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 Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
420Germany;United Kingdom;Netherlands;Spain;Austria
2481EUCTR2005-003558-83-IT
(EUCTR)
28/04/200623/06/2006A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis. - AMG 108A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis. - AMG 108 Rheumatoid Arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073
Product Code: AMG 108
Product Code: AMG 108
Product Code: AMG 108
AMGEN S.P.A.NULLNot RecruitingFemale: yes
Male: yes
784Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden
2482EUCTR2005-002396-33-DE
(EUCTR)
27/04/200610/11/2005A 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.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. Rheumatoid arthritisTrade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
375Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
2483EUCTR2005-002395-15-DE
(EUCTR)
27/04/200622/11/2005A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis. Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
2484EUCTR2004-003295-10-ES
(EUCTR)
25/04/200617/02/2006A 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 metotrexatoA 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 BVNULLNot RecruitingFemale: yes
Male: yes
600Hungary;United Kingdom;Spain;Italy
2485EUCTR2005-002392-32-DE
(EUCTR)
20/04/200629/09/2005A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis. Active rheumatoid arthritisTrade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
500Slovenia;Ireland;Germany;United Kingdom;Sweden
2486EUCTR2005-002909-23-FI
(EUCTR)
19/04/200623/01/2006Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. Rheumatoid arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden
2487EUCTR2005-000158-61-DE
(EUCTR)
18/04/200616/05/2006A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: Celecoxib
INN or Proposed INN: Celecoxib
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
2210Phase 3Hungary;Czech Republic;United Kingdom;Germany;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2488EUCTR2004-001930-18-EE
(EUCTR)
17/04/200619/01/2006A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RAA MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RA RHEUMATOID ARTHRITISTrade Name: Persantin 100 mg and
Product Name: N/A
Product Code: CRx-102
INN or Proposed INN: prednisolone & dipyridamole
CombinatoRx, IncNULLNot RecruitingFemale: yes
Male: yes
60Estonia
2489EUCTR2004-005102-68-CZ
(EUCTR)
14/04/200614/04/2006A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, Version 1.0 dated 7-Feb-2006.A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, Version 1.0 dated 7-Feb-2006. RHEUMATOID ARTHRITIS,NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Germany;United Kingdom;Czech Republic;Belgium;Spain;Ireland;Italy
2490EUCTR2005-003558-83-AT
(EUCTR)
13/04/200620/03/2006A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden
2491EUCTR2005-002909-23-IT
(EUCTR)
11/04/200614/03/2006Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. 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: RoActemra
INN or Proposed INN: Ro Actemra
F. Hoffmann - La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
2420Sweden;Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;United Kingdom;Italy
2492EUCTR2004-004995-35-DK
(EUCTR)
10/04/200620/09/2005A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RAA PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA ACTIVE RHEUMATOID ARTHRITISProduct Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone
CombinatoRx, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2Czech Republic;Germany;United Kingdom;Denmark;Italy
2493EUCTR2005-003558-83-CZ
(EUCTR)
07/04/200623/01/2006A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - AMG 108A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - AMG 108 Rheumatoid arthritis (RA)Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784United Kingdom;Czech Republic;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden
2494EUCTR2005-001889-13-PT
(EUCTR)
07/04/200617/01/2006Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3 Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab
Schering Plough Research Institute, a Division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
315Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden
2495EUCTR2005-005013-37-GB
(EUCTR)
06/04/200620/01/2006A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEAA multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA Early Rheumatoid ArthritisTrade Name: Remicade
Product Name: Remicade
Product Code: Infliximab
Trade Name: Mextrex
Product Name: Methotrexate
Product Code: Mextrex
INN or Proposed INN: n/a
Other descriptive name: Methotrexate
Trade Name: Ferrograd Folic Tablets
Product Name: Folic Acid
Product Code: Ferrograd
INN or Proposed INN: n/a
Other descriptive name: Folic Acid
Trade Name: Solu-Medrone 2 Gram
Product Name: Methylprednisolone
Product Code: Solu-Medrone 2 Gram
INN or Proposed INN: n/a
Other descriptive name: Methylprednisolone
Trade Name: Solu-Medrone 2 Gram
Product Name: Methylprednisolone
Product Code: Solu-Medrone 2 Gram
INN or Proposed INN: n/a
University of LeedsNULLNot Recruiting Female: yes
Male: yes
112 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
2496EUCTR2005-003558-83-ES
(EUCTR)
04/04/200616/02/2006Estudio 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 108Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Phase 2Estonia;Czech Republic;Slovakia;Belgium;Spain;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden
2497EUCTR2005-002909-23-NO
(EUCTR)
30/03/200611/01/2006Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. Rheumatoid arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Norway;Germany;Iceland;Sweden
2498EUCTR2004-001234-17-PT
(EUCTR)
30/03/200626/05/2006Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not ApplicableDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Trade Name: Celebrex
Product Name: Celebrex
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltrarol SR
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Laboratórios Pfizer, LdaNULLNot RecruitingFemale: yes
Male: yes
4402Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
2499EUCTR2004-003296-36-DE
(EUCTR)
29/03/200624/11/2005A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy - NA Active rheumatoid arthritis (RA) despite methotrexate (MTX) therapyProduct Name: Golimumab Liquid in Vial
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: Methotrexate sodium tablets 2.5 mg
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Product Name: Golimumab Pre-Filled Syringe
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.NULLNot RecruitingFemale: yes
Male: yes
400Hungary;Germany
2500EUCTR2005-002396-33-GB
(EUCTR)
28/03/200611/05/2006A 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.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. Rheumatoid arthritisProduct Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
375 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Hungary;Slovakia;Finland;Belgium;Spain;Germany;Italy;United Kingdom
2501EUCTR2005-002909-23-GB
(EUCTR)
27/03/200613/01/2006Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NALong-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA Rheumatoid arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche AGNULLNot Recruiting Female: yes
Male: yes
2420 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden
2502EUCTR2005-004582-41-GB
(EUCTR)
24/03/200627/01/2006 Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RA Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RA Active Rheumatoid ArthritisTrade Name: Mabthera
Product Name: Mabthera
Product Code: Rituximab
Trade Name: Arava
Product Name: Arava
Product Code: Leflunomide
Trade Name: Solu-Medrone 2 Gram
Product Name: Solu-Medrone 2mg
Product Code: Methylprednisolone
University of LeedsNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
2503EUCTR2005-000784-26-AT
(EUCTR)
22/03/200621/02/2006A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with MethotrexateProtocol Version 1.0 dated 06-May-2005, andProtocol Amendments 3 & 4 - Site Specific dated 28-Dec-2005.A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with MethotrexateProtocol Version 1.0 dated 06-May-2005, andProtocol Amendments 3 & 4 - Site Specific dated 28-Dec-2005. Rheumatoid Arthritis, NosProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy;Austria
2504EUCTR2005-003558-83-SK
(EUCTR)
22/03/200623/01/2006A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - AMG 108A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - AMG 108 Rheumatoid arthritis (RA)Product Name: AMG 108
Product Code: AMG 108
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Phase 2Estonia;Czech Republic;Slovakia;Belgium;Spain;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden
2505EUCTR2005-003558-83-GB
(EUCTR)
21/03/200613/01/2006A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)Product Code: AMG 108Amgen Inc.NULLNot Recruiting Female: yes
Male: yes
784 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noEstonia;Czech Republic;Slovakia;Belgium;Spain;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden
2506EUCTR2004-001234-17-DE
(EUCTR)
20/03/200614/12/2005Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - CONDORDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - CONDOR Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Trade Name: Celebrex 200 mg Hartkapseln
Product Name: Celebrex
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)- 1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltarol SR
Product Name: Voltarol SR
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]- phenyl]-acetate
Trade Name: Losec Capsules 20 mg
Product Name: Losec
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy- 3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
4402Portugal;Estonia;Czech Republic;Greece;Spain;Ireland;Lithuania;Latvia;Germany;United Kingdom;Sweden
2507EUCTR2005-002219-26-GB
(EUCTR)
20/03/200613/01/2006A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA) Rheumatoid arthritis (RA)Product Name: SB-681323 Tablets
Product Code: SB-681323
Product Name: SB-681323 Tablets
Product Code: SB-681323
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
82 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
2508EUCTR2005-002909-23-SI
(EUCTR)
16/03/200620/02/2006A long-term 5-year study investigation whethetr tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studiesLong-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96 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
Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
2420United States;Portugal;Hong Kong;Thailand;Spain;Costa Rica;Israel;Russian Federation;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Panama;Slovenia;Finland;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Iceland;Norway;Germany;Sweden
2509EUCTR2005-002909-23-CZ
(EUCTR)
13/03/200613/01/2006A long-term 5-year study investigating whether tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studiesLong-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96 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: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F Hoffmann La-Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
2420France;Peru;Australia;Denmark;South Africa;Netherlands;China;Panama;Slovenia;Finland;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Iceland;Norway;Germany;Sweden;Portugal;United States;Hong Kong;Thailand;Spain;Costa Rica;Israel;Russian Federation;Italy;Switzerland
2510EUCTR2005-002909-23-LT
(EUCTR)
07/03/200611/01/2006Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. Rheumatoid arthritisTrade Name: RoActemra
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;Italy;United Kingdom;Sweden
2511EUCTR2005-002396-33-FI
(EUCTR)
06/03/200622/12/2005A 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.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. Rheumatoid arthritisTrade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
Product Name: Methotrexate
Product Code: Methotrexate
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
375United Kingdom;Germany;Spain;Italy;Hungary;Finland;Slovakia
2512EUCTR2005-001889-13-BE
(EUCTR)
06/03/200619/12/2005Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3 Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab
Schering Plough Research Institute, a Division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
315 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Portugal;Belgium;Denmark;Austria;Germany;Netherlands;Sweden
2513EUCTR2004-003771-37-HU
(EUCTR)
03/03/200603/11/2005A double-blind, randomized, placebo controlled, dose escalation, multi-center phase I/II trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with active rheumatoid arthritis who have previously failed one or more disease modifying anti-rheumatic drugs. - HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/IIA double-blind, randomized, placebo controlled, dose escalation, multi-center phase I/II trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with active rheumatoid arthritis who have previously failed one or more disease modifying anti-rheumatic drugs. - HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II Active Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073
Product Name: HuMax-CD20
Product Code: HuMax-CD20
INN or Proposed INN: N/A
Other descriptive name: Human monoclonal antibody directed against CD20 on B-cells
Genmab A/SNULLNot RecruitingFemale: yes
Male: yes
230Phase 1/2Hungary
2514NCT00603993
(ClinicalTrials.gov)
March 200610/1/2008Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid ArthritisA Non-Randomized, Open-Label, Roll-Over Study With Self Injection of Adalimumab in Adult Japanese Subjects With Rheumatoid ArthritisRheumatoid ArthritisBiological: AdalimumabAbbottAbbott Japan Co.,Ltd;Eisai Co., Ltd.Completed20 YearsN/AAll88Phase 3Japan
2515EUCTR2005-003495-38-GR
(EUCTR)
27/02/200630/06/2006Part A: A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.Part B: A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 1 dose of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapyPart A: A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.Part B: A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 1 dose of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid 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
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
440Phase 2Estonia;Greece;Spain;Ireland;Germany;United Kingdom
2516EUCTR2005-002395-15-CZ
(EUCTR)
27/02/200627/02/2006A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis. Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
2517EUCTR2005-003694-25-CZ
(EUCTR)
27/02/200617/03/2006A 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).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). Rheumatoid ArthritisProduct 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 LtdNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Spain;Italy
2518EUCTR2005-002629-30-LV
(EUCTR)
27/02/200601/03/2006A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050 Rheumatoid arthritis
Classification code 10039073
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Czech Republic;Estonia;Latvia;Lithuania
2519EUCTR2004-001234-17-LV
(EUCTR)
27/02/200613/02/2008Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not ApplicableDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
NULLNot RecruitingFemale: yes
Male: yes
4402Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
2520EUCTR2004-004995-35-GB
(EUCTR)
24/02/200616/03/2005A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RAA PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA ACTIVE RHEUMATOID ARTHRITISTrade Name: Paroxetine hydrochloride 10 & 20 mg and Prednisolone 1 mg BP
Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone
CombinatoRx, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2Czech Republic;Austria;Denmark;Germany;Italy;United Kingdom
2521EUCTR2005-002909-23-DK
(EUCTR)
21/02/200623/01/2006Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NALong-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA Rheumatoid arthritisTrade Name: RoActemra
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden
2522EUCTR2004-003295-10-IT
(EUCTR)
20/02/200629/11/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNF 945; Monoclonal Antibody, Administered Subcutaneously, in Methotrexatena ve Subjects with Active Rheumatoid Arthritis - CNTO148 T05 A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNF 945; Monoclonal Antibody, Administered Subcutaneously, in Methotrexatena ve Subjects with Active Rheumatoid Arthritis - CNTO148 T05 RA in subjects who are naive to metotrexate
MedDRA version: 8.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders
Product Name: golimumab
Product Code: CNTO148
INN or Proposed INN: Methotrexate
Product Name: golimumab
Product Code: CNTO148
CENTOCORNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Hungary;Spain;Austria;United Kingdom;Italy
2523EUCTR2005-003558-83-SE
(EUCTR)
16/02/200624/01/2006A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis Rheumatoid arthritis (RA)Product Code: AMG 108Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
784Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden
2524EUCTR2005-002629-30-CZ
(EUCTR)
15/02/200601/02/2006A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050 Rheumatoid arthritis
Classification code 10039073
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB IncNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Czech Republic;Estonia;Latvia;Lithuania
2525EUCTR2005-003436-21-CZ
(EUCTR)
15/02/200607/11/2005A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: SMP-114
Product Code: SMP-114
INN or Proposed INN: rimacalib
Dainippon Sumitomo Pharma Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Hungary;Germany;United Kingdom;Czech Republic
2526EUCTR2005-002629-30-EE
(EUCTR)
13/02/200623/02/2006A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050 Rheumatoid arthritis
Classification code 10039073
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB IncNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Czech Republic;Estonia;Lithuania;Latvia
2527EUCTR2005-002395-15-SE
(EUCTR)
13/02/200612/12/2005A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis. Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
2528EUCTR2005-002909-23-SE
(EUCTR)
09/02/200623/12/2005A long-term 5-year study investigating whether tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studiesLong-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96 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: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F Hoffmann La-Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
2420Portugal;United States;Hong Kong;Thailand;Spain;Costa Rica;Israel;Russian Federation;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Panama;Slovenia;Finland;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Iceland;Germany;Norway;Sweden
2529EUCTR2005-002629-30-SK
(EUCTR)
03/02/200604/01/2006A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050 Rheumatoid arthritis
Classification code 10039073
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Estonia;Czech Republic;Slovakia;Lithuania;Latvia
2530EUCTR2004-001234-17-BE
(EUCTR)
02/02/200624/10/2005Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - N/ADouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - N/A Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Trade Name: Celebrex
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltarol SR (generics also available in the EU)
Product Name: Voltarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer SA/NVNULLNot RecruitingFemale: yes
Male: yes
4402Portugal;Estonia;Czech Republic;Greece;Spain;Belgium;Ireland;Lithuania;Latvia;Germany;United Kingdom;Sweden
2531EUCTR2005-005295-32-GB
(EUCTR)
01/02/200602/12/2005Trial in rheumatoid arthritis of lisinopril (TRALIS) - TRALISTrial in rheumatoid arthritis of lisinopril (TRALIS) - TRALIS Rheumatoid arthritisTrade Name: Lisinopril
Product Name: Lisinopril
Product Code: N/A
Research and Development Department, Addenbrookes NHS Foundation TrustNULLNot 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): yesUnited Kingdom
2532NCT00502996
(ClinicalTrials.gov)
February 200617/7/2007A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.Multicenter Non-Comparative Expanded Access Program of to Assess Safety of Rituximab (Mab Anti Cd-20) in Patients With Rheumatoid Arthritis (Ser)Rheumatoid ArthritisDrug: Methotrexate;Drug: rituximab [MabThera/Rituxan]Hoffmann-La RocheNULLCompleted18 YearsN/AAll246Phase 3Argentina;Brazil;Chile;Colombia;Ecuador;El Salvador;Mexico;Peru;Uruguay;Venezuela
2533EUCTR2005-002629-30-LT
(EUCTR)
30/01/200606/12/2005A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050 Rheumatoid arthritis
Classification code 10039073
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB IncNULLNot RecruitingFemale: yes
Male: yes
634Phase 3Czech Republic;Estonia;Latvia;Lithuania
2534EUCTR2005-003694-25-ES
(EUCTR)
27/01/200628/11/2005Ensayo 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 ArthritisProduct 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 LtdNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Czech Republic;Spain;Italy
2535EUCTR2005-000784-26-IT
(EUCTR)
25/01/200617/01/2007A phase IIIB multi-center, randomized, double-blind study to evaluate remission and joint damage progression in methotrexate naive early erosive RA subjects treated with abatacept plus methotrexate compared with methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005.A phase IIIB multi-center, randomized, double-blind study to evaluate remission and joint damage progression in methotrexate naive early erosive RA subjects treated with abatacept plus methotrexate compared with methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005. Arthritis rheumatoid treatment
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: abatacept
Product Code: BMS-188667
INN or Proposed INN: abatacept
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Belgium;Spain;Ireland;Austria;Germany;United Kingdom;Italy
2536EUCTR2004-003295-10-AT
(EUCTR)
20/01/200616/12/2005A 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 Arthritis - NAA 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 Arthritis - NA Active Rheumatoid Arthritis (methotrexate [MTX]-naïve)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
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
600Hungary;Spain;Austria;Italy;United Kingdom
2537EUCTR2005-002395-15-GB
(EUCTR)
20/01/200625/04/2006A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis. Rheumatoid arthritisTrade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
853 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Czech Republic;Finland;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
2538EUCTR2005-000158-61-CZ
(EUCTR)
18/01/200605/12/2005A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Trade Name: CELEBREX
Product Name: Celecoxib
INN or Proposed INN: Celecoxib
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
2210Phase 3Czech Republic;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania;Hungary;Germany;United Kingdom
2539EUCTR2005-003436-21-DE
(EUCTR)
18/01/200624/10/2005A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: SMP-114
Product Code: SMP-114
INN or Proposed INN: rimacalib
Dainippon Sumitomo Pharma Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Hungary;Czech Republic;United Kingdom;Germany
2540EUCTR2005-000158-61-EE
(EUCTR)
16/01/200611/11/2005A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Trade Name: CELEBREX
Product Name: Celecoxib
INN or Proposed INN: Celecoxib
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
2210Phase 3Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2541EUCTR2004-001234-17-IE
(EUCTR)
16/01/200602/11/2006Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not ApplicableDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer Healthcare IrelandNULLNot RecruitingFemale: yes
Male: yes
4402Portugal;Czech Republic;United Kingdom;Estonia;Spain;Ireland;Greece;Latvia;Lithuania;Sweden
2542EUCTR2005-003694-25-IT
(EUCTR)
12/01/200627/01/2006A 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 . - NDA 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 . - ND rheumatoid arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073
Product Name: P38 Map Kinase Inhibitor
Product Name: P38 Map Kinase Inhibitor
Product Name: P38 Map Kinase Inhibitor
INN or Proposed INN: Methotrexate
ROCHENULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Spain;Italy
2543EUCTR2005-002909-23-DE
(EUCTR)
10/01/200607/10/2005Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. Rheumatoid arthritisTrade Name: RoActemra
Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann-La Roche AGNULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Finland;United Kingdom;Czech Republic;Germany;Iceland;Slovenia;Denmark;Spain;Italy;Sweden
2544EUCTR2005-002395-15-FI
(EUCTR)
09/01/200626/10/2005A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis. Rheumatoid arthritisTrade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
Product Name: Methotrexate
Product Code: Methotrexate
INN or Proposed INN: methotrexate
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
853Phase 3Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
2545EUCTR2005-002395-15-DK
(EUCTR)
06/01/200619/06/2007A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis. Rheumatoid arthritisProduct Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
853Phase 3Czech Republic;Finland;Belgium;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
2546EUCTR2005-004385-16-GB
(EUCTR)
03/01/200608/12/2005CIRCADIAN VARIATIONS IN CYTOKINES AND THE EFFECT OF TIMED RELEASE TABLET PREDNISONE IN RHEUMATOID ARTHRITISCIRCADIAN VARIATIONS IN CYTOKINES AND THE EFFECT OF TIMED RELEASE TABLET PREDNISONE IN RHEUMATOID ARTHRITIS Rheumatoid arthritisProduct Name: Prednisone
INN or Proposed INN: Prednisone
United Bristol Healthcare NHS TrustNULLNot Recruiting Female: yes
Male: yes
12 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4):United Kingdom
2547EUCTR2005-004530-40-AT
(EUCTR)
30/12/200525/11/2005Induction of remission in RA patients at low disease activity by additional Infliximab-therapyInduction of remission in RA patients at low disease activity by additional Infliximab-therapy Patients with a diagnose of rheumatoid arthritis according to ACR-criteria at least 1 year (max. 10 years) prior to start of therapy with active disease: DAS 28 between 2,8 and 3,5 and a change in DAS 28 score <0.6 during the last 6 weeks before inclusion.Trade Name: Remicade
Product Name: Remicade
AESCA Pharma Ges.m.b.HNULLNot RecruitingFemale: yes
Male: yes
160Austria
2548EUCTR2005-002395-15-ES
(EUCTR)
29/12/200531/10/2005Estudio 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 arthritisTrade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
853Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
2549EUCTR2005-002395-15-BE
(EUCTR)
29/12/200524/11/2005A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis. Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy;Sweden
2550EUCTR2004-001234-17-LT
(EUCTR)
29/12/200523/11/2005Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - N/ADouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - N/A Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Celebrex
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltarol SR (generics also available in the EU)
Product Name: Voltarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
4402Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Sweden;Lithuania
2551EUCTR2005-002396-33-ES
(EUCTR)
27/12/200528/10/2005Estudio 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.NULLNot RecruitingFemale: yes
Male: yes
375Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
2552EUCTR2005-002396-33-BE
(EUCTR)
27/12/200524/11/2005A 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.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. Rheumatoid arthritisTrade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
375Phase 3Hungary;Slovakia;Finland;Spain;Belgium;Germany;United Kingdom;Italy
2553EUCTR2004-001234-17-ES
(EUCTR)
20/12/200521/10/2005Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse eventsDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Trade Name: Celebrex
Product Name: Celebrex
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltrarol SR
Product Name: Voltrarol SR
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer, S.A.NULLNot RecruitingFemale: yes
Male: yes
4402Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
2554EUCTR2005-002423-13-HU
(EUCTR)
19/12/200505/11/2005Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - NALong-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - NA Rheumatoid arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Slovakia;Germany;Bulgaria;Italy
2555EUCTR2005-003436-21-HU
(EUCTR)
15/12/200511/10/2005A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073
Product Name: SMP-114
Product Code: SMP-114
Sumitomo Pharmaceuticals Europe LimitedNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Hungary;Czech Republic;Germany;United Kingdom
2556EUCTR2004-001234-17-CZ
(EUCTR)
14/12/200531/10/2005Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not ApplicableDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Trade Name: Celebrex
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltrarol SR
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer LimitedNULLNot RecruitingFemale: yes
Male: yes
4402Portugal;United Kingdom;Czech Republic;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
2557EUCTR2005-003495-38-DE
(EUCTR)
13/12/200506/10/2005A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy. Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid 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
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
440United Kingdom;Germany;Estonia;Spain;Ireland;Greece
2558EUCTR2005-000902-30-GB
(EUCTR)
09/12/200505/08/2005A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis PatientsA Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients Rheumatoid arthritisTrade Name: Prednisolone Tablets USP 5 mg
Product Name: Prednisolone Tablets USP 5 mg
INN or Proposed INN: Prednisolone
GlaxoSmithKline Research & Development LimitedNULLNot Recruiting Female: yes
Male: yes
45 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
2559EUCTR2005-002392-32-GB
(EUCTR)
07/12/200515/09/2005A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis. Active rheumatoid arthritisProduct Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
500Phase 3Slovenia;Ireland;Germany;United Kingdom;Sweden
2560EUCTR2005-003495-38-EE
(EUCTR)
05/12/200529/11/2005A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy. Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid 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
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
440United Kingdom;Germany;Estonia;Spain;Ireland;Greece
2561EUCTR2004-002482-20-GB
(EUCTR)
02/12/200515/02/2005A Pilot Study to Test the Effect of Treating Depression Associated with Rueumatoid Arthritis (RA) using Venlaflaxine - Venlaflaxine & Numact StudyA Pilot Study to Test the Effect of Treating Depression Associated with Rueumatoid Arthritis (RA) using Venlaflaxine - Venlaflaxine & Numact Study Symptoms of Depression as defined by the Hospital Anxiety and Depression Questionnaire associated with Rheumatoid ArthritisTrade Name: Efexor XL 75 mg
Product Name: Efexor XL 75 mg (venlafaxine)
Product Code: NA
INN or Proposed INN: Venlafaxine Hydrochloride
Newcastle upon Tyne Hospitals NHS TrustNULLNot RecruitingFemale: yes
Male: yes
20United Kingdom
2562EUCTR2005-002395-15-IT
(EUCTR)
02/12/200502/03/2006A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis. 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] - Immune System Diseases [C20]
Trade Name: METHOTREXATE*100CPR 2,5MG
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*25CPR 2,5MG
INN or Proposed INN: Methotrexate
Trade Name: MabThera
INN or Proposed INN: Rituximab
F. Hoffmann - La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Finland;Spain;Czech Republic;Denmark;Germany;United Kingdom;Italy;Sweden
2563NCT00669942
(ClinicalTrials.gov)
December 200529/4/2008Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis PatientsA Randomized, Double Blind, Placebo-controlled, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients With Pharmacodynamics Assessed in an Expanded Cohort at the Maximum Tolerated DoseRheumatoid ArthritisBiological: AIN457;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years75 YearsAll104Phase 1/Phase 2United States;Belgium;Germany;Netherlands;Singapore;Spain
2564EUCTR2005-002396-33-IT
(EUCTR)
30/11/200501/03/2006A 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.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. 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: Mabthera
INN or Proposed INN: Rituximab
F. Hoffmann- La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
375Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
2565EUCTR2005-002969-37-ES
(EUCTR)
25/11/200519/10/2005A 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 - GM2005/00244/00A 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 ArthritisProduct Code: GW856553
Product Code: GW856553
Product Code: GW856553
GlaxoSmithKline S.A.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Spain;Germany;Sweden
2566EUCTR2005-000784-26-GB
(EUCTR)
25/11/200515/07/2005 A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with Methotrexate Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005. A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with Methotrexate Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005. Rheumatoid Arthritis, NosTrade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol Myers Squibb International CorporationNULLNot 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): noCzech Republic;Belgium;Spain;Ireland;Austria;Germany;Italy;United Kingdom
2567EUCTR2005-003495-38-ES
(EUCTR)
25/11/200506/10/2005A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy. Rheumatoid ArthritisProduct 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
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
330Phase 2Estonia;Greece;Spain;Ireland;Germany;United Kingdom
2568EUCTR2005-001889-13-SE
(EUCTR)
24/11/200513/10/2005Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3 Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
315Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden
2569EUCTR2005-002392-32-IE
(EUCTR)
23/11/200513/09/2005A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis. Active rheumatoid arthritisTrade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
500Phase 3Slovenia;Ireland;Germany;United Kingdom;Sweden
2570EUCTR2005-000784-26-DE
(EUCTR)
23/11/200528/09/2005A Phase IIIB, Multi-Center, Randomized, Double Blind, Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept Plus Methotrexate Compared with Methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005. And Protocol Amendment 07 - Site Specific (v2.0, date 27-Jul-2007).A Phase IIIB, Multi-Center, Randomized, Double Blind, Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept Plus Methotrexate Compared with Methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005. And Protocol Amendment 07 - Site Specific (v2.0, date 27-Jul-2007). Rheumatoid Arthritis, NosTrade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Belgium;Spain;Ireland;Austria;Germany;Italy;United Kingdom
2571EUCTR2005-003495-38-IE
(EUCTR)
17/11/200513/09/2005A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy. Rheumatoid ArthritisProduct 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
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
330Phase 2Estonia;Greece;Spain;Ireland;Germany;United Kingdom
2572EUCTR2004-005210-37-FI
(EUCTR)
17/11/200514/03/2005A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;Czech Republic;Germany;Spain;Sweden
2573EUCTR2004-005102-68-BE
(EUCTR)
15/11/200525/07/2005A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating Amendments 2, 3 and 8. + Protocol Amendments 1 & 5.+ Protocol Amendment 11 - Site specific: All sites in Belgium (v1.0, dated 23-Sep-2008)A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating Amendments 2, 3 and 8. + Protocol Amendments 1 & 5.+ Protocol Amendment 11 - Site specific: All sites in Belgium (v1.0, dated 23-Sep-2008) RHEUMATOID ARTHRITIS,NOSTrade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy
2574EUCTR2005-002219-26-IT
(EUCTR)
11/11/200516/03/2007A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein CRP in subjects with rheumatoid arthritis RAA randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein CRP in subjects with rheumatoid arthritis RA Rheumatoid arthritis RA
MedDRA version: 6.1;Level: PT;Classification code 10039073
Product Name: SB-681323
Product Code: SB-681323
Product Name: SB-681323
Product Code: SB-681323
GLAXO SMITHKLINENULLNot RecruitingFemale: yes
Male: yes
Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden
2575EUCTR2005-002219-26-DE
(EUCTR)
09/11/200520/07/2005A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA) Rheumatoid arthritis (RA)Product Name: SB-681323 Tablets
Product Code: SB-681323
Product Name: SB-681323 Tablets
Product Code: SB-681323
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
82Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden
2576EUCTR2004-000482-35-LT
(EUCTR)
08/11/200526/09/2005A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arthritis. - HM2004/00255/03A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arthritis. - HM2004/00255/03 Rheumatoid ArthritisProduct Name: Rosiglitazone Extended Release Tablets
Product Code: BRL-049653
INN or Proposed INN: Rosiglitazone
Other descriptive name: Rosiglitazone maleate
GlaxoSmithKline Research & Development Ltd.NULLNot RecruitingFemale: yes
Male: yes
96United Kingdom;Lithuania
2577EUCTR2004-005102-68-IT
(EUCTR)
03/11/200504/11/2005A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic OptionsA Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options Rheumatiod arthritis
MedDRA version: 6.1;Level: HLT;Classification code 10039075
Product Name: abatacept
Product Code: BMS-188667
BRISTOL-M.SQUIBBNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy
2578NCT00380744
(ClinicalTrials.gov)
November 200522/9/2006A Safety and Pharmacokinetics Study in Participants With Rheumatoid ArthritisA Phase 1b/2 Multiple-Dose Safety Study and Pharmacokinetic/ Pharmacodynamic Study of LY2189102 in Patients With Rheumatoid ArthritisArthritis, RheumatoidDrug: LY2189102;Drug: placeboEli Lilly and CompanyNULLCompleted18 Years75 YearsAll121Phase 1/Phase 2United States;Poland;Argentina;Hungary;Spain
2579NCT00162292
(ClinicalTrials.gov)
November 20059/9/2005Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate BackgroundMultiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate BackgroundRheumatoid ArthritisDrug: BMS-582949 and MethotrexateBristol-Myers SquibbNULLCompleted18 Years70 YearsBoth33Phase 1United States;Mexico
2580NCT00160641
(ClinicalTrials.gov)
November 20058/9/2005A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid ArthritisA Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Participated in Study CDP870-050Rheumatoid ArthritisBiological: Certolizumab PegolUCB PharmaNULLCompleted18 YearsN/AAll567Phase 3United States;Bulgaria;Croatia;Czechia;Estonia;Israel;Latvia;Lithuania;Poland;Russian Federation;Serbia;Slovakia;Ukraine;Czech Republic;Former Serbia and Montenegro
2581NCT00316771
(ClinicalTrials.gov)
November 200520/4/2006A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate TherapyA Randomized, Double-blind, Placebo-controlled, Study to Determine the Efficacy and Safety of 5 Dose Regimens of RO4402257 in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy.Rheumatoid ArthritisDrug: P38 Inhibitor (4) 150mg;Drug: P38 Inhibitor (4) 25mg;Drug: P38 Inhibitor (4) 300mg;Drug: P38 Inhibitor (4) 50mg;Drug: P38 Inhibitor (4) 75mg;Drug: PlaceboHoffmann-La RocheNULLCompleted18 YearsN/ABoth374Phase 2South Africa;Spain;United Kingdom;United States;Australia;Brazil;Canada;Estonia;Germany;Greece;Ireland;Mexico;New Zealand;Poland
2582NCT00256919
(ClinicalTrials.gov)
November 200521/11/2005Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)A Randomised, Placebo-controlled, Parallel Group Single Dose Study of GW856553 in Patients With Active RA to Investigate the C-Reactive Protein (CRP) Dose Response RelationshipArthritis, RheumatoidDrug: GW856553GlaxoSmithKlineNULLCompleted18 YearsN/ABoth51Phase 2Bulgaria;Germany;Spain;Sweden;Ukraine
2583NCT00292422
(ClinicalTrials.gov)
November 200515/2/2006Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid ArthritisA Randomized, Blinded, Placebo-Controlled, Multicenter, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to DMARD TherapyRheumatoid ArthritisDrug: BG9924Biogen IdecNULLCompleted18 Years75 YearsBoth50Phase 2United States;Poland
2584NCT00320450
(ClinicalTrials.gov)
November 200528/4/2006SB-681323 In Subjects With Rheumatoid ArthritisA Randomised, Parallel Group, Placebo-controlled, Double Blind Study to Assess the Safety and Tolerability of SB-681323 at 7.5mg Daily Dose for 28 Days and Its Effect on the Levels of Serum C-reactive Protein (CRP) in Subjects With Rheumatoid Arthritis (RA)Arthritis, RheumatoidDrug: SB-681323GlaxoSmithKlineNULLCompleted18 YearsN/ABoth78Phase 2Denmark;Germany;Hong Kong;Italy;Norway;Poland;Spain;Sweden;United Kingdom;Hungary
2585EUCTR2005-002326-63-LV
(EUCTR)
28/10/200522/11/2005A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. Rheumatoid Arthritis
Classification code 10039073
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
590Phase 3Czech Republic;Estonia;Latvia;Lithuania
2586EUCTR2005-000158-61-LV
(EUCTR)
28/10/200522/11/2005A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: Celecoxib
INN or Proposed INN: Celecoxib
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
2210Phase 3Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2587EUCTR2005-003436-21-GB
(EUCTR)
26/10/200505/09/2005A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: SMP-114
Product Code: SMP-114
INN or Proposed INN: rimacalib
Dainippon Sumitomo Pharma Europe LtdNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Hungary;Czech Republic;Germany;United Kingdom
2588EUCTR2005-000784-26-BE
(EUCTR)
21/10/200528/10/2005A Phase IIIB, Multi-Center, Randomized, Double Blind, Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept Plus Methotrexate Compared with Methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005. And Protocol Amendment 07 - Site Specific (v2.0, date 27-Jul-2007).A Phase IIIB, Multi-Center, Randomized, Double Blind, Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept Plus Methotrexate Compared with Methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005. And Protocol Amendment 07 - Site Specific (v2.0, date 27-Jul-2007). Rheumatoid Arthritis, NosTrade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy;Austria
2589EUCTR2005-001319-23-IT
(EUCTR)
21/10/200530/09/2005A 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 TherapyA 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 Rheumatoid arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073
Product Name: ERB-041
Product Code: ERB-041
Other descriptive name: NA
Product Name: ERB-041
Product Code: ERB-041
Other descriptive name: NA
Product Name: ERB-041
Product Code: ERB-041
Other descriptive name: NA
WYETH LEDERLENULLNot RecruitingFemale: yes
Male: yes
Hungary;Spain;Italy
2590EUCTR2005-000158-61-IE
(EUCTR)
21/10/200513/09/2005A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Trade Name: Celebrex
Product Name: Celecoxib
INN or Proposed INN: Celecoxib
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
2210Phase 3Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Spain;Ireland;Italy;Latvia;Lithuania
2591EUCTR2005-000784-26-IE
(EUCTR)
21/10/200515/08/2005A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with MethotrexateProtocol Version 1.0 dated 06-May-2005 + Amendment 1 dated 16-May-2005.A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with MethotrexateProtocol Version 1.0 dated 06-May-2005 + Amendment 1 dated 16-May-2005. Rheumatoid Arthritis, NosProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy;Austria
2592EUCTR2005-002421-31-DE
(EUCTR)
20/10/200503/11/2005A phase II randomised, double-blind, multicenter, placebo-controlled, dose-ranging, parallel group study to compare the efficacy, safety and tolerability of 3 strengths of AD 452 in adult subjects with active rheumatoid arthritis who are currently taking methotrexate. - Efficacy, safety and tolerability of AD 452 in patients wih RAA phase II randomised, double-blind, multicenter, placebo-controlled, dose-ranging, parallel group study to compare the efficacy, safety and tolerability of 3 strengths of AD 452 in adult subjects with active rheumatoid arthritis who are currently taking methotrexate. - Efficacy, safety and tolerability of AD 452 in patients wih RA The purpose of this clinical trial is to evaluate the clinical efficacy, safety and tolerability of three doses of AD 452 in comparison with placebo in the treatment of subjects with active rheumatoid arthritis.
MedDRA version: 7.0;Level: PT;Classification code 10039073
Product Name: AD 452
INN or Proposed INN: (+) isomer of racemic mefloquine
Other descriptive name: (+)erythromefloquine
Product Name: AD 452
INN or Proposed INN: (+) isomer of racemic mefloquine
Other descriptive name: (+) erythromefloquine
Product Name: AD 452
INN or Proposed INN: (+) isomer or racemic mefloquine
Other descriptive name: (+) erythromefloquine
Arakis Ltd.NULLNot RecruitingFemale: yes
Male: yes
292Phase 2United Kingdom;Germany
2593EUCTR2005-002423-13-SK
(EUCTR)
18/10/200520/09/2005Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 Rheumatoid arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Slovakia;Austria;Bulgaria;Germany;Italy
2594EUCTR2005-003495-38-GB
(EUCTR)
18/10/200518/10/2005A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy. Rheumatoid ArthritisProduct 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
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
330 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4):Estonia;Greece;Spain;Ireland;Germany;United Kingdom
2595EUCTR2004-004995-35-AT
(EUCTR)
16/10/200509/11/2005A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RAA PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA ACTIVE RHEUMATOID ARTHRITISTrade Name: Paroxetine Hydrochloride tablets 10 & 20 mg and Prednisolone 1 mg BP
Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone
CombinatoRx, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2Czech Republic;Denmark;Austria;Germany;Italy;United Kingdom
2596EUCTR2005-001319-23-ES
(EUCTR)
14/10/200522/06/2005A 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 metotrexatoA 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 arthritisProduct 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 DevelopmentNULLNot RecruitingFemale: yes
Male: yes
260Phase 2Hungary;Spain;Italy
2597EUCTR2005-002969-37-SE
(EUCTR)
14/10/200529/08/2005A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship. - GM2005/00244/02A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship. - GM2005/00244/02 Rheumatoid ArthritisProduct Code: GW856553
Product Code: GW856553
Product Code: GW856553
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
48Germany;Spain;Sweden
2598EUCTR2004-002846-36-AT
(EUCTR)
13/10/200508/09/2005A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/AA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/A Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073
Product Name: CP690,550
Product Code: CP690,550
INN or Proposed INN: N/A
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,
Product Name: CP690,550
Product Code: CP690,550
INN or Proposed INN: N/A
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,
Pfizer Corporation Austria Ges.m.b.H.NULLNot RecruitingFemale: yes
Male: yes
312Phase 2Spain;Austria;Germany;Italy
2599EUCTR2005-002392-32-SE
(EUCTR)
12/10/200519/09/2005A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis. Active rheumatoid arthritisProduct Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
500Slovenia;Ireland;Germany;United Kingdom;Sweden
2600EUCTR2005-002392-32-SI
(EUCTR)
11/10/200526/10/2005A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis. Active rheumatoid arthritisProduct Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
500Slovenia;Ireland;Germany;United Kingdom;Sweden
2601EUCTR2005-000784-26-ES
(EUCTR)
11/10/200513/09/2005A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with Methotrexate.A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with Methotrexate. Rheumatoid Arthritis, NosProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Belgium;Spain;Ireland;Austria;Germany;Italy;United Kingdom
2602EUCTR2005-000784-26-CZ
(EUCTR)
04/10/200504/10/2005A Phase IIIB, Multi-Center, Randomized, Double Blind, Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept Plus Methotrexate Compared with Methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendment 4 - Site Specific - dated 28-Dec-2005.A Phase IIIB, Multi-Center, Randomized, Double Blind, Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept Plus Methotrexate Compared with Methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendment 4 - Site Specific - dated 28-Dec-2005. Rheumatoid Arthritis, NosProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Germany;United Kingdom;Czech Republic;Belgium;Spain;Ireland;Italy;Austria
2603EUCTR2004-002846-36-SK
(EUCTR)
03/10/200519/07/2005A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, DMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/AA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, DMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/A Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073
Product Name: CP690,550
Product Code: CP690,550
INN or Proposed INN: N/A
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,
Product Name: CP690,550
Product Code: CP690,550
INN or Proposed INN: N/A
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,
Pfizer Global & Developement, Pfizer LimitedNULLNot RecruitingFemale: yes
Male: yes
312Phase 2Slovakia;Spain;Austria;Germany;Italy
2604EUCTR2005-001138-33-PT
(EUCTR)
29/09/200521/09/2005A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium
INN or Proposed INN: Methotrexate sodium
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
650Portugal;Denmark;Slovenia;Norway;Spain;Italy
2605EUCTR2005-002423-13-IT
(EUCTR)
28/09/200504/11/2005Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA 17822Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA 17822 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: RoActemra
INN or Proposed INN: RoActemra
F.Hoffmann La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Slovakia;Bulgaria;Germany;Italy
2606EUCTR2005-001138-33-IT
(EUCTR)
28/09/200501/02/2007A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate MTX monotherapy, in patients with active rheumatoid arthritis.A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate MTX monotherapy, in patients with active rheumatoid arthritis. rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Tocilizumab
Product Code: Ro 48-77533
Trade Name: METHOTREXATE*25CPR 2,5MG
INN or Proposed INN: Methotrexate
ROCHENULLNot RecruitingFemale: yes
Male: yes
650Portugal;Denmark;Slovenia;Norway;Spain;Italy
2607EUCTR2005-002219-26-ES
(EUCTR)
21/09/200510/10/2005A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA) Rheumatoid arthritis (RA)Product Name: SB-681323 Tablets
Product Code: SB-681323
Product Name: SB-681323 Tablets
Product Code: SB-681323
GlaxoSmithKline S.A.NULLNot RecruitingFemale: yes
Male: yes
82Phase 2Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
2608EUCTR2005-002326-63-LT
(EUCTR)
21/09/200504/08/2005A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. Rheumatoid Arthritis
Classification code 10039073
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
590Phase 3Czech Republic;Estonia;Latvia;Lithuania
2609EUCTR2005-002909-23-ES
(EUCTR)
21/09/200508/09/2005Long-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 MRALong-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 arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Finland;United Kingdom;Czech Republic;Germany;Iceland;Slovenia;Denmark;Spain;Italy;Sweden
2610EUCTR2005-002326-63-SK
(EUCTR)
20/09/200505/08/2005A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. Rheumatoid Arthritis
Classification code 10039073
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
590Phase 3Estonia;Czech Republic;Slovakia;Lithuania;Latvia
2611EUCTR2004-005102-68-DE
(EUCTR)
15/09/200515/07/2005A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, version 1.0 dated 7-Feb-2006.A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, version 1.0 dated 7-Feb-2006. RHEUMATOID ARTHRITIS,NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;United Kingdom;Germany;Belgium;Spain;Ireland;Italy
2612EUCTR2005-001889-13-AT
(EUCTR)
15/09/200508/11/2005Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3 Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab.Trade Name: Remicade
Product Name: Remicade
Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.NULLNot RecruitingFemale: yes
Male: yes
315France;Portugal;Greece;Belgium;Denmark;Austria;Germany;Netherlands;Sweden
2613EUCTR2004-005115-29-DE
(EUCTR)
14/09/200516/05/2006A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationshipA randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship Rheumatoid arthritisProduct Name: SB-681323 Tablets
Product Code: SB-681323
Product Name: SB-681323 Tablets
Product Code: SB-681323
Product Name: Overencapsulated Prednisolone Tablets
INN or Proposed INN: Prednisolone
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
77United Kingdom;Germany
2614EUCTR2005-001977-82-GB
(EUCTR)
09/09/200514/07/2005A 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 subjectsA 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 arthritisProduct Name: GW274150 Tablets
Product Code: GW274150
Trade Name: Deltacortril Enteric
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
GlaxoSmithKline Research & Development LimitedNULLNot 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): noUnited Kingdom
2615EUCTR2005-002219-26-SE
(EUCTR)
08/09/200514/07/2005A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA) Rheumatoid arthritis (RA)Product Name: SB-681323 Tablets
Product Code: SB-681323
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
82Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden
2616EUCTR2005-002423-13-DE
(EUCTR)
06/09/200505/07/2005Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 Rheumatoid arthritisTrade Name: RoActemra
Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Slovakia;Germany;Bulgaria;Italy
2617EUCTR2005-000551-15-GB
(EUCTR)
05/09/200505/08/2005Effect of folic acid supplementation and allopurinol on endothelial function in patients with rheumatoid arthritis treated with methotrexate - Endothelial function in rheumatoid arthritis patients on methotrexateEffect 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 DundeeNULLNot RecruitingFemale: yes
Male: yes
Phase 4United Kingdom
2618EUCTR2005-002326-63-CZ
(EUCTR)
05/09/200508/08/2005A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. Rheumatoid Arthritis
Classification code 10039073
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
634Phase 3Czech Republic;Estonia;Latvia;Lithuania
2619EUCTR2004-005102-68-GB
(EUCTR)
01/09/200527/05/2005 A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options. Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options. Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RHEUMATOID ARTHRITIS,NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot 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): noCzech Republic;Belgium;Spain;Ireland;Germany;Italy;United Kingdom
2620NCT00720798
(ClinicalTrials.gov)
September 200522/7/2008An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core StudiesLong-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core StudiesRheumatoid ArthritisDrug: Tocilizumab;Drug: Disease-modifying anti-rheumatic drugs;Drug: Non-steroidal anti-inflammatory drugs;Drug: Oral corticosteroidsHoffmann-La RocheNULLCompleted18 YearsN/AAll2067Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;China;Costa Rica;Czech Republic;Denmark;Finland;France;Germany;Hong Kong;Iceland;Israel;Italy;Lithuania;Mexico;Netherlands;Norway;Panama;Peru;Portugal;Puerto Rico;Russian Federation;Serbia;Slovenia;South Africa;Spain;Sweden;Switzerland;Thailand;United Kingdom
2621EUCTR2004-004995-35-CZ
(EUCTR)
30/08/200530/08/2005A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RAA PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA ACTIVE RHEUMATOID ARTHRITISTrade Name: Prednisolone Tablets BP 1 mg
Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone
CombinatoRx, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2Germany;United Kingdom;Czech Republic;Denmark;Italy
2622EUCTR2005-001138-33-DK
(EUCTR)
23/08/200520/06/2005A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium
INN or Proposed INN: Methotrexate sodium
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
650Portugal;Slovenia;Denmark;Norway;Spain;Italy
2623EUCTR2005-002219-26-DK
(EUCTR)
23/08/200509/08/2005A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA) Rheumatoid arthritis (RA)Product Name: SB-681323 Tablets
Product Code: SB-681323
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
82Phase 2Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
2624EUCTR2005-002423-13-AT
(EUCTR)
22/08/200518/07/2005Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 Rheumatoid arthritisTrade Name: RoActemra
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Slovakia;Austria;Bulgaria;Germany;Italy
2625EUCTR2004-005102-68-ES
(EUCTR)
16/08/200517/06/2005A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including Protocol amendment 2 + Pharmacogenetic Amendment 1.A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including Protocol amendment 2 + Pharmacogenetic Amendment 1. RHEUMATOID ARTHRITIS,NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Belgium;Spain;Ireland;Germany;Italy;United Kingdom
2626EUCTR2005-000884-25-SE
(EUCTR)
11/08/200507/06/2005A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann-La Roche AGNULLNot RecruitingFemale: yes
Male: yes
450United Kingdom;Germany;Iceland;Italy;Sweden
2627EUCTR2005-000158-61-AT
(EUCTR)
10/08/200507/06/2005A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid ArthritisA Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Trade Name: CELEBREX
Product Name: Celecoxib
INN or Proposed INN: Celecoxib
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
2210Phase 3Czech Republic;Estonia;Hungary;Spain;Ireland;Lithuania;Denmark;Austria;Germany;Latvia;Italy;United Kingdom
2628EUCTR2005-000158-61-ES
(EUCTR)
09/08/200509/06/2005A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid ArthritisA Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Trade Name: Artilog
Product Name: Celecoxib
INN or Proposed INN: Celecoxib
GlaxoSmithKline s.a.NULLNot RecruitingFemale: yes
Male: yes
2210Phase 3Czech Republic;Estonia;Hungary;Spain;Ireland;Lithuania;Austria;Denmark;Germany;Latvia;Italy;United Kingdom
2629EUCTR2005-000158-61-HU
(EUCTR)
08/08/200508/06/2005A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: Celecoxib
INN or Proposed INN: Celecoxib
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
2210Phase 3Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2630EUCTR2004-005102-68-IE
(EUCTR)
05/08/200502/06/2005A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including protocol amendment 2 + Pharmacogenetic Amendment 1.A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including protocol amendment 2 + Pharmacogenetic Amendment 1. RHEUMATOID ARTHRITIS,NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy
2631EUCTR2005-001350-24-FI
(EUCTR)
04/08/200523/06/2005A 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 CDP870-027A 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.NULLNot RecruitingFemale: yes
Male: yes
800Phase 3Hungary;Finland;Czech Republic;Estonia;Latvia;Lithuania
2632EUCTR2005-001350-24-HU
(EUCTR)
01/08/200519/05/2005A 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 CDP870-027A 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.NULLNot RecruitingFemale: yes
Male: yes
800Phase 3Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania
2633NCT00141830
(ClinicalTrials.gov)
August 200530/8/2005Study Evaluating ERB-041 With Methotrexate in Rheumatoid ArthritisA 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 TherapyRheumatoid ArthritisDrug: Methotrexate plus ERB-041 for 12 weeks;Drug: Placebo for 12 weeksWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years80 YearsAll159Phase 2United States;Canada;Hungary;Italy;Mexico;Spain
2634EUCTR2005-001319-23-HU
(EUCTR)
22/07/200503/06/2005A 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 TherapyA 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 Rheumatoid arthritisProduct Name: ERB-041
Product Code: ERB-041
INN or Proposed INN: Not available
Product Name: ERB-041
Product Code: ERB-041
INN or Proposed INN: Not available
Product Name: ERB-041
Product Code: ERB-041
INN or Proposed INN: Not available
Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical resaearch and DevelopmentNULLNot RecruitingFemale: yes
Male: yes
260Hungary;Spain;Italy
2635EUCTR2004-002215-80-HU
(EUCTR)
20/07/200517/05/2005A Double-Blind, Parallel, Randomized Extension Trial to Evaluate Safety and Efficacy of TMI-005 (Apratastat) in Subjects with Rheumatoid Arthritis on Methotrexate Who Have Completed Protocol 3140A1-200-WWA Double-Blind, Parallel, Randomized Extension Trial to Evaluate Safety and Efficacy of TMI-005 (Apratastat) in Subjects with Rheumatoid Arthritis on Methotrexate Who Have Completed Protocol 3140A1-200-WW Rheumatoid ArthritisProduct Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
INN or Proposed INN: Not yet established
Other descriptive name: WAY-177005
Product Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
INN or Proposed INN: Not yet established
Other descriptive name: WAY-177005
Product Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
INN or Proposed INN: Not yet established
Other descriptive name: WAY-177005
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and DevelopmentNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Hungary
2636EUCTR2005-001350-24-EE
(EUCTR)
18/07/200514/06/2005A 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 CDP870-027A 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.NULLNot RecruitingFemale: yes
Male: yes
800Phase 3Hungary;Czech Republic;Estonia;Finland;Lithuania;Latvia
2637EUCTR2005-000158-61-GB
(EUCTR)
18/07/200527/05/2005A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Trade Name: Celebrex 200 mg capsule, hard
Product Name: Celecoxib
INN or Proposed INN: Celecoxib
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
2210Phase 3Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2638EUCTR2005-001138-33-LT
(EUCTR)
14/07/200530/05/2005A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis. Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
Product Name: Methotrexate sodium
INN or Proposed INN: Methotrexate sodium
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
650Portugal;Slovenia;Spain;Lithuania;Denmark;Norway;Italy
2639EUCTR2005-001350-24-LT
(EUCTR)
14/07/200508/06/2005A 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 CDP870-027A 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.NULLNot RecruitingFemale: yes
Male: yes
800Phase 3Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania
2640EUCTR2004-004995-35-DE
(EUCTR)
14/07/200517/03/2005A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RAA PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA ACTIVE RHEUMATOID ARTHRITISProduct Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine
Product Name: N/A
Product Code: CRX-139
INN or Proposed INN: Prednisolone
Product Name: N/A
Product Code: CRX-139
INN or Proposed INN: paroxetine
CombinatoRx, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2Czech Republic;United Kingdom;Germany;Denmark;Italy
2641EUCTR2005-000884-25-GB
(EUCTR)
11/07/200519/04/2005A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann-La Roche AGNULLNot 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): noIceland;Germany;Italy;United Kingdom;Sweden
2642EUCTR2005-001138-33-NO
(EUCTR)
06/07/200506/06/2005A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium
INN or Proposed INN: Methotrexate sodium
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
650Phase 3Portugal;Slovenia;Spain;Lithuania;Denmark;Norway;Italy
2643EUCTR2005-001138-33-ES
(EUCTR)
05/07/200516/05/2006A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium
INN or Proposed INN: Methotrexate sodium
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
650Phase 3Portugal;Slovenia;Spain;Lithuania;Denmark;Norway;Italy
2644EUCTR2004-005210-37-CZ
(EUCTR)
01/07/200530/06/2005A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;Germany;Czech Republic;Spain;Sweden
2645EUCTR2004-002620-18-BE
(EUCTR)
30/06/200504/08/2005A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid ArthritisA Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid Arthritis Rheumatoid Arthritis, NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Germany;Belgium;Spain;Italy
2646EUCTR2005-000884-25-IS
(EUCTR)
27/06/200527/04/2005A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann-La Roche AGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Germany;Iceland;Italy;United Kingdom;Sweden
2647EUCTR2004-005115-29-GB
(EUCTR)
24/06/200527/05/2005A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationshipA randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship Rheumatoid arthritisProduct Name: SB-681323 Tablets
Product Code: SB-681323
Product Name: SB-681323 Tablets
Product Code: SB-681323
Trade Name: Prednisolone Tablets BP
Product Name: Overencapsulated Prednisolone Tablets
INN or Proposed INN: Prednisolone
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
77 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noGermany;United Kingdom
2648EUCTR2005-000158-61-DK
(EUCTR)
24/06/200502/06/2005A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: Celecoxib
INN or Proposed INN: Celecoxib
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
2210Phase 3Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2649EUCTR2005-001350-24-LV
(EUCTR)
21/06/200521/06/2005A 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 CDP870-027A 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.NULLNot RecruitingFemale: yes
Male: yes
800Phase 3Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania
2650EUCTR2004-003741-40-SK
(EUCTR)
16/06/200507/12/2004A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
630Phase 3Hungary;Slovakia;Austria;Germany;Italy
2651EUCTR2005-000549-13-CZ
(EUCTR)
15/06/200502/05/2005A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study of Two Doses of VX-702 in Subjects with Moderate to Severe Rheumatoid Arthritis - VeRAA 12-Week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study of Two Doses of VX-702 in Subjects with Moderate to Severe Rheumatoid Arthritis - VeRA rheumatoid arthritisProduct Code: VX-702Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Czech Republic
2652EUCTR2004-002846-36-DE
(EUCTR)
14/06/200501/03/2005A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/AA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/A Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073
Product Name: CP690,550
Product Code: CP690,550
INN or Proposed INN: N/A
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,
Product Name: CP690,550
Product Code: CP690,550
INN or Proposed INN: N/A
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,
Pfizer Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
312Phase 2Germany;Spain;Italy
2653EUCTR2005-000884-25-DE
(EUCTR)
14/06/200513/04/2005A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann-La Roche AGNULLNot RecruitingFemale: yes
Male: yes
450United Kingdom;Germany;Iceland;Italy;Sweden
2654EUCTR2005-000158-61-IT
(EUCTR)
09/06/200505/01/2006A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - RHEUMATOID ARTHRITIS
MedDRA version: 6.1;Level: PT;Classification code 10039073
Product Name: GW406381
Product Code: GW406381
Product Name: GW406381
Product Code: GW406381
Product Name: GW406381
Product Code: GW406381
Product Name: GW406381
Product Code: GW406381
Trade Name: CELEBREX 200MG 20CPS
INN or Proposed INN: Celecoxib
GLAXO SMITHKLINENULLNot RecruitingFemale: yes
Male: yes
2208Phase 3Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2655EUCTR2005-001350-24-SK
(EUCTR)
31/05/200521/04/2005A 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 CDP870-027A 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 CelltechNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Latvia
2656EUCTR2005-001350-24-CZ
(EUCTR)
27/05/200504/05/2005A 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 CDP870-027A 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.NULLNot RecruitingFemale: yes
Male: yes
800Phase 3Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania
2657EUCTR2004-002620-18-DE
(EUCTR)
13/05/200516/02/2005A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid Arthritis.Revised protocol 2, dated 02-Feb-06, incorporating Amendments 02 and 03;and Pharmacogenetics Blood Sample Amendment Number 01A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid Arthritis.Revised protocol 2, dated 02-Feb-06, incorporating Amendments 02 and 03;and Pharmacogenetics Blood Sample Amendment Number 01 Rheumatoid Arthritis, NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Germany;Belgium;Spain;Italy
2658EUCTR2004-002620-18-IT
(EUCTR)
11/05/200519/09/2005A multi-national randomized, double-blind exploratory study of Abatacept versus placebo in preventing the development of rheumatoid arthritis in adults subjects with undifferentiated inflammatory arthritis at high risk for the development of rheumatoid arthritis.A multi-national randomized, double-blind exploratory study of Abatacept versus placebo in preventing the development of rheumatoid arthritis in adults subjects with undifferentiated inflammatory arthritis at high risk for the development of rheumatoid arthritis. rheumatoid arthritis
MedDRA version: 6.1;Level: HLT;Classification code 10039075
Product Name: CTLA4Ig
Product Code: BMS-188667
BRISTOL-M.SQUIBBNULLNot RecruitingFemale: yes
Male: yes
United Kingdom;Germany;Belgium;Spain;Italy
2659EUCTR2004-002620-18-ES
(EUCTR)
06/05/200529/03/2006A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid ArthritisA Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid Arthritis Rheumatoid Arthritis, NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Belgium;Spain;Germany;Italy;United Kingdom
2660EUCTR2004-002993-49-BE
(EUCTR)
05/05/200519/07/2005A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate.A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. Rheumatoid Arthritis
Classification code 10039073
Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Celltech R&D LtdNULLNot RecruitingFemale: yes
Male: yes
950Phase 3Estonia;Czech Republic;Hungary;Finland;Belgium;Lithuania;Latvia;Sweden
2661EUCTR2004-005210-37-DE
(EUCTR)
04/05/200510/03/2005A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;Czech Republic;Germany;Spain;Sweden
2662EUCTR2005-000549-13-SK
(EUCTR)
03/05/200505/04/2005A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study of Two Doses of VX-702 in Subjects with Moderate to Severe Rheumatoid Arthritis - VeRAA 12-Week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study of Two Doses of VX-702 in Subjects with Moderate to Severe Rheumatoid Arthritis - VeRA rheumatoid arthritisProduct Code: VX-702Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Czech Republic;Slovakia
2663EUCTR2005-000884-25-IT
(EUCTR)
02/05/200522/06/2005A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combionation with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combionation with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy. rheumatoid arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073
Product Name: Tocilizumab
Product Code: Ro 48-77533
Trade Name: METHOTREXATE*2,5MG 25CPR
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*7,5MG/ML 4SIR.
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*10MG/1,33ML 4S
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*20MG/2,66ML 4S
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*15MG/2ML 4SIR
INN or Proposed INN: Methotrexate
ROCHENULLNot RecruitingFemale: yes
Male: yes
570United Kingdom;Germany;Iceland;Italy;Sweden
2664EUCTR2004-002846-36-IT
(EUCTR)
26/04/200520/06/2005A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP-690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITISA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP-690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS Rheumatoid Arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073
Product Name: CP 690,550
Product Code: CP 690,550
Product Name: CP 690,550
Product Code: CP 690,550
Product Name: CP 690,550
Product Code: CP 690,550
PFIZERNULLNot RecruitingFemale: yes
Male: yes
312Phase 2Germany;Spain;Italy
2665EUCTR2004-005210-37-SE
(EUCTR)
26/04/200510/03/2005A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;Czech Republic;Germany;Spain;Sweden
2666EUCTR2004-003741-40-HU
(EUCTR)
15/04/200507/02/2005A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Germany;Italy
2667EUCTR2004-002620-18-GB
(EUCTR)
14/04/200515/06/2005A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid ArthritisRevised protocol 2, dated 02-Feb-06, incorporating Amendments 02 and 03;and Pharmacogenetics Blood Sample Amendment Number 01A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid ArthritisRevised protocol 2, dated 02-Feb-06, incorporating Amendments 02 and 03;and Pharmacogenetics Blood Sample Amendment Number 01 Rheumatoid Arthritis, NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Spain;Belgium;Germany;Italy;United Kingdom
2668EUCTR2004-002846-36-ES
(EUCTR)
12/04/200524/01/2006A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTERSTUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, DMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE IGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITISA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTERSTUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, DMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE IGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLD;Classification code 10039073
Product Name: CP690,550
Product Code: CP690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,
Product Name: CP690,550
Product Code: CP690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,
Pfizer, S.A.NULLNot RecruitingFemale: yes
Male: yes
312Phase 2Slovakia;Spain;Austria;Germany;Italy
2669EUCTR2005-000674-43-GB
(EUCTR)
06/04/200503/10/2005 AN OPEN LABEL STUDY OF THE EFFECT OF TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: Clinical, radiological, synovial and immunological outcomes - Rituximab in Rheumatoid Arthritis AN OPEN LABEL STUDY OF THE EFFECT OF TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: Clinical, radiological, synovial and immunological outcomes - Rituximab in Rheumatoid Arthritis Rheumatoid ArthritisTrade Name: Mabthera
Product Name: Mabthera
Product Code: N/A
INN or Proposed INN: n/a
Other descriptive name: none
University of LeedsNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
2670NCT00124982
(ClinicalTrials.gov)
April 200530/6/2005Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF TherapyA Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic OptionsRheumatoid ArthritisDrug: Abatacept;Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD);Drug: Anti-Tumor Necrosing Factor (TNF) TherapyBristol-Myers SquibbNULLCompleted18 YearsN/AAll1286Phase 3United States;Belgium;Czech Republic;France;Germany;Ireland;Italy;Mexico;Spain;United Kingdom;Canada
2671EUCTR2004-002993-49-FI
(EUCTR)
29/03/200516/12/2004A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage studyA Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study Rheumatoid Arthritis
Classification code 10039073
Product Name: CDP870
Product Code: CDP870
Celltech R&D LtdNULLNot RecruitingFemale: yes
Male: yes
950Phase 3Estonia;Czech Republic;Hungary;Slovakia;Finland;Belgium;Lithuania;Latvia;Sweden
2672EUCTR2004-005210-37-ES
(EUCTR)
29/03/200504/11/2005A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Czech Republic;Finland;Spain;Germany;Sweden
2673EUCTR2004-003733-14-FI
(EUCTR)
23/03/200517/11/2004A study investigating whether tocilizumab (study drug) prevents joint damage, and how safe it is, in patients with moderate to severe rheumatoid arthritis randomly divided to groups receiving treatment with tocilizumab and methotrexate or methotrexate and placebo.A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. - LITHE Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: RoActemra
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: Tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann La-Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1170Phase 3United States;Greece;Finland;Spain;Italy;France;Mexico;Brazil;Poland;Australia;Denmark;South Africa;Norway;China
2674EUCTR2004-004302-24-DE
(EUCTR)
23/03/200511/01/2005A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid ArthritisA Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073
Product Name: L-000883191
Product Code: L-000883191
INN or Proposed INN: NA
Other descriptive name: NA
Merck & Co. Inc.NULLNot RecruitingFemale: yes
Male: yes
136Finland;Czech Republic;Germany;Spain;Italy
2675EUCTR2005-000129-47-SE
(EUCTR)
21/03/200525/02/2005The effect of Adalimumab (Humira) on vascular abnormalities in rheumatoid arthritis. A pilot study.The effect of Adalimumab (Humira) on vascular abnormalities in rheumatoid arthritis. A pilot study. Rheumatoid Arthritis.Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Dept. of Rhematology UMASNULLNot RecruitingFemale: yes
Male: yes
15Sweden
2676EUCTR2004-000922-59-CZ
(EUCTR)
15/03/200515/03/2005A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to MethotrexateA Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate Rheumatoid Arthrithis, NosProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
675Phase 3Czech Republic;Denmark;Spain;Sweden
2677EUCTR2004-000074-31-BE
(EUCTR)
15/03/200507/07/2004A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid ArthritisA Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis rheumatoid arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073
Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c
Product Code: L-000124467 (freebase); L-000124467-009J (succinat
INN or Proposed INN: not available
Other descriptive name: L-000124467
Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c
Product Code: L-000124467 (freebase); L-000124467-009J (succinat
INN or Proposed INN: not available
Other descriptive name: L-000124467
Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c
Product Code: L-000124467 (freebase); L-000124467-009J (succinat
INN or Proposed INN: not available
Other descriptive name: L-000124467
Trade Name: paracetamol (acetaminophen)
Product Name: paracetamol (acetaminophen)
Merck Sharp & Dohme BVNULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelgium;Sweden
2678EUCTR2004-002993-49-SE
(EUCTR)
15/03/200505/01/2005A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study Rheumatoid Arthritis
Classification code 10039073
Product Name: CDP870
Product Code: CDP870
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
950Phase 3Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania;Sweden
2679EUCTR2004-004302-24-IT
(EUCTR)
09/03/200510/08/2007A Randomized, Placebo-Controlled, Parallel-Group, Double Blind, 12 week study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis A Randomized, Placebo-Controlled, Parallel-Group, Double Blind, 12 week study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: L-883191MERCK SHARP DOHMENULLNot RecruitingFemale: yes
Male: yes
100Phase 2Czech Republic;Finland;Spain;Germany;Italy
2680EUCTR2004-004302-24-CZ
(EUCTR)
09/03/200504/02/2005A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability and Safety Study in Rheumatoid ArthritisA Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073
Product Name: L-000883191
Product Code: L-000883191
INN or Proposed INN: NA
Other descriptive name: NA
Trade Name: PARALEN 500
Product Name: PARALEN 500
Product Code: 8594739041288
INN or Proposed INN: paracetamol
Other descriptive name: NA
Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
136Phase 2Czech Republic;Finland;Spain;Germany;Italy
2681EUCTR2004-000563-96-FI
(EUCTR)
08/03/200511/10/2004A 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) - COMETA 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 ArthritisProduct 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
580Hungary;Finland;Denmark;Norway;Ireland;Spain;Italy;Sweden
2682NCT00503503
(ClinicalTrials.gov)
March 200516/7/2007Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in JapanSafety and Efficacy From Large Scale All Cases Surveillance for Etanercept in JapanRheumatoid ArthritisDrug: Enbrel (etanercept)Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted11 Years90 YearsBothNULL
2683EUCTR2004-002993-49-LV
(EUCTR)
28/02/200528/02/2005A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study Rheumatoid Arthritis
Classification code 10039073
Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Celltech R&D LtdNULLNot RecruitingFemale: yes
Male: yes
950Phase 3Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania
2684EUCTR2004-003741-40-DE
(EUCTR)
28/02/200501/12/2004A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Germany;Italy
2685EUCTR2004-000012-13-IT
(EUCTR)
18/02/200512/04/2007A Double-Blind, Placebo-controlled, Parallel, Randomized Study to evaluate the Efficacy and Safety of 3 Oral Dose levels of TMI-005 in Subjects with Active Rheumatoid Arthritis on A Background of Methotrexate - heumatoid Artrhitis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: TMI-005 WAY-177005
Product Code: TMI-005 WAY-177005
INN or Proposed INN: Apratastat
Product Name: TMI-005 WAY-177005
Product Code: TMI-005 WAY-177005
INN or Proposed INN: Apratastat
Product Name: TMI-005 WAY-177005
Product Code: TMI-005 WAY-177005
INN or Proposed INN: Apratastat
WYETH LEDERLENULLNot RecruitingFemale: yes
Male: yes
360Czech Republic;Estonia;Italy
2686EUCTR2004-004302-24-ES
(EUCTR)
16/02/200504/11/2005A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid ArthritisA Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073
Product Name: L-000883191
Product Code: L-000883191
INN or Proposed INN: NA
Other descriptive name: NA
Trade Name: Paracetamol
Product Name: Paracetamol
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: NA
Merck & Co. Inc.NULLNot RecruitingFemale: yes
Male: yes
136Phase 2Czech Republic;Finland;Spain;Germany;Italy
2687EUCTR2004-002993-49-CZ
(EUCTR)
11/02/200504/02/2005A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study Rheumatoid Arthritis
Classification code 10039073
Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
950Phase 3Finland;Hungary;Germany;Czech Republic;Estonia;Latvia;Sweden;Lithuania
2688EUCTR2004-002993-49-HU
(EUCTR)
11/02/200515/12/2004A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study Rheumatoid Arthritis
Classification code 10039073
Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Celltech R&D LtdNULLNot RecruitingFemale: yes
Male: yes
950Phase 3Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania
2689EUCTR2004-002993-49-LT
(EUCTR)
09/02/200503/01/2005A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study Rheumatoid Arthritis
Classification code 10039073
Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
950Phase 3Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania
2690EUCTR2004-002993-49-SK
(EUCTR)
08/02/200531/01/2005A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage studyA Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study Rheumatoid Arthritis
Classification code 10039073
Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
950Phase 3Estonia;Czech Republic;Hungary;Slovakia;Finland;Belgium;Lithuania;Latvia;Sweden
2691EUCTR2004-002132-26-ES
(EUCTR)
07/02/200507/12/2005A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of rhuMAb 2H7 (Ro 496-4913, PRO70769) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/AA randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of rhuMAb 2H7 (Ro 496-4913, PRO70769) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/A Rheumatoid ArthritisProduct Name: rhuMAb 2H7
Product Code: Ro 496-4913
INN or Proposed INN: N/A
Other descriptive name: rhuMAb 2H7
F Hoffmann-La Roche LimitedNULLNot RecruitingFemale: yes
Male: yes
160Phase 1/2United Kingdom;Spain
2692EUCTR2004-004893-96-GB
(EUCTR)
04/02/200515/02/2005Randomised double-blind trial of combination antibiotic therapy in rheumatoid arthritisRandomised double-blind trial of combination antibiotic therapy in rheumatoid arthritis Patients with medical diagnosis of Rheumatoid ArthritisTrade Name: Dalacin C phosphate
Product Name: Clindamycin
Trade Name: Tetraccycline
Product Name: Tetraccycline-hydrochloride
Hammersmith Hospitals NHS trustNULLNot RecruitingFemale: yes
Male: yes
50Phase 3United Kingdom
2693EUCTR2004-000922-59-DK
(EUCTR)
02/02/200501/12/2004A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to MethotrexateA Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate Rheumatoid Arthrithis, NosProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
675Phase 3Czech Republic;Denmark;Spain;Sweden
2694EUCTR2004-001909-10-GB
(EUCTR)
02/02/200515/08/2005Effect of Rosuvastatin on surrogate markers for cardiovascular events and joint disease progression in patients with rheumatoid arthritis - RORA trialEffect of Rosuvastatin on surrogate markers for cardiovascular events and joint disease progression in patients with rheumatoid arthritis - RORA trial Rheumatoid ArthritisTrade Name: rosuvastatin
Product Name: rosuvastatin
Product Code: ZD 4522
University of DundeeNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
2695NCT00522184
(ClinicalTrials.gov)
February 200527/8/2007Intra-Articular Injection of Etanercept in Patient Suffering From Rheumatoid Arthritis : a Double-Blind Randomized StudyIntra-Articular Injection of Etanercept in Patient Suffering From Rheumatoid Arthritis : a Double-Blind Randomized Study for Evaluation of Efficacy and Safety of Etanercept Versus Intra-Articular Steroid Injection in Acute SynovitisRheumatoid ArthritisProcedure: intra-articular injection of etanercept;Procedure: intra-articular injection of steroidCentre Hospitalier Universitaire de NiceWyeth is now a wholly owned subsidiary of PfizerCompleted18 YearsN/ABoth34Phase 3France
2696EUCTR2004-003733-14-ES
(EUCTR)
28/01/200507/12/2005A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1170Finland;Denmark;Spain;Italy
2697EUCTR2004-003733-14-DK
(EUCTR)
26/01/200507/12/2004A randomized, double-blind, parallel group study of the safetyand prevention of structural joint damage during treatment withMRA versus placebo, in combination with methotrexate, inpatients with moderate to severe active rheumatoid arthritis.A randomized, double-blind, parallel group study of the safetyand prevention of structural joint damage during treatment withMRA versus placebo, in combination with methotrexate, inpatients with moderate to severe active rheumatoid arthritis. Rheumatoid arthritisTrade Name: RoActemra®
Product Name: Tocilizumab Roche
Product Code: RO4877533
INN or Proposed INN: Tocilizumab Roche
Other descriptive name: MRA, Actemra
F Hoffmann La-Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
1170Finland;Spain;Denmark;Italy
2698EUCTR2004-000012-13-EE
(EUCTR)
20/01/200520/01/2005A Double-Blind, Placebo-Controlled, Parallel, Randomized Study To Evaluate The Efficacy And Safety Of 3 Oral Dose Levels Of TMI-005 In Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate - Rheumatoid Arthritis Product Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
INN or Proposed INN: Not yet established
Other descriptive name: WAY-177005
Product Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
INN or Proposed INN: Not yet established
Other descriptive name: WAY-177005
Product Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
INN or Proposed INN: Not yet established
Other descriptive name: WAY-177005
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and DevelopmentNULLNot RecruitingFemale: yes
Male: yes
360Czech Republic;Estonia;Italy
2699EUCTR2004-000563-96-AT
(EUCTR)
19/01/200515/12/2004A 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) - COMETA 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 ArthritisTrade 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
580Hungary;Finland;Spain;Ireland;Denmark;Austria;Norway;Italy;Sweden
2700EUCTR2004-004302-24-FI
(EUCTR)
18/01/200517/11/2004A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid ArthritisA Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073
Product Name: L-000883191
Product Code: L-000883191
INN or Proposed INN: NA
Other descriptive name: NA
Trade Name: Paracetamol
Product Name: Paracetamol
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: NA
Suomen MSD OyNULLNot RecruitingFemale: yes
Male: yes
136Finland;Czech Republic;Germany;Spain;Italy
2701NCT00132769
(ClinicalTrials.gov)
January 20052/8/2005A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK-0873 in Rheumatoid ArthritisRheumatoid ArthritisDrug: MK-0873;Drug: Comparator: PlaceboMerck Sharp & Dohme Corp.NULLCompleted18 Years65 YearsAll106Phase 2Belgium;Canada;Czech Republic;Finland;Germany;Italy;Norway;Spain;Switzerland
2702EUCTR2004-002157-30-SK
(EUCTR)
27/12/200410/11/2004A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis Rheumatoid ArthritisProduct Code: TAK-715
Product Code: TAK-715
Takeda Europe R&D Centre Ltd. (TEuR&D)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Slovakia;Finland;Denmark
2703EUCTR2004-000563-96-ES
(EUCTR)
22/12/200426/10/2004A 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) - COMETA 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 ArthritisTrade 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
580Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
2704EUCTR2004-000922-59-ES
(EUCTR)
21/12/200418/05/2005A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to MethotrexateA Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate Rheumatoid Arthrithis, NosProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
675Phase 3Czech Republic;Spain;Denmark;Sweden
2705EUCTR2005-000492-18-IT
(EUCTR)
16/12/200409/11/2007Insulin resistance and endothelial dysfunction TNF-Alpha dependent in patients with rheumatoid arthritis or metabolic syndromeInsulin 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 GEMELLINULLNot RecruitingFemale: yes
Male: yes
Italy
2706EUCTR2004-002157-30-DK
(EUCTR)
07/12/200405/11/2004A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis Rheumatoid ArthritisProduct Code: TAK-715
Product Code: TAK-715
Takeda Europe R&D Centre Ltd. (TEuR&D)NULLNot RecruitingFemale: yes
Male: yes
400Finland;Denmark
2707EUCTR2004-000922-59-SE
(EUCTR)
01/12/200413/10/2004A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate.Revised Protocol 1 , incorporating Amendment 02 (v5.0). Pharmacogenomic Amendment 01. Protocol Amendment 03 - Long-Term Extension. Protocol Amendment 05 - Long Term Extension Site Specific (V2.0, Date 23-Dec-2006).A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate.Revised Protocol 1 , incorporating Amendment 02 (v5.0). Pharmacogenomic Amendment 01. Protocol Amendment 03 - Long-Term Extension. Protocol Amendment 05 - Long Term Extension Site Specific (V2.0, Date 23-Dec-2006). Rheumatoid Arthrithis, NosProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Bristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Czech Republic;Denmark;Spain;Sweden
2708EUCTR2004-002157-30-FI
(EUCTR)
01/12/200422/10/2004A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis Rheumatoid ArthritisProduct Code: TAK-715
Product Code: TAK-715
Takeda Europe R&D Centre Ltd. (TEuR&D)NULLNot RecruitingFemale: yes
Male: yes
400Finland;Denmark
2709EUCTR2004-000563-96-IE
(EUCTR)
26/11/200429/01/2007A 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) - COMETA 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 ArthritisTrade 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
580Finland;Hungary;Denmark;Norway;Spain;Ireland;Italy;Sweden
2710EUCTR2004-003741-40-AT
(EUCTR)
26/11/200422/10/2004A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: Tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Austria;Germany;Italy
2711EUCTR2004-000563-96-DK
(EUCTR)
23/11/200428/08/2007A 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) - COMETA 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 ArthritisProduct 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
580Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
2712EUCTR2004-002006-30-GB
(EUCTR)
17/11/200417/02/2005Triple therapy in early active rheumatoid arthritis - TEARTriple therapy in early active rheumatoid arthritis - TEAR Rheumatoid arthritisProduct 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 TrustNULLNot RecruitingFemale: yes
Male: yes
96United Kingdom
2713EUCTR2004-000563-96-SE
(EUCTR)
17/11/200415/09/2004A 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) - COMETA 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 ArthritisProduct 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
580Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
2714EUCTR2004-000563-96-HU
(EUCTR)
12/11/200413/09/2004A 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) - COMETA 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 ArthritisTrade 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
580Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
2715EUCTR2004-003733-14-IT
(EUCTR)
09/11/200418/05/2005A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. active rheumatoid arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073
Product Name: Tocilizumab
Product Code: RO 487-7533
INN or Proposed INN: Tocilizumab
Other descriptive name: NA
Trade Name: METHOTREXATE*2,5MG 25CPR
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*10MG/1,33ML 4S
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*15MG/2ML 4SIR
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*20MG/2,66ML 4S
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
ROCHENULLNot RecruitingFemale: yes
Male: yes
1170Finland;Denmark;Spain;Italy
2716NCT00379600
(ClinicalTrials.gov)
November 200421/9/2006The Anti-Inflammatory And Metabolic Effects Of Rosiglitazone In Subjects With Rheumatoid ArthritisA Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Anti-inflammatory and Metabolic Effects of Rosiglitazone XR, 8mg Once Daily, in Subjects With Rheumatoid ArthritisArthritis, RheumatoidDrug: rosiglitazone XRGlaxoSmithKlineNULLCompleted18 YearsN/ABoth96Phase 2Lithuania;United Kingdom
2717NCT00747214
(ClinicalTrials.gov)
November 20043/9/2008A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RAA Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to That of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects With RARheumatoid ArthritisDrug: CRx-102;Drug: Placebo;Drug: DMARD TherapyZalicusNULLCompleted18 YearsN/AAll59Phase 2NULL
2718NCT01600521
(ClinicalTrials.gov)
November 20045/4/2012A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional MedicationsA Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional MedicationsRheumatoid ArthritisDrug: A Natural Remedy for Rheumatoid Arthritis vs. Common DrugsUniversity of Minnesota - Clinical and Translational Science InstituteNULLCompleted18 YearsN/ABoth1748N/AChina
2719NCT00170872
(ClinicalTrials.gov)
November 20049/9/20056 Week Open-label Trial With Lumiracoxib 200mg o.d. in Primary Knee Osteoarthritis or Rheumatoid ArthritisA 6 Week, Multicenter, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of Lumiracoxib 200mg o.d. in Patients With Primary Knee Osteoarthritis or Rheumatoid ArthritisOsteoarthritis;Rheumatoid ArthritisDrug: LumiracoxibNovartisNULLCompleted18 YearsN/ABoth135Phase 3NULL
2720NCT00854321
(ClinicalTrials.gov)
November 20042/3/2009Patients With Rheumatoid Arthritis (RA) Treated With Rituximab in Kuopio University HospitalOne Centre Follow-up Study on Safety and EfficacyRheumatoid ArthritisDrug: rituximab;Drug: rituximab, observational study amon patients with active RAKuopio University HospitalNULLCompleted18 YearsN/ABoth49N/AFinland
2721NCT00236028
(ClinicalTrials.gov)
November 20047/10/2005A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid ArthritisA Randomized, Double-blind, Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared With Methotrexate Alone for the Treatment of Patients With Early Rheumatoid ArthritisRheumatoid ArthritisDrug: InfliximabCentocor, Inc.NULLCompleted18 Years75 YearsBoth607Phase 3NULL
2722NCT00651625
(ClinicalTrials.gov)
November 200421/3/2008Reciprocating Medical Devices - a Study of a New Safety DeviceRandomized Controlled Trial of the Reciprocating Procedure Device Versus the Conventional Syringe in Syringe-and-Needle ProceduresOsteoarthritis;Rheumatoid Arthritis;Trauma;Thyroid Nodule;CancerDevice: Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001;Device: conventional syringe - BD Ref 309604University of New MexicoNULLCompleted18 YearsN/AAll437N/AUnited States
2723NCT00195494
(ClinicalTrials.gov)
November 200413/9/2005Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid ArthritisA 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 Early Rheumatoid ArthritisRheumatoid ArthritisDrug: Etanercept;Drug: Methotrexate;Drug: PlaceboWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/AAll542Phase 4United States
2724EUCTR2004-003741-40-IT
(EUCTR)
28/10/200421/09/2005A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. Active rheumatoid arthritis.
MedDRA version: 6.1;Level: PT;Classification code 10039073
Product Name: Tocilizumab
Product Code: RO 487-7533
INN or Proposed INN: Tocilizumab
Trade Name: METHOTREXATE*2,5MG 25CPR
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*10MG/1,33ML 4S
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*15MG/2ML 4SIR
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*20MG/2,66ML 4S
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
ROCHENULLNot RecruitingFemale: yes
Male: yes
Hungary;Germany;Italy
2725EUCTR2004-000012-13-CZ
(EUCTR)
26/10/200403/11/2004A Double-Blind, Placebo-Controlled, Parallel, Randomized Study To Evaluate The Efficacy And Safety Of 3 Oral Dose Levels Of TMI-005 In Subjects With Active Rheumatoid Arthritis On A Background Of MethotrexateA Double-Blind, Placebo-Controlled, Parallel, Randomized Study To Evaluate The Efficacy And Safety Of 3 Oral Dose Levels Of TMI-005 In Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate Rheumatoid ArthritisProduct Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
INN or Proposed INN: Not yet established
Other descriptive name: WAY-177005
Product Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
INN or Proposed INN: Not yet established
Other descriptive name: WAY-177005
Product Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
INN or Proposed INN: Not yet established
Other descriptive name: WAY-177005
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and DevelopmentNULLNot RecruitingFemale: yes
Male: yes
360Phase 2Estonia;Czech Republic;Italy
2726EUCTR2004-000482-35-GB
(EUCTR)
11/10/200408/02/2005A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arthritis. - HM2004/00255/00A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arthritis. - HM2004/00255/00 Rheumatoid ArthritisProduct Name: Rosiglitazone Extended Release Tablets
Product Code: BRL-049653
INN or Proposed INN: Rosiglitazone
Other descriptive name: Rosiglitazone maleate
GlaxoSmithKline Research & Development Ltd.NULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noLithuania;United Kingdom
2727EUCTR2004-001490-26-GB
(EUCTR)
15/09/200401/06/2005A SINGLE-CENTER, RANDOMIZED, SINGLE-BLIND STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RAA SINGLE-CENTER, RANDOMIZED, SINGLE-BLIND STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA RHEUMATOID ARTHRITISTrade Name: Asendis 50 mg
Product Name: N/A
Product Code: CRx-150
INN or Proposed INN: Amoxapine & dipyridamole
CombinatoRx, IncNULLNot RecruitingFemale: yes
Male: yes
Estonia;United Kingdom
2728EUCTR2004-000563-96-IT
(EUCTR)
13/09/200414/03/2007A 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 COMETA 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 LEDERLENULLNot RecruitingFemale: yes
Male: yes
540Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
2729EUCTR2004-000612-54-SE
(EUCTR)
11/09/200407/07/2004A 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 StudyA 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: 10031161 Rheumatoid Arthritis (RA) ICD: M06.9 MedDRA: 10039037Product 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) ABNULLNot Recruiting Female: yes
Male: yes
1360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSweden
2730EUCTR2004-000106-41-SE
(EUCTR)
07/09/200403/08/2004A study to investigate the effect of GW406381 on methotrexate pharmacokinetics in patients treated with methotrexate for rheumatoid arthritis - GW406381 and methotrexateA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
Sweden
2731NCT00279734
(ClinicalTrials.gov)
August 200419/1/2006Vaccination Study of Abatacept (BMS-188667) for Normal Healthy VolunteersAn Exploratory Study to Evaluate the Effect of Abatacept (BMS-188667) on the Antibody Response Following Tetanus Toxoid and 23-Valent Pneumococcal Vaccinations in Healthy SubjectsRheumatoid ArthritisDrug: Tetanus + pnemococcal vaccines alone;Drug: Abatacept + vaccines;Drug: Abatacept + VaccinesBristol-Myers SquibbNULLCompleted18 Years65 YearsBoth80Phase 1United States
2732EUCTR2004-000362-12-CZ
(EUCTR)
23/07/200420/08/2004A Double-Blind, Randomised, Dose-Ranging Study to Compare K-832 with Placebo in the treatment of Patients with Active Rheumatoid Arthritis - N/AA Double-Blind, Randomised, Dose-Ranging Study to Compare K-832 with Placebo in the treatment of Patients with Active Rheumatoid Arthritis - N/A Rheumatoid Arthritis
MedDRA version: 6.0;Level: LLT;Classification code 10028395
Product Name: K-832
Product Code: K-832
INN or Proposed INN: To be confirmed
Other descriptive name: N/A
Product Name: K-832
Product Code: K-832
INN or Proposed INN: To be confirmed
Other descriptive name: N/A
Kowa Research Europe LtdNULLNot RecruitingFemale: yes
Male: yes
260Czech Republic
2733EUCTR2004-000074-31-SE
(EUCTR)
06/07/200421/05/2004A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid ArthritisA Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis rheumatoid arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073
Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c
Product Code: L-000124467 (freebase); L-000124467-009J (succinat
INN or Proposed INN: not available
Other descriptive name: L-000124467
Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c
Product Code: L-000124467 (freebase); L-000124467-009J (succinat
INN or Proposed INN: not available
Other descriptive name: L-000124467
Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c
Product Code: L-000124467 (freebase); L-000124467-009J (succinat
INN or Proposed INN: not available
Other descriptive name: L-000124467
Trade Name: paracetamol (acetaminophen)
Product Name: paracetamol (acetaminophen)
Merck Sharp & Dohme (Sweden) ABNULLNot RecruitingFemale: yes
Male: yes
150Sweden
2734NCT00089921
(ClinicalTrials.gov)
July 200417/8/2004SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving MethotrexateA 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than HydroxychloroquineArthritis, RheumatoidDrug: SCIO-469;Drug: PlaceboScios, Inc.NULLCompleted18 YearsN/ABoth302Phase 2United States
2735NCT00154336
(ClinicalTrials.gov)
July 20048/9/2005A Study of Imatinib 400 mg Once Daily in Combination With Methotrexate in the Treatment of Rheumatoid Arthritis.3-Month, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety & Tolerability of Imatinib 400 mg Daily in Combination With Methotrexate (MTX)Compared to MTX Alone in the Treatment of Rheumatoid Arthritis (RA).Rheumatoid ArthritisDrug: Imatinib;Drug: Methotrexate;Drug: Imatinib PlaceboNovartis PharmaceuticalsNULLCompleted18 Years75 YearsAll50Phase 2Austria;Canada;Finland;United Kingdom
2736NCT00252668
(ClinicalTrials.gov)
June 20049/11/2005Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis SubjectsAn Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis SubjectsRheumatoid ArthritisDrug: Etanercept;Drug: MethotrexateWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/ABoth300Phase 4NULL
2737NCT00468377
(ClinicalTrials.gov)
March 200430/4/2007Safety and Efficacy Study of Re-treatment With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Respond Poorly to Anti-TNFa TherapiesAn Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa TherapiesArthritis, RheumatoidDrug: RituximabHoffmann-La RocheGenentech, Inc.Active, not recruiting18 Years80 YearsBoth341Phase 3United States
2738NCT00484809
(ClinicalTrials.gov)
March 20048/6/2007Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and ChildrenA Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA).Rheumatoid ArthritisDrug: Enbrel (Etanercept)Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted4 YearsN/ABoth100NULL
2739NCT00619905
(ClinicalTrials.gov)
December 20038/2/2008Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Rheumatoid Arthritis With Ongoing Treatment With MethotrexateA Randomized, Double-Blind, Placebo-Controlled, Cohort Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 (Anti-Interleukin-1Beta Monoclonal Antibody) in Patients With Active Rheumatoid Arthritis (RA) Despite Ongoing Treatment With Methotrexate (MTX) 15 mg or More Weekly for at Least 3 Months.Rheumatoid ArthritisDrug: ACZ885NovartisNULLCompleted18 Years75 YearsBoth53Phase 1/Phase 2Germany;Netherlands;Switzerland
2740NCT00076206
(ClinicalTrials.gov)
December 200315/1/2004Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate TherapyA Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Oral Dose Levels (1, 2, And 4 Mg) of CCI-779 in Subjects With Active Rheumatoid Arthritis on Concomitant Methotrexate TherapyRheumatoid ArthritisDrug: CCI-779;Drug: PlaceboWyeth is now a wholly owned subsidiary of PfizerNULLTerminated18 Years75 YearsBothPhase 2United States
2741NCT00207714
(ClinicalTrials.gov)
November 200313/9/2005An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid ArthritisA Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With MethotrexateRheumatoid ArthritisDrug: Golimumab;Drug: MTX;Drug: Placebo;Drug: InfliximabCentocor, Inc.Centocor BVCompleted18 YearsN/AAll172Phase 2NULL
2742NCT00195364
(ClinicalTrials.gov)
July 200313/9/2005Study Evaluating Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in SpainLong-Term Safety Study of Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in SpainRheumatoid Arthritis;InflammationDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/ABoth93Spain
2743NCT00245934
(ClinicalTrials.gov)
June 200326/10/2005Study Evaluating Enbrel in Patients With Rheumatoid ArthritisObservational Study With Enbrel in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: EnbrelWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/ABoth1500N/ANULL
2744NCT00095342
(ClinicalTrials.gov)
May 20032/11/2004Study Evaluating TMI-005 in Active Rheumatoid ArthritisA Double-Blind, Placebo-Controlled, Parallel, Randomized Study to Evaluate the Efficacy and Safety of 3 Oral Dose Levels of TMI-005 in Subjects With Active Rheumatoid Arthritis on a Background of MethotrexateRheumatoid ArthritisDrug: TMI-005Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years75 YearsBoth390Phase 2United States;Canada
2745NCT00195377
(ClinicalTrials.gov)
April 200313/9/2005Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in SpainEvaluating Safety and QoL in Patients Treated With Etanercept: an Open Multicenter StudyArthritis, Psoriatic;Arthritis, RheumatoidDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted4 YearsN/ABoth1000Spain
2746NCT00244556
(ClinicalTrials.gov)
March 200312/10/2005Study Comparing Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Active Rheumatoid Arthritis Despite Current Methotrexate TherapyA Randomized Comparison of the Safety and Efficacy of Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Patients With Active Rheumatoid Arthritis Despite Current Methotrexate TherapyRheumatoid ArthritisDrug: Methotrexate plus ENBREL or ENBREL aloneWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/ABoth300Phase 4NULL
2747NCT00908089
(ClinicalTrials.gov)
March 200322/5/2009TNF-blocking Therapy in Combination With Disease-modifying Antirheumatic Drugs in Early Rheumatoid ArthritisUse of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid ArthritisRheumatoid ArthritisDrug: Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab;Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + placeboHelsinki UniversitySeinajoki Central Hospital;Oulu University Hospital;Jyväskylä Central Hospital;Kuopio University Hospital;Satakunta Central Hospital;University of Turku;Rheumatism Foundation Hospital;Orton Invalid Foundation;South Karelia central hospital;Lappi Central Hospital;Central Hospital of Kanta-HameActive, not recruiting18 Years60 YearsBoth100Phase 4Finland
2748NCT00546533
(ClinicalTrials.gov)
January 200318/10/2007Study Evaluating the Efficacy and Safety of EtanerceptOpen-Label Evaluation Of The Efficacy And Safety Of Etanercept In Patients With Active Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompletedN/AN/ABoth40Phase 4NULL
2749NCT00116727
(ClinicalTrials.gov)
October 200230/6/2005Rheumatoid Arthritis DMARD Intervention and UtilizationStudyRheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 2)Rheumatoid ArthritisDrug: ENBREL®AmgenImmunex Corporation;Wyeth is now a wholly owned subsidiary of PfizerCompleted18 YearsN/ABoth5103N/AUnited States
2750NCT00282412
(ClinicalTrials.gov)
September 200224/1/2006Rheumatoid Arthritis:Tolerance Induction by Mixed ChimerismRheumatoid Arthritis: Tolerance Induction by Mixed ChimerismRheumatoid ArthritisBiological: Hematopoietic Stem Cell TransplantationNorthwestern UniversityNULLTerminated18 Years60 YearsBoth4Phase 1United States
2751NCT02180516
(ClinicalTrials.gov)
October 20011/7/2014Safety and Efficacy of Meloxicam Compared to Other Nonsteroidal Antiinflammatory Drugs (NSAIDs) in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm SyndromeSafety and Efficacy of Meloxicam (MOBIC) Compared to Other NSAIDs in Approved Therapeutic Dosages and Routes of Administration in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm SyndromeArthritis, RheumatoidDrug: Meloxicam;Drug: Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolacBoehringer IngelheimNULLCompletedN/AN/ABoth9984N/ANULL
2752NCT00116714
(ClinicalTrials.gov)
October 200130/6/2005Rheumatoid Arthritis (DMARD) Intervention and UtilizationStudyRheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 1)Rheumatoid ArthritisDrug: DMARDAmgenImmunex Corporation;Wyeth is now a wholly owned subsidiary of PfizerCompleted18 YearsN/ABoth4968N/AUnited States
2753NCT00393471
(ClinicalTrials.gov)
October 200026/10/2006Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.A Double-Blind Study Evaluating the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Comparison to Etanercept Alone or Methotrexate Alone in Rheumatoid Arthritis Patients.Active Rheumatoid ArthritisDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/AMale615Phase 3Australia;Austria;Belgium;Czech Republic;Denmark;Finland;France;Germany;Greece;Israel;Italy;Netherlands;Norway;Poland;Portugal;Romania;Spain;Sweden;United Kingdom
2754NCT00006055
(ClinicalTrials.gov)
March 20005/7/2000Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune DiseasesPurpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu ArteritisDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell TransplantationFairview University Medical CenterNULLActive, not recruiting1 Year55 YearsBoth10N/AUnited States
2755NCT00000435
(ClinicalTrials.gov)
September 199921/1/2000dnaJ Peptide for Relieving Rheumatoid ArthritisA Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: dnaJ peptide;Drug: None-placeboNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompleted18 Years85 YearsBoth160Phase 2United States
2756JPRN-JapicCTI-080531
21/02/2008A Phase III, Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) UseA Phase III, Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, LumbagoIntervention name : esomeprazole
Dosage And administration of the intervention : Oral
AstraZenecaNULL20BOTHPhase 3NULL
2757EUCTR2004-000563-96-NO
(EUCTR)
06/10/2004A 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) - COMETA 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 ArthritisProduct 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
580Phase 4Hungary;Finland;Spain;Ireland;Denmark;Austria;Norway;Italy;Sweden
2758JPRN-JapicCTI-132134
23/05/2013A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic DrugsA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs Rheumatoid ArthritisIntervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 52.
Control intervention name : Placebo
Dosage And administration of the control intervention : Baricitinib placebo administered orally once daily through Week 52 and MTX placebo administered orally once weekly through Week 52.
Control intervention name : Methotrexate
Dosage And administration of the control intervention : Methotrexate (MTX) administered orally once weekly with dose ranging from 7.5 to 12.5 mg per week through Week 52.
Eli Lilly Japan K.K.NULLcomplete18BOTHPhase 3NULL
2759EUCTR2012-003655-11-DE
(EUCTR)
09/12/2013Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of lifeA multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis Moderately to severely active 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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
739Phase 2United States;Czechia;Spain;Guatemala;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of
2760EUCTR2007-002536-29-PL
(EUCTR)
15/01/2008A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RAA randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA Rheumatoid 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Austria;Poland;Sweden
2761EUCTR2005-002969-37-DE
(EUCTR)
17/05/2006A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship. - GM2005/00244/00A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship. - GM2005/00244/00 Rheumatoid ArthritisProduct Code: GW856553
Product Code: GW856553
Product Code: GW856553
Product Name: Methotrexat
INN or Proposed INN: Methotrexate Disodium
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
48Germany;Spain;Sweden
2762JPRN-JapicCTI-080565
09/04/2008A Long Term Study to Investigate the Efficacy and Safety Study of D961H (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) UseA Long Term Study to Investigate the Efficacy and Safety Study of D961H (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, LumbagoIntervention name : esomeprazole
Dosage And administration of the intervention : Oral
AstraZenecaNULL20BOTHPhase 3NULL
2763EUCTR2008-000744-13-DE
(EUCTR)
07/10/2008An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 StudyAn Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
800France;Belgium;Bulgaria;Germany;Italy
2764EUCTR2009-017438-32-DE
(EUCTR)
22/02/2010A 12-week study of 4 doses of VX-509 in subjects with active rheumatoid arthritisA 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritis Active 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]
Product Name: VX-509
Product Code: VX-509
Product Code: VX-509
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Hungary;Russian Federation;Germany;Serbia;Belgium;Romania;United States;Croatia;Poland
2765JPRN-JapicCTI-111601
05/09/2011A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNF-alpha agentsA randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNF-alpha agents Rheumatoid ArthritisIntervention name : Secukinumab
INN of the intervention : Secukinumab
Dosage And administration of the intervention : s.c. i.v.
Novartis Pharma K.K.NULL18BOTHPhase 3NULL
2766EUCTR2012-001145-40-Outside-EU/EEA
(EUCTR)
07/03/2012Study evaluating long-term safety in adults with rheumatoid arthritis and in children and adolescents with childhood arthritisOpen-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 91320NULLNAFemale: yes
Male: yes
783Canada;United States
2767EUCTR2011-002896-40-ES
(EUCTR)
26/06/2012A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritisA RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES RHEUMATOID ARTHRITIS
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-05280586
INN or Proposed INN: Not Applicable
Other descriptive name: Not Applicable
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
195Phase 2United States;Taiwan;Spain;Korea, Democratic People's Republic of;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany
2768EUCTR2005-002423-13-BG
(EUCTR)
03/08/2010Study of safety and efficacy of long-term treatment with tocilizumab in adult patients with rheumatoid arthritis.Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - GROWTH95 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: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Germany;Switzerland;Bulgaria;France;Italy;Singapore;Hong Kong;Austria;Australia;Brazil;Israel;Slovakia;Canada;Mexico;Argentina;Thailand
2769EUCTR2010-023692-26-DE
(EUCTR)
07/12/2010Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared with Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 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: Fostamatinib disodium
Product Code: previously known as R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
370Phase 2United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands
2770EUCTR2005-001138-33-SI
(EUCTR)
13/06/2005A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis. Rheumatoid ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium
INN or Proposed INN: Methotrexate sodium
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
650Portugal;Denmark;Slovenia;Norway;Spain;Italy
2771EUCTR2007-003591-19-DE
(EUCTR)
05/09/2007AN OPEN, COMPARATIVE, WITHIN PATIENT CONTROLLED MULTICENTRE STUDY OF REPEATED SUBCUTANEOUS INJECTIONS OF METHOTREXATE 50MG/ML AND 10MG/ML TO COMPARE PATIENT SATISFACTION AND LOCAL TOLERABILITY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS - MTX 50 versus 10mg/mlAN OPEN, COMPARATIVE, WITHIN PATIENT CONTROLLED MULTICENTRE STUDY OF REPEATED SUBCUTANEOUS INJECTIONS OF METHOTREXATE 50MG/ML AND 10MG/ML TO COMPARE PATIENT SATISFACTION AND LOCAL TOLERABILITY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS - MTX 50 versus 10mg/ml Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Methotrexate 50mg/ml solution for injection, pre-filled syringe
INN or Proposed INN: Methotrexate disodium
Other descriptive name: Methotrexate disodium
Trade Name: Metex 10 mg/ml Injektionslösung, Fertigspritze
INN or Proposed INN: methotrexate disodium
Other descriptive name: Methotrexate disodium
medac Gesellschaft für klinische Spezialpräparate mbHNULLNot RecruitingFemale: yes
Male: yes
Germany
2772EUCTR2006-003983-73-DE
(EUCTR)
23/03/2007A Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients with Active Rheumatoid Arthritis Despite Methotrexate TherapyA Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: RWJ-445380 Capsules 50 mg
Product Code: RWJ-445380-002
Other descriptive name: JNJ-16240159-AAC
Product Name: RWJ-445380 capsule 100 mg
Product Code: RWJ-445380-002
Other descriptive name: JNJ-16240159-AAC
Product Name: RWJ-445380 capsules 150 mg
Product Code: RWJ-445380-002
Other descriptive name: JNJ-16240159-AAC
Janssen-Cliag International N.V.NULLNot RecruitingFemale: yes
Male: yes
240Phase 2Czech Republic;Germany
2773EUCTR2011-001626-15-ES
(EUCTR)
20/10/2011A study of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with rheumatoid arthritis with inadequate response to prior treatment with methotrexate and low disease activity with the combination de RoActemra/Actemra y methotrexate.A multi-centre, randomized, double-blind study of the safety and efficacy of tocilizumab (TCZ) in combination with methotrexate (MTX), versus TCZ (placebo controlled) in patients with active rheumatoid arthritis (RA) with inadequate response to prior MTX treatment and low disease activity (DAS 28 ? 3.2) with the combination TCZ and MTX. 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 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
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
Roche Farma, S.A.NULLNot RecruitingFemale: yes
Male: yes
Spain
2774EUCTR2012-000609-58-ES
(EUCTR)
09/07/2012A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNF? biologicsA randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNF? biologics 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 Code: 0109-0012A 100 mg/ml
Product Code: 0109-0012A 50 mg/ml
Product Code: 0109-0012A 25 mg/ml
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
268Phase 2United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany