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 46. Malignant rheumatoid arthritis
 [ 1,999 clinical trials,    1,752 drugs（DrugBank: 321 drugs),    172 target genes / 213 target pathways ] 

Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT02903212March 202027 May 2019Tolerance 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 BesanconNot recruiting18 Years80 YearsAll22Phase 1/Phase 2
2NCT04086745January 2, 202011 November 2019A Study of Baricitinib in Participants With Rheumatoid ArthritisA Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Baricitinib;Drug: TNF InhibitorEli Lilly and CompanyIncyte CorporationNot recruiting18 YearsN/AAll1300Phase 4
3NCT04115423January 1, 202014 October 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, KoreaNot recruiting18 YearsN/AAll4540Phase 4
4NCT04117165January 1, 202014 October 2019Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid ArthritisAssessment of the Clinical and Medico-economic Impact of SinnoTest®, a Software That Predicts the Effectiveness of Biotherapy Treatments, in Patients With Rheumatoid Arthritis (RA)Arthritis, Rheumatoid;Biological TherapyDiagnostic Test: Biotherapy Prescription with SinnoTest® software;Drug: Patient Current CareUniversity Hospital, GrenobleNot recruiting18 Years70 YearsAll180N/AFrance
5NCT04115397January 202022 October 2019Bisphosphonates for the Treatment of Seropositive Musculoskeletal ComplaintsTowards Efficient Prediction and Prevention of Rheumatoid ArthritisSeropositive Muskuloskeletal ComplaintsDrug: Zoledronic Acid;Drug: PlaceboKarolinska InstitutetNot recruiting18 YearsN/AAll80Phase 4
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6NCT04078191December 201916 September 2019Comparison of Tc 99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue of Subjects With Rheumatoid Arthritis (RA)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 ArthritisDrug: Tc 99m tilmanoceptNavidea BiopharmaceuticalsNot recruiting18 YearsN/AAll24Phase 2United Kingdom
7JPRN-jRCTs07119003001/11/20195 November 2019Non-inferiority trial of efficacy after switching from Remicade to infliximab BS[CTH] in rheumatoid arthritis patientsNon-inferiority trial of clinical non-relapse rate after switching from Remicade to infliximab BS[CTH] in rheumatoid arthritis patients with clinical remission, a multicenter prospective trial - IFX-SIRIUS STUDY IRheumatoid arthritisRheumatoid arthritis patients who have been treated with Remicade over 24 weeks and persisted with clinical remission are switched to infliximab BS [CTH] from Remicade.
The dose and infusion intervals of infliximab BS[CTH] are kept unchanged from those of Remicade.		Atsushi KawakamiRecruiting>= 20age oldNot applicableBoth80Phase 4none
8NCT04134728November 1, 20194 November 2019Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) InhibitorsA 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 InhibitorsArthritis, RheumatoidBiological: GSK3196165;Biological: Sarilumab;Drug: Placebo to GSK3196165/ Sarilumab;Drug: csDMARDsGlaxoSmithKlineIqvia Pty LtdNot recruiting18 YearsN/AAll525Phase 3United States
9NCT04130178October 25, 201928 October 2019Nerve Block of the Proximal Interphalangeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot StudyNerve Block of the Proximal Interphalyngeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot StudyRheumatoid ArthritisDrug: Nerve blockSohag UniversityRecruiting18 YearsN/AAll42N/AEgypt
10NCT04120831October 7, 201922 October 2019TOLERA: Tolerance Enhancement in RASequential B Cell/T Cell Therapy to Re-induce Humoral Immune TOLErance in ACPA- Positive Rheumatoid Arthritis A Prospective, Randomized Controlled Open Label Single-centre Clinical Trial in Adult Subjects With Active ACPA-positive Rheumatoid Arthritis Failing MethotrexateRheumatoid ArthritisDrug: Abatacept InjectionUniversity of Erlangen-Nürnberg Medical SchoolRecruiting18 YearsN/AAll20Phase 2Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
11JPRN-JapicCTI-19493201/10/20195 November 2019An Extension Study of TS-152 in Subjects with Rheumatoid ArthritisAn Extension Study of TS-152 in Subjects with Rheumatoid ArthritisRheumatoid ArthritisIntervention name : ozoralizumab
INN of the intervention : ozoralizumab
Dosage And administration of the intervention : Subcutaneous injection of TS-152 30mg or TS-152 80mg every 4 weeks
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -		Taisho Pharmaceutical Co.LtdRecruiting20BOTH505Phase 3Japan
12NCT04077567October 1, 201922 October 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.Recruiting20 YearsN/AAll505Phase 3Japan
13NCT03828344October 201911 February 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.Not recruiting18 Years70 YearsAll16Phase 1
14NCT04136262October 20194 November 2019Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid ArthritisTripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis: a Randomized Controlled TrialRheumatoid ArthritisDrug: Tripterygium wilfordii Hook F (TwHF);Drug: Methotrexate;Other: Dummy Tripterygium wilfordii Hook F (TwHF)Guang'anmen Hospital of China Academy of Chinese Medical SciencesNot recruitingN/AN/AFemale300Phase 2/Phase 3
15ChiCTR19000262572019-09-2830 September 2019A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated FatigueEfficacy, dose comparison, and safety of Wisconsin Ginseng (Panax quinquefolius) in patients with rheumatoid arthritis associated fatigue: Three-arm parallel, multicenter, randomized, double-blind, placebo-controlled, phase 2 trialRheumatoid arthritis (RA)High-dose experimental group :6000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ;Low-dose experimental group:3000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg); 3000mg Placebo: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg) ;Control group :6000mg Placebo: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ;Zhejiang Provincal Hospital of TCMNot Recruiting1870BothHigh-dose experimental group :30;Low-dose experimental group:30;Control group :30;Phase 2China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
16NCT03971253September 2, 201928 October 2019Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid ArthritisJapan Post-Marketing Surveillance - Specified Drug Use-results Survey for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid ArthritisRheumatoid Arthritis (RA)Drug: PeficitinibAstellas Pharma IncRecruitingN/AN/AAll3000Phase 4Japan
17NCT03895879September 201930 September 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
18NCT03938701September 201926 August 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 recruiting18 YearsN/AAll30Phase 1Netherlands
19NCT03976245September 201922 July 2019Advanced Therapeutics in Rheumatoid Arthritis (RA)Advanced Therapeutics in Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: Etanercept;Drug: tofacitinibLawson Health Research InstituteAcademic Medical Organization of Southwestern OntarioNot recruiting18 YearsN/AAll144Phase 4Canada
20JPRN-JapicCTI-19492826/8/201910 September 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 MJK101Rheumatoid 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 GmbHRecruiting2075BOTH100Phase 3Japan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
21NCT04004429August 26, 201911 November 2019A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint DiseaseA Double-blind, Multicenter, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients With Active Joint DiseaseRheumatoid ArthritisDrug: 50 mg AP1189;Drug: AP1189;Drug: PlaceboSynAct Pharma ApsRecruiting18 Years85 YearsAll90Phase 2Denmark
22ChiCTR19000250132019-08-0827 August 2019Clinical observation of multiple dose use of tranexamic acid in patients with rheumatoid arthritis after total knee arthroplastyEffects of multiple dose use of tranexamic acid on blood loss and inflammatory factors after total knee arthroplasty in patients with rheumatoid arthritisTotal knee arthroplastygroup 1:Intravenous infusion of 1g of tranexamic acid + 100 ml 3 hours after surgery, intravenous infusion of 100 ml of normal saline 6 and 12 hours after surgery.;group 2:Intravenous infusion of 1g of tranexamic acid + 100 ml of normal saline at 3, 6, and 12 hours after surgery;Guanghua Hospital, Shanghai University of Traditional Chinese MedicineRecruiting5075Bothgroup 1:38;group 2:38;Phase 4China
23ChiCTR19000249022019-08-0127 August 2019A randomized, double-blind, prospective, controlled trial for Yishen-Tongbi-Tang in the treatment of active rheumatoid arthritisA randomized, double-blind, prospective, controlled trial for Yishen-Tongbi-Tang in the treatment of active rheumatoid arthritisRheumatoid ArthritisExperimental group:Traditional Chinese medicine (Yi-Shen Tong-Bi Tang);Positive control group:Methotrexate;The First Affiliated Hospital of Guangzhou University of Traditional Chinese MedicineNot Recruiting1865BothExperimental group:50;Positive control group:50;N/AChina
24NCT02418273August 1, 201916 December 2017Denosumab for Glucocorticoid-treated Children With Rheumatic DisordersDenosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot StudyOsteoporosis;Juvenile Rheumatoid Arthritis;Dermatomyositis;Polyarthritis;Systemic Lupus Erythematosis;Vasculitis;Glucocorticoid-induced OsteoporosisDrug: denosumabIndiana UniversityNot recruiting4 Years16 YearsAll24Phase 1/Phase 2United States
25NCT04068246August 1, 20192 September 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: MetforminSadat City UniversityRecruiting18 YearsN/AAll100Early Phase 1Egypt
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
26ChiCTR19000250212019-07-2527 August 2019Safety, Tolerance and Pharmacokinetics of Single Administration of Meloxicam Suspension Injection in Healthy Chinese SubjectsSafety, Tolerance and Pharmacokinetics of Single Administration of Meloxicam Suspension Injection in Healthy Chinese SubjectsOsteoarthritis, rheumatoid arthritisA:TR group: phase I: Meloxicam Suspension Injection (T) 7.5 mg, phase II: Mobi (R) 7.5 mg; RT group: phase I: R, phase II: T.;B:Meloxicam Suspension Injection 15 mg;C:Meloxicam Suspension Injection 30 mg;D:Meloxicam Suspension Injection 60 mg;Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South UniversityRecruitingBothA:12;B:12;C:12;D:12;Phase 1China
27ChiCTR19000242612019-07-1515 July 2019Efficacy and safety of sirolimus in new-onset rheumatoid arthritis: a prospective, double-blinded, randomized, placebo-controlled, monocentric study in ChinaEfficacy and safety of sirolimus in new-onset rheumatoid arthritis: a prospective, double-blinded, randomized, placebo-controlled, monocentric study in Chinarheumatoid arthritisA:methotrexate (7.5~15 mg/week)+ placbo (1 mg/d);B:sirolimus (1 mg/d) + methotrexate (7.5~15 mg/week);The Second Hospital of Shanxi Medical UniversityNot Recruiting1865BothA:30;B:30;Phase 4China
28NCT04018599July 15, 201930 September 2019Comparison of PK and Tolerability of MSB11022 Administered by AI or PFSA Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy SubjectsRheumatoid Arthritis;Polyarticular Juvenile Idiopathic Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Crohn Disease;Ulcerative Colitis;Plaque Psoriasis;Pediatric Plaque Psoriasis;Pediatric Crohns Disease;Hidradenitis Suppurativa;Non-infectious UveitisDrug: 40 mg MSB11022Fresenius Kabi SwissBioSim GmbHPRA Health SciencesRecruiting18 Years55 YearsAll216Phase 1United States
29NCT03813199July 4, 201929 July 2019Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid ArthritisPhase 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 TherapyRheumatoid ArthritisDrug: ABX464 50mg;Drug: Matching Placebo;Drug: ABX464 100mg;Drug: MethotrexateAbivax S.A.Recruiting18 Years75 YearsAll60Phase 2France
30NCT03656627June 27, 201922 October 2019Nivolumab 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 SquibbRecruiting18 YearsN/AAll72Phase 1United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
31NCT03912428June 14, 20191 July 2019Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and MyositisEvaluation of Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and MyositisMyositisDrug: CelecoxibNational Institute of Mental Health (NIMH)Recruiting18 Years99 YearsAll47Phase 1United States
32NCT03970837June 5, 201922 October 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;Drug: Tofacitinib;Drug: Placebo to GSK3196165;Drug: Placebo to Tofacitinib;Drug: csDMARDsGlaxoSmithKlineIqvia Pty LtdRecruiting18 YearsN/AAll1500Phase 3United States;Colombia
33NCT03886038June 1, 20191 April 2019Subunit Vaccine Against Herpes Zoster in RA Patients Treated With JAK-inhibitors (VACCIMIL-ZOSTER)The Immunogenicity and Efficacy of Subunit Vaccine Against Herpes Zoster in RA Treated With JAK-inhibitors (VACCIMIL-ZOSTER)Rheumatoid Arthritis;Healthy ControlsBiological: ShingrixRegion SkaneNot recruiting18 YearsN/AAll150Phase 4Sweden
34NCT03619876June 201927 May 2019Effects of Abatacept on Myocarditis in Rheumatoid ArthritisEffects of Abatacept on Myocarditis in Rheumatoid ArthritisRheumatoid Arthritis;Myocardial InflammationDrug: Abatacept;Drug: AdalimumabColumbia UniversityBristol-Myers SquibbNot recruiting18 YearsN/AAll20Phase 4United States
35NCT04033809May 30, 201929 July 2019Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis PatientsEffectiveness of High Fiber Multigrain Supplementation Among the Rheumatoid Arthritis Patients: A Randomized, Open Label TrialRheumatoid ArthritisDietary Supplement: Multigrain powder (S)University of Science MalaysiaNot recruiting21 YearsN/AAll50N/AMalaysia
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
36NCT03980483May 16, 201922 October 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, RheumatoidBiological: GSK3196165;Drug: Tofacitinib 5 mg;Drug: Placebo to GSK3196165;Drug: Placebo to tofacitinib;Drug: Methotrexate;Drug: Folic (or folinic) acidGlaxoSmithKlineIqvia Pty LtdRecruiting18 YearsN/AAll1500Phase 3United States
37NCT03823378May 13, 20193 June 2019A Study in Rheumatoid Arthritis Patients Who Have Completed 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 (RA)Drug: Upadacitinib;Drug: Upadacitinib placebo;Drug: ABBV-105 placebo;Drug: ABBV-105AbbVieRecruiting18 YearsN/AAll50Phase 2Belgium;Canada;Czechia;Hungary;Poland;Spain;United Kingdom
38NCT03882008April 25, 201929 April 2019A Study to Evaluate Biomarkers to Predict Efficacy of Abatacept in Rheumatoid ArthritisPhase IV Open-Label Study to Evaluate Biomarkers to Predict the Efficacy of Abatacept in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: AbataceptUniversity of WashingtonBristol-Myers SquibbRecruiting18 YearsN/AAll25Phase 4United States
39NCT03915964April 25, 201911 November 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 CorporationRecruiting18 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
40EUCTR2018-003933-14-EE09/04/201930 April 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 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: LLT 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		Galapagos NVAuthorised Female: no
Male: yes		250Phase 2Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany;Latvia;Moldova, Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
41NCT03938636April 8, 201922 October 2019Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar ImagingEvaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar ImagingRheumatoid ArthritisDrug: TC99m-tilmanoceptNavidea BiopharmaceuticalsRecruiting18 YearsN/AAll105Phase 2United States
42NCT03816345April 4, 201911 November 2019Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant NeoplasmBiological: NivolumabNational Cancer Institute (NCI)Recruiting18 YearsN/AAll264Phase 1United States
43NCT03669367April 1, 201921 January 2019EFFECTS 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 BiomédicaNot recruiting18 YearsN/AAll98Phase 4
44NCT03700021April 20194 February 2019Response 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 MedicineNot recruiting18 YearsN/AAll25Phase 4United States
45NCT03823391March 27, 20199 September 2019A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid ArthritisA Randomized, 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 ArthritisRheumatoid Arthritis (RA)Drug: ABBV-3373;Drug: Placebo for ABBV-3373;Drug: Adalimumab;Drug: Placebo for adalimumabAbbVieRecruiting18 Years75 YearsAll45Phase 1United States;Germany;Hungary;Israel;Netherlands;Poland;Puerto Rico
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
46NCT03885037March 20, 20194 November 2019Infliximab Biosimilar for Intravenous Drip Infusion 100 mg Pfizer Drug Use Investigation (Rheumatoid Arthritis)Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Rheumatoid Arthritis)Rheumatoid ArthritisDrug: Infliximab [infliximab biosimilar 3]PfizerRecruitingN/AN/AAll300Phase 3Japan
47NCT04057118March 20, 20194 November 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.Recruiting18 YearsN/AAll148Phase 2United States;Czechia;Poland;Russian Federation;Ukraine
48NCT03890302March 14, 20198 April 2019A Placebo-controlled Study to Evaluate the Safety, Movement Through, and Reaction of the Body to Single and Multiple Increasing Doses of FB704AA Phase 1, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Single and Multiple Ascending Doses of FB704ARheumatoid ArthritisDrug: FB704A;Drug: PlaceboFountain Biopharma Inc.Recruiting18 Years55 YearsAll41Phase 1United States
49ChiCTR19000218082019-03-0818 March 2019A Phase 1, Randomized, Double-Blind and Paralle, Controlled Single-dose Clinical Trial of Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of QX003S and Tocilizumab in Chinese Health Male SubjectsA Phase 1, Randomized, Double-Blind and Paralle, Controlled Single-dose Clinical Trial of Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of QX003S and Tocilizumab in Chinese Health Male SubjectsActive rheumatoid arthritis1:8 mg/kg QX003S ;2:Tocilizumab, 8 mg/kg;JiangSu Qyuns Therapeutics Co., LtdRecruiting1850Male1:43;2:43;Phase 1China
50NCT03813771March 20194 February 2019Targeted 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 recruiting18 YearsN/AAll106Phase 4United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
51NCT03858725February 26, 201918 March 2019Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy VolunteersA Randomized, Open-label, Fasted, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy VolunteerRheumatoid ArthritisDrug: D569 Tab.;Drug: CKD-374 5mg Tab.Chong Kun Dang PharmaceuticalRecruiting19 Years54 YearsAll36Phase 1Korea, Republic of
52NCT03852355February 25, 20191 April 2019the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritisthe Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis; a Randomized Controlled TrialRheumatoid Arthritis;HeadacheDrug: Radiofrequency;Drug: SteroidsAssiut UniversityRecruiting18 Years60 YearsAll60N/AEgypt
53NCT03868072February 22, 201918 March 2019Study to Evaluate the Bioequivalence of Pfizer Korea Inc. XELJANZ 5Mg Tablet in Healthy VolunteersAn Open-label, Randomized, Fasted, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical Chong Kun Dang Tofacitinib Tablet and Pfizer Korea Inc. XELJANZ 5Mg Tablet in Healthy VolunteersRheumatoid ArthritisDrug: XELJANZ 5Mg Tablet;Drug: Chong Kun Dang Tofacitinib TabletChong Kun Dang PharmaceuticalRecruiting19 YearsN/AAll40Phase 1Korea, Republic of
54NCT03737708February 13, 201918 March 2019A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)Compare Efficacy and Safety Between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched From Biologics + Methotrexate (MTX)) in the Patients With Rheumatoid Arthritis (RA): Randomized, Interventional, Open, Active Controlled, Parallel Group, Multicenter-designed, Phase 4 Clinical TrialRheumatoid Arthritis (RA)Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abataceptAstellas Pharma Korea, Inc.Recruiting19 Years75 YearsAll148Phase 4Korea, Republic of
55NCT03729349January 15, 201922 October 2019Golimumab for Adherence in Rheumatoid ArthritisGolimumab for Adherence in Rheumatoid ArthritisArthritis, RheumatoidBiological: GolimumabJanssen Inc.Recruiting18 Years85 YearsAll300Early Phase 1Canada
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
56NCT03863405January 9, 20193 June 2019Metformin Use in Rheumatoid ArthritisThe Effect of Metformin on the Clinical Outcome of Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Placebo Oral Tablet;Drug: Conventional DMARDs;Drug: MetforminAin Shams UniversityFuture University in EgyptRecruiting18 YearsN/AAll60Phase 2Egypt
57NCT03981900January 4, 201922 July 2019IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid ArthritisIDentification of Predictive Factors of Continuation of Treatment With Tofacitinib in Patients With Rheumatoid Arthritis in Common Practice and the Impact of the Patient's Behavioural Strategies on Clinical Parameters: The DeFacTo Study.Arthritis, RheumatoidDrug: TofacitinibPfizerRecruiting18 YearsN/AAll500Phase 1France
58EUCTR2018-000666-10-HU03/01/201928 February 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 DMARDsRheumatoid 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
Pharmaceutical Form: Capsule
CAS Number: 1643570-24-4
Current Sponsor code: ABBV-105
Other descriptive name: ABBV-105, A-1519938.0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Code: ABBV-105
Pharmaceutical Form: Capsule
CAS Number: 1643570-24-4
Current Sponsor code: ABBV-105
Other descriptive name: ABBV-105, A-1519938.0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: Upadacitinib
Product Code: ABT-494
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Current Sponsor code: ABT-494
Other descriptive name: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		AbbVie Deutschland GmbH & Co. KGAuthorisedFemale: yes
Male: yes		240Phase 2United States;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Spain;Germany;United Kingdom
59NCT03896594December 24, 201815 April 2019A Multiple Dose of HL237 in Healthy Male SubjectA Dose Block-randomized, Double-blind, Placebo Controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Oral Dose of HL237 in Healthy Male SubjectRheumatoid ArthritisDrug: HL237;Drug: Placebo Oral TabletHanlim Pharm. Co., Ltd.Recruiting20 Years45 YearsMale36Phase 1Korea, Republic of
60NCT03652961December 21, 201814 January 2019Rheumatoid Arthritis Memory B Cells and Abatacept (RAMBA)Rheumatoid Arthritis Memory B Cells and Abatacept (RAMBA)Rheumatoid ArthritisDrug: AbataceptDartmouth-Hitchcock Medical CenterNew York University School of MedicineRecruiting18 YearsN/AAll25Phase 4United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
61NCT03574545December 19, 20184 November 2019Study 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: VAY736Novartis PharmaceuticalsRecruiting18 Years65 YearsAll50Phase 1Germany;Jordan
62NCT03830203December 19, 201825 February 2019Comparative Study of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to MethotrexateA 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 MethotrexateRheumatoid ArthritisDrug: BAT1806;Drug: Actemra(EU-licensed)Bio-Thera SolutionsRecruiting18 YearsN/AAll612Phase 3China
63EUCTR2018-001690-25-PL11/12/20187 January 2019Evaluating 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 ArthritisModerate 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: CT-P17
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-		Celltrion, IncAuthorisedFemale: yes
Male: yes		564Phase 3Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Bosnia and Herzegovina
64NCT03729674November 26, 20183 December 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 CenterUniversité 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 GroupNot recruiting18 YearsN/AAll800Phase 3
65NCT03789292November 26, 20188 April 2019A 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 SCCelltrionNot recruiting18 Years75 YearsAll564Phase 3Bulgaria
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
66NCT03755466November 21, 201810 December 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 UniversityRecruiting20 YearsN/AAll90Phase 2Japan
67NCT03980639November 20, 201824 June 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, ToulouseRecruiting18 YearsN/AAll594226N/AFrance
68NCT03852888November 14, 201811 March 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 ReimsRecruiting18 YearsN/AAll60N/AFrance
69EUCTR2018-001690-25-HU13/11/201819 November 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 ArthritisModerate 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: CT-P17
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-		Celltrion, IncAuthorisedFemale: yes
Male: yes		564Phase 3Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Bosnia and Herzegovina
70NCT03707535November 12, 201829 April 2019To 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: RemicadeCelltrionRecruiting18 Years75 YearsAll270Phase 3China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
71ChiCTR18000192772018-11-015 November 2018The Zoledronic Acidameliorate theSecondary Osteoporosis in Rheumatoid Arthritis patientsThe Zoledronic Acidameliorate theSecondary Osteoporosis in Rheumatoid Arthritis patientsRheumatoid ArthritisControl group:MTX;Treatment group 1:Zoledronate Acid(ZA);Treatment group 2:MTX+Zoledronate Acid;Shanghai Traditional Medicine University Affiliated Guanghua HospitalRecruiting1865BothControl group:22;Treatment group 1:22;Treatment group 2:22;OtherChina
72EUCTR2017-004226-15-DK26/10/201826 November 2018Can-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-ArtRheumatoid 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 Level: PT 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
Pharmaceutical Form: Tablet
CAS Number: 13956-29-1
Other descriptive name: CANNABIDIOL
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Dronabinol capsule 2.5. mg
Pharmaceutical Form: Capsule
INN or Proposed INN: DRONABINOL
CAS Number: 1972-08-3		King Christian 10th Hospital for RheumatologyAuthorisedFemale: yes
Male: yes		180Phase 2Denmark
73ChiCTR19000260792018-10-2530 September 2019Wangbi capsule combined methotrexate tablets for treatment of Rheumatoid Arthritis: A Randomized,Double-blind,Single analog,Positive Drug Parallel-group controlled clinical studyWangbi capsule combined methotrexate tablets for treatment of Rheumatoid Arthritis: A Randomized,Double-blind,Single analog,Positive Drug Parallel-group controlled clinical studyRheumatoid ArthritisExperimental group:Wangbi capsule combined methotrexate tablets;Control group:Simulation of Wangbi capsule combined methotrexate tablets;Longhua Hospital Shanghai University of Traditional Chinese MedicineRecruiting1870BothExperimental group:60;Control group:60;Phase 4China
74NCT03718611October 22, 201822 July 2019To Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy SubjectsA Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy SubjectsRheumatoid ArthritisDrug: BR9001;Drug: BR900ABoryung Pharmaceutical Co., LtdNot recruiting19 Years50 YearsAll36Phase 1Korea, Republic of
75NCT03682705October 8, 201814 October 2019A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis.A 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 DMARDsRheumatoid Arthritis (RA)Drug: Upadacitinib;Drug: ABBV-105;Drug: Upadacitinib placebo;Drug: ABBV-105 placeboAbbVieRecruiting18 YearsN/AAll240Phase 2United States;Belgium;Canada;Czechia;Hungary;Poland;Puerto Rico;Spain;United Kingdom;Germany;Ireland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
76JPRN-JapicCTI-18403102/10/20187 October 2019A Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) TherapyA Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) TherapyRheumatoid 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 : -
INN of the control intervention : -
Dosage And administration of the control intervention : -		Taisho Pharmaceutical co., LTDNot Recruiting20BOTH135Phase 3Japan
77NCT03511625October 2, 20187 October 2019The 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.MallinckrodtRecruiting18 YearsN/AAll6Phase 3United States
78NCT03546335October 1, 201822 October 2018Zr-89 Cimzia PET Imaging Rheumatoid ArthritisZirconium-89 Certolizumab PET Imaging in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: 89Zr-DFO-CZPUniversity of California, San FranciscoRecruiting18 YearsN/AAll10Phase 1United States
79NCT03593837October 1, 201820 August 2018Efficacy and Safety of HQGZWWT Patients With Rheumatoid ArthritisA Multicenter, Randomized, Double-blind,Placebo-controlled Trial Evaluating the Efficacy and Safety of Huang Qi GuiZhi Wu Wu Tang Granulesin Patients With Rheumatoid ArthritisHuang Qi Gui Zhi Wu Wu Granule;Rheumatoid ArthritisDrug: Huang qi gui zhi wu wu granule;Drug: Huang qi gui zhi wu wu granule placeboCui xuejunNot recruiting18 Years80 YearsAll100Phase 2/Phase 3
80NCT03770702October 1, 201818 December 2018Statins and ARBs on Rheumatoid ActivityInvestigational and Comparative Study Between the Anti-inflammatory Effectof Both Angiotensin Reeptor Blockers and Statins on Rheumatoid Arthritis Disease Activity on Egyptian PatientsRheumatoid ArthritisDrug: Angiotensin receptor blockers;Drug: StatinsSherief Abd-ElsalamRecruiting18 Years65 YearsAll45Phase 3Egypt
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
81NCT03770923October 1, 201818 December 2018Effect of Some Drugs on Rheumatoid Arithritis ActivityClinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid ArithritisRheumatoid ArthritisDrug: Rupatadine;Drug: MontelukastSherief Abd-ElsalamRecruiting18 YearsN/AAll75Phase 3Egypt
82NCT03660059September 27, 201816 September 2019A Study to Assess Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)A Randomized, Double-Blind, Placebo-Controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to MTXRheumatoid Arthritis (RA)Drug: Peficitinib;Drug: Plaebo;Drug: Disease-modifying antirheumatic drugs (DMARDs)Astellas Pharma China, Inc.Recruiting18 YearsN/AAll375Phase 3China;Korea, Republic of;Taiwan
83ChiCTR18000186372018-09-2610 October 2018Correlation 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 arthritisrheumatoid 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 CollegeRecruitingBothTarget condition:150;Difficult condition:100Diagnostic New Technique Clincal StudyChina
84NCT03691909September 25, 20182 September 2019A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Rheumatoid ArthritisA Phase 1/2a Clinical Trial to Assess Safety of a Single IV Infusion of Autologous Adipose-derived Mesenchymal Stem Cells in Adults With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: HB-adMSCHope BiosciencesNot recruiting18 Years65 YearsAll15Phase 1/Phase 2United States
85NCT03699293September 22, 201815 October 2018NSAIDs vs. Coxibs in the Presence of AspirinNSAIDs vs. Coxibs in the Presence of Aspirin: Effects on Platelet Function, Endothelial Function, and Biomarkers of Inflammation in Subjects With Rheumatoid Arthritis and Increased Cardiovascular Risk or Cardiovascular DiseaseRheumatoid Arthritis;Cardiovascular DiseasesDrug: celecoxib 200mg capsule;Drug: naproxen sodium 550mg tablet;Drug: Aspirin 81mg tabletInova Health Care ServicesRecruiting18 Years75 YearsAll30Phase 4United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
86EUCTR2018-001114-15-NL18/09/201828 February 2019Predicting 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 RARheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: [18F]PEG-Folate
Pharmaceutical Form: Solution for injection		VU Medical Center, department of RheumatologyAuthorised Female: yes
Male: yes		60Phase 4Netherlands
87JPRN-JapicCTI-18422912/9/201816 July 2019Investigation 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-Investigation 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)
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.		DAIICHISANKYO Co., Ltd.Not RecruitingBOTH2000NA
88NCT03701789September 11, 201822 October 2019Effect 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 SchoolRecruiting18 Years74 YearsAll15Phase 3Germany
89JPRN-JapicCTI-18402904/9/20187 October 2019A 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) TherapyRheumatoid 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., LTDNot Recruiting2075BOTH370Phase 2-3Japan
90NCT04079374September 3, 201822 October 2019Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and EnbrelOpen, Randomized, Comparative, Multicenter Study in Parallel Groups of the Efficacy, Safety, Immunogenicity of Etanercept and Enbrel, Lyophilisates for Solution for Subcutaneous Injection, in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Etanercept;Drug: EnbrelJoint Stock Company FarmakSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Recruiting18 Years75 YearsAll160Phase 3Ukraine
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
91EUCTR2015-004386-91-PL26/08/20187 January 2019Study 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 DMARDsRheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INN not available
CAS Number: 1638332-55-4
Current Sponsor code: GSK3196165
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		GlaxoSmithKline Research & Development LimitedNot RecruitingFemale: yes
Male: yes		40Phase 2United States;Poland;Germany
92NCT03636984August 24, 201827 August 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.Not recruiting18 YearsN/AAll1000Phase 2/Phase 3
93NCT03535519August 7, 201826 August 2019Rheumatoid Arthritis Response to MethotrexateRheumatoid Arthritis Ultrasound Response to MethotrexateRheumatoid ArthritisDrug: MethotrexateJuan Carlos NietoNordic Pharma SASRecruiting18 YearsN/AAll50Phase 4Spain
94NCT04066803August 1, 20182 September 2019Optimal MTX Dose With Folic Acid Randomized Case-control TrialSafety and Efficacy of Optimal Methotrexate With Folic Acid in Patients With Rheumatoid Arthritis in Meizhou, Guangdong: a Randomized Case-control StudyRheumatoid ArthritisDrug: DMARDs;Drug: Folic Acid;Drug: MTXSun Yat-sen UniversityShanghai Pharmaceuticals Holding Co., LtdRecruiting18 Years70 YearsAll160Phase 4China
95EUCTR2018-002368-18-ES25/07/201820 August 2018Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity in immunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis B vaccine with increased antigenic loadPhase IV, open, low-level intervention, clinical trial to compare the immunogenicity in immunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis B vaccine with increased antigenic load1. Autoinmune rheumatic diseases undertreated by rituximab or infliximab. 2. breast and lung cancer undertreated by chemotherapy 3. HIV 4. Haematopoietic progenitor cell transplantation (TCPH).
MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870
MedDRA version: 20.0 Level: PT Classification code 10058467 Term: Lung neoplasm malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0 Level: PT Classification code 10063581 Term: Stem cell transplant System Organ Class: 10042613 - Surgical and medical procedures ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Trade Name: Fendrix suspension for injection
Product Code: Fendrix
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Other descriptive name: HEPATITIS B VACCINE (RDNA)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
Trade Name: HBVAXPRO 5 micrograms/0.5 ml
Product Code: HBVAXPRO® 40 micrograms
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: HBVAXPRO 5 micrograms/0.5 ml Suspension for injection Hepatitis B vaccine (rDNA)
Other descriptive name: HEPATITIS B VIRUS SURFACE ANTIGEN RECOMBINANT (S PROTEIN)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-		FUNDACIÓ HOSPITAL UNIVERSITARI VALL D’HEBRON – INSTITUT DE RECERCA (VHIR)AuthorisedFemale: yes
Male: yes		740Phase 4Spain
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
96NCT03618784July 11, 201826 August 2019Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid ArthritisA Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase I/2a Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisBiological: FURESTEM-RA Inj;Other: sterile salineKang Stem Biotech Co., Ltd.Not recruiting19 Years80 YearsAll33Phase 1/Phase 2Korea, Republic of
97EUCTR2017-004079-30-ES10/07/201823 July 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-EURhuematoid 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
Other descriptive name: Rituximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: RoActmera
Product Name: RoActmera
Pharmaceutical Form: Solution for injection
Trade Name: Enbrel
Product Name: Enbrel
Pharmaceutical Form: Solution for injection in pre-filled pen		Joint Research & Development Office (QMUL)AuthorisedFemale: yes
Male: yes		207Phase 3Portugal;Belgium;Spain;Italy
98NCT03445871July 2, 201829 July 2019Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable MethotrexateAssociation Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable MethotrexateRheumatoid ArthritisBiological: Blood sample;Diagnostic Test: CRQCentre Hospitalier Universitaire de Saint EtienneRecruiting18 YearsN/AAll60Phase 4France
99NCT03605251July 1, 201811 February 2019Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis.An Early Phase-II, Randomized, Double-blind, Study of TAS5315 in Rheumatoid Arthritis Patients With an Inadequate Response to MethotrexateRheumatoid ArthritisDrug: TAS5315 low dose;Drug: TAS5315 high dose;Drug: PlacebosTaiho Pharmaceutical Co., Ltd.Recruiting20 Years64 YearsAll90Phase 2Japan
100NCT02885597July 201823 July 2018Juanbi Pill for Rheumatoid ArthritisJuanbi Pill Combined With Methotrexate for Rheumatoid Arthritis: Multi-center Random Controlled Clinical TrialsJuanbi Pill;Rheumatoid ArthritisDrug: Juanbi pill;Drug: Juanbi pill placebo;Drug: MethotrexateCui xuejunShanghai Yueyang Integrated Medicine Hospital;Longhua Hospital;Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western MedicineRecruiting18 Years80 YearsAll120Phase 2/Phase 3China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
101NCT03173040July 201823 July 2018The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid ArthritisThe Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis: a Study Protocol for a Multicenter, Randomized, Controlled Clinical TrialNiu Bang Zi Pill;Rheumatoid ArthritisDrug: NiuBangZi pill or NiuBangZi pill placeboCui xuejunShanghai Yueyang Integrated Medicine Hospital;Longhua Hospital;Shanghai Seventh People's HospitalRecruiting18 Years80 YearsAll100Phase 2/Phase 3China
102NCT03589833July 201820 August 2018Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RAEffectiveness and Safety of Tumor Necrosis Factor Receptor Fusion Protein(Yisaipu) Combined With Tripterygium Wilfordii for Active Rheumatoid ArthritisArthritis, RheumatoidDrug: Tripterygium Wilfordii;Drug: Methotrexate;Drug: YisaipuPeking Union Medical College HospitalRecruiting18 Years65 YearsAll504Phase 2China
103NCT03084419June 26, 201829 July 2019APRIL (AbatacePt in Rheumatoid Arthritis-ILD)Safety of Abatacept in Rheumatoid Arthritis Associated Interstitial Lung Disease: A Feasibility TrialRheumatoid Arthritis;Interstitial Lung DiseaseDrug: AbataceptCambridge University Hospitals NHS Foundation TrustBristol-Myers SquibbRecruiting18 YearsN/AAll30Phase 2United Kingdom
104JPRN-UMIN0000330592018/06/2023 April 2019The 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 trialOsteoarthritis 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 HospitalNot Recruiting18years-oldNot applicableMale and Female120Not selectedJapan
105NCT03550833June 13, 201830 September 2019Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological ModelImpact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological ModelArthritis, Rheumatoid;Stress DisorderBehavioral: Questionnaire;Biological: blood sampleUniversity Hospital, BordeauxNot recruiting18 YearsN/AAll152Phase 3France
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
106NCT03606876June 13, 201828 January 2019Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy SubjectsA Randomized, Double-blinded, Single-dose, 3-arm Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT1806 Injection vs Actemra® in Healthy Chinese Male SubjectsRheumatoid ArthritisDrug: BAT1806 injectionBio-Thera SolutionsNot recruiting18 Years55 YearsMale138Phase 1China
107NCT03535402June 1, 201815 July 2019Measurement 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.Recruiting18 YearsN/AAll20Phase 3United States
108NCT03559686May 30, 201815 July 2019Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Aarthritis (RA)Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Arthritis (RA) Who Participated in Open Label Studies C87015, C87028 and C87051Rheumatoid ArthritisDrug: Certolizumab PegolUCB Biopharma S.P.R.L.Not recruiting18 YearsN/AAllPhase 3
109NCT03522415May 28, 201823 July 2018Study of Safety and Efficacy of HLX01+MTX in Patients With Rheumatoid ArthritisA Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HLX01 (Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection) Combined With MTX Therapy in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to MethotrexateModerately to Severely Active Rheumatoid ArthritisDrug: HLX01;Drug: Methotrexate(MTX)Shanghai Henlius BiotechRecruiting18 Years75 YearsAll267Phase 3China
110NCT03410056May 22, 20184 November 2019Safety 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 TherapyRheumatoid Arthritis RADrug: AMG 592;Drug: PlaceboAmgenNot recruiting18 Years70 YearsAll153Phase 1/Phase 2United States;Bulgaria;Germany;Poland;Spain
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
111EUCTR2017-001944-36-ES21/05/201818 June 2018Safety 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 TherapyRheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AMG 592
Current Sponsor code: AMG 592
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Amgen IncAuthorisedFemale: yes
Male: yes		137Phase 1;Phase 2United States;Czech Republic;Mexico;Poland;Spain;Romania;Australia;Bulgaria;Germany;New Zealand;United Kingdom
112NCT03378219May 18, 201826 August 2019An Observational Study on Sarilumab-exposed PregnanciesKevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance StudyRheumatoid Arthritis -Exposure During PregnancyDrug: Sarilumab SAR153191 (REGN88)SanofiRegeneron PharmaceuticalsRecruitingN/AN/AFemale300N/AUnited States;Canada
113NCT03508713May 13, 201811 June 2018Long-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 recruiting18 YearsN/AAll200Phase 3
114EUCTR2017-004054-41-BE07/05/20183 September 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. - CareRA2020early 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
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical Form: Coated tablet
INN or Proposed INN: LEFLUNOMIDE
CAS Number: 75706-12-6
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 10-20		University Hospitals LeuvenAuthorisedFemale: yes
Male: yes		440Phase 4Belgium
115EUCTR2016-002569-68-GB04/05/201828 May 2018Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung DiseaseSafety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease: A feasibility study - APRILRheumatoid-associated Interstitial Lung Disease (RA-ILD)
MedDRA version: 20.0 Level: PT Classification code 10022611 Term: Interstitial lung disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Trade Name: Orencia
Product Name: Orencia
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 3 332348-12
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 10-		Cambridge University Hospitals NHS Foundation TrustAuthorisedFemale: yes
Male: yes		30Phase 2United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
116NCT03492658May 201811 June 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 CenterNot recruiting18 YearsN/AAll46Phase 4
117NCT03435601April 18, 201811 June 2018A Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN 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)Rheumatoid ArthritisDrug: Anifrolumab;Drug: PlacebosJosef Smolen, Univ. Prof. Dr.Recruiting18 Years70 YearsAll24Phase 2Austria
118NCT03493269April 16, 201822 October 2019A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Rheumatoid Arthritis (RA) or PsoriasisA Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Exploratory Pharmacodynamics of Multiple Oral Doses of BAY1834845 in Healthy Male Subjects and in Female and Male Patients With Rheumatoid Arthritis or Psoriasis Over an Extended Treatment DurationHealthy VolunteersDrug: BAY1834845;Other: Matching Placebo;Drug: MidazolamBayerRecruiting18 Years65 YearsAll88Phase 1Germany
119JPRN-UMIN0000305752018/03/3122 July 2019Comparative 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, LimitedRecruiting20years-oldNot applicableMale and Female44Not applicableJapan
120NCT03478111March 30, 201830 September 2019CMAB008 With MTX Therapy in Adult Patients With Moderately to Severely Active Rheumatoid ArthritisA Randomized, Double-blind, Methotrexate (MTX) Based, Parallel-group, Multicenter Phase III Study to Evaluate Efficacy and Safety of CMAB008 in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis, Compared to RemicadeRheumatoid ArthritisDrug: CMAB008;Drug: MTX;Drug: RemicadeShanghai Biomabs Pharmaceutical Co., Ltd.Not recruiting18 YearsN/AAll390Phase 3China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
121JPRN-UMIN0000318902018/03/212 April 2019Triple-masked randomized comparison of 5mL or 20nL levobupivacaine to femoral triangle block for total knee arthroplastyknee osteoarthritis or knee rheumatoid arthritisGroup LV(Low volume): preoperative femoral triangle block with 0.5% levobupivacaine 5mL
Group HV(High volume): preoperative femoral triangle block with 0.125% levobupivacaine 20mL		Daiyukai General HospitalRecruiting20years-old100years-oldMale and Female120Phase 3Japan
122NCT03449758March 9, 20189 September 2019Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid ArthritisEffect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis and With Inadequate Response or Intolerance to Current Conventional Synthetic DMARDs or Tumor Necrosis Factor InhibitorsRheumatoid ArthritisDrug: SARILUMAB;Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: SulfasalazineSanofiRegeneron PharmaceuticalsNot recruiting18 YearsN/AAll84Phase 4France
123ChiCTR18000145842018-03-0129 January 2018Clinical efficacy of small dose aspirin in the prevention of deep venous thrombosis and pulmonary embolism after total knee arthroplasty.Clinical efficacy of small dose aspirin in the prevention of deep venous thrombosis and pulmonary embolism after total knee arthroplasty.Knee osteoartritis;Rheumatoid arthritisExperimental group:Asprin;Controlled group:Rivaroxaban;Department of Orthopaedics, West China Hospital, Sichuan UniversityNot Recruiting70100BothExperimental group:90;Controlled group:30;OtherChina
124ChiCTR18000148722018-03-0119 February 2018Role 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 trialosteoarthritis 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 HospitalNot RecruitingBothExperimental group:50;Control group:50;Post-marketChina
125JPRN-UMIN0000316922018/03/017 October 2019Efficacy 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 TKAknee 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 UniversityRecruiting20years-oldNot applicableMale and Female60Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
126NCT03100253March 1, 201830 September 2019Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGationOpen-label, Randomized Controlled Trial Comparing Tocilizumab to Anti-TNF Treatment and Discovery of Biomarkers for Treatment Selection in Rheumatoid Arthritis Patients With Inadequate Response to a First Anti-TNFRheumatoid ArthritisDrug: Tocilizumab;Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Golimumab;Drug: Certolizumab PegolMario Negri Institute for Pharmacological ResearchRecruiting18 YearsN/AAll400Phase 4Italy
127NCT03470688March 1, 201811 June 2018Investigating the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF AgentsAn Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian RheumatologyRheumatoid Arthritis;Psoriatic Arthritis;Ankylosing SpondylitisBiological: Originator;Biological: BiosimilarOpal Rheumatology Ltd.Merck Sharp & Dohme Corp.Recruiting18 YearsN/AAll5000Phase 4Australia
128NCT03480529March 1, 201816 September 2019Monitoring the IMmUological TOXicity of DrugsMonitoring the IMmUological TOXicity of DrugsArthritis;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Capillary Leak Syndrome;HepatitisDrug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndromGroupe Hospitalier Pitie-SalpetriereInstitut National de la Santé Et de la Recherche Médicale, FranceNot recruiting18 YearsN/AAll662Early Phase 1France
129EUCTR2017-004079-30-BE19/02/201830 April 2019Stratification 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-EURheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: RoActmera
Product Name: RoActmera
Pharmaceutical Form: Solution for injection
Trade Name: Enbrel
Product Name: Enbrel
Pharmaceutical Form: Solution for injection in pre-filled pen		Joint Research & Development Office (QMUL)Authorised Female: yes
Male: yes		219Phase 3Portugal;Spain;Belgium;Italy
130EUCTR2017-002878-38-NL07/02/20185 March 2018Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid ArthritisAbatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis - ASCARAPatients with early, methotrexate-naïve, ACPA-positive rheumatoid arthritis
MedDRA version: 20.0 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 100000018818 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Trade Name: Orencia 125 mg
Pharmaceutical Form: Solution for infusion in pre-filled syringe
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-		Leiden University Medical CenterAuthorisedFemale: yes
Male: yes		46Phase 4Netherlands
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
131NCT03455842February 1, 201811 February 2019The BCD-089 (aIL6R) in Patients With Active Rheumatoid ArthritisInternational Multicenter Comparative Randomized Double-blind Placebo-controlled Clinical Study of Efficacy and Safety of BCD-089 in Different Dosing Regimens in Patients With Active Rheumatoid ArthritisSeropositive RADrug: placebo;Biological: BCD-089, 162 mg, s/c, q2w;Biological: BCD-089, 162 mg, s/c, qwBiocadNot recruiting18 Years80 YearsAll105Phase 2Belarus;Russian Federation
132NCT04022525February 1, 201829 July 2019Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic ApproachesAssessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic ApproachesRheumatoid ArthritisDrug: Leflunomide 20Mg TabAssiut UniversityNot recruiting18 YearsN/AAll80Phase 1/Phase 2Egypt
133NCT01694693January 31, 201816 December 2017Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort StudyDescription of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort StudyRheumatoid ArthritisDrug: OrenciaBristol-Myers SquibbNot recruiting18 YearsN/AAll0N/A
134NCT03430388January 31, 20186 May 2019Yellow Fever Vaccine in Patients With Rheumatic DiseasesEvaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk AreaSystemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile DermatomyositisBiological: Yellow Fever vaccine (17D)University of Sao Paulo General HospitalNot recruiting2 Years60 YearsAll600N/ABrazil
135EUCTR2017-002753-11-FI25/01/201830 April 2019The 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) - TofaSTAT17Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Xeljanz
Product Name: Xeljanz
Product Code: PRD4862257
Pharmaceutical Form: Tablet
CAS Number: 540737-29-9
Other descriptive name: TOFACITINIB CITRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: Tofacitinib
Product Code: PRD4862257		Tampere University HospitalAuthorised Female: yes
Male: yes		24Phase 4Finland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
136NCT03227419January 22, 20183 September 2018Abatacept vs Tocilizumab for the Treatment of RA in TNF Alpha Inhibitor Inadequate RespondersAbatacept Versus Tocilizumab by Subcutaneous Administration for the Treatment of Rheumatoid Arthritis in TNF Alpha Inhibitor Inadequate Responder Patients: A Randomized, Open-labeled, Superiority TrialArthritis, RheumatoidDrug: Tocilizumab Prefilled Syringe;Drug: Abatacept Prefilled SyringeLille Catholic UniversityRecruiting18 YearsN/AAll224Phase 4France
137NCT03368235January 18, 20184 November 2019Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid ArthritisA 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 ArthritisDrug: AZD9567;Drug: PrednisoloneAstraZenecaRecruiting18 Years80 YearsAll40Phase 2Denmark;Netherlands;Sweden
138JPRN-UMIN0000308282018/01/152 April 2019The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis.Rheumatoid Arthritis Osteoporosiszoledronic acid
denosumab		Osaka City University Graduate School of MedicineRecruiting20years-oldNot applicableMale and Female500Not selectedJapan
139EUCTR2017-003259-40-ES04/01/20188 January 2018Periodontitis 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
Pharmaceutical Form: Buccal tablet
INN or Proposed INN: AMOXICILLIN
CAS Number: 26787-78-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Product Name: metronidazol
Pharmaceutical Form: Buccal tablet
INN or Proposed INN: METRONIDAZOLE
Other descriptive name: metronidazol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-		Dra Beatriz Lozano-Hospital Universitario de CanariasAuthorisedFemale: yes
Male: yes		120Phase 4Spain
140NCT02955212January 3, 201830 September 2019A Study With Upatacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)Rheumatoid Arthritis (RA)Drug: Upadacitinib;Drug: PlaceboAbbVieNot recruiting18 YearsN/AAll338Phase 3Brazil;China;Korea, Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
141JPRN-UMIN0000302372018/01/012 April 2019Additional 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 trialOsteoarthritis 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 HospitalNot Recruiting20years-oldNot applicableMale and Female100Not selectedJapan
142NCT02795299January 201823 July 2018Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFa Antagonist Failed in Rheumatoid ArthritisPhase 2, Rand, Placebo-Controlled, Double-Blind, Dose Ranging Study to Evaluating Safety/Efficacy of Gerilimzumab in Patients With Moderately to Severely Active Rheumatoid Arthritis Inadequately Treated With Methotrexate or TNFa AntagonistRheumatoid ArthritisDrug: Gerilimzumab;Drug: Methotrexate;Drug: Folic Acid;Drug: PlaceboBird Rock Bio, Inc.Techtrials Pesquisa e Tecnologia Ltda;PharmagenixNot recruiting18 Years80 YearsAll0Phase 2
143JPRN-jRCTs03118005026/12/201710 September 2019Hydroxychloroquine for Japanese patients with rheumatoid arthritisEfficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritisRheumatoid arthritis;D001172Treatment with hydroxychloroquine for 24 weeksYuko KanekoRecruiting>= 18age oldNot applicableBoth120Phase 2-3None
144NCT03798028December 26, 201721 January 2019The Safety and Effects of Mesenchymal Stem Cell (MSCs) in the Treatment of Rheumatoid ArthritisThe Effects and Safety of Mesenchymal Stem Cells in the Treatment of Moderate/Severe Rheumatoid Arthritis, a Multicenter Randomized Controlled Clinical StudyRheumatoid ArthritisBiological: UC-MSCsXijing HospitalChanghai Hospital;Southwest Hospital, ChinaRecruiting18 Years70 YearsAll250N/AChina
145EUCTR2017-001970-41-DK21/12/201724 September 2018Dose reduction and withdrawal of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months multi-centre trialDose 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: 20.0 Level: LLT Classification code 10040107 Term: Seropositive rheumatoid arthritis System Organ Class: 100000004859
MedDRA version: 20.0 Level: LLT Classification code 10062719 Term: Seronegative rheumatoid arthritis System Organ Class: 100000004859
MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 100000004859
MedDRA version: 20.0 Level: LLT Classification code 10041672 Term: Spondylitis ankylosing System Organ Class: 100000004859
MedDRA version: 20.0 Level: LLT Classification code 10002557 Term: Ankylosing spondylitis and other inflammatory spondylopathies System Organ Class: 100000004859
MedDRA version: 20.0 Level: LLT 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
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125 -
Trade Name: Orencia
Product Name: Abatacept
Product Code: L04AA24
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: up to
Concentration number: 10 -
Trade Name: Humira
Product Name: Adalimumab
Product Code: L04AB04
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40 -
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: L04AB05
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 200 -400
Trade Name: Enbrel
Product Name: Etanercept
Product Code: L04AB01
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 25 -50
Trade Name: Benepali
Product Name: Etanercept
Product Code: L04AB01
Pharmaceutical Form: Concentrate and solvent for suspension for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 25 -50
Trade Name: Simponi
Product Name: Golimumab
Product Code: L04AB06
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal		MD, PhD Salome KristensenAuthorisedFemale: yes
Male: yes		180Phase 4Denmark
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
146NCT03457792December 19, 201711 June 2018A Study of Abatacept in Participants That Only Recently Started to Develop Rheumatoid ArthritisAbatacept in Early-Stage Rheumatoid Arthritis Patients: Longterm Experience and Efficacy in Routine Clinical PracticeRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbRecruiting18 YearsN/AAll400N/AGermany
147NCT03186417December 15, 201722 July 2019Mesenchymal Stem Cells in Early Rheumatoid ArthritisCell-Based Therapy in Rheumatoid Arthritis: Proof of Concept Phase 1 TrialRheumatoid ArthritisBiological: 2 million hMSC/kg;Biological: 4 million hMSC/kg;Biological: 6 million hMSC/kg;Biological: placeboMetroHealth Medical CenterNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Recruiting18 Years80 YearsAll20Phase 1United States
148EUCTR2017-001717-92-AT11/12/20177 January 2019A 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) - TarIFNiRAHigh 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)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ANIFROLUMAB
Other descriptive name: ANIFROLUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		Medical University of ViennaAuthorisedFemale: yes
Male: yes		24Phase 2Austria;Italy;Switzerland
149EUCTR2017-001944-36-PL23/11/201715 October 2018Safety 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 TherapyRheumatoid 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: AMG 592
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AMG592
Current Sponsor code: AMG592
Other descriptive name: AMG592
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Amgen IncAuthorisedFemale: yes
Male: yes		137Phase 1;Phase 2United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;New Zealand;United Kingdom
150NCT03334851November 17, 201730 September 2019Safety 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: PlaceboPfizerRecruiting18 Years70 YearsAll112Phase 1United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
151NCT03911830November 11, 201723 April 2019Aerobic 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 BesanconNot recruiting20 Years80 YearsAll18N/AFrance
152EUCTR2017-003425-15-DK10/11/201711 December 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: 20.0 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BETAMETHASONE ACIBUTATE
CAS Number: 5534-05-4
Current Sponsor code: Glucococorticoid
Other descriptive name: Binyrebsrkhormon
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 3.5-14
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intraarticular use
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intramuscular use		Videncenter for Reumatologi og Rygsygdomme, RigshospitaletAuthorisedFemale: yes
Male: yes		100Phase 4Denmark
153NCT03357471November 3, 201710 September 2018Study 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.Not recruiting18 YearsN/AAll70Phase 3United States
154EUCTR2017-000384-32-BG02/11/201730 April 2019Phase 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/ARheumatoid 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Evobrutinib
CAS Number: N/A
Current Sponsor code: M2951
Other descriptive name: M2951
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		Merck KGaAAuthorised Female: yes
Male: yes		363Phase 2Serbia;United States;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;Bulgaria;South Africa;Germany;Japan
155JPRN-UMIN0000297972017/11/0223 April 2019Intravenous 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 trialOsteoarthritis 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 HospitalNot Recruiting18years-oldNot applicableMale and Female40Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
156NCT03329885November 2, 201720 August 2018A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Patients 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 SteatohepatitisOther: Placebo;Drug: BMS-986251Bristol-Myers SquibbNot recruiting18 Years70 YearsAll38Phase 1/Phase 2Netherlands
157NCT03387423November 2, 201711 November 2019Observational 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: TofacitinibPfizerRecruiting18 YearsN/AAll1500N/AGermany
158JPRN-JapicCTI-17374701/11/201716 July 2019Specific 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)
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.		DAIICHISANKYO Co., Ltd.RecruitingBOTH1000NA
159JPRN-UMIN0000297592017/11/012 April 2019Percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty as a component of multimodal pain management: a randomized control trialOsteoarthritis, 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 HospitalNot Recruiting20years-oldNot applicableMale and Female32Not selectedJapan
160NCT03440892November 1, 201718 March 2019Effects 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 RegionRecruiting20 YearsN/AAll2500N/ASweden
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
161NCT02647762October 30, 201714 October 2019CF101 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 BioPharmaRecruiting18 Years75 YearsAll525Phase 3Bosnia and Herzegovina;Canada;Israel;Moldova, Republic of;Poland;Romania;Serbia
162NCT03324412October 28, 201716 December 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 SciencesNot recruiting45 Years70 YearsAll216Phase 2/Phase 3
163NCT03337815October 28, 201716 December 2017A Specification Clinical Application Research of Tripterygium Wilfordii Treating Rheumatoid ArthritisA 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of Tripterygium Wilfordii Treating Rheumatoid Arthritis and Establish A Prediction ModelRheumatoid ArthritisDrug: Treatment of MTX and TwHF placebo;Drug: Treatment of TwHF and MTX placeboGuang'anmen Hospital of China Academy of Chinese Medical SciencesRecruiting45 Years70 YearsAll264Phase 2/Phase 3China
164NCT03163966October 5, 20178 January 2018A Study of the EP4 Antagonist CR6086 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 ArthritisRheumatoid Arthritis, DMARD-naive and Early Disease PatientsDrug: CR6086;Drug: Methotrexate;Drug: PlaceboRottapharm BiotechRecruiting18 YearsN/AAll240Phase 2Czechia
165JPRN-UMIN0000290032017/10/012 April 2019Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trialOsteoarthritis, 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 HospitalNot Recruiting20years-oldNot applicableMale and Female40Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
166NCT03254589October 1, 201726 August 2019Methotrexate, Blood Pressure and Arterial Function in Rheumatoid ArthritisMethotrexate, Blood Pressure and Arterial Function in Rheumatoid ArthritisRheumatoid Arthritis;Stiffness, Aortic;Endothelial Dysfunction;Cardiovascular Risk FactorDrug: Methotrexate;Drug: Sulfasalazine;Drug: Other DMARDsFlinders UniversityUniversity of South Australia;medac GmbHRecruiting18 YearsN/AAll124Phase 4Australia
167NCT03257852September 29, 201711 November 2019A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on MethotrexateA Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on MethotrexateRheumatoid Arthritis (RA)Drug: ASP5094;Drug: Placebo;Other: Methotrexate therapyAstellas Pharma IncNot recruiting20 YearsN/AAll66Phase 2Japan
168EUCTR2016-004300-65-BE26/09/201720 August 2018Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFa) blocking Agent by immunoscintigraphy with Technetium-labeled Cimzia®).Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFa) blocking Agent by immunoscintigraphy with Technetium-labeled Cimzia®). - SCINTRA TRISrheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: 99mTc-S-HYNIC Certolizumab pegol
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.25-		Ghent University HospitalAuthorisedFemale: yes
Male: yes		120Phase 4Belgium
169EUCTR2017-000384-32-CZ26/09/201711 June 2018Phase 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/ARheumatoid 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Evobrutinib
CAS Number: N/A
Current Sponsor code: M2951
Other descriptive name: M2951
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		Merck KGaAAuthorisedFemale: yes
Male: yes		363Phase 2Japan;Germany;Bulgaria;South Africa;Poland;Brazil;Argentina;Mexico;Czech Republic;Colombia;Chile;Russian Federation;Ukraine;United States;Serbia
170NCT03233230September 18, 201715 July 2019Phase IIb Study of Evobrutinib in Subjects With 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 MethotrexateRheumatoid ArthritisDrug: Evobrutinib;Drug: Placebo;Drug: MethotrexateEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyNot recruiting18 Years75 YearsAll390Phase 2United States;Argentina;Brazil;Bulgaria;Chile;Colombia;Czechia;Mexico;Poland;Russian Federation;Serbia;South Africa;Ukraine;Germany;Hungary;Romania;Slovakia;Spain
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
171EUCTR2017-000838-64-SE11/09/201716 October 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
Pharmaceutical Form: Oral suspension
INN or Proposed INN: N/A
CAS Number: 1893415-64-9
Current Sponsor code: ADZ9567
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 0.5-10
Pharmaceutical form of the placebo: Oral suspension
Route of administration of the placebo: Oral use
Trade Name: PredniHEXAL
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Prednisolone
CAS Number: -
Current Sponsor code: -
Other descriptive name: -
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		AstraZeneca ABAuthorisedFemale: yes
Male: yes		40Phase 2Denmark;Netherlands;Sweden
172NCT03262740September 11, 201712 March 2018The 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 SquibbNot recruiting18 Years40 YearsFemale58Phase 1United States
173EUCTR2016-004834-11-BG04/09/201728 February 2019A 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 arthritisRheumatoid 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
Pharmaceutical Form: Capsule
INN or Proposed INN: see D.3.9.3 'Other descriptive name' below
CAS Number: 1417742-86-9
Current Sponsor code: CR6086Z
Other descriptive name: CR6086
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: CR6086
Product Code: CR6086Z
Pharmaceutical Form: Capsule
INN or Proposed INN: see D.3.9.3 'Other descriptive name' below
CAS Number: 1417742-86-9
Current Sponsor code: CR6086Z
Other descriptive name: CR6086
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Methotrexate® 2.5 mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate
CAS Number: 59-05-2
Other descriptive name: METHOTREXATE 2.5 mg tablets
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-		Rottapharm Biotech S.r.l.Not Recruiting Female: yes
Male: yes		240Phase 2Moldova, Republic of;United Kingdom;Bulgaria;Denmark;Romania;Poland;Argentina;Czech Republic
174NCT03241446September 201715 October 2018Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA)A Phase I, Open-Label Study to Investigate the Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid ArthritisArthritis, RheumatoidDrug: TilmanoceptNavidea BiopharmaceuticalsNot recruiting30 Years65 YearsAll0Phase 1
175NCT03254966September 201716 December 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.Not recruiting18 Years70 YearsAll170Phase 2China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
176EUCTR2017-000947-41-FR18/08/201716 October 2017ORENCIA VERSUS ROACTEMRA BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS.ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPEN-LABELED, SUPERIORITY TRIAL. - SUNSTARAdults patients suffering from rheumatoid arthritis and in adequate response to a first line of treatment with a TNF alpha inhibitor.
MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Trade Name: ORENCIA 125 mg, solution injectable en seringue préremplie
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe
Trade Name: RoActemra 162 mg solution injectable en seringue préremplie
Pharmaceutical Form: Solution for injection		Groupement des Hôpitaux de l’Institut Catholique de LilleAuthorisedFemale: yes
Male: yes		Phase 4France
177NCT03160001August 15, 201718 December 2018Niclosamide With Etanercept in Rheumatoid ArthritisAdjuvant Use of Niclosamide With Etanercept in Rheumatoid Arthritis: Experimental and Clinical StudyRheumatoid Arthritis (RA)Drug: Placebo;Drug: Niclosamide;Drug: EtanerceptFaiq GorialNot recruiting18 YearsN/AAll110Phase 1/Phase 2Iraq
178NCT03245515August 15, 201718 January 2018A Study of BMS-986195 in Healthy Male SubjectsPharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male SubjectsRheumatoid ArthritisDrug: BMS-986195Bristol-Myers SquibbNot recruiting18 Years55 YearsMale24Phase 1Netherlands
179NCT03156023August 14, 20174 November 2019Multiple Ascending Doses of AMG 570 in Subjects With Rheumatoid ArthritisA Randomized, Double Blind Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of AMG 570 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: AMG 570;Drug: PlaceboAmgenNot recruiting18 Years75 YearsAll34Phase 1United States;Germany
180NCT03327454August 10, 20175 November 2018Benepali® PEN Patient Satisfaction SurveyNon-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled PenRheumatoid Arthritis;SpondyloarthropathiesBiological: BenepaliBiogenNot recruiting18 YearsN/AAll500N/AGermany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
181NCT03188081August 4, 201723 July 2018A Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous (SC) AbataceptA Prospective, Multicentric, Observational Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life RA Patients Treated With Abatacept SCRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbRecruiting18 YearsN/AAll300N/AItaly
182NCT03155347August 2, 20174 November 2019An 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 RocheRecruiting18 Years70 YearsAll300Phase 3China
183NCT03215407August 1, 201716 December 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 HospitalNot recruiting18 Years65 YearsAll60Phase 4
184NCT03250767August 1, 201730 September 2019Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint ReplacementA Post-Market, Prospective, Multi-Center, Open-Label, Single Arm Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint ReplacementOsteo Arthritis Shoulders;Traumatic Arthritis;Rheumatoid ArthritisDevice: Integra Titan Modular Shoulder System 2.5Integra LifeSciences CorporationRecruiting18 YearsN/AAll140Phase 1/Phase 2United States
185JPRN-UMIN0000283762017/07/262 April 2019Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritisrheumatoid arthritisCombination of anti-rheumatic therapy and denosumab
Anti-rheumatic therapy alone		Hokkaido Medical Center for Rheumatic DiseasesRecruiting20years-old75years-oldMale and Female30Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
186NCT02541955July 20, 20179 September 2019Use of Acthar in Rheumatoid Arthritis (RA) Related FlaresUse of Acthar in Rheumatoid Arthritis Related FlaresRheumatoid Arthritis (RA)Drug: ActharDr. Veena RanganathRecruiting18 YearsN/AAll40Phase 4United States
187EUCTR2016-004834-11-DK06/07/201730 April 2019A 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 arthritisRheumatoid 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
Pharmaceutical Form: Capsule
INN or Proposed INN: see D.3.9.3 'Other descriptive name' below
CAS Number: 1417742-86-9
Current Sponsor code: CR6086Z
Other descriptive name: CR6086
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: CR6086
Product Code: CR6086Z
Pharmaceutical Form: Capsule
INN or Proposed INN: see D.3.9.3 'Other descriptive name' below
CAS Number: 1417742-86-9
Current Sponsor code: CR6086Z
Other descriptive name: CR6086
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Methotrexate® 2.5 mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate
CAS Number: 59-05-2
Other descriptive name: METHOTREXATE 2.5 mg tablets
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-		Rottapharm Biotech S.r.l.Not Recruiting Female: yes
Male: yes		240Phase 2Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
188NCT03120949July 4, 201718 December 2018Evaluation of the Long Term Safety, Tolerability and Efficacy of Two Dosing Regimens of Olokizumab (OKZ), in Subjects With Rheumatoid Arthritis (RA) Who Previously Completed 24 Weeks of Blinded Treatment in One of the Core Studies - CREDO 1, 2 or 3.A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Olokizumab 64 mg SC q4w;Drug: Olokizumab 64 mg SC q2w;Drug: MethotrexateR-PharmQuintiles, Inc.;OCT Clinical Trials;Mene ResearchRecruiting18 YearsN/AAll1880Phase 3United States;Argentina;Brazil;Bulgaria;Colombia;Czechia;Estonia;Germany;Hungary;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Romania;Russian Federation;Taiwan;United Kingdom
189NCT03189017July 3, 201726 August 2019A Phase I Study of ICP-022 in Healthy SubjectsA Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-022 Following Single and Multiple Escalating DoseSystemic Lupus Erythematosus;Rheumatoid ArthritisDrug: ICP-022;Drug: PlacebosInnocare Pharma Australia Pty LtdNot recruiting18 Years55 YearsMale64Phase 1Australia
190NCT03285191July 3, 201727 August 2018Subject Insights to Understand Rheumatoid Arthritis (RA)Patient Interviews to Better Understand Disease Experience and Unmet Treatment Needs in Rheumatoid ArthritisArthritis, RheumatoidOther: Numerical rating scale;Other: Real-time data capture appGlaxoSmithKlineNot recruiting18 YearsN/AAll30Phase 1/Phase 2United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
191ChiCTR-IPR-170115662017-07-0112 June 2017The 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 ChinaRheumatoid Arthritis;M05.901Sirolimus group: Sirolimus; Non-Sirolimus group:Glucocorticoids and Immunosuppressant;the Second Hospital of Shanxi Medical UniversityRecruiting1865BothSirolimus group:200; Non-Sirolimus group:100;Post-marketChina
192NCT03394131July 1, 201723 July 2018?Efficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis PatientsTreatment of Carpal Tunnel in Rheumatoid ArthritisTreatment Resistant Carpal Tunnel in RA PatientsDrug: Hylase;Drug: Insulin;Other: salineAssiut UniversityRecruiting20 Years80 YearsAll90N/AEgypt
193ChiCTR-INR-170117722017-06-273 July 2017The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agentsThe efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agentsRheumatoid Arthritistest group:Metformin tablets, 0.25g, 3 / day, oral, atorvastatin tablets 10mg, 1 / night, oral;;Control group:Traditional DMARDs group;Inner Mongolia University of Science and Technology Baotou Medical College First Affiliated HospitalRecruiting1865Bothtest group:80;Control group:40;New Treatment Measure Clinical StudyChina
194NCT03278470June 26, 201727 August 2018A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male SubjectA Dose Block-randomized, Double Blinded, Placebo Controlled, Dose-escalation Clinical Trial to Find the Maximum Tolerable Dose After Single Oral Dose of HL237 in Healthy Male SubjectRheumatoid ArthritisDrug: HL237;Drug: Placebo Oral TabletHanlim Pharm. Co., Ltd.Not recruiting20 Years45 YearsMale57Phase 1Korea, Republic of
195NCT03239080June 19, 201711 February 2019Effect of Denosumab in Erosion Healing in RAEffect of RANKL Inhibition on Healing of Bone Erosion in Rheumatoid Arthritis Using HR-pQCTRheumatoid ArthritisDrug: Denosumab;Other: PlaceboChinese University of Hong KongNot recruiting18 YearsN/AAll110Phase 2China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
196EUCTR2015-005309-35-GB16/06/201728 February 2019Study 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) 4Moderately 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)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		R-PharmAuthorised Female: yes
Male: yes		1880Phase 3United 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
197JPRN-UMIN0000277192017/06/122 April 2019Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy.rheumatoid arthritis/remissionadd-on iguratimod
tapering MTX
continuing the treatment		Osaka Medical CollegeRecruiting20years-old100years-oldMale and Female100Not selectedJapan
198EUCTR2016-000569-21-FR08/06/201728 February 2019Filgotinib 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) TreatmentModerately 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Filgotinib
Product Code: GS-6034
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		Gilead Sciences, Inc.Not Recruiting Female: 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
199NCT03100734June 1, 201715 July 2019Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From EnbrelA Multicentre Observational Study to Evaluate the Real-Life Effectiveness of Benepali® Following Transition From Enbrel® in Patients With Rheumatoid Arthritis (RA) and Axial Spondyloarthritis (axSpA) - The BENEFIT StudyRheumatoid Arthritis;Axial SpondyloarthritisBiological: Benepali;Biological: EnbrelBiogenSamsung Bioepis Co., Ltd.Not recruiting18 YearsN/AAll585N/AGermany
200NCT03139136May 30, 201726 August 2019Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid ArthritisA 12-Week, Double-Blind, Placebo-Controlled, Phase 2a Study to Investigate the Safety, Tolerability and Efficacy of MBS2320 in Patients With Active Rheumatoid Arthritis Receiving MethotrexateRheumatoid ArthritisDrug: MBS2320;Drug: PlaceboModern Biosciences plcNot recruiting18 Years75 YearsAll121Phase 2Georgia;Moldova, Republic of;Romania
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
201NCT03193957May 15, 201716 December 2017An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid ArthritisAn Open-label, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: Etanercept;Device: AutoinjectorSamsung Bioepis Co., Ltd.Not recruiting18 Years55 YearsAll50Phase 2Poland
202NCT03131973May 13, 20178 January 2018Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and PravastatinEffects of Concomitant Administration of BMS-986195 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates for Cytochrome P450 1A2, 2C8, 2C9, 2C19, 3A4, Organic Anion Transporter Polypeptide 1B1 and P-glycoprotein in Healthy ParticipantsRheumatoid ArthritisDrug: BMS-986195;Drug: Methotrexate;Drug: Leucovorin;Drug: Caffeine;Drug: Montelukast;Drug: Flurbiprofen;Drug: Omeprazole;Drug: Midazolam;Drug: Digoxin;Drug: PravastatinBristol-Myers SquibbNot recruiting18 Years50 YearsAll26Phase 1United States
203EUCTR2016-005017-45-HU12/05/201718 June 2018A 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 ArthritisRheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: NI-0101
Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		NovImmune S.A.Not RecruitingFemale: yes
Male: yes		81Phase 2Bosnia and Herzegovina;United Kingdom;Moldova, Republic of;Bulgaria;Georgia;Poland;Hungary;Serbia
204EUCTR2016-005017-45-BG11/05/201728 February 2019A 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 ArthritisRheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: NI-0101
Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		NovImmune S.A.Not Recruiting Female: yes
Male: yes		81Phase 2Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina
205NCT03241108May 10, 201727 August 2018Study 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 ArthritisOther: Placebo;Drug: NI-0101NovImmune SANot recruiting18 YearsN/AAll90Phase 2Bosnia and Herzegovina;Bulgaria;Georgia;Hungary;Moldova, Republic of;Poland;Serbia
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
206NCT03086343May 9, 201722 October 2019A 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 DMARDs ( SELECT-CHOICE )A 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: Upadacitinib;Drug: Abatacept matching placebo;Drug: Upadacitinib matching placeboAbbVieNot recruiting18 YearsN/AAll657Phase 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
207EUCTR2016-001825-15-BE08/05/201728 February 2019A 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) FORMULATIONRheumatoid 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
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: tofacitinib
CAS Number: 540737-29-9
Current Sponsor code: CP 690,550
Other descriptive name: TOFACITINIB CITRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 11-
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
Pharmaceutical Form: Capsule
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use		Pfizer Inc., 235 East 42nd Street, New York, New YorkNot Recruiting Female: yes
Male: yes		680Phase 3;Phase 4United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
208NCT02808871April 7, 20177 October 2019Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1)Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients With Rheumatoid Arthritis Interstitial Lung Disease (TRAIL1)Rheumatoid Arthritis Interstitial Lung DiseaseDrug: Pirfenidone;Drug: PlaceboIvan O. RosasRecruiting18 Years85 YearsAll270Phase 2United States;Australia;Canada;United Kingdom
209NCT02908490April 1, 201725 February 2019Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis?Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis?Arthritis, Rheumatoid;AtherosclerosisDrug: Sildenafil;Other: PlaceboKimberly LiangRecruiting18 YearsN/AAll60Phase 2United States
210NCT03275025April 1, 201722 July 2019A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid ArthritisA Multicenter, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of YRA-1909 in Patients With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)Rheumatoid ArthritisDrug: YRA-1909 low dose;Drug: YRA-1909 mid dose;Drug: YRA-1909 high dose;Drug: PlaceboYungjin Pharm. Co., Ltd.Recruiting19 Years80 YearsAll200Phase 2Korea, Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
211NCT03291457March 30, 201722 October 2019A 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 RocheNot recruiting18 YearsN/AAll101Phase 3Belgium
212NCT03178955March 27, 201724 June 2019Circadian RA Study in Rheumatoid Arthritis SubjectsThe Effects of Biologic Therapy With Disease Activity and Circadian RhythmRheumatoid ArthritisDrug: EtanerceptUniversity of California, DavisNot recruiting18 Years80 YearsAll0Phase 1United States
213NCT03348046March 23, 201712 March 2018Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in JordanPost-Authorization Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in JordanRheumatoid ArthritisDrug: Biosimilar InfliximabHikma Pharmaceuticals LLCINC ResearchRecruiting18 YearsN/AAll40N/AJordan
214NCT03245320March 20, 20174 February 2019Clinical 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 1.0Integra LifeSciences CorporationNot recruiting18 YearsN/AAll50Phase 1United States
215NCT03755258March 16, 201710 December 2018Trial of Ginsenoside Compound K (GCK) Tablet in Patients With Rheumatoid ArthritisA Phase Ib Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GCK in Rheumatoid Arthritis PatientsEarly Rheumatoid ArthritisDrug: GCK 100 mg + Placebo 200 mg;Drug: GCK 200 mg + Placebo 100 mg;Drug: GCK 300 mg;Drug: Placebo 300mgZhejiang Hisun Pharmaceutical Co. Ltd.Recruiting18 Years65 YearsAll128Phase 1China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
216NCT03110094March 13, 201711 June 2018Investigation of Immunological and Pharmacological Factors for Response to Adalimumab in Rheumatoid ArthritisInvestigation of Immunological and Pharmacological Factors for Response to Adalimumab in Rheumatoid Arthritis, With Analysis of CD4 + Follicular Helper T SubpopulationsRheumatoid ArthritisOther: Adalimumab;Other: Healthy volunteersRennes University HospitalRecruiting18 YearsN/AAll60N/AFrance
217EUCTR2015-005307-83-LV03/03/201730 April 2019Study 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) 2Moderately 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)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-		R-PharmAuthorised Female: yes
Male: yes		1575Phase 3United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of
218NCT03082573March 3, 201716 December 2017Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar GelOpen-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Were Treated With H.P. Acthar Gel After an Incomplete Response to Combinations of DMARDs and Biologic DMRADsRheumatoid ArthritisDrug: H.P. Acthar gelIraj Sabahi Research Inc.MallinckrodtRecruiting21 YearsN/AAll30Phase 4United States
219EUCTR2016-002126-36-AT01/03/201710 December 2018A 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 inhibitorsRheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Not available
Current Sponsor code: RO7123520/F03-01
Other descriptive name: RO7123520
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use		F. Hoffmann-La Roche LtdNot RecruitingFemale: yes
Male: yes		204Phase 2United States;Spain;Guatemala;Austria;Chile;Colombia;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;Germany
220NCT03025308February 28, 20174 November 2019Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid ArthritisA Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid ArthritisRheumatoId ArthritisDrug: Filgotinib;Drug: Placebo to match filgotinibGilead SciencesGalapagos NVNot 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
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
221NCT03161457February 27, 201723 July 2018A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Efficacy of JHL1101 Versus EU-sourced MabThera® in Anti TNF Inadequate Responder Patients With Moderate to Severe Rheumatoid Arthritis (RA) on Background Methotrexate (MTX) TherapyRheumatoid Arthritis;Arthritis, RheumatoidBiological: JHL1101;Biological: MabTheraJHL Biotech, Inc.Recruiting18 Years80 YearsAll150Phase 1Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;Lithuania;Poland;Russian Federation;Taiwan;Ukraine;United Kingdom
222JPRN-UMIN0000261372017/02/155 November 2019Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total knee arthroplasty: randomized controlled trialIntravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total knee arthroplasty: randomized controlled trial - Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral TKA: randomized controlled trialOsteoarthritis of the knee Rheumatoid arthritisThe combined tranexamic acid group received 1000 mg of tranexamic acid administered intravenously just before skin incision of the first knee. After closure of the capsule and retinaculum, 1000 mg of tranexamic acid (10 mL of 100 mg/mL tranexamic acid) was administered intra-articularly for each knee. Six 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 knee. After closure of the capsule and retinaculum, 10 mL of normal saline was administered intra-articularly for each knee. Six hours after the first intravenous administration of tranexamic acid, 1000 mg of tranexamic acid was again given intravenously.		Hokusuikai Kinen HospitalNot Recruiting20years-oldNot applicableMale and Female32Not selectedJapan
223NCT03667131February 13, 201726 November 2018Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.Effect of Prophylactic Treatment With Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis Patients.Rheumatoid ArthritisDrug: Enalapril Maleate;Drug: PlaceboUniversity of GuadalajaraNot recruiting18 Years80 YearsFemale59Phase 2Mexico
224ChiCTR-IPR-170103252017-01-3118 April 2017The efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trialThe efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trialrheumatic disease;M05.901Metformin Group:Metformin combined Glucocorticoids and DMARDs;Non-Metformin Group:Glucocorticoids and DMARDs;Metformin combined with Coenzyme Q10 Group:Metformin and Coenzyme Q10 combined Glucocorticoids and DMARDs;the Second Hospital of Shanxi Medical UniversityNot Recruiting1865BothMetformin Group:100;Non-Metformin Group:100;Metformin combined with Coenzyme Q10 Group:100;Post-marketChina
225NCT02997605January 31, 20174 February 2019Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis PatientsComparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission.RheumatoId ArthritisDrug: GlucoCorticoidUniversity Hospital, ToulouseRecruiting18 YearsN/AAll122Phase 4France
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
226NCT03052322January 31, 20171 July 2019MSB11022 in Moderate to Severe 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 ArthritisModerate to Severe Rheumatoid ArthritisDrug: MSB11022;Drug: EU-HumiraFresenius Kabi SwissBioSim GmbHNot recruiting18 YearsN/AAll288Phase 3Czech Republic;United Kingdom;Poland;Hungary;Germany;Czechia;Bulgaria
227EUCTR2013-003413-18-NL30/01/201712 March 2018Arthritis prevention with abataceptArthritis Prevention In the Pre-clinical Phase of RA with Abatacept. - APIPPRAThe 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 injection
Pharmaceutical Form: Solution for infusion in pre-filled syringe
Pharmaceutical form of the placebo: Solution for infusion in pre-filled syringe
Route of administration of the placebo: Subcutaneous use		Leiden University Medical CenterAuthorisedFemale: yes
Male: yes		206Phase 2Netherlands;United Kingdom
228NCT03028467January 24, 201727 August 2018Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid ArthritisA Phase 1/2, Double-Blind, Placebo-Controlled Study of the Pharmacokinetics, Safety and Tolerability of GSK3196165 in Combination With Methotrexate Therapy, in Japanese Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With MethotrexateArthritis, RheumatoidDrug: GSK3196165 Dose 1;Drug: GSK3196165 Dose 2;Drug: GSK3196165 Dose 3;Drug: Methotrexate;Drug: Placebo;Drug: Folic acidGlaxoSmithKlineNot recruiting20 YearsN/AAll15Phase 2Japan
229NCT03085940January 20, 201716 December 2017Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid ArthritisRole of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Hydroxychloroquine;Drug: PlaceboIndonesia UniversityNot recruiting18 YearsN/AAll37N/AIndonesia
230NCT02984943January 19, 20174 November 2019The Effects of Hyperbaric Oxygen on Rheumatoid ArthritisThe Effects of Hyperbaric Oxygen on Rheumatoid Arthritis: A Pilot StudyRheumatoId ArthritisDevice: Hyperbaric OxygenDavid Grant U.S. Air Force Medical CenterNot recruiting18 YearsN/AAll14N/AUnited States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
231NCT03112213January 12, 201718 December 2018Characterization 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 RocheNot recruiting18 YearsN/AAll135Phase 3Germany
232EUCTR2015-003140-39-PL09/01/201710 September 2018A 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-RARheumatoid 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
Pharmaceutical Form: Tablet
INN or Proposed INN: No proposed INN available
CAS Number: 1309784-13-1
Current Sponsor code: JTE-051
Other descriptive name: JTE-051
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Akros Pharma Inc.Not RecruitingFemale: yes
Male: yes		250Phase 2United States;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Russian Federation;Bulgaria;Colombia
233ChiCTR-IPR-170103072017-01-0118 April 2017The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in ChinaThe efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in ChinaRheumatoid Arthritis;M05.901Rapamycin group:Rapamycin;Non-rapamycin group :conventional glucocorticoids and DMARDs;the Second Hospital of Shanxi Medical UniversityRecruiting1865BothRapamycin group:200;Non-rapamycin group :100;Post-marketChina
234NCT03855007January 1, 201711 March 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 UniversityRecruiting16 Years90 YearsAll200Phase 4China
235NCT02865434January 20171 April 2019Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RAAn Evaluation of the Safety of Escalating Doses of Tc 99m Tilmanocept by Intravenous (IV) Injection and Skeletal Joint Imaging With SPECT in Subjects With Active Rheumatoid Arthritis (RA) and Healthy ControlsArthritis, RheumatoidDrug: Tc99m-tilmanocept;Procedure: SPECT Imaging (60 Minutes post-injection);Procedure: SPECT Imaging (180 Minutes post-injection);Procedure: Whole body planar SPECT imaging (15 Minutes post-injection);Procedure: Whole body planar SPECT imaging (60 Minutes post-injection);Procedure: Whole body planar SPECT imaging (180 Minutes post-injection);Procedure: Whole body planar SPECT imaging (18-20 Hours post-injection);Procedure: Blood Collection for PK Testing (15 Mins Before Injection);Procedure: Blood Collection for PK Testing (after injection);Procedure: Blood Collection for PK Testing (15 minutes post injection);Procedure: Blood Collection for PK Testing (60 minutes post injection);Procedure: Blood Collection for PK Testing (180 minutes post injection);Procedure: Blood Collection for PK Testing (18-20 hours post injection);Procedure: Planar Image with both Hands in Field of ViewNavidea BiopharmaceuticalsNot recruiting18 YearsN/AAll39Phase 1/Phase 2United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
236NCT03016884January 20175 February 2018Safety 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, IsraelRecruiting50 YearsN/AAll250Phase 4Israel
237NCT03288584January 201716 July 2018Effects 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 AthensRecruiting18 Years80 YearsAll60Phase 1Greece
238NCT02965599December 27, 20168 April 2019Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Rheumatoid ArthritisA Randomised, Multi-center, Double Blind (Sponsor Open), Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Severe, Active Rheumatoid ArthritisArthritis, RheumatoidDrug: Placebo;Drug: GSK3117391GlaxoSmithKlineNot recruiting18 YearsN/AAll3Phase 1/Phase 2Mexico;Poland;Romania
239EUCTR2016-000569-21-GB23/12/201628 February 2019Filgotinib 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) TreatmentModerately 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Filgotinib
Product Code: GS-6034
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		Gilead Sciences, Inc.Not Recruiting Female: yes
Male: yes		423Phase 3United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
240NCT02969044December 20, 201629 January 2018Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To MethotrexateA Phase 2a, Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study To Assess The Efficacy And Safety Profile Of Pf-06651600 In Subjects With Moderate To Severe Active Rheumatoid Arthritis With An Inadequate Response To MethotrexateRheumatoid ArthritisDrug: Placebo;Drug: PF-06651600PfizerNot recruiting18 Years75 YearsAll74Phase 2United States;Bulgaria;Czechia;Georgia;Germany;Hungary;Poland;Serbia;Slovakia
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
241EUCTR2014-004704-29-CZ15/12/20161 October 2018This 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 applicableRheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ABP 710
Current Sponsor code: ABP 710
Other descriptive name: ABP 710 - Biosimilar to infliximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: Remicade
Product Name: infliximab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-		Amgen Inc.Not RecruitingFemale: yes
Male: yes		550Phase 3United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
242NCT02862574December 15, 201616 December 2017Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid ArthritisEvaluation 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 ArthritisRheumatoid ArthritisDrug: Andecaliximab;Drug: Placebo;Drug: Methotrexate;Drug: TNF InhibitorGilead SciencesNot recruiting18 Years80 YearsAll15Phase 2United States;Australia;Hungary;Taiwan
243EUCTR2016-002852-26-CZ07/12/201617 September 2018MSB11022 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-RAmoderately 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: MSB11022
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-		Merck KGaANot RecruitingFemale: yes
Male: yes		260Phase 3Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom
244EUCTR2015-003140-39-BG05/12/201620 August 2018A 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-RARheumatoid 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
Pharmaceutical Form: Tablet
INN or Proposed INN: No proposed INN available
CAS Number: 1309784-13-1
Current Sponsor code: JTE-051
Other descriptive name: JTE-051
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Akros Pharma Inc.Not RecruitingFemale: yes
Male: yes		250Phase 2United States;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Russian Federation;Bulgaria;Colombia
245NCT02760433December 201618 December 2018Evaluation 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 ResearchRecruiting18 YearsN/AAll350Phase 3United States;Argentina;Brazil;Colombia;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Russian Federation;Turkey;Czech Republic
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
246NCT02982083December 201612 December 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: Placebo Oral Tablet;Drug: Raloxifene hydrochlorideSara Saeidi ShahriNot recruiting50 YearsN/AFemale40N/A
247NCT02990806December 201611 November 2019A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis (RADIANCE)A 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 ArthritisRheumatoid Arthritis (RA)Biological: NI-071;Biological: InfliximabNichi-Iko Pharmaceutical Co., Ltd.Not recruiting18 Years75 YearsAll683Phase 3United States;Czechia;Poland;Puerto Rico;Russian Federation;Spain;Ukraine;United Kingdom
248NCT03016260December 201616 December 2017RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFa BIologicals in Rheumatoid ArthritisProof-of-Performance Study of RABIOPRED Assay as an In Vitro Diagnostic Test to Identify Patients With Rheumatoid Arthritis Who Are Unlikely to Show Response to 1st Treatment With Anti-TNFa and Methotrexate Combination.RheumatoId ArthritisBiological: Infliximab;Biological: Adalimumab;Biological: Etanercept;Biological: Golimumab;Biological: Certolizumab Pegol;Biological: Infliximab biosimilar;Biological: Etanercept biosimilarTcLand Expression S.A.European CommissionRecruiting18 YearsN/AAll720N/ACzechia;France;Israel;Netherlands;Turkey;Czech Republic
249NCT03337165December 201630 September 2019Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid ArthritisSafety/Efficacy of Intra-articular Administration of Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid ArthritisMusculoskeletal Diseases;Joint Disease;Arthritis;Arthritis, Rheumatoid;Rheumatic Diseases;Connective Tissue Diseases;Autoimmune Diseases;Immune System DiseasesBiological: tolerogenic dendritic cellsRussian Academy of Medical SciencesNot recruiting18 Years75 YearsAll10Phase 1Russian Federation
250NCT02983227November 30, 20164 November 2019A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350 (NCT02833350)A Phase II Open-Label Extension Study of Patients Previously Enrolled in Study GA29350 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Rheumatoid ArthritisRheumatoId ArthritisDrug: GDC 0853Genentech, Inc.Not recruiting18 Years76 YearsAll497Phase 2United States;Argentina;Brazil;Bulgaria;Colombia;Mexico;Poland;Russian Federation;Serbia;Ukraine;Chile;Korea, Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
251NCT02986139November 29, 201622 July 2019Study 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 EtanerceptAmgenNot recruiting18 YearsN/AAll111Phase 3United States;Puerto Rico
252NCT02960490November 26, 201628 October 2019A 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.Not recruiting18 Years75 YearsAll64Phase 2Japan
253EUCTR2016-000933-37-HU24/11/201622 May 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: 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
Pharmaceutical Form: Tablet
INN or Proposed INN: ABT-494
CAS Number: 1310726-60-3
Other descriptive name: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion
Product Name: Abatacept
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use		AbbVie Deutschland GmbH & Co. KGAuthorisedFemale: yes
Male: yes		313Phase 3Portugal;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;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
254EUCTR2014-005368-13-DE22/11/201623 July 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).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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: SAIT101
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: MabThera®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: Rituxan®
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-		Archigen Biotech LimitedAuthorisedFemale: 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
255JPRN-UMIN0000268192016/11/2123 April 2019A 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 SciencesRecruiting20years-oldNot applicableMale and Female80Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
256NCT02874092November 15, 201622 July 2019Ticagrelor in Methotrexate-Resistant Rheumatoid ArthritisTicagrelor in Methotrexate-Resistant Rheumatoid ArthritisRheumatoid ArthritisDrug: MTX therapy;Drug: TicagrelorNYU Langone HealthNot recruiting18 YearsN/AAll9Phase 4United States
257EUCTR2015-005800-27-PL08/11/20165 March 2018Study 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 arthritisRheumatoid 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
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not applicable
CAS Number: 1018673-42-1
Current Sponsor code: GSK3117391
Other descriptive name: GSK3117391
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		GlaxoSmithKline Research & Development LtdNot RecruitingFemale: yes
Male: yes		40Phase 2Poland;Romania;Russian Federation
258EUCTR2016-002908-15-NL08/11/201618 April 2017REDO 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 - REDORheumatoid 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
Pharmaceutical Form: Infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7		Sint MaartenskliniekAuthorisedFemale: yes
Male: yes		Phase 4Netherlands
259NCT02919761November 7, 201611 November 2019Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid ArthritisA Multicenter, 2 Part Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Rheumatoid Arthritis With Persistently Active DiseaseArthritis, RheumatoidDrug: Acthar;Drug: PlaceboMallinckrodtNot recruiting18 YearsN/AAll259Phase 4United States;Argentina;Mexico;Peru;Puerto Rico;Colombia
260NCT02960438November 2, 201628 October 2019A 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.Not recruiting18 Years75 YearsAll190Phase 2Japan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
261ChiCTR-INR-160095462016-11-0118 April 2017The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid ArthritisThe Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritisrheumatoid arthritis;M05.901IL-2 group:lL-2;IL-2 + IL-6 antagonist group:Tocilizumab;non IL-2 or IL-6 antagonist group:glucocorticoids and DMARDs;the Second Hospital of Shanxi Medical UniversityRecruiting1865BothIL-2 group:15;IL-2 + IL-6 antagonist group:15;non IL-2 or IL-6 antagonist group:15;New Treatment Measure Clinical StudyChina
262ChiCTR-IPR-160090292016-11-0118 April 2017Clinical Study of the Bone Protection Effect of Biqi Capsule for Treatment of Rheumatoid ArthritisClinical Study of the Bone Protection Effect of Biqi Capsule for Treatment of Rheumatoid ArthritisRheumatoid arthritisRA:the experimental group:MTX 10-15mg po qw+BiQi Capsule, 1.2g po bid;RA:the control group:MTX 10-15mg po qw+LEF, 10mg, po, bid;OA:The traditional Chinese group:BiQi Capsule, 1.2g po bid+Celecoxib capsules 0.2g po take as needed;OA:The western medicine control group:Calcitriol Soft Capsules 0.25ug, po, bid+Celecoxib capsules 0.2g po take as needed;Guangdong Provincial Hospital of Chinese MedicineNot Recruiting1865BothRA:the experimental group:60;RA:the control group:60;OA:The traditional Chinese group:60;OA:The western medicine control group:60;Post-marketChina
263NCT02996500November 201612 November 2018Safety 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: TofacitinibPfizerNot recruiting18 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
264NCT03011281November 201616 December 2017Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid ArthritisEffectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: TofacitinibHanyang UniversityRecruiting19 YearsN/AAll378N/AKorea, Republic of
265NCT03067870November 201618 June 2018Transplantation 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 ArabiaNot recruiting17 Years75 YearsAll100Phase 1
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
266NCT02819726October 31, 201618 December 2018PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid ArthritisA 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)Rheumatoid ArthritisBiological: SAIT101;Biological: MabThera;Biological: Rituxan;Biological: Rituxan/SAIT101Archigen Biotech LimitedNot recruiting18 Years80 YearsAll294Phase 1United States;Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;India;Korea, Republic of;Mexico;Poland;Spain
267NCT03061838October 27, 201629 July 2019Safety, Tolerability, PK and PD of Biosimilar Drug Ritumax® Compared to Original Drug MabThera®Multicenter Double-blind Randomized Clinical Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Biosimilar Drug Ritumax® Compared to Original Drug MabThera® in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: MabThera®;Drug: Ritumax®Biointegrator LLCNot recruiting18 YearsN/AAll8Phase 1Russian Federation
268NCT02858492October 17, 201626 November 2018Safety and Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Repeat Doses of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)A Multicenter, Randomized, 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 ArthritisArthritis, RheumatoidDrug: GSK2982772 60 mg;Drug: PlaceboGlaxoSmithKlineNot recruiting18 Years75 YearsAll52Phase 1/Phase 2Germany;Italy;Poland;Russian Federation;Spain;United Kingdom
269EUCTR2016-000498-19-BG13/10/201610 December 2018A 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 ARTHRITISRheumatoid 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
Pharmaceutical Form: Tablet
INN or Proposed INN: not available
Other descriptive name: GDC-0853 RO7010939
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		Genentech, Inc.AuthorisedFemale: yes
Male: yes		580Phase 2Serbia;United States;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of
270EUCTR2016-002061-54-IT13/10/20167 January 2019Switch 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 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0 Level: PT 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
Pharmaceutical Form: Powder for solution for infusion		UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLINot RecruitingFemale: yes
Male: yes		250Phase 4Italy
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
271JPRN-jRCTs04118007113/10/20167 October 2019T-ReX studyTocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX studyRheumatoid 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.Toshihisa KojimaNot Recruiting>= 20age oldNot applicableBoth51N/Anone
272NCT02937701October 10, 201621 January 2019Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to InfliximabA 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 ArthritisArthritis, RheumatoidDrug: ABP 710;Drug: InfliximabAmgenNot recruiting18 Years80 YearsAll558Phase 3United States;Australia;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Spain;Czech Republic
273NCT03403140October 6, 201629 January 2018Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 )Multicenter Extension Study To 104 Weeks To Asses The Efficacy, Safety And Immunogenicity Of Enerceptan® In Combination With Methotrexate For The Treatment Of Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: EtanerceptGema Biotech S.A.QUID-Quality in Drugs and Devices Latin American Consulting SRLNot recruiting19 Years99 YearsAll141Phase 3Argentina
274EUCTR2015-004858-17-NL05/10/201610 October 2016REMission INDuction in very early Rheumatoid ArthritisREMission INDuction in very early Rheumatoid Arthritis - REMINDRAVery 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
Pharmaceutical Form:
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 7.5-25
Trade Name: Golimumab
Product Name: Golimumab
Product Code: GOL
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		University Medical Center Utrecht (UMCU)AuthorisedFemale: yes
Male: yes		Phase 4Netherlands
275NCT03364088October 1, 20164 February 2019Outcome After Total Knee Arthroplasty Under General or Spinal AnesthesiaOutcome After Total Knee Arthroplasty Under General or Spinal Anesthesia, a Randomized Controlled TrialKnee Osteoarthritis;Arthropathy of Knee Joint;Knee Pain Chronic;Rheumatoid Arthritis;AnesthesiaProcedure: Spinal anesthesia with tourniquet;Procedure: Spinal anesthesia without tourniquet;Procedure: General anesthesia with tourniquet;Procedure: General anesthesia without tourniquet;Drug: Oxycodone by patient-controlled analgesia (PCA)Riku Antero PalanneHelsinki University Central Hospital;Helsinki University;FinlandNot recruiting18 Years75 YearsAll402N/AFinland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
276NCT02805010October 201612 December 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 SquibbNot recruiting18 Years45 YearsBoth22Phase 1
277NCT02881307October 20169 September 2019Ultrasound 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 RanganathRecruiting18 YearsN/AAll60N/AUnited States
278NCT02927522October 201617 October 2016Donepezil Attenuate Postoperative Cognitive DysfunctionDonepezil Attenuate Postoperative Cognitive Dysfunction in Aged Patients- A Multi-center, Case Control, Randomized Clinical TrailOsteoarthritis;Femoral Head Necrosis;Rheumatoid ArthritisDrug: Donepezil;Drug: PlaceboRenJi HospitalShanghai Sixth Hospital;Shanghai Guanghua Hospital;Sanya People's Hospital;Shanghai Sixth Hospital;Shanghai Guanghua Hospital;Sanya People's HospitalNot recruiting65 YearsN/ABoth550Phase 3
279NCT02936180October 201627 August 2018Standard Versus High Dose Inactivated Influenza Vaccine in RAImproving Influenza Immunization Responses in Rheumatoid Arthritis: A Strategy To Enhance Protection Against A Preventable Cause Of Death In An At Risk Population?Rheumatoid ArthritisBiological: HD-TIV;Biological: SD-QIVMcGill University Health CenterThe Arthritis Society, CanadaNot recruiting18 YearsN/AAll280Phase 4Canada
280NCT02037737September 30, 201619 February 2018Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life SettingImpact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting in Patients With Inadequate Response to One or Several Conventional DMARDs Including Methotrexate in France. A Database Analysis Based on the ACTION StudyRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbNot recruiting18 YearsN/AAll153N/A
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
281NCT02648035September 22, 20168 April 2019EMBRACE-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 RocheNot recruiting18 YearsN/AAll200Phase 1Greece
282EUCTR2014-004904-31-BE21/09/201620 August 2018A 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)
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion		Mundipharma Pharmaceuticals B.V.Not RecruitingFemale: yes
Male: yes		156Phase 4Belgium;Netherlands
283NCT02885181September 21, 201616 December 2017Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With MethotrexateA 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 MethotrexateRheumatoid ArthritisDrug: GS-9876;Drug: Filgotinib;Drug: GS-9876 placebo;Drug: Filgotinib placebo;Drug: MethotrexateGilead SciencesNot recruiting18 Years75 YearsAll83Phase 2United States;Bulgaria;Czechia;Georgia;Moldova, Republic of;Poland;Ukraine;Czech Republic;Hungary
284NCT02919475September 14, 201627 August 2018Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid ArthritisA 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)Rheumatoid ArthritisDrug: Placebo;Drug: JTE-051Akros Pharma Inc.Not recruiting18 Years75 YearsAll260Phase 2United States;Argentina;Bulgaria;Colombia;Mexico;Peru;Poland;Romania;Russian Federation;Ukraine
285NCT03147248September 12, 201626 August 2019A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RAA 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 RARheumatoid ArthritisBiological: InfliximabCelltrionNot recruiting18 Years75 YearsAll412Phase 3Korea, Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
286NCT02833350September 9, 201630 September 2019Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)A Two-Cohort Randomized Phase II, Double-Blind, 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 ArthritisDrug: GDC-0853;Drug: Adalimumab;Drug: Folic Acid;Drug: MTX;Drug: PlaceboGenentech, Inc.Not recruiting18 Years75 YearsAll578Phase 2United States;Argentina;Brazil;Bulgaria;Colombia;Korea, Republic of;Mexico;Poland;Russian Federation;Serbia;Ukraine;Chile
287NCT02831855September 1, 20161 April 2019Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid ArthritisA 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) FORMULATIONRheumatoid ArthritisDrug: Placebo;Drug: Methotrexate;Drug: CP-690,550PfizerNot recruiting18 YearsN/AAll695Phase 4United States;Australia;Belgium;Bulgaria;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Philippines;Poland;Russian Federation;Slovakia;South Africa;Spain;United Kingdom
288NCT02666443September 201612 September 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: Intravenous Dexamethasone 1 mg;Drug: Peri-neural Dexamethasone 1 mg;Drug: Control intervention (no dexamethasone)University of CalgaryRecruiting18 Years80 YearsBoth306N/ACanada
289NCT02897011September 20167 November 20162-week dc of MTX and Influenza Vaccination in RAEffect of Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical TrialRheumatoid Arthritis;Influenza;MethotrexateDrug: MethotrexateSeoul National University HospitalRecruiting18 Years65 YearsBoth318N/AKorea, Republic of
290NCT02930343September 201614 October 2019Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate MonotherapyComparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control TrialRheumatoid ArthritisDrug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid;Drug: SulfasalazineJawaharlal Institute of Postgraduate Medical Education & ResearchNot recruiting18 Years65 YearsAll136Phase 3India
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
291NCT03016013September 201610 September 2018A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis.A Phase III Study of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Poor Efficacy of MTX Due to Treat Moderate and Severe Rheumatoid Arthritis.Moderate and Severe RheumatoId ArthritisBiological: Placebo plus MTX;Biological: RC18 160 mg plus MTXRemeGenRecruiting18 Years65 YearsAll480Phase 3China
292JPRN-UMIN0000272422016/08/312 April 2019the effect of tofacitinib on bone mineral density in patients with rheumatoid arthritisto determine the effect of tofacitinib on bonetofacitinibDivision of rheumatology, hiroshima clinicHatta clinic Sky clinic Toyohira hospitalNot Recruiting18years-old90years-oldMale and Female50Phase 4Japan
293EUCTR2016-000912-13-DE30/08/201612 November 2018A 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not Available
CAS Number: Not Availabl
Other descriptive name: GSK2982772A, where A denotes the free base
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		GlaxoSmithKline Research & Development LtdNot RecruitingFemale: yes
Male: yes		36Phase 2Poland;Spain;Romania;Germany;Italy;United Kingdom
294NCT02889796August 30, 201615 July 2019Filgotinib 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 MethotrexateRheumatoid ArthritisDrug: Filgotinib;Drug: Placebo to match filgotinib;Drug: Adalimumab;Drug: Placebo to match adalimumab;Drug: MTXGilead SciencesGalapagos NVNot recruiting18 YearsN/AAll1759Phase 3United States;Argentina;Australia;Belgium;Bulgaria;Canada;Czechia;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic;France
295EUCTR2016-000335-40-BG23/08/201620 August 2018A 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
Pharmaceutical Form: Tablet
INN or Proposed INN: not available
Current Sponsor code: GDC-0853 RO7010939
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection/infusion in pre-filled syringe
Route of administration of the placebo: Subcutaneous use		Genentech, Inc.Not RecruitingFemale: yes
Male: yes		600Phase 2Serbia;United States;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
296EUCTR2016-002125-11-LV23/08/201629 August 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 ArthritisActive 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
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: CT-P13
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Product Code: CT-P13
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: CT-P13
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Trade Name: REMSIMA
Product Code: CT-P13
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: CT-P13
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-		Celltrion, IncAuthorisedFemale: yes
Male: yes		258Phase 1;Phase 3Hungary;Estonia;Czech Republic;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina
297NCT02628028August 22, 20166 May 2019A Study of LY3337641 in 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 StudyRheumatoid ArthritisDrug: LY3337641;Drug: PlaceboEli Lilly and CompanyNot recruiting18 Years65 YearsAll286Phase 2United States;Argentina;Australia;Austria;Italy;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Slovakia;South Africa;Spain;Germany
298ChiCTR-IIR-160086932016-08-2018 April 2017Pharmacokinetics, 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 ArthritisAbatacept Group:Single dose of abatacept;Placebo Group:Single dose of placebo;The First Hospital, Jilin UniversityNot Recruiting1845BothAbatacept Group:20;Placebo Group:2;Phase 1 studyChina
299NCT02705989August 18, 201611 February 2019Safety, 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 SquibbNot recruiting18 Years55 YearsAll439Phase 1Australia
300EUCTR2016-000393-37-BG08/08/201626 September 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 ARTHRITISRHEUMATOID 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
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Bimekizumab
CAS Number: 1418205-77-2
Current Sponsor code: CDP4940
Other descriptive name: UCB4940
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use		UCB Biopharma SprlNot RecruitingFemale: yes
Male: yes		60Phase 2Serbia;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
301EUCTR2016-001532-35-HU08/08/201630 October 2017A 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: LNP1955
Pharmaceutical Form: Capsule, soft
Current Sponsor code: LND400111
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use		Lupin LimitedNot RecruitingFemale: yes
Male: yes		64Phase 2Hungary;Bulgaria
302NCT02886728August 8, 20163 June 2019Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX TherapyA 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 TherapyRheumatoid ArthritisDrug: Filgotinib;Drug: Placebo to match filgotinib;Drug: MTX;Drug: Placebo to match MTXGilead SciencesGalapagos NVNot recruiting18 YearsN/AAll1252Phase 3United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Czechia;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;Czech Republic
303NCT03775824August 1, 201630 September 2019Faecal Analyses in Rheumatoid Arthritis TherapyFaecal Analyses in Rheumatoid Arthritis Therapy: An Prospective Observational Study of the Intestinal Microbiome in Patients With Rheumatoid Arthritis Receiving Immunosuppressive TherapyRheumatoid ArthritisDrug: MTX start;Drug: TNF startRegion SkaneNot recruiting18 YearsN/AAll50N/A
304NCT02722694August 201626 September 2016A Phase 3 Study of Abatacept in Chinese Patients With Active Rheumatoid Arthritis and Inadequate Response to MethotrexateA Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept 125mg Administered Subcutaneously in Chinese Subjects With Active Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to MethotrexateRheumatoid Arthritis (RA)Drug: Subcutaneous(SC) Abatacept;Other: Placebo;Drug: MethotrexateJiangsu Simcere Pharmaceutical Co., Ltd.Bristol-Myers SquibbRecruiting18 YearsN/ABoth360Phase 3China
305NCT02892370August 201619 September 2016Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy SubjectsAn Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR0302 and Mass Balance in Healthy VolunteersRheumatoid ArthritisDrug: SHR0302Jiangsu HengRui Medicine Co., Ltd.Recruiting18 Years45 YearsMale14Phase 1China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
306NCT02940561August 201631 October 2016BE Study in Patients - Methotrexate TabletsA Multicenter, Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single-dose, Two-way, Crossover, Bioequivalence Study of Methotrexate Tablets USP, 2.5 mg Manufactured by Amneal Pharmaceuticals, With Methotrexate Tablets USP 2.5 mg Manufactured for DAVA Pharmaceuticals, Inc., Fort Lee, NJ 07024 USA in Patients With Mild to Severe Psoriasis or Rheumatoid Arthritis, Who Are Already on Established Regimens of 2.5 mg Every 12 Hours Under Fasting Condition.Psoriasis;Rheumatoid ArthritisDrug: Methotrexate - Amneal;Drug: Methotrexate - DAVAAmneal Pharmaceuticals, LLCAccutest Research Laboratories (I) Pvt. Ltd.Recruiting18 Years65 YearsBoth48Phase 1India
307NCT02784106July 31, 201611 June 2018Safety and Efficacy Study of M2951 in Participants With Rheumatoid ArthritisPhase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects With Rheumatoid Arthritis on Stable Methotrexate TherapyRheumatoid ArthritisDrug: Placebo;Drug: M2951EMD Serono Research & Development Institute, Inc.Merck KGaANot recruiting18 Years75 YearsAll65Phase 2United States;Germany
308JPRN-JapicCTI-16331728/7/201616 July 2019Efficacy 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 InhibitorsRheumatoid 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.Not Recruiting18120BOTH408Phase 2Japan, Asia except Japan, North America, South America, Europe, Oceania
309EUCTR2016-000064-42-SK27/07/201631 October 2016Safety and Efficacy study of M2951 in Subjects with Rheumatoid ArthritisPhase 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/ARheumatoid 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
Pharmaceutical Form: Capsule
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: M2951
Other descriptive name: M2951
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use		Merck KGaAAuthorisedFemale: yes
Male: yes		64Phase 2Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria
310NCT02873936July 27, 201625 March 2019Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) TreatmentA 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) TreatmentRheumatoid ArthritisDrug: Filgotinib;Drug: Placebo to match filgotinib;Drug: csDMARDsGilead SciencesGalapagos NVNot recruiting18 YearsN/AAll449Phase 3United States;Argentina;Australia;Belgium;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Poland;Spain;Switzerland;United Kingdom;Italy;Netherlands
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
311NCT02867306July 25, 201625 March 2019A Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid ArthritisA Phase 1 Open-label, Single-sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: ASP1707;Drug: methotrexate (MTX)Astellas Pharma Global Development, Inc.Not recruiting18 Years65 YearsAll10Phase 1Moldova, Republic of
312ChiCTR-IPR-160087932016-07-1518 April 2017A multi center, randomized, double blind, positive parallel controlled clinical study of Zhengqing Fengtongning sustained release tablets in the treatment of rheumatoid arthritisA multi center, randomized, double blind, positive parallel controlled clinical study of Zhengqing Fengtongning sustained release tablets in the treatment of rheumatoid arthritisRheumatoid arthritisexperimental group:ZHENGQING FENGTONGNING sustained release tablets; control group:methotrexate;The combined treatment group:ZHENGQING FENGTONGNING sustained release tablets combine methotrexate;The First Affiliated Hospital of Third Military Medical UniversityRecruiting1875Bothexperimental group:80; control group:80;The combined treatment group:80;Post-marketChina
313EUCTR2015-003433-10-GB05/07/201618 April 2017ADMYRA 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 trialrheumatoid 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: GP2017
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		Hexal, AGAuthorisedFemale: 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
314NCT02683421July 20169 January 2017Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT ImagingEvaluation of Subcutaneous (SC) Injected Tc 99m Tilmanocept Localization in Active Rheumatoid Arthritis (RA) Subjects by SPECT and SPECT/CT ImagingRheumatoid ArthritisDrug: tilmanoceptNavidea BiopharmaceuticalsNot recruiting21 YearsN/ABoth18Phase 1United States
315NCT02585258June 30, 201610 September 2018The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis StudyThe 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 ArthritisRheumatoId ArthritisDrug: Prednisolone;Other: PlaceboVU University Medical CenterEuropean CommissionRecruiting65 YearsN/AAll500Phase 4Finland;Germany;Hungary;Italy;Netherlands;Portugal;Romania;Slovakia
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
316NCT02765074June 30, 201620 May 2019Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of Subcutaneous Tocilizumab in Rheumatoid ArthritisFilling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of 12 Months Subcutaneous Tocilizumab in Rheumatoid Arthritis Phase IV Prospective Multicentrique StudyRheumatoid ArthritisDrug: subcutaneous tocilizumabCentre Hospitalier Régional d'OrléansRennes University HospitalRecruiting18 Years85 YearsAll60Phase 4France
317NCT03106259June 29, 201619 February 2018Long-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.Not recruiting19 Years80 YearsAll9N/AKorea, Republic of
318EUCTR2015-003376-75-ES23/06/20164 July 2016A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTXModerately 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
Pharmaceutical Form: Tablet
INN or Proposed INN: ABT-494
CAS Number: 1310726-60-3
Current Sponsor code: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Methotrexate
Pharmaceutical Form: Capsule
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: Methotrexate
Pharmaceutical Form: Capsule
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: ABT-494
CAS Number: 1310726-60-3
Current Sponsor code: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		AbbVie Deutschland GmbH & Co. KGAuthorisedFemale: yes
Male: yes		600Phase 3Serbia;United States;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;European Union;Mexico;Puerto Rico;Argentina;Australia;Japan;New Zealand
319NCT03333681June 20, 201625 March 2019Evaluation of Stem Cell Therapy Effects on the Immune Response in Rheumatoid Arthritis PatientsEvaluation of Mesenchymal Stem Cell Therapy Effects on the Cellular and Humoral Immune Responses and Additionally Study on the Effect of Chemokines in Homing of the Immune Cells in Refractory Rheumatoid Arthritis PatientsRheumatoid ArthritisBiological: Autologous mesenchymal stem cellsMashhad University of Medical SciencesNot recruiting35 Years60 YearsFemale15Phase 1
320NCT02799472June 15, 201615 July 2019Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active Rheumatoid ArthritisA Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination With Methotrexate Therapy in Subjects With Active Rheumatoid Arthritis Despite Treatment With DMARDsArthritis, RheumatoidDrug: GSK3196165;Drug: Placebo;Drug: MTX;Drug: Folic (or folinic) acidGlaxoSmithKlineParexelNot recruiting18 YearsN/AAll39Phase 2United States;Germany;Poland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
321NCT03762824June 14, 201618 December 2018Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic DiseaseCombined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response.Rheumatoid Arthritis;Systemic Lupus;Sjögren Syndrome;Systemic Vasculitis;SpondyloarthritisBiological: 23-valent pneumococcal polysaccharide vaccine;Biological: 13-valent pneumococcal conjugate vaccineRegion SkaneNot recruiting18 YearsN/AAll300Phase 4
322EUCTR2015-005308-27-CZ07/06/201627 August 2018Study 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) 3Moderately to Severely Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: Olokizumab
Product Code: (CDP6038; L04041)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		R-PharmAuthorisedFemale: yes
Male: yes		350Phase 3United States;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Germany;Colombia;Korea, Republic of
323JPRN-UMIN0000219292016/06/017 October 2019Optimization of Infliximab Withdrawal Strategy for Rheumatoid ArthritisOptimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT StudyRheumatoid arthritisDiscontinuation of infliximabChiba UniversityNot Recruiting18years-oldNot applicableMale and Female200Not selectedJapan
324NCT02804204June 201625 February 2019Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMFAnalysis of Circulant Rheumatoid Factor, Cyclic Citrullinated Anti-peptide Anti-bodies and Albumin as a Potential Predictor in the Response to the Treatment With Anti-TNF in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Anti-TNFHospital Universitari Vall d'Hebron Research InstituteUCB PharmaRecruiting18 YearsN/AAll200Phase 2Spain
325NCT02804581June 201627 June 2016Gum Arabic as Immunomodulator In Rheumatoid Arthritis PatientsPotential Role of Gum Arabic as Immunomodulator In Sudanese Rheumatoid Arthritis PatientsRheumatoid ArthritisDietary Supplement: Gum ArabicLamis KaddamUniversity of Khartoum;Military hospitalRecruiting20 Years50 YearsBoth45Phase 2Sudan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
326EUCTR2016-002035-15-FI20/05/201613 June 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 anesthesiaPatients 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 Level: LLT 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: bupivacaine hydrochloride
Other descriptive name: BUPIVACAINE HYDROCHLORIDE
Trade Name: Propolipid
Pharmaceutical Form: Solution for injection
INN or Proposed INN: propofol
Other descriptive name: PROPOFOL		Helsinki University Central HospitalAuthorisedFemale: yes
Male: yes		Phase 4Finland
327NCT02659150May 18, 201614 January 2019Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid ArthritisA Multicenter, Open-Label, Proof-of-Activity Study of the Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: tocilizumabMassachusetts General HospitalBrigham and Women's HospitalRecruiting50 Years75 YearsFemale21Phase 4
328NCT02792699May 17, 201622 October 2018Study to Assess if ABP798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to RituximabA Randomized, Double-blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid ArthritisArthritis, RheumatoidDrug: ABP 798;Drug: RituximabAmgenNot recruiting18 Years80 YearsAll311Phase 3United States;Bulgaria;Estonia;Germany;Hungary;Poland;Canada
329EUCTR2014-004719-36-BG14/05/20169 January 2017Study 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 Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 1Moderately 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Olokizumab
Current Sponsor code: CDP6038
Other descriptive name: CDP6038
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		R-PharmAuthorisedFemale: yes
Male: yes		420Phase 3Belarus;Turkey;Russian Federation;Bulgaria
330NCT02780388May 12, 201610 September 2018A Phase 1b Study of MEDI4920 in Subjects With Adult-onset Rheumatoid ArthritisA Phase 1b Randomized, Double-blind, Placebo-controlled Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Clinical Response of MEDI4920 in Subjects With Adult-onset Rheumatoid ArthritisAdult Onset Rheumatoid ArthritisBiological: MEDI4920;Other: PlaceboMedImmune LLCNot recruiting18 Years70 YearsAll57Phase 1United States;Poland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
331JPRN-UMIN0000223642016/05/102 April 2019Treatment 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 arthritisOsteoprotic 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 MedicineNot Recruiting50years-old100years-oldMale and Female140Not applicableJapan
332NCT02760316May 2, 201616 December 2017A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567.A Phase I, Randomised, Single-blind Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567 in Healthy Volunteers Using Prednisolone as Positive ControlRheumatoid ArthritisDrug: AZD9567 10 mg;Drug: AZD9567 20 mg;Drug: AZD9567 40 mg;Drug: AZD9567 80 mg;Drug: Prednisolone 20 mg;Drug: AZD9567 125 mg;Drug: AZD9567 155 mg;Drug: Prednisolone 5 mg;Drug: Prednisolone 40 mgAstraZenecaNot recruiting18 Years55 YearsAll64Phase 1Germany;United Kingdom
333NCT01815411May 201611 June 2018Effect 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 ASNot recruiting19 Years75 YearsAll10N/ANorway
334NCT02538341May 201615 April 2019Safety 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 UniversityNot recruiting50 YearsN/AAll617Phase 2United States
335NCT02665910May 20162 May 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.Not recruiting18 Years70 YearsBoth48Phase 1China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
336NCT02760368May 201618 December 2018Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate 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 Methotrexate TherapyRheumatoid ArthritisDrug: Olokizumab q4w;Drug: Olokizumab q2w;Drug: Placebo q2wR-PharmQuintiles, Inc.;OCT Clinical Trials;Mene ResearchNot recruiting18 YearsN/AAll428Phase 3Bulgaria;Russian Federation;Turkey
337NCT02760407May 201618 December 2018Evaluation 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 TrialsRecruiting18 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
338NCT02762123May 201626 September 2016A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe SubstratesEffects of Concomitant Administration of BMS-986142 on the Single-dose Pharmacokinetics of Probe Substrates for CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-gp in Healthy SubjectsRheumatoid ArthritisDrug: BMS-986142 200mg;Drug: BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin);Drug: BMS-986142 350mgBristol-Myers SquibbNot recruiting18 Years50 YearsBoth28Phase 1United States
339NCT02770794May 201623 May 2016Optimization of Infliximab Withdrawal Strategy for Rheumatoid ArthritisMulticenter Prospective Trial to Investigate Accuracy of Ultrasound to Predict Relapse After Discontinuation of Infliximab and Efficacy/Safety of Readministration of Infliximab in Patients With Rheumatoid Arthritis in Low Disease ActivityArthritis, RheumatoidDrug: InfliximabChiba UniversityNot recruiting18 YearsN/ABoth200Phase 4
340NCT02603146April 27, 201628 October 2019Strategy 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 ExcellenceRecruiting18 YearsN/AAll200Phase 2United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
341NCT02714881April 201623 July 2018Lipids, Inflammation, and CV Risk in RALipids, Inflammation, and Cardiovascular Risk in Rheumatoid ArthritisRheumatoid Arthritis;Cardiovascular DiseaseRadiation: Stress myocardial perfusion PET;Drug: certolizumabBrigham and Women's HospitalRecruiting35 Years90 YearsAll75N/AUnited States
342NCT02715908April 201616 July 2018A Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 in Subjects With Active RA Despite Methotrexate (MTX)A Extension Clinical Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 When Co-administered With Methotrexate (MTX) for Additional 48 Weeks in Patients With RA Who Have Completed the Treatment Period of LG-ECCL002Rheumatoid ArthritisDrug: LBEC0101LG Life SciencesNot recruiting20 Years75 YearsAll148Phase 3Korea, Republic of
343NCT02722044April 201611 June 2018Usability of an AI for M923 in Subjects With Moderate to Severe RAAn Open-label Single-arm Multicenter Study to Evaluate Usability of a Subcutaneous (SC) Autoinjector (AI) for a Proposed Adalimumab Biosimilar (M923) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)Rheumatoid ArthritisBiological: M923;Device: AutoinjectorMomenta Pharmaceuticals, Inc.Not recruiting18 YearsN/AAll33Phase 3United States
344NCT02746380April 201616 December 2017A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate TherapyMulti-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate the Similarity of Efficacy and Safety of LBAL 40mg Subcutaneous Biweekly Injection to Humira® 40mg Subcutaneous Biweekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTXArthritis, RheumatoidDrug: LBAL;Drug: Humira®LG Life SciencesMochida Pharmaceutical Company, Ltd.Not recruiting20 Years75 YearsAll380Phase 3Japan;Korea, Republic of
345NCT02573012March 29, 201611 November 2019Study to Compare the Efficacy of Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis ParticipantsProspective, Multicentre, Placebo-controlled, Double-blind Interventional Study to Compare the Efficacy of Maintenance Treatment With Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: Placebo matched to prednisone;Drug: Prednisone;Biological: TocilizumabHoffmann-La RocheNot recruiting18 YearsN/AAll314Phase 4France;Germany;Italy;Russian Federation;Serbia;Tunisia;Egypt;Switzerland;Turkey
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
346NCT02679001March 24, 201620 August 2018A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment.A COMPARATIVE OBSERVATIONAL STUDY FOLLOWING THE USE OF CONCOMITANT CORTICOSTEROID TREATMENT IN RA PATIENTS WHO ARE TREATED WITH A TNF INHIBITOR OR TOCILIZUMAB AS THEIR SECOND BIOLOGICAL TREATMENTRheumatoid ArthritisDrug: TNF inhibitor/TCZHoffmann-La RocheNot recruiting18 YearsN/AAll200Phase 1/Phase 2Sweden
347NCT02720523March 22, 201628 October 2019A 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: UpadacitinibAbbVieNot recruiting18 YearsN/AAll197Phase 2/Phase 3Japan
348NCT02682823March 21, 201612 November 2018Tocilizumab Real-Life Human Factors (RLHFs) Validation StudyTocilizumab Real-Life Human Factors Validation StudyRheumatoid ArthritisDevice: AI-1000 G2;Drug: TocilizumabHoffmann-La RocheNot recruiting18 YearsN/AAll91Phase 4United States
349EUCTR2015-002523-26-HU08/03/201611 April 2016Effects of JAK inhibition on rheumatoid arthritis-related comorbidities: link between bone and vascular effects (investigator-initiated grant proposal)Effects of JAK inhibition on rheumatoid arthritis-related comorbidities: link between bone and vascular effects (investigator-initiated grant proposal)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
Product Code: CP-690,55-10
Pharmaceutical Form: Film-coated tablet		Arthritis AlapítványAuthorisedFemale: yes
Male: yes		Hungary
350NCT01961310March 8, 201611 June 2018Evaluation of the Intestinal Microbiota and Bacterial Translocation in Patients With Rheumatoid ArthritisEvaluation of the Intestinal Microbiota and Bacterial Translocation in Patients With Rheumatoid ArthritisArthritis, RheumatoidBiological: Plasma analysis for bacterial translocation;Biological: Stool analysisCentre Hospitalier Universitaire de NimesNot recruiting18 YearsN/AAll55N/AFrance
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
351NCT02547493March 3, 201611 June 2018Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis PatientsComparison of Humoral Response to Conjugate Pneumococcal Vaccine and Polysaccharide Pneumococcal Vaccine in Rheumatoid Arthritis (RA) Patients Treated With AbataceptRheumatoid ArthritisBiological: pneumococcal polysaccharide vaccine;Biological: pneumococcal conjugate vaccine;Drug: AbataceptUniversity Hospital, MontpellierBristol-Myers SquibbRecruiting18 Years85 YearsAll80N/AFrance;Monaco
352NCT02706951March 2, 201618 March 2019A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects 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 Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTXRheumatoid ArthritisDrug: Methotrexate;Drug: ABT-494;Drug: ABT-494 matching placebo;Drug: Methotrexate matching placeboAbbVieNot recruiting18 Years99 YearsAll648Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Chile;Czechia;Estonia;Greece;Hungary;Israel;Italy;Japan;Mexico;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;South Africa;Spain;Turkey;Ukraine;Colombia;Czech Republic;New Zealand
353JPRN-UMIN0000214922016/03/012 April 2019To 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 HospitalNot Recruiting18years-oldNot applicableMale and Female40Not selectedJapan
354NCT02636829March 201626 September 2016Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory ArthritisValidation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory ArthritisMultiple Sclerosis;Rheumatoid ArthritisOther: QALCIMUM questionnaire;Other: Determination of calcium intake by a dietician interviewCentre Hospitalier Universitaire de NimesNot recruiting18 Years69 YearsBoth100N/AFrance
355NCT02652299March 201625 March 2019Fibrocytes in Early and Longstanding Rheumatoid ArthritisFibrocytes in Early and Longstanding Rheumatoid ArthritisRheumatoid ArthritisBiological: Synovial biopsyOdense University HospitalNot recruiting18 YearsN/AAll60N/ADenmark
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
356NCT02714634March 201611 April 2016Clinical Trial Evaluating Methotrexate + Biologic Versus Methotrexate, Salazopyrine and Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to MethotrexateRandomized Controlled Clinical Trial Evaluating Methotrexate + Biologic Versus Methotrexate, Salazopyrine and Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to MethotrexateRheumatoid Arthritis;Insufficient Response to Methotrexate.Drug: Methotrexate + biologic administration;Drug: methotrexate + salazopyrine + hydroxychloroquine administrationUniversity Hospital, Strasbourg, FranceNot recruiting18 YearsN/ABoth286Phase 4
357NCT02728934February 25, 201611 November 2019Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid ArthritisComparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid ArthritisArthritis, RheumatoidBiological: Golimumab Intravenous (IV);Biological: Infliximab;Biological: Biosimilar InfliximabJanssen Scientific Affairs, LLCNot recruiting18 YearsN/AAll1279N/AUnited States
358EUCTR2015-002924-17-BE24/02/201623 July 2018A 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 ArthritisActive Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Nanocort
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: prednisolone
Other descriptive name: PREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Depo Medrol
Product Name: Depo Medrol
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use		Sun Pharma Global FZENot RecruitingFemale: yes
Male: yes		330Phase 3Belgium;Netherlands
359NCT02698657February 23, 201615 July 2019A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on MethotrexateA Phase 1, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on MethotrexateRheumatoid Arthritis (RA)Drug: ASP5094;Drug: PlaceboAstellas Pharma Global Development, Inc.Not recruiting18 Years65 YearsAll30Phase 1United States;Poland
360NCT02706873February 23, 201625 March 2019A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects 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: ABT-494 matching placebo;Drug: Methotrexate;Drug: Methotrexate matching placebo;Drug: ABT-494AbbVieNot recruiting18 Years99 YearsAll1002Phase 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
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
361NCT02638948February 16, 201620 August 2018Efficacy 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 InhibitorsRheumatoid ArthritisDrug: BMS-986142;Drug: Placebo;Drug: MethotrexateBristol-Myers SquibbNot recruiting18 Years120 YearsAll536Phase 2United States;Argentina;Austria;Brazil;Canada;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;South Africa;Spain;Taiwan;Belgium
362NCT02683564February 201623 February 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) GmbHNot recruiting18 Years80 YearsBoth548Phase 3
363NCT03332719February 201616 December 2017Efficacy, 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 SRLNot recruiting19 Years99 YearsAll168Phase 3Argentina
364NCT03355872February 20169 October 2018A Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDsA Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDsRheumatoid ArthritisDrug: HLX01Shanghai Henlius BiotechNot recruiting18 Years65 YearsAll194Phase 1/Phase 2
365EUCTR2014-004868-38-GR26/01/201614 March 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Methotrexate
Product Name: methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN: methotrexate
CAS Number: 59-05-2
Current Sponsor code: methotrexate
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Amgen Inc.AuthorisedFemale: yes
Male: yes		720United States;Hungary;Czech Republic;Canada;Greece;Argentina;Spain;Bulgaria
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
366NCT02925351January 25, 201611 November 2019Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory DiseasesThe Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory DiseasesAutoimmune Disease;Crohn Disease;Inflammatory Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Takayasu ArteritisProcedure: Computed Tomography;Radiation: Fluorine F 18 Clofarabine;Procedure: Positron Emission TomographyJonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Not recruiting18 YearsN/AAll8N/AUnited States
367NCT02640612January 22, 201618 December 2018Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With 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 AdalimumabArthritis, RheumatoidDrug: BI 695501Boehringer IngelheimNot recruiting18 Years80 YearsAll430Phase 3United States;Bulgaria;Chile;Estonia;Germany;Hungary;Korea, Republic of;Malaysia;Poland;Russian Federation;Serbia;Spain;Thailand;Ukraine
368JPRN-UMIN0000189312016/01/172 April 2019Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trialOsteoarthritis, 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 HospitalNot Recruiting20years-oldNot applicableMale and Female50Not selectedJapan
369EUCTR2014-004673-16-DE12/01/201630 April 2018Randomized, 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 patientsRheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 180-
Trade Name: Prednisone Tablets USP, 5 mg
Product Code: RO001-9265/F04
Pharmaceutical Form: Capsule
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Prednisone Tablets USP, 1 mg
Product Code: RO 001-9265/F02-01
Pharmaceutical Form: Capsule
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: RoActemra
Product Code: L04AC07
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-		F. Hoffmann-La Roche LtdNot RecruitingFemale: yes
Male: yes		226Phase 4Serbia;France;Egypt;Lebanon;Turkey;Russian Federation;Germany;Italy;Switzerland
370EUCTR2015-003332-13-SK12/01/20168 February 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 csDMARDsModerately 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
Pharmaceutical Form: Tablet
INN or Proposed INN: ABT-494
CAS Number: 1310726-60-3
Current Sponsor code: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: ABT-494
CAS Number: 1310726-60-3
Current Sponsor code: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		AbbVie Deutschland GmbH & Co. KGAuthorisedFemale: yes
Male: yes		600Phase 3Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Turkey;Egypt;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Japan;New Zealand
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
371NCT02742597January 12, 20168 January 2018Patient-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;St. Michael's Hospital, Toronto;University Health Network, Toronto;Toronto East General Hospital;Providence HealthCare;Mount Sinai Hospital, Canada;Toronto Central Community Care Access Centre;Women's College HospitalNot recruiting18 Years80 YearsAll1980N/ACanada
372EUCTR2012-002009-23-HU07/01/20163 July 2017Clinical 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 - EQUIRAModerate 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Enbrel 50 mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		Hexal AGNot 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
373EUCTR2015-002634-41-HU07/01/201611 December 2017Long-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 adalimumabRheumatoid 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: -
CAS Number: -
Current Sponsor code: BI 695501
Other descriptive name: BI 695501
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		Boehringer Ingelheim International GmbHNot RecruitingFemale: yes
Male: yes		400Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
374NCT02636907January 6, 201616 December 2017Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled SyringeAssessment of Real-life Patient Handling Experience of BI 695501 Administered Subcutaneously With an Autoinjector in Patients With Rheumatoid Arthritis: an Open-label, Interventional Clinical Trial Followed by an Extension Phase of BI 695501 Administered With a Prefilled SyringeArthritis, RheumatoidDrug: BI 695501 Autoinjector;Drug: BI 695501 Prefilled syringeBoehringer IngelheimNot recruiting18 Years80 YearsAll77Phase 2United States;Poland;Ukraine
375NCT02321930January 201616 December 2017Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis PatientsMusculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: tofacitinib 5mg po bidUniversity of California, Los AngelesNot recruiting18 YearsN/AAll25Phase 4United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
376NCT02626026January 201610 October 2016Safety and Pharmacokinetics of GS-4059 in Healthy Volunteers and Subjects With Rheumatoid Arthritis (RA)A Phase 1, Placebo-Controlled, Randomized Study Evaluating the Safety and Pharmacokinetics of GS-4059 in Healthy Volunteers and Subjects With Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: GS-4059;Drug: PlaceboGilead SciencesNot recruiting18 Years65 YearsBoth42Phase 1United States
377NCT02643823January 201613 June 2016Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid ArthritisSafety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid ArthritisRheumatoid ArthritisBiological: hUC-MSC + DMARDs;Drug: DMARDsShenzhen Hornetcorn Bio-technology Company, LTDFutian People's HospitalRecruiting18 Years80 YearsBoth40Phase 1China
378NCT02762838January 201624 June 2019Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisInternational Multi-center Comparative Double-blind Randomized Clinical Trial of Efficacy and Safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: BCD-055;Biological: Remicade®;Drug: Methotrexate;Drug: Folic acidBiocadNot recruiting18 Years75 YearsAll426Phase 3Belarus;India;Russian Federation
379NCT02878161January 201629 August 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 LiRecruiting18 Years75 YearsBoth240Phase 4
380NCT02608112December 31, 20155 November 2018Study 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 RocheNot recruiting18 YearsN/AAll291Phase 1France
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
381NCT02644499December 31, 201514 October 2019Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid ArthritisComparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid ArthritisRheumatoid ArthritisDrug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic AcidJawaharlal Institute of Postgraduate Medical Education & ResearchNot recruiting18 YearsN/AAll186Phase 4India
382EUCTR2015-003333-95-SK18/12/20156 November 2018A Study Comparing Upadacitinib (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 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)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
Pharmaceutical Form: Tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Current Sponsor code: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use		AbbVie Deutschland GmbH & Co. KGAuthorisedFemale: yes
Male: yes		1500Phase 3Ukraine;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;Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain
383EUCTR2015-004173-32-DK18/12/201530 April 2019Personalized 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
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Humira
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Remsima
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: up to
Concentration number: 5-
Trade Name: Benepali
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 50-
Trade Name: Remicade
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: up to
Concentration number: 7,5-		Department of Clinical Biochemestry, Aarhus University HospitalNot Recruiting Female: yes
Male: yes		500Phase 4Denmark
384NCT02675426December 17, 201518 March 2019A 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 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: ABT-494AbbVieNot 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;Belarus;Brazil;Colombia;Czech Republic;Denmark;Israel;Netherlands;Norway;Serbia;Singapore
385EUCTR2015-003334-27-SK11/12/20156 November 2018A 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 ArthritisModerately 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
Pharmaceutical Form: Tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Current Sponsor code: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Upadacitinib
Product Code: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Current Sponsor code: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Methotrexate
Pharmaceutical Form: Capsule
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: Methotrexate
Pharmaceutical Form: Capsule
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use		AbbVie Deutschland GmbH & Co. KGAuthorisedFemale: 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
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
386NCT02680067December 8, 201529 April 2019NIR 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)Recruiting18 Years89 YearsAll30Phase 1United States
387ChiCTR-IPR-150073682015-12-0118 April 2017Clinical Research for the Effect of Chinese and Western Medicine on Treating Rheumatoid ArthritisComparative Study on the Influences of Gut Microbiota of Chinese and Western Medicine for Treatment of Rheumatoid ArthritisRheumatoid Arthritis1:HuaYuTongBiFang;2:HuaYuTongBiFang+MTX;3:ZhengQingFengTongNing Pills+MTX;4:Methotrexate;Guangdong Provincial Hospital of Chinese MedicineNot Recruiting1865Male1:96;2:96;3:96;4:96;Pilot studyChina
388NCT02629159December 1, 201525 February 2019A 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 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: ABT-494;Drug: Adalimumab;Drug: Placebo for ABT-494AbbVieNot 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
389NCT02944799December 201522 October 2018Alendronate 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 AarhusRecruiting18 YearsN/AAll160Phase 2Denmark
390NCT02758769November 30, 201516 December 2017Long-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. LtdRecruiting20 YearsN/AAll300N/AJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
391NCT02557100November 19, 201526 August 2019Study 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 SquibbNot recruiting18 YearsN/AAll120Phase 4United States;Algeria;Canada;Mexico
392NCT02512575November 18, 20159 October 2018A 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: PrednisoloneAstraZenecaNot recruiting18 Years55 YearsMale72Phase 1Germany
393EUCTR2015-002809-12-HU17/11/20152 October 2017A 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 ArthritisRheumatoid 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Current Sponsor code: YLB113
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Enbrel
Product Name: Enbrel
Product Code: Enbrel
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		YL Biologics LtdNot RecruitingFemale: yes
Male: yes		500Phase 3Czech Republic;Hungary;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India
394EUCTR2013-000337-13-PT13/11/201512 February 2018Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled study Prediction 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 study Prediction of response to Certolizumab-Pegol in RA (PreCePRA) - PreCePRAPatients 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
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Current Sponsor code: UCB SA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution and suspension for suspension for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use		Universitätsklinikum ErlangenAuthorisedFemale: yes
Male: yes		156Phase 3Serbia;United States;Portugal;Germany
395JPRN-UMIN0000188482015/11/015 November 2019Tapering 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 arthritisRheumatoid 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 HospitalNot RecruitingNot applicableNot applicableMale and Female900Not applicableJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
396NCT02534896November 201526 November 2018To 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: Sunpharma1505 1;Drug: Sunpharma1505 2;Drug: Reference1505Sun Pharma Global FZENot recruiting18 Years90 YearsAll330Phase 3Belgium;Netherlands
397NCT02543931November 201512 December 2016Curcuma 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)Not recruiting18 YearsN/ABoth3Phase 1United States
398NCT02723760November 201511 April 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 UniversityRecruiting20 Years70 YearsBoth40Phase 0China
399NCT02552940October 31, 201511 June 2018An 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 saNot recruiting18 YearsN/AAll140N/ABelgium;Luxembourg
400ChiCTR-OPB-150072842015-10-3018 April 2017Characterization of linkage between symbiotic gut microbes and fatty acid metabolism in rheumatoid arthritis patientsCharacterization of linkage between symbiotic gut microbes and fatty acid metabolism in rheumatoid arthritis patientsRheumatoid ArthritisRA group1:Doxycycline;RA group 2:Placebo;Hong Kong Baptist UniversityRecruiting1880BothRA group1:20;RA group 2:20;Pilot studyChina
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
401EUCTR2015-001246-28-BE19/10/201516 November 2015Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study)Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study) - TOVERARheumatoid 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
Product Name: RoActemra
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe		Cliniques Universitaires Saint-Luc, Université catholique de LouvainAuthorisedFemale: yes
Male: yes		Belgium
402EUCTR2015-000581-58-CZ14/10/201515 October 2018A 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 - BioBioRheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 100-
Trade Name: Orencia
Product Name: Orencia
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 250-
Trade Name: Ro-Actemra
Product Name: Ro Actemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumabum
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 20-
Trade Name: Mabthera
Product Name: Mabthera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 10-		Revmatologicky ustav PrahaNot RecruitingFemale: yes
Male: yes		40Phase 4Czech Republic
403NCT02534311October 13, 201512 March 2018A Phase IV Study to Evaluate the Effect of Subcutaneous (SC) Tocilizumab Administered to Participants With Rheumatoid Arthritis (RA) Assessed Using Disease Activity Score (DAS28)Prospective Evaluation of Rheumatoid Arthritis Activity Using DAS28 in Patients Treated With Subcutaneously Administered Tocilizumab on Local LevelRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNot recruiting18 YearsN/AAll60N/ASlovakia
404NCT02778789October 20157 October 2019Comparing 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 SchoolNot recruiting18 YearsN/AAll66N/AGermany
405NCT02780323October 201516 December 2017Study 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® placebo;Drug: CELEBREX® placebo;Drug: CELEBREX®;Drug: CELBESTA®Dong-A ST Co., Ltd.Recruiting19 YearsN/AAll158Phase 4Korea, Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
406NCT02882087October 201515 April 2019A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to TNF-a Antagonists Due to Treat Moderate and Severe Rheumatoid ArthritisA Phase II, Placebo-Controlled, Multicenter, Dynamic Randomized, Double Blind Trial of RC18, a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Inadequate Response of TNF-a Antagonists Due to Treat Moderate and Severe Rheumatoid ArthritisModerate and Severe Rheumatoid ArthritisDrug: RC18 160 mg plus MTX;Drug: Placebo plus MTXRemeGenNot recruiting18 Years65 YearsAll60Phase 2China
407EUCTR2015-003638-28-DK30/09/201530 April 2019Treatment of osteoporosis in patients with rheumatoid arthritis.ALOSTRA Alendronate 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. - ALOSTRARheumatoid arthritis and osteoporosis
MedDRA version: 20.0 Level: LLT Classification code 10031289 Term: Osteoporosis, unspecified System Organ Class: 100000004859
MedDRA version: 20.0 Level: LLT 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
Pharmaceutical Form: Tablet
INN or Proposed INN: Alendronic Acid
Other descriptive name: ALENDRONIC ACID
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 0.07-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use		Aarhus University HospitalAuthorised Female: yes
Male: yes		160Phase 2Denmark
408EUCTR2015-002284-42-FI18/09/201528 September 2015The rationale for this study is to gain insight in the extent and impact of immunogenicity of TNF inhibitors in the European daily clinical practice. Furthermore, an European wide database will give insight in factors influencing immunogenicity and treatment outcome in terms of disease activitINTENT: immunogenicity in patients failing response on anti-TNF -Immunogenicity and pharmacokinetics in patients failing to respond to TNF inhibitors (phase 1); -Clinical effectiveness of subsequent TNF inhibitor treatment and predictive value of pharmacokinetics and immunogenicity (phase 2) - INTENTrheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specifyTrade Name: Enbrel
Product Name: etanercept
Pharmaceutical Form: Injection
Trade Name: Humira
Product Name: adalimumab
Pharmaceutical Form: Injection
Trade Name: Cimzia
Product Name: certolizumab pegol
Pharmaceutical Form: Injection
Trade Name: Simponi
Product Name: golimumab
Pharmaceutical Form: Injection
Trade Name: Remicade
Product Name: infliximab
Pharmaceutical Form: Infusion		READEAuthorisedFemale: yes
Male: yes		1650Phase 1Finland
409NCT02605642September 10, 201518 March 2019Post-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 PfizerNot recruiting18 YearsN/AAll351Phase 3Bulgaria;Canada;Czechia;Germany;Greece;Spain;United Kingdom;Czech Republic;France;Italy
410NCT02535832September 201524 June 2019Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA)Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA)Rheumatoid Arthritis;Insulin ResistanceDrug: Pioglitazone;Drug: PlaceboUniversity of Alabama at BirminghamRecruiting35 Years65 YearsAll36Phase 1United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
411NCT02553018September 201516 December 2017Comparison 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 SASNot recruiting18 YearsN/AAll278Phase 3France
412NCT02565810September 201516 December 2017An Multicentre Clinical Study to Evaluate the Usability and Safety 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 ArthritisRheumatoid ArthritisDrug: Adalimumab PFS and PenSamsung Bioepis Co., Ltd.Not recruiting18 Years55 YearsAll49Phase 2Poland
413NCT02717988September 201512 March 2018Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of SKI-O-703 in Healthy VolunteersA Phase 1, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of SKI-O-703 in Healthy VolunteersRheumatoid ArthritisDrug: SKI-O-703 capsule;Drug: Placebo capsuleOscotec Inc.PPDNot recruiting18 Years55 YearsAll48Phase 1United States
414NCT02748785September 20157 November 2016MTX Discontinuation and Vaccine ResponseEffect of Methotrexate Discontinuation on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical TrialArthritis, RheumatoidDrug: Methotrexate;Biological: Seasonal Influenza vaccineSeoul National University HospitalNot recruiting18 YearsN/ABoth277Phase 4Korea, Republic of
415NCT02764515September 201516 December 2017Kunxian for the Treatment of Rheumatoid ArthritisComparison of the Efficacy and Safety of Kunxian Capsule and Methotrexate for the Treatment of Rheumatoid ArthritisRheumatoid ArthritisDrug: Kunxian Capsule;Drug: MethotrexateChinese SLE Treatment And Research GroupCHENLIJI Pharmaceutical Company,Guangzhou Pharmaceutical Group;CHINESE RHEUMATISM DATA CENTERRecruiting40 Years70 YearsAll428Phase 4China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
416JPRN-UMIN0000272412015/08/312 April 2019the change of IMT of carotide artery in RA with treatment of tocilizumabrheumatoid arthritistofacitinibhiroshima clinicNot Recruiting18years-old80years-oldMale and Female50Not applicableJapan
417NCT02504268August 31, 201522 October 2019Effects 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 NaiveRheumatoid ArthritisDrug: Abatacept;Drug: Methotrexate;Other: Abatacept Placebo;Other: Methotrexate PlaceboBristol-Myers SquibbNot recruiting18 YearsN/AAll1067Phase 3United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Monaco;Netherlands;Peru;Poland;Qatar;Romania;Russian Federation;Singapore;South Africa;Spain;Sweden;Taiwan;United Kingdom;Czech Republic;Puerto Rico;Saudi Arabia;United Arab Emirates
418NCT02350426August 12, 201516 December 2017A Study to Assess Inflammation in Rheumatoid Arthritis Using Molecular Imaging TechniquesAn Adaptive Design Open Label Pilot Study in Rheumatoid Arthritis Patients to Assess Inflammation Using Molecular Imaging TechniquesArthritis, RheumatoidOther: Gadobutrol;Other: 18F-FDG;Other: 18F-GE-180GlaxoSmithKlineCambridge University Hospitals NHS Foundation TrustNot recruiting30 Years85 YearsAll10Phase 1United Kingdom
419JPRN-JapicCTI-15308101/8/201516 July 2019Effects 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 NaiveRheumatoid ArthritisIntervention name : 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
Dosage And administration of the control intervention : Methotrexate at least 15mg per week tablet or capsule orally
Control intervention name : Abatacept Placebo
Dosage And administration of the control intervention : Placebo for Abatacept subcutaneous injection once per week
Control intervention name : Methotrexate Placebo
Dosage And administration of the control intervention : Placebo to match Methotrexate capsule orally once per week		Bristol-Myers Squibb K.K.Not Recruiting18BOTH1000Phase 3
420NCT02451748August 201529 April 2019IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIAIL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells, Peripheral Blood Monocytes or Differentiated Macrophages of Rheumatoid Arthritis Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIARheumatoid ArthritisOther: Lab Work;Drug: Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg);Drug: Certolizumab pegol (CDP870, tradename Cimzia)University of Illinois at ChicagoUCB PharmaNot recruiting18 YearsN/AAll32Phase 4United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
421NCT02797769August 201521 July 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 RocheNot recruiting18 YearsN/ABoth75000N/A
422NCT02481180July 31, 201522 July 2019Tolerance, Pharmacokinetics and Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)An Open, Dose Escalation, Multiple Dose Study to Assess Tolerance?Pharmacokinetics?Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)Rheumatoid ArthritisDrug: T0001;Drug: EnbrelShanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Not recruiting18 Years65 YearsAll36Phase 1China
423EUCTR2015-000665-30-GB30/07/201527 August 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) - OLSESRheumatoid arthritis Chronic Plaque Psoriasis
MedDRA version: 18.0 Level: LLT Classification code 10042952 Term: Systemic rheumatoid arthritis System Organ Class: 100000004859
MedDRA version: 18.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Product Code: CHS-0214
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Etanercept
CAS Number: 185243-69-0
Current Sponsor code: CHS-0214
Other descriptive name: BGX-0214
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		Coherus BioSciences, Inc.Not RecruitingFemale: yes
Male: yes		447Phase 3France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;Italy;United Kingdom
424NCT02504671July 23, 201515 April 2019Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid ArthritisA 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 MethotrexateArthritis, RheumatoidDrug: GSK3196165;Drug: MTX;Drug: Folic acid;Drug: PlaceboGlaxoSmithKlineNot recruiting18 YearsN/AAll222Phase 2Bulgaria;Canada;Czechia;Estonia;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic
425EUCTR2012-003876-38-DE21/07/201528 November 2016Clinical 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-RTRheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: GP2013
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade Name: MabThera®
Product Name: MabThera®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-		Hexal AG (a Sandoz company)Not RecruitingFemale: yes
Male: yes		100Phase 3United States;Hungary;Poland;Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
426NCT02242474July 201520 August 2018Anti-TNFa Use During Elective Foot and Ankle Surgery in Patients With Rheumatoid ArthritisProspective Randomized Multicentric Trial on Anti-TNFa Treatment and Infection Risk in the Perioperative Period During Elective Foot and Ankle Surgery in Patients With Rheumatoid Arthritis.Rheumatoid ArthritisDrug: Anti-TNF suspended perioperatively;Drug: Anti-TNFa continued perioperativelyCHU de Quebec-Universite LavalRecruiting18 YearsN/AAll660Phase 4Canada
427NCT02467504July 201523 November 2015Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid ArthritisA Randomized, Double Blind, Placebo-controlled Pilot-study to Evaluate Efficacy and Safety of Low-dose hrIL-2 in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-Naive Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: hrIL-2 active;Drug: hrIL-2 placebo;Drug: MTX;Drug: Folic Acid;Drug: LoxoprofenPeking University People's HospitalMonash University;Beijing ShuangLu Pharmaceutical Co., Ltd.Recruiting18 Years70 YearsBoth60Phase 2China
428NCT02480946July 201516 December 2017Safety and Tolerability Study of MBS2320 in Healthy Subjects and Subjects With Rheumatoid ArthritisA Four-Part Phase-1 Study Investigating the Tolerability, Safety and Pharmacokinetics (PK) of MBS2320 in Healthy Subjects and in Subjects With Rheumatoid Arthritis (RA) Also Treated With MethotrexateArthritis, RheumatoidDrug: MBS2320;Drug: Placebo;Drug: MethotrexateModern Biosciences plcCovanceNot recruiting18 Years70 YearsAll105Phase 1United Kingdom
429NCT02486939July 201516 December 2017A Long Term Safety Extension Study (CHS-0214-05)An Open-Label Safety Extension Study (OLSES) Evaluating the Long Term Safety and Durability of Response of CHS-0214 (CHS-0214-05)Rheumatoid Arthritis;Plaque PsoriasisDrug: CHS-0214Coherus Biosciences, Inc.Daiichi Sankyo Co., Ltd.;ShireNot recruiting18 YearsN/AAll359Phase 3Japan
430NCT02514772July 201516 December 2017GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®A 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®Rheumatoid ArthritisBiological: GP2013 - A Proposed biosimilar rituximab;Biological: Originator rituximab - Rituxan ® or MabThera ®SandozHexal AGNot recruiting18 YearsN/AAll107Phase 3United States;Germany;Hungary;Poland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
431NCT02518620July 201526 August 2019An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of 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-0061Rheumatoid ArthritisBiological: ALX-0061AblynxNot recruiting18 Years74 YearsAll406Phase 2Belgium;Bulgaria;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Macedonia, The Former Yugoslav Republic of
432NCT02531178July 201511 April 2016A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABBV-257 in Subjects With Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABBV-257Rheumatoid ArthritisBiological: ABBV-257;Biological: PlaceboAbbVieNot recruiting18 Years75 YearsBoth8Phase 1Germany
433NCT02598466July 201515 February 2016Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South AfricaPatient-Reported Efficacy of Subcutaneous Abatacept in Rheumatoid Arthritis: An Evaluation Of Patients In a Compassionate Use Programme in South AfricaRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbHexor, South AfricaNot recruiting18 YearsN/ABoth69N/A
434NCT02480153June 25, 20154 February 2019A 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 METHOTREXATERheumatoid ArthritisBiological: PF-06410293;Biological: AdalimumabPfizerNot recruiting18 YearsN/AAll597Phase 3United States;Australia;Brazil;Bulgaria;Colombia;Czechia;Estonia;Georgia;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Russian Federation;Serbia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Canada;Czech Republic
435EUCTR2014-003453-34-EE18/06/201529 January 2018Study 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INN not available
CAS Number: 1638332-55-4
Current Sponsor code: GSK3196165
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		GlaxoSmithKline Research & Development LimitedNot RecruitingFemale: yes
Male: yes		210Phase 2Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
436NCT02405780June 10, 20155 March 2018A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis PatientsAn 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 MethotrexateArthritis, RheumatoidDrug: FKB327;Drug: Humira®Fujifilm Kyowa Kirin Biologics Co., Ltd.Not recruiting18 YearsN/AAll645Phase 3United States;Canada;Chile;Czechia;Germany;Peru;Poland;Romania;Russian Federation;Spain;Ukraine;Bulgaria;Czech Republic
437EUCTR2015-000538-31-DE01/06/20154 August 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 jointchronic 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Morphinsulfat
Other descriptive name: MORPHINE SULFATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: Triam 40 mg Lichtenstein
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: TRIAMCINOLONACETONID
Other descriptive name: TRIAMCINOLONACETONID EP
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-		Charité University medicine BerlinAuthorisedFemale: yes
Male: yes		Germany
438NCT02402686May 20, 201511 November 2019Non-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 RocheNot recruiting18 YearsN/AAll353N/AHungary
439EUCTR2014-004904-31-NL19/05/20155 September 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)
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion		Mundipharma Pharmaceuticals B.V.AuthorisedFemale: yes
Male: yes		Phase 4Netherlands
440JPRN-UMIN0000174402015/05/187 October 2019In 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 studyRheumatoid 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 University the department of allergy and clinical immunologyNot Recruiting18years-old90years-oldMale and Female134Phase 4Japan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
441EUCTR2014-000110-61-CZ11/05/201519 February 2018Study 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-OLERheumatoid 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: FKB327
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration number: 50-
Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Product Code: FKB327 AI
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: FKB327
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration number: 50-		Fujifilm Kyowa Kirin Biologics Co., Ltd.Not RecruitingFemale: yes
Male: yes		680Phase 3Bulgaria;Germany;United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru
442EUCTR2014-003034-42-HU08/05/201510 September 2018An 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-0061Rheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not available
CAS Number: 1628814-88-9
Other descriptive name: ALX-0061
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-		Ablynx NVNot 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
443EUCTR2014-005418-45-SE04/05/201522 May 2017Are 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) - HCQCVDRASLERheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Plaquenil
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: HYDROXYCHLOROQUINE
CAS Number: 118-42-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-		Christine BengtssonSolveig Wållberg-JonssonNot RecruitingFemale: yes
Male: yes		Phase 2Sweden
444NCT02404558May 201511 April 2016Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid ArthritisAn Open-label, Randomized, Parallel Group, Single-dose Study to Describe the Safety of IL-6 Receptor Blockade With Sarilumab or Tocilizumab Monotherapy in Japanese Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: sarilumab SAR153191 (REGN88);Drug: tocilizumabSanofiRegeneron PharmaceuticalsNot recruiting20 YearsN/ABoth30Phase 1Japan
445NCT02456844May 20158 February 2016Study to Investigate the Effect of BMS-986142 on the Pharmacokinetics (PK) of Methotrexate and Probe Substrate Cocktail in Healthy PatientsEffects of BMS-986142 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates Montelukast (CYP2C8), Flurbiprofen (CYP2C9), Midazolam (CYP3A4), Digoxin (P-gp), and Pravastatin (OATP1B1) in Healthy SubjectsRheumatoid ArthritisDrug: Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142;Drug: Methotrexate, Leucovorin and BMS-986142Bristol-Myers SquibbNot recruiting18 Years50 YearsBoth24Phase 1
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
446NCT02460393May 20158 January 2018A Trial With Humanized TNFa Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy SubjectsA Randomized, Double Blind, Placebo Controlled Trial With Humanized TNFa Monoclonal Antibody Injection by Single Dose and Dose Escalation to Explore the Tolerance, Safety and Pharmacokinetic Characteristics in Healthy SubjectsRheumatoid ArthritisDrug: Humanized TNFa monoclonal antibody;Other: placeboShenyang Sunshine Pharmaceutical Co., LTD.Not recruiting18 Years45 YearsAll72Phase 1China
447NCT02566967May 201515 July 2019An 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, MDNot recruiting18 YearsN/AAll20Phase 3United States
448EUCTR2014-003307-30-HU16/04/201522 May 2017Multiple 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 ArthritisRheumatoid 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
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Bimekizumab
CAS Number: 1418205-77-2
Current Sponsor code: UCB4940
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Cimzia
Product Name: Cimzia
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-		UCB Celltech, UK Registered Branch of UCB Pharma SANot RecruitingFemale: yes
Male: yes		180Phase 2Czech Republic;Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Moldova, Republic of
449NCT02387762April 20158 April 2019ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background MethotrexateA Phase 2a, 4-Week, Double-Blind, Proof-of-Concept Efficacy and Safety Study of ACP-196 Versus Placebo in Subjects With Active Rheumatoid Arthritis on Background MethotrexateRheumatoid ArthritisDrug: acalabrutinib;Drug: PlaceboAcerta Pharma BVNot recruiting18 Years75 YearsAll31Phase 2United States
450NCT02423538April 20151 February 2016First-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.Not recruiting18 Years45 YearsBoth64Phase 1China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
451NCT02499315April 201517 May 2016Study to Evaluate the Safety, Tolerability, and Action of AMG 357 in Females With Rheumatoid ArthritisA Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 357 in Female Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: AMG 357;Drug: PlaceboAmgenNot recruiting25 Years70 YearsFemale32Phase 1United States
452NCT02800811April 20158 August 2016Safety, Tolerability, PK, PD, and Immunogenicity of Single and Multiple Ascending Intravenous Doses of FR104Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Intravenous Doses of FR104 in Healthy SubjectsRheumatoid Arthritis;Complication of TransplantDrug: FR104;Drug: PlaceboOSE ImmunotherapeuticsNot recruiting18 Years60 YearsBoth64Phase 1Belgium
453ChiCTR-IPR-150061072015-03-3018 April 2017The clinical trial of tolerance of Ginsenoside compound KTo study the pharmacokinetics and tolerance of Ginsenoside compound K tablet in healthy volunteers after multiple dosing administrationrheumatoid arthritisthree groups:Ginsenoside compound K is administrated after single dose or multiple doses;Institute of Clinical Pharmacology, Central South UniversityNot Recruiting1845Malethree groups:12;Phase 1 studyChina
454JPRN-UMIN0000169502015/03/272 April 2019Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abataceptrheumatoid arthritisInfliximab or adalimumab or golimumabOsaka Medical CollegeNot Recruiting20years-oldNot applicableMale and Female50Not selectedJapan
455EUCTR2015-000089-72-IT26/03/201519 February 2018abatacept in obese and overweight RA patiensFAT GENE EXPRESSION IN OVERWEIGHT AND OBESE PATIENTS WITH PERSISTENTLY ACTIVE RHEUMATOID ARTHRITIS TREATED WITH ABATACEPT AND CLINICAL RESPONSEMedDRA 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
Pharmaceutical Form: Solution for injection		Policlinico Gemelli-CIC- UCSCNot RecruitingFemale: yes
Male: yes		40Phase 4Italy
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
456NCT02486302March 24, 20155 February 2018A 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: EtanerceptPfizerNot recruiting18 YearsN/AAll1535N/AGermany
457EUCTR2014-001471-31-HU23/03/201513 June 2016This 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
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: na
Other descriptive name: ABT-122
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Product Name: ABT-122
Product Code: ABT-122
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: na
Other descriptive name: ABT-122
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-		AbbVie Deutschland GmbH & Co. KGNot RecruitingFemale: yes
Male: yes		160Phase 2Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;New Zealand
458EUCTR2014-003033-26-BE23/03/201512 September 2016A 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 TherapyRheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not available
Other descriptive name: ALX-0061
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Ablynx NVNot 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
459EUCTR2014-004419-35-GB18/03/201517 August 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: 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: Abatacept
Product Name: Abatacept
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Abatacept
CAS Number: 332348-12-6
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 125-		Greater Glasgow Health BoardUniversity of GlasgowAuthorisedFemale: yes
Male: yes		25United Kingdom
460EUCTR2013-005524-42-NL10/03/201528 November 2016STAtins 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
Pharmaceutical Form: Tablet
INN or Proposed INN: ATORVASTATIN
CAS Number: 134523-00-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		ReadeAuthorisedFemale: yes
Male: yes		Phase 4Netherlands
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
461NCT02304354March 9, 20157 October 2019Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis (LYRITUX)Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis (LYRITUX)Rheumatoid ArthritisDrug: RituximabUniversity Hospital, ToursNot recruiting18 YearsN/AAll70Phase 3France
462JPRN-UMIN0000154332015/03/012 April 2019Safety study of methotrexate low-dose once daily administration in rheumatoid arthritis patientsrheumatoid arthritismethotrexateDepartment of Medical Pharmaceutics , Graduate School of Medicine and Pharmaceutical Sciences for Research, University of ToyamaRecruiting20years-oldNot applicableMale and Female35Not selectedJapan
463NCT02287922March 201526 August 2019A 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 InappropriateRheumatoid ArthritisBiological: ALX-0061;Biological: Placebo;Biological: TocilizumabAblynxNot recruiting18 Years74 YearsAll251Phase 2United States;Belgium;Bulgaria;Czechia;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Czech Republic;Macedonia, The Former Yugoslav Republic of
464NCT02353780March 201511 June 2019Mechanistic Studies of B- and T-Cell Function in RA Patients Treated With TNF Antagonists, Tocilizumab, or AbataceptMechanistic Studies of B- and T-Cell Function in Rheumatoid Arthritis Patients Treated With TNF Antagonists, Tocilizumab, or AbataceptRheumatoid Arthritis (RA)Drug: TNF Antagonist (enbrel, humire, remicade, cimzia, symponi);Drug: Abatacept;Drug: TocilizumabDr. Larry W. MorelandGenentech, Inc.;Bristol-Myers SquibbNot recruiting18 Years64 YearsAll10Phase 4United States
465NCT02414984March 201516 December 2017Registry for Analysis of Compliance in Colombian Participants With Rheumatoid Arthritis Exposed to GolimumabRegistry of Patients With Rheumatoid Arthritis Exposed to Golimumab (Go-Compl-Ar): Review and Analysis of Compliance in ColombiaRheumatoid ArthritisBiological: GolimumabJanssen-Cilag, S.A.Not recruiting18 YearsN/AAll37N/AColombia
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
466NCT02620189March 201514 December 2015Th17 Responses Evaluated in RA Patients on Inhibitors of TNFaA Study to Investigate the Role of IL-17 and Th17 Pathway Activation in RA Patients With Inadequate Response to Anti-TNFa TherapiesRheumatoid ArthritisDrug: Anti-TNF Biologics TherapyQueen Mary University of LondonRecruiting18 YearsN/ABoth50N/AUnited Kingdom
467NCT02638259February 21, 20151 October 2018Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid ArthritisA Randomized, Double-blind, Parallel-group Phase III Study to Demonstrate Equivalent Efficacy and to Compare Safety & Immunogenicity of GP2015 and Enbrel® (EU Authorized) in Patients With Moderate to Severe, Active Rheumatoid ArthritisRheumatoid ArthritisDrug: GP2015SandozNot recruiting18 YearsN/AAll376Phase 3United States;Bulgaria;Czechia;Estonia;Germany;Hungary;Italy;Latvia;Lithuania;Mexico;Poland;Russian Federation;Serbia;Slovakia;Spain;United Kingdom;Czech Republic
468NCT02373813February 20, 20154 November 2019Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis RemissionA Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: etanercept pre-filled syringe sq injection;Drug: Oral methotrexate;Drug: Placebo for etanercept sq injection;Drug: Placebo for methotrexateAmgenNot recruiting18 YearsN/AAll371Phase 3United States;Argentina;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Italy;Mexico;Poland;Portugal;South Africa;Spain;Czech Republic
469EUCTR2014-002945-23-GB18/02/201511 April 2016A 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: namilumab
CAS Number: 1206681-39-1
Current Sponsor code: MT203
Other descriptive name: NAMILUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-		Takeda Development Centre Europe Ltd.Not RecruitingFemale: yes
Male: yes		36Phase 2Estonia;Czech Republic;Spain;Russian Federation;United Kingdom
470EUCTR2013-005418-37-DE05/02/201529 January 2018A multicenter, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate.A multicenter, randomized, double-blind, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 (Dekavil) administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate.Patients with active Rheumatoid Arthritis despite methotrexate therapy that had unsuccessful response to at least one anti-TNF treatment.
MedDRA version: 17.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Product Name: Dekavil
Product Code: F8IL10
Pharmaceutical Form: Solution for injection
INN or Proposed INN: dekavil
Current Sponsor code: F8IL10
Other descriptive name: F8IL10
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 3.75-20
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Philogen S.p.A.AuthorisedFemale: yes
Male: yes		87Phase 2Germany;Italy;Switzerland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
471EUCTR2013-004569-16-HU03/02/20158 August 2016A 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 ArthritisRheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Etanercept
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		Pfizer Inc., 235 East 42nd Street, New York, NY 10017Not RecruitingFemale: yes
Male: yes		180Phase 3Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany
472JPRN-JapicCTI-15297901/2/20152 April 2019Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA)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)Rheumatoid ArthritisIntervention name : Namilumab
Dosage And administration of the intervention : Namilumab 20 mg, 80 mg or 150 mg subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24 and a stable dose of methotrexate (15-25 mg weekly, 6-16 mg weekly in Japan), and folic acid (at least 5 mg/week), orally, throughout the duration of the study.
Control intervention name : Placebo
Dosage And administration of the control intervention : Namilumab placebo-matching SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24 and a stable dose of methotrexate (15-25 mg weekly, 6-16 mg weekly in Japan), and folic acid (at least 5 mg/week), orally, throughout the duration of the study.		TAKEDA PHARMACEUTICAL COMPANY LTD.20BOTH108Phase 2
473NCT02332590February 201528 October 2019Efficacy 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 PharmaceuticalsNot 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
474NCT02357069February 201518 January 2016A 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.Not recruiting20 Years75 YearsBoth372Phase 3Japan;Korea, Republic of
475NCT02373202February 20159 January 2017A 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 SAR153191 (REGN88);Drug: non-MTX DMARDs (e.g. sulfasalazine, leflunomide, bucillamine, tacrolimus, or mizoribin);Drug: sulfasalazine;Drug: leflunomide;Drug: bucillamine;Drug: tacrolimus;Drug: mizoribinSanofiRegeneron PharmaceuticalsNot recruiting20 YearsN/ABoth91Phase 3Japan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
476NCT02390700February 201528 November 2016Observational Study of Golimumab Intravenous InfusionGolimumab Intravenous Infusion Registry (GO-IV)Rheumatoid ArthritisBiological: Golimumab IntravenousJanssen Inc.Not recruiting18 YearsN/ABoth78Phase 4Canada
477NCT02466581February 201518 December 2018Dose 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 InstitutetRecruiting18 YearsN/AAll500Phase 4Sweden
478NCT02633332February 201528 December 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 & NaturaNot recruiting18 Years75 YearsBoth15Phase 1Italy
479EUCTR2014-002541-22-CZ26/01/20159 January 2017Efficacy 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-MONARCHRheumatoid 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)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Sarilumab
Current Sponsor code: SAR153191
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Humira, 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Sarilumab
Current Sponsor code: SAR153191
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-		sanofi-aventis recherche & développementNot RecruitingFemale: yes
Male: yes		540Phase 3United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Puerto Rico;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
480EUCTR2014-000109-11-DE22/01/201516 August 2016Study 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. - ARABESCRheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: FKB327
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		Fujifilm Kyowa Kirin Biologics Co., Ltd.Not RecruitingFemale: yes
Male: yes		730Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
481EUCTR2014-003255-54-CZ21/01/201511 June 2018A 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 PatientsRheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: RGB-03
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: MabThera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-		Gedeon Richter PlcNot RecruitingFemale: yes
Male: yes		142Phase 1;Phase 3Hungary;Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Romania;Austria;Russian Federation;Israel;Germany
482NCT03719469January 20, 20155 November 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 UniversityNot recruiting18 Years85 YearsAll150N/A
483ChiCTR-IPR-150057872015-01-1518 April 2017The effect of food on the pharmacokinetics of Ginsenoside C-KTo study the effect of food on pharmacokinetics of Ginsenoside C-K tablet in healthy volunteersrheumatoid arthritisTwo groups:Ginsenoside compound K is administrated after taking food versus fasting;Institute of Clinical Pharmacology, Central South UniversityNot Recruiting1845BothTwo groups:24;Phase 1 studyChina
484NCT02309359January 201526 August 2019A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With 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 TherapyRheumatoid ArthritisBiological: ALX-0061;Other: Placebo;Drug: MethotrexateAblynxNot recruiting18 Years74 YearsAll345Phase 2United States;Belgium;Bulgaria;Czechia;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Czech Republic;Macedonia, The Former Yugoslav Republic of
485NCT02371096January 20152 March 2015Comparative Pharmacokinetic Trial of RGB-03 and MabTheraRheumatoid ArthritisDrug: MabThera (rituximab);Drug: RGB-03Gedeon Richter Plc.Not recruiting18 Years75 YearsBothPhase 1
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
486NCT02744196January 20155 February 2018Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC BIOCAD) With Methotrexate in First Line Biological Therapy of Patients With Active Rheumatoid ArthritisMulticenter Comparative Randomised Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC BIOCAD) With Methotrexate in First Line of Biological Therapy of Patients With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: Acellbia;Drug: Placebo;Drug: MethotrexateBiocadNot recruiting18 Years80 YearsAll159Phase 3
487NCT02837978January 201525 February 2019The Clinical Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months TreatmentProspective Clinical Study to Observe the Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months Treatment in ChinaArthritis, RheumatoidDrug: Tacrolimus;Drug: MTXQiang ShuRecruiting18 Years80 YearsAll100Phase 4China
488NCT02927535January 201517 October 2016Evaluation of TNFa Blockers Monotherapy in Early Rheumatoid Arthritis in FranceRheumatoid ArthritisDrug: TNF blockers monotherapyCentre Hospitalier Universitaire de NimesPfizer;PfizerNot recruiting18 Years70 YearsBoth813N/A
489EUCTR2015-002466-22-Outside-EU/EEA28 December 2015A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Openlabel Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuiL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid ArthritisA Randomized, Multi-center, Blinded, Placebo-controlled Study With an Open­label Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuiL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid ArthritisJuvenile Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: anakinra
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ANAKINRA
CAS Number: 143090-92-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Amgen IncNot AvailableFemale: yes
Male: yes		90United States;Australia;Canada;Costa Rica;New Zealand
490JPRN-UMIN0000126502014/12/312 April 2019In 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 CollegeRecruiting20years-old90years-oldMale and Female60Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
491EUCTR2014-003529-16-GB16/12/20144 December 2018Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification of Biologic Therapies for RA by Pathobiology (STRAP): A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAPRheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: RoActmera
Product Name: RoActmera
Pharmaceutical Form: Solution for injection
Trade Name: Enbrel
Product Name: Enbrel
Pharmaceutical Form: Solution for injection in pre-filled pen		Joint Research & Development Office (QMUL)AuthorisedFemale: yes
Male: yes		219Phase 3United Kingdom
492JPRN-UMIN0000206632014/12/162 April 2019A 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 scienceNot Recruiting20years-oldNot applicableMale and Female20Not applicableJapan
493JPRN-UMIN0000157942014/12/152 April 2019Efficacy 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 MedicineNot Recruiting20years-oldNot applicableMale and Female165Phase 4Japan
494NCT02198651December 15, 201427 August 2018A 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) SubjectsA 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;Musculoskeletal and Connective Tissue DiseasesDrug: Adalimumab;Other: PlaceboAbbVieNot recruiting18 Years99 YearsAll149Phase 4United States;Australia;Austria;Canada;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom
495EUCTR2014-000993-20-SE04/12/20145 February 2018Dosing of glucocorticoid (triamcinolone hexacetonid) when injecting knee joints of rheumatic diseasesDosing of intraarticular triamcinolone hexacetonid for knee synovitis in chronic polyarthritisPsoriatic 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
Pharmaceutical Form: Injection
Trade Name: triamcinolone hexacetonide (Lederspan)
Product Name: triamcinolone hexacetonid (Lederspan)
Product Code: 9512
Pharmaceutical Form: Injection		Center for Research and Development Uppsala University/County Council of GävleborgNot RecruitingFemale: yes
Male: yes		160Phase 4Sweden
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
496ChiCTR18000148462014-12-0112 February 2018Effect of preemptive analgesia with parecoxib sodium on multimodal analgesia in primary unilateral total hip arthroplastyEffect of preemptive analgesia with parecoxib sodium on multimodal analgesia in primary unilateral total hip arthroplasty: A prospective randomized double-blind controlled trialosteonecrosis of the femoral head, femoral neck fracture, developmental dysplasia of hip, osteoarthritis, rheumatoid arthritis or ankylosing spondylitisExperiment group:preoperative intravenous parecoxib sodium and postoperative intravenous parecoxib sodium and patient-controlled analgesia;Control Group:preoperative intravenous pure 0.9% saline and postoperative intravenous parecoxib sodium and patient-controlled analgesia;Peking Union Medical College HospitalNot RecruitingBothExperiment group:50;Control Group:50;Post-marketChina
497NCT02260791December 201416 December 2017A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis PatientsA Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on MethotrexateArthritis, RheumatoidDrug: FKB327;Drug: Humira®Fujifilm Kyowa Kirin Biologics Co., Ltd.Not recruiting18 YearsN/AAll728Phase 3United States;Bulgaria;Canada;Chile;Czechia;Germany;Peru;Poland;Romania;Russian Federation;Spain;Ukraine;Czech Republic;Serbia
498NCT02328027December 201411 June 201899mTc-rhAnnexin V-128 a Phase I/IIa Study in Patients With Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS)A Phase I-IIa Study of Safety, Tolerance, Pharmacokinetics, Dosimetry and Benefice of Early Nuclear Medicine Imaging of 99mTc-rhAnnexin V-128 in Patients With Rheumatoid Arthritis or Ankylosing SpondylitisRheumatoid Arthritis;Ankylosing SpondylitisDrug: 99mTc-rhAnnexin V-128Advanced Accelerator ApplicationsNot recruiting18 YearsN/AAll16Phase 1/Phase 2Switzerland
499NCT02876874December 201429 August 2016Relationship 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 MedicineRecruiting18 Years65 YearsBoth21N/AChina
500EUCTR2014-001114-26-GB25/11/201428 February 2019A 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		AbbVie Deutschland GmbH & Co. KGNot Recruiting Female: yes
Male: yes		150Phase 4United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
501EUCTR2014-002374-36-SE19/11/20141 December 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-STARRheumatoid 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
Pharmaceutical Form: Injection
Trade Name: Orencia
Pharmaceutical Form: Solution for infusion in pre-filled syringe
Trade Name: RoActemra
Pharmaceutical Form: Infusion
Trade Name: Methotrexate
Pharmaceutical Form: Tablet
Trade Name: Metoject
Pharmaceutical Form:
Trade Name: Azathioprine
Pharmaceutical Form: Tablet
Trade Name: Leflunomide
Pharmaceutical Form: Tablet		The Karolinska Institutet, ClinTRIDAuthorisedFemale: yes
Male: yes		500Phase 4Sweden
502NCT02281552November 18, 201416 December 2017A 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: TofacitinibPfizerNot recruiting20 YearsN/AAll209Phase 3Japan
503JPRN-UMIN0000156162014/11/042 April 2019Biologic MateR clinical performance test for ADA and TCZ Efficacy predictionrheumatoid arthritisAdalimumab plus Methotrexate
Tocilizumab plus Methotrexate		Biologic Mate Study GroupNot Recruiting20years-old75years-oldMale and Female300Not selectedJapan
504NCT02030028November 201418 March 2019ACTH 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 gelDr. Larry W. MorelandMallinckrodtRecruiting18 Years100 YearsAll20N/AUnited States
505NCT02287610November 201416 December 2017A 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 IrelandNot recruiting18 YearsN/AAll75N/A
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
506NCT02293902November 20149 January 2017A 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;Drug: methotrexate;Drug: folic acidSanofiRegeneron PharmaceuticalsNot recruiting20 Years75 YearsBoth243Phase 3Japan
507NCT02296775November 201419 February 2015Comparative 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 LimitedRecruiting18 Years65 YearsBoth276Phase 1/Phase 2India;Ukraine
508NCT02342977November 20145 September 2016Effects 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 DevelopmentNot recruiting18 Years70 YearsBoth0Phase 2United States
509NCT02551575November 201427 June 2016Efficacy 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 SciencesNot recruiting18 Years65 YearsBoth468Phase 2/Phase 3China
510EUCTR2014-000352-29-CZ27/10/20148 January 2018A 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 METHOTREXATERHEUMATOID 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Current Sponsor code: PF-06410293
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: HUMIRA
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB-EU
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Product Name: Adalimumab-Pfizer
Product Code: PR-06410293
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: ADALIMUMAB
Current Sponsor code: PF-06410293
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		Pfizer Inc.Not 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
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
511EUCTR2014-001299-79-DK06/10/20142 October 2017Pnemococcal vaccination of rheumatoid arthritis patients in biological treatmentPneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy - Immunovax_RAImmunoresponse 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
Pharmaceutical Form: Suspension for injection
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
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30.8-
Trade Name: Pneumovax
Pharmaceutical Form: Suspension for injection
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)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 575-		Department of Infectious Diseases, Odense University HospitalNot RecruitingFemale: yes
Male: yes		Phase 3Denmark
512JPRN-UMIN0000152172014/10/012 April 2019Identification 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 MedicineRecruiting20years-oldNot applicableMale and Female40Not applicableJapan
513JPRN-UMIN0000154622014/10/012 April 2019Clinical 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, JapanRecruiting18years-oldNot applicableMale and Female400Not selectedJapan
514NCT02102594October 201410 December 2018Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)Myasthenia Gravis;Systemic Lupus Erythematosus;Rheumatoid ArthritisDrug: BortezomibCharite University, Berlin, GermanyProf. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology);NeuroCure Clinical Research Center, Charite, BerlinRecruiting18 Years75 YearsAll18Phase 2Germany
515NCT02148640October 201416 December 2017The 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 AuthorityNot recruiting18 YearsN/AAll482Phase 4Norway
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
516NCT02150473October 201416 December 2017The Effect of Adalimumab Plus Methotrexate (MTX) Versus Placebo Plus MTX on Cartilage in (RA) PatientsDelayed Gadolinium-enhanced Magnetic Resonance (MR) Imaging of Cartilage - A Pilot Study to Measure the Effect of Adalimumab Plus MTX Versus Placebo Plus MTX on Cartilage in Early RA PatientsRheumatoid ArthritisDrug: Adalimumab;Drug: PlaceboHeinrich-Heine University, DuesseldorfAbbottNot recruiting18 Years80 YearsAll21Phase 3Germany
517NCT02221258October 201417 October 2016Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis(RA)Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisBiological: FURESTEM-RA Inj.Kang Stem Biotech Co., Ltd.Not recruiting19 Years80 YearsBoth9Phase 1Korea, Republic of
518NCT02265705October 201425 March 2019A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA)A Randomized, Double-Blind, Placebo-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 TherapyRheumatoid ArthritisDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyNot recruiting18 YearsN/AAll290Phase 3Argentina;Brazil;China
519NCT02270632October 20145 December 2016A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTXA Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate Safety and Clinical Efficacy of Two Different Doses of F8IL10 (Dekavil) Administered Subcutaneously to Patients With Active Rheumatoid Arthritis Receiving Methotrexate.Rheumatoid ArthritisDrug: F8IL10;Drug: MTX;Drug: PlaceboPhilogen S.p.A.Recruiting18 Years74 YearsBoth87Phase 2Germany;Italy;Switzerland
520NCT02500498October 20143 August 2015Safety Profile of Nulojix in Home Infusion SettingsSafety Profile of Nulojix in Home Infusion SettingsRheumatoid ArthritisDrug: NulojixBristol-Myers SquibbBiologicTx, LLCNot recruiting18 YearsN/ABoth37N/A
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
521EUCTR2012-002945-40-DE22/09/201414 November 2016BI695501 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 trialRheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: -
CAS Number: -
Current Sponsor code: BI 695501
Other descriptive name: BI 695501
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		Boehringer Ingelheim International GmbHNot 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
522EUCTR2013-005418-37-IT15/09/201423 March 2015A multicenter, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate.A multicenter, randomized, double-blind, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 (Dekavil) administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate.Patients with active Rheumatoid Arthritis despite methotrexate therapy that had unsuccessful response to at least one anti-TNF treatment.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: Dekavil
Product Code: F8IL10
Pharmaceutical Form: Solution for injection
INN or Proposed INN: dekavil
Current Sponsor code: F8IL10
Other descriptive name: F8IL10
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 3.75-20
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Philogen S.p.A.AuthorisedFemale: yes
Male: yes		87Phase 2Germany;Italy
523EUCTR2013-002805-76-CZ11/09/20142 October 2017A 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: namilumab
CAS Number: 1206681-39-1
Current Sponsor code: MT203
Other descriptive name: NAMILUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: Namilumab
Product Code: MT203
Pharmaceutical Form: Solution for injection
INN or Proposed INN: namilumab
CAS Number: 1206681-39-1
Current Sponsor code: MT203
Other descriptive name: NAMILUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: Namilumab
Product Code: MT203
Pharmaceutical Form: Solution for injection
INN or Proposed INN: namilumab
CAS Number: 1206681-39-1
Current Sponsor code: MT203
Other descriptive name: NAMILUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Takeda Development Centre Europe Ltd.Not RecruitingFemale: yes
Male: yes		108Phase 2Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Japan;United Kingdom
524JPRN-UMIN0000146242014/09/012 April 2019Effects 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 TsukubaNot Recruiting20years-oldNot applicableMale and Female120Phase 4Japan
525NCT01717859September 201420 May 2019Musculoskeletal Ultrasound in Predicting Early Dose Titration With TocilizumabMusculoskeletal Ultrasound in Predicting Early Dose Titration With TocilizumabRheumatoid ArthritisDrug: TocilizumabUniversity of California, Los AngelesGenentech, Inc.Not recruiting18 YearsN/AAll74Phase 4United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
526NCT02154425September 201411 June 2018A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating MothersA Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol)Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid ArthritisProcedure: Breast milk sampling;Biological: Certolizumab PegolUCB BIOSCIENCES, Inc.PPD;ParexelNot recruiting18 YearsN/AFemale17Phase 1United States;Netherlands;Switzerland;France
527NCT02246257September 201410 December 2018Early Rheumatoid Arthritis COR InterventionMultifactorial Intervention to Prevent Cardiovascular Disease in Patients With Early Rheumatoid ArthritisRheumatoid Arthritis;Cardiovascular DiseasesOther: Simvastatin;Other: Losartan;Other: Metformin;Other: Outpatient rheumatology department;Other: Refered to general practiceMD, PhD, Annemarie Lyng SvenssonRecruiting18 YearsN/AAll300N/ADenmark
528EUCTR2013-005543-90-HU26/08/20144 December 2018This 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 applicableRheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: rituximab
CAS Number: 1446410-99-6
Current Sponsor code: ABP 798
Other descriptive name: ABP 798 - Biosimilar to rituximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: Rituxan
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Other descriptive name: Rituxan
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: MabThera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Other descriptive name: MabThera
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-		Amgen IncNot RecruitingFemale: yes
Male: yes		300Phase 1;Phase 3United States;Estonia;Hungary;Canada;Poland;Bulgaria;Germany
529NCT02222493August 26, 201411 June 2018A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).A 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 MethotrexateRheumatoid ArthritisBiological: PF-06438179;Biological: InfliximabPfizerNot recruiting18 YearsN/AAll650Phase 3United States;Australia;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Czechia;Georgia;Germany;Guatemala;Hungary;Israel;Japan;Jordan;Korea, Republic of;Lithuania;Mexico;Morocco;Peru;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Tunisia;Ukraine;United Kingdom;Colombia;Czech Republic;France
530NCT02202837August 12, 201416 December 2017Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical PracticeDefining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Rheumatoid Arthritis Patients Treated With Etanercept (Enbrel (Registered))Rheumatoid ArthritisDrug: etanerceptPfizerNot recruiting18 YearsN/AAll135N/ABelgium
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
531NCT02308163August 8, 201415 July 2019A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDsPhase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDsRheumatoid ArthritisDrug: peficitinib;Drug: Placebo;Biological: EtanerceptAstellas Pharma IncNot recruiting20 YearsN/AAll509Phase 3Japan;Korea, Republic of;Taiwan
532ChiCTR-RNC-140048872014-08-0118 April 2017The pharmacogenomics study on Methotrexate in treating rheumatoid arthritisThe pharmacogenomics study on Methotrexate in treating rheumatoid arthritisrheumatoid arthritisCase series:Methotrexate;The people's hospital, Yichun CityRecruiting1865Case series:400;Post-marketChina
533JPRN-UMIN0000147372014/08/012 April 2019The 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 CenterNot Recruiting50years-old90years-oldMale and Female286Not selectedJapan
534NCT02176876August 20143 August 2015Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid ArthritisA Phase 1b, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: GS-5745;Drug: Placebo to match GS-5745Gilead SciencesNot recruiting18 Years70 YearsBoth18Phase 1Czech Republic;Hungary
535NCT02187055August 201416 December 2017An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With MethotrexateA 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 ArthritisRhematoid ArthritisDrug: Tofacitinib with methotrexate;Drug: Tofacitinib without methotrexate;Biological: Adalimumab with methotrexatePfizerNot recruiting18 YearsN/AAll1132Phase 4United States;Argentina;Australia;Bosnia and Herzegovina;Bulgaria;Canada;Chile;Czech Republic;Estonia;France;Israel;Korea, Republic of;Latvia;Lithuania;Mexico;Peru;Philippines;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Thailand;Turkey;United Kingdom;Croatia
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
536NCT02211469August 201428 September 2015A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male SubjectsA Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male SubjectsRheumatoid ArthritisDrug: BMS-986104;Drug: PlaceboBristol-Myers SquibbNot recruiting18 Years49 YearsMale41Phase 1United States
537NCT02219191August 201416 December 2017Puerarin 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 HospitalNot recruiting18 Years75 YearsAll150N/AChina
538NCT02219347August 201416 December 2017Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)Rheumatoid ArthritisDrug: DMARD cessationNewcastle-upon-Tyne Hospitals NHS TrustNewcastle University;Wellcome TrustNot recruiting18 YearsN/AAll74N/AUnited Kingdom
539NCT02234960August 201414 November 2016Local, 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 RocheNot recruiting18 YearsN/ABoth102N/APoland
540NCT02264301August 201416 December 2017Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid ArthritisThe Effect of Qingkailing Injection on Corticosteroids Withdrawal Rate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Puerarin injection 400 mg;Drug: Qingkailing injection 40 mlChengdu PLA General HospitalRecruiting18 Years75 YearsAll150N/AChina
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
541NCT02311855August 201416 December 2017Duration of Immune Response to Influenza Vaccination in Patients With RADuration of Immune Response to Influenza Vaccination in Patients With Rheumatoid Arthritis Receiving Treatment With Biologic AgentsRheumatoid ArthritisBiological: Influenza vaccineBassett HealthcareNew York State Department of HealthNot recruiting40 Years75 YearsAll87Phase 4United States
542NCT02305849July 25, 201415 July 2019A Study to Evaluate Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate (MTX) TreatmentPhase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to MTXRheumatoid ArthritisDrug: Peficitinib;Drug: Placebo;Drug: MethotrexateAstellas Pharma IncNot recruiting20 YearsN/AAll519Phase 3Japan
543EUCTR2013-005362-19-DE17/07/201417 July 2017Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB)Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB) - TAVABMyasthenia Gravis Systemic Lupus Erythematosus Rheumatoid Arthritis ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Velcade®
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BORTEZOMIB
CAS Number: 179324-69-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3,5-		Charité - Universitätsmedizin BerlinAuthorisedFemale: yes
Male: yes		Phase 2Germany
544EUCTR2013-004148-49-LT14/07/20143 July 2017RANDOMIZED 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 METHOTREXATERheumatoid 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
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: PF-06438179
Other descriptive name: Infliximab-Pfizer
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Other descriptive name: Infliximab-EU
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-		Pfizer Inc.Not 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
545JPRN-UMIN0000169282014/07/032 April 2019Targeted Ultrasound in Rheumatoid ArthritisRheumatoid 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 UniversityRecruiting18years-oldNot applicableMale and Female400Not selectedJapan,Europe
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
546JPRN-UMIN0000151752014/07/012 April 2019Head-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 MedicineRecruiting20years-oldNot applicableMale and Female120Not selectedJapan
547NCT02011334July 201414 November 2016A 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 RocheNot recruiting18 YearsN/ABoth285Phase 3Argentina;Brazil;Colombia;Dominican Republic;Mexico;Venezuela;Ecuador;Uruguay
548NCT02053727July 201425 June 2018Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir BackgroundPilot Study to Evaluate Subcutaneous Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background- a Pilot, Double-blind, Placebo-controlled, Randomized, Controlled Trial.Rheumatoid Arthritis;Chronic Hepatitis BDrug: Abatacept;Drug: PlaceboSuzanne KafajaRecruiting18 YearsN/AAll20N/AUnited States
549NCT02141997July 201419 October 2017A 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 MethotrexateRheumatoid ArthritisBiological: adalimumab;Biological: ABT-122AbbVieNot recruiting18 Years99 YearsAll222Phase 2Australia;Bulgaria;Canada;Czech Republic;Germany;Hungary;New Zealand;Poland;Romania;Turkey;United States
550JPRN-UMIN0000143112014/06/242 April 2019Examination of the clinical remission and functional remission in Infliximab using the increase-in-quantity protocol to TNF-alpha inhibitory drug resistance rheumatoid arthritisrheumatoid arthritisThe quantity of Infliximab is increased.Institute of Health Biosciences, The University of Tokushima Graduate SchoolNot Recruiting20years-old75years-oldMale and Female10Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
551ChiCTR-TRC-140048242014-06-2318 April 2017Clinical studies on Ginsenoside C-KStudy on tolerability and pharmacokinetics of Ginsenoside C-K tablet in healthy volunteers after a single doserheumatoid arthritis7 groups:Seven different doses with ginsenoside compound K;Institute of Clinical Pharmacology, Central South UniversityNot Recruiting1845Both7 groups:77;Phase 1 studyChina
552ChiCTR-BOC-160089252014-06-1018 April 2017Circulating Tfh subpopulation in very early rheumatoid arthritisCirculating Bcl-6+ICOS+ Tfh subpopulation correlates with disease activity in very early rheumatoid arthritisRheumatoid ArthritisRA patients:methotrexate;Healthy control (HC) individuals:Nil;The First Hospital, Jilin University, ChangchunNot RecruitingBothRA patients:22;Healthy control (HC) individuals:15;OtherChina
553JPRN-JapicCTI-14262109/6/20142 April 2019CHS-0214 Phase III trialA 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 MethotrexateRheumatoid ArthritisIntervention name : CHS-0214
Dosage And administration of the intervention : subcutaneous injection
Control intervention name : Enbrel
INN of the control intervention : Etanercept
Dosage And administration of the control intervention : subcutaneous injection		DAIICHISANKYO Co.,Ltd.Coherus Biosciences, Inc.20BOTH620Phase 3
554NCT02196558June 9, 201416 December 2017A Phase 1/2 Study of E6011 in Japanese Subjects With Rheumatoid ArthritisA Phase 1/2 Study of Repeated Subcutaneous E6011 Administration in Japanese Subjects With Rheumatoid ArthritisArthritis, RheumatoidDrug: E6011Eisai Co., Ltd.Not recruiting20 Years64 YearsAll37Phase 1/Phase 2Japan
555EUCTR2013-002790-22-HU02/06/201410 July 2015To 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-ONERheumatoid 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)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Sarilumab
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 131.6-
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Sarilumab
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 175-		sanofi-aventis recherche & développementNot RecruitingFemale: yes
Male: yes		120United States;Estonia;Czech Republic;Hungary;Argentina;Poland;Russian Federation;Chile
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
556ChiCTR19000261162014-06-0130 September 2019The efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trialThe efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trialrheumatoid arthritisExperimental group:Prednisone+methotrexate+Hydrochloroquine;control group:placebo+methotrexate+Hydrochloroquine;Central Hospital of JinhuaNot Recruiting2173BothExperimental group:40;control group:40;Phase 4China
557JPRN-UMIN0000135462014/06/012 April 2019The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimusrheumatoid 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 HospitalNot Recruiting16years-old80years-oldMale and Female20Not applicableJapan
558NCT01984268June 20145 September 2016ACTHAR for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to MethotrexateAdenocorticotrophic Hormone for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to MethotrexateRheumatoid ArthritisDrug: ACTHARDartmouth-Hitchcock Medical CenterMallinckrodtRecruiting18 Years70 YearsBoth60Phase 2United States
559NCT02147587June 201411 June 2018A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background MethotrexateA 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 TreatmentRheumatoid ArthritisDrug: Tofacitinib;Drug: PlaceboPfizerNot recruiting50 YearsN/AAll112Phase 2United States;United Kingdom
560NCT02151851June 201420 June 2016A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid ArthritisA Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel Group, Randomized 24-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol (CZP) as Additional Medication to Methotrexate in Chinese Subjects With Active Rheumatoid Arthritis Who Have an Incomplete Response to MethotrexateRheumatoid ArthritisBiological: Certolizumab Pegol;Drug: Methotrexate;Other: PlaceboUCB Pharma SA, BelgiumParexelNot recruiting18 YearsN/ABoth431Phase 3China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
561NCT02202395June 201416 December 2017Hydroxytriptolide in Active Rheumatoid Arthritis Patients With an Inadequate Response to MethotrexateA Radomized, Double-blind, and Placebo-controlled Multicenter Clinical Trial of Hydroxytriptolide, in Active Rheumatoid Arthritis Patients With an Inadequate Response to MethotrexateRheumatoid ArthritisDrug: LTS 0.25mg;Drug: LTS 0.5mg;Drug: LTS 1.0mg;Drug: PlaceboShanghai Pharmaceuticals Holding Co., LtdNot recruiting35 Years65 YearsFemale120Phase 1/Phase 2China
562NCT02277574June 201428 November 2016Assess Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid ArthritisA Randomized, Multi-Dose, Placebo-Controlled, Study of the Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisBiological: AMP-110;Other: PlaceboMedImmune LLCDaiichi Sankyo Co., Ltd.Not recruiting18 Years75 YearsBoth29Phase 1United States
563EUCTR2013-003984-72-LV30/05/201428 February 2019A 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
Pharmaceutical Form: Capsule
INN or Proposed INN: ABT 494
Current Sponsor code: ABT 494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: ABT 494 12mg
Pharmaceutical Form: Capsule
INN or Proposed INN: ABT 494
Current Sponsor code: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use		AbbVie Deutschland GmbH & Co. KGNot Recruiting Female: 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
564EUCTR2013-003413-18-GB13/05/20143 July 2017Arthritis prevention with abataceptArthritis Prevention In the Pre-clinical Phase of RA with Abatacept. - APIPPRAThe 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 injection
Pharmaceutical Form: Solution for infusion in pre-filled syringe
Pharmaceutical form of the placebo: Solution for infusion in pre-filled syringe
Route of administration of the placebo: Subcutaneous use		King’s College LondonGuy's and St. Thomas' NHS Foundation TrustAuthorisedFemale: yes
Male: yes		206Phase 2Netherlands;United Kingdom
565NCT03604406May 8, 20149 September 2019The Immunogenicity and Safety of Zostavax® in Rheumatoid Arthritis Patients Using AbataceptThe Immunogenicity and Safety of Zostavax® in Rheumatoid Arthritis Patients Using AbataceptHerpes Zoster;Inflammatory Disease;Rheumatoid ArthritisBiological: Varicella Zoster Vaccine;Other: Placebo InjectionKevin WinthropUniversity of Alabama at Birmingham;Bristol-Myers SquibbRecruiting50 YearsN/AAll50Phase 2United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
566ChiCTR-TRC-140045202014-05-0118 April 2017To study the signal pathways of Rheumatoid Arthritis Syndrome of Accumulated Dampness and intervention mechanism of Sanhuang Yilong Decoction based the theory that lung, spleen and kidney regulate waterTo study the signal pathways of Rheumatoid Arthritis Syndrome of Accumulated Dampness and intervention mechanism of Sanhuang Yilong Decoction based the theory that lung, spleen and kidney regulate water metabolismrheumatoid arthritistwo:Methotrexate, hydroxychloroquine sulfate pills and NSAIDs in both groups; Sanhuang Yinong decoction will be give in the experimental group;RA patients:NA;General Hospital of Chengdu Military RegionRecruiting4565Bothtwo:240;RA patients:40;Phase 1 studyChina
567NCT01967316May 201418 April 2016Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-TNF UsersA Pilot Study of the Safety and Effectiveness of the Live Zoster Vaccine in Anti-TNF UsersRheumatoid ArthritisBiological: Herpes Zoster Vaccine;Drug: PlaceboUniversity of Alabama at BirminghamOregon Health and Science UniversityRecruiting50 YearsN/ABoth125Phase 2United States
568NCT02105129May 20149 May 2016A Study of the Safety, Tolerability and Pharmacokinetics of HMPL-523A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL-523Rheumatoid Arthritis (RA)Drug: HMPL-523;Drug: PlaceboHutchison Medipharma LimitedNot recruiting18 Years45 YearsMale118Phase 1Australia
569NCT02115750May 201417 October 2016Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With MethotrexateRheumatoid ArthritisDrug: Etanercept;Drug: CHS-0214Coherus Biosciences, Inc.Daiichi Sankyo Co., Ltd.;Daiichi Sankyo Co., Ltd.Not recruiting18 YearsN/ABoth647Phase 3United States;Belarus;France;Germany;Hungary;Israel;Japan;Poland;Russian Federation;South Africa;Spain;United Kingdom
570NCT02123264May 20144 March 2019Zoledronic Acid in Rheumatoid ArthritisRandomized Clinical Trial on the Prevention of Radiographic Progression With Zoledronic Acid in Patients With Early Rheumatoid Arthritis and Low Disease ActivityArthritis, RheumatoidDrug: Zoledronic acidCarmen Gómez-VaqueroNot recruiting18 YearsN/AAll28Phase 3Spain
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
571NCT02151474May 201419 February 2015INCB047986 in Rheumatoid ArthritisA Double-Blind, Placebo-Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28-Day Course of INCB047986 in Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: INCB047986;Drug: PlaceboIncyte CorporationRecruiting18 YearsN/ABoth60Phase 2United States
572NCT02157012May 201410 December 2018Evaluation of the Condition of Rheumatoid Arthritis After TreatmentEvaluation of the Condition After Xeljanz Treatment in Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: The effectiveness of Xeljanz in rheumatoid arthritis patientsShinshu UniversityShowa Inan General HospitalRecruiting20 Years90 YearsAll100Phase 4Japan
573NCT02167139May 201416 December 2017A 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 ArthritisRheumatoid ArthritisDrug: Humira (adalimumab);Drug: SB5 (proposed biosimilar to adalimumab)Samsung Bioepis Co., Ltd.Not recruiting18 Years75 YearsAll544Phase 3Lithuania;Poland
574NCT02927509May 201417 October 2016Evaluation of Tumour Necrosis Factor Alpha (TNFa) Blockers in Early Rheumatoid Arthritis in FranceRheumatoid ArthritisDrug: TNF alpha blockersCentre Hospitalier Universitaire de NimesPfizer;PfizerNot recruiting18 Years70 YearsBoth813N/A
575EUCTR2013-003177-99-SE11/04/201417 October 2016A 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 ARTHRITISRheumatoid 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tofacitinib
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550-10
Other descriptive name: TOFACITINIB CITRATE CP-690550
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tofacitinib
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550-10
Other descriptive name: TOFACITINIB CITRATE CP-690550
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: Enbrel
Product Name: Etanercept
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		Pfizer Inc. 235 East 42nd Street, New York, 10017AuthorisedFemale: yes
Male: yes		4000Phase 3;Phase 4Portugal;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
576EUCTR2013-003493-27-HU08/04/201414 April 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 to investigate the safety, tolerability and efficacy of orally administered QAL964 in patients with active rheumatoid arthritis on stable doses of methotrexate and with inadequate response to methotrexate - CQAL964B2201Rheumatoid 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
Pharmaceutical Form: Capsule
Current Sponsor code: QAL964
Other descriptive name: QAL964
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 10-25
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use		Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes		42Hungary;Ukraine;Russian Federation
577EUCTR2013-005013-13-LT08/04/201416 November 2015A 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 TherapySubjects 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: SB5
Other descriptive name: SB5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Humira®
Product Name: Humira®
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: not applicable
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		Samsung Bioepis Co., Ltd.Not RecruitingFemale: yes
Male: yes		490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
578EUCTR2013-004555-21-AT07/04/201429 May 2017This 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 ArthritisRheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade Name: MabThera
Product Name: MabThera
Product Code: L01XC02
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade Name: Rituxan
Product Name: Rituxan
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-		CELLTRION, Inc.Not 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
579NCT02019472April 4, 201416 December 2017A 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 Sirukumab Monotherapy Compared With HUMIRA® Monotherapy Administered Subcutaneously, in Subjects With Active Rheumatoid ArthritisArthritis, RheumatoidBiological: adalimumab 40 mg;Biological: sirukumab 100 mg;Biological: sirukumab 50 mg;Drug: PlaceboJanssen Research & Development, LLCGlaxoSmithKlineNot recruiting18 YearsN/AAll559Phase 3United States;Bulgaria;Chile;Colombia;Germany;Hungary;Lithuania;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Ukraine;Argentina;Peru
580JPRN-UMIN0000134402014/04/012 April 2019To evaluate the efficacy and safety of subcutaneous and intravenous abatacept.Rheumatoid arthritisSC abatacept
IV abatacept
Extension of SC abatacept		Osaka Medical CollegeNot Recruiting20years-old80years-oldMale and Female50Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
581NCT02109289April 201416 December 2017Etanercept in Rheumatoid Arthritis and Vascular InflammationPilot Open-label Study of the Effect of Etanercept on Vascular Inflammation in Patients With Active Rheumatoid ArthritisRheumatoid Arthritis;Vascular InflammationDrug: etanerceptInnovaderm Research Inc.Not recruiting18 Years80 YearsAll5Phase 4Canada
582NCT02101073March 31, 201414 January 2019ALX-0061 Phase I Bioavailability Study in Healthy VolunteersA Phase I, Open-Label Study Evaluating the Bioavailability of ALX-0061 After Subcutaneous and Intravenous Administration in Healthy Volunteers.Rheumatoid ArthritisBiological: ALX-0061AblynxNot recruiting18 Years55 YearsAll70Phase 1Netherlands
583EUCTR2010-020992-21-DE25/03/201428 September 2015Comparison 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: masitinib mesylate
CAS Number: 790-299-79-5
Current Sponsor code: AB1010
Other descriptive name: not applicable
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Current Sponsor code: not applicable
Other descriptive name: not applicable
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5 mg-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Masitinib
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: masitinib mesylate
CAS Number: 790-299-79-5
Current Sponsor code: AB1010
Other descriptive name: not applicable
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		AB ScienceNot RecruitingFemale: yes
Male: yes		140Phase 2b/3Serbia;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
584EUCTR2013-005001-31-ES25/03/201419 September 2016Study 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 acidRheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ZOLEDRONIC ACID
CAS Number: 118072-93-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.8-		Dra. Carmen Gómez Vaquero (Servicio de Reumatología del Hospital Universiari de Bellvitge - Idibell)Not RecruitingFemale: yes
Male: yes		Phase 3Spain
585EUCTR2013-003780-65-IT24/03/201418 January 2016Phase 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 inhibitorsRheumatoid Arthritis
MedDRA version: 14.1 Level: LLT Classification code 10066578 Term: Progression of rheumatoid arthritis System Organ Class: 100000004859
MedDRA version: 14.1 Level: LLT 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: CLAZAKIZUMAB
CAS Number: 1236278-28-6
Current Sponsor code: BMS945429
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Bristol-Myers Squibb International CorporationNot RecruitingFemale: yes
Male: yes		240Phase 2BFrance;United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Australia;South Africa;Japan;Italy
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
586JPRN-UMIN0000133622014/03/152 April 2019Examination of the remission maintenance effect by low dose etanercept after clinical remission in the rheumatoid arthritis.Rheumatoid ArthritisMethotrexate
Etanercept		Takarazuka city hospitalNot Recruiting20years-oldNot applicableMale and Female60Not selectedJapan
587NCT02092467March 14, 201414 October 2019Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid ArthritisPHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITISArthritis, RheumatoidDrug: tofacitinib;Biological: adalimumab;Biological: etanerceptPfizerNot recruiting50 YearsN/AAll4414Phase 4United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;China;Colombia;Czechia;Finland;Hong Kong;Israel;Jordan;Lebanon;Malaysia;Mexico;Netherlands;New Zealand;Peru;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Czech Republic;Sweden
588EUCTR2013-004555-21-LV03/03/201422 May 2017This 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 ArthritisRheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade Name: MabThera
Product Name: MabThera
Product Code: L01XC02
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade Name: Rituxan
Product Name: Rituxan
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-		CELLTRION, Inc.Not 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
589NCT02029599March 201419 October 2015The Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid ArthritisA Phase 2 Randomised, Double-blind, Placebo-controlled Multiple Ascending Dose Study Evaluate the Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: Fang yi qing feng shi granule;Drug: placebo;Drug: Methotrexate;Drug: Acetaminophen tabletsMaoxiang Group Jilin Pharmaceutical Co., Ltd.Not recruiting18 Years65 YearsBoth240Phase 2China
590NCT02057250March 201416 December 2017To 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 TherapyRADrug: Sarilumab;Device: Auto-Injector Device (AID);Device: Pre-filled Syringe (PFS);Drug: Methotrexate;Drug: Sulfasalazine;Drug: Leflunomide;Drug: HydroxychloroquineSanofiRegeneron PharmaceuticalsNot recruiting18 YearsN/AAll217Phase 3United States;Chile;Mexico;Poland;Russian Federation;South Africa;France
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
591NCT02066389March 201427 June 2016A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate (MTX) in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX AloneA 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 AloneRheumatoid ArthritisDrug: ABT-494;Drug: PlaceboAbbVieNot recruiting18 Years100 YearsBoth300Phase 2United States;Bulgaria;Chile;Czech Republic;Hungary;Israel;Latvia;Mexico;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Turkey;Ukraine;Romania;Serbia
592NCT02097524March 201425 May 2015Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: Sarilumab;Drug: TocilizumabRegeneron PharmaceuticalsSanofiNot recruiting18 YearsN/ABoth105Phase 1United States
593EUCTR2013-004051-20-ES26/02/20146 November 2018NOT 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 MONOTHERAPYRHEUMATOID ARTHRITIS;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: RoActemra 20 mg/ml concentrado para solución para perfusión
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: ROACTEMRA
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: up to
Concentration number: 800-		FUNDACIÓN ESPAÑOLA DE REUMATOLOGIANot RecruitingFemale: yes
Male: yes		122Phase 4Spain
594NCT02065700February 25, 201422 July 2019Long-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: FilgotinibGilead SciencesGalapagos NVNot 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
595EUCTR2013-004654-13-CZ12/02/201428 November 2016The 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 ArthritisModerate 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: N/A
CAS Number: 1446410-95-2
Current Sponsor code: ABP 501
Other descriptive name: ABP 501
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		Amgen Inc.Not RecruitingFemale: yes
Male: yes		425Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
596EUCTR2013-002007-34-FI10/02/201410 October 2016Safety 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. - TOZULTRARheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 180-		Roche a/sNot RecruitingFemale: yes
Male: yes		137Phase 3Finland;Denmark;Sweden
597JPRN-UMIN0000168442014/02/072 April 2019The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF InhibitorsRheumatoid arthritisinfliximab: standard strategy
infliximab: aggressive strategy
golimumab: standard strategy
golimumab: aggressive strategy		Takarazuka city hospitalRecruiting20years-old90years-oldMale and Female80Not applicableJapan
598JPRN-JapicCTI-14250501/2/20142 April 2019Phase III study of MRA-SC 162 mg/weekA Randomized, Double-blind, Parallel-group, Phase III Study of MRA-SC in Rheumatoid Arthritis Patients with Inadequate Response to Tocilizumab Subcutaneous Injection 162 mg every 2 weeksRheumatoid arthritisIntervention name : MRA-SC
INN of the intervention : tocilizumab
Dosage And administration of the intervention : 162 mg QW
Control intervention name : MRA-SC
INN of the control intervention : tocilizumab
Dosage And administration of the control intervention : 162 mg Q2W		Chugai Pharmaceutical Co., Ltd.20BOTH50Phase 3
599NCT02001987February 201414 November 2016A Study Of RoActemra/Actemra (Tocilizumab) in Tocilizumab-Naive Patients With Rheumatoid Arthritis With Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) or Biologic TherapyA Multicenter 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 [RoActemra/Actemra]Hoffmann-La RocheNot recruiting18 YearsN/ABoth139Phase 3France
600NCT02078375February 201423 April 2019The PRESS RA: Protein and Resistance Exercise Supplementation Study for Rheumatoid ArthritisThe PRESS RA Study: Protein and Resistance Exercise Supplementation Study for Rheumatoid ArthritisRheumatoid ArthritisDietary Supplement: Protein;Dietary Supplement: Carbohydrate (Placebo);Other: Resistance Exercise ProgramJohns Hopkins UniversityNational Institute on Aging (NIA);American College of Rheumatology Research and Education FoundationNot recruiting60 Years95 YearsAll23N/AUnited States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
601NCT02173587February 201419 February 2015Study 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 HospitalNot recruiting18 Years75 YearsBoth56N/AChina
602NCT02434757February 201411 May 2015Addition of H.P. Acthar Gel to Treatment Regimen of Patients With Rheumatoid ArthritisAddition of H. P Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis Inadequately Controlled With Biologic Disease-Modifying Antirheumatic DrugsRheumatoid ArthritisDrug: H.P. Acthar GelRonald J. Rapoport, MDQuestcor Pharmaceuticals, Inc.Recruiting18 YearsN/ABoth10N/AUnited States
603NCT02169544January 31, 201416 December 2017Post-marketing Study Assessing the Long-Term Safety of AbataceptPost-marketing Study Assessing the Long-Term Safety of AbataceptRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbNot recruiting18 YearsN/AAll100000N/A
604NCT02049138January 24, 20144 March 2019An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Rheumatoid Arthritis SubjectsA 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)Rheumatoid ArthritisDrug: ABT-494AbbVieNot recruiting18 Years100 YearsAll494Phase 2United States;Belgium;Bulgaria;Chile;Czechia;Hungary;Israel;Latvia;Mexico;New Zealand;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Australia;Czech Republic
605EUCTR2012-003655-11-BE23/01/201430 April 2018Evaluation 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 arthritisModerately 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: GLPG0634
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: INN - FILGOTINIB
Current Sponsor code: GLPG0634
Other descriptive name: GLPG0634
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Product Name: Filgotinib
Product Code: GS-6034
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Current Sponsor code: GS-6034
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-		Gilead Sciences Inc.AuthorisedFemale: yes
Male: yes		739Phase 2United States;Spain;Guatemala;Ukraine;Austria;Russian Federation;Israel;Chile;Colombia;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
606JPRN-UMIN0000123642014/01/102 April 2019Drug 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 SurgeryNot Recruiting25years-old75years-oldMale and Female31Not applicableJapan
607NCT01988506January 6, 201427 August 2018Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory DiseasesInduction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic ApproachRheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic SclerosisDrug: Interleukin 2Assistance Publique - Hôpitaux de ParisIltoo PharmaRecruiting18 YearsN/AAll132Phase 2France
608JPRN-JapicCTI-14249701/1/20142 April 2019Phase 2b, Rheumatoid Arthritis Dose Ranging Study for Clazakizumab in Subjects who have Experienced an Inadequate Response to TNF inhibitors.A Phase 2b, 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 ArthritisIntervention name : Clazakizumab
Dosage And administration of the intervention : Injection, 1 mg, 5 mg, 25 mg
Control intervention name : null		Bristol-Myers K.K.18BOTH140Phase 2
609NCT01988012January 201416 December 2017A Study of the Efficacy and Safety of Tocilizumab in Adults With Rheumatoid Arthritis.An Open-label, Multicenter Study to Evaluate Disease Activity and Safety of Treatment With Actemra (Tocilizumab) Administered as Subcutaneous Injection in Adult RA Patients.Rheumatoid ArthritisBiological: tocilizumabHoffmann-La RocheNot recruiting18 YearsN/AAll100Phase 3Israel
610NCT02017639January 201418 April 2016Sarilumab Effect on the Pharmacokinetics of SimvastatinA Multi-center, Open-label, 2-treatment, Single-sequence Clinical Study to Evaluate the Effects of a Single 200 mg Subcutaneous Injection of Sarilumab on the Pharmacokinetics of a Single 40 mg Oral Dose of Simvastatin, With Optional 1-year Extension of Open Label Treatment of Sarilumab, in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: sarilumab SAR153191 (REGN88);Drug: simvastatinSanofiRegeneron PharmaceuticalsNot recruiting18 Years75 YearsBoth19Phase 1United States;Korea, Republic of;Moldova, Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
611NCT02019602January 201416 December 2017A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the PlacentaA Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid ArthritisProcedure: Blood sampling from mother;Procedure: Blood sampling from infant;Procedure: Blood sampling from umbilical cord;Biological: Certolizumab PegolUCB BIOSCIENCES, Inc.PPD;ParexelNot recruiting18 YearsN/AAll16Phase 1United States;France;Netherlands;Switzerland
612NCT02031471January 201416 December 2017TOSCARA Study: A Study of Subcutaneous Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis Naïve to RoActemra/Actemra TreatmentTOSCARA: An Open-label, Single Arm Study to Evaluate the Efficacy, Safety and Tolerability of Tocilizumab (TCZ) Subcutaneous in TCZ-naïve Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: tocilizumabHoffmann-La RocheNot recruiting18 YearsN/AAll57Phase 3Belgium;Luxembourg
613EUCTR2014-004558-33-Outside-EU/EEA6 January 2015A Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid ArthritisA Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid ArthritisJuvenile 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: Body processes [G] - Immune system processes [G12]		Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		Abbott Japan Co., Ltd.Not AvailableFemale: yes
Male: yes		25Japan
614JPRN-UMIN0000126902013/12/282 April 2019Study of Actemura Remission induction of RA and Sequential Maintenance of Remission by Reasonable cost TreatmentRheumatoid Arthritistocilizumab+tacrolimus+Bucillamine
tocilizumab		National hospital organization Chiba east national hospital Clinical Research CenterNot Recruiting20years-old99years-oldMale and Female60Not applicableJapan
615EUCTR2013-004006-26-DK18/12/201326 September 2016OPALOptical images for monitoring treatment changes in rheumatoid arthritis – a longitudinal study with RheumascanDetection 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
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
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
CAS Number: 3599-32-4
Other descriptive name: INDOCYANINE GREEN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-		Knowledge Centre for Rheumatology and Back DiseasesNot RecruitingFemale: yes
Male: yes		Phase 4Denmark
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
616EUCTR2013-002150-79-BE16/12/201322 August 2016A 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 - TOSCARARheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-		N.V. Roche S.A.Not RecruitingFemale: yes
Male: yes		60Phase 3Belgium
617JPRN-UMIN0000188162013/12/052 April 2019Study on the relationship between arthritis and sleep disturbanceStudy on the relationship between arthritis and sleep disturbance - Sleep study in arthritisRheumatoid ArthritisTreatment with melatonin-mimetics, ramelteon.
Treatment with biological disease-modifying anti-rheumatic drugs.		Shunichi ShiozawaRheumatic Diseases Center, Kohnan Kakogawa HospitalNot Recruiting20years-oldNot applicableMale and Female200Not applicableJapan
618JPRN-UMIN0000120732013/12/012 April 2019Effects of Subcutaneous Actemura and MTX Blending in RArheumatoid arthritisAdults with active RA (DAS28 >3.2) despite methotrexate prescription were randomly assigned to continue methotrexate with the addition of tocilizumab (MTX+TCZ) 162mg/body every other week for 52 weeks.
Adults with active RA (DAS28 >3.2) despite methotrexate prescription were randomly assigned to switch to tocilizumab (TCZ) 162mg/body every other week for 52 weeks.		Department of Orthopaedic Surgery, Graduate School of Medicine, Osaka City University Medical SchoolNot Recruiting20years-old85years-oldMale and Female100Phase 4Japan
619NCT01668966December 201314 November 2016A Long Term Extension Study of WA19926 (NCT01649804) of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNot recruiting18 YearsN/ABoth24Phase 3Brazil
620NCT02047604December 201316 December 2017(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid ArthritisA Randomized, Double-blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients With Active Rheumatoid Arthritis With Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).Rheumatoid ArthritisDrug: SAN-300;Drug: PlaceboValeant Pharmaceuticals International, Inc.Not recruiting18 Years75 YearsAll41Phase 2United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
621EUCTR2013-000114-38-DE29/11/20134 August 2015A 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Tregalizumab
Current Sponsor code: BT061
Other descriptive name: A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 12.5-
INN or Proposed INN: Tregalizumab
Current Sponsor code: BT061
Other descriptive name: B
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
INN or Proposed INN: Tregalizumab
Current Sponsor code: BT061
Other descriptive name: C
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: Tregalizumab
Current Sponsor code: BT061
Other descriptive name: D
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
INN or Proposed INN: Tregalizumab
Current Sponsor code: BT061
Other descriptive name: E
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Biotest AGNot RecruitingFemale: yes
Male: yes		304Phase 2bSerbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden
622NCT03736044November 25, 201319 November 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 FerraraNot recruiting18 YearsN/AAll48N/A
623EUCTR2013-002777-22-GB14/11/201316 November 2015Targeted Ultrasound in Rheumatoid Arthritis (TURA)Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURARheumatoid 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-		University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular MedicineAuthorisedFemale: yes
Male: yes		310France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom
624EUCTR2013-003658-26-NL13/11/201326 November 2013Individualised treatment strategy based on disease activity for early RA patients in usual clinical practice: The COBRA Cohort StudyTreat-to-target strategy for early RA patients in usual clinical practice: The COBRA Cohort Study - COBRA Cohort StudyEarly Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Methotrexate
Product Name: Methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 10-25
Trade Name: Prednison
Product Name: Prednison
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 10-60
Trade Name: Plaquenil
Product Name: hydroxycholoquine
Pharmaceutical Form: Tablet
INN or Proposed INN: hydroxychloroquine sulfate
CAS Number: 747-36-4
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 400-
Trade Name: Sulfasalazine
Product Name: Sulfasalazine
Pharmaceutical Form: Tablet
INN or Proposed INN: Sulfasalazine
Other descriptive name: SULFASALAZINE
Concentration unit: g gram(s)
Concentration type: up to
Concentration number: 2-		VU University Medical CenterAuthorisedFemale: yes
Male: yes		Netherlands
625JPRN-UMIN0000122572013/11/122 April 2019Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trialosteoarthritis, 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 HospitalNot Recruiting18years-oldNot applicableMale and Female74Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
626EUCTR2013-003486-34-DK04/11/201314 March 2016Treatment of Tenosynovitis among rheumatoid arthritis patientsSystemic versus ultrasound-guided local glucocorticoid treatment, among rheumatoid arthritis patients with tenosynovitis - a randomized double blind study - SULTANMedDRA 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BETAMETHASONE ACIBUTATE
CAS Number: 5534-05-4
Current Sponsor code: Glucocorticoid
Other descriptive name: Binyrebarkhormon
Concentration unit: mg/l milligram(s)/litre
Concentration type: range
Concentration number: 3,5-14
Trade Name: Natriumklorid 9mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SODIUM CHLORIDE
Current Sponsor code: Natriumklorid
Other descriptive name: SODIUM CHLORIDE
Concentration unit: mg/l milligram(s)/litre
Concentration type: range
Concentration number: 4,5-18		Knowledge Centre for Rheumatology and Back DiseasesNot RecruitingFemale: yes
Male: yes		Denmark
627NCT01855789November 201314 November 2016A 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 RocheNot recruiting18 YearsN/ABoth718Phase 3United States
628NCT01951170November 201319 October 2017An 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 RocheNot recruiting18 YearsN/AAll52Phase 3Australia
629NCT01980836November 201319 February 2015Effect 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 CenterNot recruiting18 YearsN/ABoth40Phase 4Israel
630NCT01990157November 201316 December 2017Safety, 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 LLCNot recruiting18 Years65 YearsAll18Phase 1/Phase 2Russian Federation
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
631NCT02005757November 20133 August 2015Efficacy 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 PharmaceuticalRecruiting20 Years80 YearsBoth60Phase 2Korea, Republic of
632NCT02027298November 201316 December 2017Abatacept 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 SquibbNot recruiting18 YearsN/AAll0Phase 2United States
633NCT02254655November 201329 January 2018The 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 HospitalNot recruiting18 Years75 YearsAll119Phase 2China
634NCT02293590November 201320 August 2018RICE: 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 PharmaNot recruiting18 YearsN/AAll43Phase 2Switzerland
635EUCTR2012-004074-25-DE30/10/201323 July 2018Comparison 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 - CORRAEarly 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
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: PredniHEXAL® 5mg Tabletten
Product Name: PredniHEXAL
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7,5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: PredniHEXAL® 10mg Tabletten
Product Name: PredniHEXAL
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 10mg Tabletten
Product Name: PredniHEXAL
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: PredniHEXAL® 20mg Tabletten
Product Name: PredniHEXAL
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 20mg Tabletten
Product Name: PredniHEXAL
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Prednisolon		Ruhr-Universität BochumNot RecruitingFemale: yes
Male: yes		450Phase 3Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
636EUCTR2013-002341-11-GB25/10/20134 August 2015This 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 SUBJECTShealthy 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use		F. Hoffmann-La Roche LtdNot RecruitingFemale: no
Male: yes		Phase 4United Kingdom
637EUCTR2013-000342-19-NL24/10/20135 September 2016A 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 - OSCARRheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: TOCILIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 162-		Roche Nederland B.V.Not RecruitingFemale: yes
Male: yes		Phase 3Netherlands
638JPRN-UMIN0000123992013/10/162 April 2019Performance of Rheumascan in healthy subjects and patients with active rheumatoid arthritisRheumatoid 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 ClinicNot Recruiting20years-oldNot applicableMale and Female9Not applicableJapan
639EUCTR2013-001999-38-BE07/10/201317 August 2015A 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 ArthritisActive 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
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: not assigned yet
Current Sponsor code: TNF-K
Other descriptive name: TNF-Kinoid
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Emulsion for injection
Route of administration of the placebo: Intramuscular use		Neovacs SANot 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
640EUCTR2013-000054-22-GB01/10/20133 April 2017OPEN-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-MOVERheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: Recombinant humanised anti-human monoclonal antibody directed against the IL-6R
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-		Roche Products LimitedNot RecruitingFemale: yes
Male: yes		Phase 3United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
641JPRN-JapicCTI-13227701/10/20132 April 2019AMG 162 Phase III study (DESIRABLE study)A Confirmatory Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on DMARDs treatment (Phase III)rheumatoid arthritisIntervention name : AMG 162
INN of the intervention : Denosumab
Dosage And administration of the intervention : Administer 60 mg every 6 months or every 3 months as a subcutaneous injection
Control intervention name : Placebo
Dosage And administration of the control intervention : Administer placebo as a subcutaneous injection		DAIICHISANKYO Co.,Ltd.20BOTH642Phase 3
642JPRN-UMIN0000118912013/10/012 April 2019Multicenter 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 MedicineNot Recruiting20years-old70years-oldMale and Female50Not selectedJapan
643NCT01773681October 201310 December 2018Novel 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 FranciscoNot recruiting18 YearsN/AAll30N/AUnited States
644NCT01947465October 201314 March 2016Immunogenicity and Safety of Vaccinations in Immunocompromised PersonsA Prospective Cohort Study in 6 Swiss Rheumatology Centres and 4 Travel Clinics on the Immunogenicity and Safety of Tetanus and Hepatitis A Vaccine in Patients With Rheumatoid Arthritis, Axial Spondyloarthritis and Vasculitis and Healthy ControlsArthritis, Rheumatoid;Spondylarthritis;VasculitisBiological: Hepatitis A vaccine and tetanus vaccineUniversity of ZurichUniversity of Basel;Swiss Tropical & Public Health Institute;University of Bern;University Hospital, Geneva;Cantonal Hospital of St. Gallen;Cantonal Hospital of Aarau, SwitzerlandNot recruiting18 YearsN/ABoth645N/ASwitzerland
645NCT01960855October 201311 July 2016A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (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 TherapyRheumatoid ArthritisDrug: ABT-494;Drug: PlaceboAbbVieNot recruiting18 Years100 YearsBoth276Phase 2United States;Australia;Belgium;Czech Republic;Hungary;New Zealand;Poland;Puerto Rico;Spain;United Kingdom;Canada;Netherlands
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
646NCT01962337October 201319 February 2018Phase 1 Single and Multiple Dose Study of FPA008 in Healthy Volunteers and Rheumatoid Arthritis SubjectsA Phase 1, Randomized, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose Study of FPA008 in Healthy Volunteers and Subjects With Rheumatoid ArthritisHealthy;Rheumatoid ArthritisDrug: FPA008;Drug: PlaceboFive Prime Therapeutics, Inc.Not recruiting21 Years70 YearsAll66Phase 1Hungary;Netherlands;Poland
647NCT01962974October 201316 December 2017A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)Arthritis, RheumatoidBiological: Golimumab 2 mg/kg IVJanssen Biotech, Inc.Not recruiting18 Years76 YearsAll7Phase 3United States;Canada;Argentina;Brazil;Colombia;Mexico
648NCT01966718October 201319 October 2017Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.Repository Corticotropin Injection As Adjunctive Therapy In Patients With Rheumatoid Arthritis Who Have Failed At Least Three Biologic Therapies With Different Modes Of ActionRheumatoid ArthritisDrug: Repository corticotropin injectionArthritis Treatment Center, MarylandNot recruiting18 Years80 YearsAll8Phase 4United States
649NCT01973569October 201316 December 2017AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Patients With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) TreatmentA Confirmatory Study of AMG 162 (Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment (Phase III)Rheumatoid ArthritisDrug: denosumab;Drug: placeboDaiichi Sankyo, Inc.Not recruiting20 YearsN/AAll667N/AJapan
650NCT01975610October 201316 December 2017Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid ArthritisA Phase 2a, 4-Week Double-Blind, Proof-of-Concept Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid ArthritisRheumatoid ArthritisDrug: CC-292;Drug: PlaceboCelgeneNot recruiting18 Years80 YearsFemale47Phase 2United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
651NCT01985464October 201315 July 2019Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid ArthritisFeasibility Study of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UC-MSC) in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid ArthritisRheumatoid ArthritisBiological: Umbilical cord mesenchymal stem cellsTranslational BiosciencesNot recruiting18 YearsN/AAll20Phase 1/Phase 2Panama
652NCT02036931October 201321 January 2019A 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 BiometNot recruiting18 YearsN/AAll315Phase 1United States;France;Germany;Ireland;Netherlands;Spain
653NCT02538757October 201321 August 2017Safety 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 UniversityNot recruiting50 YearsN/AAll125Phase 2United States
654NCT01942174September 27, 201311 February 2019VACcination In Methotrexate Treated Rheumatoid Arthritis PatientsLead Time of the Methotrexate Establishment and Vaccinal Protection Against the Pneumococcal Agent in Patients Affected With Rheumatoid PolyarthritisRheumatoid ArthritisBiological: Prevenar 13;Biological: Pneumo23 / Pneumovax;Drug: Methotrexate - Immediate;Drug: Methotrexate - DelayUniversity Hospital, MontpellierAPHP (Hospital Cochin);PfizerNot recruiting18 YearsN/AAll276Phase 3France;Monaco
655EUCTR2013-000359-42-GR12/09/201321 August 2017Not 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 ArthritisRheumatoid 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
Pharmaceutical Form: Solution for injection		ROCHE HELLAS S.A.Not RecruitingFemale: yes
Male: yes		Phase 3Greece
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
656EUCTR2012-005674-61-BE11/09/201321 August 2017Mesenchymal 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 arthritisRheumatoid 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
Pharmaceutical Form: Suspension for injection
Other descriptive name: ALLOGENEIC MESENCHYMAL PRECURSOR CELLS
Concentration unit: Munit million units
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use		Mesoblast, IncNot RecruitingFemale: yes
Male: yes		90Phase 2Serbia;Hungary;Estonia;Czech Republic;Poland;Belgium;Croatia;Latvia
657NCT01907230September 10, 201325 March 2019Entecavir 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, TaiwanNot recruiting20 Years90 YearsAll115Phase 4Taiwan
658ChiCTR-ONRC-130035782013-09-0118 April 2017Agkistrodon different formulations inflammatory and analgesic effects on rheumatoid arthritis clinical studyAgkistrodon different formulations inflammatory and analgesic effects on rheumatoid arthritis clinical studyRheumatoid arthritisThe water decoction group of Agkistrodon:Taking the water decoction of Agkistrodon;Agkistrodon liquor:Taking Agkistrodon liquor agents;Agkistrodon pulvis:Taking the Agkistrodon pulvis;Control group:Taking placebo;Zhejiang Chinese Medical UniversityNot Recruiting1865BothThe water decoction group of Agkistrodon:30;Agkistrodon liquor:30;Agkistrodon pulvis:30;Control group:30;Phase 1 studyChina
659JPRN-JapicCTI-13220901/9/20132 April 2019Safety 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 ArthritisRheumatoid 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.18BOTH454Phase 3
660NCT01787149September 201311 June 2018A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid ArthritisA Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid ArthritisCombination With DMARDsDrug: DMARDsMycenax Biotech Inc.Not recruiting20 YearsN/AAll98Phase 3Taiwan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
661NCT01911234September 20131 April 2019Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid ArthritisA 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 TherapyRheumatoid ArthritisBiological: TNF-Kinoid;Other: PlaceboNeovacsNot recruiting18 Years75 YearsAll143Phase 2Belgium;Georgia;Hungary;Lebanon;Macedonia, The Former Yugoslav Republic of;Moldova, Republic of;Poland;Russian Federation;Serbia;Ukraine;Czech Republic
662NCT01948388September 201328 January 2019The 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.Not recruiting18 YearsN/AAll20Phase 4United States
663NCT01955603September 201319 February 2015A 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/SNot recruiting18 Years75 YearsBoth24Phase 1Germany;Hungary;Poland;Russian Federation
664NCT02072200September 201319 October 2017Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE)A New Modified-Release Tablet Formulation of Prednisone in Patients With Rheumatoid Arthritis- Multicenter, Phase IV, Interventional Study to Assess Reduction of Morning StiffnessRheumatoid ArthritisDrug: Lodotra®Mundipharma Korea LtdNot recruiting20 Years80 YearsAll147Phase 4Korea, Republic of
665NCT02275299September 201319 February 2015Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid ArthritisA Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod or Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Methotrexate;Drug: Leflunomide;Drug: IguratimodJiangsu Simcere Pharmaceutical Co., Ltd.Recruiting18 Years70 YearsBoth240Phase 4China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
666NCT02600455September 201316 December 2017Use-Results Survey for ORENCIA® Subcutaneous Injection 125mg Syringe 1mLOutline of Use-Results Survey for ORENCIA® Subcutaneous Injection 125mg Syringe 1mLRheumatoid ArthritisDrug: OrenciaBristol-Myers SquibbOno Pharmaceutical Co. LtdNot recruiting18 YearsN/AAll505N/AJapan
667NCT02600468September 201316 December 2017Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mgOutline of Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mgRheumatoid ArthritisDrug: OrenciaBristol-Myers SquibbOno Pharmaceutical Co. LtdNot recruiting18 YearsN/AAll671N/A
668EUCTR2013-000525-31-GB27/08/201310 July 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 ArthritisModerate 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
Current Sponsor code: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Humira
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Other descriptive name: Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		Amgen IncNot RecruitingFemale: yes
Male: yes		500Phase 3United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
669EUCTR2013-002429-52-ES23/08/201317 May 2016STUDY 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 ARTHRITISRheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-		Roche Farma S.ANot RecruitingFemale: yes
Male: yes		420Phase 3Portugal;Spain;Ireland
670EUCTR2011-005649-10-DE19/08/201310 July 2015An 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 ArthritisRheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: mavrilimumab
CAS Number: 1085337-57-0
Current Sponsor code: CAM-3001
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Trade Name: Simponi
Product Name: Golimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		MedImmune LtdNot RecruitingFemale: yes
Male: yes		120Phase 2Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
671EUCTR2012-002181-12-SE19/08/201327 October 2014A 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 RAActive 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
Pharmaceutical Form: Capsule
INN or Proposed INN: None
Other descriptive name: MK-8457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use		Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to asNot RecruitingFemale: yes
Male: yes		178Phase 2aUnited States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden
672EUCTR2012-005733-37-CZ16/08/20138 August 2016A 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 TherapyRheumatoid 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
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: SB2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Remicade®
Product Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-		Samsung Bioepis Co., Ltd.Not RecruitingFemale: yes
Male: yes		584Phase 3Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
673EUCTR2012-003654-86-HU15/08/20134 August 2015Evaluation 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 alonemoderately 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
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Proposed INN - FILGOTINIB
Current Sponsor code: GLPG0634
Other descriptive name: GLPG0634
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GLPG0634
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Proposed INN - FILGOTINIB
Current Sponsor code: GLPG0634
Other descriptive name: GLPG0634
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GLPG0634
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Propsoed INN - FILGOTINIB
Current Sponsor code: GLPG0634
Other descriptive name: GLPG0634
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		Galapagos NVNot RecruitingFemale: yes
Male: yes		280Phase 2bUnited 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
674EUCTR2012-005026-30-HU15/08/20132 September 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 TherapySubjects 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Current Sponsor code: SB4
Other descriptive name: TNFR:Fc
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Enbrel®
Product Name: Enbrel®
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Other descriptive name: TNFR:Fc
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		Samsung Bioepis Co., Ltd.AuthorisedFemale: yes
Male: yes		498Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
675NCT01856309August 7, 20131 October 2018Long-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)Arthritis, RheumatoidDrug: Sirukumab 100 mg;Drug: Sirukumab 50 mg;Drug: PlaceboJanssen Research & Development, LLCGlaxoSmithKlineNot recruiting18 YearsN/AAll1822Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;France;Germany;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Ukraine;United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
676EUCTR2013-000944-25-IT02/08/201322 December 2015Extension 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 ExtensionRheumatoid 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-		Novartis Farma S.p.A.Not RecruitingFemale: yes
Male: yes		454Panama;United States;Thailand;Guatemala;Colombia;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Japan
677EUCTR2013-001569-17-IT02/08/201310 February 2014A 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: TOCILIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 180-		Roche S.p.A.AuthorisedFemale: yes
Male: yes		Phase 3BItaly
678NCT01394913August 201319 February 2015Comparison of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid ArthritisA Prospective, Double-blind, Randomized Study to Compare Efficacy of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid ArthritisRheumatoid ArthritisDrug: Reumatocept (etanercept);Drug: Enbrel (etanercept)EMSNot recruiting18 Years70 YearsBoth216Phase 3Brazil
679NCT01905735August 201319 February 2015A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid ArthritisA Multicentric,Double-blind,Placebo Controlled,Phase-2 Study to Assess the Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis .Rheumatoid Arthritis.Drug: Rhustoxicodendron 30;Drug: placeboHealthcare Homoeo Charitable SocietyRecruiting25 Years60 YearsBoth60Phase 2India
680NCT01915537August 201319 February 2015Infliximab 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 recruiting18 Years70 YearsBoth170N/AChina
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
681NCT01925157August 201312 October 2015A Study of LY3090106 in Healthy Participants and Participants With Rheumatoid Arthritis (RA)A Single-Dose, Multicenter, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3090106 in Healthy Subjects and Subjects With Rheumatoid ArthritisRheumatoid ArthritisBiological: LY3090106 - SQ;Biological: LY3090106 - IV;Biological: Placebo - SQEli Lilly and CompanyNot recruiting18 Years80 YearsBoth43Phase 1Bulgaria;Moldova, Republic of;Poland;Romania;Hungary;United States
682NCT01936181August 201316 December 2017A Study Comparing SB2 to Remicade® 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 SB2 Compared to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate TherapyRheumatoid ArthritisDrug: Remicade (infliximab);Drug: SB2 (proposed biosimilar to infliximab)Samsung Bioepis Co., Ltd.Not recruiting18 Years75 YearsAll584Phase 3Bulgaria;Lithuania
683NCT01932372July 26, 201311 November 2019Tofacitinib (Xeljanz) Special Investigation for Rheumatoid ArthritisXELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE)Rheumatoid ArthritisDrug: Tofacitinib (Xeljanz);Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etcPfizerNot recruitingN/AN/AAll10477N/AJapan
684JPRN-JapicCTI-15307301/7/20132 April 2019Long-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)Rheumatoid arthritisIntervention name : Sirukumab
Dosage And administration of the intervention : 100 mg
Intervention name : Sirukuma
Dosage And administration of the intervention : 50mg
Control intervention name : null		Janssen Pharmaceutical K.K.18BOTH280Phase 3
685NCT01774877July 201319 February 2015A Clinical Study of Xin'an Medicine in the Treatment of Bi SyndromeEfficacy and Safety of Xinfeng Capsule in the Treatment of Rheumatoid Arthritis (RA):A Randomized, Double-blind, Double-dummy, Multi-center TrialRheumatoid ArthritisDrug: Xinfeng capsule;Drug: leflunomideThe First Affiliated Hospital of Anhui University of Traditional Chinese MedicineMinistry of Science and Technology of the People´s Republic of ChinaNot recruiting18 Years65 YearsBoth304N/AChina
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
686NCT01851070July 201311 June 2018A 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.PPDNot recruiting18 Years80 YearsAll48Phase 2United States;Australia
687NCT01853033July 201316 December 2017A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid ArthritisA Study in Patients With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABT-122Rheumatoid ArthritisBiological: ABT-122;Biological: PlaceboAbbVieNot recruiting18 Years75 YearsAll19Phase 1United States
688NCT01862224July 201319 February 2015A Synovial Biopsy Study of JNJ-38518168 in Participants With Active Rheumatoid Arthritis Despite Methotrexate TherapyA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Synovial Biopsy Study of JNJ-38518168 in Subjects With Active Rheumatoid Arthritis Despite Methotrexate TherapyRheumatoid ArthritisDrug: JNJ-38518168;Drug: Placebo;Drug: Placebo / JNJ-38518168Janssen Research & Development, LLCNot recruiting18 Years65 YearsBoth21Phase 2United States;Moldova, Republic of
689NCT01890473July 201319 October 2017Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled SyringePhase Ib, Multicenter, Randomized, Open-Label, Parallel-Group Study to Characterize the Pharmacokinetics of a Single Dose of Abatacept 125 mg Administered Subcutaneously Using the BD Physioject™ Autoinjector or the UltraSafe Passive Needle Guard Prefilled SyringeRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbNot recruiting18 YearsN/AAll356Phase 1United States;Argentina;Mexico;Peru;South Africa
690NCT01893996July 201316 December 2017Study of Adalimumab to Lower Cardiovascular Risk in RA Patients With Well Controlled Joint DiseaseAdalimumab to Mitigate Cardiovascular Risk in RA Patients With Well-Controlled Joint DiseaseRheumatoid Arthritis;Cardiovascular DiseaseDrug: Adalimumab;Drug: PlaceboUniversity of California, San FranciscoAmerican College of Rheumatology Research and Education Foundation;AbbVieNot recruiting18 YearsN/AAll60Phase 4United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
691NCT01894516July 20133 August 2015Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Patients (DARWIN2)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 (MTX) AloneRheumatoid ArthritisDrug: GLPG0634;Drug: PlaceboGalapagos NVNot recruiting18 YearsN/ABoth287Phase 2United States;Argentina;Australia;Austria;Bulgaria;Chile;Colombia;Germany;Guatemala;Hungary;Latvia;Mexico;Moldova, Republic of;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine
692NCT01927263July 201318 April 2016A Phase 3 Study of NI-071 in Patients With Rheumatoid ArthritisA Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis ?A Double-blind, Active Drug-controlled Study and Long-term Study?Rheumatoid ArthritisBiological: NI-071;Biological: InfliximabNichi-Iko Pharmaceutical Co.,Ltd.Not recruiting20 Years75 YearsBoth242Phase 3Japan
693NCT02236481July 201318 December 2018Clinical 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 GiacomelliNot recruiting18 YearsN/AAll41Phase 4Italy
694NCT02519387July 201319 October 2017Efficacy 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.Not recruiting40 YearsN/AAll78Phase 4Malaysia
695NCT02894047July 201319 September 2016Study of the Influence of the Expression of the Calcium-sensitive Receptor (CaSR) by Monocytes in the Synovial Liquid on Structural Alterations in Patients Diagnosed With Rheumatoid Arthritis in the Previous Two YearsStudy of the Influence of the Expression of the Calcium-sensitive Receptor (CaSR) by Monocytes in the Synovial Liquid on Structural Alterations in Patients Diagnosed With Rheumatoid Arthritis in the Previous Two YearsArthritis, RheumatoidBiological: bloodCentre Hospitalier Universitaire, AmiensNot recruiting18 YearsN/ABoth42N/AFrance
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
696EUCTR2012-003635-31-BE26/06/201317 August 2015Evaluation 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
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Proposed INN - FILGOTINIB
Current Sponsor code: GLPG0634
Other descriptive name: GLPG0634
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GLPG0634
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Proposed INN - FILGOTINIB
Current Sponsor code: GLPG0634
Other descriptive name: GLPG0634
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GLPG0634
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Propsoed INN - FILGOTINIB
Current Sponsor code: GLPG0634
Other descriptive name: GLPG0634
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		Galapagos NVNot RecruitingFemale: yes
Male: yes		595Phase 2bUnited 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
697EUCTR2012-004482-40-ES18/06/201322 July 2013Evaluation of a protocol for the reduction of doses in patients with rheumatoid arthritis (RA) in clinical remission in treatment with biological therapiesEvaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis (RA) in persistent clinical remission in treatment with biological therapies: open, controlled study and randomized.Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis in clinical remission at treatment with biologic therapies;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: Infliximab
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 3-
Trade Name: HUMIRA
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: ENBREL
Product Name: Etanercept
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: CIMZIA
Product Name: Certolizumab Pegol
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: SIMPONI
Product Name: Golimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: ORENCIA
Product Name: Abatacept
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 1000-
Trade Name: RoActemra
Product Name: Tocilizumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 8-
Product Name: Infliximab
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram		FRANCISCO J. BLANCO GARCÍAAuthorisedFemale: yes
Male: yes		Spain
698NCT01881308June 17, 201330 September 2019Assessing 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 AuthorityNot recruiting18 Years80 YearsAll360Phase 4Norway
699EUCTR2012-003686-17-SK05/06/20137 January 2019A 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-BEYONDRheumatoid 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
Pharmaceutical Form: Tablet
INN or Proposed INN: baricitinib
Current Sponsor code: LY3009104
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Tablet
INN or Proposed INN: baricitinib
Current Sponsor code: LY3009104
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Eli Lilly and CompanyAuthorisedFemale: yes
Male: yes		3000Phase 3Portugal;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
700NCT01861782June 201319 February 2015Comparison 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 CenterNot recruiting18 YearsN/ABoth30N/AIsrael
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
701NCT01875991June 201319 October 2017Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With EtanerceptAn Open-label, Randomized, Crossover Study to Assess the Preference for Autoinjector A Versus Autoinjector B in Rheumatoid Arthritis and Plaque Psoriasis Subjects Treated With EtanerceptRheumatoid Arthritis;Plaque PsoriasisDrug: Etanercept via Autoinjector A;Drug: Etanercept via Autoinjector BAmgenNot recruiting18 YearsN/AAll217Phase 4United States;Canada
702NCT01878318June 201314 November 2016A 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 RocheNot recruiting18 YearsN/ABoth0Phase 4Venezuela
703NCT01885819June 201316 December 2017Autologous 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 BiosciencesNot recruiting18 YearsN/AAll0Phase 1/Phase 2Panama
704NCT01895309June 201316 December 2017A 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 TherapyRheumatoid ArthritisDrug: Enbrel (etanercept);Drug: SB4 (proposed biosimilar to etanercept)Samsung Bioepis Co., Ltd.Not recruiting18 Years75 YearsAll596Phase 3Poland;United Kingdom
705NCT01901185June 201319 October 2017Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject EtanerceptA Single-arm, Multicenter Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Electromechanical Autoinjector to Self-inject EtanerceptRheumatoid Arthritis;Psoriatic ArthritisDrug: Etanercept / Autoinjector AAmgenNot recruiting18 YearsN/AAll77Phase 3United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
706NCT01961271June 201319 October 2017Evaluation 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)Not recruiting18 Years80 YearsAll114Phase 4Hong Kong;Korea, Republic of;Philippines
707NCT02132234June 201319 February 2015Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing SpondylitisEffects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing SpondylitisRheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;HypertensionDrug: Etanercept;Drug: Adalimumab;Drug: Certolizumab;Drug: InfliximabJagiellonian UniversityDepartmet of Rheumatology, J Dietl Hospital, Krakow, PolandRecruiting18 YearsN/ABoth100Phase 4Poland
708NCT01955733May 31, 201316 December 2017Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid ArthritisSafety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis: an Open-label Extension TrialArthritis, RheumatoidDrug: BI 695500Boehringer IngelheimNot recruiting18 Years82 YearsAll91Phase 3United States;Belgium;Bulgaria;Germany;Greece;Netherlands;Poland;Portugal;Spain;Argentina;Brazil;Canada;Chile;Hungary;Ireland;Mexico;United Kingdom
709EUCTR2012-003686-17-IT29/05/201326 February 2018A 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-BEYONDRheumatoid 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
Pharmaceutical Form: Tablet
INN or Proposed INN: baricitinib
Current Sponsor code: LY3009104
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: baricitinib
Product Code: LY3009104
Pharmaceutical Form: Tablet
INN or Proposed INN: baricitinib
Current Sponsor code: LY3009104
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Eli Lilly and CompanyAuthorisedFemale: yes
Male: yes		3000Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;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;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
710JPRN-UMIN0000144852013/05/242 April 2019Golimumab study for development of tight control and biologics-free condition.rheumatoid arthritisTreatment with Golimumab for patients with rheumatoid arthritisRheumatology, Internal MedicineJuntendo University School of Medicine, Juntendo Koshigaya HospitalRecruiting20years-oldNot applicableMale and Female40Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
711EUCTR2013-000337-13-DE13/05/201311 December 2017Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled study Prediction 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 study Prediction of response to Certolizumab-Pegol in RA (PreCePRA)Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy
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: Cimzia
Product Name: Cimzia
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Current Sponsor code: UCB SA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution and suspension for suspension for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use		Universitätsklinikum ErlangenAuthorisedFemale: yes
Male: yes		156Phase 3Serbia;Portugal;Germany
712NCT01357759May 201323 November 2015Safety and Tolerability of MORAb-022 in Healthy and Rheumatoid Arthritis SubjectsA Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Trial of MORAb-022 in Healthy Subjects and Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: MORAb-022MorphotekNot recruiting18 Years75 YearsBoth20Phase 1United States;Netherlands
713NCT01846975May 201316 March 2015Introducing a Single IV Abatacept Treatment in RA Patients Currently Receiving Weekly SC Abatacept to Simulate a HolidayA Phase IV, Open Label Study Introducing a Single IV Treatment With Abatacept in Patients With Rheumatoid Arthritis Currently Receiving Weekly Injections of SC Abatacept to Simulate a Holiday or Patient VacationRheumatoid ArthritisDrug: IV AbataceptRüdiger B. MüllerBristol-Myers SquibbNot recruiting18 YearsN/ABoth49Phase 4Switzerland
714NCT01873443May 20137 December 2015Long-Term Efficacy and Safety of CT-P10 in Patients With RAAn Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1Rheumatoid ArthritisDrug: Rituximab, MTX, folic acidCelltrionNot recruiting18 Years75 YearsBoth87Phase 1Korea, Republic of
715NCT01927757May 201319 October 2017Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to AdalimumabA Single Arm Trial to Evaluate the Efficacy of Etanercept in Moderate to Severe Rheumatoid Arthritis Patients Who Failed to Respond or Lost a Satisfactory Response to Treatment With Adalimumab When Used as Their First Biologic AgentModerate to Severe Rheumatoid ArthritisBiological: Etanercept;Drug: MethotrexateAmgenNot recruiting18 YearsN/AAll90Phase 4United States;Canada;Puerto Rico
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
716NCT02035800May 201311 June 2018Bone Resorption, Osteoclastogenesis and AdalimumabBone Resorption, Osteoclastogenesis and AdalimumabRheumatoId ArthritisDrug: AdalimumabUniversité de SherbrookeAbbVieRecruiting18 YearsN/AAll120Phase 4Canada
717NCT02350881May 201319 October 2017Mid-term Outcomes of First MTP Arthroplasty With Primus™ FGT Implant.A Post-Market Observational Study to Evaluate Safety and Performance of Primus™ FGT Implant at a Minimum of 5 Years Follow-upHallux Limitus of Left Great Toe;Rheumatoid Arthritis;Arthritis of 1st Metatarsophalangeal Joint;Osteoarthritis;Bunion;Hallux Limitus of Right Great ToeDevice: Primus FGTI (Flexible Great toe Implant)Tornier, Inc.Not recruiting18 YearsN/AAll70N/AItaly
718NCT02468791May 201317 November 2015MabionCD20® Compared to MabThera® in Patients With Rheumatoid ArthritisA Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: RituximabMabion SARecruiting18 Years80 YearsBoth863Phase 3Bosnia and Herzegovina;Georgia;Poland;Serbia;Ukraine
719NCT04157010May 201311 November 2019Tocilizumab REMission in Early RAProspective, Single-centre, Open-Label, Randomised, Pilot Study Assessing the Changes in Expression of Janus Kinase/Signal Transducers and Activators of Transcription (JAK-STAT) and Speed & Depth of Remission Induced by Tocilizumab & Methotrexate Combination and Tocilizumab Monotherapy in Patients With Early Rheumatoid ArthritisRheumatoid ArthritisDrug: Methotrexate;Drug: TocilizumabUniversity of LeedsHoffmann-La RocheNot recruiting18 YearsN/AAll20Phase 4United Kingdom
720EUCTR2012-004090-16-DE23/04/201310 July 2015Safety, 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 therapyRheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: BI 655064
Pharmaceutical Form: Solution for injection
Current Sponsor code: BI 655064
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Boehringer Ingelheim Pharma GmbH & Co. KGNot RecruitingFemale: yes
Male: yes		106Czech Republic;Poland;Spain;Netherlands;Germany;New Zealand
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
721EUCTR2012-004342-14-LT11/04/201328 August 2014A 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 DrugsRheumatoid 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
Pharmaceutical Form: Tablet
INN or Proposed INN: VX-509
Current Sponsor code: VX-509
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes		40Phase 2/3United States;Estonia;Lithuania;Denmark;South Africa;Netherlands
722NCT01758198April 11, 201316 December 2017Abatacept Post-marketing Clinical Study in JapanA Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to MethotrexateRheumatoid ArthritisBiological: Abatacept;Drug: Placebo matching with Abatacept;Drug: MethotrexateBristol-Myers SquibbOno Pharmaceutical Co. LtdNot recruiting20 YearsN/AAll405Phase 4Japan
723EUCTR2011-004017-17-GB08/04/201315 April 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). - TREMERARheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: RoActemra
Product Name: Tocilizumab
Product Code: RoActemra
Pharmaceutical Form: Concentrate and solvent for solution for infusion		The University of LeedsAuthorisedFemale: yes
Male: yes		20United Kingdom
724EUCTR2012-003057-29-CZ02/04/201312 January 2015A 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 PatientsXmAb5871 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: XmAb®5871
Current Sponsor code: XENP5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 9.0-11.0
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: XmAb5871_3.0MG
Product Code: XENP5871
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: XmAb®5871
Current Sponsor code: XENP5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 9.0-11.0
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: XmAb5871_1.0MG
Product Code: XENP5871
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: XmAb®5871
Current Sponsor code: XENP5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 9.0-11.0
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: XmAb5871_0.3MG
Product Code: XENP5871
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: XmAb®5871
Current Sponsor code: XENP5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 9.0-11.0		Xencor Inc.Not RecruitingFemale: yes
Male: yes		58Phase 2aHungary;Czech Republic;Slovakia
725JPRN-JapicCTI-13212101/4/20132 April 2019Abatacept Post-marketing Clinical Study in JapanA Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to MethotrexateRheumatoid ArthritisIntervention name : Abatacept
Dosage And administration of the intervention : 10 mg/kg IV / month
Control intervention name : Placebo
Dosage And administration of the control intervention : 0 mg/kg IV / month		Bristol-Myers Squibb K.K.Ono Pharmaceutical Co.,LTD.20BOTH400Phase 4
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
726JPRN-UMIN0000098872013/04/012 April 2019Associations 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-6Rheumatoid 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 HospitalNot Recruiting20years-oldNot applicableMale and Female100Not applicableJapan
727NCT01547091April 201319 February 2015Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid ArthritisClinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/IIRheumatoid ArthritisBiological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs);Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs);Biological: UC-MSC+DMARDSAlliancells Bioscience Corporation LimitedRecruiting18 Years70 YearsBoth200Phase 1/Phase 2China
728NCT01764997April 201316 December 2017An 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 PharmaceuticalsNot recruiting18 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
729NCT01850680April 201319 February 2015Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered Sarilumab in Japanese Patients With Rheumatoid Arthritis Receiving Concomitant MethotrexateRheumatoid ArthritisDrug: sarilumab SAR153191 (REGN88);Drug: placebo;Drug: methotrexate;Drug: folic acidSanofiRegeneron PharmaceuticalsNot recruiting20 Years65 YearsBoth61Phase 1Japan
730NCT01851278April 201319 February 2015Effectiveness Intraarticular CorticosteroidEffectiveness and Tolerance Infiltration Intraarticular Corticosteroid According to DoseRheumatoid ArthritisDrug: Triamcinolone hexacetonideFederal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloRecruiting18 Years65 YearsBoth60N/ABrazil
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
731NCT01878123April 201310 October 2016Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid ArthritisA Randomized, Single-Dose, Placebo-Controlled, Study of the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisBiological: AMP-110;Other: PlaceboMedImmune LLCDaiichi Sankyo Co., Ltd.;Daiichi Sankyo Co., Ltd.Not recruiting18 Years75 YearsBoth26Phase 1United States
732JPRN-UMIN0000102862013/03/212 April 2019Maintenance Trial by Orencia in Rheumatoid ArthritisRheumatoid ArthritisPatients whose RA status is in low disease activity after 24 weeks of treatment with abatacept receive the reduced dosage of abatacept.Hokkaido University HospitalNot Recruiting20years-oldNot applicableMale and Female150Not selectedJapan
733EUCTR2012-005275-14-NO19/03/201328 November 2016Remission 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 REWINDRheumatoid 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
Pharmaceutical Form: Tablet
Trade Name: Methotrexate Pfizer 2,5 mg tabletter
Pharmaceutical Form: Tablet
Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte
Pharmaceutical Form: Injection
Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte
Pharmaceutical Form: Injection
Trade Name: Salazopyrin EN 500 mg enterotabletter
Pharmaceutical Form: Tablet
Trade Name: Salazopyrin EN 500 mg enterotabletter
Pharmaceutical Form: Tablet
Trade Name: Plaquenil 200 mg filmdrasjerte tabletter
Pharmaceutical Form: Tablet
Trade Name: Plaquenil 200 mg filmdrasjerte tabletter
Pharmaceutical Form: Tablet
Trade Name: Arava 20 mg filmdrasjerte tabletter
Pharmaceutical Form: Tablet
Trade Name: Arava 20 mg filmdrasjerte tabletter
Pharmaceutical Form: Tablet
Trade Name: ENBREL 25 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte.
Pharmaceutical Form: Injection
Trade Name: Cimzia 200 mg injeksjonsvæske, oppløsning
Pharmaceutical Form: Injection
Trade Name: Simponi 50 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte.
Pharmaceutical Form: Injection
Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning.
Pharmaceutical Form: Infusion
Trade Name: Humira 40 mg injeksjonsvæske, oppløsning, i ferdigfylt sprøyte
Pharmaceutical Form: Injection		Diakonhjemmet Hospital ASAuthorisedFemale: yes
Male: yes		Phase 4Norway
734EUCTR2012-003644-71-ES12/03/20135 August 2014Randomized, 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for infusion in pre-filled syringe
Route of administration of the placebo: Subcutaneous use		Pfizer Inc.Not RecruitingFemale: yes
Male: yes		168France;Hong Kong;Czech Republic;Spain;Australia;Israel;Chile;Russian Federation;Netherlands;Germany;Colombia
735EUCTR2012-003629-40-CZ11/03/201311 April 2016An 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 TherapyRheumatoid 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
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: CNTO6785
Current Sponsor code: CNTO6785
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Janssen-Cilag International NVNot RecruitingFemale: yes
Male: yes		250Phase 2Philippines;Czech Republic;Argentina;Thailand;Poland;Russian Federation;Colombia;China;India
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
736NCT01558089March 201319 October 2017Good EULAR Response In Patients With Early Rheumatoid ArthritisAbility To Achieve A Good Eular Response In Patients With Moderate-to-severe Active Early Rheumatoid Arthritis Who Satisfy The New Acr/Eular Classification Criteria Receiving Etanercept + Mtx In Real World Clinical Practice In GreeceRheumatoid ArthritisDrug: etanercept;Drug: methotrexatePfizerNot recruiting18 YearsN/AAll76N/AGreece
737NCT01715896March 201319 October 2017A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid ArthritisA Phase 2 Exploratory Study of Mavrilimumab Versus Anti-tumor Necrosis Factor in Subjects With Rheumatoid ArthritisRheumatoid ArthritisBiological: Golimumab 50 mg;Biological: Mavrilimumab 100 mgMedImmune LLCNot recruiting18 Years80 YearsAll215Phase 2Argentina;Colombia;Czech Republic;France;Greece;Hungary;Israel;Mexico;Portugal;Russian Federation;Serbia;Slovakia;Spain;United Kingdom;Turkey
738NCT02843789March 201319 February 2018Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab TherapyEvolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab TherapyArthritis, RheumatoidDrug: TocilizumabCentre Hospitalier Universitaire de BesanconNot recruiting18 Years80 YearsAll109Phase 4France
739EUCTR2012-002324-32-BE25/02/201316 August 2016A 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 - BEGINModerately 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
Pharmaceutical Form: Tablet
Current Sponsor code: LY3009104
Other descriptive name: baricitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: baricitinib
Product Code: LY3009104
Pharmaceutical Form: Tablet
Current Sponsor code: LY3009104
Other descriptive name: baricitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Pharmaceutical Form: Capsule
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
Pharmaceutical Form: Capsule
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Methotrexate 2.5mg Tablets
Pharmaceutical Form: Capsule
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Methotrexate 2.5 mg tablets
Pharmaceutical Form: Capsule
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use		Eli Lilly and CompanyNot 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
740JPRN-UMIN0000101262013/02/2523 April 2019Efficacy 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-ILDInterstitial 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 UniversityNot Recruiting20years-oldNot applicableMale and Female34Not applicableJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
741EUCTR2012-000609-58-BE20/02/201317 August 2015A 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 biologicsRheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
Current Sponsor code: NNC0109-0012
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: 0109-0012A 50 mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
Current Sponsor code: NNC0109-0012
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: 0109-0012A 25 mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
Current Sponsor code: NNC0109-0012
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Novo Nordisk A/SNot RecruitingFemale: yes
Male: yes		268Phase 2bUnited States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Germany
742EUCTR2012-000610-11-BE20/02/201317 August 2015A 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 MethotrexateRheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
Current Sponsor code: NNC0109-0012
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: 0109-0012A 50 mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
Current Sponsor code: NNC0109-0012
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: 0109-0012A 25 mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
Current Sponsor code: NNC0109-0012
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Novo Nordisk A/SNot RecruitingFemale: yes
Male: yes		268Phase 2bUnited States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Germany
743EUCTR2012-003536-23-CZ20/02/20134 August 2015To 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 - ASCERTAINRheumatoid 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)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Sarilumab
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 131.6-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Sarilumab
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 175-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use		sanofi-aventis recherche & développementNot 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
744EUCTR2012-003724-20-HU19/02/201319 January 2015A 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 AloneRheumatoid 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
Pharmaceutical Form: Capsule
CAS Number: 1201438-56-3
Other descriptive name: IPI-145
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Code: IPI 145
Pharmaceutical Form: Capsule
CAS Number: 1201438-56-3
Other descriptive name: IPI-145
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Code: IPI 145
Pharmaceutical Form: Capsule
CAS Number: 1201438-56-3
Other descriptive name: IPI-145
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use		Infinity Pharmaceuticals, IncNot RecruitingFemale: yes
Male: yes		316Phase 2Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;Colombia;New Zealand
745EUCTR2012-004090-16-ES19/02/201310 July 2015Safety, 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 therapyRheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: BI 655064
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BI 655064
Current Sponsor code: BI 655064
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Boehringer Ingelheim España, S.A.Not RecruitingFemale: yes
Male: yes		130Czech Republic;Spain;Australia;Netherlands;Germany;New Zealand
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
746EUCTR2012-005370-62-IT18/02/20137 January 2019clinical 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ANAKINRA
CAS Number: 143090-92-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-		OSPEDALE CIVILE SAN SALVATORE, ASL 04, L'AQUILANot RecruitingFemale: yes
Male: yes		200Phase 4Italy
747JPRN-UMIN0000100332013/02/142 April 2019To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapyRheumatoid ArthritisTocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks.Daihei KidaNot Recruiting20years-old75years-oldMale and Female20Not selectedJapan
748EUCTR2011-006344-71-DE08/02/20138 August 2016Treatment 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
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Trichuris suis ova
Current Sponsor code: TSO
Other descriptive name: Pig whipworm eggs
Concentration unit: thousand organisms thousand organisms
Concentration type: equal
Concentration number: 2500-
Pharmaceutical form of the placebo: Oral suspension
Route of administration of the placebo: Oral use		Immanuel Krankenhaus BerlinNot RecruitingFemale: yes
Male: yes		50Phase 2Germany
749NCT01768858February 5, 201311 February 2019Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical PracticeAssessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical PracticeCrohn´s Disease;Ulcerative Colitis;Plaque Psoriasis;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: AdalimumabAbbVieRaffeiner GmbHNot recruiting18 Years99 YearsAll96Phase 2Austria
750EUCTR2011-003538-16-LT04/02/201310 July 2015To 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-TARGETRheumatoid 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Sarilumab
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 131.6-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: Sarilumab
Product Code: SAR153191
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Sarilumab
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 175-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use		sanofi-aventis recherche & développementNot 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
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
751EUCTR2012-003194-25-LT04/02/201327 October 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 ArthritisActive 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
Current Sponsor code: MabionCD20
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: MabThera
Product Name: MabThera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-		Mabion S.A.Not RecruitingFemale: yes
Male: yes		863Serbia;Poland;Ukraine;Croatia;Romania;Lithuania;Russian Federation;Georgia
752NCT01724931February 20131 June 2015Aminopterin Dose Finding Treatment for Methotrexate-Naïve Rheumatoid ArthritisA Phase 2 Double-Blind, Placebo-Controlled, Randomized Dose Finding Study For The Efficacy And Safety Of Aminopterin In Methotrexate-Naive Rheumatoid ArthritisRheumatoid ArthritisDrug: LD-aminopterin;Drug: placeboSyntrix Biosystems, Inc.Not recruiting18 YearsN/ABoth175Phase 2Ukraine
753NCT01742468February 201319 October 2015Intervention With Long-chain n-3 Polyunsaturated Fatty Acids From Microalgae Oil in Patients With Rheumatoid ArthritisIntervention With Products Enriched With Long Chain n-3 Polyunsaturated Fatty Acids (n-3 LC-PUFA) From Microalgae Oil in Patients With Rheumatoid Arthritis - Influence on Disease Activity and Inflammation StatusRheumatoid ArthritisDietary Supplement: long-chain n-3 PUFA;Dietary Supplement: sunflower oilUniversity of JenaGerman Federal Ministry of Education and ResearchNot recruiting40 Years80 YearsBoth38N/AGermany
754NCT01712399January 28, 201316 December 2017A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid ArthritisAn Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects With Rheumatoid ArthritisRheumatoid ArthritisBiological: Mavrilimumab 100 mgMedImmune LLCNot recruiting19 Years79 YearsAll409Phase 2Argentina;Bulgaria;Chile;Colombia;Czechia;Estonia;Germany;Greece;Hungary;Israel;Mexico;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Czech Republic
755EUCTR2012-002323-15-PL25/01/20132 February 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 - BEACONModerately 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
Pharmaceutical Form: Tablet
Current Sponsor code: LY3009104
Other descriptive name: baricitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: baricitinib
Product Code: LY3009104
Pharmaceutical Form: Tablet
Current Sponsor code: LY3009104
Other descriptive name: baricitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Eli Lilly and CompanyNot 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
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
756EUCTR2012-002535-28-GB21/01/201311 December 2017A 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-RARheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: RoActemra
Product Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion		Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)AuthorisedFemale: yes
Male: yes		160Phase 4Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
757EUCTR2012-004631-22-BE15/01/20137 October 2014TapERA: Tapering Etanercept in Reumatoid Artritis.TapERA: Maintaining remission in RA while tapering Etanercept. - TapERAreumatoid arthritis
MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Trade Name: Enbrel
Product Name: Enbrel
Product Code: EMEA/H/C000262
Pharmaceutical Form: Solution for injection in pre-filled syringe		University Hospitals LeuvenAuthorisedFemale: yes
Male: yes		Belgium
758NCT01715831January 15, 201316 December 2017A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488A Multicenter, Open-Label, Single-Arm Extension Study to Describe the Safety of Tocilizumab Treatment In Brazilian Patients With DMARDs Refractory Rheumatoid Arthritis Which Completed Studies ML21530 and MA21488 and Presenting an Indication of Maintaining the Tocilizumab TreatmentArthritis, RheumatoidDrug: DMARDs;Drug: TocilizumabHoffmann-La RocheNot recruiting18 YearsN/AAll26Phase 4Brazil
759EUCTR2012-002322-73-HU14/01/20137 December 2015A 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-BEAMModerately 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
Pharmaceutical Form: Tablet
Current Sponsor code: LY3009104
Other descriptive name: baricitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: baricitinib
Product Code: LY3009104
Pharmaceutical Form: Tablet
Current Sponsor code: LY3009104
Other descriptive name: baricitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40/0.8-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Eli Lilly and CompanyNot 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
760EUCTR2012-002339-27-HU14/01/201319 January 2015A 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 - BUILDModerately 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
Pharmaceutical Form: Tablet
Current Sponsor code: LY3009104
Other descriptive name: baricitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: baricitinib
Product Code: LY3009104
Pharmaceutical Form: Tablet
Current Sponsor code: LY3009104
Other descriptive name: baricitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Eli Lilly and CompanyNot 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
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
761ChiCTR-TRC-130029812013-01-0718 April 2017Effectiveness and safety of Chinese herbal medicine in low responders in patient population of rheumatoid arthritis under MTX-based conventional therapyEffectiveness and safety of Chinese herbal medicine in low responders in patient population of rheumatoid arthritis under MTX-based conventional therapyrheumatoid arthritis;M06.991A:GTT tablets, 10 mg 3 times a day after meals. Yi Shen Juan Bi (YSJB) ,1 pocket (8 g) 3 times a day after meals;B:Methotrexate (MTX)10 mg/week and Sulfasalazine (SSZ),at an initial dose of 0.5 g three times a day in the first week, from the second week the dose was 1.0g twice a day;Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical SciencesNot Recruiting1870BothA:110;B:110;Post-market
762NCT02089087January 7, 201315 April 2019Safety, 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 PharmaceuticalsNot recruiting18 Years55 YearsAll75Phase 1United States;Taiwan
763ChiCTR-TRC-130039482013-01-0118 April 2017The 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 patternrheumatoid 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 MedicineNot Recruiting1870BothControl:60;EA combined with medicine group:60;OtherChina
764JPRN-UMIN0000074042013/01/012 April 2019Open-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 GroupRecruitingNot applicableNot applicableMale and Female90Not applicableJapan
765NCT01965132January 1, 201318 June 2018Korean College of Rheumatology Biologics RegistryKorean College of Rheumatology Biologics RegistryRheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: Biologic DMARDSeoul National University HospitalRecruiting18 YearsN/AAll3500Phase 3Korea, Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
766NCT01389388January 201325 May 2015Effects 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 HospitalNot recruiting35 Years80 YearsBoth114N/ANorway
767NCT01721044January 201330 September 2019A Moderate to Severe Rheumatoid Arthritis StudyA 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 InhibitorsRheumatoid ArthritisDrug: Placebo;Drug: Baricitinib;Drug: cDMARDEli Lilly and CompanyNot recruiting18 YearsN/AAll527Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Puerto Rico;Spain;Switzerland;Turkey;United Kingdom;Croatia;India
768NCT01754935January 201319 February 2015A 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 DrugsRheumatoid ArthritisDrug: VX-509;Drug: VX-509 matching placeboVertex Pharmaceuticals IncorporatedNot recruiting18 Years65 YearsBoth43Phase 2United States;Denmark;Estonia;Lithuania;Netherlands;South Africa
769NCT01765478January 201325 May 2015Safety,PK/PD, Food Effect Study of Orally Administered HM71224 in Healthy Adult Male VolunteersA Phase1 Study, to Determine the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Doses of Orally Administered HM71224 in Healthy, Adult Male VolunteersRheumatoid ArthritisDrug: HM71224 single ascending dose;Drug: HM71224 food effect;Drug: HM71224 Multiple ascending doseHanmi Pharmaceutical Company LimitedNot recruiting18 Years65 YearsMale62Phase 1Netherlands
770NCT01767844January 201319 February 2015Can 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 UniversityNot recruiting18 YearsN/ABoth43N/AUnited Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
771NCT01793519January 201311 November 2019Stopping 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;Washington Hospital Center;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
772EUCTR2012-002323-15-IT18/12/201214 September 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 - BEACONModerately 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
Pharmaceutical Form: Tablet
Current Sponsor code: LY3009104
Other descriptive name: Baricitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: BARICITINIB
Product Code: LY3009104
Pharmaceutical Form: Tablet
Current Sponsor code: LY3009104
Other descriptive name: Baricitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		ELI LILLY AND COMPANYNot 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
773JPRN-UMIN0000094252012/12/062 April 2019A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patientRheumatoid 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 SchoolRecruiting20years-oldNot applicableMale and Female150Phase 4Japan
774NCT01491815December 201218 December 2018Active 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 InstitutetRecruiting18 YearsN/AAll800Phase 4Sweden
775NCT01717846December 201223 May 2016Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid ArthritisIn Vivo Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and Antigen Presenting (APC) Cells in Rheumatoid ArthritisApoptotic DNA Damage;Rheumatoid Arthritis;T-cell LymphocytosisDrug: Group 1 or Orencia treated group;Other: Group 2 (DMARDS treated group)University of California, Los AngelesBristol-Myers SquibbNot recruiting18 Years85 YearsBoth0Phase 4United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
776NCT01721057December 201230 September 2019A Study in Moderate to Severe Rheumatoid Arthritis ParticipantsA 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 ArthritisRheumatoid ArthritisDrug: Placebo;Drug: Baricitinib;Drug: cDMARDEli Lilly and CompanyNot recruiting18 YearsN/AAll684Phase 3United States;Argentina;Australia;Belgium;Canada;Croatia;Czechia;Germany;Hungary;India;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Taiwan;United Kingdom;Czech Republic
777NCT01752855December 201219 October 2017Study in Rheumatoid Arthritis for 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 AdalimumabRheumatoid ArthritisBiological: New formulation adalimumabAbbVie (prior sponsor, Abbott)Not recruiting18 YearsN/AAll88Phase 2United States;Belgium;Czech Republic;Germany;Puerto Rico;Romania;Slovakia
778NCT01759030December 201216 December 2017Study of Safety and Efficacy of BCD-020 Comparing to MabThera in Patients With Rheumatoid ArthritisDouble Blind Randomized Clinical Study Evaluating Efficacy and Safety of BCD-020 and MabThera in Patients With Rheumatoid Arthritis Who Had an Inadequate Response or Intolerance to Other DMARDs Including One or More TNF Inhibitor TherapiesRheumatoid ArthritisDrug: RituximabBiocadNot recruiting18 Years80 YearsAll181Phase 3Belarus;India;Russian Federation;Ukraine;Colombia
779NCT01770106December 201219 February 2015RA Denosumab on Bone Microstructure StudyComparison of the Effect of Denosumab and Alendronate on Bone Density and Microarchitecture in Rheumatoid Arthritis Females With Low Bone Mass: A Randomized Controlled TrialRheumatoid ArthritisDrug: Denosumab;Drug: AlendronateChinese University of Hong KongNot recruiting18 Years80 YearsFemale40Phase 4Hong Kong
780JPRN-UMIN0000111812012/11/192 April 2019Continuous epidural infusion versus periarticular multimodal drug injection in bilateral simultaneous total knee arthroplasty: a randomized controlled trialOsteoarthritis 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 hospitalNot Recruiting18years-oldNot applicableMale and Female60Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
781EUCTR2012-001618-40-CZ05/11/20126 January 2015Evaluation 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
Pharmaceutical Form: Solution for injection
Other descriptive name: TABALUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-		Eli Lilly and CompanyNot RecruitingFemale: yes
Male: yes		180United States;Czech Republic;Argentina;Poland;Russian Federation
782EUCTR2012-001760-30-IT05/11/20127 January 2013Evaluation 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-		OSSERVATORIO EPIDEMIOLOGICO GISEAAuthorisedFemale: yes
Male: yes		Italy
783EUCTR2012-000609-58-GB01/11/201228 February 2019A 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 biologicsRheumatoid 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
Pharmaceutical Form: Solution for injection
Current Sponsor code: NNC0109-0012
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: 0109-0012A 50 mg/ml
Pharmaceutical Form: Solution for injection
Current Sponsor code: NNC0109-0012
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: 0109-0012A 25 mg/ml
Pharmaceutical Form: Solution for injection
Current Sponsor code: NNC0109-0012
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Novo Nordisk A/SNot Recruiting Female: yes
Male: yes		268Phase 2United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany
784JPRN-UMIN0000090882012/11/012 April 2019Bio Logic MateTM clinical performance test for IFX Efficacy predictionrheumatoid arthritisIFX plus methotrexateBio Logic Mate Study GroupNot Recruiting20years-old75years-oldMale and Female150Not selectedJapan
785NCT01689532November 201219 October 2017A 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.GlaxoSmithKlineNot recruiting20 YearsN/AAll122Phase 3Japan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
786NCT01709760November 201211 June 2018A 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.Not recruiting20 YearsN/AAll91Phase 3Taiwan
787NCT01711359November 201230 September 2019A 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 CompanyNot recruiting18 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
788NCT01725230November 201219 February 2015Assess 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: SimvastatinAstraZenecaNot recruiting18 Years55 YearsBoth42Phase 1United States
789NCT01741493November 201216 December 2017A 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)Not recruiting18 Years75 YearsAll67Phase 1United States
790NCT01749787November 201219 February 2015Safety 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.Not recruiting18 YearsN/ABoth61Phase 1United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
791NCT01679951October 31, 201225 March 2019A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With 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 TherapyRheumatoid ArthritisDrug: Placebo;Drug: JNJ-38518168 (3 mg);Drug: JNJ-38518168 (10 mg);Drug: JNJ-38518168 (30 mg);Drug: MethotrexateJanssen Research & Development, LLCNot recruiting18 Years80 YearsAll272Phase 2United States;Argentina;Chile;Colombia;Czechia;Hungary;Japan;Korea, Republic of;Latvia;Mexico;Poland;Romania;Russian Federation;Taiwan;Thailand;Ukraine;Czech Republic
792NCT01636843October 30, 201217 September 2018A 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/SNot recruiting18 Years75 YearsAll298Phase 2United States;Argentina;Belgium;Brazil;Czechia;France;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;Spain;Ukraine;Czech Republic
793NCT01741688October 26, 201216 December 2017An 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 RocheNot recruiting18 YearsN/AAll16N/APeru
794EUCTR2010-021146-22-GB23/10/201229 October 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 studyRheumatoid 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 TrustAuthorisedFemale: yes
Male: yes		United Kingdom
795NCT01590966October 18, 20122 September 2019Scintigraphic Detection of the Biodistribution of Tumor Necrosis Factor With a Radiolabeled Anti-TNFa in Patients With Active Rheumatoid Arthritis and Active Axial and Peripheral SpondyloarthritisScintigraphic Detection of the Biodistribution of Tumor Necrosis Factor With a Radiolabeled Anti-TNFa in Patients With Active Rheumatoid Arthritis and Active Axial and Peripheral SpondyloarthritisAxial and Peripheral Spondyloarthritis;Rheumatoid ArthritisDrug: administration of Cimzia®;Drug: Immunoscintigraphy with radiolabeled Cimzia®.University Hospital, GhentUCB Pharma SANot recruiting18 Years70 YearsAll41Phase 3Belgium
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
796NCT01636557October 11, 201216 December 2017A Study to Evaluate the Effect of a Single Dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Patients With Rheumatoid ArthritisA Phase I, Open-label, Drug Interaction Study to Evaluate the Effect of a Single-dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Subjects With Rheumatoid ArthritisArthritis, RheumatoidDrug: Sirukumab;Drug: Midazolam;Drug: Warfarin;Drug: Vitamin K;Drug: Omeprazole;Drug: CaffeineJanssen Research & Development, LLCNot recruiting18 Years65 YearsAll12Phase 1Germany;Korea, Republic of;Moldova, Republic of;South Africa
797NCT01736189October 11, 201215 July 2019Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical PracticeAssessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice (Combo Study; Adalimumab With High Dose MTX)Rheumatoid ArthritisDrug: AdalimumabAbbVie (prior sponsor, Abbott)Not recruiting16 Years99 YearsAll346N/AJapan
798JPRN-JapicCTI-13209101/10/20122 April 2019A 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 AgentsRheumatoid 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.18BOTH234Phase 3
799JPRN-UMIN0000088122012/10/012 April 2019Efficacy 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 Immunology Saitama Medical Center, Saitama Medical UniversitityNot Recruiting16years-old80years-oldMale and Female40Not selectedJapan
800JPRN-UMIN0000103152012/10/012 April 2019Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessmentrheumatoid 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.Recruiting20years-oldNot applicableMale and Female50Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
801JPRN-UMIN0000181012012/10/012 April 2019Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective studyOsteoarthritis, 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 MedicineRecruitingNot applicableNot applicableMale and Female100Not selectedJapan
802NCT01609205October 201211 June 2018Doppler Evaluation in RA Patients After Adalimumab.Doppler 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 AdalimumabRheumatoid ArthritisBiological: AdalimumabHamed RezaeiAbbottNot recruiting18 YearsN/AAll60Phase 4Sweden
803NCT01619176October 201219 February 2015Acupuncture 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 medicineNot recruiting18 Years65 YearsFemale15N/AChina
804NCT01709578October 201216 December 2017To 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 PharmaceuticalsNot recruiting18 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
805NCT01710358October 201230 September 2019A Study in Moderate to Severe Rheumatoid ArthritisA 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 TherapyRheumatoid ArthritisDrug: Adalimumab;Drug: Baricitinib;Drug: Methotrexate;Drug: Adalimumab Placebo;Drug: Baricitinib PlaceboEli Lilly and CompanyNot recruiting18 YearsN/AAll1307Phase 3United States;Argentina;Belgium;Canada;China;Croatia;Czechia;France;Germany;Greece;Hungary;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Slovenia;South Africa;Spain;Switzerland;Taiwan;United Kingdom;Czech Republic;Netherlands
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
806NCT01730456October 201214 November 2016A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926A 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 ARTHRITISRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNot recruiting18 YearsN/ABoth13Phase 3Macedonia, The Former Yugoslav Republic of
807NCT01734993October 201219 October 2017A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA).A Multicenter, Open-Label Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNot recruiting18 YearsN/AAll11Phase 3France
808NCT01789151October 20127 November 201699m-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 SydneyAbbVieNot recruiting18 Years90 YearsBothN/AAustralia
809NCT01871961October 201223 March 2015Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)PatientEvaluation of Rheumatoid Arthritis Patient Performance Using the Metoject® Prefilled Pen (Methotrexate 50 mg/mL, Prefilled Pen) for Subcutaneous Injection and Subsequent Pharmacokinetic Assessment of Drug DeliveryRheumatoid Arthritis (RA)Drug: Methotrexate (Metoject® prefilled pen)medac GmbHPPD (CRO)Not recruiting16 YearsN/ABoth105Phase 1United States
810NCT02915094October 201216 December 2017Kineret in the Treatment of Rheumatoid ArthritisKineret in the Treatment of Rheumatoid ArthritisRheumatoid ArthritisDrug: AnakinraSwedish Orphan BiovitrumNot recruiting18 YearsN/AAll30N/AGermany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
811JPRN-jRCTs03218024528/09/20127 October 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 studyHip 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)		Masanobu SaitoNot Recruiting>= 20age old<= 75age oldBoth352Phase 4none
812EUCTR2011-006058-94-CZ26/09/201211 April 2016Secukinumab 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 2Rheumatoid 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: SECUKINUMAB
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: SECUKINUMAB
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use		Novartis Pharma Services AGNot 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
813NCT01711814September 26, 20123 June 2019A 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.Not recruiting18 YearsN/AAll611Phase 2United States;Belgium;Bulgaria;Colombia;Czechia;Hungary;Mexico;Poland;Czech Republic
814JPRN-UMIN0000152972012/09/1923 April 2019The feasibility study of accelated infliximab infusion from initial administrationThe feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administrationpatient 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 HospitalRecruiting20years-old70years-oldMale and Female54Phase 2Japan
815EUCTR2011-002894-48-GB14/09/201230 April 2019Efficacy, 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
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: BI 695500
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: Rituxan
Product Name: Rituxan
Pharmaceutical Form: Injection
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-		Boehringer Ingelheim International GmbHNot Recruiting Female: yes
Male: yes		300Phase 1;Phase 3Bulgaria;Germany;Norway;Belgium;Brazil;Poland;Argentina;Canada;Mexico;Hungary;United Kingdom;Guatemala;Netherlands;South Africa;Peru;France;Italy;Chile;Russian Federation;Ireland;Ukraine;Spain;Greece;Estonia;United States;Portugal;Serbia;New Zealand;Sweden
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
816JPRN-JapicCTI-13205112/9/201223 April 2019Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritisInvestigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritisRheumatoid ArthritisIntervention name : iguratimod (Careram)
Dosage And administration of the intervention : Oral		Eisai Co., Ltd.BOTH2000NA
817JPRN-JapicCTI-15278212/9/201223 April 2019Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritisInvestigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritisRheumatoid ArthritisIntervention name : Kolbet
INN of the intervention : Iguratimod
Dosage And administration of the intervention : Oral		Toyama Chemical Co., Ltd. (Current FUJIFILM Toyama Chemical Co., Ltd.)BOTH2000NA
818NCT01694264September 1, 201216 December 2017Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFaA Randomized, Double-blinded, Phase 3, Multicenter, Investigator-initiated Trial for Entecavir for Prophylaxis of Hepatitis B Virus (HBV) Reactivation in HBV Surface Antigen or Anti-HBc Positive Patients Undergoing Anti-TNFa TreatmentChronic Hepatitis B;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Juvenile Idiopathic ArthritisDrug: Entecavir;Drug: PlaceboSeoul National University HospitalKonkuk University Medical Center;Kyungpook National University;Kyunghee University Medical Center;Kyung Hee University Hospital at Gangdong;Gachon University Gil Medical Center;Daegu Catholic University Medical Center;Eulji University Hospital;SMG-SNU Boramae Medical Center;The Catholic University of Korea;Severance Hospital;Ajou University School of Medicine;Ewha Womans University Mokdong Hospital;Inha University Hospital;Chonnam National University Hospital;Chonbuk National University Hospital;Chungnam National University Hospital;Hallym University Medical Center;Hanyang University;Dong-A University;Korea University Guro HospitalNot recruiting16 Years85 YearsAll43Phase 3Korea, Republic of
819NCT01635686September 201219 February 2015Comparison 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.Not recruiting20 Years45 YearsMale38Phase 1Korea, Republic of
820NCT01640938September 201217 November 2015Study 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 PharmaceuticalsNot recruiting18 YearsN/ABoth259Phase 3United States;Brazil;Bulgaria;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Mexico;Russian Federation;Slovakia;Spain;Romania
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
821NCT01676701September 201211 June 2018Evaluation of Tabalumab Using Auto-Injector or Prefilled Syringe in Participants With Rheumatoid Arthritis (RA)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 MethotrexateRheumatoid ArthritisDrug: Tabalumab Auto-Injector;Drug: Tabalumab Prefilled SyringeEli Lilly and CompanyNot recruiting18 YearsN/AAll8Phase 3United States;Argentina;Czechia;Poland;Puerto Rico;Russian Federation;Czech Republic
822EUCTR2011-006070-73-DE28/08/201227 January 2014Evaluation 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 ABPMRheumatoid 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib disodium
CAS Number: 914295-16-2
Current Sponsor code: R935788 sodium
Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		AstraZeneca ABNot RecruitingFemale: yes
Male: yes		130United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Bulgaria;South Africa;Germany
823EUCTR2012-000535-36-BE28/08/201221 August 2017A 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Abbott GmbH & Co. KGNot RecruitingFemale: yes
Male: yes		100Phase 2United States;Czech Republic;Slovakia;Puerto Rico;Poland;Belgium;Romania;Germany
824NCT01643928August 16, 201216 December 2017Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)Extension Study Evaluating Treatment With Pf-05280586 Versus Rituximab In Subjects With Active Rheumatoid Arthritis Who Have Participated In Other Pf-05280586 Clinical TrialsRheumatoid ArthritisBiological: Rituximab-Pfizer (PF-05280586) x 3 courses;Biological: Rituximab-EU+ Rituximab-Pfizer x 2 Courses;Biological: Rituximab-US + Rituximab-Pfizer x 2 CoursesPfizerNot recruiting18 YearsN/AAll185N/AUnited States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Switzerland;Ukraine
825NCT01604343August 20129 January 2017A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D)A 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 TherapyArthritis, RheumatoidDrug: Placebo;Drug: SirukumabJanssen Research & Development, LLCGlaxoSmithKlineNot recruiting18 YearsN/ABoth1670Phase 3United States;Bulgaria;Canada;Chile;Colombia;Croatia;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;South Africa;Taiwan;Ukraine;Argentina;Brazil;India;Peru
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
826NCT01606761August 20122 November 2015A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T)A 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 TherapyArthritis, RheumatoidDrug: Placebo;Drug: SirukumabJanssen Research & Development, LLCGlaxoSmithKlineNot recruiting18 YearsN/ABoth879Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Croatia;France;Germany;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;Spain;Taiwan;United Kingdom;Brazil;China
827NCT01636817August 201217 September 2018A 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/SNot recruiting18 Years75 YearsAll239Phase 2United States;Argentina;Belgium;Brazil;Czechia;France;Germany;Hungary;Italy;Mexico;Poland;Spain;United Kingdom;Czech Republic
828NCT01652937August 201219 February 2015BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic DrugsA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BIIB057 in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic DrugsRheumatoid ArthritisDrug: BIIB057;Drug: PlaceboBiogen IdecNot recruiting18 YearsN/AFemale0Phase 2Canada
829NCT01662063August 201219 October 2017A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA)A Multicenter Open-Label, Long-Term Extension Study of WA22762 and NA25220 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisDrug: TocilizumabGenentech, Inc.Not recruiting18 YearsN/AAll218Phase 3United States;Puerto Rico
830NCT01706926August 201219 October 2017A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid ArthritisA Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid ArthritisRheumatoid ArthritisBiological: Mavrilimumab 30 mg;Biological: Mavrilimumab 100 mg;Biological: Mavrilimumab 150 mg;Other: PlaceboMedImmune LLCMedImmune LtdNot recruiting18 Years80 YearsAll420Phase 2Argentina;Bulgaria;Chile;Colombia;Czech Republic;Estonia;Germany;Hungary;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;France;Mexico
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
831NCT01746680August 201224 August 2015Efficacy and Safety Study of Tacrobell to Treat Rheumatoid ArthritisPhase IV STudy of Tacrobell in Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Tacrolimus with MethotrexateChong Kun Dang PharmaceuticalNot recruiting20 YearsN/ABoth111Phase 4Korea, Republic of
832NCT01870908August 201212 October 2015Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis PatientsDrug Use-result Survey to Assess the Safety and Efficacy of the Combination of Tacrolimus + Biological Agents in Daily Clinical SettingsRheumatoid ArthritisDrug: tacrolimus;Drug: biological agentsAstellas Pharma IncNot recruitingN/AN/ABoth664N/AJapan
833JPRN-UMIN0000085722012/07/312 April 2019The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patientsRheumatoid 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 hospital 2)Kitasato institute hospital 3)Ishikawa internal medicine clinicRecruiting20years-old70years-oldMale and Female80Not applicableJapan
834NCT01705730July 31, 201210 September 2018A 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 RocheNot recruiting18 YearsN/AAll71N/ABelgium
835EUCTR2011-005648-93-EE19/07/201211 April 2016A 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 ArthritisRheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: mavrilimumab
CAS Number: 1085337-57-0
Current Sponsor code: CAM-3001
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-		MedImmune LtdNot 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
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
836JPRN-UMIN0000109022012/07/112 April 2019A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplastyOsteoarthritis 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 hospitalNot Recruiting18years-oldNot applicableMale and Female100Not selectedJapan
837EUCTR2011-005376-42-LV06/07/201215 July 2013A 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 arthritisRheumatoid 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: 0114-0006B
Pharmaceutical Form: Powder for solution for infusion
Current Sponsor code: NNC0114-0006
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intravenous use		Novo Nordisk A/SNot RecruitingFemale: yes
Male: yes		60Serbia;Hungary;Spain;Poland;Bulgaria;Russian Federation;Latvia
838NCT01554696July 6, 201211 June 2019A 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 in Patients Who Have Had an Inadequate Response to MethotrexateArthritis, RheumatoidDrug: peficitinib;Drug: Placebo;Drug: methotrexateAstellas Pharma IncNot recruiting18 YearsN/AAll379Phase 2United States;Belgium;Bulgaria;Colombia;Czechia;Hungary;Mexico;Poland;Czech Republic
839JPRN-UMIN0000084042012/07/012 April 2019Extension 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 HospitalNot Recruiting20years-oldNot applicableMale and Female50Not selectedJapan
840JPRN-UMIN0000332222012/07/012 April 2019Clinical Results of Prophylactic Iodine-supported Primary TKA for Compromised CasesOsteoarthritis, Rheumatoid arthritis of knee jointprophylactic iodine-suported primaru TKAFukui General HospitalNot Recruiting50years-old90years-oldMale and Female30Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
841NCT01640054July 201219 October 2017A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in AsiaRheumatoid ArthritisDrug: FostamatinibAstraZenecaNot recruiting18 YearsN/AAll115Phase 2Hong Kong;Japan;Korea, Republic of;Taiwan;Thailand;Vietnam
842NCT01659242July 201219 February 2015Leflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis:an Ultrasound/Magnetic Resonance Imaging StudyLeflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis Patients With Active Disease Despite Methotrexate: an Ultrasound and Magnetic Resonance Imaging StudyRheumatoid ArthritisDrug: Methotrexate plus sulfasalazine;Drug: LeflunomideSingapore General HospitalNot recruiting21 Years65 YearsBoth1Phase 4Singapore
843NCT01665430July 201219 February 2018A Long-Term Extension Study to WA19926 (NCT01007435) of Tocilizumab in Participants With Early, Moderate to Severe Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNot recruiting18 YearsN/AAll38Phase 3Poland
844NCT01793259July 201219 February 2015Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)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 ArthritisRheumatoid ArthritisDrug: methotrexate prefilled pen;Drug: methotrexate prefilled syringemedac GmbHNot recruiting18 Years75 YearsBoth120Phase 3Germany
845NCT01893151July 201219 February 2015Effectiveness of Iguratimod Versus Placebo to Treat Early Rheumatoid Arthritis on MRIA Randomized, Double-blind Study to Evaluate the Efficacy of Iguratimod Versus Placebo in Patients With Rheumatoid Arthritis on Magnetic Resonance Imaging (MRI)Rheumatoid ArthritisDrug: Iguratimod;Drug: Iguratimod placeboJiangsu Simcere Pharmaceutical Co., Ltd.Recruiting18 Years65 YearsBoth200Phase 4China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
846EUCTR2011-005260-20-GB28/06/201228 February 2019RoActemra® (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-TAPERAdult 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Methotrexate Disodium
CAS Number: 7413345
Other descriptive name: Methotrexate as methotrexate disodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Methotrexate Disodium
CAS Number: 7413345
Other descriptive name: Methotrexate as methotrexate disodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Methotrexate 2.5mg Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate Disodium
CAS Number: 7413345
Other descriptive name: Methotrexate as methotrexate disodium
Concentration unit: mg milligram(s)
Concentration type: equal		Roche Products LimitedNot Recruiting Female: yes
Male: yes		618Phase 4United Kingdom
847EUCTR2011-005204-15-AT20/06/201230 April 2019Could 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) - RABioStopbiological 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
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Enbrel
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Humira
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Cimzia
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Trade Name: Simponi
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Roactemra
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB		Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und ImmunologieAuthorised Female: yes
Male: yes		110Phase 4Austria
848NCT01565655June 19, 201211 June 2019A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid ArthritisA 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 PatientsArthritis, RheumatoidDrug: peficitinib;Drug: PlaceboAstellas Pharma Global Development, Inc.Not recruiting18 YearsN/AAll289Phase 2Hungary;Mexico;Poland;Bulgaria;Czechia;United States;Czech Republic
849EUCTR2011-001122-18-HU13/06/201210 June 2014A 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 TherapyRheumatoid 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
Pharmaceutical Form: Lyophilisate for solution for injection
Current Sponsor code: CNTO 1959
Other descriptive name: CNTO 1959 IgG
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: CNTO 1959
Pharmaceutical Form: Lyophilisate for solution for injection
Current Sponsor code: CNTO 1959
Other descriptive name: CNTO 1959 IgG
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: Ustekinumab
Product Code: CNTO1275
Pharmaceutical Form: Solution for injection
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: Ustekinumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Janssen-Cilag International NVNot 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
850NCT01638013June 13, 201222 October 2019A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015KOpen-label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase 2b Study or Phase 3 Study of ASP015KArthritis, RheumatoidDrug: peficitinibAstellas Pharma IncNot recruiting20 YearsN/AAll843Phase 3Japan;Korea, Republic of;Taiwan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
851EUCTR2009-017998-37-BE08/06/20122 May 2016Scintigraphic 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 Level: HLT 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
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Product Name: 99mTc-S-HYNIC Certolizumab pegol
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-		Ghent University HospitalAuthorisedFemale: yes
Male: yes		Belgium
852NCT01611688June 4, 201216 December 2017First 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/SNot recruiting18 Years75 YearsAll36Phase 1Germany
853JPRN-UMIN0000078062012/06/012 April 2019The feasibility study of accelated infliximab infusion during maintenance phasepatient 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 HospitalNot RecruitingNot applicableNot applicableMale and Female54Phase 2Japan
854NCT01602302June 20123 September 2018Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid ArthritisUltrasound as Biomarker for Withdrawal of Biological DMARDs in Rheumatoid ArthritisRheumatoid ArthritisDrug: bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept)Medical University of GrazRecruiting18 Years90 YearsAll110Phase 4Austria
855NCT01664104June 201216 December 2017A Study to Evaluate Tocilizumab Treatment in a Real-Life SettingCRP and BMI Study: Evaluation in Real Life of Clinical Remission Rate and Correlation Between CRP and BMI in Patients Treated With TocilizumabRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNot recruiting18 YearsN/AAll151N/AItaly
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
856NCT02052375June 201219 February 2015A Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Multiple Dose Subcutaneous Injections in Patients With Rheumatoid Arthritis on MethotrexateA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Subcutaneous Injections in Patients With Rheumatoid Arthritis on MethotrexateRheumatoid Arthritis;Pharmacokinetics of ASP2408Drug: ASP2408;Drug: PlaceboAstellas Pharma Global Development, Inc.Not recruiting18 Years75 YearsBoth24Phase 1United States
857EUCTR2012-000222-21-DE31/05/201213 May 2013Comparison 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 RARheumatoid 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Methotrexate disodium
CAS Number: 59-05-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Product Name: methotrexate pre-filled pen
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Methotrexate disodium
CAS Number: 59-05-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		medac Gesellschaft für klinische Spezialpräparate mbHNot RecruitingFemale: yes
Male: yes		Germany
858EUCTR2011-005634-19-HU30/05/201225 February 2013A 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: mavrilimumab
CAS Number: 1085337-57-0
Current Sponsor code: CAM-3001
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		MedImmune LtdAuthorisedFemale: yes
Male: yes		280Phase 2bSerbia;Estonia;Spain;Ukraine;Chile;Russian Federation;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Bulgaria;South Africa;Germany
859EUCTR2011-006040-79-DK25/05/20128 January 2018A 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 EarlyAdult 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®
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		Aarhus University Hospital, Department of Rheumatology UNot RecruitingFemale: yes
Male: yes		180Phase 4Denmark
860EUCTR2011-004419-22-DE23/05/201221 September 2015Study 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 ExtensionRheumatoid 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
Pharmaceutical Form: Tablet
Current Sponsor code: VX-509
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes		350Phase 2Serbia;United States;Estonia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
861NCT01569152May 22, 20121 April 2019Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008)A 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 TherapyRheumatoid Arthritis (RA)Drug: MK-8457 100 mg;Drug: Dose-Matched Placebo;Drug: MethotrexateMerck Sharp & Dohme Corp.Not recruiting18 YearsN/AAll82Phase 2Canada;Chile;Denmark;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Moldova, Republic of;Peru;Poland;South Africa;Taiwan;United Kingdom;United States
862EUCTR2011-005448-87-HU14/05/201210 July 2015A 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)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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Pfizer Inc, 235 East 42nd Street, New York, NY 10017Not 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
863EUCTR2012-000139-21-AT14/05/201215 October 2018Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of ActionA Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBioRheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: millilitre(s)/gram
Concentration type: up to
Concentration number: 100-5
Trade Name: Orencia
Product Name: Orencia
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 250-
Trade Name: Ro-Actemra
Product Name: Ro Actemra
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: Mabthera
Product Name: Mabthera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Orencia
Product Name: Orencia
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Trade Name: Ro-Actemra
Product Name: Ro Actemra
Pharmaceutical Form: Solution for injection
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB
Concentration unit: millilitre(s)/gram
Concentration type: equal
Concentration number: 162-		Medizinische Universität Wien, Universitätsklinik für Innere Medizin IIINot RecruitingFemale: yes
Male: yes		Phase 4Czech Republic;Slovakia;Austria;Russian Federation;Switzerland
864EUCTR2012-000439-17-LT11/05/201223 September 2013A 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 Arthritisactive rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: MK-8457
Product Code: MK-8457
Pharmaceutical Form: Tablet
INN or Proposed INN: None
Other descriptive name: MK-8457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: MK-8457
Product Code: MK-8457
Pharmaceutical Form: Tablet
INN or Proposed INN: None
Other descriptive name: MK-8457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		MERCK SHARP & DOHME CORP.Not 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
865EUCTR2011-005008-14-HU10/05/201212 November 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 AloneRheumatoid 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
Pharmaceutical Form: Capsule, hard
Current Sponsor code: GLPG0634
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GLPG0634
Pharmaceutical Form: Capsule, hard
Current Sponsor code: GLPG0634
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Product Name: GLPG0634
Pharmaceutical Form: Capsule, hard
Current Sponsor code: GLPG0634
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: GLPG0634
Pharmaceutical Form: Capsule, hard
Current Sponsor code: GLPG0634
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-		Galapagos SASUNot RecruitingFemale: yes
Male: yes		90Phase 2Hungary;European Union;Ukraine;Russian Federation;Moldova, Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
866EUCTR2011-005021-48-HU04/05/20129 October 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) - ALTOadult 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TL011
Current Sponsor code: TL011
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-		Teva Pharmaceutical IndustriesNot RecruitingFemale: yes
Male: yes		544Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
867EUCTR2011-006125-14-HU04/05/201223 February 2015A 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 LTERheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion		Roche (Magyarország) Kft.Not RecruitingFemale: yes
Male: yes		241Hungary
868JPRN-UMIN0000077862012/05/012 April 2019"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 UniversityNot Recruiting20years-old75years-oldMale and Female40Not applicableJapan
869JPRN-UMIN0000144842012/05/012 April 2019Saitama Actemra study for QOL in patients with Rheumatoid arthritisrheumatoid arthritisTreatment with TocilizumabJuntendo University, Juntendo Koshigaya HospitalNot Recruiting20years-oldNot applicableMale and Female40Not selectedJapan
870NCT01548001May 201214 March 2016Long-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.Not recruiting18 Years65 YearsBoth910Phase 4China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
871NCT01554917May 201214 March 2016A Study of Iguratimod in Patients With Active Rheumatoid ArthritisA Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: IguratimodJiangsu Simcere Pharmaceutical Co., Ltd.Not recruiting18 YearsN/ABoth1759Phase 4China
872NCT01559103May 20122 March 2015Study 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 PlaceboAstraZenecaNot recruiting20 Years75 YearsBoth39Phase 1United States;Germany;United Kingdom
873NCT01576549May 201211 June 2018A Study of LY2127399 in Rheumatoid ArthritisAn Exploratory Open-Label Biomarker Study of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Synovial BiopsiesRheumatoid ArthritisDrug: LY2127399Eli Lilly and CompanyNot recruiting18 YearsN/AAll2Phase 2United States
874NCT01579006May 201219 October 2017Observational 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 ServicesNot recruiting18 YearsN/AAll184N/AIsrael
875NCT01613079May 201219 February 2015Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid ArthritisEvaluation of Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of RA Patients With Clinical Efficacy and Safety.Arthritis, RheumatoidDrug: Tripterygium wilfordii Hook F;Drug: MethotrexatePeking Union Medical College HospitalNot recruiting18 Years65 YearsBoth201Phase 2/Phase 3China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
876NCT01617005May 201219 October 2017A 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 RocheNot recruiting18 YearsN/AAll50N/AMontenegro
877NCT01617590May 201219 February 2015Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy ResearchA 48-week, Multi-center, Randomized, Open-lable, Controlled Study to Assess the Response (ACR20) Using Different Disease-Modifying Antirheumatic Drugs Cycle Combination Regimen in Adult Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: leflunomide;Drug: methotrexateShanxi Medical UniversityRecruiting18 Years75 YearsBoth500N/AChina
878NCT01638715May 201212 November 2018A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of ActionA Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of ActionRheumatoid ArthritisDrug: Remicade;Drug: Orencia;Drug: Ro-Actemra;Drug: MabtheraMedical University of ViennaNot recruiting18 Years75 YearsAll115Phase 4Austria;Czechia;Russian Federation;Switzerland;Czech Republic;Saudi Arabia
879NCT01664598May 201215 August 2016An Extension Study of WA19926 of the Long-Term Safety of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNot recruiting18 YearsN/ABoth49Phase 3Russian Federation
880NCT01668641May 201219 February 2015Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis PatientsRandomized, 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 AloneRheumatoid ArthritisDrug: GLPG0634;Drug: PlaceboGalapagos NVNot recruiting18 Years70 YearsBoth91Phase 2Hungary;Moldova, Republic of;Russian Federation;Ukraine
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
881NCT01724268May 201219 February 2015Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis PatientRandomized Controlled Clinical Trial of Low Dose Corticosteroids vs Anti TNF Treatment in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient- a Pilot StudyRHEUMATOID ARTHRITISDrug: Pred + Meth;Drug: Anti TNF + MethHamad Medical CorporationRecruiting18 YearsN/ABoth80Phase 3Qatar
882JPRN-UMIN0000180172012/04/232 April 2019Analysis 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 therapyrheumatoid 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 hospitalNot Recruiting20years-oldNot applicableMale and Female70Not selectedJapan
883EUCTR2011-004529-28-HU18/04/201229 April 2013A 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 availableRheumatoid 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
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not assigned
CAS Number: ---
Current Sponsor code: JNJ-40346527-AAC
Other descriptive name: Not assigned
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		Janssen-Cilag International NVNot RecruitingFemale: yes
Male: yes		90Phase 2aCzech Republic;Hungary;Argentina;Poland;Ukraine;Singapore;Chile;Bulgaria;Russian Federation;Korea, Republic of
884EUCTR2011-001729-25-DE11/04/201216 November 2015Study 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Current Sponsor code: CDP870
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Trexan
Product Name: Methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-		UCB Pharma SANot 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
885JPRN-UMIN0000110872012/04/112 April 2019Efficacy of monthly minodronate for the treatment of osteoporosis associated with rheumatoid arthritis after previous treatment with bisphosphonatesOsteoporosisMinodronic acid (50mg/month or 1mg/day)Osaka University Graduate School of MedicineNot Recruiting20years-oldNot applicableMale and Female100Not applicableJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
886JPRN-UMIN0000073802012/04/012 April 2019Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritisrheumatoid arthritistocilizumab + methotrexate (10mg/week)
high-dose methotrexate (stepwisely increased to 16mg/week)		Kinki University Faculty of Medicine, Division of Hematology and RheumatologyNot Recruiting20years-old80years-oldMale and Female40Not selectedJapan
887JPRN-UMIN0000074322012/04/012 April 2019Prospective 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 UniversityNot Recruiting20years-old75years-oldMale and Female100Not selectedJapan
888NCT01484561April 201219 October 2017A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid ArthritisA Phase 1, Randomized, Placebo-Controlled, Two-Period, Fixed Sequence Study To Evaluate The Effect Of CP-690,550 On Measured Glomerular Filtration Rate In Patients With Active Rheumatoid ArthritisArthritis, RheumatoidDrug: CP-690,550 or Placebo;Drug: PlaceboPfizerNot recruiting18 YearsN/AAll148Phase 1United States;Czech Republic;Germany;Korea, Republic of;Mexico;Poland;Russian Federation;Spain
889NCT01557374April 201225 February 2019TOward the Lowest Effective DOse of Abatacept or TocilizumabTapering Abatacept or Tocilizumab in Rheumatoid Arthritis in Remission. An Evaluation of Disease Activity, Relapse Risk, Structural Progression and the Economic Impact of a Tapering StrategyRheumatoid ArthritisDrug: Tocilizumab, Abatacept;Drug: Decrease Tocilizumab, AbataceptAssistance Publique - Hôpitaux de ParisMinistry of Health, FranceNot recruiting18 YearsN/AAll232Phase 4France
890NCT01569074April 201219 October 2017Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis(OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate TherapyRheumatoid ArthritisDrug: Fostamatinib;Drug: PlaceboAstraZenecaNot recruiting18 YearsN/AAll163Phase 2Hong Kong;Japan;Korea, Republic of;Taiwan;Thailand;Vietnam
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
891NCT01579890April 201219 February 2015Compassionate 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.Not recruitingN/AN/ABothN/A
892NCT01583959April 201219 February 2015Study of Different Doses of Folic Acid in Combination With Methotrexate in Rheumatoid ArthritisRandomized Trial of 10 mg Versus 30 mg Per Week of Folic Acid in Combination With Methotrexate in Rheumatoid ArthritisRheumatoid ArthritisDrug: Folic Acid;Drug: PlaceboPostgraduate Institute of Medical Education and ResearchNot recruiting18 Years75 YearsBoth100Phase 4India
893NCT01655381April 201219 October 2017A Long-Term Extension Study of WA19926 on the Safety of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNot recruiting18 YearsN/AAll15Phase 3France
894NCT02171143April 201219 February 2015A Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on MethotrexateA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on MethotrexateRheumatoid Arthritis;Pharmacokinetics of ASP2409Drug: ASP2409;Drug: PlaceboAstellas Pharma Global Development, Inc.Not recruiting18 Years75 YearsBoth58Phase 1United States
895NCT02818361April 20123 December 2018Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid ArthritisTopical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid ArthritisArthritis, RheumatoidDrug: Topical tripterygium gel;Drug: Placebo gelGuang'anmen Hospital of China Academy of Chinese Medical SciencesNot recruiting18 Years65 YearsAll70N/AChina
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
896EUCTR2011-002392-41-HU28/03/201214 January 2013A 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 ARTHRITISTreatment 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
Pharmaceutical Form: Capsule
INN or Proposed INN: Prednisolone
CAS Number: 52438-85-4
Current Sponsor code: Prednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.7-
INN or Proposed INN: Dipyridamole
CAS Number: 58-32-2
Current Sponsor code: Dipyridamole
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 180-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Dacortin ®
Product Name: Prednisone
Pharmaceutical Form: Capsule
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5.0-7.5
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use		Zalicus, Inc.Not RecruitingFemale: yes
Male: yes		200Phase 2Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria
897EUCTR2011-006001-10-IT19/03/201225 September 2012Efficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical responseEfficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response -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] - Immune System Diseases [C20]		Trade Name: MABTHERA*EV 1FL 50ML 500MG
Pharmaceutical Form: Injection
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Trade Name: MABTHERA*EV 1FL 50ML 500MG
Pharmaceutical Form: Injection
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-		A.O. UNIVERSITARIA INTEGRATA DI VERONAAuthorisedFemale: yes
Male: yes		48Italy
898EUCTR2011-002275-41-CZ15/03/201218 March 2013A 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-		Abbott GmbH & Co. KGNot RecruitingFemale: yes
Male: yes		60Belgium;Czech Republic
899JPRN-UMIN0000172302012/03/012 April 2019Correlation 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 UniversityRecruiting20years-oldNot applicableMale and Female60Not selectedJapan
900NCT01649999March 1, 201222 July 2019A Study to Evaluate the Efficacy and Safety of ASP015K in Moderate to Severe Rheumatoid Arthritis SubjectsPhase 2b Study of ASP015K - A Double-Blind, Placebo-Controlled, Dose-Finding Study in Moderate to Severe Rheumatoid Arthritis PatientsArthritis, RheumatoidDrug: peficitinib;Drug: PlaceboAstellas Pharma IncNot recruiting20 Years75 YearsAll281Phase 2Japan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
901NCT01526057March 201219 February 2015A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)A 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 TherapiesRheumatoid ArthritisBiological: PF-05280586;Biological: MabThera;Biological: RituxanPfizerNot recruiting18 YearsN/ABoth222Phase 1/Phase 2United States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Taiwan
902NCT01565408March 201216 December 2017Safety 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/SNot recruiting18 Years75 YearsAll32Phase 1Germany;Russian Federation
903NCT01582880March 20124 November 2019Use of Cross-linked Donor Corneas as Carriers for the Boston KeratoprosthesisThe Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston KeratoprosthesisChemical Injuries;Unspecified Complication of Corneal Transplant;Autoimmune Diseases;Ocular Cicatricial Pemphigoid;Stevens Johnson Syndrome;Lupus Erythematosus, Systemic;Rheumatoid Arthritis;Other Autoimmune DiseasesDrug: RiboflavinJoseph B. Ciolino, MDNot recruiting18 YearsN/AAll1Phase 1/Phase 2United States
904NCT01612377March 201219 February 2015Long Term Safety Trial of z102 and Prednisone in Patients With Moderate to Severe Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: Prednisolone-Dipyridamole;Drug: Prednisone;Drug: prednisoneZalicusNot recruiting18 YearsN/ABoth18Phase 2Serbia
905NCT01626573March 201225 March 2019A Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid ArthritisA Double- Blind, Placebo Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Itacitinib;Drug: Itacitinib PlaceboIncyte CorporationNot recruiting18 Years75 YearsAll106Phase 2United States;Puerto Rico
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
906NCT01670045March 201219 October 2017A 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 RocheNot recruiting18 YearsN/AAll43N/AIndonesia;Greece
907EUCTR2011-004171-36-CZ15/02/201221 August 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: 14.0 Level: PT 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: SAIT101
Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: MabThera®
Product Name: MabThera®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-		Samsung Electronics Co. Ltd.Not RecruitingFemale: yes
Male: yes		616Poland;Spain;Korea, Republic of;Romania;Mexico;Argentina;Taiwan;Canada;United Kingdom;Russian Federation;Czech Republic;Brazil;South Africa;Turkey;Switzerland;Hungary
908NCT01623752February 10, 20122 July 2018Prospective Evaluation of the Radiographic Efficacy of EnbrelA Prospective Evaluation Of The Radiographic Efficacy Of Etanercept In Patients With Rheumatoid Arthritis Or Psoriatic Arthritis.Rheumatoid Arthritis;Psoriasis ArthritisDrug: EtanerceptPfizerNot recruiting18 YearsN/AAll1816Phase 2
909JPRN-UMIN0000067022012/02/012 April 2019A 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 Arthritisrheumatoid 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 PharmacovigilanceNot Recruiting20years-old70years-oldMale and Female290Not applicableJapan
910JPRN-UMIN0000070192012/02/012 April 2019Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's diseaseRheumatoid arthritistocilizumab monotherapyDepartment of Rheumatology & Clinical Immunology,Saitama Medical Center, Saitama Medical UniversitityNot Recruiting16years-old70years-oldMale and Female40Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
911JPRN-UMIN0000072052012/02/012 April 2019The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritisRheumatoid 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 UniversityNot Recruiting65years-oldNot applicableMale and Female30Not selectedJapan
912NCT01352858February 201217 September 2018Autologous Tolerogenic Dendritic Cells for Rheumatoid Arthritis (AutoDECRA)Phase 1 Study of Autologous Tolerogenic Dendritic Cells for Rheumatoid ArthritisRheumatoid ArthritisDrug: TolDC;Drug: Arthroscopy & saline irrigation aloneNewcastle UniversityArthritis Research UK;Newcastle-upon-Tyne Hospitals NHS TrustRecruiting18 YearsN/AAll15Phase 1United Kingdom
913NCT01395251February 201225 May 2015Diagnostic Value of Oral Prednisolone Test for Rheumatoid ArthritisPhase II/III Study of Oral Prednisolone Test in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: PrednisoloneRheumazentrum RuhrgebietNot recruiting18 YearsN/ABoth130Phase 2/Phase 3Germany
914NCT01438892February 201219 February 2015Impact Of RA Therapy Compliance On Patient-Reported OutcomesImpact Of RA Therapy Compliance On Patient-Reported OutcomesRheumatoid ArthritisDrug: tDMARDs;Drug: biodmardsPfizerNot recruiting18 YearsN/ABoth396N/AUnited States
915NCT01534884February 20121 June 2015Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid ArthritisPhase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid ArthritisRheumatoid ArthritisBiological: rituximabCelltrionNot recruiting18 Years75 YearsBoth154Phase 1Korea, Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
916NCT01562327February 201219 October 2017A 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 RocheNot recruiting18 YearsN/AAll50N/AArgentina
917NCT01567358February 201219 February 2015Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid ArthritisA Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With MethotrexateRheumatoid ArthritisBiological: InfliximabNichi-Iko Pharmaceutical Co.,Ltd.Not recruiting20 Years75 YearsBoth14Phase 1Japan
918NCT01613027February 201219 October 2017An Observational Study of MabThera in Participants With Severe Active Rheumatoid ArthritisA Multicenter Observational Study of the Response to Rituximab (MabThera®) in Seropositive Patients With Rheumatoid Arthritis With Inadequate Response or Intolerance to Treatment With One or More Tumor Necrosis Factor Inhibitors (TNFi)Rheumatoid ArthritisBiological: RituximabHoffmann-La RocheNot recruiting18 YearsN/AAll135N/AGreece
919NCT01646385February 201219 October 2017Study 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 drugsPfizerNot recruiting18 YearsN/AAll6393N/A
920NCT01940926February 201216 December 201768Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid ArthritisDiagnostic Performance and Evaluation Efficacy of 68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: 68Ga-BNOTA-PRGD2Peking Union Medical College HospitalNot recruiting18 YearsN/AAll50Early Phase 1China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
921NCT02090556January 31, 201226 November 2018Long-term Experience With Abatacept SC in Routine Clinical PracticeLong-term Experience With Abatacept SC in Routine Clinical PracticeRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbinVentiv Health Clinical;PharmaNetNot recruiting18 YearsN/AAll2896N/AAustralia;Austria;France;Germany;Greece;Italy;Monaco;Netherlands;Spain;Switzerland;United Kingdom
922EUCTR2011-002849-36-LV12/01/201228 September 2015A 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 availableRheumatoid 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
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Not assigned
CAS Number: Not assigned
Current Sponsor code: JNJ-39758979-AAC
Other descriptive name: Not assigned
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Gastro-resistant tablet
Route of administration of the placebo: Oral use
Product Name: JNJ-39758979-AAC - enteric coated tablet - 30 mg
Product Code: JNJ-39758979
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Not assigned
CAS Number: Not assigned
Current Sponsor code: JNJ-39758979-AAC
Other descriptive name: Not assigned
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Gastro-resistant tablet
Route of administration of the placebo: Oral use
Product Name: JNJ-39758979-AAC - enteric coated tablet - 100 mg
Product Code: JNJ-39758979
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Not assigned
CAS Number: Not assigned
Current Sponsor code: JNJ-39758979-AAC
Other descriptive name: Not assigned
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Gastro-resistant tablet
Route of administration of the placebo: Oral use		Janssen-Cilag International NVNot RecruitingFemale: yes
Male: yes		325Phase 2bJapan;Latvia;Romania;Singapore;Malaysia;Poland;Argentina;Mexico;Czech Republic;Colombia;Chile;Russian Federation;Ukraine;United States
923EUCTR2011-004468-31-GB06/01/201228 August 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 3.1Rheumatoid 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
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Infliximab
CAS Number: 170277-31-3
Current Sponsor code: CT-P13
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-		CELLTRION, IncAuthorisedFemale: yes
Male: yes		617Poland;Philippines;Bosnia and Herzegovina;Spain;Romania;Mexico;Peru;Ukraine;Slovakia;United Kingdom;Lithuania;Austria;Latvia;Italy;Chile;Bulgaria;Colombia;Portugal
924ChiCTR-TRC-120018592012-01-0118 April 2017Treatment of coronary heart disease in rheumatoid arthritis with leflunomide combined with ligustrazine in clinical researchTreatment of coronary heart disease in rheumatoid arthritis with leflunomide combined with ligustrazine in clinical researchcoronary heart disease in rheumatoid arthritis1:leflunomide combined with ligustrazine;2:leflunomide combined with placebo;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical SciencesNot Recruiting1865Both1:30;2:30;OtherChina
925JPRN-UMIN0000126132012/01/012 April 2019Reduction 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 CollegeNot Recruiting20years-old70years-oldMale and Female30Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
926NCT01474291January 201219 October 2017An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical PracticeEvaluation of Factors Influencing Use of RoActemra® as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLORheumatoid ArthritisBiological: TocilizumabHoffmann-La RocheNot recruiting18 YearsN/AAll608N/AFrance;Monaco
927NCT01502423January 201219 October 2017A Crossover Study of the Safety and Tolerability of Two Formulations of AdalimumabA Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid ArthritisRheumatoid ArthritisBiological: AdalimumabAbbVie (prior sponsor, Abbott)Not recruiting18 YearsN/AAll61Phase 2Australia;Canada;Germany
928NCT01506661January 201216 December 2017Zostavax in Rheumatoid ArthritisImmune Response to Varicella Zoster Vaccination (ZOSTAVAX) in Subjects With Rheumatoid ArthritisRheumatoid Arthritis;Varicella ZosterDrug: Zostavax (varicella zoster virus) vaccineOklahoma Medical Research FoundationNot recruiting50 Years80 YearsAll20Phase 1United States
929NCT01519791January 201211 June 2018A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early 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 ArthritisRheumatoid ArthritisBiological: Certolizumab Pegol;Other: Placebo;Biological: MethotrexateUCB Pharma SANot recruiting18 YearsN/AAll880Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;Ireland;Italy;Mexico;Monaco;Netherlands;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom;Czech Republic
930NCT01521923January 201211 June 2018A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early 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 ArthritisRheumatoid ArthritisBiological: Certolizumab Pegol + Methotrexate (MTX);Biological: Placebo + Methotrexate (MTX)UCB PharmaNot recruiting18 YearsN/AAll359Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;Ireland;Italy;Mexico;Monaco;Netherlands;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom;Czech Republic
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
931NCT01533714January 201219 February 2015The Long-term Safety and Efficacy of Olokizumab (CDP6038) With Active Rheumatoid ArthritisMulti-center, Open-label, Follow-up Study to Assess the Long-term Safety and Efficacy of CDP6038 Administered Subcutaneously to Asian Subjects With Active Rheumatoid Arthritis Who Completed Study RA0083Rheumatoid ArthritisBiological: OlokizumabUCB PharmaNot recruiting20 YearsN/ABoth103Phase 2Japan;Korea, Republic of;Taiwan
932EUCTR2010-023782-22-ES16/12/201118 September 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 DRUGRheumatoid Arthritis
MedDRA version: 14.0 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
Pharmaceutical Form: Tablet
CAS Number: 1044535-58-1
Current Sponsor code: PF-04171327
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: PF-04171327
Pharmaceutical Form: Tablet
CAS Number: 1044535-58-1
Current Sponsor code: PF-04171327
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: PF-04171327
Pharmaceutical Form: Tablet
CAS Number: 1044535-58-1
Current Sponsor code: PF-04171327
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Decortin
Pharmaceutical Form: Capsule
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-02
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use		Pfizer, S.L.U.AuthorisedFemale: yes
Male: yes		315Phase 2Poland;United States;Spain;Romania;Korea, Republic of;Mexico;Canada;Serbia;Ukraine;Czech Republic;Russian Federation;Slovakia;India;South Africa;Bulgaria;Malaysia;Germany;Colombia;Hungary
933EUCTR2011-000436-28-PL07/12/201118 March 2013A 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 ARTHRITISTreatment 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
Pharmaceutical Form: Capsule
INN or Proposed INN: Z102 (Prednisolone and Dipyridamole).
Current Sponsor code: Z102 (Prednisolone and Dipyridamole).
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 360-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: Prednisolone
Product Code: Prednisolone
Pharmaceutical Form: Capsule
INN or Proposed INN: Prednisolone
CAS Number: 52438-85-4
Current Sponsor code: Prednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.7-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: Dipyridamole
Product Code: Dipyridamole
Pharmaceutical Form: Capsule
INN or Proposed INN: Dipyridamole
CAS Number: 58-32-2
Current Sponsor code: Dipyridamole
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 180-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Dacortin ®
Pharmaceutical Form: Capsule
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use		Zalicus, Inc.Not RecruitingFemale: yes
Male: yes		250Phase 2United States;Serbia;Hungary;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Chile;Bulgaria;Russian Federation
934NCT01511003December 5, 201120 August 2018A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDsRheumatoid ArthritisDrug: TacrolimusAstellas Pharma IncAstellas Pharma Korea, Inc.Not recruiting20 Years75 YearsAll128Phase 4Korea, Republic of
935NCT01443364December 201116 December 2017Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid ArthritisMulticenter, 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)Rheumatoid ArthritisBiological: Certolizumab pegolUCB Italy s.p.a.Not recruiting18 YearsN/AAll132Phase 4Italy
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
936NCT01500278December 201116 December 2017Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to MethotrexateA Multicenter, Single-blind, Randomized Parallel-group Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis Responding Inadequately to MethotrexateRheumatoid ArthritisBiological: Certolizumab Pegol (CZP);Biological: Adalimumab (ADA);Drug: Methotrexate (MTX)UCB Pharma SAParexelNot recruiting18 YearsN/AAll915Phase 4Czechia;France;Germany;Greece;Hungary;Ireland;Italy;Mexico;Monaco;Poland;Portugal;Romania;Spain;Switzerland;United Kingdom;United States;Czech Republic;Canada;Bulgaria;Austria;Australia
937NCT01326962November 30, 201116 December 2017A 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 RocheNot recruiting18 YearsN/AAll28Phase 3Saudi Arabia
938EUCTR2011-005036-26-GB29/11/201128 August 2012A 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 DiseaseAsthma Chronic obstructive pulmonary disease Rheumatoid arthritis Psoriasis
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 Level: PT 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 System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Product Code: FX125L
Pharmaceutical Form: Capsule
Current Sponsor code: FX125L
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use		Funxional Therapeutics LtdNot RecruitingFemale: yes
Male: yes		Phase 2aUnited Kingdom
939ChiCTR-TRC-110017892011-11-1418 April 2017Effect of TGP combined with MTX and LEF on liver function in RA patients: Clinical study protocolEffect of TGP combined with MTX and LEF on liver function in RA patients: Clinical study protocolRheumatoid ArthritisTreatment:TGP capsules (TGP) + methotrexate (MTX) + leflunom;Control:methotrexate(MTX) + leflunomide (LEF);Anhui Provincial Hospital Department of RheumatismNot Recruiting1865BothTreatment:140;Control:140;Post-marketChina
940NCT01251120November 201119 October 2017A 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 RocheNot recruiting18 YearsN/AAll2Phase 4Finland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
941NCT01408602November 201119 February 2015A 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 SuppliesNot recruiting18 YearsN/ABoth300Phase 2United States
942NCT01468077November 201119 October 2017A 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 RocheNot recruiting18 YearsN/AAll47Phase 2Denmark;Iceland
943NCT01469013November 201130 September 2019Oral 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 CompanyNot recruiting20 Years75 YearsAll145Phase 2Japan
944NCT01592292November 201119 October 2017An 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 RocheNot recruiting20 YearsN/AAll90N/AKorea, Republic of
945NCT02243800November 20118 August 2016Study 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
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
946NCT01451203October 11, 201116 December 2017Efficacy Confirmation Study of CDP870 in Early Rheumatoid ArthritisA Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Patients With Early-stage Rheumatoid Arthritis Who Are Naïve to Methotrexate and Have Poor Prognostic FactorsRheumatoid ArthritisDrug: Placebo;Drug: CZP;Drug: methotrexate (MTX)Astellas Pharma IncUCB Japan Co. Ltd.Not recruiting20 Years64 YearsAll319Phase 3Japan
947NCT01548768October 10, 201115 July 2019RHYTHM (Formerly Escape II Myocardium)RHYTHM (RHeumatoid Arthritis studY of THe Myocardium): How Rheumatoid Arthritis (RA) and Tumor Necrosis Factor (TNF) Inhibitors Affect the Myocardial Structure and Function.Rheumatoid ArthritisDrug: TNF inhibitors;Drug: DMARDsColumbia UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 YearsN/AAll175Phase 4United States
948NCT01292616October 201119 February 2015Effect of TNF-Inhibition Combined With Conventional DMARDs on Cervical Pannus in Patients With RA and Cervical Spine InvolvementRheumatoid ArthritisDrug: therapy with disease-modifying anti rheumatic drugs (DMARD)University of ZurichRecruiting18 YearsN/ABoth15N/ASwitzerland
949NCT01359943October 201119 October 2017Efficacy, 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 PharmaceuticalsNot recruiting18 YearsN/AAll221Phase 2United States;Bulgaria;Canada;Hungary;Italy;Poland;Puerto Rico;Slovakia
950NCT01436370October 201119 October 2017TIV and High Dose TIV in Subjects With Rheumatoid ArthritisA Phase II Study in Adults With Rheumatoid Arthritis Receiving TNF-alpha-inhibitor Therapy to Assess the Immunogenicity and Safety of Trivalent Inactivated Vaccine (TIV) and High Dose Trivalent Inactivated Vaccine (High-Dose TIV) Administered at Two Dosage LevelsInfluenzaBiological: Trivalent inactivated influenza vaccineNational Institute of Allergy and Infectious Diseases (NIAID)Not recruiting18 Years64 YearsAll102Phase 2United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
951NCT01439204October 201119 October 2017Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers SquibbA Randomized, Open-label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of Abatacept (BMS-188667) Drug Products Using Active Pharmaceutical Ingredient Manufactured at Devens, MA Site Relative to Active Pharmaceutical Ingredient Manufactured at Lonza, New Hampshire (NH) in Healthy SubjectsRheumatoid ArthritisBiological: Abatacept (BMS-188667)Bristol-Myers SquibbNot recruiting18 Years55 YearsAll223Phase 1United States
952NCT01463059October 201119 February 2015Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) TherapyA Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker TherapyRheumatoid ArthritisBiological: Placebo;Biological: Olokizumab 60 mg;Biological: Olokizumab 120 mg;Biological: Olokizumab 240 mgUCB Japan Co. Ltd.Not recruiting20 YearsN/ABoth119Phase 2Japan;Korea, Republic of;Taiwan
953NCT01557322October 201119 October 2017Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)Evaluation of the Clinical Characteristics, Real-world Treatment Pathways, and Outcomes of Patients With Moderate Rheumatoid ArthritisRheumatoid ArthritisBiological: etanercept;Drug: methotrexate (MTX)PfizerNot recruiting18 YearsN/AAll1754N/A
954NCT01641952October 201119 October 2017An 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 RocheNot recruiting18 YearsN/AAll505N/ARomania
955NCT01954381October 20113 August 2015Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid ArthritisImpact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid ArthritisRheumatoid ArthritisDevice: transthoracic echocardiographic;Device: Doppler ultrasound.;Biological: blood samplesAssistance Publique Hopitaux De MarseilleNot recruiting18 YearsN/ABoth60Phase 3France
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
956NCT01961505October 201116 December 2017Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid ArthritisA Randomized Controlled Study to Determine the Effects and Safety of Topical Compound Tripterygium Wilfordii Hook F in Patients With Active Rheumatoid Arthritis.Active Rheumatoid ArthritisDrug: Topical compound tripterygium;Drug: PlaceboGuang'anmen Hospital of China Academy of Chinese Medical SciencesNot recruiting18 Years65 YearsAll70N/A
957NCT01245439September 201119 October 2017A 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 RocheNot recruiting18 YearsN/AAll65Phase 3Turkey
958NCT01350804September 201119 October 2017Efficacy 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 PharmaceuticalsNot recruiting18 YearsN/AAll551Phase 3United States;Brazil;Bulgaria;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Mexico;Romania;Russian Federation;Slovakia;Spain
959NCT01359150September 201119 October 2017A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or PlaceboA Randomized, Double Blind, Placebo Controlled Phase 2 Study To Assess The Immune Response Following Administration Of Influenza And Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving Cp-690,550 Or Placebo Cp-690,550 With And Without Background MethotrexateRheumatoid ArthritisDrug: CP-690,550;Drug: placeboPfizerNot recruiting18 YearsN/AAll223Phase 2United States;Poland
960NCT01374971September 201119 October 2017Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)Open-Label Pre and Post Treatment Arthroscopic Synovial Biopsy Study for the Assessment of Certolizumab Pegol Immunomodulatory Synovial Effects on Select Biomarkers and Gene ExpressionRheumatoid ArthritisDrug: Certolizumab Pegol (CZP);Procedure: Arthroscopic synovial tissue biopsyNathan Wei, MD, FACP, FACR:University of California, San DiegoNot recruiting18 YearsN/AAll12Phase 3United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
961NCT01393639September 201118 December 2018Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid ArthritisA 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 ArthritisDrug: PF-04171327;Drug: prednisone;Other: prednisone;Other: placeboPfizerNot recruiting18 YearsN/AAll323Phase 2United States;Bulgaria;Colombia;Czechia;Germany;Hungary;India;Korea, Republic of;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;Canada;Czech Republic
962NCT01399697September 201119 October 2017A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to MethotrexateA Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With MTX Versus Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 > 3,2)Rheumatoid ArthritisDrug: methotrexate;Drug: placebo;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNot recruiting18 YearsN/AAll261Phase 4Spain
963NCT01404585September 201119 February 2015Proof-of-Concept Study With BMS-817399 to Treat Moderate to Severe Rheumatoid ArthritisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults With Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to MethotrexateRheumatoid ArthritisDrug: Placebo;Drug: BMS-817399Bristol-Myers SquibbNot recruiting18 YearsN/ABoth123Phase 2United States;Argentina;Korea, Republic of;Mexico;Russian Federation;South Africa;Spain
964NCT01417052September 201119 February 2015A Study to Determine the Safety and Efficacy of LX3305 in Subjects With Active Rheumatoid ArthritisA Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects With Active Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: 50 mg LX3305 QD;Drug: 100 mg LX3305 QD;Drug: 150 mg LX3305 QD;Drug: 200 mg LX3305 QD;Drug: 250 mg LX3305 QD;Drug: 300 mg LX3305 QD;Drug: 400 mg LX3305 QD;Drug: 250 mg LX3305 BID;Drug: 500 mg LX3305 QD;Drug: PlaceboLexicon PharmaceuticalsNot recruiting18 Years75 YearsBoth10Phase 1United States
965NCT01446978September 20117 December 2015Three 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, SwedenNot recruiting18 YearsN/ABoth150Phase 2Sweden
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
966NCT01462162September 201119 October 2017A Prospective Observational Study of Tocilizumab (RoActemra/Actemra) in Participants With Rheumatoid ArthritisA Prospective Observational Study to Evaluate and Correlate the Impact of Treatment With Tocilizumab (RoActemra®) on Fatigue and Different Factors Influencing Fatigue in Participants With Rheumatoid Arthritis in Routine Clinical PracticeRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNot recruiting18 YearsN/AAll122N/ASpain
967NCT01544101September 201119 February 2015A Nutritional Intervention for ArthritisA Nutritional Intervention for ArthritisRheumatoid ArthritisOther: Vegan Diet;Dietary Supplement: dietary supplement omega3 fatty acids aand vitaminsPhysicians Committee for Responsible MedicineNot recruiting18 YearsN/ABoth32N/AUnited States
968NCT02076659September 201111 June 2018Combination Therapy of F8IL10 and Methotrexate in Rheumatoid Arthritis PatientsA Dose-finding, Pharmacokinetic Phase I Study of the Human Monoclonal Antibody-cytokine Fusion Protein F8IL10 (Dekavil) in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: F8IL10;Drug: MethotrexatePhilogen S.p.A.Not recruiting18 Years75 YearsAll36Phase 1Italy
969NCT02164214September 201121 September 2015Does Etanercept Influence Tweak Modulation of Inflammation During Inflammatory Rheumatisms (Psoriatic Arthritis and Rheumatoid Arthritis)?DOES ETANERCEPT INFLUENCE TWEAK MODULATION OF INFLAMMATION DURING INFLAMMATORY RHEUMATISMS (PSORIATIC ARTHRITIS AND RHEUMATOID ARTHRITIS)?Inflammatory Rheumatism;Psoriatic Arthritis;Rheumatoid ArthritisDrug: etanercept TreatmentAssistance Publique Hopitaux De MarseilleNot recruiting18 YearsN/ABoth60Phase 3France
970EUCTR2011-000102-21-CZ19/08/201123 February 2015Safety 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-1Rheumatoid 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
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Secukinumab
Current Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Trade Name: Orencia
Product Name: Abatacept
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use		Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes		548Germany;Bulgaria;Romania;Brazil;Canada;Mexico;Hungary;Czech Republic;France;Italy;Colombia;Russian Federation;Spain;Slovakia;United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
971EUCTR2010-023956-99-HU17/08/20114 August 2015Phase 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 Pharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011) Revised Protocol 04 incorporating Protocol Amendment 12RHEUMATOID 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CLAZAKIZUMAB
Current Sponsor code: BMS-945429
Other descriptive name: anti-IL-6 mAb
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40/0.8-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: CLAZAKIZUMAB
CAS Number: 1236278-28-6
Current Sponsor code: BMS945429
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-		Bristol-Myers Squibb International CorporationNot RecruitingFemale: yes
Male: yes		677Phase 2BKorea, Republic of;Japan;Germany;Netherlands;South Africa;Peru;Brazil;Belgium;Argentina;Canada;Mexico;Czech Republic;Hungary;France;Italy;Russian Federation;Spain;Taiwan;United States
972EUCTR2011-002363-15-IS17/08/201119 January 2015A 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 FASTAdult 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®
Pharmaceutical Form: Concentrate for solution for infusion		Roche a/sNot RecruitingFemale: yes
Male: yes		56Denmark;Iceland
973NCT01331837August 2, 201116 December 2017A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk FactorsA 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)Rheumatoid ArthritisDrug: Etanercept;Drug: TocilizumabHoffmann-La RocheNot recruiting50 YearsN/AAll3080Phase 4United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Canada;Chile;Croatia;Czechia;Ecuador;France;Germany;Greece;Hungary;India;Israel;Italy;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Turkey;United Kingdom;Brazil;China;Czech Republic
974NCT01400516August 201116 December 2017Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA TrialTeriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA TrialRheumatoid ArthritisDrug: Teriparatide;Drug: calcium citrate;Drug: Vitamin D;Drug: TNF antagonistBrigham and Women's HospitalEli Lilly and CompanyNot recruiting45 YearsN/AAll26Phase 4United States
975NCT01414101August 201119 February 2015Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ISIS 329993 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: ISIS CRP Rx or PlaceboIsis PharmaceuticalsNot recruiting18 Years75 YearsBoth51Phase 2Canada;Russian Federation
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
976NCT01426789August 201119 October 2017A 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 PharmaceuticalsNot recruiting18 YearsN/AAll100Phase 2United States;Belgium;Germany;Russian Federation;United Kingdom
977NCT01442545August 201119 February 2015A Study to Investigate How JNJ-39758979 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis ParticipantsA Study to Investigate the Effect of Multiple Doses of JNJ 39758979 on Methotrexate Pharmacokinetics in Rheumatoid Arthritis Patients on a Stable Methotrexate DoseRheumatoid ArthritisDrug: JNJ-39758979 / MTXJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Not recruiting18 Years75 YearsBoth21Phase 1United States;Germany
978JPRN-UMIN0000137502011/07/312 April 2019Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritisRheumatoid 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 SciencesNot RecruitingNot applicableNot applicableMale and Female80Not selectedJapan
979EUCTR2011-000275-13-HU29/07/201110 July 2015Safety 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 agentsRheumatoid 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
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Secukinumab
Current Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use		Novartis Pharma AGNot RecruitingFemale: yes
Male: yes		630Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan
980EUCTR2011-001863-39-AT28/07/20117 April 2014A 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) - OPTIMISEMild 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: Methotrexat Lederle 2.5mg tablets
Product Name: Methotrexat
Product Code: RO0029893
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Methotrexate Disodium
CAS Number: 7413345
Current Sponsor code: RO0029893
Other descriptive name: Methotrexate as methotrexate disodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		Roche Austria GmbHNot RecruitingFemale: yes
Male: yes		Austria
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
981NCT01382940July 26, 201116 December 2017A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid ArthritisA Multicenter, Open-label, Single-arm Study to Evaluate the Safety Administering Rituximab at a More Rapid Infusion Rate in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: rituximab;Drug: methotrexate;Drug: methylprednisolone;Drug: acetaminophen;Drug: antihistamineHoffmann-La RocheNot recruiting18 YearsN/AAll351Phase 4United States
982EUCTR2011-001220-38-GB12/07/20112 October 2012A 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 extensionRheumatoid 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
Pharmaceutical Form: Powder for solution for injection or infusion
INN or Proposed INN: Secukinumab
Current Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use		Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes		350United States;Belgium;United Kingdom;Russian Federation;Germany
983JPRN-jRCTs03218027311/07/201110 September 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 studyHip 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)		Haruhiko AkiyamaNot Recruiting>= 20age old<= 75age oldBoth1308Phase 4none
984JPRN-JapicCTI-11162801/7/20112 April 2019Phase 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.18BOTH406Phase 2
985NCT01390441July 201119 October 2017A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002)A Two-Part, Phase I Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of MK-8808 and to Compare the Pharmacokinetics of MK-8808 With EU-approved MabThera® and US-licensed Rituxan® in Patients With Rheumatoid Arthritis (RA)Rheumatoid ArthritisBiological: MK-8808;Biological: MabThera® (rituximab);Drug: Methotrexate;Biological: Rituxan® (rituximab);Drug: Methylprednisolone;Drug: Acetaminophen;Drug: LoratadineMerck Sharp & Dohme Corp.Not recruiting18 Years65 YearsAll100Phase 1Belarus;Bulgaria;Colombia;Georgia;Hungary;Italy;Philippines;Poland;Russian Federation;Singapore;Spain;Ukraine;United Kingdom;United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
986NCT01410695July 201118 December 2018Masitinib in Refractory Active 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 6 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 DrugsRheumatoid Arthritis (RA)Drug: masitinib 3 mg;Drug: masitinib 6.0 mg;Drug: methotrexate;Drug: Placebo (methotrexate);Drug: Placebo (masitinib)AB ScienceNot recruiting18 YearsN/AAll324Phase 2/Phase 3Czechia;Czech Republic;France;United States
987NCT02433184July 201130 September 2019Very Early Versus Delayed Etanercept in Patients With RAA 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 ArthritisRheumatoid ArthritisDrug: Etanercept;Drug: Methotrexate;Drug: Sulfasalazine;Drug: HydroxychloroquineUniversity of LeedsNot recruiting18 Years80 YearsAll120Phase 4United Kingdom
988EUCTR2010-019262-86-ES22/06/20112 October 2012Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa ______________________________________________ A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa ______________________________________________ A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)Artritis Reumatoide _______________________ Rheumatoid Arthritis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: SAR153191
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-		sanofi-aventis Recherche & DéveloppementAuthorisedFemale: yes
Male: yes		1500Hungary;Finland;Germany;Netherlands;Estonia;Spain;Greece;Lithuania;Austria
989EUCTR2011-000107-40-GB16/06/20114 February 2013A 12 weeks study to evaluate effect of revamilst in addition to methotrexate 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
Pharmaceutical Form: Tablet
INN or Proposed INN: Revamilast
Current Sponsor code: GRC 4039
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Revamilast
Product Code: GRC 4039
Pharmaceutical Form: Tablet
INN or Proposed INN: Revamilast
Current Sponsor code: GRC 4039
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Revamilast
Product Code: GRC 4039
Pharmaceutical Form: Tablet
INN or Proposed INN: Revamilast
Current Sponsor code: GRC 4039
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Glenmark Pharmaceuticals SANot RecruitingFemale: yes
Male: yes		406Phase 2bPhilippines;Poland;Sri Lanka;United Kingdom;India
990EUCTR2008-001523-57-NO10/06/201119 March 2012Multicenter, 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 MethotrexateAdult 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
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Abatacept
CAS Number: 332348-12-6
Current Sponsor code: BMS-188667
Other descriptive name: CTLA4Ig
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-		Bristol Myers Squibb International CorporationAuthorisedFemale: yes
Male: yes		100Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;Italy
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
991EUCTR2010-022504-42-GB07/06/201121 August 2012A 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 TherapyRheumatoid Arthritis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: LY3009104
Product Code: LY3009104
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not available
CAS Number: 1187595-84-1
Current Sponsor code: LY3009104 phosphate
Other descriptive name: JAK1 / JAK2 Inhibtor
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: LY3009104
Product Code: LY3009104
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not available
CAS Number: 1187595-84-1
Current Sponsor code: LY3009104 phosphate
Other descriptive name: JAK1 / JAK2 Inhibtor
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		Eli Lilly and CompanyAuthorisedFemale: yes
Male: yes		270Phase 2bHungary;United Kingdom
992EUCTR2011-000215-79-FR07/06/201130 April 2019Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRATociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRAPolyarthrite rhumatoïdeTrade Name: Roactemra
Pharmaceutical Form: Solution for injection
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-		CHU de Clermont FerrandNot Recruiting Female: yes
Male: yes		30Phase 3France
993JPRN-UMIN0000055902011/06/012 April 2019Maintenance of remission by tocilizumab mono-therapy after remission obtained by combination with methotrexate in patients with rheumatoid arthritisRheumatoid arthritisCessation of MTX (tocilizumab monotherapy)
Continue MTX with tocilizumab		Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical UniversityNot Recruiting20years-old75years-oldMale and Female40Not selectedJapan
994NCT01215942June 201119 February 2015An Open Label Study for Patients With Rheumatoid ArthritisA Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: LY2127399Eli Lilly and CompanyNot recruiting18 YearsN/ABoth1505Phase 3United States;Argentina;Australia;Brazil;Bulgaria;Colombia;Croatia;France;Germany;Greece;Hungary;India;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Sri Lanka;Taiwan;Ukraine;Italy;Peru
995NCT01351480June 201116 December 2017Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) PatientsAssessment of Structural Benefits of Injectable Abatacept as Measured by MRI in RA Patients Who Have Failed Prior Anti-Tumor Necrosis (TNF) Therapy and Correlated With Clinical OutcomesRheumatoid ArthritisBiological: abataceptArthritis & Rheumatic Disease Specialties ResearchBristol-Myers SquibbNot recruiting18 YearsN/AAll34Phase 3United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
996NCT01355354June 201119 February 2015Effects 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: FostamatinibAstraZenecaNot recruiting18 Years45 YearsBoth21Phase 1United Kingdom
997NCT01369745June 201119 October 2017A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid ArthritisA Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid ArthritisRheumatoid ArthritisDrug: Prednisolone;Drug: dipyridamole;Drug: Prednisone;Drug: Z102;Other: placeboZalicusNot recruiting18 YearsN/AAll294Phase 2United States
998NCT01384422June 201119 February 2015Safety and Preliminary Efficacy of GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: GLPG0634Galapagos NVNot recruiting18 Years70 YearsBoth36Phase 2Moldova, Republic of
999NCT01405118June 201119 February 2015Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy VolunteersA Phase 1, Open Labeled, Fixed Sequence Study To Estimate The Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy VolunteersRheumatoid ArthritisDrug: Metformin/CP-690,550PfizerNot recruiting18 Years55 YearsBoth24Phase 1Belgium
1000NCT01450982June 201119 February 2015A Study to Investigate How JNJ-38518168 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis ParticipantsA Study to Investigate the Effects of JNJ-38518168 on Methotrexate Pharmacokinetics in Rheumatoid Arthritis Participants on a Stable Methotrexate DoseRheumatoid ArthritisDrug: JNJ-38518168 / MTXJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Not recruiting18 Years75 YearsBoth20Phase 1United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1001EUCTR2010-022378-15-DE25/05/201122 October 2012A 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. - VELVETRheumatoid 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)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Veltuzumab
CAS Number: 728917-18-8
Current Sponsor code: hA20, IMMU-106
Other descriptive name: humanised anti-CD 20 antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 70-80
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Nycomed GmbHNot RecruitingFemale: yes
Male: yes		300Phase 2United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom
1002EUCTR2011-003016-23-IT11/05/201127 January 2014Controlled randomized study on maintenance to low activity disease with low doses of SKA citokines compared with standard therapyControlled randomized study on maintenance to low activity disease with low doses of SKA citokines compared with standard therapy (DMARDS)of arthritis management - CIDAI STUDYRheumatoid Arthritis
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: Guna-Anti Interleukin 1
Product Code: NA
Pharmaceutical Form: Oral drops
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: 36172
Other descriptive name: Guna-Antiinterleukin 1 alfa
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: .000000001-
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: 36172
Other descriptive name: Guna-Antiinterleukin 1 beta
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: .000000001-
Product Name: Interleukin 10
Product Code: NA
Pharmaceutical Form: Oral drops
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: 36247
Other descriptive name: Guna-Interleukin 10
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: .000000001-
Product Name: Interleukin 4
Product Code: NA
Pharmaceutical Form: Oral drops
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: 36241
Other descriptive name: Guna-Interleukin 4
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: .000000001-		GUNA SPAAuthorisedFemale: yes
Male: yes		Italy
1003EUCTR2009-015019-42-DE10/05/201127 October 2014Study 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 KIDSJuvenile 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Current Sponsor code: CNTO148
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Janssen Biologics B.V.Not RecruitingFemale: yes
Male: yes		170United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Peru;Germany;Netherlands
1004EUCTR2009-016266-90-ES03/05/201111 September 2012Estudio 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 - MOBILITYArtritis Reumatoide _____________________________________ Rheumatoid Arthritis
MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis ;Artritis Reumatoide _____________________________________ Rheumatoid Arthritis
MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: SAR153191
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: SAR153191
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: SAR153191
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: SAR153191
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: SAR153191
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Sanofi-aventis Recherche & DéveloppementAuthorisedFemale: yes
Male: yes		1740Portugal;Hungary;Finland;Germany;Czech Republic;Netherlands;Estonia;Spain;Greece;Austria;Lithuania
1005NCT01262118May 201119 October 2017Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid ArthritisAn Exploratory Phase 1, Fixed Sequence, Open-Label Study To Assess The Effects Of CP-690,550 On The Kinetics Of Cholesterol Flux Through The High Density Lipoprotein/Reverse Cholesterol Transport Pathway In Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: CP-690,550 (tasocitinib)PfizerNot recruiting18 YearsN/AAll69Phase 1United States;Hungary
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1006NCT01283971May 201119 October 2017A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (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 InhibitorRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: adalimumab;Drug: placebo to tocilizumab;Drug: placebo to adalimumab;Drug: methotrexate;Drug: folateHoffmann-La RocheNot recruiting18 YearsN/AAll96Phase 4Germany;Greece;Italy;Netherlands;Puerto Rico;Russian Federation;Spain;Sweden;Denmark;Finland;France;United States;United Kingdom
1007NCT01328522May 201119 February 2015Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: SAR153191 (REGN88)SanofiRegeneron PharmaceuticalsNot recruiting18 Years75 YearsBoth32Phase 1United States
1008NCT01329991May 201119 February 2015Phase 1b Study of PLX5622 in Rheumatoid Arthritis Patients Who Are Receiving MethotrexateA Phase 1b Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Drug-Drug Interaction of PLX5622 in Patients With Rheumatoid Arthritis Who Are Receiving MethotrexateRheumatoid ArthritisDrug: Placebo;Drug: PLX5622PlexxikonNot recruiting18 YearsN/ABoth26Phase 1United States
1009NCT01347983May 201119 February 2015Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis PatientsExtension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: Tocilizumab+Methotrexate(MTX)Chugai Pharma TaiwanNot recruiting20 Years75 YearsBoth72Phase 3Taiwan
1010NCT01370902May 201119 February 2015Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid ArthritisA Randomised, Double-blind, Placebo-controlled, Single-dose and Multiple-dose, Dose-escalation Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0141-0000-0100 in Subjects With Rheumatoid ArthritisInflammation;Rheumatoid ArthritisDrug: NNC 0141-0000-0100;Drug: placeboInnate PharmaNot recruiting18 Years75 YearsBoth92Phase 1Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1011NCT01404429May 201119 October 2017Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid ArthritisRandomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid ArthritisRheumatoid ArthritisDrug: MethotrexatePostgraduate Institute of Medical Education and ResearchNot recruiting18 Years65 YearsAll100Phase 4India
1012NCT01405326May 201119 February 2015REstore Working Ability in RheumatoiD ArthritisThe Effect of Six Months Adalimumab Treatment on Sick Leaves and Retirement in Patients With Rheumatoid Arthritis Who Are at a Risk of Losing Their Ability to WorkRheumatoid ArthritisBiological: adalimumabThe Rheumatological Center of HelsinkiAbbottRecruiting25 Years55 YearsBoth160Phase 4Finland
1013EUCTR2010-022224-77-GB27/04/201127 May 2013Open-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 - RA0057Rheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Olokizumab
CAS Number: 1007223-17-7
Current Sponsor code: CDP6038
Other descriptive name: Recombinant human Mab of IgG4 subtype
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-		UCB Biosciences IncNot RecruitingFemale: yes
Male: yes		190Phase 2United Kingdom;Belgium;United States
1014EUCTR2010-023692-26-GB07/04/20112 October 2012Evaluation 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 - 4Rheumatoid 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib disodium
CAS Number: 914295-16-2
Other descriptive name: Fostamatinib disodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Other descriptive name: Humira
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		AstraZeneca ABAuthorisedFemale: yes
Male: yes		280Phase 2BHungary;Germany;Netherlands;Bulgaria;South Africa;United Kingdom;Czech Republic;Russian Federation;Slovakia;Canada;Ukraine;United States;Poland
1015EUCTR2008-007346-63-GB05/04/201115 April 2013Reumap: 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 - REUMAPRheumatoid ArthritisProduct Name: bIAP
Product Code: EC 3.1.3.1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: bovine intesastinal alkaline phosphatase (bIAP)
CAS Number: EC 3.1.3.1
Current Sponsor code: bIAP
Other descriptive name: bIAP
Concentration unit: IU international unit(s)
Concentration type: range
Concentration number: 800-1500		Alloksys Life Sciences B.V.Not RecruitingFemale: yes
Male: yes		Phase 2United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1016JPRN-UMIN0000053622011/04/012 April 2019Clinical 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 MedicineNot Recruiting20years-old70years-oldMale and Female13Not selectedJapan
1017NCT01336218April 201119 February 2015Effects 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: rifampicinAstraZenecaNot recruiting18 Years55 YearsBoth15Phase 1United States
1018EUCTR2010-023910-30-GB23/03/201119 March 2012A 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Etanercept
CAS Number: 185243-69-0
Current Sponsor code: RR10/9592
Other descriptive name: Enbrel
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Enbrel 50mg pre-filled syringe
Product Name: Etanercept (Enbrel)
Product Code: EU/1/99/126/017
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Etanercept
CAS Number: 185243-69-0
Current Sponsor code: RR10/9592
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		University of LeedsAuthorisedFemale: yes
Male: yes		120United Kingdom
1019EUCTR2010-021020-94-DE10/03/201119 March 2012A 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-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-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-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-aactive 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
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Simponi
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Sanofi-aventis Recherche & DéveloppementNot RecruitingFemale: yes
Male: yes		250Hungary;Czech Republic;Germany;Spain;Italy
1020EUCTR2010-023469-22-NL09/03/201119 March 2012A phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis - ARA 290 in ARAA phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis - ARA 290 in ARARheumatoid arthritis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 12.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: ARA290
Product Code: ARA290
Pharmaceutical Form: Solution for infusion		LUMCAuthorisedFemale: yes
Male: yes		12Phase 2Netherlands
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1021EUCTR2010-022865-81-CZ02/03/201129 July 2013Clinical 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 arthritisRheumatoid 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
Pharmaceutical Form: Solution for infusion
Other descriptive name: ALX-0061 Nanobody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use		Ablynx NVNot RecruitingFemale: yes
Male: yes		72Phase 1/2Czech Republic;Hungary
1022NCT01313520March 1, 201116 December 2017A 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.Not recruiting18 YearsN/AAll61Phase 2Moldova, Republic of;Romania
1023NCT01232569March 201119 October 2017A 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 Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Tocilizumab 162 mg;Drug: PlaceboHoffmann-La RocheNot recruiting18 YearsN/AAll656Phase 3United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;Greece;Guatemala;Hungary;Israel;Malaysia;Mexico;New Zealand;Panama;Philippines;Poland;Russian Federation;South Africa;Spain;Switzerland;Thailand;Peru
1024NCT01276262March 201119 February 2015Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female SubjectsA Single-blind, Placebo-controlled, 2-period, Fixed Sequence Study to Determine the Effects of Coadministration of Fostamatinib 100 mg Twice Daily on the Pharmacokinetics of an Oral Contraceptive in Healthy Female SubjectsScientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction;Laymen Terminology Level of Oral Contraceptive in Blood, Oral Contraceptive, Rheumatoid Arthritis, Drug -Drug InteractionDrug: fostamatinib;Drug: Microgynon® 30 (Oral contraceptive);Drug: PlaceboAstraZenecaNot recruiting18 Years45 YearsFemale22Phase 1United Kingdom
1025NCT01284569March 201114 January 2019Study to Assess Safety and Efficacy of Anti-Interleukin 6-receptor (IL6R) Nanobody in Rheumatoid Arthritis (RA) PatientsA Phase I/II, Randomised, Double-Blind, Placebo Controlled Study, Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Single and Multiple Intravenous Doses of ALX-0061 in Patients With RARheumatoid ArthritisBiological: ALX-0061;Biological: PlaceboAblynxNot recruiting18 Years80 YearsAll65Phase 1/Phase 2Czechia;Hungary;Poland;Czech Republic;Netherlands
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1026NCT01294397March 201116 December 2017Effects of Denosumab on the Pharmacokinetics of EtanerceptThe Effects of Denosumab on the Pharmacokinetics of Etanercept in Postmenopausal Women With Low Bone Mineral Density and Rheumatoid ArthritisPostmenopausal;Osteopenia;Rheumatoid Arthritis;OsteoporosisDrug: Etanercept;Drug: DenosumabAmgenNot recruiting45 Years80 YearsFemale19Phase 1United States
1027NCT01299961March 201119 October 2017Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid ArthritisMusculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid ArthritisRheumatoid ArthritisDrug: abataceptUniversity of California, Los AngelesNot recruiting18 YearsN/AAll25Phase 3United States
1028NCT01301703March 201119 February 2015Vaccination 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 CenterNot recruiting18 Years64 YearsBoth100Phase 4Israel
1029NCT01309854March 201119 February 2015Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy SubjectsAn Open-Label, Single Center Study to Assess the Pharmacokinetics of Pioglitazone in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice DailyRheumatoid Arthritis;Healthy Volunteers;Pharmacokinetics;Pioglitazone;Drug-drug Interaction;Amount of Pioglitazone in BloodDrug: fostamatinib;Drug: pioglitazoneAstraZenecaNot recruiting18 Years55 YearsBoth15Phase 1United States
1030NCT01311622March 201119 February 2015Effects of Administration of Fostamatinib on Blood Concentrations of Warfarin in Healthy SubjectsAn Open-Label, Single Centre Study to Assess the Pharmacokinetics and Pharmacodynamics of Warfarin When Co-Administered With Fostamatinib in Healthy SubjectsRheumatoid Arthritis;Healthy SubjectsDrug: warfarin;Drug: fostamatinibAstraZenecaNot recruiting18 Years55 YearsBoth15Phase 1United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1031NCT01313208March 201116 December 2017Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD TherapyRheumatoid ArthritisDrug: etanercept;Drug: Placebo;Drug: DMARD TherapyAmgenNot recruiting18 Years80 YearsAll210Phase 4United States;Canada
1032NCT01317797March 201119 October 2017A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid ArthritisA Phase Ib Double-blind, Placebo-controlled, Randomized, Dose-escalating Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Subcutaneous Injections of MT203 in Patients With Mild to Moderate Rheumatoid Arthritis on Treatment With MethotrexateRheumatoid ArthritisDrug: namilumab (MT203);Drug: PlaceboTakedaNot recruiting18 YearsN/AAll24Phase 1Bulgaria;Netherlands
1033NCT01332994March 201119 October 2017A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid ArthritisEfficacy and Safety Study of a Sequential Therapy of Tocilizumab (TCZ) and, if Initially Inadequately Responded to Tocilizumab (TCZ), Followed by Rituximab (RTX) in DMARD-IR Patients With Rheumatoid Arthritis (MIRAI)Rheumatoid ArthritisDrug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNot recruiting18 YearsN/AAll519Phase 3Germany
1034NCT01333878March 201119 February 2015Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural DamageAn Open-Label, Pilot Trial to Assess the Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage Determined by Low Field Extremity MRI (eMRI) and X-rayRheumatoid ArthritisBiological: Subcutaneous AbataceptOrrin M Troum, M.D. and Medical AssociatesBristol-Myers SquibbNot recruiting18 YearsN/ABoth12Phase 2/Phase 3United States
1035NCT01353859March 201119 October 2017A 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 RocheNot recruiting18 YearsN/AAll39Phase 3Indonesia;Greece
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1036NCT01566201March 201119 February 2015Effects of Interleukin-1 Inhibition on Vascular and Left Ventricular Function in Rheumatoid Arthritis Patients With Coronary Artery DiseaseThe Effect of Inhibition of Interleukin-1 Activity on Vascular and Left Ventricular Function in Patients With Coronary Artery Disease and Coexistent Rheumatoid ArthritisRheumatoid Arthritis;Coronary Artery Disease;InflammationDrug: anakinra;Drug: placeboUniversity of AthensNot recruiting18 YearsN/ABoth80N/AGreece
1037EUCTR2010-020839-39-GB25/02/201128 August 2012Efficacy 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 WITH AN 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 - RA0056Rheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Olokizumab
CAS Number: 1007223-17-7
Current Sponsor code: CDP6038
Other descriptive name: Recombinant human Mab of IgG4 subtype
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: Tocilizumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RoActemra®
CAS Number: 375823-41-9
Current Sponsor code: EU/1/08/492/001-6
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		UCB Biosciences, IncNot RecruitingFemale: yes
Male: yes		220United Kingdom;United States
1038EUCTR2010-022206-40-HU23/02/201123 September 2013A 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) TherapyRheumatoid Arthritis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: LY2127399
Product Code: LY2127399
Pharmaceutical Form: Solution for injection
Current Sponsor code: LY2127399
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: LY2127399
Product Code: LY2127399
Pharmaceutical Form: Solution for injection
Current Sponsor code: LY2127399
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Eli Lilly and CompanyNot RecruitingFemale: yes
Male: yes		1002Phase 3Hungary;Poland;Lithuania;Bulgaria
1039EUCTR2010-022205-17-HU18/02/20114 March 2013A 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 TherapyRheumatoid Arthritis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: LY2127399
Product Code: LY2127399
Pharmaceutical Form: Solution for injection
Current Sponsor code: LY2127399
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: LY2127399
Product Code: LY2127399
Pharmaceutical Form: Solution for injection
Current Sponsor code: LY2127399
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Eli Lilly and CompanyNot RecruitingFemale: yes
Male: yes		990Phase 3Bulgaria;Lithuania;Poland;Hungary
1040EUCTR2009-012615-18-FR16/02/201125 January 2016Efficacy 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 - SCORPIONRheumatoid arthritis (RA)
MedDRA version: 12.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions		Trade Name: UVEDOSE
Pharmaceutical Form: Oral solution
INN or Proposed INN: COLECALCIFEROL
CAS Number: 67-97-0
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 100000-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use		CHU de Clermont-FerrandNot RecruitingFemale: yes
Male: yes		France
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1041EUCTR2010-021558-21-HU08/02/201111 September 2012A 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 ArthritisRheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis ;Rheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: AK106-001616
Product Code: AK106-001616
Pharmaceutical Form: Capsule, hard
CAS Number: 590416-75-4
Current Sponsor code: AK106-001616 (form B)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: naproxen
CAS Number: 22204-53-1
Current Sponsor code: naproxen
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: AK106-001616
Product Code: AK106-001616
Pharmaceutical Form: Capsule, hard
CAS Number: 590416-75-4
Current Sponsor code: AK106-001616 (form B)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Code: AK106-001616
Pharmaceutical Form: Capsule, hard
CAS Number: 590416-75-4
Current Sponsor code: AK106-001616 (form B)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: naproxen
CAS Number: 22204-53-1
Current Sponsor code: naproxen
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: AK106-001616
Product Code: AK106-001616
Pharmaceutical Form: Capsule, hard
CAS Number: 590416-75-4
Current Sponsor code: AK106-001616 (form B)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		Asahi Kasei Pharma CorporationNot RecruitingFemale: yes
Male: yes		240Phase 2aHungary;Slovakia;Czech Republic;Germany;United Kingdom
1042JPRN-UMIN0000081642011/02/012 April 2019Restart for sustaining remission of rheumatoid arthritis in use of etanerceptRheumatoid 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 SchoolRecruiting20years-oldNot applicableMale and Female50Phase 4Japan
1043NCT01235507February 201119 October 2017A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)Actemra - Local Bosnian Open, Multicentric, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis After Inadequate Response to DMARDsRheumatoid ArthritisDrug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNot recruiting18 YearsN/AAll71Phase 3Bosnia and Herzegovina
1044NCT01254331February 201119 October 2017An 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 RocheNot recruiting18 YearsN/AAll51Phase 3Tunisia
1045NCT01285752February 20118 August 2016A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: Active comparator;Drug: AK106-001616Asahi Kasei Pharma CorporationNot recruiting18 Years65 YearsBoth240Phase 2Czech Republic;Germany;Hungary;Poland;Slovakia;Ukraine;United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1046NCT01292265February 201119 October 2017A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA)A Phase 3b, Open Label, Multicenter, Exploratory Study to Assess Changes in Joint Inflammation Using Ultrasonography in Subjects With Rheumatoid Arthritis Treated for 12 Weeks With Certolizumab PegolRheumatoid ArthritisBiological: Certolizumab PegolUCB PharmaNot recruiting18 YearsN/AAll3Phase 3United States
1047NCT01339481February 201119 February 2015A Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating AbataceptA Phase 0, Open-Label, Multi-Center, Observational Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating AbataceptRheumatoid ArthritisDrug: abataceptAstellas Pharma IncPerseid Therapeutics LLCNot recruiting18 YearsN/ABoth26N/AUnited States
1048NCT01765374February 201119 February 2015Study of Sonographic Efficacy of Rituximab in Rheumatoid ArthritisStudy of Sonographic Efficacy of Rituximab in Rheumatoid ArthritisRheumatoid ArthritisDevice: ESAOTE MyLab60;Drug: RituximabUniversity Hospital, RouenNot recruiting18 YearsN/ABoth30Phase 4France
1049NCT02092961February 201119 October 2017Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-StudyA Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Placebo or Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-StudyRheumatoid ArthritisDrug: Fostamatinib;Drug: Adalimumab;Drug: Placebo of Fostamatinib;Drug: Placebo of AdalimumabAstraZenecaNot recruiting18 YearsN/AAll198Phase 2United States;Bulgaria;Canada;Czech Republic;Germany;Hungary;Netherlands;Poland;Russian Federation;South Africa;United Kingdom
1050EUCTR2010-022049-88-DE05/01/201130 June 2014Efficacy 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) - MIRAIRheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: Mabthera 500 mg Concentrate for solution for infusion
Product Name: Rituximab
Product Code: RO045-2294
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: RO045-2294
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-		Roche Pharma AGNot RecruitingFemale: yes
Male: yes		Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1051NCT01202773January 201111 June 2018A Study in Participants With Rheumatoid ArthritisA 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 ArthritisDrug: LY2127399;Drug: Placebo Q4W;Drug: Placebo Q2WEli Lilly and CompanyNot recruiting18 YearsN/AAll456Phase 3United States;Argentina;Australia;Brazil;Colombia;France;Germany;Greece;Italy;Japan;Korea, Republic of;Malaysia;Mexico;New Zealand;Poland;Russian Federation;South Africa;Spain;Taiwan
1052NCT01207453January 201119 October 2017Milnacipran 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)Not recruiting24 YearsN/AAll49Phase 4United States
1053NCT01270035January 201119 February 2015Efficacy and Safety of Adalimumab 80 mg Every Other Week With MethotrexateRheumatoid ArthritisDrug: AdalimumabKeio UniversitySaitama Medical UniversityRecruitingN/AN/ABoth40Phase 4Japan
1054NCT01274910January 201119 February 2015Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control TrialEffect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control TrialRheumatoid ArthritisDietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA);Dietary Supplement: Capsules (Placebo)Rabin Medical CenterRecruiting50 Years80 YearsBoth60N/AIsrael
1055NCT01351805January 201122 July 2019Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee PainVitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee PainSystemic Inflammatory Process;Knee Pain Chronic;Osteoarthritis;Rheumatoid Arthritis;Autoimmune DiseasesDrug: Fish Oil;Dietary Supplement: Vitamin D;Other: placebo pillBrigham and Women's HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting50 YearsN/AAll25876N/AUnited States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1056NCT01411215January 201119 October 2017A 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: EnbrelPfizerNot recruiting18 YearsN/AAll160N/AChina
1057NCT01737944January 201119 October 2017Exposure Study Comparing 3 Routes of Methotrexate (MTX) AdministrationExposure, Safety and Local Tolerance Study Comparing 3 Routes of Methotrexate (MTX) Administration: Vibex-MTX Device, Subcutaneous (SC)and Intramuscular (IM) in Adult Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: Methotrexate (MTX)Antares Pharma Inc.Not recruiting18 YearsN/AAll38Phase 1/Phase 2United States
1058NCT02586246January 201123 November 2015Long-term Treatment Study of CDP870 Self-injection in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870Long-term Treatment Study of CDP870 Self-injection. A Multicenter, Open-label, Long-term Safety Study to Evaluate the Safety and Efficacy of CDP870 Self-injection Administered at a Dose of 200 mg Biweekly for 24 Weeks or Longer in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870 Administered Concomitantly With or Without Methotrexate (MTX)Active Rheumatoid ArthritisDrug: CDP870Astellas Pharma IncUCB Japan Co. Ltd.Not recruitingN/AN/ABoth86Phase 3Japan
1059EUCTR2011-001626-15-ES30 June 2014A 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Methotrexate Disodium
CAS Number: 7413345
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		Roche Farma, S.A.Not RecruitingFemale: yes
Male: yes		Spain
1060NCT02675803December 20, 201021 January 2019Safety, 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 PharmaceuticalsNot recruiting18 Years65 YearsAll65Phase 1Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1061EUCTR2010-021283-14-CZ15/12/201012 May 2014A 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 arthritisRheumatoid 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
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: NNC 0109-0000-0012
Other descriptive name: Anti-IL-20
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Novo Nordisk A/SNot RecruitingFemale: yes
Male: yes		66Portugal;Hungary;Czech Republic;Spain;Italy;United Kingdom
1062EUCTR2009-015898-12-NL10/12/201019 March 2012Randomized, 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 MethotrexatePatients 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
Pharmaceutical Form: Capsule, hard
CAS Number: 1195065-29-2
Current Sponsor code: GLPG0259
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GLPG0259
Product Code: GLPG0259
Pharmaceutical Form: Capsule, hard
CAS Number: 1195065-29-2
Current Sponsor code: GLPG0259
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GLPG0259
Product Code: GLPG0259
Pharmaceutical Form: Capsule, hard
CAS Number: 1195065-29-2
Current Sponsor code: GLPG0259
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6.25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GLPG0259
Product Code: GLPG0259
Pharmaceutical Form: Capsule, hard
CAS Number: 1195065-29-2
Current Sponsor code: GLPG0259
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		Galápagos NVNot RecruitingFemale: yes
Male: yes		200Phase 2Netherlands;Belgium
1063NCT01285310December 9, 201016 December 2017Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid ArthritisA 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 MethotrexateRheumatoid ArthritisDrug: Apremilast 30 mg;Drug: Apremilast 20 mg;Drug: PlaceboCelgeneNot recruiting18 YearsN/AAll237Phase 2United States;Czechia;Poland;Spain;Czech Republic
1064EUCTR2010-021435-14-NL06/12/201019 March 2012Effects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritisEffects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritisrheumatoid arthritisTrade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
Pharmaceutical Form: Powder for solution for injection		Academisch Medisch Centrum AmsterdamAuthorisedFemale: yes
Male: yes		Netherlands
1065EUCTR2010-019871-31-GB01/12/201028 February 2019A 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 ArthritisRheumatoid 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ETORICOXIB
CAS Number: 202409-33-4
Current Sponsor code: MK-0663
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ETORICOXIB
CAS Number: 202409-33-4
Current Sponsor code: MK-0663
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Not Recruiting Female: yes
Male: yes		1800Phase 3Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1066NCT01142726December 201019 October 2017Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid ArthritisA 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 RARheumatoid ArthritisDrug: Abatacept;Drug: Methotrexate;Drug: Abatacept placebo;Drug: Methotrexate placeboBristol-Myers SquibbNot recruiting18 YearsN/AAll511Phase 3United States;Australia;Belgium;Canada;Denmark;Finland;France;Germany;Italy;Korea, Republic of;Mexico;Poland;Russian Federation;South Africa;Sweden;Norway
1067NCT01236118December 201019 October 2017A Study of LY2439821 in Rheumatoid ArthritisAn Open-Label Extension Study to Evaluate Safety and Tolerability of Multiple Subcutaneous Doses of LY2439821 in Japanese Patients With Rheumatoid Arthritis on Concomitant MethotrexateRheumatoid ArthritisDrug: LY2439821Eli Lilly and CompanyNot recruiting20 YearsN/AAll28Phase 1Japan
1068NCT01258712December 201019 February 2015Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis PatientsRandomized, Placebo-controlled Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis PatientsRheumatoid Arthritis (RA)Drug: Tocilizumab + methotrexate(MTX);Drug: Tocilizumab placebo + methotrexate(MTX)Chugai Pharma TaiwanNot recruiting20 Years75 YearsBoth86Phase 3Taiwan
1069NCT01261403December 201012 March 2018Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Active Rheumatoid ArthritisA Phase 2, Randomized, Double- Blind, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: PDA001;Drug: Vehicle Controlled PlaceboCelularity IncorporatedCelgene CorporationNot recruiting18 Years75 YearsAll26Phase 2United States
1070NCT01270997December 201019 February 2015Randomized Double-blind Parallel Trial to Evaluate Equivalence in Efficacy and Safety of HD203 and Enbrel in RA PatientsA Multicenter Randomized Double-blind Active-controlled Parallel Group Phase ? Trial to Evaluate the Equivalence in Efficacy and Safety of HD203 and Enbrel in Combination With Methotrexate in Patients With Rheumatoid ArthritisRheumatoid ArthritisBiological: EtanerceptHanwha ChemicalNot recruiting20 YearsN/ABoth294Phase 3Korea, Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1071EUCTR2010-021184-32-DE30/11/201024 October 2016GP2013 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 therapiesRefractory 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
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: GP2013
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 1000-
Trade Name: Mabthera
Product Name: MabThera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-		Hexal AGNot RecruitingFemale: yes
Male: yes		164Phase 2Germany;Bulgaria;Romania;Brazil;Belgium;Poland;Argentina;Hungary;France;India;Italy;United Kingdom;Austria;Turkey;Spain;Estonia
1072EUCTR2010-020745-27-BE23/11/201021 August 2017Evaluation 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 - 3Rheumatoid 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib disodium
CAS Number: 914295-16-2
Current Sponsor code: FosD
Other descriptive name: Fostamatinib disodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		AstraZeneca ABNot 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
1073EUCTR2010-020892-22-BE23/11/201021 August 2017Evaluation 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 - XRheumatoid 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib disodium
CAS Number: 914295-16-2
Current Sponsor code: FosD
Other descriptive name: Fostamatinib disodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		AstraZeneca ABNot 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
1074JPRN-UMIN0000044122010/11/012 April 2019Corticosteroid-sparing effect of Actemra in patients with Rheumatoid Arthritis refractory to anti-TNF agents, methotrexate and corticosteroidrheumatoid arthritistocilizumabGeneral Internal Medicine, Tenri HospitalRecruiting16years-old80years-oldMale and Female25Not applicableJapan
1075JPRN-UMIN0000087562010/11/012 April 2019Abatacept-based approach to cure of RARheumatoid ArthritisAbatacept treatmentat month 12
MTX treatment at month 12		University of Occupational and Environmental Health, JapanRecruiting15years-oldNot applicableFemale40Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1076NCT01225393November 201014 November 2016A 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.Not recruiting18 Years75 YearsBoth211Phase 2Romania;Spain;Bulgaria;Chile;Germany;Hungary;Mexico;Peru;Poland;United States
1077NCT01225991November 201019 October 2017Milnacipran 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 LaboratoriesNot recruiting50 YearsN/AAll18Phase 4United States
1078NCT01245790November 201019 February 2015A 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: fostamatinibAstraZenecaNot recruiting18 YearsN/ABoth24Phase 1United States
1079NCT01255761November 201011 June 2018A 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 PharmaNot recruiting18 YearsN/AAll736Phase 4United States
1080NCT01287858November 201017 November 2015Study 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.Not recruiting18 Years45 YearsBoth88Phase 1United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1081NCT01618019November 201019 October 2017N-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 UniversityNot recruiting18 Years80 YearsAll109N/AKorea, Republic of
1082EUCTR2008-006924-68-AT28/10/201017 October 2016Extension 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 MA21573Rheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Actemra
Product Code: RO4877533
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-		F. Hoffmann-La Roche LtdNot RecruitingFemale: yes
Male: yes		1200Phase 3France;Portugal;Hungary;Czech Republic;Spain;Austria;Netherlands;United Kingdom;Italy
1083EUCTR2010-020743-12-GB26/10/201019 March 2012A 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 - 1Rheumatoid arthritis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Fostamatinib disodium
Product Code: FosD
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib disodium
CAS Number: 914295-16-2
Current Sponsor code: FosD
Other descriptive name: Fostamatinib disodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		AstraZeneca ABAuthorisedFemale: yes
Male: yes		900Phase 3Hungary;Germany;United Kingdom;Bulgaria;France;Estonia;Poland
1084EUCTR2010-020744-35-GB26/10/201027 May 2013Evaluation 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 - 2Rheumatoid 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib disodium
CAS Number: 914295-16-2
Current Sponsor code: FosD
Other descriptive name: Fostamatinib disodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		AstraZeneca ABNot 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
1085NCT01362062October 26, 201016 December 2017Study 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 RocheNot recruiting18 YearsN/AAll110N/AIndia
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1086EUCTR2010-018485-24-CZ20/10/20101 December 2014To 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 RAPatients 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
Current Sponsor code: BT061
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
Current Sponsor code: BT061
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Biotest AGNot RecruitingFemale: yes
Male: yes		128Hungary;Czech Republic;Spain;Latvia;Germany
1087EUCTR2010-019134-27-CZ19/10/201019 May 2014A 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 MONOTHERAPYRhuematoid 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
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Dipotassium Salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.3-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: CH-4051
Product Code: CH-4051
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Dipotassium Salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: CH-4051
Product Code: CH-4051
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Dipotassium Salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.0-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Methotrexate
Product Name: Methotrextate
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Methotrexate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Folic Acid
Product Name: Folic Acid
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Folic Acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-		Chelsea Therapeutics, IncNot RecruitingFemale: yes
Male: yes		250Phase 2Czech Republic;Bulgaria
1088EUCTR2010-019871-31-FI18/10/20107 October 2014Etoricoxib 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 ArthritisRheumatoid 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ETORICOXIB
CAS Number: 202409-33-4
Current Sponsor code: MK-0663
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ETORICOXIB
CAS Number: 202409-33-4
Current Sponsor code: MK-0663
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.Not 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
1089EUCTR2010-020738-24-GB12/10/201019 March 2012To 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) - OPTTIRAPatients 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: etanercept
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Humira
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adalimumab
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Enbrel pre-filled syringe
Product Name: Etanercept
Pharmaceutical Form: Solution for injection
INN or Proposed INN: etanercept
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		King's College LondonAuthorisedFemale: yes
Male: yes		0United Kingdom
1090EUCTR2010-018646-31-SK11/10/20103 April 2017A 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 ArthritisRheumatoid Arthritis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 12.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: CT-P13
Product Code: CT-P13
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Infliximab
CAS Number: 170277-31-3
Current Sponsor code: CT-P13
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: Remicade
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-		CELLTRION, IncNot RecruitingFemale: yes
Male: yes		584Phase 3Portugal;Slovakia;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1091EUCTR2010-021449-28-FR04/10/201019 March 2012Valeur prédictive de la concentration sérique d’Adalimumab (Humira) sur la réponse clinique dans la polyarthrite rhumatoïde - AFORAValeur prédictive de la concentration sérique d’Adalimumab (Humira) sur la réponse clinique dans la polyarthrite rhumatoïde - AFORAPolyarthrite rhumatoïde
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: HUMIRA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-		CHRU de TOURSAuthorisedFemale: yes
Male: yes		France
1092NCT01034306October 201019 October 2017Oral CF101 Tablets Treatment in Patients With Rheumatoid ArthritisA Phase IIB Study of the Efficacy and Safety of Daily CF101 in Patients With Active Rheumatoid Arthritis and Elevated Baseline Expression Levels of Peripheral Blood Mononuclear Cell A3 Adenosine ReceptorsRheumatoid ArthritisDrug: CF101;Drug: Placebo controlCan-Fite BioPharmaNot recruiting18 Years75 YearsAll79Phase 2Bulgaria;Israel
1093NCT01098201October 201028 September 2015Certolizumab and Lower Extremity Lymph Flow in Rheumatoid Arthritis (RA)The Effect of Certolizumab on Lower Extremity Lymph Flow in Rheumatoid ArthritisRheumatoid ArthritisDrug: CertolizumabUniversity of RochesterNot recruiting18 YearsN/ABoth5Phase 4United States
1094NCT01149057October 201019 October 2017A 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 ServicesNot recruiting18 YearsN/AAll145Phase 4Israel
1095NCT01164579October 201019 October 2017Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Tasocitinib plus Methotrexate;Drug: Tofacitinib plus placebo methotrexate;Drug: Placebo tofacitinib plus MethotrexatePfizerNot recruiting18 YearsN/AAll109Phase 2United States;Argentina;Chile;Croatia;Czech Republic;Hungary;Mexico;Poland;Puerto Rico
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1096NCT01185301October 201019 October 2017Study 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, Multicenter Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy With Adalimumab in Subjects With Early Rheumatoid Arthritis (CONCERTO)Early Rheumatoid ArthritisBiological: adalimumab;Drug: methotrexateAbbVie (prior sponsor, Abbott)Not recruiting18 YearsN/AAll395Phase 3United States;Argentina;Austria;Belgium;Canada;Czech Republic;Germany;Poland;Puerto Rico;Spain
1097NCT01185353October 201016 December 2017A Study in Participants With 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 TherapyArthritis, RheumatoidDrug: LY3009104;Drug: Placebo;Drug: MethotrexateEli Lilly and CompanyIncyte CorporationNot recruiting18 Years75 YearsAll301Phase 2United States;Croatia;Czechia;Hungary;India;Mexico;Poland;Romania;Ukraine;Argentina;Czech Republic;Peru;United Kingdom
1098NCT01214733October 201014 December 2015A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid ArthritisAn Open Label Study of the Safety During Treatment With Tocilizumab (TCZ), in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNot recruiting18 YearsN/ABoth30Phase 3South Africa
1099NCT01217086October 201019 February 2015Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)Randomized, Double-blind, Parallel-group, Phase 3 StudyRheumatoid ArthritisDrug: InfliximabCelltrionNot recruiting18 Years75 YearsBoth617Phase 3Korea, Republic of
1100NCT01221636October 201014 September 2015Pharmacokinetic Study to Compare the Blood Levels of Low vs High Metal Manufacture of AbataceptA Study to Compare the Pharmacokinetics of Abatacept (BMS-188667) Drug Product Using Active Pharmaceutical Ingredient Manufactured With a High Concentration of Metals Relative to the Active Pharmaceutical Ingredient Manufactured With a Low Concentration of MetalsRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbNot recruiting18 Years55 YearsBoth0Phase 1United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1101NCT01264211October 201017 November 2015Safety and Efficacy of the Combination of Diacerein 100 mg Daily and MTX Versus MTX Alone in the Treatment of Early Rheumatoid Arthritis (RA)A 6-month Pilot Randomised Double-blind Placebo-controlled Multicentre, Phase 2 StudyRheumatoid ArthritisDrug: Diacerein;Drug: PlaceboTRB ChemedicaNot recruiting18 Years65 YearsBoth40Phase 2Thailand
1102NCT01781702October 201019 February 2015Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis PatientsA Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis PatientsPelubiprofen;Celebrex;Rheumatoid ArthritisDrug: Pelubiprofen 30 mg;Drug: Celebrex 200 mgDaewon Pharmaceutical Co., Ltd.Not recruiting18 Years80 YearsBoth120Phase 3
1103NCT02528292October 201031 August 2015Clinical 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 TrustNot recruiting18 YearsN/ABoth24N/AUnited Kingdom
1104ChiCTR19000241072010-09-291 July 2019A randomized, controlled, open label, multicenter clinical trial to evaluate the efficacy and safety of recombinant tumor necrosis factor receptor:Fc fusion protein (rhTNFR:Fc) with Methotrexate in active rheumatoid arthritis (ReABLE-II)A randomized, controlled, open label, multicenter clinical trial to evaluate the efficacy and safety of recombinant tumor necrosis factor receptor:Fc fusion protein (rhTNFR:Fc) with Methotrexate in active rheumatoid arthritis (ReABLE-II)Active Rheumatoid ArthritisA:Treatment of Yisaipu combined with methotrexate for 52 weeks;B:Treatment of Yisaipu combined with methotrexate for the first 24 weeks and followed by methotrexate monotherapy;C:Methotrexate monotherapy for 52 weeks;Chinese Academy of Medical Sciences & Peking Union Medical College HospitalNot Recruiting1860BothA:30;B:30;C:30;Phase 4China
1105EUCTR2010-019694-15-BE28/09/201021 August 2017Act-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-AloneRheumatoid 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
Pharmaceutical Form: Tablet
CAS Number: 83-43-2
Other descriptive name: METHYLPREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Trade Name: Medrol A 16 mg tablets
Pharmaceutical Form: Tablet
CAS Number: 83-43-2
Other descriptive name: METHYLPREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 16-		N.V. Roche S.A.Not RecruitingFemale: yes
Male: yes		Phase 4Belgium
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1106JPRN-UMIN0000117892010/09/212 April 2019Usefulness of intravenous abatacept at an increased dose in rheumatoid arthritis patients with a poor prognosisRheumatoid arthritisAdministration of increased dose of abatacept to patients with rheumatoid arthritis previously treated with abatacept.National Health Organization Nagoya Medical CenterNot RecruitingNot applicableNot applicableMale and Female20Not applicableJapan
1107EUCTR2010-019935-37-FI15/09/201013 May 2013A 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 ArthritisRheumatoid Arthritis (RA)
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: 		Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-		Roche OyNot RecruitingFemale: yes
Male: yes		160Finland
1108ChiCTR-TRC-100010142010-09-0118 April 2017Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Method of Activating Blood Circulation by Removing Blood StasisRandomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Method of Activating Blood Circulation by Removing Blood StasisRheumatoid Arthritis;M06.991Group A:observation group: Leflunomide Tablets, from the first day to the third day, 50mg, qd, po, then 20mg, qd, po. Ligustrazine Powder-Needle, 0.12g, solubling in 5% GS/NS 100ml, qd, iv, in 30 to 60 minutes. ;Group B:control group: Leflunomide Tablets, from the first day to the third day, 50mg, qd, po, then 20mg, qd, po. ;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical SciencesNot Recruiting1865BothGroup A:60;Group B:60;Phase 1 studyChina
1109NCT01116141September 201019 February 2015A Study of CH-4051 in Patients With Rheumatoid Arthritis (RA)A Phase II, Multi-center, Randomized, Parallel Group, Double-blind, MTX Controlled Study to Assess the Clinical Efficacy, Safety and Tolerability of CH-4051 in Patients With Active RA Who Have Shown an Inadequate Response to MTX MonotherapyRheumatoid ArthritisDrug: CH-4051;Drug: Methotrexate (MTX);Drug: Folic AcidChelsea TherapeuticsNot recruiting18 Years80 YearsBoth250Phase 2
1110NCT01154647September 201019 February 2015Pain 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 recruiting18 Years65 YearsFemale70N/ABelgium
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1111NCT01162421September 201019 October 2017A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid ArthritisRadiographic, Clinical and Patient Outcomes in a Multicenter, Open Label Phase IV Randomized Trial of Earlier Adalimumab Introduction Therapy Versus Later Introduction as Per Standard of Care After Initial Methotrexate Failure in Early Rheumatoid Arthritis PatientsRheumatoid ArthritisBiological: adalimumab;Drug: MethotrexateAbbVie (prior sponsor, Abbott)Mount Sinai Hospital, CanadaNot recruiting18 Years99 YearsAll77Phase 4Canada
1112NCT01163747September 201019 October 2017A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background MethotrexateRheumatoid ArthritisBiological: tocilizumab;Drug: methotrexate;Biological: 23-Valent Pneumococcal Polysaccharide Vaccine;Biological: Tetanus Toxoid Adsorbed VaccineGenentech, Inc.Not recruiting18 Years64 YearsAll91Phase 4United States
1113NCT01184001September 201019 February 2015A Study To Evaluate The Effect Of Food On How Tasocitinib (CP-690,550) Is Absorbed And Moves Through The Body Following Oral Administration Of Tasocitinib (CP-690,550) Tablets To Healthy SubjectsA Phase 1, Randomized, 2-Period, 2-Sequence, Open Label, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On Pharmacokinetics Of Tasocitinib (CP-690,550) Tablets In Healthy SubjectsRheumatoid ArthritisDrug: Treatment A;Drug: Treatment BPfizerNot recruiting21 Years55 YearsBoth16Phase 1Singapore
1114NCT01185288September 201019 October 2017A Study to Determine the Effect of Methotrexate (MTX) Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Treated With Adalimumab (MUSICA)A Multicenter, Double-Blind, Randomized, Parallel-Arm Study to Determine the Effect of Methotrexate Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis Treated With Adalimumab (MUSICA)Rheumatoid ArthritisBiological: Adalimumab;Drug: MethotrexateAbbVie (prior sponsor, Abbott)Not recruiting18 YearsN/AAll309Phase 4United States;Puerto Rico
1115NCT01208506September 201016 December 2017First-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/SNot recruiting18 Years75 YearsAll64Phase 1Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1116NCT01213017September 201016 December 2017The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis PatientsThe Effect of Certolizumab Pegol in Combination With Methotrexate on MRI Synovitis and Bone Edema and Patient Reported Outcomes as Measured Using an Automated Visit Manager System in Moderate to Severe Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: certolizumab pegolOklahoma Medical Research FoundationUCB PharmaNot recruiting18 YearsN/AAll20Phase 3United States
1117NCT01248780September 201019 October 2017Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate TherapyA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Active Rheumatoid Arthritis Despite Methotrexate TherapyRheumatoid ArthritisDrug: Golimumab;Drug: Placebo;Drug: Methotrexate (MTX)Centocor, Inc.Schering-PloughNot recruiting18 YearsN/AAll264Phase 3China
1118NCT01282528September 201019 February 2015Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid ArthritisUltrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid ArthritisRheumatoid Arthritis;Ultrasonography;InfliximabBiological: infliximabPeking Union Medical College HospitalShanghai Changzheng Hospital;First Hospital of China Medical University;Shenzhen People's Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Wenzhou Medical University;First People's Hospital of Foshan;West China HospitalRecruiting18 Years65 YearsBoth85Phase 4China
1119EUCTR2010-019964-36-BE26/08/201021 August 2017A 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-2Rheumatoid arthritis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: CCX354-C
Product Code: CCX354-C
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: CCX354-C
Other descriptive name: CCX354
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		ChemoCentryx, Inc.Not RecruitingFemale: yes
Male: yes		150Phase 2Czech Republic;Hungary;Belgium;Germany
1120EUCTR2010-018375-22-ES03/08/201019 March 2012A 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 arthritis Artritis 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use		F. Hoffmann-La Roche Ltd.AuthorisedFemale: yes
Male: yes		1200Germany;United Kingdom;Bulgaria;Spain;Italy;Lithuania
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1121ChiCTR-TRC-100009892010-08-0118 April 2017A 24 Week Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Chinese Medicines –the Second TrialA 24 Week Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Chinese Medicinesrheumatoid arthritis;M06.991observation group:Methotrexate Tablets, once per week, for first tim;observation group:Leigongtengduogan Pian, 10mg per time, 3 times per day, Yishen Juanbi Wan, 8g per time, 3 times per day, for oral administration, after meals ;Total:;The Ministry of Science and Technology of the People's Republic of ChinaNot Recruiting1870Maleobservation group:120;observation group:120;Total:240;Post-marketChina
1122JPRN-JapicCTI-10126301/8/20102 April 2019DRIVEA Dose-response Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on Methotrexate (MTX) to Validate Inhibitory Effect on Bone Erosion (Phase II)Rheumatoid ArthritisIntervention name : AMG 162
INN of the intervention : Denosumab
Dosage And administration of the intervention : AMG 162 60 mg administered subcutaneously - Every 6 months/ Every 3 months/ Every 2 months
Control intervention name : Placebo
Dosage And administration of the control intervention : Subcutaneously for placebo		DAIICHISANKYO Co.,Ltd.2075BOTH320Phase 2
1123NCT01184092August 201019 February 2015A Study To Compare The Amount Of Tasocitinib (CP-690,550) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Three Different Tablet Versions Of Tasocitinib (CP-690,550)Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, Cross-Over, Bioequivalence Study Comparing Phase 2b, Phase 3 And Commercial Image Tablet Formulations Of Tasocitinib (CP-690,550) Under Fasted ConditionsRheumatoid ArthritisDrug: Treatment A;Drug: Treatment B;Drug: Treatment CPfizerNot recruiting21 Years55 YearsBoth24Phase 1Singapore
1124EUCTR2010-019261-28-DE26/07/201019 March 2012A 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 arthritisRheumatoid arthritis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: NNC 0142-0000-0002
Product Code: NNC 142-0002
Pharmaceutical Form: Powder and solvent for solution for injection
Current Sponsor code: NNC 142-0002
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Novo Nordisk A/SNot RecruitingFemale: yes
Male: yes		160Germany
1125EUCTR2009-017051-10-NL13/07/201019 March 2012Metabolic adverse events before and after glucocorticoid pulse therapy in rheumatoid arthritisMetabolic adverse events before and after glucocorticoid pulse therapy in rheumatoid arthritisPatients with rheumatoid arthritis, who suffer from a exacerbation of disease can be included in this study. Exacerbation is defined as a Disease Activity Score of 5.1 or higher. Patients will be excluded if they suffer from diabetes (irrespective of medication) or if they have a contra-indication for dexamethason use.
MedDRA version: 12.0 Level: LLT Classification code 10060732 Term: Rheumatoid arthritis flare up		Trade Name: Dexamethason
Product Name: dexamethason
Pharmaceutical Form: Intravenous infusion		UMC UtrechtAuthorisedFemale: yes
Male: yes		Netherlands
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1126EUCTR2009-012041-35-BE02/07/20107 October 2014A 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-003Rheumatoid 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
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Not assigned yet
Current Sponsor code: TNF-K
Other descriptive name: N.A.
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 360-
Pharmaceutical form of the placebo: Emulsion for injection
Route of administration of the placebo: Intramuscular use		Neovacs SAAuthorisedFemale: yes
Male: yes		48Phase 2France;Argentina;Belgium;Croatia;Romania;Chile;Bulgaria
1127JPRN-UMIN0000038072010/07/012 April 2019A 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 arthritisRheumatoid ArthritisCombination therapy of three DMARDs (bucillamine, salazosulphapyridine and methotrexate)
Combination therapy of TNF-bloking biologics and methotrexate		Japan Association of Rheumatologists in Private PracticeNot RecruitingNot applicableNot applicableMale and Female160Not applicableJapan
1128JPRN-UMIN0000038802010/07/012 April 2019Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai areaRheumatoid 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
1129NCT01147341July 201019 October 2017Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to CimziaCan TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response By Switching to Certolizumab Pegol (Cimzia)? A Phase IV, Randomized, Multi-Center, Double-Blind, Twelve-Week Study Followed by a 12-Week Open-Label PhaseRheumatoid ArthritisDrug: Cimzia;Drug: PlaceboMichael Schiff, MDUCB PharmaNot recruiting18 Years75 YearsAll37Phase 4United States
1130NCT01593332July 201019 February 2015Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid ArthritisDMARD Resistant Rheumatoid ArthritisDrug: RituximabMashhad University of Medical SciencesRoche Pharma AGNot recruiting19 Years75 YearsBoth44Phase 4Iran, Islamic Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1131EUCTR2009-013758-33-SE17/06/201027 January 2014MULTICENTER 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 ARTHRITISRheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Current Sponsor code: CDP870
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		UCB Pharma S.A.Not RecruitingFemale: yes
Male: yes		36Denmark;Netherlands;Sweden
1132EUCTR2009-012055-19-IE16/06/201019 March 2012A 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 arthritisRheumatoid arthritis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: GSK315234 Injection 100mg/mL
Product Code: GSK315234
Pharmaceutical Form: Injection*
Current Sponsor code: GSK315234
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intravenous use		GlaxoSmithKline Research & Development LimitedNot RecruitingFemale: yes
Male: yes		45United Kingdom;Belgium;France;Ireland
1133EUCTR2010-019873-13-BE07/06/201021 August 2017Comparative study of the clinical response and cardiorespiratory endurance in early rheumatoid arthritis patients treated with Tociluzimab or Methotrexate Addendum 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 Methotrexate Addendum protocol : Global gene expression profiles in synovial biopsies from early rheumatoid arthritis patients treated with Tocilizumab or Methotrexate - TOMERAearly rheumatoid arthritis
MedDRA version: 12.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions		Trade Name: RoActemra
Product Name: Tocilizumab
Pharmaceutical Form: Solution for infusion		UCL Cliniques Universitaires Saint LucNot RecruitingFemale: yes
Male: yes		Phase 2Belgium
1134EUCTR2008-005708-18-GB04/06/201019 March 2012Prevention 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 excessRheumatoid arthritis, SLE, Polymyalgia rheumatica, Disthyroid eye disease, Cushing's syndromeTrade Name: Glucophage (metformin)
Product Name: Metformin
Pharmaceutical Form: Tablet		Queen Mary University of LondonAuthorisedFemale: yes
Male: yes		United Kingdom
1135NCT01132118June 201019 October 2017Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid ArthritisHydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid ArthritisRheumatoid Arthritis;Insulin ResistanceDrug: HydroxychloroquineBrigham and Women's HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 YearsN/AAll30Phase 3United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1136NCT01143337June 201019 October 2017Efficacy and Safety Study of MP-435 in Combination With Methotrexate (MTX) in Patients With Rheumatoid ArthritisA Multicenter Randomized, Double-blind, Placebo-controlled Study of MP-435 in Combination With MTX in Patients With Rheumatoid Arthritis - Exploratory StudyRheumatoid ArthritisDrug: MP-435(dose1) + Methotrexate;Drug: Placebo + MethotrexateMitsubishi Tanabe Pharma CorporationNot recruiting20 Years75 YearsAll112Phase 2Japan
1137NCT01146652June 201015 October 2018Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: SAR153191 (REGN88)SanofiRegeneron PharmaceuticalsNot recruiting18 YearsN/AAll2000Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Brazil;Canada;Chile;Colombia;Czechia;Ecuador;Estonia;Finland;Germany;Greece;Guatemala;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;South Africa;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Czech Republic
1138EUCTR2009-017163-42-SE18/05/201022 May 2017Pain 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 - PARADERheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Subcutaneous use		Karolinska InstituteNot RecruitingFemale: yes
Male: yes		Phase 4Sweden
1139EUCTR2010-019438-28-SE17/05/201019 March 2012Vaccination against TBE in patients who use immunosuppressive drugsVaccination against TBE in patients who use immunosuppressive drugsTBE vaccin in patients using immunosuppressive drugs
MedDRA version: 12.1 Level: LLT Classification code 10046859 Term: Vaccination
MedDRA version: 12.1 Level: LLT Classification code 10037153 Term: Psoriasis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 12.1 Level: LLT Classification code 10054980 Term: Immunosuppressant drug therapy		Trade Name: FSME-IMMUN
Pharmaceutical Form: Suspension for injection
CAS Number: 0
Other descriptive name: TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2,4-		Mälarsjukhuset EskilstunaAuthorisedFemale: yes
Male: yes		Sweden
1140EUCTR2009-015845-21-GB13/05/20107 August 2012A 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 arthritisAdult Rheumatoid Arthritis (RA)
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Humira®
Product Code: RO 551-6922
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: RO 551-6922
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		F. Hoffmann-La Roche Ltd.AuthorisedFemale: yes
Male: yes		300Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1141EUCTR2009-015740-42-DE12/05/201023 March 2015A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSION RETRO – 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 REMISSION RETRO – REduction of Therapy in RA patients in Ongoing remission, Reduzierung der Therapie bei RA-Patienten in Remission - RETRORheumatoid 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
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Trade Name: Humira
Pharmaceutical Form: Injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Product Name: Azathioprin
Pharmaceutical Form: Coated tablet
CAS Number: 446-86-6
Current Sponsor code: 52424.00.00
Other descriptive name: AZATHIOPRINE
Concentration unit: mg/kg milligram(s)/kilogram
Trade Name: Immunosporin
Product Name: Immunosporin
Pharmaceutical Form: Tablet
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Trade Name: Cimzia
Product Name: Cimzia
Pharmaceutical Form: Injection
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Current Sponsor code: EU/1/09/544/001-002
Concentration unit: mg milligram(s)
Trade Name: Enbrel
Product Name: Enbrel
Pharmaceutical Form: Injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Current Sponsor code: EU/1/99/126/016
Concentration unit: mg milligram(s)
Product Name: Quensyl
Pharmaceutical Form: Tablet
CAS Number: 747-36-4
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Concentration unit: mg/kg milligram(s)/kilogram
Trade Name: REMICADE
Product Name: Remicade
Pharmaceutical Form:
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: EU/1/99/116/001
Concentration unit: mg/kg milligram(s)/kilogram
Trade Name: Lantarel
Product Name: Lantarel
Pharmaceutical Form: Injection
INN or Proposed INN: METHOTREXATE SODIUM
CAS Number: 15475-56-6
Current Sponsor code: 9709.01.01
Other descriptive name: Lantarel
Concentration unit: mg milligram(s)
Trade Name: Arava
Product Name: Arava
Pharmaceutical Form: Tablet
INN or Proposed INN: LEFLUNOMIDE
CAS Number: 75706-12-6
Current Sponsor code: EU 1/99/118/007 – 008
Other descriptive name: Arava
Concentration unit: mg milligram(s)
Product Name: Metex 2,5mg
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE SODIUM
CAS Number: 15475-56-6
Other descriptive name: Metex 2,5mg		Universitätsklinkum ErlangenAuthorisedFemale: yes
Male: yes		Phase 3Germany
1142EUCTR2009-015950-39-DE12/05/201025 January 2016Rituximab-Treatment in Addition to Leflunomide in Patients with active rheumatoid arthritisAddition of Rituximab to Leflunomide in patients with active rheumatoid arthritis - AMARAActive 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		Johann Wolfgang Goethe-Universität Frankfurt/M.Not RecruitingFemale: yes
Male: yes		Germany
1143EUCTR2010-018331-18-GB12/05/201017 June 2013A 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 TherapyAdult Rheumatoid Arthritis (RA)
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: R04877533
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-		F. Hoffmann-La Roche Ltd.Not RecruitingFemale: yes
Male: yes		United Kingdom
1144NCT01101555May 12, 201016 December 2017Repeat Dose Subcutaneous Rhumatoid Arthritis Efficacy StudyA Randomised, Single-blind, Placebo-controlled, Study Toevaluate the Safety, Tolerability, Pharmacodynamics Andpharmacokinetics of Repeat Subcutaneous Administration Ofotelixizumab in Subjects With Rheumatoid ArthritisArthritis, RheumatoidDrug: subcutanious administration;Other: PlaceboGlaxoSmithKlineNot recruiting18 Years75 YearsAll28Phase 1Russian Federation
1145JPRN-UMIN0000036152010/05/012 April 2019Evaluation of the effectiveness of three nonbiologic DMARDs [salazosulfapyridine(SSZ), bucillamine(BUC), methotrexate(MTX)] combination therapy for early RARA(Rheumatoid Arthritis)Using 3 DMARDs(Salazosulfapyridine, Bucillamine, and Methotrexate) for 24 monthsSt Luke's International HospitalRecruiting20years-old80years-oldMale and Female20Not selectedJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1146NCT01059448May 201013 April 2015Safety 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 ArthritisRheumatoid ArthritisDrug: AMG 827AmgenNot recruitingN/AN/ABoth211Phase 2United States;Bulgaria;Canada;Czech Republic;Latvia;Mexico;Poland;United Kingdom
1147NCT01090570May 201023 March 2015Safety, Pharmacokinetic (PK), Pharmcodynamic (PD), and Drug-Drug Interaction of PLX3397 in Patients With Rheumatoid Arthritis Who Are Receiving MethotrexateRheumatoid ArthritisDrug: PLX3397PlexxikonNot recruiting18 YearsN/ABoth0Phase 1United States
1148NCT01163617May 201019 October 2017The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis PatientsA Multicenter, Randomized, Open-Label Study of the Injection Time and Usability of the Physiolis Syringe and Autoinjector in Injection-Experienced Rheumatoid Arthritis PatientsRheumatoid ArthritisDevice: Adalimumab delivered in current syringe;Device: Adalimumab delivered in Physiolis syringe;Device: Adalimumab delivered in current autoinjector;Device: Adalimumab delivered in Physiolis autoinjectorAbbVie (prior sponsor, Abbott)Not recruiting18 YearsN/AAll85Phase 2United States
1149NCT01245452May 201019 February 2015Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or MethotrexateComparative Study of the Clinical Response and Cardiorespiratory Endurance in Early Rheumatoid Arthritis Patients Treated With Tocilizumab or Methotrexate Addendum Protocol : Global Gene Expression Profiles in Synovial BiopsiesRheumatoid ArthritisDrug: Tocilizumab;Drug: MethotrexatePatrick DurezNot recruiting18 Years70 YearsBoth30N/ABelgium
1150NCT01250548May 201019 February 2015The Controlled Trial of Apremilast for Rheumatoid Arthritis Treatment (CARAT)The Controlled Trial of Apremilast for Rheumatoid Arthritis TreatmentRheumatoid ArthritisBiological: apremilast;Other: PlaceboBaylor Research InstituteNot recruiting18 YearsN/ABoth34Phase 2United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1151NCT01253265May 201019 October 2017A Study in Rheumatoid ArthritisMultiple-Dose, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2439821 in Japanese Patients With Rheumatoid Arthritis on Concomitant Methotrexate TreatmentRheumatoid ArthritisDrug: LY2439821;Drug: PlaceboEli Lilly and CompanyNot recruiting20 Years75 YearsAll32Phase 1Japan
1152NCT01253291May 201019 February 2015A Study of Japanese Rheumatoid Arthritis PatientsAn Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With MethotrexateRheumatoid ArthritisDrug: LY2127399Eli Lilly and CompanyNot recruiting20 Years75 YearsBoth32Phase 1Japan
1153NCT01077531April 28, 201016 December 2017Safety, Pharmacodynamics and Pharmacokinetics of GSK2136525 Repeat Dose in Rheumatoid ArthritisA Randomized, Placebo-controlled, Single-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of Otelixizumab in Rheumatoid Arthritis SubjectsArthritis, RheumatoidDrug: Otelixizumab;Drug: Matching placeboGlaxoSmithKlineNot recruiting18 Years75 YearsAll12Phase 1Russian Federation;Spain;United Kingdom
1154EUCTR2009-017379-90-IT27/04/201014 September 2015Characterization 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 - NDRA 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		Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		AZIENDA OSPEDALIERA SENESENot RecruitingFemale: yes
Male: yes		Italy
1155EUCTR2009-011791-30-GB14/04/201021 August 2012A 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 arthritisRheumatoid 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
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: NNC0151-0000-0000
Other descriptive name: Anti-C5aR
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Novo Nordisk A/SAuthorisedFemale: yes
Male: yes		48Hungary;Germany;Czech Republic;Russian Federation;United Kingdom;Ukraine;Denmark;Romania;Poland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1156EUCTR2010-018696-21-FR14/04/201019 March 2012Etude de l’évolution de la réponse immunitaire Th17 chez des patients atteints de polyarthrite rhumatoïde et traités par tocilizumab après échec des autres thérapies - TOCI 17Etude de l’évolution de la réponse immunitaire Th17 chez des patients atteints de polyarthrite rhumatoïde et traités par tocilizumab après échec des autres thérapies - TOCI 17Polyarthrite rhumatoïde
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: RoACTEMRA
Product Name: TOCILIZUMAB
Pharmaceutical Form: Solution for injection		CHU DIJONAuthorisedFemale: yes
Male: yes		France
1157EUCTR2009-015835-34-IT09/04/20103 April 2017VITAMIN D EFFECT ON T LYMPHOCYTES AND OSTEOCLASTOGENESIS IN RHEUMAOID ARTHRITIS - NDVITAMIN D EFFECT ON T LYMPHOCYTES AND OSTEOCLASTOGENESIS IN RHEUMAOID ARTHRITIS - NDRheumatoid Arthritis
MedDRA version: 12.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid		Trade Name: DIBASE*IM OS 2F 1ML 300000UI/M
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Colecalciferol
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 300000-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Oral use		AZIENDA OSPEDALIERA ORDINE MAURIZIANONot RecruitingFemale: yes
Male: no		Phase 3Italy
1158NCT01021735April 20108 June 2015Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic TherapyOptimal Management of Rheumatoid Arthritis Patients Requiring Biologic TherapyRheumatoid ArthritisDrug: etanercept or adalimumab;Drug: RituximabUniversity of GlasgowArthritis Research Campaign;NHS Lothian;NHS Grampian;NHS Tayside;NHS Borders;NHS FifeNot recruiting18 YearsN/ABoth302Phase 4United Kingdom
1159NCT01060098April 201030 March 2015T Cells and TNF: The Impact of TNF BlockadeT Cells and TNF: The Impact of TNF Blockade on Effector T Cell Populations in Rheumatoid Arthritis and Other Conditions Treated With Anti-TNFalpha AgentsRheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: anti-TNF therapy (etanercept or adalimumab)Imperial College LondonNot recruiting18 Years80 YearsBoth52N/AUnited Kingdom
1160NCT01067430April 201019 February 2015Comparison 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 TrustNot recruiting18 YearsN/ABoth20Phase 4United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1161NCT01151644April 201019 February 2015Safety 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 PauloNot recruitingN/AN/ABoth5000Phase 4Brazil
1162NCT01287533April 201019 February 2015Efficacy of Monthly Ibandronate in Women With RA and Reduced Bone Mineral Density Receiving Long-term SteroidsEfficacy of Monthly Ibandronate in Women With Rheumatoid Arthritis and Reduced Bone Mineral Density Receiving Long-term GlucocorticoidsRheumatoid Arthritis;Osteoporosis;OsteopeniaDrug: Ibandronate;Drug: PlaceboYeong-Wook SongNot recruiting18 Years75 YearsFemale167Phase 4Korea, Republic of
1163NCT01313858April 201019 October 2017A 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.Not recruiting18 YearsN/AAll1613N/AGermany
1164EUCTR2009-015636-15-HU25/03/201019 March 2012Rheumatoid arthritisAn Open-label Extension Study to Assess the Long-term Safety and Tolerability of ATN-103 in Subjects With Rheumatoid ArthritisRheumatoid 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
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: ATN-103
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer CompanyNot RecruitingFemale: yes
Male: yes		260Hungary;Russian Federation;Germany;Canada;Switzerland;Belgium;Japan;United States;South Africa
1165EUCTR2009-015653-20-NL08/03/201019 March 2012Prospective 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 applicablerheumatoid arthritis
MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: etanercept
Product Name: Etanercept
Pharmaceutical Form: Injection*
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Current Sponsor code: ETN-cohortRA2009
Other descriptive name: methotrexate
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-30		AuthorisedFemale: yes
Male: yes		Netherlands
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1166NCT01197066March 201030 September 2019Open-label, Extension Study of CDP870 in Patients With Rheumatoid ArthritisA Phase ? Multicenter, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Certolizumab Pegol as Additional Medication to Methotrexate, in Patients With Active Rheumatoid Arthritis Who Participated in Study 101-KOA-0801iRheumatoid ArthritisDrug: Certolizumab PegolKorea Otsuka Pharmaceutical Co., Ltd.Not recruiting18 YearsN/AAll110Phase 3Korea, Republic of
1167NCT01256736March 201019 February 2015To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid ArthritisProspective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 StudyRheumatoid ArthritisDrug: Tocilizumab;Drug: DMARDsJW PharmaceuticalNot recruiting18 YearsN/ABoth89Phase 3Korea, Republic of
1168NCT01610791March 201019 October 2017A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study)Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNot recruiting18 YearsN/AAll121Phase 3Morocco
1169NCT02010216March 201019 October 2017A 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 RocheNot recruiting18 YearsN/AAll23Phase 4Kazakhstan
1170NCT01063062February 28, 201016 December 2017A 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 RocheNot recruiting18 YearsN/AAll107Phase 3Egypt
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1171EUCTR2009-016789-10-NL19/02/201019 March 2012Efficacy of the H1N1 Flu (swine flu) vaccination in patients with Rheumatoid Arthritis treated with rituximabEfficacy of the H1N1 Flu (swine flu) vaccination in patients with Rheumatoid Arthritis treated with rituximabTo assess the efficacy of A/H1N1 vaccination in patients treated with rituximab therapyTrade Name: Focetria
Trade Name: Pandemrix,		Div KIR AMCAuthorisedFemale: yes
Male: yes		Netherlands
1172EUCTR2009-017325-19-FI11/02/201019 March 2012“The effect of Six months Adalimumab Treatment on Sick Leaves and retirement in Patients with rheumatoid Arthritis who are at risk of losing their ability to work”“The effect of Six months Adalimumab Treatment on Sick Leaves and retirement in Patients with rheumatoid Arthritis who are at risk of losing their ability to work”Rheumatoid arthritis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: HUMIRA
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Route of administration of the placebo: Subcutaneous use		Helsingin reumakeskusAuthorisedFemale: yes
Male: yes		Finland
1173EUCTR2009-016987-34-SE09/02/201027 May 2013.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 ARTHRITISModerate 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
Pharmaceutical Form: Film-coated tablet
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Methotrexate Sodium
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE SODIUM
CAS Number: 15475-56-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use		Pfizer Inc., 235 East 42nd Street, New York, NY 10017Not 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
1174EUCTR2009-012566-32-CZ05/02/201019 March 2012A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, 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 the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to MethotrexateRheumatoid arthritis (RA)
MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: AMG 827
Product Code: AMG 827
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AMG 827
Current Sponsor code: AMG 827
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Amgen IncNot RecruitingFemale: yes
Male: yes		240Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland
1175NCT00979771February 201016 December 2017A Study to Investigate the Ability of GSK706769 to Maintain Clinical Remission After Withdrawal of Enbrel in Rheumatoid Arthritis PatientsA Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Ability of GSK706769 to Maintain Clinical Remission After Withdrawal of Enbrel in Patients With Rheumatoid ArthritisArthritis, RheumatoidDrug: GSK706769;Drug: PlaceboGlaxoSmithKlineNot recruiting18 YearsN/AAll0Phase 2Netherlands
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1176NCT01038674February 201016 December 2017Safety 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/SNot recruiting18 Years75 YearsAll16Phase 1Belgium;Poland
1177NCT01052194February 201019 February 2015A 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 ArthritisRheumatoid ArthritisDrug: Placebo;Drug: VX-509Vertex Pharmaceuticals IncorporatedNot recruiting18 Years75 YearsBoth206Phase 2United States;Belgium;Croatia;Germany;Hungary;Poland;Puerto Rico;Romania;Russian Federation;Serbia
1178NCT01059864February 201019 October 2017Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550Phase 2 Study Of The Effects Of Open-Label CP-690,550 And Double-Blind Atorvastatin On Lipids In Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: CP-690,550;Drug: Atorvastatin;Drug: Atorvastatin PlaceboPfizerNot recruiting18 YearsN/AAll111Phase 2United States;Korea, Republic of
1179NCT01063803February 201019 February 2015Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid ArthritisAn Open-Label Extension Study To Assess The Long-term Safety And Tolerability Of ATN-103 In Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: ATN-103AblynxNot recruiting18 Years80 YearsBoth266Phase 2United States;Canada;Hungary;Japan;Russian Federation;Serbia;South Africa;Switzerland
1180NCT01111357February 201019 February 2015Study of Human Leukocyte Antigen (HLA) Polymorphisms in Patients With Rheumatoid ArthritisStudy of HLA Polymorphisms in French West-Indian Patients With Rheumatoid Arthritis : A Case Control StudyRheumatoid ArthritisBiological: Collect of 10 ml of peripheric blood for DNA extractionCentre Hospitalier Universitaire de Fort-de-FranceNot recruiting18 YearsN/ABoth200N/AMartinique
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1181NCT01123070February 201019 February 2015TL011 in Severe, Active Rheumatoid Arthritis PatientsRheumatoid ArthritisBiological: TL011, anti CD20, for the treatment of rheumatoid arthritis;Biological: MabThera infusionsTeva Pharmaceutical IndustriesNot recruiting18 Years80 YearsBoth48Phase 1/Phase 2Czech Republic;Hungary;Italy;Spain;United Kingdom;Germany
1182NCT01754805January 22, 201024 June 2019A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Patients With Rheumatoid ArthritisA Phase 1b, Open-Label, Single Sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: peficitinib;Drug: methotrexateAstellas Pharma IncNot recruiting18 Years65 YearsAll15Phase 1United States
1183EUCTR2008-007185-33-DE12/01/201019 March 2012A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103 Administered to Subjects With Active Rheumatoid Arthritis on a Background of MethotrexateA Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103 Administered to Subjects With Active Rheumatoid Arthritis on a Background of MethotrexateRheumatoid arthritis
MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: ATN-103
Product Code: ATN-103
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: ATN-103
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use		Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer CompanyNot RecruitingFemale: yes
Male: yes		240Phase 1/2Hungary;United Kingdom;Germany;Netherlands;Belgium
1184EUCTR2009-010582-23-DE04/01/201024 February 2014A 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
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Golimumab
Current Sponsor code: CNTO 148
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 12.5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: Golimumab liquid in prefilled pen
Product Code: CNTO 148
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Current Sponsor code: CNTO 148
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Janssen Biologics B.V.Not RecruitingFemale: yes
Male: yes		400Phase 3bGreece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
1185NCT00752154January 201019 February 2015Curcumin in Rheumatoid ArthritisCurcumin in Rheumatoid Arthritis - ACross-Over Pilot StudyRheumatoid ArthritisDrug: Curcumin (Longvida™)University of California, Los AngelesRecruiting18 YearsN/ABoth40Phase 0United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1186NCT00995449January 201019 October 2017Study of KB003 In Biologics-Inadequate Rheumatoid ArthritisA Phase 2, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of the Anti-GM-CSF Monoclonal Antibody KB003 in Subjects With Active Rheumatoid Arthritis and Inadequate Prior Treatment Outcome From Biologic TherapyRheumatoid ArthritisBiological: KB003;Other: Placebo ComparatorKaloBios PharmaceuticalsNot recruiting18 YearsN/AAll9Phase 2United States
1187NCT01039688January 201011 June 2018Comparing 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 drugPfizerNot recruiting18 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
1188NCT01071798January 201019 October 2017An 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 RocheNot recruiting18 YearsN/AAll1653N/AGermany;United States
1189NCT01089023January 201019 October 2017A 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 RocheNot recruiting18 YearsN/AAll95Phase 4Bahrain;Iran, Islamic Republic of;Kuwait;Qatar;United Arab Emirates
1190NCT01198509January 201019 October 2017Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)Rheumatoid Arthritis;Psoriatic Arthritis;Periodontal DiseaseDrug: doxycycline;Drug: vancomycinNew York University School of MedicineNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Memorial Sloan Kettering Cancer CenterNot recruiting18 Years70 YearsAll178N/AUnited States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1191NCT02368093January 201019 October 2017Efficacy Study of Dextromethorphan to Treat Rheumatoid ArthritisA Double-blind, Placebo-controlled, Therapeutic Trial With Antitussive Drug-Dextromethorphan: Aimed to Determine Its Therapeutic Effect in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Dextromethorphan hydrobromideTaichung Veterans General HospitalTSH Biopharm Corporation LimitedNot recruiting18 YearsN/AAll48N/A
1192NCT02731560January 201018 April 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, RawalpindiNot recruiting18 Years80 YearsBoth74Phase 4
1193EUCTR2009-014735-20-LV29/12/200911 February 2013A 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 - EARTHRheumatoid 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
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: mavrilimumab
CAS Number: 1085337-57-0
Current Sponsor code: CAM-3001
Other descriptive name: anti-GM-CSF receptor alpha
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		MedImmune LtdNot RecruitingFemale: yes
Male: yes		264Phase 2Hungary;Estonia;Czech Republic;Poland;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Japan
1194NCT00950989December 200912 September 2016AMG 827 in Rheumatoid Arthritis Subjects With Inadequate Response to MethotrexateA Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis and an Inadequate Response to MethotrexateRheumatoid ArthritisDrug: AMG 827 70 mg;Drug: AMG 827 140 mg;Drug: AMG 827 210 mg;Drug: Placebo;Drug: Stable weekly dose of methotrexateAmgenNot recruiting18 Years70 YearsBoth240Phase 2Bulgaria;Canada;Czech Republic;Hungary;Latvia;Mexico;Poland;United Kingdom;United States
1195NCT01000441December 200919 February 2015Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid ArthritisRotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid ArthritisRheumatoid ArthritisDrug: infliximab, etanercept, adalimumab;Drug: abatacept, rituximab or tocilizumabUniversity Hospital, Strasbourg, FranceRecruiting18 YearsN/ABoth300Phase 4France;Monaco
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1196NCT01001832December 200919 October 2017Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese PatientsA Phase II/III, Multicenter, Randomized, Double-Blind, Double-Dummy Study to Assess Similarity of the Efficacy, Pharmacokinetics, Safety and Immunogenicity of Abatacept Administered Subcutaneously or Intravenously in Japanese Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to MethotrexateRheumatoid ArthritisDrug: Intravenous (IV) abatacept;Drug: Subcutaneous (SC) abataceptBristol-Myers SquibbNot recruiting20 YearsN/AAll118Phase 2/Phase 3Japan
1197NCT01008852December 200919 February 2015Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid ArthritisRandomized, 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 MethotrexateActive Rheumatoid ArthritisDrug: SBI-087;Drug: PlaceboPfizerEmergent Product Development Seattle LLCNot recruiting18 YearsN/ABoth210Phase 2United States;Argentina;Canada;Chile;Hungary;Japan;Mexico;Poland;Serbia;Spain;Greece;Turkey
1198NCT01023256December 200919 October 2017Safety and Preliminary Efficacy of MOR103 in Patients With Active Rheumatoid ArthritisA Multi-center, 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 ArthritisRheumatoid ArthritisDrug: MOR103MorphoSys AGNot recruiting18 YearsN/AAll96Phase 1/Phase 2Bulgaria;Germany;Netherlands;Poland;Ukraine
1199NCT01027728December 200919 February 2015Study to Evaluate Safety and Efficacy of CCX 354-C in Subjects With Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase I/II Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: CCX 354-CChemoCentryxNot recruiting18 Years75 YearsBoth24Phase 1/Phase 2Belgium;Romania
1200NCT01029613December 200931 August 2015Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating BiomarkersAdalimumab 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 BiomarkersRheumatoid ArthritisDrug: AdalimumabGlostrup University Hospital, CopenhagenNot recruiting18 Years85 YearsBoth40N/ADenmark
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1201NCT01044498December 200919 October 2017A 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 RocheNot recruiting18 Years44 YearsFemale46Phase 3United States
1202EUCTR2009-016055-22-FI27/11/200927 October 2014Immuunipuutteisten matkailijoiden A-hepatiittisuojausImmuunipuutteisten matkailijoiden A-hepatiittisuojausTerveet 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
Pharmaceutical Form: Solution for injection		HY, HUSNot RecruitingFemale: yes
Male: yes		Finland;Sweden
1203EUCTR2009-012424-87-GB26/11/200919 March 2012T 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 TNFRheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis
MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 12.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis
MedDRA version: 12.0 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis		Trade Name: Enbrel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: etanercept
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: adalimumab
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Enbrel
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: etanercept
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Enbrel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Etanercept
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-		Imperial College London South Kensington LondonAuthorisedFemale: yes
Male: yes		United Kingdom
1204EUCTR2009-009696-34-DE23/11/200924 April 2012A 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 TherapyRheumatoid 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
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: N.A.
Current Sponsor code: LY2439821
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 48-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Eli Lilly and CompanyNot RecruitingFemale: yes
Male: yes		648Phase 2India;Russian Federation;Germany;Peru;Taiwan;Argentina;Romania;Korea, Republic of;Chile;Poland
1205EUCTR2009-012185-32-IT23/11/20097 January 2013Open 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) - NDModerate 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RoActemra
CAS Number: 375823-41-9
Current Sponsor code: Ro487-7533
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-		ROCHENot RecruitingFemale: yes
Male: yes		Phase 3bItaly
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1206EUCTR2009-012204-42-IE13/11/200919 March 2012A 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 arthritisRheumatoid arthritis
MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: GSK706769
Product Code: GSK706769
Pharmaceutical Form: Film-coated tablet
CAS Number: 880356-67-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		GlaxoSmithKline Research & Development LimitedNot RecruitingFemale: yes
Male: yes		50Belgium;Ireland
1207EUCTR2009-014296-40-DE12/11/200910 December 2012PHASE 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 INHIBITORSRheumatoid arthritis
MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: not applicable
Product Code: CP-690,550
Pharmaceutical Form: Film-coated tablet
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550-10
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		Pfizer Inc., 235 East 42nd Street, New York, NY 10017Not RecruitingFemale: yes
Male: yes		396Phase 3France;Belgium;Spain;Ireland;Austria;Germany;United Kingdom;Italy
1208EUCTR2009-013223-37-CZ10/11/200912 December 2016A 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 ARTHRITISRheumatoid Arthritis
MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: PF-04171327
Product Code: PF-04171327
Pharmaceutical Form: Tablet
Current Sponsor code: PF-04171327
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: PF-04171327
Product Code: PF-04171327
Pharmaceutical Form: Tablet
Current Sponsor code: PF-04171327
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Pharmaceutical Form: Capsule*
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Other descriptive name: Decortin®
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		Pfizer Inc.Not RecruitingFemale: yes
Male: yes		119Phase 2Hungary;Czech Republic;Spain
1209EUCTR2009-013316-12-NL10/11/20091 December 2014A 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-EarlyRheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Methotrexate 'Lederle' 2,5mg tablets
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		Roche Nederland B.V.Not RecruitingFemale: yes
Male: yes		Netherlands
1210EUCTR2007-006129-29-DE03/11/200927 January 2014A 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 StudyRheumatoid 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
Pharmaceutical Form: Solution for infusion
Current Sponsor code: MOR103
Other descriptive name: Human Recombinant IgG1, lambda
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 8-12
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use		MorphoSys AGNot RecruitingFemale: yes
Male: yes		89Poland;Ukraine;Bulgaria;Netherlands;Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1211EUCTR2009-014824-40-CZ03/11/200919 March 2012An 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: ART621
Pharmaceutical Form: Solution for injection
Current Sponsor code: ART621
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		Arana Therapeutics LtdNot RecruitingFemale: yes
Male: yes		200Czech Republic
1212JPRN-UMIN0000027442009/11/012 April 2019Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuationrheumatoid arthritistocilizumab plus methotrexate
tocilizumab		Keio UniversityNot Recruiting20years-old75years-oldMale and Female300Not selectedJapan
1213NCT00844714November 200919 October 2017Cardiovascular 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.Not recruiting18 YearsN/AAll20N/AUnited States
1214NCT00976599November 200919 October 2017A 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 + MethotrexatePfizerNot recruiting18 YearsN/AAll29Phase 2United States
1215NCT01006681November 200919 February 2015Vaccination 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 CenterNot recruiting18 Years65 YearsBoth400Phase 2
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1216NCT01007175November 200919 February 2015Study 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 q8wksAblynxNot recruiting20 Years75 YearsBoth60Phase 1/Phase 2Japan
1217NCT01009879November 200919 February 2015Human Tumor Necrosis Factor Alpha (TNFa)-Induced Pre-B Cell Bone Marrow EmigrantsHuman TNFa-Induced Pre-B Cell Bone Marrow EmigrantsRheumatoid ArthritisDrug: EtanerceptUniversity of PittsburghAmgenNot recruiting18 YearsN/ABoth0Phase 4United States
1218NCT01010581November 200919 February 2015SC12267 (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 AGNot recruiting18 YearsN/ABoth266Phase 2Bulgaria;Czech Republic;Poland;Romania
1219EUCTR2008-005450-20-BE29/10/200919 March 2012The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)Rheumatoid arthritis
MedDRA version: 12.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: Remicade (infliximab)
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Other descriptive name: remicade
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 10-
Trade Name: Humira (adalimumab)
Pharmaceutical Form: Injection*
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Enbrel (etanercept)
Pharmaceutical Form: Injection*
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Other descriptive name: Enbrel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Mabthera (rituximab)
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Other descriptive name: Mabthera
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Trade Name: Orencia (abatacept)
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Other descriptive name: Orencia
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-		Radboud University Nijmegen Medical Centre, department of Rheumatic DiseasesAuthorisedFemale: yes
Male: yes		261Belgium
1220EUCTR2008-008954-22-NL27/10/200919 March 2012Non Steroidal Anti-Inflammatory Drugs and the antiplatelet effects of acetylsalicylic acid - NSAIDs and ASA researchNon Steroidal Anti-Inflammatory Drugs and the antiplatelet effects of acetylsalicylic acid - NSAIDs and ASA researchThis is a healthy volunteer trial. Indications of the IMP's in the context of this trial are: Elevated risk on cardiovascular event Rheumatoid arthritisTrade Name: Naproxen Pch Tablet 500mg
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Ibuprofen Pch Tablet 600mg
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Diclofenac Natrium Pch Retard Tablet Mga 75mg
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Meloxicam Cf Tablet 7,5mg
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Acetylsalicylzuur Cardio Pch Disp Tablet 80mg
Pharmaceutical Form: Tablet		Medisch Spectrum TwenteAuthorisedFemale: yes
Male: yes		Netherlands
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1221EUCTR2009-012118-27-NL27/10/200919 March 2012A 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 SubstudyJNJ-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
Pharmaceutical Form: Over encapsulated tablet
Current Sponsor code: JNJ-38518168
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Over encapsulated tablet
Route of administration of the placebo: Oral use		Janssen-Cilag International NVNot RecruitingFemale: yes
Male: yes		90Phase 2aCzech Republic;United Kingdom;Netherlands;Spain
1222EUCTR2009-012759-12-GB14/10/200919 March 2012A 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Methotrexate Disodium
CAS Number: 7413345
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		F. Hoffmann-La Roche Ltd.AuthorisedFemale: yes
Male: yes		1128Hungary;Portugal;Finland;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Sweden
1223EUCTR2009-014394-41-DK12/10/200912 December 2016Adalimumab 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
Pharmaceutical Form: Injection*
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: Humira
Other descriptive name: Adalimumab
Concentration unit: 1X 100 milligrams/millilitre
Concentration type: equal
Concentration number: 40-40		Hvidovre HospitalNot RecruitingFemale: yes
Male: yes		Phase 4Denmark
1224EUCTR2009-012218-30-PT06/10/20095 November 2012A 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 - PORTRAITMen 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: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion		Roche Farmacêutica Química, Lda.Not RecruitingFemale: yes
Male: yes		Portugal
1225EUCTR2009-011137-26-DE05/10/200927 January 2014An 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-MOREActive 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: Golimumab
Product Code: SCH 900259
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Golimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		Schering-Plough Research Institute, A Division of Schering CorporationNot RecruitingFemale: yes
Male: yes		3150Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1226NCT00929864October 200919 October 2017Abatacept Versus Adalimumab Head-to-HeadA Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: Abatacept;Drug: AdalimumabBristol-Myers SquibbNot recruiting18 YearsN/AAll869Phase 3United States;Argentina;Canada;Chile;Peru
1227NCT00938587October 200918 December 2018A 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 ArthritisRheumatoid ArthritisDrug: PF-04171327 10 mg;Other: Prednisone Placebo;Drug: PF-04171327 25 mg;Drug: Prednisone 5 mg;Other: Placebo for PF-04171327;Other: PlaceboPfizerNot recruiting18 YearsN/AAll86Phase 2United States;Czechia;Hong Kong;Hungary;Korea, Republic of;Russian Federation;Serbia;Singapore;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic
1228NCT00960440October 200919 October 2017Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (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 InhibitorsArthritis, RheumatoidDrug: CP-690,550;Drug: PlaceboPfizerNot recruiting18 YearsN/AAll399Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Ireland;Italy;Korea, Republic of;Puerto Rico;Spain;Taiwan;United Kingdom
1229NCT00993317October 200919 October 2017A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid ArthritisA Phase III Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 24-week Study to Assess the Efficacy and Safety of Certolizumab Pegol as Additional Medication to MTX in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to MethotrexateRheumatoid ArthritisDrug: Placebo of CDP870;Drug: CDP870 200mg;Drug: MethotrexateKorea Otsuka Pharmaceutical Co., Ltd.Not recruiting18 Years75 YearsAll127Phase 3Korea, Republic of
1230NCT00996203October 200919 October 2017A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ)Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: DMARDs (disease-modifying antirheumatic drugs)Hoffmann-La RocheNot recruiting18 YearsN/AAll201Phase 4Russian Federation
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1231NCT01002716October 200919 February 2015Cell Immunity Response to Vaccination Against Influenza in Patients With Rheumatoid ArthritisCell Immunity Response to Vaccination Against Influenza in Patients With Rheumatoid ArthritisRheumatoid ArthritisBiological: Agrippal S1 (Influenza vaccination)Tel-Aviv Sourasky Medical CenterRecruiting18 Years90 YearsBoth90Phase 4Israel
1232NCT01123655October 200914 December 2015Phase 1 Trial of Type II Collagen (CII) APL A12 in Rheumatoid Arthritis PatientsPhase 1 Trial of CII APL A12 in Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: APL A12VA Office of Research and DevelopmentNot recruiting18 Years85 YearsBoth22Phase 1United States
1233NCT01211834October 200919 February 2015Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid ArthritisA Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD TherapyRheumatoid ArthritisDrug: tocilizumab;Drug: DMARDs;Drug: PlaceboJW PharmaceuticalNot recruiting18 YearsN/ABoth90Phase 3Korea, Republic of
1234NCT01873625October 200919 February 2015Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Affected Knee Osteoarthritis by Rheumatoid ArthritisResurfacing Articular Cartilage With Mesenchymal Stem Cells Transplantation in Patients With Knee Joint Osteoarthritis Affected by Rheumatoid Arthritis: Randomized Triple Blind Clinical Trial Phase II/III (ACRCT)Rheumatoid ArthritisBiological: mesenchymal cell transplantation;Biological: placeboRoyan InstituteNot recruiting10 Years65 YearsBoth60Phase 2/Phase 3Iran, Islamic Republic of
1235EUCTR2009-011000-34-DE30/09/200919 March 2012A 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 methotrexateModerate to severe Rheumatoid Arthritis.
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: AIN457
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: AIN457
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use		Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes		200Hungary;Slovakia;Czech Republic;Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1236EUCTR2009-012953-39-CZ02/09/200919 March 2012A 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 ArthritisRheumatoid Arthritis
MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: SC12267
Product Code: SC12267
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: SC12267
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 35-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Metex 2,5mg Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Trade Name: Metex 7,5mg Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7.5-
Trade Name: Metex 10mg Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-		4SC AGNot RecruitingFemale: yes
Male: yes		244Phase 2Czech Republic;Bulgaria;Poland
1237NCT00913458September 200919 October 2017Study 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 MethotrexateActive Rheumatoid Arthritis;Arthritis, Rheumatoid;Rheumatoid ArthritisDrug: etanerceptPfizerNot recruiting18 YearsN/AAll306Phase 4France;Germany;Ireland;Italy;Monaco;Netherlands;Poland;Qatar;Romania;Russian Federation;Spain;Switzerland;United Kingdom
1238NCT00959036September 200919 February 2015Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid ArthritisA Seamless, Phase 1/2, Multiple Ascending Dose, Proof Of Concept Study Of ATN-103 Administered To Subjects With Active Rheumatoid Arthritis On A Background Of MethotrexateActive Rheumatoid ArthritisDrug: ATN-103;Drug: Placebo;Drug: MethotrexateAblynxNot recruiting18 Years80 YearsBoth252Phase 1/Phase 2United States;Belgium;Canada;Germany;Hungary;Russian Federation;Serbia;South Africa;Switzerland
1239NCT00969527September 200919 February 2015Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid ArthritisAssessment of the Efficacy of Oncoxin+Viusid Administration in the Treatment of Rheumatoid ArthritisRheumatoid ArthritisDietary Supplement: Oncoxin + Viusid;Dietary Supplement: PlaceboCatalysis SLNot recruiting18 YearsN/ABoth86Phase 3Cuba
1240NCT00973479September 200919 October 2017An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFalpha Monoclonal Antibody, Administered Intravenously, in Patients With Active Rheumatoid Arthritis Despite Methotrexate TherapyArthritis, RheumatoidDrug: Golimumab;Other: Placebo;Drug: methotrexate (MTX)Centocor, Inc.Schering-PloughNot recruiting18 YearsN/AAll592Phase 3United States;Argentina;Australia;Colombia;Hungary;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Poland;Russian Federation;Ukraine
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1241NCT00975130September 200916 December 2017Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)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)Arthritis, RheumatoidBiological: SC golimumab;Biological: IV golimumabMerck Sharp & Dohme Corp.Not recruiting18 YearsN/AAll3366Phase 3Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czech Republic;Denmark;Ecuador;Finland;France;Germany;Greece;Guatemala;Hungary;Ireland;Israel;Italy;Korea, Republic of;Mexico;Monaco;Netherlands;Norway;Panama;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Turkey;United Kingdom
1242NCT00984815September 200919 October 2017Safety 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 IrelandNot recruiting40 Years80 YearsAll86Phase 3United States
1243NCT00993668September 200919 October 2017Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal VaccinesA Phase 4, Randomized, Single-blind, Placebo-controlled, Multicenter Study to Evaluate the Immunogenicity of Pneumococcal and Influenza Vaccines in Adult Subjects With Rheumatoid Arthritis Receiving Certolizumab Pegol or PlaceboRheumatoid ArthritisOther: Placebo;Biological: Certolizumab pegolUCB PharmaNot recruiting18 YearsN/AAll224Phase 4United States
1244NCT01075477September 200914 November 2016An 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 RocheNot recruiting18 YearsN/ABoth151N/AFinland;United States
1245NCT01253226September 20095 November 2018A Study for Japanese Participants With Rheumatoid Arthritis (RA)Multiple-Dose, Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With MethotrexateRheumatoid ArthritisDrug: LY2127399 (Tabalumab);Drug: PlaceboEli Lilly and CompanyNot recruiting20 Years75 YearsAll32Phase 1Japan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1246EUCTR2009-010813-57-DE28/08/200919 March 2012A 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
Pharmaceutical Form: Solution for injection
CAS Number: 1007223-17-7
Current Sponsor code: CDP6038
Other descriptive name: recombinant human Mab of IgG4 subtype
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: CDP6038
Product Code: CDP6038
Pharmaceutical Form: Solution for injection
CAS Number: 1007223-17-7
Current Sponsor code: CDP6038
Other descriptive name: recombinant human Mab of IgG4 subtype
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use		UCB CelltechNot RecruitingFemale: yes
Male: yes		72Germany
1247EUCTR2009-011206-42-CZ18/08/200919 March 2012A 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 BiologicsActive Rheumatoid Arthritis
MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: INCB028050 phosphate
Product Code: INCB028050
Pharmaceutical Form: Capsule*
Current Sponsor code: INCB028050 phosphate
Other descriptive name: INCB028050 phosphate salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: INCB028050 phosphate
Product Code: INCB028050
Pharmaceutical Form: Capsule*
Current Sponsor code: INCB028050 phosphate
Other descriptive name: INCB028050 phosphate salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: INCB028050 phosphate
Product Code: INCB028050
Pharmaceutical Form: Capsule*
Current Sponsor code: INCB028050 phosphate
Other descriptive name: INCB028050 phosphate salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		Incyte CorporationNot RecruitingFemale: yes
Male: yes		100Phase 2Czech Republic
1248EUCTR2009-012705-19-HU17/08/200919 March 2012A 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 - LX3305.201Rheumatoid Arthritis (RA)
MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: 		Product Name: LX3305 Dihydrate
Product Code: LX3305
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: None as of yet
CAS Number: 1078151-47-9
Current Sponsor code: LX3305 Dihydrate
Other descriptive name: LX3305
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: LX3305 Dihydrate
Product Code: LX3305
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: None as of yet
CAS Number: 1078151-47-9
Current Sponsor code: LX3305 Dihydrate
Other descriptive name: LX3305
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		Lexicon Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes		104Phase 2Hungary;Czech Republic;Bulgaria
1249EUCTR2009-010516-15-HU14/08/200910 February 2014Randomized, 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 MethotrexateRheumatoid arthritis (seropositive)
MedDRA version: 9.1 Level: LLT Classification code 10040107 Term: Seropositive rheumatoid arthritis		Product Name: SBI-087
Product Code: SBI-087
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: SBI-087
Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use		Wyeth Research Division of Wyeth Pharmaceuticals Inc.Not RecruitingFemale: yes
Male: yes		200Hungary;Greece;Poland;Spain
1250JPRN-UMIN0000023402009/08/012 April 2019Comparison 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 SchoolNot Recruiting20years-oldNot applicableMale and Female60Phase 4Japan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1251NCT03681639August 1, 200928 October 2019Metasul 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 BiometNot recruiting18 Years65 YearsAll225N/AGermany
1252NCT00929357August 200919 October 2017Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic TreatmentA Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice.Rheumatoid ArthritisDrug: DMARDs or BiologicsPfizerNot recruiting18 YearsN/AAll156N/ADenmark
1253NCT00965653August 200914 November 2016A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid ArthritisOpen-label, Multicenter, Randomized, Parallel Study to Investigate pk, pd, Efficacy and Safety of Tocilizumab (TCZ, RO4877533) Following Subcutaneous Administration of TCZ 162 mg Weekly or Every Other Week in Combination With Methotrexate in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: folic acid;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNot recruiting18 Years75 YearsBoth29Phase 1Canada;New Zealand;Spain;United Kingdom
1254NCT01224041August 200918 January 2016Study 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.Not recruiting18 Years75 YearsBoth78Phase 4Korea, Republic of
1255NCT01870128August 200919 February 2015Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled TrialComparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled TrialRheumatoid ArthritisDrug: Combination Steroid;Drug: Methotrexate;Drug: CombinationAll India Institute of Medical Sciences, New DelhiNot recruiting18 Years60 YearsBoth60Phase 3India
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1256EUCTR2008-002623-85-NL27/07/200911 February 2013A 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 METHOTREXATEModerate 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
Pharmaceutical Form: Injection*
INN or Proposed INN: Etanercept
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use
Trade Name: Enbrel 50mg PFS
Product Name: Enbrel (Etanercept)
Product Code: 0881
Pharmaceutical Form: Injection*
INN or Proposed INN: Etanercept
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate 2.5mg Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59052
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and DevelopmentNot RecruitingFemale: yes
Male: yes		300France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
1257ChiCTR-TRC-090004722009-07-2018 April 2017Weekly dose of leflunomide for the treatment of early rheumatoid arthritisWeekly dose of leflunomide for the treatment of early rheumatoid arthritis: a multicentre, open, randomized clincal trialRheumatoid arthritisGroup A:leflunomide 10mg,orally taken once daily for 24 weeks;Group B:leflunomide 50mg, orally taken weekly for 24 weeks;People's Hospital, Peking UniversityNot Recruiting1865BothGroup A:160;Group B:160;Post-marketChina
1258ChiCTR-TRC-090004732009-07-2018 April 2017Efficacy and safety of Alendronate on Structural Benefit and Inflammation in Rheumatoid Arthritis(RA): A randomized, open, placebo-controlled, multicentre clinical trial.Efficacy and safety of Alendronate on Structural Benefit and Inflammation in Rheumatoid Arthritis(RA): A randomized, open, placebo-controlled, multicentre clinical trial.Rheumatoid ArthritisGroup B:MTX 7.5-20mg, orally taken once weekly for 48 week;Group A:MTX7.5-20mg, orally taken once weekly combined Alendronate Sodium 70mg,orally taken once weekly for 48 weeks ;People's Hospital, Peking UniversityNot Recruiting18BothGroup B:160;Group A:160;Post-marketChina
1259EUCTR2009-010955-29-NL13/07/200919 March 2012Prevention of clinically manifest rheumatoid arthritis by B cell directed therapy in the earliest phase of the disease.Prevention of clinically manifest rheumatoid arthritis by B cell directed therapy in the earliest phase of the disease.Pre-clinical RA patients with a high risk on developing the disease.Trade Name: MabThera 500 mg (10mg/ml)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use		Division of Clinically Immunology and Rheumatology, AMCAuthorisedFemale: yes
Male: yes		Netherlands
1260JPRN-UMIN0000021692009/07/012 April 2019Safety and efficacy of 3 DMARDs for 2 years of treatment in patients with early rheumatoid arthritisRheumatoid ArthritisSalazosulfapyridine
Bucillamine		Higashi-Hiroshima Memorial HospitalNot Recruiting20years-old80years-oldMale and Female60Phase 4Japan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1261NCT00903383July 200919 October 2017Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable MethotrexateA 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) TherapyRheumatoid ArthritisDrug: LX3305 low dose;Drug: LX3305 mid dose;Drug: LX3305 high dose;Drug: PlaceboLexicon PharmaceuticalsNot recruiting18 Years75 YearsAll208Phase 2United States;Bulgaria;Czech Republic;Hungary;Poland;Serbia
1262NCT00965757July 200919 October 2017A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to MethotrexateA Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to MethotrexateRheumatoid ArthritisDrug: T-614;Drug: PlaceboEisai Co., Ltd.Toyama Chemical Co., Ltd.Not recruiting20 Years69 YearsAll253Phase 3Japan
1263EUCTR2009-012141-34-GB29/06/200919 March 2012Randomised 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
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Local use (Noncurrent)		University Hospital of North Tees and HartlepoolNot RecruitingFemale: yes
Male: yes		150United Kingdom
1264EUCTR2008-002381-55-ES16/06/200919 March 2012Evaluación 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
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Other descriptive name: RITUXIMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use		ROCHE FARMA, S.A.Not RecruitingFemale: yes
Male: yes		Spain
1265JPRN-JapicCTI-09076401/6/200923 April 2019Long-Term Treatment Study of Ocrelizumab for Rheumatoid ArthritisLong-Term Treatment Study of Ocrelizumab for Rheumatoid ArthritisRheumatoid ArthritisIntervention name : Ocrelizumab
Dosage And administration of the intervention : 500 mg will be administered by intravenous infusion on Day 1 and Day 15. Repeat courses of therapy with ocrelizumab may be administered basically every 24 weeks, a minimum interval of 12 weeks, between courses.		Chugai Pharmaceutical Co., Ltd.20BOTH200Phase 3
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1266NCT00848354June 200919 October 2017Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) TherapyA Randomized, Open-label Study In The Latin America Region Comparing The Safety And Efficacy Of Etanercept With Conventional Dmard Therapy In Subjects With Rheumatoid Arthritis.Rheumatoid ArthritisBiological: Phase 1: Etanercept;Drug: Phase 1: Methotrexate;Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX;Drug: Phase 1: Conventiaonal DMARDPfizerAmgenNot recruiting18 Years69 YearsAll429Phase 4Argentina;Chile;Colombia;Mexico;Panama;Brazil;Ecuador;Spain;Venezuela
1267NCT00883896June 200919 February 2015Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid ArthritisA 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 MethotrexateRheumatoid ArthritisOther: Placebo;Drug: ILV-094PfizerNot recruiting18 YearsN/ABoth195Phase 2United States;Belgium;Colombia;Croatia;Germany;Hungary;Japan;Mexico;Netherlands;Romania;Russian Federation;Denmark
1268NCT00927927June 200919 October 2017First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid ArthritisA Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single and Multiple Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0142-0002 Administered Subcutaneously to Subjects With Rheumatoid ArthritisInflammation;Rheumatoid ArthritisDrug: NNC0142-0002;Drug: placeboJanssen Research & Development, LLCNot recruiting18 Years75 YearsAll65Phase 1Germany
1269NCT00947492June 200919 February 2015Monitoring 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 MarseilleNot recruiting18 YearsN/ABoth60N/AFrance
1270EUCTR2008-008337-11-SE27/05/200919 November 2012PHASE 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 DMARDSRheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: CP-690,550
Pharmaceutical Form: Film-coated tablet
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		Pfizer Inc.Not RecruitingFemale: yes
Male: yes		750Phase 3Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1271EUCTR2008-007788-17-CZ20/05/200924 July 2012PHASE 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
Pharmaceutical Form: Film-coated tablet
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550-10
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		Pfizer Inc.Not RecruitingFemale: yes
Male: yes		611Phase 3Germany;Czech Republic;Bulgaria
1272EUCTR2008-008338-35-CZ20/05/200910 July 2015PHASE 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 METHOTREXATECP 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
Pharmaceutical Form: Film-coated tablet
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Pfizer Inc.Not RecruitingFemale: yes
Male: yes		700Phase 3Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom
1273EUCTR2008-004875-23-BE18/05/200911 August 2014An 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 ArthritisRheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: LY2127399
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 48-		Eli Lilly and CompanyNot RecruitingFemale: yes
Male: yes		236France;Hungary;Poland;Belgium;Austria;Germany
1274EUCTR2008-007023-26-CZ18/05/200926 June 2012PHASE 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 METHOTREXATECP 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-690,550
Pharmaceutical Form: Film-coated tablet
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		Pfizer Inc.Not RecruitingFemale: yes
Male: yes		750Phase 3Czech Republic;Bulgaria;Poland
1275EUCTR2009-011105-17-IT17/05/200919 March 2012A 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 FatigueRheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Tocilizumab
Product Code: Ro 487-7533
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RoActemra
CAS Number: 375823-41-9
Current Sponsor code: Ro 487-7533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-		ROCHENot RecruitingFemale: yes
Male: yes		Italy
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1276EUCTR2007-006657-63-FI08/05/20093 September 2012Study 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). - DOSERARheumatoid 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
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Enbrel 50 mg powder and solvent for solution for injection
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use		Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United KingdomNot RecruitingFemale: yes
Male: yes		72Hungary;Finland;Iceland;Denmark;Norway;Sweden
1277EUCTR2009-011520-53-SK04/05/200918 April 2016Evaluation 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 environmentmoderate to severe active rheumatoid arthritisTrade Name: RoActemra®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Other descriptive name: RoActemra
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal		Roche Slovensko s.r.o.Not RecruitingFemale: yes
Male: yes		Slovakia
1278ChiCTR-TRC-120038712009-05-0118 April 2017Phase II of Tong Luo Hua Shi Capsules in Rheumatoid ArthritisA Multi-center, Randomized, Double-blind, Phase II Study Evaluating the Safety and Efficacy of Tong Luo Hua Shi Capsules in Participants with Rheumatoid ArthritisRheumatoid arthritisA:2 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary;B:3 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary;C:4 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary;D:4 pieces placebo;The First Teaching Hospital of Tianjin University of Traditional Chinese MedicineNot Recruiting1868BothA:60;B:60;C:60;D:60;Phase 1+Phase 2China
1279NCT00279461May 200910 August 2015Vitamin D Deficiency Causes Immune Dysfunction and Enables or Perpetuates the Development of Rheumatoid ArthritisVitamin D Deficiency Causes Immune Dysfunction and Enables or Perpetuates the Development of Rheumatoid Arthritis: Clinical Trial and Investigations on Dendritic CellsArthritis, Rheumatoid;Vitamin D DeficiencyDrug: Placebo in arm A and Vitamin D in arm B;Drug: vitamin D 3 for arm A ,and matching placebo for arm BIndiana UniversityNot recruiting18 YearsN/ABoth0Phase 2United States
1280NCT00838565May 200919 February 2015Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid ArthritisPhase I, Randomized, Patient and Investigator-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Intravenously Administered Doses of PF-04236921 in Patients With Rheumatoid Arthritis Receiving MethotrexateRheumatoid ArthritisDrug: Placebo;Drug: dose level 1;Drug: dose level 2;Drug: dose level 3;Drug: dose level 4PfizerNot recruiting18 Years70 YearsBoth41Phase 1United States;Korea, Republic of;Spain
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1281NCT00853385May 200919 October 2017A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid ArthritisPhase 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 MethotrexateRheumatoid ArthritisDrug: CP 690,550;Drug: CP-690,550;Other: Placebo;Biological: Biologic TNFiPfizerNot recruiting18 YearsN/AAll717Phase 3United States;Australia;Bosnia and Herzegovina;Bulgaria;Canada;Chile;Costa Rica;Croatia;Czech Republic;Denmark;Dominican Republic;Finland;Germany;Korea, Republic of;Mexico;Philippines;Poland;Slovakia;Spain;Thailand;United Kingdom
1282NCT00856544May 200919 October 2017A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis MedicationsPhase 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 DMARDSArthritis, RheumatoidDrug: CP-690,550;Drug: PlaceboPfizerNot recruiting18 YearsN/AAll795Phase 3United States;Australia;Chile;China;Colombia;Croatia;Denmark;Finland;Germany;Greece;Malaysia;Mexico;Poland;Russian Federation;Slovakia;Spain;Sweden;Thailand;United Kingdom;Venezuela
1283NCT00888745May 200919 February 2015A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid ArthritisA Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: placebo;Drug: PRO283698Genentech, Inc.Not recruiting18 Years75 YearsBoth65Phase 1United States;Hungary;United Kingdom
1284NCT00891020May 200919 October 2017A 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 RocheNot recruiting18 YearsN/AAll886Phase 3United States;Puerto Rico;United Kingdom
1285NCT00902369May 20098 August 2016A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: AK106-001616;Drug: Placebo;Drug: Active comparatorAsahi Kasei Pharma CorporationNot recruiting18 Years65 YearsBoth130Phase 2Czech Republic;Germany;Hungary;Lithuania;Romania;United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1286NCT00902486May 200910 September 2018INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic DrugsA Randomized, Double-blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients With Active RA With Inadequate Response to Any Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including BiologicsRheumatoid ArthritisDrug: INCB028050;Drug: PlaceboIncyte CorporationNot recruiting18 YearsN/AAll127Phase 2United States;Czechia;Czech Republic
1287NCT00920608May 200919 February 2015A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis PatientsA Phase I, Multi-centre, Open-label, Fixed-sequence Study to Assess the Pharmacokinetics of Methotrexate Alone and When Co-administered With AZD9056 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: AZD9056;Drug: MethotrexateAstraZenecaNot recruiting18 Years70 YearsBoth12Phase 1
1288EUCTR2008-006917-25-DE24/04/200919 March 2012A 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
Pharmaceutical Form: Tablet
INN or Proposed INN: Tranilast
CAS Number: 53902-12-8
Current Sponsor code: None
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Ribazen
Product Name: Tranilast
Pharmaceutical Form: Tablet
INN or Proposed INN: Tranilast
CAS Number: 53902-12-8
Current Sponsor code: None
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Product Name: methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59052		Nuon Therapeutics, Inc.Not RecruitingFemale: yes
Male: yes		250Phase 2United Kingdom;Czech Republic;Germany;Bulgaria;Poland
1289EUCTR2008-008309-23-FR24/04/200919 March 2012Etude clinique comparative en double aveugle versus placebo sur la rapidité d’action du tocilizumab sur le soulagement des patients atteints de polyarthrite rhumatoïde active avec réponse inadéquate aux DMARDs et/ou aux biothérapies. - TORPEDOEtude clinique comparative en double aveugle versus placebo sur la rapidité d’action du tocilizumab sur le soulagement des patients atteints de polyarthrite rhumatoïde active avec réponse inadéquate aux DMARDs et/ou aux biothérapies. - TORPEDOPolyarthrite rhumatoïde active modérée à sévère de moins de 10 ans d'ancienneté, avec réponse inadéquate au méthotrexate (MTX) et/ou à un autre DMARD et/ou à au moins un anti-TNF
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: RoActemra
Product Code: RO487-7533/F01-F05
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tolicizumab
CAS Number: 357823-41-9
Current Sponsor code: RO4877533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for injection
Route of administration of the placebo: Intravenous use		ROCHEAuthorisedFemale: yes
Male: yes		France
1290EUCTR2008-004875-23-PL22/04/200915 May 2012An 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 ArthritisRheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: LY2127399
Product Code: NA
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 48-		Eli Lilly and CompanyNot RecruitingFemale: yes
Male: yes		236Hungary;Germany;Belgium;France;Austria;Poland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1291EUCTR2008-006075-75-DE22/04/200919 March 2012A 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 ArthritisRheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: AK106-001616
Pharmaceutical Form: Capsule, hard
CAS Number: 590416-75-4
Current Sponsor code: AK106-001616 (form B)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: naproxen
CAS Number: 22204-53-1
Current Sponsor code: naproxen
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		Asahi Kasei Pharma CorporationNot RecruitingFemale: yes
Male: yes		130Phase 2aHungary;Czech Republic;United Kingdom;Germany
1292NCT01081717April 14, 200915 July 2019Golimumab 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.Not recruitingN/A99 YearsAll1064N/AUnited States
1293EUCTR2009-011044-20-GB08/04/200919 March 2012A 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 Volunteersrheumatoid arthritis
MedDRA version: 9.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions		Product Code: AZD5672
Pharmaceutical Form: Tablet
Current Sponsor code: AZD5672
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Avelox®
Product Name: Avelox- Moxifloxacin
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		AstraZeneca ABNot RecruitingFemale: no
Male: yes		64United Kingdom
1294JPRN-JapicCTI-09075101/4/20092 April 2019A study of Adalimumab in Japanese subjects with Rheumatoid ArthritisA Phase 3 Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects with Rheumatoid ArthritisRheumatoid ArthritisIntervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : 40 mg every other week, subcutaneous
Control intervention name : Placebo
Dosage And administration of the control intervention : every other week, subcutaneous		Abbott Japan Co., Ltd.Eisai Co., Ltd.20BOTH300Phase 3
1295JPRN-UMIN0000042712009/04/012 April 2019Upper gastrointestinal endoscopic findings in Japanese with rheumatoid arthritis (RA) receiving long-term NSAIDs therapy, and the usefulness of switching to selective COX-2 inhibitor celecoxibRheumatoid 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 HospitalNot Recruiting20years-oldNot applicableMale and Female100Not applicableJapan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1296NCT00763139April 200919 October 2017Inflammation and Insulin Resistance in Rheumatoid ArthritisInflammation and Insulin Resistance in Rheumatoid ArthritisRheumatoid ArthritisDrug: Pioglitazone;Drug: PlaceboVanderbilt UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 YearsN/AAll34N/AUnited States
1297NCT00887770April 200919 February 2015A Study to Investigate the Potential for AZD5672 to Affect the Electrical Conduction Pathways in the HeartA Single-centre, Double-blind, Double-dummy, Randomised, Placebo-controlled, Four-period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600 mg and 150 mg) on QT/QTc Interval, Compared to Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male VolunteersRheumatoid ArthritisDrug: AZD5672;Drug: Moxifloxacin;Drug: placeboAstraZenecaQuintiles LimitedNot recruiting18 Years45 YearsMale64Phase 1United Kingdom
1298NCT00928317April 200919 February 2015Dose Ranging Study of ART621 in Subjects Diagnosed With Rheumatoid Arthritis Taking MethotrexateMulti-Centre Randomised Double-Blind Pbo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability, Efficacy, PK and Immunogenicity of Multiple Doses of ART621 for 3 Months in Patients With Rheumatoid Arthritis Taking MethotrexateRheumatoid ArthritisDrug: ART621;Drug: PlaceboArana Therapeutics LtdNot recruiting18 Years80 YearsBoth13Phase 2United States;Argentina;Australia;Czech Republic;India;Malaysia;New Zealand;Poland
1299NCT00931086April 200919 February 2015Expanded 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 CompanyGlaxoSmithKlineNot recruiting18 YearsN/ABothPhase 4United States
1300NCT01075711April 200919 February 2015Determine 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, GermanyNot recruiting18 YearsN/ABoth2728N/AGermany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1301EUCTR2008-006930-92-CZ31/03/200919 March 2012A 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 methotrexateRheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: ART621
Pharmaceutical Form: Solution for injection
Current Sponsor code: ART621
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Arana Therapeutics LtdNot RecruitingFemale: yes
Male: yes		200Czech Republic
1302EUCTR2008-003011-12-GB30/03/200919 March 2012Prospective 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 - TOCRARheumatoid ArthritisTrade Name: RoActemra®EV Product Code: PRD82321
Product Name: Tocilizumab
Product Code: RO4877533
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		University of LeedsAuthorisedFemale: yes
Male: yes		30United Kingdom
1303EUCTR2008-006936-37-HU25/03/200919 March 2012A 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 MethotrexateRheumatoid Arthritis (RA)
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: ILV-094
Product Code: ILV-094
Pharmaceutical Form: Powder for injection*
Current Sponsor code: ILV-094
Other descriptive name: Recombinant human anti IL-22 monoclonal antibody IgG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder for injection*
Route of administration of the placebo: Subcutaneous use		Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and DevelopmentNot RecruitingFemale: yes
Male: yes		180Hungary;Germany;Netherlands;Belgium
1304NCT00687193March 200919 October 2017Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In JapanA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARDArthritis, RheumatoidDrug: Placebo;Drug: CP-690,550PfizerNot recruiting20 Years70 YearsAll318Phase 2Japan
1305NCT00808210March 200914 November 2016A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or AdalimumabA PHASE II RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN COMBINATION WITH METHOTREXATE, COMPARED TO INFLIXIMAB PLUS METHOTREXATE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS CURRENTLY RESPONDING INADEQUATELY TO ETANERCEPT OR ADALIMUMABRheumatoid ArthritisDrug: infliximab;Drug: methotrexate;Drug: methylprednisolone;Drug: ocrelizumab;Drug: shamGenentech, Inc.Not recruiting18 YearsN/ABoth28Phase 2United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1306NCT00837434March 200918 December 2018Anti-TNF Agents for the Treatment of Rheumatoid ArthritisA Partially Blinded, Randomized, Multi-Center, Phase IV Trial to Evaluate Mechanism of Action of Anti-TNF Agents in Rheumatoid ArthritisRheumatoid ArthritisDrug: Etanercept;Drug: AdalimumabNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceNot recruiting18 Years75 YearsAll63Phase 4United States
1307NCT00847613March 200919 October 2017A 2-Year Phase 3 Study 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 MethotrexateArthritis, RheumatoidDrug: CP-690,550;Drug: PlaceboPfizerNot recruiting18 YearsN/AAll800Phase 3United States;Australia;Brazil;Bulgaria;Canada;Colombia;Czech Republic;Greece;India;Japan;Korea, Republic of;Mexico;Poland;Taiwan;Ukraine;Venezuela
1308NCT00850343March 200919 October 2017Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) PatientsA Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered Without Coadministration of Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-003)Rheumatoid ArthritisDrug: Certolizumab pegolAstellas Pharma IncUCB Japan Co. Ltd.Not recruiting20 Years74 YearsAll208Phase 3Japan
1309NCT00851318March 200919 October 2017Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) PatientsA Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered in Combination With Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-001)Rheumatoid ArthritisDrug: Certolizumab pegol;Drug: MethotrexateAstellas Pharma IncUCB Japan Co. Ltd.Not recruiting20 Years74 YearsAll285Phase 3Japan
1310NCT00870467March 200919 October 2017A Study of Adalimumab in Japanese Subjects With Rheumatoid ArthritisA Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid ArthritisRheumatoid ArthritisBiological: Double-blind adalimumab;Drug: Double-blind Placebo;Biological: Open-label Adalimumab;Biological: Open-labelAdalimumabRescueAbbottEisai Co., Ltd.Not recruiting20 YearsN/AAll334Phase 3Japan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1311NCT00871767March 200919 February 2015AZD5672 Bioavailability Study in Healthy Male and Female SubjectsAn Open-Label, Randomized, 4 Period Crossover, Replicate Study to Assess the Relative Bioavailability of the Phase III and Phase IIb Formulations of AZD5672 in Healthy Male and Female SubjectsRheumatoid ArthritisDrug: AZD5672AstraZenecaNot recruiting18 Years55 YearsBoth24Phase 1United Kingdom
1312NCT00882024March 200919 February 2015Safety and Efficacy Study of Tranilast 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)Active Rheumatoid ArthritisDrug: Tranilast;Drug: PlaceboNuon Therapeutics, Inc.Not recruiting18 Years75 YearsBoth250Phase 2United States;Argentina;Bulgaria;Czech Republic;Germany;Mexico;Serbia;United Kingdom
1313NCT02721004March 200921 July 2016Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With Rheumatoid ArthritisDocumentation of the Efficacy and Safety of RoActemra in the Treatment of Rheumatoid ArthritisRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNot recruitingN/AN/ABoth592N/AAustria
1314EUCTR2008-006443-39-ES23/02/200924 April 2012Estudio 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Tocilizumab
Current Sponsor code: RO4877533
Other descriptive name: RoActemra
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-		Roche Farma, S.A.Not RecruitingFemale: yes
Male: yes		Spain
1315EUCTR2008-004894-16-DE12/02/200919 March 2012Phase 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 TherapyRheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: LY2127399
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 48-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use		Eli Lilly and Company limitedNot RecruitingFemale: yes
Male: yes		150Phase 2Hungary;Czech Republic;Germany;Poland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1316NCT00754572February 200919 October 2017A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid ArthritisA Single-arm, Open-label Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: methotrexateHoffmann-La RocheNot recruiting18 YearsN/AAll418Phase 3Argentina;Brazil;Chile;Colombia;Costa Rica;Ecuador;Mexico;Peru;Uruguay;Venezuela
1317NCT00777816February 200918 January 2016Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Active, Stable, Moderate to Severe Rheumatoid ArthritisA Blinded, Placebo-controlled, Study of the Safety and Pharmacokinetics of XOMA 052 Administered to Subjects With Active, Stable, Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisDrug: XOMA 052;Drug: PlaceboXOMA (US) LLCNot recruiting18 Years75 YearsBoth18Phase 2United States
1318NCT00814307February 200919 October 2017A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of 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 ArthritisArthritis, RheumatoidDrug: CP-690,550;Drug: PlaceboPfizerNot recruiting18 YearsN/AAll611Phase 3United States;Brazil;Bulgaria;Chile;Colombia;Czech Republic;Dominican Republic;Germany;India;Malaysia;Mexico;Philippines;Poland;Puerto Rico;Russian Federation;Ukraine
1319NCT00837811February 200911 June 2018An Open Label Extension Study in Participants With Rheumatoid ArthritisAn Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis.Rheumatoid ArthritisBiological: LY2127399Eli Lilly and CompanyNot recruiting18 YearsN/AAll182Phase 2United States;Australia;Austria;Belgium;Brazil;Canada;Chile;Germany;Hungary;India;Mexico;Poland;Puerto Rico;Romania;Argentina;Czech Republic;France;Slovakia;Ukraine
1320NCT00847886February 200919 October 2017Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid ArthritisA Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of LX3305 and Methotrexate in Subjects With Stable Rheumatoid ArthritisRheumatoid ArthritisDrug: LX3305;Drug: LX3305 Placebo;Drug: MethotrexateLexicon PharmaceuticalsNot recruiting18 YearsN/AAll15Phase 1United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1321NCT00851240February 200919 February 2015BTT-1023 in Rheumatoid ArthritisA Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Repeated Intravenous Doses of BTT-1023 in Patients With Rheumatoid Arthritis - a Double-blind Randomized Placebo-controlled Sequential Group TrialRheumatoid ArthritisDrug: BTT-1023;Drug: PlaceboBiotie Therapies Corp.Not recruiting18 Years75 YearsBoth24Phase 1Bulgaria
1322NCT00854685February 200919 February 2015Dose Optimisation Study of ART621 in Subjects Diagnosed With Rheumatoid Arthritis Taking MethotrexateA Factorial-design, Randomised, Double-blind, Placebo-controlled, Dose Optimisation Study to Investigate the Safety, Efficacy, Immunogenicity and Pharmacokinetics of ART621 Following Multiple Dose Administration in Subjects Diagnosed With Rheumatoid Arthritis Concomitantly Taking MethotrexateRheumatoid ArthritisDrug: ART621;Drug: PlaceboArana Therapeutics LtdTrident Clinical Research Pty LtdNot recruiting18 Years80 YearsBoth27Phase 2Sri Lanka
1323NCT01447264February 200919 February 2015Effectiveness of Water Exercises on Isokinetic Muscle StrengthComparison of the Effectiveness Between Land and Water Exercises on Isokinetic Muscle Strength of Lower Limbs in Women With Rheumatoid Arthritis: a Randomized Controlled TrialRheumatoid ArthritisProcedure: Land exercises;Procedure: Water exercisesFederal University of São PauloDepartment of MedicineNot recruiting40 Years65 YearsFemale100Phase 3Brazil
1324EUCTR2008-004754-33-SK29/01/200913 March 2017A 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 TherapyRheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: BG00012
Pharmaceutical Form: Capsule, hard
CAS Number: 624497
Other descriptive name: Dimeythl Fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		Biogen Idec LimitedNot RecruitingFemale: yes
Male: yes		150Phase 2Czech Republic;Slovakia;Poland
1325EUCTR2008-005525-11-ES29/01/200918 April 2012Estudio 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 reumatoide Rheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: MABTHERA 500 mg concentrado para solución para perfusión
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: Ro 45-2294
Other descriptive name: RITUXIMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: tocilizumab
Product Code: RO4877533
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
Current Sponsor code: Ro4877533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		F Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes		81United Kingdom;Germany;Netherlands;France;Spain
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1326EUCTR2008-007225-39-BE06/01/20095 June 2018A 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 - CareRAearly 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
Pharmaceutical Form: Tablet
INN or Proposed INN: methotrexate
CAS Number: 7413-34-5
Other descriptive name: METHOTREXATE DISODIUM
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 7.5-20
Trade Name: Salazopyrine
Pharmaceutical Form: Tablet
INN or Proposed INN: SULFASALAZINE
CAS Number: 599-79-1
Concentration unit: g gram(s)
Concentration type: range
Concentration number: 1-3
Trade Name: Arava
Pharmaceutical Form: Coated tablet
INN or Proposed INN: LEFLUNOMIDE
CAS Number: 75706-12-6
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 10-20		University Hospitals LeuvenNot RecruitingFemale: yes
Male: yes		400Phase 4Belgium
1327NCT00825409January 200919 February 2015Safety and Effectiveness Study of Ascension's PyroCarbon Radial Head Compared to Ascension's Metal Radial HeadSafety and Effectiveness Study of Ascension's PyroCarbon Radial Head Compared to Ascension's Metal Radial Head to Treat Arthritis, Fractures of the Radial Head, Relief of Symptoms After Radial Head Resection, or Revision of a Failed Radial Head Implant.Degenerative Arthritis;Post-Traumatic Arthritis;Rheumatoid ArthritisDevice: Carbon Modular Radial Head;Device: Metal Radial HeadAscension Orthopedics, Inc.Recruiting18 Years85 YearsBoth203N/AUnited States
1328NCT00838058January 200919 February 2015A 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 224,535PfizerNot recruiting18 Years55 YearsBoth11Phase 1United States
1329NCT00858780January 200919 October 2017Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RADose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA)Rheumatoid ArthritisDrug: Etanercept;Drug: PlaceboPfizerNot recruiting18 YearsN/AAll91Phase 4Denmark;Finland;Hungary;Iceland;Norway;Sweden
1330NCT01426347January 200916 December 2017Treatment of Vitamin D Deficiency in Patients With Rheumatoid ArthritisVitamin Therapy in Rheumatoid ArthritisRheumatoid Arthritis;Vitamin D DeficiencyDrug: Placebo sugar pill;Drug: ErgocalciferolJohns Hopkins UniversityNot recruiting18 Years75 YearsAll139N/AUnited States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1331NCT02405234January 200916 December 2017Ascension PyroCarbon Radial Head StudySafety and Effectiveness Study of Ascension PyroCarbon Radial Head Compared to Ascension Metal Radial HeadDegenerative Arthritis;Radial Head Fracture;Rheumatoid ArthritisDevice: Carbon Modular Radial Head replacement;Device: Metal Radial Head replacementIntegra LifeSciences CorporationNot recruiting18 Years85 YearsAll78N/AUnited States
1332NCT02779114January 200930 May 2016RETRO (REduction of Therapy in RA Patients in Ongoing Remission)A Phase 3, Multicenter, Randomized, Open, Prospective, Controlled, Parallel Group Study of Reduction of Therapy in Patients With Rheumatoid Arthritis in Ongoing Remission.Rheumatoid ArthritisDrug: Control group;Other: Reduction group 1;Other: Reduction group 2University of Erlangen-Nürnberg Medical SchoolRecruiting18 YearsN/ABoth318Phase 3Germany
1333NCT02809833January 200919 October 2017Use of Tocilizumab for Rheumatoid Arthritis (RA) in Daily RoutineTocilizumab for the Treatment of Rheumatoid Arthritis: Findings on The Use of Tocilizumab in Daily Clinical RoutineRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNot recruiting18 YearsN/AAll850N/AGermany
1334NCT00848120December 31, 200816 December 2017A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid ArthritisAn Open Label Study to Evaluate the Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab in Patients With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNot recruiting18 YearsN/AAll29Phase 3Philippines
1335EUCTR2008-002046-27-DE08/12/200824 April 2012Clinical 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 MethotrexateRheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Ofatumumab
Product Code: GSK1841157
Pharmaceutical Form: Concentrate for solution for injection
Current Sponsor code: GSK1841157
Other descriptive name: HuMax-CD20
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use		GlaxoSmithKline Research & Development LtdNot RecruitingFemale: yes
Male: yes		70Phase 1/2AGermany;Belgium;France;Spain
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1336EUCTR2008-004931-39-PL08/12/200819 March 2012A 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
Pharmaceutical Form: Intravenous infusion
Current Sponsor code: ALD518
Other descriptive name: ALD518 monoclonal antibody (anti IL-6 mAb)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use		Alder Biopharmaceuticals, IncNot RecruitingFemale: yes
Male: yes		120Poland
1337ChiCTR-TRC-100010602008-12-0118 April 2017Efficacy and safety of infliximab in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trialEfficacy and safety of infliximab in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trialrheumatoid arthritis;M05.901infliximab:intravenous injections of infliximab (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy;placebo:intravenous injections of placebo (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy;People's Hospital, Beijing University; Shanghai Changzheng HospitalNot Recruiting1865Bothinfliximab:0;placebo:0;Phase 3 studyChina
1338NCT00767325December 200819 October 2017A Rheumatoid Arthritis Study to Assess Early Response to Abatacept+MTX as Defined by Improvement of Synovitis Measures by Power Doppler UltrasonographyMulti-Center, 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 MethotrexateRheumatoid ArthritisDrug: Abatacept;Drug: MethotrexateBristol-Myers SquibbNot recruiting18 YearsN/AAll104Phase 3Denmark;France;Germany;Hungary;Italy;Norway;Spain;United Kingdom
1339NCT00805116December 200817 May 2016Marine 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, NorwayNot recruiting18 YearsN/ABoth7N/ANorway
1340NCT00810836December 200819 February 2015Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid ArthritisA Phase 2a, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of BG00012 When Given With Methotrexate to Subjects With Active RA Who Have Had an Inadequate Response to Conventional Disease-Modifying Anti-rheumatic Drug TherapyRheumatoid ArthritisDrug: BG00012;Drug: placeboBiogen IdecNot recruiting18 Years75 YearsBoth153Phase 2Australia;Canada;Czech Republic;India;Poland;Slovakia
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1341NCT00815906December 200819 February 2015Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid ArthritisAn Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid ArthritisArthritis, RheumatoidDrug: SBI-087PfizerEmergent Product Development Seattle LLCNot recruiting20 Years70 YearsBoth20Phase 1Japan
1342NCT00818064December 200816 December 2017Safety 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/SNot recruiting18 Years75 YearsAll32Phase 1Netherlands
1343NCT01011959December 200819 February 2015A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis SubjectsA Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Parallel-group Study of the Safety and Tolerability of REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant MethotrexateRheumatoid ArthritisBiological: REGN88Regeneron PharmaceuticalsSanofiNot recruiting18 YearsN/ABoth60Phase 1United States
1344NCT01179971December 200819 February 2015n-3 and n-6 Fatty Acids in Rheumatoid ArthritisIncorporation of n-3 Long Chain Polyunsaturated Fatty Acids and Gamma Linolenic Acid in Plasma Lipids, Cholesteryl Esters, and Erythrocyte Membranes and Their Influence on Disease Activity in Patients With Rheumatoid ArthritisRheumatoid ArthritisDietary Supplement: Fish oil, gamma-linolenic acidCharite University, Berlin, GermanyUniversity of JenaNot recruiting18 Years80 YearsBoth60Phase 2
1345EUCTR2008-006256-22-FR21/11/200819 March 2012Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy.Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy.rheumatoid arthritis requiring anti-TNF alpha treatment
MedDRA version: 9.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions		Trade Name: remicade
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: infliximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: humira
Pharmaceutical Form: Injection*
INN or Proposed INN: adalimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: enbrel
Pharmaceutical Form: Injection*
INN or Proposed INN: etanercept
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-		CHU Saint-EtienneAuthorisedFemale: yes
Male: yes		France
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1346NCT00771030November 200814 November 2016Multiple-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: PlaceboAmgenNot recruiting18 Years70 YearsBoth40Phase 1/Phase 2Canada;Mexico;United States
1347NCT00783536November 200819 February 2015A 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 PfizerNot recruiting18 Years80 YearsBoth402Phase 4Mexico
1348NCT00791921November 200819 October 2017Efficacy 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.Not recruiting20 Years74 YearsAll230Phase 3Japan
1349NCT00791999November 200819 October 2017Efficacy 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.Not recruiting20 Years74 YearsAll316Phase 2/Phase 3Japan
1350NCT00796705November 200819 October 2017Switching 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)Not recruiting18 YearsN/AAll13Phase 4United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1351NCT00901550November 200819 February 2015The Chinese University of Hong Kong Early Arthritis StudyThe Chinese University of Hong Kong Early Arthritis StudyRheumatoid ArthritisDrug: Methotrexate;Drug: InfliximabChinese University of Hong KongNot recruiting18 Years80 YearsBoth40N/AChina
1352NCT00948610November 200816 December 2017Sleep 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)Not recruiting18 Years85 YearsAll20N/AUnited States
1353NCT00773461October 31, 200816 December 2017A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.A Randomized, Double Blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With DMARD Therapy, in Patients With Active Rheumatoid Arthritis and Inadequate Response to Current DMARD TherapyRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: PlaceboHoffmann-La RocheNot recruiting18 Years70 YearsAll209Phase 3China
1354EUCTR2008-005320-81-AT21/10/200819 March 2012A 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 - A2201E2Rheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: ACZ885
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Canakinumab
Current Sponsor code: ACZ885
Other descriptive name: Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-		Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes		200Germany;Spain;Austria
1355EUCTR2008-000742-30-HU18/10/200819 March 2012A 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 MethotrexateRheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: R935788
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib Disodium
CAS Number: 914295-16-2
Current Sponsor code: R935788 sodium hexahydrate
Other descriptive name: R788 Sodium, R788 Na, R788
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: R935788
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib Disodium
CAS Number: 914295-16-2
Current Sponsor code: R935788 sodium hexahydrate
Other descriptive name: R788 Sodium, R788 Na, R788
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		Rigel Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes		420Phase 2Hungary;Bulgaria;Poland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1356EUCTR2008-001847-20-ES17/10/200828 August 2014Estudio 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
Current Sponsor code: RO4877533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: METOTREXATO SODIO
Other descriptive name: METHOTREXATE SODIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		F Hoffmann-La Roche LtdNot RecruitingFemale: yes
Male: yes		470France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
1357EUCTR2007-003288-36-NL15/10/200818 April 2012A 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) - RESTARTRheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-		Centocor BVNot RecruitingFemale: yes
Male: yes		200Phase 4Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
1358EUCTR2008-005212-40-SE14/10/200819 March 2012Pain 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 PROCESSINGRheumatoid 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 Level: LLT Classification code 10060016 Term: Alpha tumor necrosis factor
MedDRA version: 9.1 Level: LLT Classification code 10029817 Term: Nuclear magnetic resonance imaging brain
MedDRA version: 9.1 Level: LLT Classification code 10053689 Term: Cardiovascular autonomic function test		Trade Name: Remicade
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Infliximab
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use		Karolinska InstituteAuthorisedFemale: yes
Male: no		Sweden
1359EUCTR2008-004398-16-SE08/10/200816 September 2013A 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 - ADMIREAdalimumab 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
Pharmaceutical Form: Injection
INN or Proposed INN: Adalimumab
Current Sponsor code: ABT-Humira
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-		Abbott Scandinavia ABNot RecruitingFemale: yes
Male: yes		50Sweden
1360EUCTR2007-000830-38-FR07/10/200819 March 2012A 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Certolizumab pegol
CAS Number: 428863-50-7
Current Sponsor code: CDP870
Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-		UCB Pharma S.A.AuthorisedFemale: yes
Male: yes		132Phase 3BGermany;France;Italy;Poland;Austria
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1361ChiCTR-TRC-100008502008-10-0118 April 2017Phase III clinical trial of Iguratimodin rheumatoid arthritisPhase III clinical trial of Iguratimodin rheumatoid arthritisrheumatoid arthritis3:Experimental group: Iguratimod tablet, nimesulide dummy tablet; positive control group: taking nimesulide and Iguratimod dummy tablet; placebo group: taking Iguratimod dummy tablet and nimesulide dummy tablet. ;Anhui Medical UniversityNot Recruiting1865Both3:600;Phase 3 studyChina
1362NCT00768053October 200819 October 2017Evaluation 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;depolaboNot recruiting18 YearsN/AAll108Phase 4France;Monaco
1363NCT00771329October 200819 February 2015BIIB023 (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 IdecNot recruiting18 Years65 YearsBoth53Phase 1United States;Russian Federation;Ukraine
1364NCT00771420October 200819 February 2015A Single Dose Study of the CAM-3001 in Patients With Rheumatoid ArthritisA Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CAM-3001 in Patients With Rheumatoid Arthritis.Rheumatoid ArthritisDrug: CAM-3001;Other: PlaceboMedImmune LtdNot recruiting18 Years70 YearsBoth38Phase 1Germany
1365NCT00779220October 20087 April 2015A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid ArthritisA Randomized, Double-blind, Parallel-group, Study to Evaluate the Efficacy, Safety and PK/PD of Ocrelizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate TherapyRheumatoid ArthritisDrug: placebo;Drug: methotrexate;Drug: ocrelizumabu 50mg;Drug: ocrelizumabu 200mg;Drug: ocrelizumab 500mgChugai PharmaceuticalNot recruiting20 YearsN/ABoth152Phase 2Japan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1366NCT00785928October 200819 February 2015A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate TherapyPhase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate TherapyRheumatoid ArthritisBiological: LY2127399;Drug: PlaceboEli Lilly and CompanyNot recruiting18 Years75 YearsBoth158Phase 2United States;Argentina;Australia;Chile;Germany;Hungary;India;Mexico;Poland;Romania;Slovakia;Ukraine;Brazil;Canada;Czech Republic
1367NCT00867516October 200816 December 2017Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid ArthritisA Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80,160 and 320mg ALD518 Versus Placebo Administered as Multiple IV Infusions to Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to MethotrexateArthritis, RheumatoidBiological: ALD518;Biological: Infusion without ALD518`Vitaeris INCNot recruiting18 Years80 YearsAll127Phase 2Canada;Georgia;India;Poland;Russian Federation;Serbia
1368EUCTR2008-001282-28-NL23/09/200819 March 2012Influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune diseases treated with immunosuppressive therapy - Vaccinations in rheumatic autoimmune diseasesInfluenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune diseases treated with immunosuppressive therapy - Vaccinations in rheumatic autoimmune diseasesRheumatic autoimmune diseases including rheumatoid arthritis and poly or dermatomyositis.Trade Name: Influvac
Pharmaceutical Form:
INN or Proposed INN: Influvac
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 0,5-
Trade Name: Pneumovax 23
Pharmaceutical Form:
INN or Proposed INN: Pneumovax 23
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 0,5-
Trade Name: HBvaxpro
Pharmaceutical Form:
INN or Proposed INN: HBVAXPRO
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 10-		Radboud University Nijmegen Medical CentreAuthorisedFemale: yes
Male: yes		Netherlands
1369EUCTR2008-001241-26-HU18/09/200819 March 2012A 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
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BT061 (CD4 monoclonal antibody)
Concentration unit: mg milligram(s)
Concentration type: equal
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use		Biotest AGNot RecruitingFemale: yes
Male: yes		110Hungary;Bulgaria
1370EUCTR2008-001105-42-BE16/09/200826 November 2013A 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 - BCDGRheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: LY2127399
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use		Eli Lilly and CompanyNot RecruitingFemale: yes
Male: yes		100Phase 2France;Poland;Belgium;Austria;Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1371EUCTR2008-004126-16-FI05/09/200819 March 2012Local 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 DMARDsRheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: tocilizumab
Product Code: RO4877533 (TCZ)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
Current Sponsor code: RO 4877533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: -20		Roche OyNot RecruitingFemale: yes
Male: yes		Finland
1372NCT00706797September 200819 October 2017Study 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 PfizerNot recruiting18 YearsN/AAll141Phase 4Czech Republic;France;Germany;Hungary;Italy;Poland;Spain;Turkey;United Kingdom;Austria;Croatia;United States
1373NCT00717808September 20088 June 2015Effects of Tranilast on Pharmacokinetics of Methotrexate (MTX) in Patients With Rheumatoid Arthritis (RA)A Phase 1, Blinded, Randomised, Crossover Pilot Study to Investigate the Safety, Tolerability and Pharmacokinetics of Tranilast in Patients With Rheumatoid Arthritis on MethotrexateRheumatoid ArthritisDrug: Tranilast;Drug: Placebo comparatorImperial College LondonNuon Therapeutics, Inc.Not recruiting18 Years75 YearsBoth0Phase 1United Kingdom
1374NCT00724672September 20088 June 2015A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Rheumatoid Arthritis During Different Forms of Anti-Tumor Necrosis-Alpha Treatments.Rheumatoid ArthritisDrug: etanercept;Drug: infliximab;Drug: adalimumabMerck Sharp & Dohme Corp.Not recruiting18 YearsN/ABoth0N/A
1375NCT00746512September 200819 October 2017A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)A Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Access the Effects of Oral Prednisone on Clinical Efficacy and the Power Doppler Ultrasound Signal of Synovium in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Prednisone 15 mg;Drug: Placebo Tablets;Drug: Prednisone 7.5 mg;Drug: Placebo Over-Encapsulated TabletsMerck Sharp & Dohme Corp.Not recruiting18 YearsN/AAll45Phase 1United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1376NCT00753454September 200819 October 2017Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)A Phase IIIb, Multi-center Open-label, Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With Methotrexate in Patients With Active Rheumatoid Arthritis Who Participated in C87077.Rheumatoid ArthritisDrug: Certolizumab pegolUCB PharmaNot recruiting18 YearsN/AAll168Phase 3United States;Canada
1377NCT00780793September 200819 February 2015Spacing of TNF-blocker Injections in Rheumatoid Arthritis StudyEffect of TNF-blocker Injections Spacing on Rheumatoid Arthritis Inflammatory Activity in Patients in Clinical Remission or Low Disease ActivityRheumatoid ArthritisDrug: progressive spacing of TNF-blocker injections;Drug: DMARD maintenanceAssistance Publique - Hôpitaux de ParisFrench Society of RheumatologyNot recruiting18 YearsN/ABoth250Phase 4France
1378NCT00814866September 20087 November 2016Bone Resorption, Osteoclastogenesis and AdalimumabBone Resorption, Osteoclastogenesis and AdalimumabRheumatoid ArthritisDrug: AdalimumabUniversité de SherbrookeAbbottNot recruiting18 YearsN/ABoth28N/ACanada
1379NCT01026519September 200819 February 2015A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid ArthritisA Single-dose, Double-Blind, Placebo-Controlled, Parallel Group Safety, Tolerability and Pharmacodynamic Study of Subcutaneous REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant MethotrexateRheumatoid ArthritisDrug: REGN88;Other: PlaceboRegeneron PharmaceuticalsSanofiNot recruiting18 YearsN/ABoth32Phase 1Russian Federation
1380EUCTR2008-000105-11-DE19/08/200819 March 2012Effectiveness 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 ArthritisRheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: RoActemra
Product Name: Tocilizumab
Product Code: RO4877533
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-		Roche Pharma AGNot RecruitingFemale: yes
Male: yes		Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1381EUCTR2006-000923-32-GB13/08/200819 March 2012A 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
Pharmaceutical Form: Injection*
Current Sponsor code: GSK315234
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intravenous use		GlaxoSmithKline Research & Development LtdNot RecruitingFemale: yes
Male: yes		112United Kingdom
1382NCT00718718August 11, 200816 December 2017A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate TherapyA Phase 2, 2-Part, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept, Dose-finding Study Evaluating the Efficacy and Safety of CNTO 136 Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Despite Methotrexate TherapyArthritis, RheumatoidDrug: CNTO 136 100 mg;Drug: CNTO 136 50 mg;Drug: CNTO 136 25 mg;Drug: Placebo;Drug: MethotrexateCentocor, Inc.Not recruiting18 YearsN/AAll187Phase 2United States;Hungary;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Argentina;Taiwan;Ukraine
1383NCT00828997August 200818 December 2018Effects of Different Antirheumatic Treatments of Arthritis on Antibody Response Following Vaccination Using Prevenar®Effects of Different Anti-rheumatic Treatments of Arthritis on Antibody Response Following Pneumococcal Vaccination Using Prevenar®Rheumatoid Arthritis;SpondylarthropathyBiological: Prevenar vaccinationRegion SkaneLund UniversityNot recruiting18 YearsN/AAll505Phase 4Sweden
1384EUCTR2007-007888-24-FR31/07/200819 March 2012Open-label Study to Evaluate the EULAR-RAID Score, Rheumatoid Arthritis Impact of Disease Score, in Rheumatoid Arthritis Patients Eligible to Etanercept and Who Will Receive Etanercept. - RAINBOWOpen-label Study to Evaluate the EULAR-RAID Score, Rheumatoid Arthritis Impact of Disease Score, in Rheumatoid Arthritis Patients Eligible to Etanercept and Who Will Receive Etanercept. - RAINBOWRHEUMATOID ARTHRITISTrade Name: ENBREL
Pharmaceutical Form: Injection*
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		Wyeth Pharmaceuticals FranceAuthorisedFemale: yes
Male: yes		107France
1385ChiCTR-TCC-120028242008-07-1018 April 2017Traditional Chinese and anti-rheumatic drugs for the treatment of rheumatoid arthritisIntegration of Traditional Chinese and Western Medicine treat rheumatoid witharthritis: A prospective, randomized, controlled trialrheumatoid arthritis with peptic ulcerAcupuncture treatment:ARD treatment and concomitant ginger-partitioned moxibustion of the Zusanli acupoint. ;ARD treatment:esomeprazole magnesium enteric-coated tablets ,celecoxib capsules and methotrexate tablets ;Combined therapy:ARD treatment and concomitant ginger-partitioned moxibustion of the Zusanli acupoint + oral Shanhuang Wuji decoction ;Hospital of Chengdu Military Area Command PLANot Recruiting4565BothAcupuncture treatment:20;ARD treatment:20;Combined therapy:20;OtherChina
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1386JPRN-UMIN0000012402008/07/012 April 2019The efficacy of tocilizumab to patients with rheumatoid arthritis refractory to anti-TNF agents: the open trialrheumatoid arthritisTocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks for 3 yearsDivision of Rheumatology & Clinical Immunology, Jichi Medical UniversityNot Recruiting20years-oldNot applicableMale and Female20Not selectedJapan
1387JPRN-UMIN0000017982008/07/012 April 2019Prevention 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 SchoolNot Recruiting20years-old80years-oldMale and Female100Not applicableJapan
1388JPRN-UMIN0000024212008/07/012 April 2019Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosisrheumatoid arthritistocilizumab
Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab		AA amyloidosis clinical research conferenceRecruiting20years-oldNot applicableMale and Female40Not selectedJapan
1389NCT00712114July 200819 February 2015Safety, Tolerance, Pharmacokinetics and Activity of HE3286 in Patients With Rheumatoid ArthritisA Phase I/II, Open Label, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Potential Anti-Inflammatory Activity of HE3286 When Administered Orally for 29 Days to Patients With Rheumatoid Arthritis on a Stable Dose of MethotrexateRheumatoid ArthritisDrug: HE3286Harbor TherapeuticsNot recruiting18 Years75 YearsBoth14Phase 1/Phase 2United States
1390NCT00713544July 200819 October 2017A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid ArthritisA 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.Rheumatoid ArthritisDrug: AZD5672;Drug: Etanercept;Drug: PlaceboAstraZenecaNot recruiting18 YearsN/AAll373Phase 2Bulgaria;Colombia;Czech Republic;Hungary;Italy;Latvia;Malta;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Ukraine;Argentina;Netherlands;Peru
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1391NCT00714493July 200819 October 2017RESTART C0168Z05 Rheumatoid Arthritis StudyA Phase 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) or Adalimumab (HUMIRA).Rheumatoid ArthritisBiological: InfliximabCentocor Ortho Biotech Services, L.L.C.Schering-PloughNot recruiting18 YearsN/AAll203Phase 4United States;Austria;Canada;Finland;France;Germany;Israel;Netherlands;Spain;United Kingdom;Belgium
1392NCT00717236July 200819 October 2017Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid ArthritisA Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis.Rheumatoid ArthritisDrug: Certolizumab pegol (CZP);Other: PlaceboUCB PharmaNot recruiting18 YearsN/AAll1648Phase 3United States;Canada;France;Germany;Italy;Netherlands;Spain
1393NCT00718588July 200819 February 2015A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MTRX1011A in Patients With Rheumatoid ArthritisA Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial, With a Single Ascending-Dose Stage Followed by a Multiple Ascending-Dose Stage, of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous MTRX1011A in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: MTRX1011AGenentech, Inc.Not recruiting18 Years80 YearsBoth66Phase 1United States
1394NCT00729209July 200819 February 2015A Study of ARRY-371797 in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: ARRY-371797, p38 inhibitor; oral;Drug: PlaceboArray BioPharmaNot recruiting18 YearsN/ABoth28Phase 1United States
1395NCT00782600July 200819 February 2015Study 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 3PfizerNot recruiting18 Years55 YearsBoth16Phase 1United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1396NCT01055899July 200819 February 2015Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant MethotrexateRheumatoid ArthritisBiological: REGN88Regeneron PharmaceuticalsSanofiNot recruiting18 YearsN/ABoth15Phase 1United States
1397EUCTR2007-006150-25-FR24/06/200811 September 2012A 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 MethotrexateRheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis ;Rheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: TRU-015
Pharmaceutical Form: Intravenous infusion
Current Sponsor code: TRU-015
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
Trade Name: Decortin 5mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
CAS Number: 53032
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Trade Name: Solu-Medrone 125mg
Pharmaceutical Form: Powder for solution for injection
CAS Number: 2375033
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Pharmaceutical Form: Intravenous infusion
Current Sponsor code: TRU-015
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
Trade Name: Decortin 5mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
CAS Number: 53032
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Trade Name: Solu-Medrone 125mg
Pharmaceutical Form: Powder for solution for injection
CAS Number: 2375033
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use		Wyeth Research Division of Wyeth Pharmaceuticals Inc.AuthorisedFemale: yes
Male: yes		216Hungary;Germany;Netherlands;Belgium;France;Austria
1398EUCTR2007-006527-13-BG18/06/200819 March 2012A 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 ArthritisRheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: CF101
Pharmaceutical Form: Tablet
INN or Proposed INN: methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-ß-Dribofuronamide
Current Sponsor code: CF101
Other descriptive name: IB-MECA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.1-
INN or Proposed INN: methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-ß-Dribofuronamide
Current Sponsor code: CF101
Other descriptive name: IB-MECA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Can-Fite BioPharma Ltd.Not RecruitingFemale: yes
Male: yes		228Phase 2Bulgaria
1399EUCTR2008-000587-17-GB18/06/200819 March 2012Multi-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 TherapyRheumatoid arthritis.
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Actemra
Product Code: RO4877533 (TCZ)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
Current Sponsor code: RO4877533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-		F. Hoffmann-La Roche LtdNot RecruitingFemale: yes
Male: yes		1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
1400EUCTR2008-000743-34-BE18/06/200826 November 2013A 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 BiologicRheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: R935788
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib Disodium
CAS Number: 914295-16-2
Current Sponsor code: R935788 sodium hexahydrate
Other descriptive name: R788 Sodium, R788 Na, R788
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		Rigel Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes		195Phase 2France;Belgium;Germany;Italy
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1401EUCTR2007-003508-36-HU17/06/200821 August 2012A 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-2Rheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: Lodotra®
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Concentration unit: MBq/mg megabecquerel(s)/milligram
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Nitec Pharma AGNot RecruitingFemale: yes
Male: yes		350Hungary;Germany;United Kingdom
1402EUCTR2007-001625-10-HU16/06/20083 July 2012An 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. - ExtraRHEUMATOID ARTHRITIS
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: Etanercept
Pharmaceutical Form: Injection*
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		Wyeth Pharmaceuticals FranceNot RecruitingFemale: yes
Male: yes		700Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
1403NCT00686868June 13, 200816 December 2017Study to Evaluate SC Route of Administration of Ofatumumab in RA PatientsClinical Phase I/IIA Study of Subcutaneously Administration of Ofatumumab in Rheumatoid Arthritis Patients on Stable Dose MethotrexateArthritis, RheumatoidOther: placebo;Drug: ofatumumabGlaxoSmithKlineNot recruiting18 YearsN/AAll35Phase 1United States;Australia;Belgium;France;Italy;New Zealand;Poland;Russian Federation;Spain;Canada;Germany;Hungary;Netherlands
1404EUCTR2007-001377-28-FR11/06/200819 March 2012Phase 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™-TRAILAdult 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 newly diagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1 Level: LLT Classification code 10061664 Term: Autoimmune disorder
MedDRA version: 9.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic
MedDRA version: 9.1 Level: LLT Classification code 10047888 Term: Wegener's granulomatosis
MedDRA version: 9.1 Level: LLT Classification code 10002817 Term: Antiphospholipid syndrome
MedDRA version: 9.1 Level: LLT Classification code 10040767 Term: Sjogren's syndrome
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease
MedDRA version: 9.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative
MedDRA version: 9.1 Level: LLT Classification code 10003827 Term: Autoimmune hepatitis
MedDRA version: 9.1 Level: LLT Classification code 10049046 Term: Autoimmune thyroiditis
MedDRA version: 9.1 Level: LLT Classification code 10003822 Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1 Level: LLT Classification code 10034697 Term: Pernicious anemia
MedDRA version: 9.1 Level: LLT Classification code 10028417 Term: Myasthenia gravis
MedDRA version: 9.1 Level: LLT Classification code 10018620 Term: Goodpasture's syndrome
MedDRA version: 9.1 Level: LLT Classification code 10		Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-		Merck Serono International S.A.AuthorisedFemale: yes
Male: yes		92Phase 4Portugal;Germany;Netherlands;France;Austria
1405EUCTR2007-005464-26-GB05/06/200811 March 2013Devlopment 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 IIRheumatoid 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
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: up to
Concentration number: 3-
Trade Name: Enbrel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 50-
Trade Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Cimzia
Product Name: Cimzia
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-		Kings College LondonGuys and St Thomas'NHS Foundation TrustAuthorisedFemale: yes
Male: yes		United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1406EUCTR2008-000170-20-FR03/06/200819 March 2012A 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 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 the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with Rheumatoid Arthritis 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-582949
Pharmaceutical Form: Tablet
Current Sponsor code: BMS-582949
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Bristol Myers Squibb International CorporationAuthorisedFemale: yes
Male: yes		240Czech Republic;France;Spain
1407JPRN-JapicCTI-08058701/6/20082 April 2019Safety, Efficacy and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid ArthritisA Multicenter, Open-label Study of Adalimumab in Children With Polyarticular Juvenile Rheumatoid ArthritisJuvenile Rheumatoid Arthritis (JRA)Intervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : adalimumab 20 mg for chldren with body weight < 30 kg; adalimumab 40 mg for chldren with body weight >= 30 kg
Control intervention name : null		Abbott Japan Co., Ltd.Eisai Co., Ltd.417BOTH25Phase 3
1408NCT00147966June 200819 October 2017Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)Assessment of the Immunomodulatory Effects of Rituximab in Seropositive Rheumatoid Arthritis Using Arthroscopic Synovial BiopsiesRheumatoid ArthritisDrug: rituximabUniversity of California, San DiegoGenentech, Inc.Not recruiting18 Years75 YearsAll24Phase 2United States
1409NCT00654368June 200819 October 2017CAMEO: 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 PfizerNot recruiting18 YearsN/AAll258Phase 4Canada
1410NCT00689728June 200819 February 2015A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFa Inhibitor TherapyA Phase 2 Study of Multiple Intravenous Doses of LY2127399 in Patients With Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor TherapyArthritis, RheumatoidBiological: LY2127399;Drug: PlaceboEli Lilly and CompanyNot recruiting18 Years75 YearsBoth100Phase 2United States;Argentina;Austria;Belgium;Brazil;Canada;Germany;Mexico;Poland;Puerto Rico;France
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1411NCT00700986June 200819 February 2015Cross-over Study to Investigate Retinal Function Following Administration of a Single Dose of AZD9056A Randomised, Double-Blind, Placebo-Controlled, 2-Period Cross-Over Study in Healthy Male Volunteers, to Investigate Retinal Function Following a Single 800mg Oral Dose of AZD9056Rheumatoid ArthritisDrug: AZD9056;Drug: PlaceboAstraZenecaNot recruiting18 Years65 YearsMale12Phase 1United Kingdom
1412NCT00711074June 200819 February 2015Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male VolunteersAn Open-Label, Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of [14C]AZD5672 in Healthy Male VolunteersRheumatoid ArthritisDrug: AZD5672AstraZenecaNot recruiting50 YearsN/AMale4Phase 1United Kingdom
1413NCT02151409June 200816 December 2017Dose-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/SNot recruiting18 Years55 YearsMale60Phase 1Netherlands
1414EUCTR2007-001625-10-ES28/05/20083 July 2012Estudio 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 moderada An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - 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 moderada An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - ExtraArtritis reumatoide RHEUMATOID ARTHRITIS
MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: Enbrel
Pharmaceutical Form: Injection*
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		Wyeth Pharmaceuticals FranceAuthorisedFemale: yes
Male: yes		700Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
1415EUCTR2007-007859-14-HU22/05/200819 March 2012A 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 METHOTREXATEActive Rheumatoid Arthritis incompletely responsive to methotrexate
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: ARRY-438162
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ARRY-438162
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: ARRY-438162
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ARRY-438162
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		Array BioPharma Inc.Not RecruitingFemale: yes
Male: yes		200Phase 2Hungary;Poland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1416EUCTR2008-000327-25-ES19/05/200819 March 2012ESTUDIO 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 METROTEXATO A 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 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 METROTEXATO A 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 METHOTREXATEArtritis Reumatoide
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: CE-224,535
Pharmaceutical Form: Tablet
CAS Number: 724424-43-5
Current Sponsor code: CE-224,535
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125 mg-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		PFIZER S.A.AuthorisedFemale: yes
Male: yes		78Phase 2ACzech Republic;Spain;Poland
1417EUCTR2007-007539-14-SK16/05/200813 March 2017A 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 - ESCAPERheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: AZD5672
Product Code: AZD5672
Pharmaceutical Form: Tablet
Current Sponsor code: AZD5672
Other descriptive name: AZD5672
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: AZD5672
Product Code: AZD5672
Pharmaceutical Form: Tablet
Current Sponsor code: AZD5672
Other descriptive name: AZD5672
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Enbrel
Product Name: Enbrel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Etanercept
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		AstraZeneca ABNot RecruitingFemale: yes
Male: yes		360Phase 2Hungary;Czech Republic;Slovakia;Poland;Bulgaria;Latvia;Malta;Italy
1418EUCTR2007-006288-56-AT14/05/200810 July 2015Methotrexat-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 ArthritisRheumatoid ArthritisTrade Name: Ebetrexat
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59052
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 15-25		Ludwig Boltzmann Cluster für Rheumatologie, Balneologie und RehabilitationNot RecruitingFemale: yes
Male: yes		Austria
1419EUCTR2007-005905-23-DE13/05/200819 March 2012A 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 DosingRheumatoid 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adalimumab
CAS Number: 331731-18-1
Other descriptive name: ABT-Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adalimumab
CAS Number: 331731-18-1
Other descriptive name: ABT-Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-		Abbott GmbH & Co. KGNot RecruitingFemale: yes
Male: yes		424United Kingdom;Germany
1420NCT00665626May 200816 December 2017Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis (Taski-3)A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients With Rheumatoid Arthritis Who Have Failed at Least One BiologicRheumatoid ArthritisDrug: Fostamatinib disodium (R935788);Drug: PlaceboRigel PharmaceuticalsNot recruiting18 YearsN/AAll219Phase 2United States;Belgium;Colombia;France;Germany;Italy;Peru;Brazil
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1421NCT00665925May 200819 October 2017Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid ArthritisA Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to MethotrexateRheumatoid ArthritisDrug: Fostamatinib disodium (R935788);Drug: PlaceboRigel PharmaceuticalsNot recruiting18 YearsN/AAll457Phase 2United States;Bulgaria;Colombia;Mexico;Poland;Romania;Israel
1422NCT00667758May 200819 February 2015Gonadotropin-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 OsloNot recruiting18 YearsN/ABoth104Phase 2Norway
1423NCT00690573May 200819 October 2017Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid ArthritisA Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid ArthritisJuvenile Rheumatoid ArthritisBiological: AdalimumabAbbottEisai Co., Ltd.Not recruiting4 Years17 YearsAll25Phase 3Japan
1424NCT00727987May 200819 February 2015A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate TherapyA Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: CNTO 148;Drug: Placebo;Drug: Methotrexate (MTX)Janssen Pharmaceutical K.K.Mitsubishi Tanabe Pharma CorporationNot recruiting20 Years74 YearsBoth269Phase 3Japan
1425NCT00771251May 200817 November 2015A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)A Study of Golimumab (CNTO148) Monotherapy in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: CNTO 148;Drug: PlaceboJanssen Pharmaceutical K.K.Mitsubishi Tanabe Pharma Corporation;Mitsubishi Tanabe Pharma CorporationNot recruiting20 Years74 YearsBoth311Phase 3Japan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1426NCT01224418May 200819 February 2015A 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.Not recruiting18 Years75 YearsBoth50Phase 4Korea, Republic of
1427EUCTR2007-004399-38-EE18/04/200826 June 2012A 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 ARTHRITISRHEUMATOID ARTHRITIS (RA)
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: CRx-102
Pharmaceutical Form: Capsule*
INN or Proposed INN: Prednisolone
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.9 and 1.8-
INN or Proposed INN: Dipyridamole
CAS Number: 58-32-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 180-
Product Code: CRx-102
Pharmaceutical Form: Capsule*
INN or Proposed INN: Prednisolone
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.9 and 1.8-
INN or Proposed INN: Dipyridamole
CAS Number: 58-32-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90 -		CombinatoRx, IncorporatedNot RecruitingFemale: yes
Male: yes		616United Kingdom;Estonia;Lithuania
1428NCT00658047April 200819 February 2015A Study to Assess CH1504 in Patients With Active Rheumatoid ArthritisA Phase II, Multi-center, Randomized, Double-blind, Methotrexate Controlled Study to Assess the Clinical Efficacy, Safety, and Tolerability of CH-1504 in Subjects With Active Rheumatoid ArthritisArthritis, RheumatoidDrug: CH-1504;Drug: Methotrexate (MTX)Chelsea TherapeuticsNot recruiting18 Years80 YearsBoth201Phase 2Canada
1429NCT00661661April 200819 October 2017Long-Term, Open-Label Study Of CP-690,550 For Treatment Of Rheumatoid Arthritis In JapanA Long-term, Open-label Study Of Cp-690,550 to Confirm The Safety Following Long Term Administration Of Cp-690,550 In The Treatment Of Rheumatoid ArthritisRheumatoid ArthritisDrug: CP-690,550PfizerNot recruiting20 YearsN/AAll487Phase 3Japan
1430NCT00673920April 200816 December 2017A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With 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 TherapyRheumatoid ArthritisDrug: methotrexate;Drug: ocrelizumab;Drug: placeboGenentech, Inc.Roche Pharma AGNot recruiting18 YearsN/AAll314Phase 3United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1431NCT00674635April 200812 December 2016Phase II Study Evaluating the Safety and Efficacy of GSK315234A in Patients With Rheumatoid ArthritisA Randomized, 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)Arthritis, RheumatoidDrug: GSK3152314A;Drug: PlaceboGlaxoSmithKlineNot recruiting18 Years75 YearsBoth135Phase 2Australia;New Zealand;Russian Federation;Serbia;Ukraine;Former Serbia and Montenegro;United Kingdom
1432NCT02622503April 20089 January 2017A Study on Rheumatoid Arthritis Patients Treated With RituximabRetrospective Data Collection on Rheumatoid Arthritis (RA) Patients Treated With Rituximab in Finland.Rheumatoid ArthritisDrug: RituximabHoffmann-La RocheNot recruitingN/AN/ABoth81N/AFinland
1433EUCTR2007-000593-24-GB28/03/200819 March 2012An 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
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Etanercept
CAS Number: 185243-69-0
Other descriptive name: Enbrel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: adalimumab
CAS Number: 331731-18-1
Other descriptive name: Humira
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-		F. Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes		52United Kingdom;Sweden
1434EUCTR2007-002066-35-HU28/03/200819 March 2012A 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 - 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 THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableRheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: CP-690,550
Pharmaceutical Form: Tablet
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550
Other descriptive name: CP-690,550-10
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: CP-690,550
Pharmaceutical Form: Tablet
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550
Other descriptive name: CP-690,550-10
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Humira® 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
Pharmaceutical Form: Injection*
INN or Proposed INN: Humira®
Current Sponsor code: Adalimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use		Pfizer Inc, 235 East 42nd Street, New York, NY 10017Not RecruitingFemale: yes
Male: yes		350Phase 2BHungary;Germany;Czech Republic;Bulgaria;Italy;Greece
1435EUCTR2007-000896-41-HU27/03/200818 April 2012A 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 ethotrexateA 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 ethotrexateRheumatoid arthritisTrade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
Pharmaceutical Form: Injection*
Trade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
Pharmaceutical Form: Injection*
Trade Name: Methotrexate
Product Name: Methotrexate
Pharmaceutical Form: Tablet		Wyeth Pharmaceuticals FranceNot RecruitingFemale: yes
Male: yes		900Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1436EUCTR2007-005759-41-FR19/03/200819 March 2012A 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 TherapyRheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: ocrelizumab
Product Code: RO 496-4913/F03
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO 496-4913/F03
Other descriptive name: RhuMAb 2H7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		F. Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes		300United Kingdom;Germany;France;Spain;Italy
1437NCT01000610March 17, 200816 December 2017A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to MethotrexateAn Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With MethotrexateRheumatoid ArthritisDrug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisoloneHoffmann-La RocheNot recruiting18 YearsN/AAll18Phase 4Tunisia
1438EUCTR2007-006539-29-SE14/03/200819 March 2012Effects of different anti-rheumatic treatments of arthritis on antibody response following pneumococcal vaccination using PrevenarEffects of different anti-rheumatic treatments of arthritis on antibody response following pneumococcal vaccination using PrevenarPatients with rheumatic diseases (rheumatoid arthritis and spondyloarthripaties) who are going to be vaccinated with Prevenar vaccine in order to study the serological responses to two pneumococcal serotypes and to study the impact of different treatment modalities on serological responses.Trade Name: Prevenar vaccine
Product Name: Prevenar vaccine
Pharmaceutical Form: Injection*
INN or Proposed INN: 7-valent Pneumococcal Conjugate vaccine		Dept of Rheumatology, Lund University Hospital, Lund, SwedenAuthorisedFemale: yes
Male: yes		500Sweden
1439EUCTR2007-003623-20-ES12/03/200819 March 2012Estudio de los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide (Estudio TESICE-AR). Study of the B-cell-targeted therapy (rituximab) effects on the synovial tissue inmunopathology and peripheral blood B cells in rheumatoid arthritis (TESICE-AR study).Estudio de los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide (Estudio TESICE-AR). Study of the B-cell-targeted therapy (rituximab) effects on the synovial tissue inmunopathology and peripheral blood B cells in rheumatoid arthritis (TESICE-AR study).Se estudiaran los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide.
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: Mabthera
Product Name: Rituximab
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7		Dr. Juan D. Cañete Crespillo, Hospital Clínic de BarcelonaAuthorisedFemale: yes
Male: yes		Spain
1440EUCTR2007-002536-29-FR03/03/200818 September 2012A 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 RARheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Atacicept
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Humira
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection		Merck Serono InternationalAuthorisedFemale: yes
Male: yes		264Phase 2Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1441NCT00565409March 200819 October 2017Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid ArthritisA Randomized, Double-Blind Study Comparing the Safety & Efficacy of Once-Weekly Etanercept 50 mg, Etanercept 25 mg, & Placebo in Combination With Methotrexate in Subjects With Active Rheumatoid ArthritisArthritis, RheumatoidDrug: Etanercept;Drug: Methotrexate;Drug: PlaceboPfizerNot recruiting18 Years70 YearsAll834Phase 4Australia;Austria;Belgium;Chile;Colombia;Czech Republic;Former Serbia and Montenegro;France;Germany;Hungary;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;Spain;Sweden;Taiwan;United Kingdom;Brazil;Korea, Democratic People's Republic of;Serbia
1442NCT00605735March 200819 February 2015PoC 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 SquibbNot recruiting18 YearsN/ABoth121Phase 2United States;Argentina;Czech Republic;France;Korea, Republic of;Mexico;Spain;Taiwan;Brazil
1443NCT00620685March 200819 November 2018A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking MethotrexateA 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Safety And Pharmacokinetic Profile Of 1 And 5 Mg Ph-797804 Administered Once Daily In Subjects With Rheumatoid Arthritis Who Are Taking Oral MethotrexateArthritis, RheumatoidDrug: Placebo;Drug: PH-797804PfizerNot recruiting18 YearsN/AAll27Phase 2United States
1444NCT00628095March 200819 February 2015Study 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: PlaceboPfizerNot recruiting18 YearsN/ABoth100Phase 2/Phase 3United States;Chile;Czech Republic;Korea, Republic of;Mexico;Poland;Spain
1445NCT00634933March 200819 October 2017Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid ArthritisA 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 MethotrexateArthritis, RheumatoidDrug: TRU-015;Drug: Methylprednisolone;Drug: PrednisonePfizerTrubion Pharmaceuticals/Emergent BioSolutions Inc.Not recruiting18 YearsN/AAll222Phase 2United States;Belgium;Canada;France;Germany;Hungary;Mexico;Netherlands;Romania;Serbia;Austria
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1446NCT00641225March 200819 February 2015Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid ArthritisAn Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: SBI-087PfizerEmergent Product Development Seattle LLCNot recruiting18 Years70 YearsBoth62Phase 1United States;Canada
1447NCT00650767March 200819 October 2017A Study of ARRY-438162 in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: ARRY-438162, MEK inhibitor; oral;Drug: PlaceboArray BioPharmaNot recruiting18 YearsN/AAll201Phase 2United States;Argentina;Brazil;Hungary;Peru;Poland;Romania
1448NCT00664521March 200819 October 2017Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)A Randomized, Double-blind, Placebo Controlled, Multi-centre, Exploratory, Pilot, Phase II Trial of 150mg Atacicept Given Subcutaneously in Combination With Rituximab in Subjects With Rheumatoid Arthritis.Rheumatoid ArthritisBiological: Rituximab;Drug: Atacicept;Drug: Placebo matched to ataciceptMerck KGaANot recruiting18 YearsN/AAll27Phase 2France;Netherlands;Sweden;United Kingdom;Finland
1449NCT00664820March 200816 December 2017Effects of Probiotics on Rheumatoid Arthritis PatientsEffects of Probiotics on Rheumatoid Arthritis PatientsRheumatoid ArthritisDietary Supplement: Probiotic capsules containing Lactobacillus rhamnosus GR-1 and L. reuteri RC-14Lawson Health Research InstituteUniversity of Western Ontario, Canada;St. Joseph's Health Care LondonNot recruiting18 Years80 YearsAll50N/ACanada
1450NCT02109666March 200816 December 2017Long Term Experience With Abatacept in Routine Clinical PracticeLong Term Experience With Abatacept in Routine Clinical PracticeRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbNot recruiting18 YearsN/AAll2364N/AAustria;Belgium;Canada;Czech Republic;Denmark;France;Germany;Greece;Ireland;Italy;Netherlands;Spain;Switzerland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1451EUCTR2007-000828-40-FR26/02/200819 March 2012A 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. - C87076Rheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Certolizumab pegol
Product Code: CDP870
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Certolizumab pegol
Current Sponsor code: CDP870
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 200-+/- 15
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		UCB Pharma S.A.AuthorisedFemale: yes
Male: yes		170Phase 3BGermany;France;Italy;Poland;Austria
1452EUCTR2006-006562-42-GB21/02/200819 March 2012An 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 CachexiaCachexia in patients with Rheumatoid arthritis.
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: Enbrel
Product Name: Etanercept 50mg
Pharmaceutical Form: Powder and solvent for solution for injection		Derby Hospitals NHS Foundation TrustAuthorisedFemale: yes
Male: yes		32United Kingdom
1453EUCTR2004-002132-26-GB19/02/20082 October 2012A 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/ARheumatoid ArthritisProduct Name: Ocrelizumab / rhuMAb 2H7
Product Code: Ro 496-4913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: N/A
Current Sponsor code: Ro 496-4913
Other descriptive name: rhuMAb 2H7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		F. Hoffmann-La Roche LimitedAuthorisedFemale: yes
Male: yes		160Phase 1/2United Kingdom;Spain
1454EUCTR2007-003647-75-NL07/02/200812 June 2012A 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 arthritisRheumatoid arthritis.
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Atacicept
Product Code: TACI-Fc5
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 25-150
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Mabthera
Product Name: Rituximab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: rituximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-		Merck Serono InternationalAuthorisedFemale: yes
Male: yes		90Phase 2Sweden;France;Finland;United Kingdom;Netherlands
1455NCT00556894February 200819 October 2017Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis PatientsA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: CF101Can-Fite BioPharmaNot recruiting18 Years75 YearsAll230Phase 2Bulgaria;Czech Republic;Israel;Poland;Serbia;Ukraine;Former Serbia and Montenegro
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1456NCT00639834February 200819 February 2015Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid ArthritisA Phase 1, Multicenter, Single-dose, Dose-escalation, Safety and Tolerability Study of MDX-1342 (Anti-CD19 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: MDX-1342Bristol-Myers SquibbNot recruiting18 YearsN/ABoth26Phase 1United States;Germany;Hungary;Ukraine;United Kingdom;Poland
1457NCT01017367February 200819 February 2015Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (RA)Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: MDX-1100;Drug: PlaceboBristol-Myers SquibbNot recruiting18 YearsN/ABoth70Phase 2Romania;Ukraine
1458NCT01072058February 200819 February 2015Heart 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 PauloNot recruiting18 Years70 YearsBoth100Phase 4Brazil
1459EUCTR2007-006729-28-GB25/01/200819 March 2012Is 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 RAThe 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
Pharmaceutical Form: Injection*
INN or Proposed INN: TRIAMCINOLONE ACETONIDE
CAS Number: 76255
Concentration unit: IU/mg international unit(s)/milligram
Concentration type: equal
Concentration number: 80-
Trade Name: Prednisolone
Product Name: Prednisolone
Pharmaceutical Form: Coated tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50248
Concentration unit: IU/mg international unit(s)/milligram
Concentration type: equal
Concentration number: 5-		Trafford NHS TrustNot RecruitingFemale: yes
Male: yes		58United Kingdom
1460EUCTR2007-000012-90-GB23/01/20089 January 2017The 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 TrialThe 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
Pharmaceutical Form: Tablet
Trade Name: Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses
Pharmaceutical Form: Tablet		University of DundeeNot RecruitingFemale: yes
Male: yes		Phase 4Denmark;Netherlands;United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1461ChiCTR-CCC-100010542008-01-0118 April 2017Circulating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid ArthritisCirculating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid Arthritisra1:none;2:Infliximab ;National Sciences Foundation of ChinaNot Recruiting2858Both1:39;2:39;Pilot studyChina
1462ChiCTR-TRC-090003832008-01-0118 April 2017Efficacy and safety of recombinant human IL-1 receptor antagonist in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trialEfficacy and safety of recombinant human IL-1 receptor antagonist in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trialrheumatoid arthritis;M05.901placebo:daily subcutaneous injections of placebo, with concurrent MTX therapy ;anakinra:daily subcutaneous injections of anakinra (80 mg), with concurrent MTX therapy;Xi-jing Hospital, the 4th Military Medical University, Shanghai Changzheng HospitalNot Recruiting1865Bothplacebo:10;anakinra:30;Phase 3 studyChina
1463NCT00611455January 1, 200816 December 2017Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX TherapyA 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 Have Had an Inadequate Response to Methotrexate TherapyArthritis, RheumatoidDrug: ofatumumab;Drug: PlaceboGlaxoSmithKlineNot recruiting18 YearsN/AAll265Phase 3Argentina;Australia;Belgium;Chile;Czechia;Hungary;Peru;Poland;Romania;Russian Federation;South Africa;Spain;United Kingdom;Czech Republic
1464NCT00655824January 1, 200816 December 2017Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial 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 PlaceboArthritis, RheumatoidDrug: ofatumumabGlaxoSmithKlineNot recruiting18 YearsN/AAll124Phase 2United States;Denmark;Hungary;Poland;United Kingdom
1465NCT00559585January 200819 October 2017Methotrexate-Inadequate Response 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 MethotrexateRheumatoid Arthritis (RA)Drug: Subcutaneous (SC) Abatacept;Drug: Intravenous (IV) AbataceptBristol-Myers SquibbNot recruiting18 YearsN/AAll2492Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Chile;France;Germany;Greece;Hungary;India;Ireland;Italy;Korea, Republic of;Mexico;Netherlands;Peru;Poland;Russian Federation;South Africa;Taiwan;Turkey;United Kingdom;Austria;Spain
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1466NCT00603512January 200819 October 2017Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in JapanA Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Confirm Dose Responsiveness Following 12 Weeks of the Administration of CP-690,550 (4 Doses) or Placebo in Subjects With Active Rheumatoid Arthritis Inadequately Controlled With Methotrexate AloneArthritis, RheumatoidDrug: Placebo;Drug: CP-690,550PfizerNot recruiting20 Years70 YearsAll140Phase 2Japan
1467NCT00603525January 200819 October 2017Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-a Antagonist TherapyA Double-blind, Randomized, Placebo Controlled, Parallel Group, Multi-center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Patients With Active Rheumatoid Arthritis Who Have Previously Had an Inadequate Response to One or More TNF Antagonist TherapiesArthritis, RheumatoidDrug: Ofatumumab;Drug: PlaceboGlaxoSmithKlineNot recruiting18 YearsN/AAll169Phase 3Argentina;Denmark;France;Germany;Italy;Korea, Republic of;Netherlands;Norway;Peru;Spain;Sweden;United Kingdom
1468NCT00741104January 200816 December 2017A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA PatientsRheumatoid ArthritisDrug: InfliximabMerck Sharp & Dohme Corp.Not recruitingN/AN/AAll363Phase 4
1469EUCTR2008-000744-13-DE27 January 2014An 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 StudyRheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: R935788
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib Disodium
CAS Number: 914295-16-2
Current Sponsor code: R935788 sodium hexahydrate
Other descriptive name: R788 Sodium, R788 Na, R788
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: R935788
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib Disodium
CAS Number: 914295-16-2
Current Sponsor code: R935788 sodium hexahydrate
Other descriptive name: R788 Sodium, R788 Na, R788
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-		AstraZeneca ABNot RecruitingFemale: yes
Male: yes		800France;Belgium;Bulgaria;Germany;Italy
1470NCT01362153December 26, 200716 December 2017A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA)An Open-label Randomized Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of Subcutaneous and Intravenous Administrations of Golimumab to Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: GolimumabCentocor, Inc.Not recruiting18 Years99 YearsAll49Phase 1United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1471EUCTR2007-002951-18-NL10/12/200719 March 2012A 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 antagonistRheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Ofatumumab
Product Code: HuMax-CD20
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ofatumumab
CAS Number: 679 818-59-8
Current Sponsor code: HuMax-CD20
Concentration unit: mg/ml milligram(s)/millilitre
Concentration number: 20-
Route of administration of the placebo: Intravenous use		Genmab A/SNot RecruitingFemale: yes
Male: yes		236Phase 3Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden
1472EUCTR2007-004878-31-DK10/12/20072 June 2014An 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-CD20-403Rheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Ofatumumab
Product Code: HuMax-CD20
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ofatumumab
CAS Number: 679 818-59-8
Current Sponsor code: HuMax-CD20
Concentration unit: mg/ml milligram(s)/millilitre
Concentration number: 20-		GlaxoSmithKline Research & Development LtdNot RecruitingFemale: yes
Male: yes		264Phase 2Hungary;Denmark;United Kingdom
1473NCT00547521December 200719 October 2017Phase IIIB Subcutaneous Abatacept Monotherapy StudyA Phase IIIb, Multi-center, Stratified, Open-Label Study to Evaluate the Immunogenicity, Steady State Trough Level, and Safety of Subcutaneous Abatacept (BMS-188667) in Subjects With Rheumatoid Arthritis Administered With or Without Background MethotrexateRheumatoid Arthritis (RA)Drug: abatacept;Drug: Methotrexate (MTX)Bristol-Myers SquibbNot recruiting18 YearsN/AAll119Phase 3United States;Australia;Mexico;South Africa;Brazil;Canada;Peru
1474NCT00576433December 200714 November 2016A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF InhibitorRheumatoid ArthritisDrug: Methotrexate;Drug: rituximab [MabThera/Rituxan]Hoffmann-La RocheNot recruiting18 Years80 YearsBoth60Phase 4Russian Federation
1475NCT00576706December 200719 February 2015PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal ToxicityA Phase III, Randomized, Double-dummy, Double Blind, Misoprostol-comparative Clinical Trial to Evaluate the Efficacy and Safety of Mucosta® Tablet in the Prevention of NSAID-induced Gastrointestinal ComplicationsRheumatoid Arthritis;Osteoarthritis;Ankylosing SpondylitisDrug: Rebamipide;Drug: MisoprostolKorea Otsuka Pharmaceutical Co.,Ltd.Not recruiting19 YearsN/ABoth396Phase 3Korea, Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1476NCT00580229December 200720 August 2018A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.Rheumatoid ArthritisDrug: prednisoneUniversity of South FloridaNot recruiting18 Years80 YearsAll50Phase 2/Phase 3United States
1477NCT00580840December 200719 October 2017Dosing Flexibility Study in Patients With Rheumatoid ArthritisA Phase IIIb Open-label run-in Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety/Efficacy of Certolizumab Pegol Administered Concomitantly With Stable-dose Methotrexate in Patients With Active Rheumatoid Arthritis.Rheumatoid ArthritisDrug: Certolizumab pegol;Other: PlaceboUCB PharmaNot recruiting18 YearsN/AAll333Phase 4United States;Canada;France;Austria
1478NCT00647270December 200719 October 2017Study 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: PlaceboAbbottNot recruiting18 YearsN/AAll420Phase 3United States;Australia;Canada;Germany;Puerto Rico;United Kingdom
1479NCT00963703December 200719 February 2015Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid ArthritisTreatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial OutcomesRheumatoid ArthritisDrug: RituximabUniversity of ManitobaHoffmann-La RocheNot recruiting18 YearsN/ABoth15N/ACanada
1480NCT01231321December 200719 October 2017A Study of Adalimumab When Added to Inadequate Standard Anti-rheumatic Therapy in Patients With Active Rheumatoid ArthritisAn Open-label, Prospective, Multi-Centre Study to Assess the Safety and Efficacy of Adalimumab (Humira®) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: adalimumabAbbottNot recruiting18 YearsN/AAll100Phase 3Russian Federation
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1481EUCTR2007-001585-33-LT13/11/20077 October 2014A 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. SCORERheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Route of administration of the placebo: Intravenous use		F. Hoffman-La Roche Ltd.Not RecruitingFemale: yes
Male: yes		180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
1482NCT00533897November 200719 October 2017Phase 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 SquibbNot recruiting18 YearsN/AAll270Phase 3United States;Argentina;Canada;Mexico;South Africa;Brazil
1483NCT00554853November 200719 October 2017PPAR-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)Not recruiting21 Years100 YearsAll143Phase 3United States
1484NCT00578305November 200719 October 2017A 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 RocheNot recruiting18 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
1485NCT00664573November 200719 February 2015Assessment 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 IdecNot recruiting18 Years75 YearsBoth339Phase 2Argentina;Brazil;Hungary;Mexico;Poland;Romania;Russian Federation;United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1486NCT01245361November 200719 February 2015A 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 DurezNot recruitingN/AN/ABoth30N/ABelgium
1487EUCTR2007-003069-42-EE31/10/200719 March 2012A 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
Pharmaceutical Form: Capsule*
INN or Proposed INN: Prednisolone
CAS Number: 52438-85-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.9 and 1.8-
INN or Proposed INN: Dipyridamole
CAS Number: 58-32-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 180-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: Prednisolone
Pharmaceutical Form: Capsule*
INN or Proposed INN: Prednisolone
CAS Number: 52438-85-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.9 and 1.8-
Product Name: Dipyridamole
Pharmaceutical Form: Capsule*
INN or Proposed INN: Dipyridamole
CAS Number: 58-32-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 180-
Product Code: CRx-102
Pharmaceutical Form: Capsule*
INN or Proposed INN: Prednisolone
CAS Number: 52438-85-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.9 and 1.8-
INN or Proposed INN: Dipyridamole
CAS Number: 58-32-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90 -
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		CombinatoRx, IncorporatedNot RecruitingFemale: yes
Male: yes		616Hungary;United Kingdom;Estonia;Lithuania
1488NCT00535782October 31, 200716 December 2017A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid ArthritisA Mechanism of Action Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) on Lipids, Arterial Stiffness, and Markers of Atherogenic Risk in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA).Rheumatoid ArthritisDrug: Tocilizumab;Drug: Placebo;Drug: MethotrexateHoffmann-La RocheNot recruiting18 Years75 YearsAll132Phase 3United States;Canada;Puerto Rico;United Kingdom
1489EUCTR2007-001035-58-ES30/10/200719 March 2012A 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 ESTUDIO 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 METHOTREXATE ESTUDIO 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/AARTRITIS REUMATOIDE RHEUMATOID ARTHRITIS
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Maraviroc
Product Code: UK-427,857
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Maraviroc
CAS Number: 376348-65-1
Current Sponsor code: UK-427,857
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Pfizer, S. A.AuthorisedFemale: yes
Male: yes		114Phase 2Portugal;Spain;Italy
1490EUCTR2006-006591-37-BE25/10/20077 October 2014A 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 ArthritisRheumatoid ArthritisTrade Name: Enbrel
Product Name: Pre-filled syringe
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: Enbrel Auto Injector
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		Wyeth Pharmaceuticals FranceNot RecruitingFemale: yes
Male: yes		264Greece;Belgium;Austria
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1491NCT00502853October 25, 200716 December 2017A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.Pilot Study to Evaluate the Effect of Mabthera 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.Rheumatoid ArthritisDrug: rituximab [MabThera/Rituxan];Drug: MethotrexateHoffmann-La RocheNot recruiting18 Years75 YearsAll10Phase 4Italy
1492EUCTR2007-002945-18-CZ15/10/200719 March 2012A 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 DMARDsRheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Ofatumumab
Product Code: HuMax-CD20
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ofatumumab
CAS Number: 679 818-59-8
Current Sponsor code: HuMax-CD20
Concentration unit: mg/ml milligram(s)/millilitre
Concentration number: 20-
Route of administration of the placebo: Intravenous use		Genmab A/SNot RecruitingFemale: yes
Male: yes		1000Phase 3Czech Republic
1493EUCTR2007-000733-19-GB02/10/200719 March 2012A 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 104RA202Rheumatoid arthritis (RA)
MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: BG9924
Pharmaceutical Form: Powder for solution for injection
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Biogen Idec LtdNot RecruitingFemale: yes
Male: yes		380Phase 2BHungary;United Kingdom
1494EUCTR2007-000734-38-GB02/10/200719 March 2012An 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 104RA203Rheumatoid arthritis (RA)
MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: BG9924
Pharmaceutical Form: Powder for solution for injection
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-		Biogen Idec LtdNot RecruitingFemale: yes
Male: yes		120United Kingdom
1495ChiCTR-TRC-110017552007-10-0118 April 2017Phase II of Tu Fu Ling Tablets in Rheumatoid ArthritisA Multi-center, Randomized, Double-blind, Double-dummy, Phase II Study Evaluating the Safety and Efficacy of Tu Fu Ling Tablets in Participants with Rheumatoid ArthritisRheumatoid ArthritisA:Tu Fu Ling Tablets, 200mg Bid. Other: Placebo;B:Tu Fu Ling Tablets, 100mg Tid. Other: Placebo. ;C:Leflunomide Tablets, 20mg Qd. Other: Placebo;The First Teaching Hospital of Tianjin University of Traditional Chinese MedicineNot Recruiting1865BothA:80;B:80;C:80;Phase 2 studyChina
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1496JPRN-UMIN0000008372007/10/012 April 2019Combination effect of bucillamine and salazosulphapyridine on rheumatoid arthritis; Prospective randomized controlled studyRheumatoid 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 groupRecruiting20years-old75years-oldMale and Female180Not applicableJapan
1497NCT00531817October 200719 October 2017A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid ArthritisA Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: Tocilizumab;Drug: Placebo;Drug: Permitted DMARDsHoffmann-La RocheNot recruiting18 YearsN/AAll619Phase 3United States;Puerto Rico
1498NCT00550043October 200719 October 2017A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid ArthritisA Double-blind, Placebo-controlled Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: INCB018424;Drug: PlaceboIncyte CorporationNot recruiting18 Years70 YearsAll50Phase 2United States;Poland
1499NCT00551707October 200719 October 2017Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid ArthritisA 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 ArthritisDrug: CRx-102 (2.7/180);Drug: prednisolone;Drug: dipyridamole;Drug: placebo;Drug: CRx-102 (2.7/360)ZalicusNot recruiting18 YearsN/AAll51Phase 2United States;Argentina;Canada;Estonia;Hungary;Lithuania;Mexico;Poland;Romania;Russian Federation;Serbia;South Africa
1500NCT00554606October 200716 December 2017Long-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: ACZ885NovartisNot recruiting18 Years75 YearsAll115Phase 2United States;Belgium;Germany;Italy;Netherlands;Russian Federation;Spain;Switzerland;Turkey
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1501NCT00595517October 200719 October 2017Long 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 mgAstraZenecaNot recruiting20 YearsN/AAll395Phase 3Japan
1502NCT00626275October 200719 October 2017Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Participants With Rheumatoid ArthritisA Phase 2a Randomized, Placebo- and Active-Controlled, Single-Dose, 3-Period, Crossover Study Followed by a Randomized, Placebo-Controlled, 14-Day, Parallel-Group Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: ADL5859;Drug: Naproxen;Drug: PlaceboCubist Pharmaceuticals LLCNot recruiting18 Years75 YearsAll46Phase 2United States
1503NCT00934648October 200719 October 2017A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to MethotrexateAn Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With MethotrexateRheumatoid ArthritisDrug: rituximab [MabThera/Rituxan];Drug: methotrexateHoffmann-La RocheNot recruiting18 YearsN/AAll15Phase 4Morocco
1504NCT02699892October 200719 October 2017Study 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 RocheNot recruiting18 Years80 YearsAll130N/ASerbia
1505EUCTR2007-004694-26-BE17/09/20077 October 2014A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UAA Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UAPatient with undifferentiated arthritis and the presence of anti-CCP antibodies are at high risk to develop RA
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: Remicade
Product Name: REMICADE® (Infliximab)
Product Code: -
Pharmaceutical Form: Powder for infusion*
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use		Saint-Luc Universitary HospitalAuthorisedFemale: yes
Male: yes		30Belgium
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1506EUCTR2006-006127-40-GB16/09/200719 March 2012Cerebral 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 RARheumatoid 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)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: recombinant human monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40mg in 0.8ml-		Newcastle-upon-Tyne Hospitals NHS Foundation TrustAuthorisedFemale: yes
Male: yes		United Kingdom
1507EUCTR2007-001665-15-ES14/09/20072 February 2015Estudio 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
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Canakinumab (proposed)
Current Sponsor code: ACZ885
Other descriptive name: ACZ885 Drug Substance
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-		Novartis Farmaceutica S.A.Not RecruitingFemale: yes
Male: yes		179Belgium;Spain;Netherlands;Germany;Italy
1508EUCTR2007-002752-42-FR13/09/200719 March 2012FAKIR : Variabilité pharmacocinétique et de la relation pharmacocinétique-phamacodynamique de l'infliximab (Remicade®) dans la polyarthrite rhumatoide - FAKIRFAKIR : Variabilité pharmacocinétique et de la relation pharmacocinétique-phamacodynamique de l'infliximab (Remicade®) dans la polyarthrite rhumatoide - FAKIRPolyarthrite rhumatoïde
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: Remicade®
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277313
Concentration unit: mg/kg/h milligram(s)/kilogram/hour
Concentration type: range
Concentration number: 1,5-3		CHRU de ToursAuthorisedFemale: yes
Male: yes		France
1509EUCTR2007-002950-42-LT13/09/200719 March 2012A 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 MTXRheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Ofatumumab
Product Code: HuMax-CD20
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ofatumumab
CAS Number: 679 818-59-8
Current Sponsor code: HuMax-CD20
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Route of administration of the placebo: Intravenous use		Genmab A/SNot RecruitingFemale: yes
Male: yes		248Phase 3Hungary;United Kingdom;Czech Republic;Spain;Poland;Lithuania
1510EUCTR2007-002976-32-NL06/09/200719 March 2012COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis.COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis.Patients with early rheumatoid arthritis wil be treated with a combination therapy: COBRA according to BEST or a modified COBRA schedule (COBRA-light).Trade Name: Prednisone
Pharmaceutical Form: Tablet
Trade Name: Methotrexate
Pharmaceutical Form: Tablet
Trade Name: Sulphasalazine
Pharmaceutical Form: Tablet		TIPharmaAuthorisedFemale: yes
Male: yes		Netherlands
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1511NCT00539760September 5, 200716 December 2017A Phase I Rheumatoid Arthritis Study in Healthy VolunteersA Phase I, Randomized, Observer- and Subject-Blind, Placebo-Controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1827771 in Healthy VolunteersArthritis, RheumatoidDrug: GSK1827771;Drug: PlaceboGlaxoSmithKlineNot recruiting18 Years55 YearsAll45Phase 1United States
1512EUCTR2006-005640-81-GB04/09/200719 March 2012A 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: - EXXTRARheumatoid arthritisTrade Name: Mabthera
Product Name: Mabthera
Product Code: Rituximab
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Methylprednisolone
Product Name: Methylprednisolone
Pharmaceutical Form: Powder for infusion*
Other descriptive name: Methylprednisolone
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 200-300		University of LeedsAuthorisedFemale: yes
Male: yes		60United Kingdom
1513NCT00411424September 200719 February 2015Safety, Tolerability and Efficacy Study of the New Medication ASK8007 to Treat Patients With Rheumatoid ArthritisSafety, Tolerability, Pharmacokinetics, Pharmacodynamics and Initial Efficacy of ASK8007 in Comparison With Placebo in Patients With Active Rheumatoid Arthritis - a Randomized, Double Blind, Placebo-controlled, Combined Single Dose Escalation and Multiple Dose StudyRheumatoid ArthritisDrug: ASK8007;Drug: PlaceboAstellas Pharma IncNot recruiting18 YearsN/ABoth54Phase 1/Phase 2Belgium;Hungary;Ireland;Netherlands;Spain;United Kingdom;France
1514NCT00550446September 200719 October 2017A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid ArthritisA 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 ArthritisArthritis, RheumatoidDrug: Adalimumab;Drug: CP-690-550;Drug: CP-690,550;Drug: PlaceboPfizerNot recruiting18 YearsN/AAll386Phase 2United States;Brazil;Bulgaria;Chile;Croatia;Czech Republic;Germany;Greece;Hungary;Italy;Korea, Republic of;Mexico;Romania;Slovakia;Ukraine
1515NCT00613106September 200719 October 2017Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)Double-Blind Follow-On Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg)in Subjects Who Have Completed Participation in Horizon Protocol HZ-CA-301 (NCT00450658)or Horizon Protocol HZ-CA-303 (NCT00450216)Osteoarthritis;Rheumatoid Arthritis;Chronic Low Back Pain;Chronic Regional Pain Syndrome;Chronic Soft Tissue PainDrug: HZT-501;Drug: IbuprofenHorizon Pharma Ireland, Ltd., Dublin IrelandNot recruiting40 Years81 YearsAll179Phase 3United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1516NCT00660647September 20077 December 2015Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA)Optimized Treatment Algorithm in Early Rheumatoid Arthritis: Methotrexate and Intra-articular Glucocorticosteroid Plus Adalimumab or Placebo in the Treatment of Early Rheumatoid ArthritisArthritis, RheumatoidDrug: Adalimumab;Drug: PlaceboUniversity of AarhusAbbott;Meda Pharmaceuticals;Aarhus University HospitalNot recruiting18 YearsN/ABoth180Phase 3Denmark
1517EUCTR2006-003054-26-CZ31/08/200719 March 2012A 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 - NARheumatoid arthritis (RA)
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: TAK-783
Pharmaceutical Form: Tablet
Current Sponsor code: TAK-783
Concentration unit: % percent
Concentration type: range
Concentration number: 90-110
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Takeda Global R&D (Europe) LtdNot RecruitingFemale: yes
Male: yes		230Hungary;Czech Republic;Latvia
1518EUCTR2007-001420-12-BE23/08/20077 October 2014A 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 SulphasalazineRheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Pharmaceutical Form: Tablet
Current Sponsor code: AZD9056
Other descriptive name: None
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Pharmaceutical Form: Tablet
Current Sponsor code: AZD9056
Other descriptive name: None
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Enbrel
Product Name: Enbrel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Etanercept
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		AstraZeneca ABNot RecruitingFemale: yes
Male: yes		360Phase 2bFrance;Czech Republic;Poland;Belgium;Sweden
1519EUCTR2007-000734-38-BE17/08/200711 November 2013An 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 104RA203Rheumatoid arthritis (RA)
MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: BG9924
Pharmaceutical Form: Solution for injection
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-		Biogen Idec LtdNot RecruitingFemale: yes
Male: yes		120Belgium;United Kingdom
1520EUCTR2007-001754-11-IT03/08/200719 March 2012Pilot 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. - NDRheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: Mabthera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-		ROCHENot RecruitingFemale: yes
Male: yes		Italy
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1521NCT00505089August 200719 February 2015Efficacy 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: ACZ885NovartisNot recruiting18 Years75 YearsBoth11Phase 1/Phase 2Belgium;Germany;Netherlands;Poland
1522NCT00511329August 200711 June 2018Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's DiseaseGrowth and the Effect of Genotropin in Chronically Ill Children With Juvenile Rheumatoid Arthritis and With Crohn's DiseaseArthritis, Juvenile Rheumatoid;Crohn DiseaseDrug: somatropin [rDNA origin] for injectionNationwide Children's HospitalPfizerNot recruiting5 Years17 YearsAll10Phase 2/Phase 3United States
1523NCT00517543August 200719 February 2015A Study to Examine the Effect of Particle Size on Bioequivalence and BioavailabilityA Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553Chronic Obstructive Pulmonary Disease (COPD);Rheumatoid Arthritis;AtherosclerosisDrug: GW856553GlaxoSmithKlineNot recruiting18 Years60 YearsBoth36Phase 1United States
1524NCT00520572August 200719 October 2017A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)A Randomised, Double-Blind (With Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients With Active Disease Receiving Background Methotrexate or SulphasalazineRheumatoid ArthritisDrug: AZD9056;Drug: Etanercept;Drug: PlaceboAstraZenecaNot recruiting18 YearsN/AAll385Phase 2United States;Argentina;Australia;Belgium;Canada;Czech Republic;France;Mexico;Poland;Romania;Russian Federation;Slovakia;Hungary;Sweden
1525NCT00523328August 200719 February 2015BG9924 in Combination With Methotrexate Extension of 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 104RA203Rheumatoid ArthritisDrug: BG9924Biogen IdecNot recruiting18 Years75 YearsBoth72Phase 2United States;Belgium;Canada;United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1526NCT00538902August 200719 October 2017Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With MethotrexateA Multi-center Randomized, Phase 2/3, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Safety and Efficacy of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With MethotrexateRheumatoid ArthritisBiological: Placebo;Biological: Adalimumab 80 mg;Biological: Adalimumab 40 mgAbbottNot recruiting18 YearsN/AAll302Phase 2/Phase 3China
1527NCT00542789August 200719 October 2017Comparative 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: PlaceboAstraZenecaNot recruiting20 YearsN/AAll343Phase 3Japan
1528NCT00550355August 200719 February 2015Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid ArthritisA Randomized, Subject and Investigator-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Intravenously Administered Doses of PD-0360324 in Patients With Rheumatoid Arthritis Receiving MethotrexateArthritis, RheumatoidDrug: PD 0360324;Drug: PlaceboPfizerNot recruiting21 Years70 YearsBoth78Phase 1United States;Argentina;Bulgaria;Czech Republic;Mexico;Poland;Slovakia;Spain
1529NCT00597818August 200719 February 2015Cobiprostone 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: PlaceboSucampo Pharmaceuticals, Inc.Not recruiting40 Years70 YearsBoth120Phase 2United States
1530NCT03414502August 20076 May 2019Treatment of Rheumatoid Arthritis With Methotrexate: Predictors of ResponseTreatment of Rheumatoid Arthritis With Methotrexate: Predictors of ResponseRheumatoid ArthritisDrug: MethotrexateUniversity of NebraskaRecruiting19 YearsN/AAll300Phase 3United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1531EUCTR2006-005147-28-DE25/07/200723 May 2016MTX-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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ocrelizumab
Current Sponsor code: RO 496-4913
Other descriptive name: RhuMAb 2H7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		F. Hoffmann-La Roche LtdNot RecruitingFemale: yes
Male: yes		1000Phase 3France;Greece;Spain;Belgium;Austria;Germany;United Kingdom
1532NCT00502840July 23, 200716 December 2017A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.An Open Label Study to Evaluate the Safety of Re-treatment With MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent (Extension Study to ML19070).Rheumatoid ArthritisDrug: rituximab [MabThera/Rituxan]Hoffmann-La RocheNot recruiting18 Years75 YearsAll193Phase 3Germany
1533EUCTR2006-003698-29-AT18/07/20077 August 2012A 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 ArthritisRheumatoid arthritis (RA)Product Name: AMG 108
Product Code: AMG 108
Pharmaceutical Form: Solution for injection
Current Sponsor code: AMG 108
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Amgen Inc.Not RecruitingFemale: yes
Male: yes		784Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
1534EUCTR2006-004666-14-DE17/07/200719 March 2012An 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 availableRheumatoid Arthritis
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: ACZ885
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Canakinumab (proposed)
Current Sponsor code: ACZ885
Other descriptive name: ACZ885 Drug Substance
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-		Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes		32Germany
1535EUCTR2007-000886-40-CZ17/07/20075 December 2016Assessment 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. - LEADERpatients 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®
Pharmaceutical Form: Coated tablet
INN or Proposed INN: LEFLUNOMIDE
CAS Number: 75706126
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Trade Name: ARAVA®
Pharmaceutical Form: Coated tablet
INN or Proposed INN: LEFLUNOMIDE
CAS Number: 75706126
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Trade Name: ARAVA®
Pharmaceutical Form: Coated tablet
INN or Proposed INN: LEFLUNOMIDE
CAS Number: 75706126
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-		sanofi-aventis groupeNot RecruitingFemale: yes
Male: yes		200Phase 3Portugal;Czech Republic;Italy
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1536EUCTR2006-004834-33-LT05/07/200720 February 2017A 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 - RobustRheumatiod Arthritis
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Rob 803
Product Code: Rob 803 6.25mg capsule
Pharmaceutical Form: Capsule*
Current Sponsor code: Rob 803
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6.25-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: Rob 803
Product Code: Rob 803 12.5mg capsule
Pharmaceutical Form: Capsule*
Current Sponsor code: Rob 803
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: Rob 803
Product Code: Rob 803 15mg capsule
Pharmaceutical Form: Capsule*
Current Sponsor code: Rob 803
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: Rob 803
Product Code: Rob 803 25mg capsule
Pharmaceutical Form: Capsule*
Current Sponsor code: Rob 803
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		OxyPharma ABNot RecruitingFemale: yes
Male: yes		224Phase 2Poland;Belgium;Lithuania;Bulgaria;Latvia;United Kingdom
1537ChiCTR-TRC-090003772007-07-0118 April 2017Multicentered Clinical Evaluation Studies on Treating Active Rheumatoid Arthritis by the Method of Clearing Heat and Promoting Blood FlowMulticentered Clinical Evaluation Studies on Treating Active Rheumatoid Arthritis by the Method of Clearing Heat and Promoting Blood Flowrheumatoid arthritisGroup of MTX:Methotrexate Tablets: 10mg 1/w ;Group of Both MTX and Herbs:The Formula of Clearing Away Damp-heat and Promoting Blood Flow: 200ml bid; Methotrexate Tablets: 10mg 1/w ;Group of Herbs:The Formula of Clearing Away Damp-heat and Promoting Blood Flow: 200ml bid ;China Academy of Chinese Medical Science Guang'an Men HospitalNot Recruiting1865BothGroup of MTX:76;Group of Both MTX and Herbs:77;Group of Herbs:77;Post-marketChina
1538NCT00405275July 200719 October 2017Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate TherapyCSP #551 - Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate TherapyRheumatoid ArthritisDrug: Etanercept;Drug: methotrexate;Drug: Sulfasalazine;Drug: Hydroxychloroquine;Drug: Placebo, triple;Drug: Placebo, etanerceptVA Office of Research and DevelopmentCanadian Institutes of Health Research (CIHR);Rheumatoid Arthritis Investigational Network (RAIN);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 YearsN/AAll353N/AUnited States;Canada
1539NCT00503139July 200716 December 2017Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in JapanEnbrel Special Use Result SurveillanceRheumatoid ArthritisDrug: Enbrel (etanercept)PfizerNot recruiting10 YearsN/AAll684Phase 4Japan
1540NCT00504777July 200719 October 2017A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.An Open Label Study to Evaluate the Safety, and Effect on Treatment Response, of MabThera in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One or More Anti-TNF Agents.Rheumatoid ArthritisDrug: rituximab [MabThera/Rituxan];Drug: MethotrexateHoffmann-La RocheNot recruiting18 YearsN/AAll36Phase 4Taiwan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1541NCT00555230July 200719 February 2015Effects of HMG-coA Reductase Inhibitor on Rheumatoid ArthritisEffects of HMG-coA Reductase Inhibitor on Progression of Carotid Intima-Media Thickness and Arterial Stiffness in Rheumatoid ArthritisRheumatoid ArthritisDrug: Rosuvastatin;Drug: PlaceboChinese University of Hong KongNot recruiting18 Years75 YearsBoth150Phase 2China
1542NCT00664716July 200719 February 2015Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) PatientsAssessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy.Rheumatoid ArthritisBiological: Placebo;Biological: baminercept alfa;Biological: Baminercept alfaBiogen IdecNot recruiting18 Years75 YearsBoth391Phase 2Argentina;Brazil;Hungary;Mexico;Poland;Romania;Russian Federation;United Kingdom
1543EUCTR2006-006746-33-DE28/06/200719 March 2012Re-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 IRRheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-		Roche Pharma AGNot RecruitingFemale: yes
Male: yes		240Germany
1544EUCTR2007-000760-24-CZ21/06/20077 November 2016Activity 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-RAPatients with active rheumatoid arthritis
MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: SSR150106XB
Product Code: SSR150106XB
Pharmaceutical Form: Oral solution
INN or Proposed INN: NA
CAS Number: 335267-09-9
Current Sponsor code: SSR150106XB
Other descriptive name: NA
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use		sanofi-aventis recherche & développementNot RecruitingFemale: yes
Male: yes		75Phase 2Czech Republic
1545EUCTR2006-005137-38-FR19/06/200719 March 2012A 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: Enbrel Auto Injector
Product Code: Auto Injector
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-		Wyeth Pharmaceuticals FranceAuthorisedFemale: yes
Male: yes		724Finland;Germany;United Kingdom;Denmark;France;Sweden
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1546EUCTR2006-005330-20-BE07/06/200725 September 2012anti TNF-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 who have an inadequate 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ocrelizumab
Current Sponsor code: RO 496-4913
Other descriptive name: RhuMAb 2H7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		F. Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes		800Phase 3Hungary;Germany;Netherlands;Slovenia;Belgium;France;Spain;Italy;Sweden
1547EUCTR2006-004140-23-CZ06/06/200710 July 2015A 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 RARheumatoid arthritis
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Atacicept
Product Code: Not Applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, GermanyNot RecruitingFemale: yes
Male: yes		240Phase 2Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Bulgaria;Germany;Netherlands;United Kingdom;Italy;Sweden
1548EUCTR2006-004666-14-BE04/06/200711 November 2013An 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 availableRheumatoid Arthritis
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: ACZ885
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Canakinumab (proposed)
Current Sponsor code: ACZ885
Other descriptive name: ACZ885 Drug Substance
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-		Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes		32Belgium;Germany
1549NCT00422227June 200719 October 2017Study 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 PfizerNot recruiting18 Years70 YearsAll300Phase 4Hong Kong;India;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand
1550NCT00447759June 200713 May 2019The 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 NottinghamNot recruiting60 YearsN/AAll7297Phase 4Denmark;Netherlands;United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1551NCT00462345June 200719 October 2017A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Treatment Response in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF TherapiesRheumatoid ArthritisDrug: rituximab;Drug: Methotrexate;Drug: Corticosteroid or NSAID;Dietary Supplement: FolateHoffmann-La RocheNot recruiting18 Years80 YearsAll40Phase 4Korea, Republic of
1552NCT00650156June 200716 December 2017Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid ArthritisA Randomized, Parallel-group, Open-Label, Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis.Rheumatoid ArthritisBiological: adalimumabAbbVieNot recruiting18 YearsN/AAll24Phase 1China
1553NCT00896168June 200719 October 2017An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid ArthritisA Multi-Center, Pre-Marketing Clinical Trial to Evaluate the Efficacy and Safety of Infliximab Treatment on Rheumatoid ArthritisArthritis, RheumatoidDrug: Infliximab;Drug: MethotrexateXian-Janssen Pharmaceutical Ltd.Not recruiting18 Years65 YearsAll234Phase 4
1554EUCTR2007-000082-38-DK24/05/20078 August 2016The 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 StudyIn 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
Pharmaceutical Form: Injection*
INN or Proposed INN: Adalimumab		Aarhus University Hospital, DenmarkNot RecruitingFemale: yes
Male: yes		180Phase 4Denmark
1555NCT00476996May 15, 200726 August 2019A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-a Therapy (SCRIPT)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 TherapyRheumatoid ArthritisDrug: Leflunomide;Drug: Methotrexate;Drug: Ocrelizumab;Drug: PlaceboGenentech, Inc.Roche Pharma AGNot recruiting18 YearsN/AAll836Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Japan;Mexico;Netherlands;New Zealand;Panama;Peru;Poland;Slovakia;Slovenia;Spain;Sweden;Switzerland;Taiwan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1556EUCTR2007-001190-28-GB09/05/20074 December 2018Randomised 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 - TACITRheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Methotrexate
Product Code: Methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59052
Current Sponsor code: Methotrexate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Product Name: Sulfasalazine
Product Code: Sulfasalazine
Pharmaceutical Form: Tablet
INN or Proposed INN: SULFASALAZINE
CAS Number: 599791
Current Sponsor code: SULFASALAZINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Product Name: Hydroxychloroquine
Product Code: Hydroxychloroquine
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydroxychloroquine
CAS Number: 118423
Current Sponsor code: Hydroxychloroquine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Product Name: Ciclosporin
Product Code: Ciclosporin
Pharmaceutical Form: Tablet
INN or Proposed INN: Ciclosporin
CAS Number: 59865133
Current Sponsor code: Ciclosporin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Product Name: Leflunomide
Product Code: Leflunomide
Pharmaceutical Form: Tablet
INN or Proposed INN: Leflunomide
CAS Number: 75706126
Current Sponsor code: Leflunomide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Product Name: Sodium aurothiomalate (intramuscular gold)
Product Code: Sodium aurothiomalate (intramuscular gold)
Pharmaceutical Form: Injection*
INN or Proposed INN: Sodium aurothiomalate
CAS Number: 12244574
Current Sponsor code: Sodium aurothiomalate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: methylprednisolone
Product Code: methylprednisolone
Pharmaceutical Form: Injection*
INN or Proposed INN: Methylprednisolone
CAS Number: 83432
Current Sponsor code: Methylprednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Product Name: Prednisolone		King's College LondonNot RecruitingFemale: yes
Male: yes		190Phase 4United Kingdom
1557EUCTR2006-005036-24-SE04/05/20077 August 2012A 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/ARheumatoid arthritis
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: CP-690,550
Pharmaceutical Form: Tablet
CAS Number: 540737-29-9
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: CP-690,550
Pharmaceutical Form: Tablet
CAS Number: 540737-29-9
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Pfizer Ltd - Ramsgate Road, Sandwich CT139NJ, UK.Not RecruitingFemale: yes
Male: yes		483Phase 2BHungary;Czech Republic;Bulgaria;Sweden
1558NCT00420199May 200719 October 2017A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to MethotrexateA Phase IIIB 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 MethotrexateActive Rheumatoid ArthritisDrug: Abatacept;Drug: PlaceboBristol-Myers SquibbNot recruiting18 YearsN/AAll50Phase 3Belgium;Germany;Netherlands;Spain;Sweden;United Kingdom;Austria
1559NCT00443430May 200719 October 2017Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic ArthritisTrial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA)Juvenile Chronic Polyarthritis;Juvenile Idiopathic Arthritis;Juvenile Rheumatoid ArthritisDrug: methotrexate;Drug: methotrexate - etanercept - prednisolone armSeattle Children's HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);AmgenNot recruiting2 Years17 YearsAll85Phase 4United States
1560NCT00455208May 200719 February 2015A 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 LLCNot recruiting20 Years50 YearsBoth20Phase 1/Phase 2United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1561NCT00504595May 200719 October 2017Safety 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: PlaceboNovartisNot recruiting18 Years75 YearsAll80Phase 2Russian Federation;Spain;Switzerland;Turkey
1562NCT00578565May 200719 October 2017Rituximab in Rheumatoid Arthritis Lung DiseaseRituximab for the Treatment of Rheumatoid Arthritis-Associated Interstitial Pneumonia: A Pilot StudyRheumatoid Arthritis;Interstitial PneumoniaDrug: RituximabEric MattesonGenentech, Inc.;National Center for Research Resources (NCRR)Not recruiting18 Years80 YearsAll10Phase 3United States
1563NCT00760669May 200719 October 2017An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis ParticipantsPost Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis PatientsSpondylitis, Ankylosing;Arthritis, Rheumatoid;Psoriasis;Arthritis, PsoriaticDrug: Infliximab; observational study;Drug: MethotrexateJanssen Korea, Ltd., KoreaNot recruitingN/AN/AAll1061Phase 4Korea, Republic of
1564EUCTR2007-000491-16-ES30/04/20072 February 2015Estudio 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 availableArtritis Reumatoide
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: ACZ885
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Canakinumab (proposed)
Current Sponsor code: ACZ885
Other descriptive name: ACZ885 Drug Substance
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-		Novartis Farmacéutica, S.A.Not RecruitingFemale: yes
Male: yes		Belgium;Spain;Austria;Germany
1565EUCTR2005-002660-29-HU20/04/200719 March 2012A 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 ArthritisRheumatoid ArthritisProduct Name: Anti IL-1ß antibody
Product Code: LY2189102
Pharmaceutical Form: Powder for solution for infusion
Current Sponsor code: LY2189102
Other descriptive name: Anti IL-1ß antibody, subclass IgG4
Concentration unit: mg milligram(s)
Concentration type: not less then
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use		Eli Lilly and Company LimitedNot RecruitingFemale: yes
Male: yes		135Phase 1b/2Hungary;Spain
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1566EUCTR2006-005466-39-GB12/04/200719 March 2012A 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 TherapyRheumatoid arthritis (RA)
MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: BG9924
Pharmaceutical Form: Powder for solution for injection
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Biogen Idec LtdAuthorisedFemale: yes
Male: yes		380Phase 2bHungary;United Kingdom
1567EUCTR2006-005467-26-GB12/04/200719 March 2012A 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 TherapyRheumatoid Arthritis
MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: BG9924
Pharmaceutical Form: Powder for solution for injection
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-		Biogen Idec LtdAuthorisedFemale: yes
Male: yes		120Phase 2bUnited Kingdom
1568EUCTR2006-004669-32-ES09/04/20072 February 2015Estudio 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 availableArtritis reumatoide establecida
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: ACZ885
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Canakinumab (proposed)
Current Sponsor code: ACZ885
Other descriptive name: ACZ885 Drug Substance
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Powder and solvent for solution for infusion
Route of administration of the placebo: Intravenous use		Novartis Farmacéutica S.ANot RecruitingFemale: yes
Male: yes		80Spain
1569EUCTR2006-004139-31-BE03/04/200715 July 2013A 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. - OPTIMARheumatoid Arthritis.
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: Humira
Pharmaceutical Form: Injection*
INN or Proposed INN: Adalimumab
Current Sponsor code: ABT-Humira
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use
Trade Name: Metex®
Pharmaceutical Form: Tablet
Current Sponsor code: Methotrexate disodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5-		Abbott GmbH & Co. KGNot RecruitingFemale: yes
Male: yes		1000France;Hungary;Czech Republic;Greece;Spain;Belgium;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
1570NCT00409838April 200719 October 2017A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to MethotrexateA Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept Administered Intravenously in Korean Subjects With Active Rheumatoid Arthritis While Receiving MethotrexateRheumatoid ArthritisDrug: Abatacept;Drug: Methotrexate;Drug: PlaceboBristol-Myers SquibbNot recruiting18 YearsN/AAll113Phase 3Korea, Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1571NCT00414661April 200719 October 2017Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of 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-690,550Arthritis, RheumatoidDrug: CP-690,550PfizerNot recruiting18 YearsN/AAll162N/AUnited States;Argentina;Brazil;Bulgaria;Canada;Chile;Czech Republic;Dominican Republic;Finland;Greece;Hungary;India;Italy;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Slovakia;Spain;Ukraine;Australia;Austria;Belgium;Costa Rica;Romania;Sweden
1572NCT00446784April 200719 February 2015Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid ArthritisA Phase 1, Double Blind Study Of The Safety And Pharmacokinetics Of Multiple Doses Of CE 224,535 In Subjects With Rheumatoid Arthritis Receiving MethotrexateArthritis, RheumatoidDrug: CE-224,535;Drug: MethotrexatePfizerNot recruiting18 YearsN/ABoth20Phase 1United States
1573NCT00484237April 200719 February 2015A 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 PfizerNot recruiting20 Years75 YearsBoth80Phase 3Japan
1574NCT00989235April 200719 October 2017Substudy - Low Dose of Abatacept in Subjects With Rheumatoid ArthritisA Phase 3B, Multi-Center, Randomized, Double-blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate-naïve Early Erosive Rheumatoid Arthritis Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate - Low Dose Sub-StudyRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbNot recruiting18 YearsN/AAll108Phase 3
1575EUCTR2006-006373-25-ES23/03/200725 September 2012ESTUDIO OBSERVACIONAL PROSPECTIVO PARA EVALUAR LA SEGURIDAD A LARGO PLAZO Y EL ESTADO FUNCIONAL DE SUJETOS CON ARTRITIS REUMATOIDE INCLUIDOS PREVIAMENTE EN ESTUDIOS DE CP-690,550 A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/ACP-690,550 se está desarrollando como fármaco antirreumático modificador de la enfermedad (FARME) para el tratamiento de la artritis reumatoide (AR). CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: CP-690,550
Pharmaceutical Form: Tablet		Pfizer, S.A.Not RecruitingFemale: yes
Male: yes		300Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1576EUCTR2006-001553-10-BE20/03/200711 November 2013A 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 - 2204Early Rheumatoid Arthritis in adults
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: ACZ885
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: ACZ885 Drug Substance
Current Sponsor code: ACZ885
Other descriptive name: ACZ885 Drug Substance
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Powder and solvent for solution for infusion
Route of administration of the placebo: Intravenous use		Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes		92Phase 2Belgium;Netherlands;Germany;Italy
1577NCT04144101March 1, 20074 November 2019Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid ArthritisComparison of Lower Dosage of Etoricoxib Versus Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis: A Single-center, Parallel-group, Randomized Controlled Pilot StudyRheumatoid ArthritisDrug: Etoricoxib;Drug: AceclofenacChung Shan Medical UniversityNot recruiting20 Years80 YearsAll40Phase 4
1578NCT00462072March 200719 October 2017Centocor Microarray Study of PatientsMicroarray Analysis of Peripheral Blood and Tissues of Patients With Immune Mediated Inflammatory DiseasesRheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Crohn's DiseaseDrug: InfliximabUniversity of RochesterCentocor, Inc.Not recruiting12 YearsN/AAll31Phase 4United States
1579NCT00487825March 200719 October 2017Safety 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)NovartisNot recruiting18 Years75 YearsAll78Phase 2United States;Belgium;Germany;Italy;Netherlands;Spain
1580NCT00913432March 200718 December 2018Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid ArthritisA 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF AlphaRheumatoid ArthritisDrug: masitinibAB ScienceNot recruiting18 YearsN/AAll20Phase 2
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1581EUCTR2006-006380-22-DE22/02/200719 March 2012Biological 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 dosimetryPatients 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: erbium citrate
Concentration unit: MBq/ml megabecquerel(s)/millilitre
Concentration type: equal
Concentration number: 111-		CIS bio internationalAuthorisedFemale: yes
Male: yes		Germany
1582NCT00413699February 5, 200716 December 2017Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid ArthritisA Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid ArthritisArthritis, RheumatoidDrug: CP-690,550PfizerNot recruiting18 YearsN/AAll4553Phase 3United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Costa Rica;Croatia;Czechia;Denmark;Dominican Republic;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Korea, Republic of;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Czech Republic;United States Minor Outlying Islands
1583NCT00418717February 200719 October 2017Open 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 PfizerNot recruiting20 Years75 YearsAll42Phase 3Japan
1584NCT00425932February 200719 February 2015Impact 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.Not recruiting18 Years80 YearsBoth60Phase 2United States
1585NCT00427934February 200719 October 2017Maraviroc in Rheumatoid ArthritisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Maraviroc in the Treatment of Rheumatoid Arthritis in Subjects Receiving MethotrexateArthritis, RheumatoidDrug: Maraviroc;Drug: Maraviroc PlaceboPfizerNot recruiting18 YearsN/AAll128Phase 2United States;Australia;Germany;India;Italy;Mexico;Portugal;Spain;Ukraine
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1586NCT00458146February 200719 February 2015A Phase 2 Study to Evaluate the Efficacy and Safety of 60mg of MM-093 in Patients With Active Rheumatoid ArthritisA Phase 2, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 60mg of MM-093 Versus Placebo in Patients With Active Rheumatoid Arthritis on Stable Doses of MethotrexateRheumatoid ArthritisDrug: MM-093Merrimack PharmaceuticalsNot recruiting18 Years80 YearsBoth100Phase 2United States
1587NCT00461448February 200719 February 2015A Pilot Study of Potassium Supplementation for Adult Patients With Rheumatoid ArthritisPilot Study of Potassium Supplementation in the Treatment of Rheumatoid Arthritis: a 4-Week, Randomized, Double-Blind, Placebo-Controlled TrialRheumatoid ArthritisDietary Supplement: Potassium supplementShahid Beheshti Medical UniversityNot recruiting18 Years60 YearsBoth36Phase 1Iran, Islamic Republic of
1588EUCTR2006-003983-73-CZ17/01/20071 May 2012A 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 TherapyRheumatoid 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
Pharmaceutical Form: Capsule*
CAS Number: 400797-45-7
Current Sponsor code: RWJ-445380-002
Other descriptive name: JNJ-16240159-AAC
Concentration unit: % (W/W) percent weight/weight
Concentration type: range
Concentration number: 45 mg-55 mg
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: RWJ-445380 capsule 100 mg
Product Code: RWJ-445380-002
Pharmaceutical Form: Capsule*
CAS Number: 400797-45-7
Current Sponsor code: RWJ-445380-002
Other descriptive name: JNJ-16240159-AAC
Concentration unit: % (W/W) percent weight/weight
Concentration type: range
Concentration number: 90 mg-110 mg
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: RWJ-445380 capsules 150 mg
Product Code: RWJ-445380-002
Pharmaceutical Form: Capsule*
CAS Number: 400797-45-7
Current Sponsor code: RWJ-445380-002
Other descriptive name: JNJ-16240159-AAC
Concentration unit: % (W/W) percent weight/weight
Concentration type: range
Concentration number: 135 mg-165 mg
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		Janssen-Cilag International N.V.Not RecruitingFemale: yes
Male: yes		240Phase 2aGermany;Czech Republic
1589EUCTR2006-006275-21-GB10/01/200719 March 2012A 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 RARheumatoid 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
Pharmaceutical Form: Injection
Trade Name: Enbrel
Pharmaceutical Form: Injection		University Hospital Birmingham NHS Foundation TrustAuthorisedFemale: yes
Male: yes		United Kingdom
1590NCT00413660January 200719 October 2017Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid ArthritisA 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 AloneArthritis, RheumatoidDrug: CP-690,550;Other: placeboPfizerNot recruiting18 YearsN/AAll509Phase 2United States;Argentina;Brazil;Bulgaria;Chile;Czech Republic;Hungary;Mexico;Poland;Slovakia;Spain;Sweden;Turkey
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1591NCT00424502January 200719 October 2017A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.An Open-label Study to Evaluate the Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.Rheumatoid ArthritisDrug: rituximab [MabThera/Rituxan];Drug: MethotrexateHoffmann-La RocheNot recruiting18 YearsN/AAll20Phase 4Hungary
1592NCT00427804January 200719 October 2017Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium AbsorptionTumor Necrosis Factor-a Induces Vitamin D Resistance in Small Intestinal Calcium AbsorptionRheumatoid Arthritis;Crohn's DiseaseDrug: calcitriolAtlanta VA Medical CenterEmory UniversityNot recruiting18 Years50 YearsMale9N/AUnited States
1593NCT00443651January 200716 December 2017A Study of the Safety of Rituximab in Combination With Other Anti-Rheumatic Drugs in Subjects With Active Rheumatoid ArthritisAn Open-Label, Prospective Study of the Safety of Rituximab in Combination With Other Disease-Modifying Anti-Rheumatic Drugs in Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Rituximab;Drug: Anti-inflammatory drugsGenentech, Inc.BiogenNot recruiting18 Years80 YearsAll578Phase 3United States
1594NCT00716248January 200719 February 2015Bucillamine 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 UniversityNot recruiting20 YearsN/ABoth40Phase 4Japan
1595NCT02886689January 200712 September 2016C.O.R.P.U.S.: Observational Cohort of Adult and Child Inflammatory Arthritis in FranceC.O.R.P.U.S. : Observational Cohort of Active Rheumatoid Arthritis, Spondylarthropathy and Idiopathic Juvenile Arthritis in FranceArthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Arthitis, Juvenile IdiopathicDrug: TNF-alpha antagonist and other biotherapyCentral Hospital, Nancy, FranceNot recruiting3 Years75 YearsBoth5400N/AFrance
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1596EUCTR2007-003591-19-DE1 May 2012AN 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/mlRheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: Methotrexate 50mg/ml solution for injection, pre-filled syringe
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Methotrexate disodium
CAS Number: 7413345
Other descriptive name: Methotrexate disodium
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Metex 10 mg/ml Injektionslösung, Fertigspritze
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methotrexate disodium
CAS Number: 7413345
Other descriptive name: Methotrexate disodium
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-		medac Gesellschaft für klinische Spezialpräparate mbHNot RecruitingFemale: yes
Male: yes		Germany
1597EUCTR2006-005386-19-BE19/12/20067 October 2014Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / miniCytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / miniRheumatoid arthritis refractory to TNF blockers patients
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Trade Name: MabThera
Pharmaceutical Form: Solution for infusion		Cliniques Universitaires Saint-LucAuthorisedFemale: yes
Male: yes		Belgium
1598EUCTR2005-005664-88-GB08/12/200619 March 2012Prospective Study of Mycobacterium Tuberculosis Specific Cellular immune Responses in Iatrogenically Immunosuppressed Patients: those undergoing TNF-alpha blockade or Awaiting Renal Trasnplants: A Potential New Method For Accurate Diagnosis of Latent Tuberculosis Infection in Clinical Practice - Diagnosis of Latent TB Infection in Anti-TNF alpha or DialysisProspective Study of Mycobacterium Tuberculosis Specific Cellular immune Responses in Iatrogenically Immunosuppressed Patients: those undergoing TNF-alpha blockade or Awaiting Renal Trasnplants: A Potential New Method For Accurate Diagnosis of Latent Tuberculosis Infection in Clinical Practice - Diagnosis of Latent TB Infection in Anti-TNF alpha or DialysisRenal failure and iatrogenic immunosuppression associated with solid organ transplantation or TNF alpha blockade in rheumatoid arthritis ICD 10 codes included: N18 Z94.0 M05 M06 M07 M45Trade Name: Tuberculin PPD RT 23 SSI for mantoux testing
Product Name: Tuberculin PPD RT 23 SSI for mantoux testing
Product Code: 1
Pharmaceutical Form: Injection*		University of OxfordAuthorisedFemale: yes
Male: yes		520United Kingdom
1599EUCTR2006-003577-27-EE01/12/200619 March 2012A 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 RHEUMATOID ARTHRITIS. - 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 RHEUMATOID ARTHRITIS. - naTreatment of rheumatoid arthritis (RA)
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: PH-797804
Pharmaceutical Form: Capsule*
CAS Number: 586414-48-4
Current Sponsor 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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Code: PH-797804
Pharmaceutical Form: Capsule*
CAS Number: 586414-48-4
Current Sponsor 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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Code: PH-797804
Pharmaceutical Form: Capsule*
CAS Number: 586414-48-4
Current Sponsor 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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		Pfizer Luxembourg SARL Branch Office EstoniaNot RecruitingFemale: yes
Male: yes		290Phase 2ACzech Republic;Estonia;Spain
1600NCT00383188December 200619 February 2015An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid ArthritisA 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 ArthritisArthritis, RheumatoidDrug: placebo;Drug: PH-797804PfizerNot recruiting18 YearsN/ABoth305Phase 2Australia;Brazil;Chile;Czech Republic;Estonia;India;Korea, Republic of;Peru;Poland;Russian Federation;South Africa;Spain
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1601NCT00392951December 200619 November 2018Sirolimus for Autoimmune Disease of Blood CellsSirolimus for Patients With Chronic and/or Refractory Autoimmune Cytopenias: A Pilot SeriesAutoimmune Pancytopenia;Autoimmune Lymphoproliferative Syndrome (ALPS);Evans Syndrome;Idiopathic Thrombocytopenic Purpura;Anemia, Hemolytic, Autoimmune;Autoimmune Neutropenia;Lupus Erythematosus, Systemic;Inflammatory Bowel Disease;Rheumatoid ArthritisDrug: sirolimusChildren's Hospital of PhiladelphiaNot recruiting1 Year30 YearsAll30Phase 1/Phase 2United States
1602NCT00406419December 200616 December 2017A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)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 TreatmentRheumatoid ArthritisDrug: methotrexate;Drug: ocrelizumab;Drug: placeboGenentech, Inc.Roche Pharma AGNot recruiting18 YearsN/AAll1015Phase 3United States
1603NCT00413452December 200619 February 2015Etanercept 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 PfizerNot recruiting18 YearsN/ABoth224Phase 3United States;Canada
1604NCT00425321December 200619 February 2015Safety and Effectiveness 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 TherapyRheumatoid ArthritisDrug: RWJ-445380 100 mg;Drug: RWJ-445380 200 mg;Drug: RWJ-445380 300 mg;Drug: PlaceboJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Not recruiting18 YearsN/ABoth259Phase 2United States;Argentina;Brazil;Czech Republic;Germany;Mexico;Poland
1605NCT00430495December 200619 October 2017A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)A Randomized, 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 TherapyRheumatoid ArthritisDrug: Atacicept;Drug: Placebo matched to ataciceptEMD SeronoMerck KGaANot recruiting18 YearsN/AAll256Phase 2United States;Canada
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1606NCT00440492December 200619 February 2015Study 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 PfizerNot recruiting18 Years75 YearsBothPhase 1United States;Canada
1607NCT00484289December 200619 October 2017A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid ArthritisA Phase III, Multi-center, Open-label, Uncontrolled, Long-term Study to Evaluate the Safety of Abatacept (BMS-188667) in Japanese Subjects With Rheumatoid Arthritis Having Completed Clinical Studies IM101-071, IM101-034, and Also Special DMARD FailuresRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbNot recruiting20 YearsN/AAll217Phase 3Japan
1608EUCTR2006-003142-42-DE30/11/200619 March 2012A 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 ArthritisActive Rheumatoid Arthritis
MedDRA version: 8.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis		Product Code: SC12267
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		4SC AGNot RecruitingFemale: yes
Male: yes		120Germany
1609EUCTR2006-002216-10-CZ27/11/200619 March 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 - RACERRheumatoid Arthritis
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: PG-760564
Product Code: PG-760564
Pharmaceutical Form: Capsule*
Current Sponsor code: PG-760564
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		Procter & Gamble PharmaceuticalsNot RecruitingFemale: yes
Male: yes		270Hungary;United Kingdom;Czech Republic;Netherlands
1610EUCTR2005-003632-22-ES22/11/200629 May 2012A study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with rheumatoid arthritis.An open-label, exploratory study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with active rheumatoid arthritisRheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: MabThera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-		F. Hoffmann-La Roche Ltd.AuthorisedFemale: yes
Male: yes		3Spain
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1611NCT00072982November 200619 February 2015Treatment 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)Not recruiting18 Years85 YearsBoth156Phase 3United States
1612NCT00395577November 200619 February 2015A 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 IncorporatedNot recruiting18 Years75 YearsBoth120Phase 2Bulgaria;Croatia;Former Serbia and Montenegro;Poland;Russian Federation;Slovenia
1613NCT00396812November 200619 October 2017Rituximab 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 ExcellenceNot recruiting18 YearsN/AAll4Phase 1/Phase 2United States
1614NCT00424346November 200619 October 2017Efficacy, 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: PlaceboNovartisNot recruiting18 YearsN/AAll274Phase 2United States;Austria;Belgium;Canada;Germany;Spain;Finland
1615NCT00589485November 200616 December 2017Total 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 ClinicNot recruiting18 YearsN/AAll0N/AUnited States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1616NCT00761514November 200619 October 2017Evaluation 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)AbbottNot recruiting18 YearsN/AAll14Phase 4Puerto Rico
1617NCT02079532November 200619 October 2017A 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 RocheNot recruiting18 Years75 YearsAll302Phase 3Germany
1618EUCTR2006-004715-22-SI26/10/200619 March 2012A 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 MethotrexateRheumatoid ArthritisProduct Code: VX-702
Pharmaceutical Form: Tablet
Current Sponsor code: VX-702
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes		120Phase 2Slovenia
1619EUCTR2006-003843-22-IT24/10/20067 January 2013prospeCtive study on intensive early rheumatoid arthritis treatment with adalimUmab: induction of REmission and maintenance - 'CURE' A Phase IV multicenter, randomized, double-blind studyprospeCtive study on intensive early rheumatoid arthritis treatment with adalimUmab: induction of REmission and maintenance - 'CURE' A Phase IV multicenter, randomized, double-blind studyrheumatoid arthritis
MedDRA version: 14.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adalimumab
Concentration unit: mg milligram(s)
Concentration number: 40-
Trade Name: METHOTREXATE*100CPR 2,5MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate
CAS Number: 59-05-2
Concentration unit: mg milligram(s)
Concentration number: 2.5-
Trade Name: DELTACORTENE FORTE*10CPR 25MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration number: 25-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		OSPEDALE POLICLINICO S. MATTEOAuthorisedFemale: yes
Male: yes		Phase 4Italy
1620EUCTR2006-004673-98-HU16/10/200619 March 2012Efficacy 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 blockerTo investigate the efficacy of treatment with Rituximab (MabThera®) in patients with active RA whose current treatment with one or more TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalimumab - Humira®) alone or in combination with MTX is insufficient measured by DAS28 activity index.Trade Name: MabThera 500 mg concentrate for solution for infusion
Pharmaceutical Form: Concentrate for solution for infusion		Roche (Hungary) Ltd.Not RecruitingFemale: yes
Male: yes		20Hungary
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1621NCT00346216October 4, 200616 December 2017Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or NaproxenA Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And IbuprofenArthritis, RheumatoidDrug: celecoxib;Drug: Ibuprofen;Drug: NaproxenPfizerThe Cleveland ClinicNot recruiting18 YearsN/AAll24081Phase 4United States;Australia;Brazil;Canada;Colombia;Costa Rica;Hong Kong;Mexico;Panama;Peru;Philippines;Taiwan;Ukraine
1622EUCTR2006-000363-28-GB03/10/200619 March 2012DIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA StudyDIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA StudyRheumatoid arthritis and Psoriatic arthritisTrade Name: Remicade
Product Name: Infliximab
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Infliximab
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 3-
Trade Name: Enbrel
Product Name: Etanercept
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Etanercept
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-		Greater Glasgow Health BoardGlasgow UniversityAuthorisedFemale: yes
Male: yes		40United Kingdom
1623JPRN-UMIN0000005122006/10/012 April 2019Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexateRheumatoid 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 SchoolNot RecruitingNot applicableNot applicableMale and Female30Not applicableJapan
1624NCT00393146October 200625 May 2015A Study To Investigate The Effect Of 28 Days Of Dosing With GW856553 On Patients With Rheumatoid ArthritisA Randomized, Double Blind, Placebo Controlled Study to Investigate the Safety and Tolerability and Clinical Activity of 28 Days of Oral Repeat Dosing With GW856553 at 7.5mg BID in Subjects With Active Rheumatoid Arthritis on Stable Anti-rheumatic Therapy.Arthritis, RheumatoidDrug: GW856553GlaxoSmithKlineNot recruiting18 YearsN/ABoth57Phase 2Romania;Russian Federation;Spain
1625NCT00399282October 200619 February 2015Omega-3 and Vitamin E Supplementation in Patients With Rheumatoid ArthritisComparison of the Effects of Simultaneous Administration of Vitamin E and Omega-3 Fatty Acids in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Omega-3 and Vitamin E supplementationShahid Beheshti Medical UniversityNot recruiting16 Years75 YearsBoth75Phase 1Iran, Islamic Republic of
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1626NCT00749645October 20064 July 2016Efficacy Study of FANG(30) for Active Rheumatoid Arthritis in Adult PatientsClinical Phase II Pilot Study of the Efficacy of FANG(30) to Treat Active Rheumatoid Arthritis in Adult PatientsArthritis, RheumatoidDrug: FANG(30);Drug: PlaceboJuan C. Bertoglio, MDFondo Nacional de Desarrollo Científico y Tecnológico, ChileNot recruiting18 Years70 YearsBoth60Phase 2Chile
1627EUCTR2006-005391-40-IT25/09/200627 January 2014Study 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 - NDPatients with Rheumatoid Arthritis
Level: PT Classification code 10039073		Product Name: Platelet Rich Plasma
Pharmaceutical Form: Solution for injection
Current Sponsor code: PRPIN AR2006
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Triamcinolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-		AZIENDA OSPEDALIERA SENESENot RecruitingFemale: yes
Male: yes		Italy
1628EUCTR2006-001000-37-DE19/09/200619 March 2012Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRSTEfficacy and safety of rituximab in patients with rheumatoid arthritis - FIRSTRheumatoid 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-		Roche Pharma AGNot RecruitingFemale: yes
Male: yes		300Germany
1629EUCTR2006-001428-38-GB18/09/200619 March 2012Remission 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 - RIVERAPatients 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
Pharmaceutical Form: Solution for injection
Trade Name: Methorexate
Pharmaceutical Form: Tablet
Trade Name: Depo-Medrone
Pharmaceutical Form: Solution for injection
Trade Name: Salazopyrin En-Tabs
Pharmaceutical Form: Tablet
Trade Name: Plaquenil
Pharmaceutical Form: Tablet		University Hospitals Birmingham NHS Foundation TrustAuthorisedFemale: yes
Male: yes		20United Kingdom
1630NCT00361335September 200619 October 2017A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate TherapyRheumatoid ArthritisDrug: Golimumab;Drug: Methotrexate;Drug: PlaceboCentocor, Inc.Schering-PloughNot recruiting18 YearsN/AAll643Phase 3United States;Argentina;Australia;Colombia;Germany;Hungary;Latvia;Lithuania;Malaysia;Malta;Mexico;New Zealand;Peru;Poland;Ukraine;Belgium;Russian Federation
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1631NCT00361634September 200619 October 2017Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) to Measure Response to Etanercept in Rheumatoid ArthritisDCE-MRI of the Wrist to Measure Short-Term Responses in Rheumatoid Arthritis Subjects Treated With EtanerceptRheumatoid ArthritisDrug: EtanerceptAmgenNot recruiting18 YearsN/AAll14Phase 1United States;United Kingdom
1632NCT00367211September 200619 February 2015Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.Osteoarthritis;Rheumatoid Arthritis;Ankylosing SpondylitisDrug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole);Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole)POZENNot recruiting18 YearsN/ABoth400Phase 3United States
1633NCT00369473September 20069 January 2017Long-Term Assessment of Safety and Physical Function With AMG 108 in RAA Long-Term Assessment of Safety and Physical Function With AMG 108 Subcutaneous Monthly Treatment in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: AMG 108AmgenNot recruiting18 YearsN/ABoth690Phase 2Australia;Belgium;Canada;Czech Republic;Estonia;France;Hungary;Ireland;Italy;Latvia;Mexico;Netherlands;Poland;Puerto Rico;Slovakia;Spain;United Kingdom;United States
1634NCT00488475September 200619 October 2017Observational Trial With EnbrelA 1 Year Observational Study of the Use of Etanercept in Routine German Clinical Practice to Treat Rheumatoid Arthritis Patients: a Health Economic, Safety and Effectiveness EvaluationRheumatoid ArthritisDrug: etanerceptPfizerNot recruiting18 YearsN/AAll4945N/AGermany
1635NCT00588393September 200619 February 2015FolateScan in Autoimmune DiseaseStudy of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory DiseasesRheumatoid Arthritis;Osteoarthritis;Multiple Sclerosis;Crohn's Disease;Systemic Lupus ErythematosusDrug: FolateScan (Technetium Tc 99mEC20)Mayo ClinicEndocyteNot recruiting18 YearsN/ABoth75Phase 2United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1636NCT01126541September 200619 October 2017SMART Study: A Study of Re-treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on Anti-TNF Alfa TherapyA Comparative Study to Assess the Effect of Retreatment With 2 Doses of MabThera on Disease Activity Score in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to antiTNF-alfa Therapy.(SMART)Rheumatoid ArthritisDrug: rituximabHoffmann-La RocheNot recruiting18 YearsN/AAll224Phase 3France
1637NCT01308255September 200611 November 2019Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA)A Multi-centre Randomised Double Blind Placebo Controlled Study Comparing Two Regimens of Combination Therapy in Early DMARD Naive Rheumatoid Arthritis.Rheumatoid ArthritisDrug: Infliximab;Drug: Methylprednisolone;Drug: Methotrexate;Dietary Supplement: Folic acidUniversity of LeedsNot recruiting18 Years80 YearsAll112Phase 4United Kingdom
1638EUCTR2006-002645-37-HU25/08/200619 March 2012A Phase II randomized double-blind placebo-controlled Study of KC706 in patients with rheumatoid arthritis inadequately controlled with a stable dose of methotrexateA Phase II randomized double-blind placebo-controlled Study of KC706 in patients with rheumatoid arthritis inadequately controlled with a stable dose of methotrexateActive rheumatoid arthritis (RA), patients taking stable doses of methotrexate
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: KC706
Product Code: KR002524
Pharmaceutical Form: Capsule*
CAS Number: 848144-15-0
Current Sponsor code: KC706
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		Kémia, Inc.AuthorisedFemale: yes
Male: yes		150Phase 2Hungary
1639NCT02006706August 10, 200616 December 2017A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD TherapyAn Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment FailureRheumatoid ArthritisDrug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisoloneHoffmann-La RocheNot recruiting18 Years80 YearsAll15Phase 3Serbia
1640EUCTR2005-006165-14-GB03/08/200619 March 2012A 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 - NARheumatoid Arthritis
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: MLN3897
Product Code: N/A
Pharmaceutical Form: Capsule*
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: MLN3897
Other descriptive name: AVE9897
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10 -
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
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
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate
CAS Number: N/A
Current Sponsor code: N/A
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 7.5-25		Millennium Pharmaceuticals Inc,AuthorisedFemale: yes
Male: yes		186Phase 2aCzech Republic;United Kingdom;Netherlands
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1641JPRN-C0000004522006/08/012 April 2019Remission Induction of Very Early Rheumatoid Arthritis with Methotrexate and Etanerceptrheumatoid 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 SummitNot RecruitingNot applicableNot applicableMale and Female50Phase 4Japan
1642NCT00302952August 200616 December 2017Lovastatin 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 ExcellenceNot recruiting18 Years70 YearsAll64Phase 2United States
1643NCT00326339August 200619 February 2015Treatment of Arthritis With Syk Kinase Inhibition (TASKI-1)A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Dose Ranging Study to Evaluate Up to Three Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to MethotrexateRheumatoid ArthritisDrug: R788;Drug: PlaceboRigel PharmaceuticalsNot recruiting18 Years75 YearsBoth189Phase 2United States;Mexico
1644NCT00369928August 200619 October 2017Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving MethotrexateA Multicenter, 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 RA Receiving MethotrexateRheumatoid ArthritisDrug: PG-760564;Drug: Placebo doseProcter and GambleNot recruiting18 Years70 YearsAll254Phase 2United States;Czech Republic;Hungary;Netherlands;Poland;United Kingdom
1645NCT00732875August 200616 December 2017A Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methorexate (Extension Part)(Study P05645)(COMPLETED)A Placebo-controlled, Double-blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment (Open-label Extension Part)Arthritis, RheumatoidBiological: Infliximab + methotrexate (MTX)Merck Sharp & Dohme Corp.Not recruiting18 Years75 YearsAll92Phase 3
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1646EUCTR2006-004062-13-IT18/07/200619 March 2012Randomised, 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: OXICODONE DC.IT
CAS Number: 76-42-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: PARACETAMOLO DC.IT FU
CAS Number: 103-90-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-		A.U.S.L. RIMININot RecruitingFemale: yes
Male: yes		149Phase 2Italy
1647NCT01272908July 18, 200616 December 2017A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)Rituximab Phase IIIb Open-label, Multi-centre Assessment of Safety and Effectiveness in Patients With RA Following an Inadequate Response to One Prior Anti-TNF Inhibitor (RESET)Rheumatoid ArthritisDrug: rituximabHoffmann-La RocheNot recruiting18 Years80 YearsAll120Phase 3Canada;Sweden
1648NCT00369187July 200619 February 2015Study of a Large Protein Molecule Administered With Escalating Doses of Recombinant Human HyaluronidaseRheumatoid ArthritisDrug: large protein moleculeHalozyme TherapeuticsNot recruiting18 YearsN/ABoth15Phase 4United States
1649NCT00445770July 200619 October 2017Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid ArthritisA Randomized, Double-Blind, Multicenter, Comparative Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Active Rheumatoid ArthritisArthritis, RheumatoidDrug: Etanercept;Drug: MethotrexatePfizerNot recruiting20 Years75 YearsAll550Phase 3Japan
1650NCT00555542July 200619 February 2015An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid ArthritisB Cell Depletion Therapy in Rheumatoid Arthritis: An Analysis of Peripheral Blood T Cell SubsetsRheumatoid ArthritisDrug: rituximabChinese University of Hong KongNot recruiting21 Years70 YearsBoth10Phase 2China
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1651NCT01685424June 30, 200616 December 2017Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated AnalysisOsteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis;Gout;ArthritisDrug: EtoricoxibMerck Sharp & Dohme Corp.Not recruitingN/AN/AAll79189N/AUnited States
1652EUCTR2004-001234-17-GB15/06/20061 May 2012Double-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 ApplicableTreatment 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
Pharmaceutical Form: Capsule*
INN or Proposed INN: Celecoxib
CAS Number: N/A
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Trade Name: Voltrarol SR
Product Name: Voltrarol SR
Product Code: Not Applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: Diclofenac sodium
CAS Number: N/A
Current Sponsor code: Not applicable
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Trade Name: Losec
Product Name: Losec
Product Code: not applicable
Pharmaceutical Form: Capsule*
INN or Proposed INN: Omeprazole
CAS Number: N/A
Current Sponsor code: Not applicable
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		Pfizer LimitedNot RecruitingFemale: yes
Male: yes		4402Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
1653EUCTR2006-001359-36-NL02/06/200619 March 2012Effects of low-dose aspirin taken at bedtime on pathophysiologic mechanisms underlying hypertension in subjects with grade 1 essential hypertension: the Aspirin In Reduction of Tension (ASPIRETENSION) study - ASPIRETENSIONEffects of low-dose aspirin taken at bedtime on pathophysiologic mechanisms underlying hypertension in subjects with grade 1 essential hypertension: the Aspirin In Reduction of Tension (ASPIRETENSION) study - ASPIRETENSIONPatients should have grade 1 essential hypertension (140/90-159/99 mmHg), but free of history of any cardiovascular events, diabetes mellitus type 1 or 2 or rheumatoid arthritis.Trade Name: Ascal(r) / carbasalate calcium
Pharmaceutical Form: Oral powder
Pharmaceutical form of the placebo: Oral powder
Route of administration of the placebo: Oral use		Leiden University Medical CenterAuthorisedFemale: yes
Male: yes		15Netherlands
1654NCT00280917June 200619 October 2017Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis PatientsRandomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: CF101Can-Fite BioPharmaNot recruiting18 Years75 YearsAll254Phase 2United States;Bulgaria;Israel;Poland;Romania;Serbia;Ukraine;Former Serbia and Montenegro
1655NCT00345748June 200619 February 2015A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving MethotrexateA Phase II, Multi-center, Randomized, Double-Blind, Placebo Controlled, Dose Response Study to Evaluate the Safety and Efficacy of Two Different Doses of Abatacept (BMS-188667) Administered Intravenously to Japanese Subjects With Active Rheumatoid Arthritis While Receiving MethotrexateRheumatoid ArthritisDrug: Abatacept;Drug: PlaceboBristol-Myers SquibbNot recruiting20 YearsN/ABoth194Phase 2Japan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1656NCT00424294June 200619 October 2017A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid ArthritisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of CP-195543 And Celecoxib Dual Therapy In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis In Subjects Who Are Inadequately Controlled On MethotrexateArthritis, RheumatoidDrug: CP-195,543;Drug: celecoxib;Drug: MethotrexatePfizerNot recruiting18 YearsN/AAll70Phase 2United States
1657NCT00439062June 200619 February 2015Treatment of Rheumatoid Arthritis With RoxithromycinTreatment of Rheumatoid Arthritis With RoxithromycinRheumatoid ArthritisDrug: RoxithromycinNazilli State HospitalNot recruiting18 Years70 YearsBoth100Phase 4Turkey
1658NCT00443950June 200619 February 2015Study 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 PfizerNot recruiting18 YearsN/ABoth150Phase 3China
1659EUCTR2006-000854-32-AT29/05/200619 March 2012Rituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-BlockersRituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-BlockersRheumatoid ArthritisTrade Name: Rituximab - MabThera
Product Name: Rituximab MabThera
Product Code: no
Pharmaceutical Form: Solution for infusion		Vienna Medical UniversityNot RecruitingFemale: yes
Male: yes		20Austria
1660EUCTR2005-001742-16-GB26/05/200621 August 2012A 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-AFTERActive rheumatoid arthritis (RA)Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50 and-100
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50 and-100
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Centocor B.V.Not RecruitingFemale: yes
Male: yes		420Germany;United Kingdom;Netherlands;Spain;Austria
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1661EUCTR2004-003295-10-GB17/05/20063 September 2012A 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 - NAActive Rheumatoid Arthritis (methotrexate [MTX]-naïve)Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50 and-100
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: Methotrexate sodium tablets 2.5 mg
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50 and-100
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Centocor BVNot RecruitingFemale: yes
Male: yes		600Hungary;United Kingdom;Spain;Italy
1662NCT00298272May 200619 October 2017Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid ArthritisA Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Tolerability and Safety of Rituximab When Given in Combination With Methotrexate and Etanercept (Enbrel) or Methotrexate and Adalimumab (Humira) in Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: IDEC-C2B8 (rituximab);Drug: Placebo;Drug: Methotrexate;Drug: Etanercept;Drug: Adalimumab;Drug: Methylprednisolone;Dietary Supplement: FolateBiogenHoffmann-La Roche;Genentech, Inc.Not recruiting18 Years65 YearsAll54Phase 2United States
1663NCT00380601May 200619 February 2015Phase?Open-label Study of MRA for Rheumatoid Arthritis(RA)An Open-label, Phase? Study to Evaluate the Efficacy and Safety of MRA in Patients With RARheumatoid ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNot recruiting20 YearsN/ABoth20Phase 3Japan
1664NCT00497614May 200619 February 2015Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)18F-FDG Positron Emission Tomography to Study the Response to Adalimumab in Rheumatoid Arthritis. A Monocentric Pilot StudyRheumatoid ArthritisDrug: adalimumabUniversity Hospital, ToursNot recruiting18 Years75 YearsBoth8N/AFrance
1665NCT01078571May 200619 October 2017Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid ArthritisSafety and Effectiveness of Adalimumab (HUMIRA®) in Patients Diagnosed With Rheumatoid Arthritis (DALI Study)Rheumatoid ArthritisBiological: adalimumab (HUMIRA®)AbbottNot recruiting18 YearsN/AAll705N/ASpain
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1666EUCTR2004-001930-18-EE17/04/200621 August 2012A 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-RARHEUMATOID ARTHRITISTrade Name: Persantin 100 mg and
Product Code: CRx-102
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisolone & dipyridamole
CAS Number: N/A
Current Sponsor code: CRx-102
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1 and 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		CombinatoRx, IncNot RecruitingFemale: yes
Male: yes		60Estonia
1667EUCTR2005-003558-83-CZ07/04/200619 March 2012A 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 108Rheumatoid arthritis (RA)Product Name: AMG 108
Product Code: AMG 108
Pharmaceutical Form: Solution for injection
Current Sponsor code: AMG 108
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Amgen Inc.Not RecruitingFemale: yes
Male: yes		784United Kingdom;Czech Republic;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden
1668EUCTR2005-005013-37-GB06/04/200619 March 2012A 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) - IDEAEarly Rheumatoid ArthritisTrade Name: Remicade
Product Name: Remicade
Product Code: Infliximab
Pharmaceutical Form: Powder for solution for infusion
Trade Name: Mextrex
Product Name: Methotrexate
Product Code: Mextrex
Pharmaceutical Form: Tablet
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: Methotrexate
Concentration unit: mol/mg mole(s)/milligram
Concentration type: equal
Concentration number: 10-
Trade Name: Ferrograd Folic Tablets
Product Name: Folic Acid
Product Code: Ferrograd
Pharmaceutical Form: Tablet
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: Folic Acid
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 350-
Trade Name: Solu-Medrone 2 Gram
Product Name: Methylprednisolone
Product Code: Solu-Medrone 2 Gram
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: Methylprednisolone
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 2-
Trade Name: Solu-Medrone 2 Gram
Product Name: Methylprednisolone
Product Code: Solu-Medrone 2 Gram
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: Methylprednisolone
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 2-		University of LeedsAuthorisedFemale: yes
Male: yes		112United Kingdom
1669NCT00303563April 200614 November 2016A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid ArthritisA Randomized, Double-blind Study to Compare the Effect of RO4402257 Monotherapy and Methotrexate Monotherapy on Disease Response in Patients With Active Rheumatoid Arthritis.Rheumatoid ArthritisDrug: P38 Inhibitor (4);Drug: PlaceboHoffmann-La RocheNot recruiting18 YearsN/ABoth204Phase 2United States;Canada;Croatia;Czech Republic;France;Italy;Mexico;Romania;Serbia;South Africa;Spain;Taiwan;Former Serbia and Montenegro
1670NCT00319917April 200619 February 2015A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA PatientsFK506 Phase 4 Study: A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA PatientsRheumatoid ArthritisDrug: tacrolimus;Drug: placeboAstellas Pharma IncNot recruiting20 Years64 YearsBoth123Phase 4Japan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1671EUCTR2004-003296-36-DE29/03/200621 August 2012A 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 - NAActive rheumatoid arthritis (RA) despite methotrexate (MTX) therapyProduct Name: Golimumab Liquid in Vial
Product Code: CNTO 148
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50 and-100
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: Methotrexate sodium tablets 2.5 mg
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50 and-100
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Centocor B.V.Not RecruitingFemale: yes
Male: yes		400Hungary;Germany
1672EUCTR2005-004582-41-GB24/03/200619 March 2012Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RASafety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RAActive Rheumatoid ArthritisTrade Name: Mabthera
Product Name: Mabthera
Product Code: Rituximab
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Arava
Product Name: Arava
Product Code: Leflunomide
Pharmaceutical Form: Film-coated tablet
Trade Name: Solu-Medrone 2 Gram
Product Name: Solu-Medrone 2mg
Product Code: Methylprednisolone
Pharmaceutical Form: Powder for injection*		University of LeedsAuthorisedFemale: yes
Male: yes		15United Kingdom
1673EUCTR2005-003558-83-GB21/03/200619 March 2012A 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 ArthritisRheumatoid arthritis (RA)Product Code: AMG 108
Pharmaceutical Form: Solution for injection
Current Sponsor code: AMG 108
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Amgen Inc.AuthorisedFemale: yes
Male: yes		784Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden
1674EUCTR2004-003771-37-HU03/03/200619 March 2012A 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/IIActive Rheumatoid Arthritis
MedDRA version: 7.0 Level: LLT Classification code 10039073		Product Name: HuMax-CD20
Product Code: HuMax-CD20
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: N/A
CAS Number: 679818-59-8
Current Sponsor code: HuMax-CD20
Other descriptive name: Human monoclonal antibody directed against CD20 on B-cells
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use		Genmab A/SNot RecruitingFemale: yes
Male: yes		230Phase 1/2Hungary
1675NCT00293826March 200619 February 2015A Multiple Dose Study to Evaluate 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 ArthritisDrug: AMG 108;Drug: PlaceboAmgenNot recruiting18 Years70 YearsBoth813Phase 2United States;Australia;Austria;Belgium;Canada;Czech Republic;Estonia;France;Hungary;Ireland;Italy;Latvia;Mexico;Netherlands;Poland;Slovakia;Spain;Sweden;United Kingdom;Puerto Rico
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1676NCT00308282March 200619 February 2015A Multi-Site Study to Evaluate the Safety and Effect of Study Drug on Patients With Rheumatoid ArthritisPhase II Study of Safety and Efficacy of Intravenous LY2127399 in Patients With Rheumatoid Arthritis Treated With MethotrexateArthritis, RheumatoidDrug: LY2127399;Drug: PlaceboEli Lilly and CompanyNot recruiting18 Years75 YearsBoth126Phase 2Romania
1677NCT00394589March 200616 December 2017Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3)Randomised Controlled Trial Evaluating Strategies to Optimize Disease Activity Control in RA Patients Treated With Infliximab in Clinical Practice.Rheumatoid ArthritisDrug: Infliximab Control;Drug: Infliximab Increased Frequency;Drug: Infliximab Increased DoseMerck Sharp & Dohme Corp.Integrated Therapeutics GroupNot recruiting18 YearsN/AAll43Phase 3Austria;Belgium;Denmark;France;Germany;Netherlands;Sweden;Turkey
1678NCT00603993March 200619 October 2017Self-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.Not recruiting20 YearsN/AAll88Phase 3Japan
1679EUCTR2004-004995-35-GB24/02/20061 May 2012A 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-RAACTIVE RHEUMATOID ARTHRITISTrade Name: Paroxetine hydrochloride 10 & 20 mg and Prednisolone 1 mg BP
Product Name: N/A
Product Code: CRx-139
Pharmaceutical Form: Tablet
INN or Proposed INN: Paroxetine & Prednisolone
CAS Number: N/A
Current Sponsor code: CRx-139
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10 & 20 and-1
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		CombinatoRx, Inc.AuthorisedFemale: yes
Male: yes		220Phase 2Czech Republic;Germany;United Kingdom;Denmark;Italy
1680NCT00286689February 3, 200618 December 2018Effects of Growth Hormone in Chronically Ill ChildrenHurler Syndrome;Cerebral Palsy;Juvenile Rheumatoid Arthritis;Crohn Disease;HIV InfectionsDrug: Growth Hormone;Procedure: Whole body Protein turnover;Procedure: DEXA scanUniversity of Texas Southwestern Medical CenterNot recruiting3 Years17 YearsAll0N/AUnited States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1681EUCTR2005-005295-32-GB01/02/200618 April 2012Trial in rheumatoid arthritis of lisinopril (TRALIS) - TRALISTrial in rheumatoid arthritis of lisinopril (TRALIS) - TRALISRheumatoid arthritisTrade Name: Lisinopril
Product Name: Lisinopril
Product Code: N/A
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		Research and Development Department, Addenbrookes NHS Foundation TrustAuthorisedFemale: yes
Male: yes		200United Kingdom
1682NCT00287794February 200619 February 2015Quality of Sleep in Patients With Rheumatoid ArthritisStudy on the Quality of Sleep in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: diazepam, melatoninKobe UniversityRecruiting17 YearsN/ABoth1000Phase 1Japan
1683NCT00296257February 200619 February 2015Assessment 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.Rheumatoid Arthritis (RA)Drug: SMP-114Dainippon Sumitomo Pharma Europe LTd.Not recruiting18 YearsN/ABoth312Phase 2Czech Republic;Germany;Hungary;Netherlands;Poland;United Kingdom
1684NCT00299546February 200619 October 2017A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis and Previously Treated With Biologic Anti- TNFa Agent(s)Arthritis, RheumatoidDrug: Placebo;Biological: Golimumab 50 mg;Biological: Golimumab 100 mgCentocor, Inc.Schering-PloughNot recruiting18 YearsN/AAll461Phase 3United States;Australia;Austria;Canada;Finland;Germany;Netherlands;New Zealand;Spain;United Kingdom;France;Switzerland
1685NCT00422383February 200619 October 2017A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.Rheumatoid ArthritisDrug: rituximab [MabThera/Rituxan]Hoffmann-La RocheNot recruiting18 YearsN/AAll378Phase 3Australia;Belgium;Brazil;Canada;China;Finland;France;Germany;Hungary;Italy;Netherlands;New Zealand;Slovakia;South Africa;Spain;Taiwan;Thailand;United Kingdom;Switzerland;United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1686NCT00502996February 200619 October 2017A 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 RocheNot recruiting18 YearsN/AAll246Phase 3Argentina;Brazil;Chile;Colombia;Ecuador;El Salvador;Mexico;Peru;Uruguay;Venezuela
1687EUCTR2005-003694-25-ES27/01/200619 March 2012Ensayo 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 Reumatoide Rheumatoid ArthritisProduct Name: P38 (4) Map Kinase Inhibitor
Product Code: RO4402257
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: RO4402257
Other descriptive name: P38(4) Map Kinase Inhibitor
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: P38 (4) Map Kinase Inhibitor
Product Code: RO4402257
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: RO4402257
Other descriptive name: P38(4) Map Kinase Inhibitor
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: P38 (4) Map Kinase Inhibitor
Product Code: RO4402257
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: RO4402257
Other descriptive name: P38(4) Map Kinase Inhibitor
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Methotrexate Sodium 2.5mg Tablets
Product Name: Methotrexate Sodium 2.5mg Tablets
Product Code: PL 00095/5079R
Pharmaceutical Form: Tablet
Other descriptive name: Methotrexate Sodium 2.5mg Tablets
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		F. Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes		200Czech Republic;Spain;Italy
1688NCT00282308January 23, 200616 December 2017A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background MethotrexateA Phase II, Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background MethotrexateRheumatoid ArthritisDrug: Rituximab;Drug: Methotrexate;Drug: Methylprednisone;Biological: C. albicans;Biological: Tetanus toxoid adsorbed booster vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine;Biological: Keyhole limpet hemocyaninGenentech, Inc.Not recruiting18 Years65 YearsAll103Phase 2United States
1689EUCTR2005-002395-15-FI09/01/200628 October 2013A 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: Methotrexate
Product Code: Methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN: methotrexate		F. Hoffmann-La Roche Ltd.Not RecruitingFemale: yes
Male: yes		853Phase 3Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
1690EUCTR2005-004385-16-GB03/01/200618 April 2012CIRCADIAN 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 ARTHRITISRheumatoid arthritisProduct Name: Prednisone
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5 -		United Bristol Healthcare NHS TrustAuthorisedFemale: yes
Male: yes		United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1691NCT03496831January 1, 200611 June 2018Predicting Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological DrugsDevelopment of a Prediction Model for the Risk of Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological DrugsRheumatoid Arthritis;Spondyloarthritis;Psoriatic ArthritisDrug: Biologic AgentsSimon KrabbeUniversity of Aarhus;Zealand University Hospital;University of Southern DenmarkNot recruiting18 YearsN/AAll7500Phase 2
1692NCT00234234January 200619 February 2015Predictors of the Response to Adalimumab in Rheumatoid ArthritisPredictors of the Response to Adalimumab in Rheumatoid ArthritisRheumatoid ArthritisDrug: AdalimumabUniversity Hospital, RouenNot recruiting18 YearsN/ABoth200Phase 4France
1693NCT00254293January 200619 October 2017Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)A Study to Assess the Steady-State Trough Serum Concentration, Safety, and Immunogenicity of Abatacept (BMS-188667) Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Who Are Receiving Disease Modifying Ant-Rheumatic Drugs (DMARDs)Rheumatoid ArthritisDrug: Abatacept or Placebo (both as IV & SC Solution);Drug: Abatacept or Placebo (both as IV & SC solution);Drug: AbataceptBristol-Myers SquibbNot recruiting18 YearsN/AAll87Phase 1/Phase 2United States
1694NCT00264147January 200619 October 2017Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Parallel-Group, 12-Week Study to Assess the Clinically Effective Dose Range of Etoricoxib and to Assess Its Safety and Tolerability in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: etoricoxib;Drug: Comparator: placebo;Drug: Comparator: diclofenacMerck Sharp & Dohme Corp.Not recruiting18 YearsN/AAll761Phase 2Canada;Colombia;Puerto Rico;Switzerland;United States
1695NCT00266227January 200619 October 2017A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background MethotrexateA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Retreatment With Rituximab in Subjects With Rheumatoid Arthritis Receiving Background MethotrexateRheumatoid ArthritisDrug: placebo;Drug: rituximab;Drug: methotrexate;Drug: folateGenentech, Inc.Not recruiting18 Years80 YearsAll559Phase 3United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1696NCT00299104January 200616 December 2017A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid ArthritisA 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-Naive Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: placebo;Drug: rituximabGenentech, Inc.Hoffmann-La RocheNot recruiting18 Years80 YearsAll755Phase 3United States
1697NCT00346294January 200619 February 2015An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-Injector in Subjects With Rheumatoid ArthritisAn Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-Injector in Subjects With Rheumatoid ArthritisRheumatoid ArthritisOther: EtanerceptAmgenImmunex CorporationNot recruiting18 YearsN/ABoth115Phase 4United States
1698NCT00379990January 200619 February 2015A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Synovial Thickness and Vascularity of 28 Days Repeat Dosing of GW274150 or 7.5mg Prednisolone in RA Subjects.Arthritis, RheumatoidDrug: GW274150;Drug: Prednisolone;Other: PlaceboGlaxoSmithKlineNot recruiting18 YearsN/ABoth48Phase 2Serbia;United Kingdom
1699NCT00422942January 200619 October 2017A Pharmacokinetic and Pharmacodynamic Study of MabThera (Rituximab) Plus Methotrexate in Patients With Rheumatoid Arthritis (RA)An Open-label, Exploratory Study of the Pharmacokinetic and Pharmacodynamic Activity of MabThera in Combination With Methotrexate in Synovial Tissue and in Peripheral Blood of Patients With Active Rheumatoid Arthritis.Rheumatoid ArthritisDrug: rituximab [MabThera/Rituxan];Drug: MethotrexateHoffmann-La RocheNot recruiting18 Years80 YearsAll3Phase 2Netherlands;Spain
1700NCT00724243January 200619 October 2017Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)Remicade Treatment Registry in Rheumatoid Arthritis IRheumatoid ArthritisDrug: InfliximabMerck Sharp & Dohme Corp.Not recruitingN/AN/AAll33N/ASlovakia
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1701NCT02922192January 200617 October 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;Group Health Cooperative;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta;Pfizer;UPMC;HealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Group Health Cooperative;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta;Pfizer;UPMCNot recruiting18 YearsN/ABoth100000N/A
1702EUCTR2005-004530-40-AT30/12/200522 April 2013Induction 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-therapyPatients 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
Pharmaceutical Form: Powder and solvent for solution for infusion		AESCA Pharma Ges.m.b.HNot RecruitingFemale: yes
Male: yes		160Austria
1703EUCTR2005-002396-33-ES27/12/200528 August 2014Estudio 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		F. Hoffmann-La Roche Ltd.Not RecruitingFemale: yes
Male: yes		375Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
1704EUCTR2005-000902-30-GB09/12/200524 April 2012A 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 PatientsRheumatoid arthritisTrade Name: Prednisolone Tablets USP 5 mg
Product Name: Prednisolone Tablets USP 5 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		GlaxoSmithKline Research & Development LimitedAuthorisedFemale: yes
Male: yes		45United Kingdom
1705EUCTR2004-002482-20-GB02/12/200515 July 2013A 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 StudySymptoms 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
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: Venlafaxine Hydrochloride
Concentration unit: mg milligram(s)
Concentration number: 75-		Newcastle upon Tyne Hospitals NHS TrustNot RecruitingFemale: yes
Male: yes		20United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1706NCT00264537December 200519 October 2017A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naiveA Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Methotrexate-naive Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Placebo injections;Drug: Placebo capsules;Drug: Methotrexate capsules;Biological: Golimumab 50 mg injections;Biological: Golimumab 100 mg injectionsCentocor, Inc.Schering-PloughNot recruiting18 YearsN/AAll637Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Chile;Hungary;India;Korea, Republic of;Malaysia;New Zealand;Philippines;Poland;Russian Federation;Singapore;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Brazil;Mexico;Turkey
1707NCT00281294December 200519 February 2015A Phase 2 Study to Evaluate the Safety, Tolerability, and Activity of Fontolizumab in Subjects With Active Rheumatoid ArthritisA Phase 2 Study to Evaluate the Safety, Tolerability, and Activity of Fontolizumab in Subjects With Active Rheumatoid ArthritisArthritis, RheumatoidDrug: FontolizumabPDL BioPharma, Inc.Not recruiting18 YearsN/ABoth40Phase 2United States
1708NCT00642629December 200519 February 2015A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, Administered to Patients With Rheumatoid Arthritis to Determine Safety, Tolerability, Pharmacokinetic and Synovial Tissue OutcomesActive, Moderate to Severe Rheumatoid ArthritisDrug: STA 5326 mesylate;Drug: PlaceboSynta Pharmaceuticals Corp.Not recruiting18 YearsN/ABoth35Phase 2Netherlands
1709NCT00669942December 200519 October 2017Double 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 PharmaceuticalsNot recruiting18 Years75 YearsAll104Phase 1/Phase 2United States;Belgium;Germany;Netherlands;Singapore;Spain
1710NCT00705289December 200519 October 2017A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250)Epidemiology, Correlation and Predictive Value of Disease Activity and Biomarkers in RA Patients Initiated on Infliximab in Clinical PracticeRheumatoid ArthritisBiological: InfliximabMerck Sharp & Dohme Corp.Not recruitingN/AN/AAll728N/A
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1711EUCTR2005-000784-26-GB25/11/200524 April 2012A 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
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Abatacept
CAS Number: 332348-12-6
Current Sponsor code: BMS-188667
Other descriptive name: CTLA4Ig
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use		Bristol Myers Squibb International CorporationAuthorisedFemale: yes
Male: yes		750Phase 3BCzech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy;Austria
1712EUCTR2005-001889-13-SE24/11/200519 March 2012Randomised 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. - Re3Adult 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
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: infliximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-		Schering-Plough Research Institute, a division of Schering CorporationNot RecruitingFemale: yes
Male: yes		315Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden
1713EUCTR2005-002392-32-IE23/11/200526 June 2012A 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		F. Hoffmann-La Roche Ltd.AuthorisedFemale: yes
Male: yes		500Germany;United Kingdom;Slovenia;Ireland;Sweden
1714EUCTR2005-003495-38-IE17/11/200518 April 2012A 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
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: RO4402257
Other descriptive name: P38(4) Map Kinase Inhibitor
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: P38 (4) Map Kinase Inhibitor
Product Code: RO4402257
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: RO4402257
Other descriptive name: P38(4) Map Kinase Inhibitor
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: P38 (4) Map Kinase Inhibitor
Product Code: RO4402257
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: RO4402257
Other descriptive name: P38(4) Map Kinase Inhibitor
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		F. Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes		330United Kingdom;Germany;Estonia;Spain;Ireland;Greece
1715EUCTR2004-001825-69-IT04/11/200519 March 2012A Multi Center, Open label, Extension study of RA 1 using Extracoproreal photoimmune therapy with UvadexA Multi Center, Open label, Extension study of RA 1 using Extracoproreal photoimmune therapy with UvadexRheumatoid arthritis
MedDRA version: 6.1 Level: PT Classification code 10039073		Trade Name: UVADEX
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Methoxsalen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-		THERAKOSAuthorisedFemale: yes
Male: yes		68Italy
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1716NCT00160641November 200519 October 2017A 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 PharmaNot recruiting18 YearsN/AAll567Phase 3United States;Bulgaria;Croatia;Czech Republic;Estonia;Israel;Latvia;Lithuania;Poland;Russian Federation;Serbia;Slovakia;Ukraine;Former Serbia and Montenegro
1717NCT00162292November 200519 February 2015Multiple 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 SquibbNot recruiting18 Years70 YearsBoth33Phase 1United States;Mexico
1718NCT00256919November 200519 February 2015Single 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: GW856553GlaxoSmithKlineNot recruiting18 YearsN/ABoth51Phase 2Bulgaria;Germany;Spain;Sweden;Ukraine
1719NCT00292422November 200519 February 2015Dose-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 IdecNot recruiting18 Years75 YearsBoth50Phase 2United States;Poland
1720NCT00316771November 200514 November 2016A 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 RocheNot recruiting18 YearsN/ABoth374Phase 2South Africa;Spain;United Kingdom;United States;Australia;Brazil;Canada;Estonia;Germany;Greece;Ireland;Mexico;New Zealand;Poland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1721NCT00320450November 200519 February 2015SB-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-681323GlaxoSmithKlineNot recruiting18 YearsN/ABoth78Phase 2Denmark;Germany;Hong Kong;Italy;Norway;Poland;Spain;Sweden;United Kingdom;Hungary
1722NCT00380744November 200519 February 2015A Safety and Pharmacokinetics Study in Patients 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 CompanyNot recruiting18 Years75 YearsBoth104Phase 1/Phase 2United States;Poland;Argentina;Hungary;Spain
1723EUCTR2005-003436-21-GB26/10/200518 April 2012A 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-114Rheumatoid Arthritis
MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis		Product Name: SMP-114
Product Code: SMP-114
Pharmaceutical Form: Tablet
INN or Proposed INN: rimacalib
CAS Number: 215174-50-8
Current Sponsor code: SMP-114
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Dainippon Sumitomo Pharma Europe LtdNot RecruitingFemale: yes
Male: yes		300Phase 2Hungary;Czech Republic;Germany;United Kingdom
1724EUCTR2005-002969-37-SE14/10/20051 May 2012A 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. - GM2005/00244/02Rheumatoid ArthritisProduct Code: GW856553
Pharmaceutical Form: Tablet
Current Sponsor code: GW856553
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: GW856553
Pharmaceutical Form: Tablet
Current Sponsor code: GW856553
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: GW856553
Pharmaceutical Form: Tablet
Current Sponsor code: GW856553
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		GlaxoSmithKline Research & Development LtdNot RecruitingFemale: yes
Male: yes		48Germany;Spain;Sweden
1725NCT00141102October 200519 October 2017Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With ArthritisDouble-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 EventsOsteoarthritis;Arthritis, RheumatoidDrug: Celecoxib;Drug: Diclofenac + OmeprazolePfizerNot recruiting18 YearsN/AAll4484Phase 4Belgium;Brazil;Canada;China;Colombia;Costa Rica;Croatia;Czech Republic;Ecuador;Estonia;France;Germany;Greece;Guatemala;Hong Kong;India;Korea, Republic of;Latvia;Lithuania;Netherlands;Panama;Peru;Portugal;Russian Federation;Serbia;Singapore;South Africa;Spain;Sweden;Taiwan;Ukraine;United Kingdom;Former Serbia and Montenegro;Ireland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1726NCT00241982October 200519 February 2015Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid ArthritisLong-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: long-circulating liposomal prednisoloneRadboud UniversityUtrecht UniversityNot recruiting18 YearsN/ABoth22Phase 2Netherlands
1727NCT00249041October 200519 February 2015Enbrel Liquid Immunogenicity ProtocolOpen-label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: 50 mg Etanercept;Drug: Enbrel liquidAmgenImmunex CorporationNot recruiting18 YearsN/ABoth447Phase 3United States;Canada
1728NCT00299130October 200516 December 2017A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid ArthritisA Randomized, Placebo Controlled, Double-blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate, Compared to Methotrexate Monotherapy, in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Folate;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Placebo;Drug: RituximabGenentech, Inc.Hoffmann-La RocheNot recruiting18 Years80 YearsAll511Phase 3United States
1729EUCTR2005-002326-63-LT21/09/200519 March 2012A 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Certolizumab pegol
Current Sponsor code: CDP870
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		UCB CelltechNot RecruitingFemale: yes
Male: yes		590Phase 3Czech Republic;Estonia;Latvia;Lithuania
1730EUCTR2005-002909-23-ES21/09/200526 June 2012Long-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 MRARheumatoid arthritisProduct Name: MRA
Product Code: RO4877533
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-		F Hoffmann La-Roche AGNot RecruitingFemale: yes
Male: yes		2420Portugal;Finland;United Kingdom;Czech Republic;Germany;Iceland;Slovenia;Denmark;Spain;Italy;Sweden
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1731EUCTR2005-002421-31-GB16/09/200524 April 2012A phase II randomized, double-blind, multicentre, 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 methotrexateA phase II randomized, double-blind, multicentre, 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 methotrexateRheumatoid arthritis
Level: PT Classification code 10039073		Product Name: AD 452 4.5 mg Tablet
Pharmaceutical Form: Tablet
CAS Number: 51742-86-0
Current Sponsor code: AD 452
Other descriptive name: (+) erythromefloquine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: AD 452 9 mg tablet
Pharmaceutical Form: Tablet
CAS Number: 51742-86-0
Current Sponsor code: AD 452
Other descriptive name: (+)erythromefloquine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: AD 452 18 mg tablet
Pharmaceutical Form: Tablet
CAS Number: 51742-86-0
Current Sponsor code: AD 452
Other descriptive name: (+)erythromefloquine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Arakis LtdAuthorisedFemale: yes
Male: yes		292Phase 2Germany;United Kingdom
1732EUCTR2005-001977-82-GB09/09/200524 April 2012A 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 subjectsRheumatoid arthritisProduct Name: GW274150 Tablets
Product Code: GW274150
Pharmaceutical Form: Tablet
Current Sponsor code: GW274150
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Deltacortril Enteric
Product Name: Prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		GlaxoSmithKline Research & Development LimitedAuthorisedFemale: yes
Male: yes		45United Kingdom
1733EUCTR2005-002219-26-SE08/09/200519 March 2012A 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
Pharmaceutical Form: Tablet
Current Sponsor code: SB-681323
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5 and 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		GlaxoSmithKline R&D LtdNot RecruitingFemale: yes
Male: yes		82Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden
1734EUCTR2005-002423-13-DE06/09/20057 August 2012Long-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 WA17822Rheumatoid arthritisTrade Name: RoActemra
Product Name: MRA
Product Code: RO4877533
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: R04877533
Other descriptive name: MRA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-		F. Hoffmann-La Roche LtdNot RecruitingFemale: yes
Male: yes		630Hungary;Slovakia;Germany;Bulgaria;Italy
1735EUCTR2005-000551-15-GB05/09/20053 April 2017Effect 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 methotrexateRheumatoid 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
Pharmaceutical Form: Capsule*
INN or Proposed INN: Allopurinol
CAS Number: 315-30-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Folic acid
Product Code: Folic acid
Pharmaceutical Form: Capsule*
INN or Proposed INN: Folic acid
CAS Number: 59-30-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		University of DundeeNot RecruitingFemale: yes
Male: yes		Phase 4United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1736EUCTR2004-005102-68-GB01/09/20051 May 2012A 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
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Abatacept
CAS Number: 332348-12-6
Current Sponsor code: BMS-188667
Other descriptive name: CTLA4Ig
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-		Bristol-Myers Squibb International CorporationAuthorisedFemale: yes
Male: yes		750Phase 3Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy
1737NCT00466037September 200519 February 2015The Effect of Rituximab on the Humoral Response to Influenza VaccineVaccination Against Influenza in Rheumatoid Arthritis Patients: The Effect of Rituximab on the Humoral ResponseRheumatoid ArthritisBiological: Influenza vaccineTel-Aviv Sourasky Medical CenterNot recruiting18 Years85 YearsBoth64N/A
1738NCT00691028September 200519 October 2017Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid ArthritisClinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: TA-650 3 mg/kg;Drug: TA-650 6 mg/kg;Drug: TA-650 10 mg/kgMitsubishi Tanabe Pharma CorporationNot recruiting20 Years75 YearsAll327Phase 3
1739EUCTR2005-001633-14-DK17/08/200519 March 2012Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira?) 40 mg s.c. eow versus infliximab (Remicade?) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH StudyRandomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira?) 40 mg s.c. eow versus infliximab (Remicade?) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH StudyRheumatoid arthritisTrade Name: Humira
Product Name: Humira
Pharmaceutical Form: Injection*
Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Injection*		Hvidovre Hospital, Dept. RheumatologyAuthorisedFemale: yes
Male: yes		112Denmark;Sweden
1740NCT00111410August 200522 August 2016Evaluating the Effect of Anakinra (r-metHuIL-1ra) on Vaccine AntibodyResponse in Subjects With Rheumatoid Arthritis (RA)A Multicenter, Double-Blind, Randomized, Placebo Controlled Study to Estimate the Effect of Anakinra (r-metHuIL-1ra) on Vaccine Antibody Response in Subjects With Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: Anakinra (r-metHuIL-1ra)AmgenNot recruiting18 Years74 YearsBothPhase 4
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1741NCT00141830August 200519 February 2015Study 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 PfizerNot recruiting18 Years80 YearsBoth159Phase 2United States;Canada;Hungary;Italy;Mexico;Spain
1742NCT00141934August 200519 February 2015A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects.Phase II Randomised, Double-Blind, Multicentre, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of 3 Strengths of AD 452 in Adults With Active RA Who Are Currently Taking Methotrexate.Rheumatoid ArthritisDrug: AD 452SoseiNot recruiting18 Years75 YearsBoth232Phase 2United States
1743NCT00243412August 200519 October 2017A Study of the Safety and Efficacy of Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis Receiving MethotrexateA Double-Blind, Randomized, Multicenter, Phase II Study of the Safety and Efficacy of Two Rituximab Regimens in Subjects With Moderate to Severe Active Rheumatoid Arthritis Receiving Stable Doses of MethotrexateRheumatoid ArthritisDrug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: Placebo;Drug: RituximabGenentech, Inc.Not recruiting18 Years65 YearsAll42Phase 2United States
1744NCT00370435August 200516 December 2017Study Of 90mg Of GW274150 In Subjects Over 50 Years, Who Have Rheumatoid Arthritis (RA)An Open-label, Single Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of 90mg of GW274150 in Adult and Elderly RA Subjects.Arthritis, RheumatoidDrug: GW274150GlaxoSmithKlineNot recruiting50 YearsN/AAll6Phase 2United Kingdom
1745NCT00508768August 200519 February 2015A Study of Oral SCIO-469 Pharmacokinetics (Study of a Drug in the Body to Watch How the Drug is Absorbed, Distributed, Metabolized and Eliminated Over a Period of Time) in the Body of Female Patients With Active Rheumatoid ArthritisA Randomized, Double-Blind, Parallel-Group, Pharmacokinetic Study of Oral SCIO-469 (90 mg qd and 30 mg Tid) in Female Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Oral SCIO-469 capsuleScios, Inc.Not recruiting18 YearsN/AFemale16Phase 1
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1746EUCTR2005-001319-23-HU22/07/200519 March 2012A 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 TherapyRheumatoid arthritisProduct Name: ERB-041
Product Code: ERB-041
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not available
CAS Number: 524684-52-4
Current Sponsor code: ERB-041
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: ERB-041
Product Code: ERB-041
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not available
CAS Number: 524684-52-4
Current Sponsor code: ERB-041
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: ERB-041
Product Code: ERB-041
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not available
CAS Number: 524684-52-4
Current Sponsor code: ERB-041
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical resaearch and DevelopmentNot RecruitingFemale: yes
Male: yes		260Hungary;Spain;Italy
1747EUCTR2004-002215-80-HU20/07/200519 March 2012A 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-WWRheumatoid ArthritisProduct Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not yet established
CAS Number: 287405-51-0
Current Sponsor code: TMI-005
Other descriptive name: WAY-177005
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not yet established
CAS Number: 287405-51-0
Current Sponsor code: TMI-005
Other descriptive name: WAY-177005
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Product Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not yet established
CAS Number: 287405-51-0
Current Sponsor code: TMI-005
Other descriptive name: WAY-177005
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-		Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and DevelopmentAuthorisedFemale: yes
Male: yes		360Hungary
1748EUCTR2005-000158-61-GB18/07/20059 October 2012A 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
Pharmaceutical Form: Capsule, hard
CAS Number: 221148-46-5
Current Sponsor code: GW406381
Other descriptive name: GW406381X
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GW406381
Product Code: GW406381X
Pharmaceutical Form: Capsule, hard
CAS Number: 221148-46-5
Current Sponsor code: GW406381
Other descriptive name: GW406381X
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GW406381
Product Code: GW406381X
Pharmaceutical Form: Capsule, hard
CAS Number: 221148-46-5
Current Sponsor code: GW406381
Other descriptive name: GW406381X
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GW406381
Product Code: GW406381X
Pharmaceutical Form: Capsule, hard
CAS Number: 221148-46-5
Current Sponsor code: GW406381
Other descriptive name: GW406381X
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Celebrex 200 mg capsule, hard
Product Name: Celecoxib
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Celecoxib
CAS Number: 169590-42-5
Current Sponsor code: Celecoxib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		GlaxoSmithKline Research & Development LimitedNot RecruitingFemale: yes
Male: yes		2210Phase 3Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
1749EUCTR2005-001138-33-LT14/07/200511 February 2013A 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: R04877533
Other descriptive name: MRA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: Methotrexate sodium
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate sodium
CAS Number: 15475-56-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		F. Hoffmann La-Roche AGNot RecruitingFemale: yes
Male: yes		650Portugal;Slovenia;Spain;Lithuania;Denmark;Norway;Italy
1750NCT00109408July 200514 November 2016A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid ArthritisA Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Methotrexate;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNot recruiting18 YearsN/ABoth673Phase 3United States;Argentina;Australia;Canada;China;Denmark;France;Israel;Italy;Lithuania;Mexico;Norway;Peru;Portugal;Serbia;Slovenia;South Africa;Spain;Croatia;Former Serbia and Montenegro
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1751NCT00122382July 200519 October 2017Remission and Joint Damage Progression in Early Rheumatoid ArthritisA 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 MethotrexateRheumatoid ArthritisDrug: Abatacept;Drug: placebo;Drug: methotrexateBristol-Myers SquibbNot recruiting18 YearsN/AAll1052Phase 3United States;Australia;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Puerto Rico;Russian Federation;South Africa;Spain;United Kingdom;Austria;Ireland
1752NCT00503425June 30, 200516 December 2017A Study of MabThera (Rituximab) in Participants With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARD) and/or Anti-Tumor Necrosis Factor (Anti-TNF) Therapy.An Open Label Study to Assess the Safety and Effect on Disease Activity of MabThera in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With DMARDs and/or One Anti-TNF Alpha AgentRheumatoid ArthritisDrug: Rituximab [MabThera/Rituxan]Hoffmann-La RocheNot recruiting18 YearsN/AAll215Phase 3Israel
1753EUCTR2004-005115-29-GB24/06/200519 March 2012A 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 relationshipRheumatoid arthritisProduct Name: SB-681323 Tablets
Product Code: SB-681323
Pharmaceutical Form: Tablet
Current Sponsor code: SB-681323
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: SB-681323 Tablets
Product Code: SB-681323
Pharmaceutical Form: Tablet
Current Sponsor code: SB-681323
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Prednisolone Tablets BP
Product Name: Overencapsulated Prednisolone Tablets
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Prednisolone
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10 (2x5)-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use		GlaxoSmithKline Research & Development LtdAuthorisedFemale: yes
Male: yes		77Germany;United Kingdom
1754NCT00134693June 21, 200516 December 2017A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein That Is an Indicator For Rheumatoid ArthritisA Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response RelationshipArthritis, RheumatoidDrug: Prednisolone;Drug: SB-681323GlaxoSmithKlineNot recruiting18 YearsN/AAll77Phase 2Australia;France;Germany;Russian Federation;United Kingdom
1755EUCTR2005-000549-13-CZ15/06/200519 March 2012A 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 - VeRArheumatoid arthritisProduct Code: VX-702
Pharmaceutical Form: Tablet
Current Sponsor code: VX-702
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Current Sponsor code: VX-702
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes		300Czech Republic
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1756EUCTR2004-002846-36-DE14/06/200519 March 2012A 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/ARheumatoid Arthritis
MedDRA version: 7.1 Level: LLT Classification code 10039073		Product Name: CP690,550
Product Code: CP690,550
Pharmaceutical Form: Tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: CP690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: CP690,550
Product Code: CP690,550
Pharmaceutical Form: Tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: CP690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Pfizer Pharma GmbHNot RecruitingFemale: yes
Male: yes		312Phase 2AGermany;Spain;Italy
1757EUCTR2005-000884-25-DE14/06/200524 April 2012A 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: R04877533
Other descriptive name: MRA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		F. Hoffmann-La Roche AGNot RecruitingFemale: yes
Male: yes		450United Kingdom;Germany;Iceland;Italy;Sweden
1758NCT00202852June 1, 200516 December 2017A Placebo-Controlled, Double-Blinded, Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate (Study P04280)(COMPLETED)A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite MethotrexateArthritis, RheumatoidOther: Placebo;Drug: MTX;Biological: InfliximabMerck Sharp & Dohme Corp.Not recruiting18 Years75 YearsAll143Phase 3Korea, Republic of
1759NCT00113308June 200516 December 2017COX-2 Inhibitor Study In Patients 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 ArthritisArthritis, RheumatoidDrug: GW406381GlaxoSmithKlineNot recruiting18 YearsN/AAll2208Phase 3United States;Argentina;Austria;Belgium;Bulgaria;Canada;Chile;Costa Rica;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Korea, Republic of;Latvia;Mexico;Netherlands;New Zealand;Norway;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic;Estonia;Lithuania;Pakistan;Slovakia;Taiwan
1760NCT00205478June 200519 February 2015Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo Controlled Study of Two Doses of VX-702 in Subjects With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisDrug: VX-702Vertex Pharmaceuticals IncorporatedNot recruiting18 Years75 YearsBoth300Phase 2Bulgaria;Croatia;Czech Republic;Former Serbia and Montenegro;Poland;Russian Federation;Slovakia;Slovenia;Ukraine
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1761NCT00233558June 200519 February 2015Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid ArthritisMulticentre, Randomised, Open Label Study Comparing a “Scheduled Steroid Reduction Strategy” Versus a Free Steroid Reduction Strategy (Physician’s Usual Practice for Reducing Steroids) in Patients With Active RA Treated With Humira 40 mg Eow + MTX During 9 MonthsRheumatoid ArthritisDrug: adalimumab (up to 9 months exposure);Drug: methotrexateAbbottNot recruiting18 YearsN/ABoth160Phase 4United States
1762NCT00688103June 200519 October 2017Efficacy and Safety of Etanercept in Active RA Despite Methotrexate Therapy in JapanEfficacy and Safety of Etanercept in Active Rheumatoid Arthritis Despite Methotrexate Therapy in JapanRheumatoid ArthritisDrug: ETN Alone;Drug: ETN+MTXJapan Biological Agent Study Integrated ConsortiumNot recruiting18 YearsN/AAll151Phase 4Japan
1763EUCTR2005-001350-24-SK31/05/200527 February 2017A 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 CDP870-027Rheumatoid arthritis
Classification code 10039073		Product Name: CDP870
Product Code: CDP870
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Certolizumab pegol
CAS Number: 428863-50-7
Current Sponsor code: CDP870
Other descriptive name: CDP870 Fab'-PEG
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 150 + or --15		UCB CelltechNot RecruitingFemale: yes
Male: yes		800Phase 3Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Latvia
1764EUCTR2004-002620-18-DE13/05/20051 May 2012A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versus Placebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects with Undifferentiated Inflammatory Arthritis at High Risk for the Development of Rheumatoid 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 versus Placebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects with Undifferentiated Inflammatory Arthritis at High Risk for the Development of Rheumatoid Arthritis. Revised protocol 2, dated 02-Feb-06, incorporating Amendments 02 and 03; and Pharmacogenetics Blood Sample Amendment Number 01Rheumatoid Arthritis, NOSProduct Name: Abatacept
Product Code: BMS-188667
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Abatacept
CAS Number: 332348-12-6
Current Sponsor code: BMS-188667
Other descriptive name: CTLA4Ig
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use		Bristol-Myers Squibb International CorporationNot RecruitingFemale: yes
Male: yes		250United Kingdom;Germany;Belgium;Spain;Italy
1765EUCTR2005-000549-13-SK03/05/200527 February 2017A 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 - VeRArheumatoid arthritisProduct Code: VX-702
Pharmaceutical Form: Tablet
Current Sponsor code: VX-702
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Current Sponsor code: VX-702
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes		300Phase 2Czech Republic;Slovakia
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1766NCT00106522May 200514 November 2016A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate TherapyA Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF TherapyRheumatoid ArthritisDrug: Methotrexate;Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNot recruiting18 YearsN/ABoth499Phase 3United States;Australia;Belgium;Canada;France;Germany;Iceland;Italy;Mexico;Netherlands;Puerto Rico;Sweden;Switzerland;United Kingdom
1767NCT00115219May 200519 February 2015Evaluating Efficacy and Safety of Etanercept 50 mg Twice Weekly (BIW) in Rheumatoid Arthritis (RA) Subjects Who Are Sub-Optimal Responders to Etanercept 50 mg Once Weekly (QW)A Multi-center, Randomized, Double-Blind, Active-Controlled Study Evaluating Efficacy and Safety of Etanercept 50 mg Twice Weekly (BIW) in Rheumatoid Arthritis Subjects Who Are Sub-optimal Responders to Etanercept 50 mg Once Weekly (QW)Rheumatoid ArthritisDrug: EtanerceptAmgenNot recruiting18 YearsN/ABoth200Phase 4United States
1768NCT00419809May 200519 February 2015SB-681323-Methotrexate Interaction StudyA Placebo Controlled Study to Evaluate the Safety and Tolerability of Repeat Doses of SB-681323 in Patients Receiving Methotrexate for Rheumatoid Arthritis.Arthritis, RheumatoidDrug: SB-681323 oral tabletsGlaxoSmithKlineNot recruiting18 Years75 YearsBoth18Phase 1Australia
1769NCT00432484May 200519 February 2015Lingzhi and Sen Miao San for the Treatment of Rheumatoid ArthritisLingzhi (Ganoderma Lucidum) and Sen Miao San Supplementation in Rheumatoid Arthritis(RA): An Animal Model and A Phase I StudyRheumatoid ArthritisDrug: Lingzhi and Sen Miao SanChinese University of Hong KongNot recruiting18 YearsN/ABoth70Phase 2China
1770EUCTR2004-005210-37-SE26/04/200519 March 2012A 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: R04877533
Other descriptive name: MRA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		F. Hoffmann La-Roche AGNot RecruitingFemale: yes
Male: yes		1200Finland;Czech Republic;Germany;Spain;Sweden
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1771EUCTR2005-000674-43-GB06/04/20053 April 2012AN OPEN LABEL STUDY OF THE EFFECT OF TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: Clinical, radiological, synovial and immunological outcomes - Rituximab in Rheumatoid ArthritisAN OPEN LABEL STUDY OF THE EFFECT OF TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: Clinical, radiological, synovial and immunological outcomes - Rituximab in Rheumatoid ArthritisRheumatoid ArthritisTrade Name: Mabthera
Product Name: Mabthera
Product Code: N/A
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: none
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-		University of LeedsAuthorisedFemale: yes
Male: yes		15United Kingdom
1772NCT00106574April 200514 November 2016A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid ArthritisA Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD TherapyRheumatoid ArthritisDrug: Placebo;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNot recruiting18 YearsN/ABoth1220Phase 3United States;Argentina;Australia;Brazil;Canada;China;Costa Rica;Czech Republic;Finland;France;Germany;Hong Kong;Mexico;Panama;Russian Federation;South Africa;Spain;Sweden;Thailand
1773NCT00124982April 200519 October 2017Study 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 SquibbNot recruiting18 YearsN/AAll1286Phase 3United States;Belgium;Czech Republic;France;Germany;Ireland;Italy;Mexico;Spain;United Kingdom;Canada
1774NCT01745055April 200519 October 2017Co-Administration Of Methotrexate And CP-690,550A Phase 1, Open Label Study Of The Pharmacokinetics Of Multiple Doses Of Oral CP-690,550 And Single Doses Of Oral Methotrexate In Rheumatoid Arthritis SubjectsRheumatoid ArthritisDrug: CP-690,550 (tofacitinib);Drug: Methotrexate (MTX)PfizerNot recruiting18 Years70 YearsAll12Phase 1United States
1775EUCTR2004-004022-27-ES24/03/200519 March 2012Phase IIa, multicenter, randomised, double-blind, placebo controlled study of the efficacy and safety of RO0506997, an a4 integrin antagonist, in combination with methotrexate, versus methotrexate alone, in patients with mild/moderate active rheumatoid arthritis (RA) who have had a partial response to a stable dose of methotrexate.Phase IIa, multicenter, randomised, double-blind, placebo controlled study of the efficacy and safety of RO0506997, an a4 integrin antagonist, in combination with methotrexate, versus methotrexate alone, in patients with mild/moderate active rheumatoid arthritis (RA) who have had a partial response to a stable dose of methotrexate.Rhematoid Arthritis
Classification code 10039073		Product Code: RO0506997
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: RO0506997
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: RO0506997
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: RO0506997
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: RO0506997
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: RO0506997
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: RO0506997
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: RO0506997
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		F.Hoffmann - La Roche LtdAuthorisedFemale: yes
Male: yes		160Phase 2aSpain
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1776EUCTR2004-003733-14-FI23/03/20051 May 2012A 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. - LITHERheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: RoActemra
Product Name: Tocilizumab
Product Code: RO4877533
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: R04877533
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		F. Hoffmann La-Roche Ltd.AuthorisedFemale: yes
Male: yes		1170France;Norway;Italy;Australia;Brazil;South Africa;Finland;Denmark;Mexico;China;Spain;United States;Greece;Poland
1777EUCTR2005-000129-47-SE21/03/200519 March 2012The 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adalimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-		Dept. of Rhematology UMASNot RecruitingFemale: yes
Male: yes		15Sweden
1778NCT00144586March 200519 February 2015Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JPAn Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA220JP or MRA221JPRheumatoid ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNot recruiting20 Years75 YearsBoth42Phase 3
1779NCT00503503March 200519 February 2015Study 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 PfizerNot recruiting11 Years90 YearsBothPhase 4
1780EUCTR2004-002993-49-HU11/02/20059 October 2012A 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 studyRheumatoid Arthritis
Classification code 10039073		Product Name: CDP870
Product Code: CDP870
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: certolizumab pegol
CAS Number: 428863-50-7
Current Sponsor code: CDP870
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 150-+ or - 15
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use		Celltech R&D LtdNot RecruitingFemale: yes
Male: yes		950Phase 3Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1781EUCTR2004-004893-96-GB04/02/20051 May 2012Randomised double-blind trial of combination antibiotic therapy in rheumatoid arthritisRandomised double-blind trial of combination antibiotic therapy in rheumatoid arthritisPatients with medical diagnosis of Rheumatoid ArthritisTrade Name: Dalacin C phosphate
Product Name: Clindamycin
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
Trade Name: Tetraccycline
Product Name: Tetraccycline-hydrochloride
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		Hammersmith Hospitals NHS trustAuthorisedFemale: yes
Male: yes		United Kingdom
1782EUCTR2004-001909-10-GB02/02/200515 July 2013Effect 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 trialRheumatoid ArthritisTrade Name: rosuvastatin
Product Name: rosuvastatin
Product Code: ZD 4522
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		University of DundeeNot RecruitingFemale: yes
Male: yes		United Kingdom
1783NCT00095147February 200519 October 2017Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid ArthritisA Phase IIIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination With Methotrexate in Controlling Disease Activity in Subjects With Rheumatoid Arthritis Having an Inadequate Clinical Response to MethotrexateRheumatoid ArthritisDrug: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB);Drug: Infliximab (INF) + MTX, DB;Drug: Placebo (PLA) + MTX, DB;Drug: PLA + MTX switched to ABA+ MTX, DB;Drug: ABA, open-label (OL)Bristol-Myers SquibbNot recruiting18 Years75 YearsAll431Phase 3United States;Argentina;Australia;Brazil;Canada;Czech Republic;Denmark;Korea, Republic of;Mexico;Peru;Poland;Puerto Rico;Russian Federation;South Africa;Spain;Sweden;Switzerland
1784NCT00105976February 200519 February 2015Efficacy Study of MM-093 in Rheumatoid Arthritis Patients on Methotrexate (MTX)A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Dose Levels (2.5, 7.5 and 20 mg) of MM-093 in Patients With Active Rheumatoid Arthritis on Stable Doses of MethotrexateRheumatoid ArthritisDrug: MM-093Merrimack PharmaceuticalsNot recruiting18 Years80 YearsBoth260Phase 2United States
1785NCT00124449February 200519 October 2017Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult PatientsA Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RAArthritis, RheumatoidDrug: Abatacept;Drug: placeboBristol-Myers SquibbNot recruiting18 Years75 YearsAll56Phase 2United States;Australia;Belgium;France;Germany;Italy;Mexico;Puerto Rico;Spain;United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1786NCT00144560February 200519 February 2015Drug-Drug Interaction Study of MRA in Patient With Rheumatoid Arthritis (RA)An Open-Label, Clinical Pharmacology Study to Investigate Drug-Drug Interaction in Patients With RARheumatoid ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNot recruiting20 Years75 YearsBoth31N/A
1787NCT00291928February 200519 February 2015HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/IIA Double-blind, Randomized, Placebo Controlled, Dose Escalation, Multi-centerphase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20antibody, in Patients With Active Rheumatoid Arthritis Who Have Previously Failedone or More Disease Modifying Anti-rheumatic DrugsArthritis, RheumatoidDrug: Part A;Drug: Part BGlaxoSmithKlineNot recruiting18 YearsN/ABoth201Phase 2United States;Denmark;Finland;France;Hungary;Poland;United Kingdom
1788NCT00423358February 200519 October 2017Treatment of Hypovitaminosis D in Rheumatoid ArthritisTreatment of Hypovitaminosis D in Rheumatoid ArthritisRheumatoid Arthritis;Hypovitaminosis DDietary Supplement: Vitamin D;Dietary Supplement: placeboUniversity of Wisconsin, MadisonNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 Years90 YearsAll22N/AUnited States
1789NCT00522184February 200519 February 2015Intra-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 PfizerNot recruiting18 YearsN/ABoth34Phase 3France
1790EUCTR2004-004302-24-FI18/01/200519 March 2012A 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 ArthritisRheumatoid Arthritis
MedDRA version: 7.0 Level: LLT Classification code 10039073		Product Name: L-000883191
Product Code: L-000883191
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.25-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Paracetamol
Product Name: Paracetamol
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: 103-90-2
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 325-		Suomen MSD OyNot RecruitingFemale: yes
Male: yes		136Finland;Czech Republic;Germany;Spain;Italy
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1791NCT00106548January 200519 February 2015A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid ArthritisA Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: MethotrexateHoffmann-La RocheNot recruiting18 YearsN/ABoth623Phase 3Argentina;Australia;Austria;Brazil;Bulgaria;Canada;China;France;Germany;Hungary;Israel;Italy;Mexico;Singapore;Slovakia;Switzerland;Thailand;Spain
1792NCT00123149January 20053 October 2016Open-Label Extension Safety Study of PROCRIT in Patients With Anemia of Chronic Disease Due to Rheumatoid ArthritisAn Open-Label (OL) Extension Study to Assess Safety of PROCRIT (Epoetin Alfa) in Patients With Anemia of Chronic Disease (ACD) Due to Rheumatoid Arthritis (RA)Anemia;Rheumatoid ArthritisDrug: Epoetin alfaOrtho Biotech Products, L.P.Not recruiting18 Years99 YearsBoth0Phase 2
1793NCT00132769January 200519 October 2017A 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.Not recruiting18 Years65 YearsAll106Phase 2Belgium;Canada;Czech Republic;Finland;Germany;Italy;Norway;Spain;Switzerland
1794NCT00144573January 200519 February 2015Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal ImpairmentAn Open-Label, Clinical Pharmacology Study to Evaluate the Safety and PK of MRA in Patients With RA With Renal ImpairmentRheumatoid ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNot recruiting20 Years75 YearsBoth14N/A
1795NCT00147498January 200519 October 2017Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 WeeksA 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 ArthritisRheumatoid ArthritisDrug: CP-690,550;Other: PlaceboPfizerNot recruiting18 Years70 YearsAll264Phase 2United States;Belgium;Brazil;Canada;Germany;Italy;Mexico;Slovakia;Spain;Austria
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1796NCT00246168January 200519 February 2015ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.ULTRACET (Tramadol Hydrochloride and Acetaminophen) add-on Therapy for the Treatment of the Pain of Rheumatoid Arthritis: A Randomized, Double-blind, Placebo-controlled StudyArthritis, RheumatoidDrug: tramadol hydrochloride + acetaminophenJanssen Korea, Ltd., KoreaNot recruiting18 Years79 YearsBoth277Phase 4
1797NCT00365001January 200519 February 2015A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.A Randomized, Open-label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis.Rheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: Methotrexate;Drug: SimvastatinHoffmann-La RocheNot recruiting18 Years75 YearsBoth23Phase 1United States;New Zealand
1798NCT00583557January 200519 October 2017A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01A Multi-Center, Open-Label, Continuation Trial of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) Who Completed the Phase 2 Protocol LBRA01Rheumatoid ArthritisDrug: belimumabHuman Genome Sciences Inc.Not recruiting18 YearsN/AAll155Phase 2United States;Poland
1799EUCTR2005-000492-18-IT16/12/200419 March 2012Insulin 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 syndromeMetabolic Syndrome and Rheumatoid Arthritis
MedDRA version: 6.1 Level: SOC Classification code 10021428		Trade Name: REMICADE*EV F 100MG+F 2ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Infliximab
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-		POLICLINICO UNIVERSITARIO AGOSTINO GEMELLINot RecruitingFemale: yes
Male: yes		Italy
1800EUCTR2004-000922-59-SE01/12/200419 March 2012A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination with Methotrexate in Controlling Disease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate Clinical Response 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 Comparative Study of Abatacept or Infliximab in Combination with Methotrexate in Controlling Disease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate Clinical Response 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
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Abatacept
CAS Number: 332348-12-6
Current Sponsor code: BMS-188667
Other descriptive name: CTLA4Ig
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Infliximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use		Bristol Myers Squibb International CorporationNot RecruitingFemale: yes
Male: yes		660Phase 3Czech Republic;Denmark;Spain;Sweden
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1801EUCTR2004-002157-30-FI01/12/200419 March 2012A 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 ArthritisRheumatoid ArthritisProduct Code: TAK-715
Pharmaceutical Form: Tablet
Current Sponsor code: TAK-715
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: TAK-715
Pharmaceutical Form: Tablet
Current Sponsor code: TAK-715
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Takeda Europe R&D Centre Ltd. (TEuR&D)Not RecruitingFemale: yes
Male: yes		400Finland;Denmark
1802EUCTR2004-003741-40-AT26/11/200422 April 2013A 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: R04877533
Other descriptive name: MRA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use		F. Hoffmann La-Roche AGNot RecruitingFemale: yes
Male: yes		630Hungary;Austria;Germany;Italy
1803EUCTR2004-002006-30-GB17/11/200415 July 2013Triple therapy in early active rheumatoid arthritis - TEARTriple therapy in early active rheumatoid arthritis - TEARRheumatoid arthritisProduct Name: Methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 25-
Trade Name: Salazopyrin En-Tabs
Product Name: sulfasalazine
Pharmaceutical Form: Tablet
INN or Proposed INN: Sulfasalazine
Concentration unit: g gram(s)
Concentration type: up to
Concentration number: 4-
Trade Name: Plaquenil
Product Name: Hydroxychloroquine
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydroxychloroquine
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 400-		North Glasgow NHS TrustNot RecruitingFemale: yes
Male: yes		96United Kingdom
1804EUCTR2004-000563-96-HU12/11/200429 May 2012A 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) - COMETRheumatoid ArthritisTrade Name: Enbrel (etanercept)
Product Code: 0881
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: etanercept
CAS Number: N/Applicable
Current Sponsor code: 0881
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Methotrexate-Lachema
Product Name: methotrexate sodium tablets 2.5 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: methotrexate
CAS Number: 7413-34-5
Other descriptive name: methotrexate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Trade Name: Methotrexate-Lachema
Product Name: methotrexate sodium tablets 2.5 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: methotrexate
CAS Number: 7413-34-5
Other descriptive name: methotrexate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		Wyeth PharmaceuticalsNot RecruitingFemale: yes
Male: yes		580Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
1805NCT00170872November 200419 February 20156 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: LumiracoxibNovartisNot recruiting18 YearsN/ABoth135Phase 3
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1806NCT00195494November 200419 October 2017Study 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 PfizerNot recruiting18 YearsN/AAll542Phase 4United States
1807NCT00236028November 200419 February 2015A 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.Not recruiting18 Years75 YearsBoth607Phase 3
1808NCT00379600November 20047 November 2016The 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 XRGlaxoSmithKlineNot recruiting18 YearsN/ABoth96Phase 2Lithuania;United Kingdom
1809NCT00747214November 200419 October 2017A 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 TherapyZalicusNot recruiting18 YearsN/AAll59Phase 2
1810NCT00854321November 200419 February 2015Patients 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 HospitalNot recruiting18 YearsN/ABoth49N/AFinland
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1811NCT01600521November 200420 April 2015A 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 InstituteNot recruiting18 YearsN/ABoth1748N/AChina
1812EUCTR2004-000012-13-CZ26/10/20049 October 2012A 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)
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not yet established
CAS Number: 287405-51-0
Current Sponsor code: TMI-005
Other descriptive name: WAY-177005
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not yet established
CAS Number: 287405-51-0
Current Sponsor code: TMI-005
Other descriptive name: WAY-177005
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not yet established
CAS Number: 287405-51-0
Current Sponsor code: TMI-005
Other descriptive name: WAY-177005
Concentration unit: mg milligram(s)
Concentration number: 150-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and DevelopmentAuthorisedFemale: yes
Male: yes		360Czech Republic;Estonia;Italy
1813EUCTR2004-000482-35-GB11/10/200419 March 2012A 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. - HM2004/00255/00Rheumatoid ArthritisProduct Name: Rosiglitazone Extended Release Tablets
Product Code: BRL-049653
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Rosiglitazone
CAS Number: 0155141-29-0
Other descriptive name: Rosiglitazone maleate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use		GlaxoSmithKline Research & Development Ltd.AuthorisedFemale: yes
Male: yes		96United Kingdom;Lithuania
1814NCT00094341October 200419 February 2015Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled SyringesAn Open-Label, Randomized, Crossover Study to Assess Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled SyringesRheumatoid ArthritisDrug: EtanerceptAmgenNot recruiting18 YearsN/ABoth215Phase 4United States
1815NCT00242853October 200419 February 2015A Study To Investigate Markers Of Inflammation In Rheumatoid ArthritisAn Enabling Study to Investigate the Correlation of Biomarkers of the Activity of Inducible Nitric Oxide Synthase (iNOS) With Disease Activity and Treatment Response in Patients With Rheumatoid Arthritis(RA)Rheumatoid Arthritis;OsteoarthritisProcedure: Power doppler ultrasonography;Procedure: High frequency ultrasonography;Procedure: Exhaled nitric oxide assessmentGlaxoSmithKlineNot recruiting18 Years75 YearsBoth48N/AUnited Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1816NCT00650390October 200419 February 2015Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody AdalimumabOpen Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody AdalimumabRheumatoid ArthritisBiological: adalimumabAbbottNot recruiting18 YearsN/ABothN/A
1817EUCTR2004-001490-26-GB15/09/200415 July 2013A 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-RARHEUMATOID ARTHRITISTrade Name: Asendis 50 mg
Product Code: CRx-150
Pharmaceutical Form: Tablet
INN or Proposed INN: Amoxapine & dipyridamole
Current Sponsor code: CRx-150
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50 or 100 and-100
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		CombinatoRx, IncNot RecruitingFemale: yes
Male: yes		Estonia;United Kingdom
1818EUCTR2004-000612-54-SE11/09/200419 March 2012A 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 StudyOsteoarthritis (OA) ICD: M19.9 MedDRA: 10031161 Rheumatoid Arthritis (RA) ICD: M06.9 MedDRA: 10039037Product Name: L-001069957
Product Code: L-001069957
Pharmaceutical Form: Tablet
INN or Proposed INN: 6-(nitrooxy)hexyl(2Z)-4-(acetyloxy)-3-[4-(methylsulfonyl)phenyl]-2-phenylbut-2-enoate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 21-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: L-001069957
Product Code: L-001069957
Pharmaceutical Form: Tablet
INN or Proposed INN: 6-(nitrooxy)hexyl(2Z)-4-(acetyloxy)-3-[4-(methylsulfonyl)phenyl]-2-phenylbut-2-enoate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 42-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Aspirin Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Acetylsalicylic acid
CAS Number: 530-75-6
Other descriptive name: Acetylsalicylic Acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Celebrex
Product Name: Celecoxib
Pharmaceutical Form: Capsule*
INN or Proposed INN: Celecoxib
CAS Number: 169590-42-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use		Merck Sharp & Dohme (Sweden) ABNot RecruitingFemale: yes
Male: yes		1360Sweden
1819EUCTR2004-000106-41-SE07/09/200419 March 2012A 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 methotrexateThe 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
Pharmaceutical Form: Capsule*		GlaxoSmithKline Research & Development LtdNot RecruitingFemale: yes
Male: yes		Sweden
1820NCT00117091September 200419 February 2015Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA)An Open-Label Multicentre Study of Anakinra (Kineret®) in Combination With DMARDS in Subjects With Active Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: Anakinra (Kineret®)AmgenNot recruiting18 YearsN/ABothPhase 3
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1821NCT00412256September 200419 February 2015Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)Clinical Trial to Evaluate the Effect of Parenteral Supplementation With Omega-3-Fatty Acids in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Omegaven (10% fish-oil emulsion; Fresenius-Kabi)Humanis Klinikum NiederosterreichNot recruiting18 YearsN/ABoth60Phase 3Austria
1822NCT00638950September 200419 February 2015A Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products in Patients With Rheumatoid ArthritisLong-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products: Effects on Pathophysiological Biomarkers in Rheumatoid ArthritisRheumatoid ArthritisDietary Supplement: n-3 LC-PUFA;Dietary Supplement: PlaceboUniversity of JenaNot recruiting35 Years74 YearsBoth45N/AGermany
1823NCT00831649September 200427 June 2016A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201Rheumatoid ArthritisDrug: natalizumabBiogenElan PharmaceuticalsNot recruiting18 Years75 YearsBothPhase 2
1824NCT00831922September 200418 December 2018Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid ArthritisA Multicenter, Open Label, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis With Inadequate Response to at Least One Disease Modifying Anti Rheumatic Drugs (DMARD)Rheumatoid ArthritisDrug: masitinib (AB1010)AB ScienceNot recruiting18 YearsN/AAll43Phase 2
1825NCT00095498August 200416 December 2017Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid ArthritisA Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid ArthritisRheumatoid ArthritisDrug: placebo;Drug: denosumabAmgenNot recruiting18 YearsN/AAll227Phase 2United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1826NCT00146640August 200419 February 2015Prednisone Timed-Release Tablet (TRT) Study: TRT Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid ArthritisA New Timed-release Tablet Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis- A Randomized, Multi-centre, Double-blind, Active Controlled Study With Open Extension on the New Drug OnlyRheumatoid ArthritisDrug: PrednisoneMerck KGaANot recruiting18 Years80 YearsBoth288Phase 3Germany;Poland
1827NCT00234897August 200419 February 2015Efficacy of HUMIRA in Subjects With Active Rheumatoid ArthritisHumira Efficacy Response Optimization Study in Subjects With Active Rheumatoid Arthritis (HERO)Rheumatoid ArthritisDrug: adalimumabAbbottNot recruiting18 YearsN/ABoth1938Phase 4United States
1828NCT00235872August 200419 October 2017Adalimumab in Adult Japanese Subjects With Rheumatoid ArthritisOpen-Label Continuous Administration Study With Adalimumab (D2E7) in Subjects With Rheumatoid ArthritisRheumatoid ArthritisBiological: adalimumabAbbottAbbott Japan Co.,Ltd;Eisai Co., Ltd.Not recruiting20 YearsN/AAll309Phase 3Japan
1829NCT00279734August 200419 February 2015Vaccination 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 SquibbNot recruiting18 Years65 YearsBoth80Phase 1United States
1830NCT00696059August 200419 February 2015Humira in Rheumatoid Arthritis - Do Bone Erosions Heal?Can Bone Erosions Heal in Adalimumab (Humira) Treated Rheumatoid Arthritis Patients. An Imaging Study Using Computed Tomography and Magnetic Resonance Imaging.Rheumatoid Arthritis;Arthritis;Joint DiseasesDrug: Adalimumab (Humira)Hvidovre University HospitalAbbottNot recruiting18 Years90 YearsBoth52Phase 4Denmark
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1831EUCTR2004-000362-12-CZ23/07/200419 March 2012A 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/ARheumatoid Arthritis
MedDRA version: 6.0 Level: LLT Classification code 10028395		Product Name: K-832
Product Code: K-832
Pharmaceutical Form: Tablet
INN or Proposed INN: To be confirmed
CAS Number: 225666-85-3
Current Sponsor code: K-832
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: K-832
Product Code: K-832
Pharmaceutical Form: Tablet
INN or Proposed INN: To be confirmed
CAS Number: 225666-85-3
Current Sponsor code: K-832
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use		Kowa Research Europe LtdNot RecruitingFemale: yes
Male: yes		260Czech Republic
1832EUCTR2004-000074-31-SE06/07/200419 March 2012A 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 Arthritisrheumatoid 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
Pharmaceutical Form: Tablet
INN or Proposed INN: not available
Other descriptive name: L-000124467
Concentration unit: mg milligram(s)
Concentration number: 0.2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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
Pharmaceutical Form: Tablet
INN or Proposed INN: not available
Other descriptive name: L-000124467
Concentration unit: mg milligram(s)
Concentration number: 1.0-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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
Pharmaceutical Form: Tablet
INN or Proposed INN: not available
Other descriptive name: L-000124467
Concentration unit: mg milligram(s)
Concentration number: 5.0-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: paracetamol (acetaminophen)
Product Name: paracetamol (acetaminophen)
Pharmaceutical Form: Tablet
CAS Number: 103-90-2
Concentration unit: mg milligram(s)
Concentration number: 325-		Merck Sharp & Dohme (Sweden) ABNot RecruitingFemale: yes
Male: yes		150Sweden
1833NCT00239382July 1, 200420 August 2018A Study to Compare Meloxicam IM Once Daily Versus Meloxicam Orally Once Daily in Patients With Rheumatoid ArthritisA Randomized, Open-labelled Study to Compare the Efficacy and Safety of Meloxicam 15 mg IM Ampoules Once Daily and Meloxicam 15 mg Tablets Administered Orally Once Daily Over a Period of 7 Days in Patients With RA.Arthritis, RheumatoidDrug: Meloxicam ampoule;Drug: Meloxicam tabletBoehringer IngelheimNot recruiting18 YearsN/AAll150Phase 3China
1834NCT00089921July 200419 February 2015SPRiNG: 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.Not recruiting18 YearsN/ABoth302Phase 2United States
1835NCT00154336July 200416 December 2017A 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 PharmaceuticalsNot recruiting18 Years75 YearsAll50Phase 2Austria;Canada;Finland;United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1836NCT00236678July 200419 February 2015Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients With ACD Due to RA Receiving PROCRITA Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients With Anemia of Chronic Disease (ACD) Due to Rheumatoid Arthritis Receiving PROCRIT? (Epoetin Alfa)Anemia;Rheumatoid ArthritisDrug: Epoetin alfaJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Ortho Biotech Products, L.P.Not recruiting18 YearsN/ABoth29Phase 2
1837NCT00506896July 200419 February 2015Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis PatientsMonoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients: A Randomized Double-Blind Controlled StudyRheumatoid ArthritisDrug: intraarticular injectionFederal University of São PauloNot recruiting18 Years65 YearsBoth60Phase 2Brazil
1838NCT00094562June 200428 January 2019A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight LossAAFA™ Fish Oil Nutritional Supplementation to Maintain Body Weight in Patients With Disease-Related Weight LossCancer;Cancer Cachexia;Chronic Obstructive Pulmonary Disease;Chronic Heart Failure;Rheumatoid ArthritisDrug: Fish oil supplementSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNational Center for Complementary and Integrative Health (NCCIH)Not recruiting18 Years90 YearsAll25Phase 2United States
1839NCT00144534June 200419 February 2015Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JPAn Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA213JPRheumatoid ArthritisDrug: MRA (Tocilizumab)Chugai PharmaceuticalNot recruiting20 Years75 YearsBoth115Phase 3
1840NCT00244153June 200419 February 2015Intraarticular Opioids Vs Glucocorticosteroids in GonarthritisIntraarticular Application of Opioids Versus Glucocorticosteroids Versus Placebo in Rheumatoid ArthritisRheumatic DiseaseDrug: intraarticular morphine;Drug: intraarticular dexamethasoneCharite University, Berlin, GermanyRecruiting19 YearsN/ABoth120Phase 1/Phase 2Germany
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1841NCT00252668June 200419 February 2015Study 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 PfizerNot recruiting18 YearsN/ABoth300Phase 4
1842NCT00273533June 200419 February 2015Ramipril in Rheumatoid ArthritisEffects of Ramipril on Endothelial Function in Patients With Rheumatoid ArthritisArthritis, RheumatoidDrug: RamiprilUniversity of ZurichSanofiNot recruiting18 Years60 YearsBoth13Phase 2/Phase 3Switzerland
1843NCT00542022June 20042 November 2015Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis (0812-008)A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK0812 in Rheumatoid Arthritis PatientsArthritis, RheumatoidDrug: MK0812 / Duration of Treatment: 12 Weeks;Drug: Comparator: placebo (unspecified) / Duration of Treatment: 12 WeeksMerck Sharp & Dohme Corp.Not recruiting18 Years65 YearsBoth149Phase 2
1844NCT02097745June 200419 October 2017A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response 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 TherapiesRheumatoid ArthritisDrug: methotrexate;Drug: rituximab [MabThera/Rituxan]Hoffmann-La RocheBiogenNot recruiting18 Years80 YearsAll341Phase 3United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom
1845NCT00083759May 200419 October 2017Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving MethotrexateA Phase II, Multicenter, Double-blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Natalizumab (300 mg) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Receiving Concomitant Treatment With Methotrexate (MTX)Rheumatoid ArthritisDrug: natalizumab;Drug: placeboBiogenElan PharmaceuticalsNot recruiting18 Years75 YearsAll299Phase 2United States;Canada
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1846NCT00099554May 200419 February 2015Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)A Phase 4, Open-Label, Single Arm, Observational Study Evaluating the Effectiveness and Safety of Enbrel® (Etanercept) 50 mg Once Weekly in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)Rheumatoid ArthritisDrug: EtanerceptAmgenNot recruiting18 YearsN/ABoth200Phase 4United States;Canada
1847NCT00110903May 200419 February 2015Treatment for Subjects With Active Rheumatoid Arthritis (RA)Open-Label Study to Assess the Safety of Etanercept Liquid Administered Once Weekly in Subjects With Active Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: Etanercept LiquidAmgenNot recruiting18 YearsN/ABothPhase 3
1848NCT00195338May 200419 October 2017Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In LuxemburgA Post-Marketing Surveillance Looking At Safety And Adherence To Treatment Of Enbrel In Adults With Active Rheumatoid Arthritis In LuxemburgRheumatoid ArthritisDrug: etanerceptPfizerInnovex, IncNot recruiting17 YearsN/AAll25N/ALuxembourg
1849NCT00195403May 200419 October 2017A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsAA Drug Use Investigation of Enbrel for Post-Marketing SurveillanceRheumatoid ArthritisDrug: EtanerceptPfizerNot recruiting4 YearsN/AAll1014N/AKorea, Republic of
1850NCT00259610May 200419 October 2017Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)Rheumatoid ArthritisDrug: methotrexate;Drug: sulfasalazine;Drug: hydroxychloroquine;Drug: etanerceptUniversity of Alabama at BirminghamAmgen;Barr Laboratories;PfizerNot recruiting18 YearsN/AAll755Phase 4United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1851NCT00291915May 200419 February 2015Multicenter Randomized Prospective Trial Comparing Methotrexate Alone or in Combination With Adalimumab in Early ArthritisMethotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early ArthritisRheumatoid Arthritis;ArthritisDrug: Adalimumab;Drug: MethotrexateGoupe d'Etudes et de Recherche Clinique En RhumatologieRecruiting18 YearsN/ABoth80Phase 4France
1852NCT00144547April 200419 February 2015Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JPAn Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA012JPRheumatoid ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNot recruiting20 YearsN/ABoth241Phase 3
1853NCT00280644April 200419 February 2015Leflunomide in Rheumatoid ArthritisEfficacy of Leflunomide on Joint Inflammation and Destruction of Joint Integrity in Active Rheumatoid Arthritis (RA) PatientsArthritis, RheumatoidDrug: LeflunomideSanofiNot recruiting18 Years75 YearsBoth60Phase 4Turkey
1854NCT00468377March 200419 February 2015Safety 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.Not recruiting18 Years80 YearsBoth341Phase 3United States
1855NCT00484809March 200419 February 2015Study 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 PfizerNot recruiting4 YearsN/ABoth100Phase 4
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1856NCT00725621March 200419 October 2017Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)Real Life Dosing Regimen of Remicade in Austria, Monitored Over 9 Consecutive Infusions in Rheumatoid Arthritis TherapyRheumatoid ArthritisBiological: InfliximabMerck Sharp & Dohme Corp.Centocor, Inc.Not recruitingN/AN/AAll516N/AAustria
1857NCT00077870February 200419 February 2015A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid ArthritisA Randomized, Placebo-Controlled, Multicenter, Blinded Phase I/II Study of the Safety of Escalating Doses of Ocrelizumab (PRO70769) in Subjects With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant MethotrexateRheumatoid ArthritisDrug: ocrelizumabGenentech, Inc.Not recruiting18 Years80 YearsBoth237Phase 1/Phase 2United States
1858NCT00144521February 200419 February 2015Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)A Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RARheumatoid ArthritisDrug: MRA(Tocilizumab);Drug: MRA placebo;Drug: MTX;Drug: MTX placeboChugai PharmaceuticalNot recruiting20 Years75 YearsBoth127Phase 3
1859NCT00224562February 200419 February 2015The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a AntagonistsThe RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a AntagonistsRheumatoid Arthritis;Crohn's Disease;Ankylosing Spondylitis;PsoriasisDrug: TNF-alpha antagonistsAssistance Publique - Hôpitaux de ParisRecruitingN/AN/ABothN/AFrance
1860NCT00367965February 200419 February 2015Study of Eszopiclone Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid ArthritisThe Effect of Eszopiclone 3 mg Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid ArthritisInsomnia;Arthritis, RheumatoidDrug: Eszopiclone;Drug: placeboSunovionNot recruiting25 Years64 YearsBoth153Phase 3United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1861NCT00647491February 200419 February 2015A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid ArthritisRheumatoid ArthritisBiological: adalimumab;Biological: placeboAbbottEisai LimitedNot recruiting20 YearsN/ABoth352Phase 2/Phase 3Japan
1862NCT00679510February 200411 November 2019Rosuvastatin in Rheumatoid Arthritis (RORA)Phase 2: Effects of Rosuvastatin on Surrogate Markers for Cardiovascular Events in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: rosuvastatin;Drug: placeboUniversity of DundeeNot recruiting40 YearsN/AAll50Phase 2/Phase 3United Kingdom
1863NCT00157872January 7, 200416 December 2017A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231)A Multicenter, Randomized, Parallel-Group, 8-Week, Double-Blind, and Active Comparator-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Rofecoxib Tablet 25 mg Once Daily Versus Naproxen Table 500 mg Twice Daily in the Treatment of Chinese Patient With Rheumatoid ArthritisRheumatoid ArthritisDrug: MK0966; rofecoxib;Drug: Comparator: naproxen tablet 500 mgMerck Sharp & Dohme Corp.Not recruiting18 YearsN/AAll150Phase 4China
1864NCT00378261January 200419 February 2015APART Advanced Profiling of Anti-Rheumatic TherapiesA Multicenter, Randomized, Open Study to Evaluate the Impact of an Electronic Data Capture System on the Care of Patients With Rheumatoid ArthritisArthritis, RheumatoidProcedure: Use of an Electronic Data Capture System by patients and physicians to assess patient-physician interactions & therapeutic decisions & outcomes in RA subjects.Centocor Ortho Biotech Services, L.L.C.Not recruiting18 YearsN/ABoth1079Phase 4
1865NCT00071812December 200319 October 2017A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)Arthritis, RheumatoidDrug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 4 mg/kg;Drug: Belimumab 10 mg/kgHuman Genome Sciences Inc.Not recruiting18 Years65 YearsAll283Phase 2United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1866NCT00076206December 200321 December 2015Study 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 PfizerNot recruiting18 Years75 YearsBothPhase 2United States
1867NCT00095173December 200319 October 2017BMS-188667 in Children and Adolescents With Juvenile Rheumatoid ArthritisA Phase III, Multi-Center, Multi-National, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents With Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)Juvenile Rheumatoid ArthritisDrug: Abatacept;Drug: PlaceboBristol-Myers SquibbNot recruiting6 Years17 YearsAll214Phase 3United States;Austria;Brazil;France;Germany;Italy;Mexico;Peru;Portugal;Spain;Switzerland
1868NCT00234936December 200319 February 2015Quality of Life Study With Adalimumab in Rheumatoid ArthritisQuality of Life Study With Adalimumab in Rheumatoid ArthritisRheumatoid ArthritisDrug: Adalimumab;Drug: MethotrexateAbbottNot recruiting18 YearsN/ABoth200Phase 3
1869NCT00619905December 200319 February 2015Safety, 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: ACZ885NovartisNot recruiting18 Years75 YearsBoth53Phase 1/Phase 2Germany;Netherlands;Switzerland
1870NCT00207714November 200319 October 2017An 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 BVNot recruiting18 YearsN/AAll172Phase 2
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1871NCT00162201October 200316 December 2017An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF TherapyAn Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF TherapyRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbNot recruiting18 YearsN/AAll16Phase 1United Kingdom
1872NCT00649922October 200319 February 2015Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid ArthritisAssessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid ArthritisRheumatoid ArthritisBiological: adalimumab;Biological: placeboAbbottNot recruiting20 YearsN/ABoth226Phase 4
1873NCT00069017September 200319 February 2015Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients With Active Rheumatoid Arthritis Suboptimally Responding to MethotrexateA Phase II, Randomized, Double-Blind Study to Evaluate the Effects of MEDI-522, a Humanized MAb to Integrin Alpha V Beta 3, On Disease Activity and Progression of Joint Damage in Pts With Active Rheumatoid Arthritis Suboptimally Responding to MethotrexateRheumatoid ArthritisBiological: MEDI-522;Other: PlaceboMedImmune LLCNot recruiting18 YearsN/ABoth300Phase 2United States;Canada
1874NCT00234884September 200319 October 2017Post-marketing Observational Study in Subjects With Rheumatoid ArthritisA Five-year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed HumiraRheumatoid ArthritisBiological: adalimumabAbbottNot recruiting18 YearsN/AAll3435Phase 4Australia;Austria;Belgium;France;Germany;Greece;Italy;Netherlands;Portugal;Spain;United Kingdom
1875NCT00221000August 200331 October 2016Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid ArthritisA Phase II, Multicenter, Randomized, Double-blind, Sham Pheresis-controlled, Study of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis in Patients Who Have an Inadequate Response to Disease Modifying Antirheumatic Drugs and Biological AgentsRheumatoid ArthritisDrug: Methoxsalen;Procedure: Extracorporeal PhotopheresisMallinckrodtNot recruiting18 YearsN/ABoth86Phase 2United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Mexico;Slovakia;South Africa
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1876NCT00794898July 1, 200316 December 2017Efficacy of Remicade in the Treatment of Active Rheumatoid Arthritis Despite Methotrexate (Study P03027)Onset of Efficacy of Anti-TNF Chimeric Monoclonal Antibody (Remicade) in the Treatment of Patients With Active Rheumatoid Arthritis Despite Methotrexate TreatmentArthritis, RheumatoidBiological: Infliximab (Remicade)Merck Sharp & Dohme Corp.Not recruiting18 Years75 YearsAll19Phase 4
1877NCT00195364July 200319 February 2015Study 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 PfizerNot recruiting18 YearsN/ABoth93Phase 4Spain
1878NCT00235859July 200319 February 2015Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With MethotrexateA Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Injections in Korean Rheumatoid Arthritis Subjects Treated With MethotrexateRheumatoid ArthritisDrug: adalimumab;Drug: methotrexateAbbottEisai LimitedNot recruiting18 YearsN/ABoth128Phase 3
1879NCT00647920July 200319 February 2015Study of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With MethotrexateStudy of the Human Anti-TNF-Antibody AdalimumabRheumatoid ArthritisBiological: adalimumab;Biological: placeboAbbottNot recruiting18 YearsN/ABoth47Phase 3Taiwan
1880NCT00649545July 200319 February 2015Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid ArthritisA Multi-Center Study of the Safety and Efficacy of Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: adalimumabAbbottNot recruiting18 YearsN/ABothN/A
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1881NCT02184052July 200319 February 2015Safety and Efficacy of Mobic® Ampoules in the Initiation of Treatment of Painful Exacerbations of Osteoarthritis, Rheumatoid Arthritis and Other Similar Painful Inflammatory ConditionsMeloxicam (MOBIC®) Ampoule Post Marketing Surveillance StudyArthritis, RheumatoidDrug: MeloxicamBoehringer IngelheimNot recruitingN/AN/ABoth121N/A
1882NCT00062465June 200319 February 2015Treating Rheumatoid Arthritis With Tripterygium Wilfordi Hook F or SulfasalazineA 24-Week, Double Blind, Randomized Study to Determine the Effects of 24 Weeks of Dosing With Tripterygium Wilfordii Hook F (TwHF) or Sulfasalazine, in Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: TwHFNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruitingN/AN/ABoth157Phase 2United States
1883NCT00074438June 200319 February 2015Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid ArthritisRandomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: methotrexate;Drug: rituximab;Drug: corticosteroids;Drug: placeboGenentech, Inc.Roche Pharma AGNot recruiting18 Years80 YearsBoth465Phase 2United States
1884NCT00213538June 200316 December 2017Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid ArthritisGene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid ArthritisRheumatoid ArthritisDrug: Response to anakinra associated with methotrexateUniversity Hospital, RouenNot recruiting18 YearsN/AAll341N/AFrance
1885NCT00235833June 200319 October 2017Adalimumab in Adult Japanese Subjects With Rheumatoid ArthritisLong-term Continuously Repeated Dose Study of Adalimumab (D2E7) in Patients With Rheumatoid ArthritisRheumatoid ArthritisBiological: adalimumabAbbottAbbott Japan Co.,Ltd;Eisai Co., Ltd.Not recruiting20 YearsN/AAll25Phase 2Japan
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1886NCT00245934June 200319 February 2015Study Evaluating Enbrel in Patients With Rheumatoid ArthritisObservational Study With Enbrel in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: EnbrelWyeth is now a wholly owned subsidiary of PfizerNot recruiting18 YearsN/ABoth1500N/A
1887NCT00317538June 200319 February 2015Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to EtanerceptOpen-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to EtanerceptRheumatoid ArthritisDrug: infliximab, etanerceptCentocor Ortho Biotech Services, L.L.C.Not recruiting18 YearsN/ABoth28Phase 3
1888NCT00396747June 200319 February 2015A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging StudyPhase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse MethylprednisoloneRheumatoid ArthritisDrug: Infliximab, methylprednisolone, methotrexate;Drug: Methotrexate;Drug: Methotrexate + Methylprednisolone;Drug: Methotrexate + InfliximabUniversité Catholique de LouvainNot recruiting18 YearsN/ABoth45Phase 4Belgium
1889NCT00548834June 200319 February 2015Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid ArthritisEfficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARDRheumatoid ArthritisDrug: CDP870UCB PharmaNot recruiting18 Years75 YearsBoth220Phase 3
1890NCT00095342May 200319 February 2015Study 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 PfizerNot recruiting18 Years75 YearsBoth390Phase 2United States;Canada
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1891NCT00468546May 200319 October 2017A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha TherapyA Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha TherapiesRheumatoid ArthritisDrug: MabThera/Rituxan;Drug: Methotrexate;Other: PlaceboHoffmann-La RocheBiogenNot recruiting18 Years80 YearsAll520Phase 3United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom
1892NCT00563849May 200319 February 2015Leflunomide + Methotrexate in Rheumatoid ArthritisAn Open-Label, Multi-Center Study to Evaluation of Leflunomide Plus Methotexate for the Treatment of Rheumatoid Arthritis in DMARDs:(Disease-Modifying Antirheumatic Drug) na¿ve or Restart (Skip DMARDs More Than 4 Weeks) Subjects.Rheumatoid ArthritisDrug: LeflunomideSanofiNot recruiting18 Years75 YearsBoth74Phase 4Korea, Republic of
1893NCT02214888May 200319 February 2015Efficacy, Safety and Pharmacokinetics of BIRB 796 BS Tablets in Patients With Active Rheumatoid ArthritisA 12 Week Double-blind, Randomized, Placebo-controlled Trial to Investigate Efficacy, Safety and Pharmacokinetics of BIRB 796 BS Tablets at Doses of 50 and 70 mg Administered Twice a Day in Patients With Active Rheumatoid Arthritis Who Have Failed at Least One DMARDArthritis, RheumatoidDrug: BIRB 796 BS, low dose;Drug: BIRB 796 BS, high dose;Drug: PlaceboBoehringer IngelheimNot recruiting18 Years75 YearsBoth170Phase 2
1894NCT00195377April 200319 February 2015Study 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 PfizerNot recruiting4 YearsN/ABoth1000Phase 4Spain
1895NCT00213564April 200319 February 2015Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid ArthritisGene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid ArthritisRheumatoid ArthritisDrug: response to infliximab associated with methotrexateUniversity Hospital, RouenNot recruiting18 YearsN/ABoth40Phase 4France
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1896NCT00144508March 200319 February 2015Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA)An Open-Label, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RARheumatoid ArthritisDrug: MRA (Tocilizumab);Other: current treatmentChugai PharmaceuticalNot recruiting20 YearsN/ABoth306Phase 3
1897NCT00160693March 200311 June 2018Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid ArthritisA Phase III, Multicenter, Open-Label Long-Term Study to Assess the Safety and Tolerability of CDP870 400 mg Subcutaneously Every 4 Weeks, in Subjects With Rheumatoid ArthritisRheumatoid ArthritisBiological: Certolizumab PegolUCB PharmaNot recruiting18 YearsN/AAll402Phase 3United States;Austria;Belgium;Czechia;Germany;Ireland;United Kingdom;Czech Republic
1898NCT00234845March 200319 February 2015Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid ArthritisA Multi-Centre Randomized, Double-Blind Study Comparing Adalimumab (D2E7) Plus Methotrexate With Placebo Plus Methotrexate on Work Disability in Subjects With Early Rheumatoid ArthritisRheumatoid ArthritisDrug: adalimumab;Drug: methotrexateAbbottNot recruiting18 YearsN/ABoth148Phase 3United States
1899NCT00244556March 200319 February 2015Study 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 PfizerNot recruiting18 YearsN/ABoth300Phase 4
1900NCT00356473March 200319 February 2015Effects of Atorvastatin on Disease Activity and HDL Cholesterol Function in Patients With Rheumatoid ArthritisEffects of Atorvastatin on Disease Activity and HDL Cholesterol Anti-inflammatory Properties in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: AtorvastatinUniversity of California, Los AngelesNot recruiting18 YearsN/ABoth20Phase 4
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1901NCT00908089March 200313 April 2015TNF-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-HameNot recruiting18 Years60 YearsBoth100Phase 4Finland
1902NCT00092742February 20033 August 2015Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of Etoricoxib 90 mg q.d. vs. Diclofenac Sodium 75 mg b.i.d. in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: MK0663, etoricoxib;Drug: Comparator: Diclofenac sodiumMerck Sharp & Dohme Corp.Not recruiting50 YearsN/ABoth4086Phase 3United States
1903NCT00650455February 200319 February 2015Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis PatientsClinical Protocol for a Multicenter, Double-Blind, Randomized, Placebo Controlled, Comparison of the Efficacy and Safety of Bextra® (Valdecoxib) 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe RA PopulationArthritis, RheumatoidDrug: valdecoxib;Drug: naproxen;Drug: placeboPfizerNot recruiting18 YearsN/ABoth489Phase 4United States;Canada
1904NCT00250445January 200310 August 2015A Study to Evaluate the Safety of an Investigational Drug (Etoricoxib) in Patients With Osteoarthritis (OA) or Rheumatoid Arthritis (RA)(0663-066)A Randomized, Double-Blind, Active-Comparator-Controlled, Parallel-Group Study to Evaluate the Safety of Etoricoxib in Patients With Osteoarthritis or Rheumatoid ArthritisRheumatoid Arthritis,OsteoarthritisDrug: MK0663, etoricoxib;Drug: Comparator: Diclofenac sodiumMerck Sharp & Dohme Corp.Not recruiting50 YearsN/ABoth23498Phase 3
1905NCT00546533January 200319 February 2015Study 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 PfizerNot recruitingN/AN/ABoth40Phase 4
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1906NCT00048568December 200219 October 2017A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to MethotrexateA Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to MethotrexateRheumatoid ArthritisDrug: Abatacept;Drug: Methotrexate;Drug: PlaceboBristol-Myers SquibbNot recruiting18 YearsN/AAll1250Phase 3United States
1907NCT00048581December 200219 October 2017Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 in Subjects With Active Rheumatoid Arthritis on Background Disease Modifying Anti-Rheumatic Drugs (DMARDS) Who Have Failed Anti-Tumor Necrosis Factor (TNF) TherapyRheumatoid ArthritisDrug: Abatacept;Drug: PlaceboBristol-Myers SquibbNot recruiting18 YearsN/AAll738Phase 3United States
1908NCT00048932December 200219 October 2017A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Double-blind Abatacept;Drug: Double-blind Placebo;Drug: Open-label AbataceptBristol-Myers SquibbNot recruiting18 YearsN/AAll1795Phase 3United States
1909NCT00433875December 200219 February 2015Phase 2 AMG 714 in Rheumatoid ArthritisA Double-Blind, Placebo Controlled, Randomized, Parallel-Group Clinical Trial With Multiple Dose Treatment of Anti-IL 15 Human Monoclonal Antibody (AMG 714) in Patients With Active Rheumatoid Arthritis Who Have Previously Failed One or More Disease Modifying Anti-Rheumatic DrugsRheumatoid ArthritisDrug: AMG 714AmgenNot recruiting18 YearsN/ABoth180Phase 2
1910NCT00482417December 20027 December 2015Efficacy and Safety Study of MK0359 in Patients With Arthritis (0359-017)Rheumatoid ArthritisDrug: MK0359Merck Sharp & Dohme Corp.Not recruiting18 Years65 YearsBoth11Phase 2
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1911NCT00764725December 200219 February 2015Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT)A Prospective Randomized, Open, Multi-Center Trial Comparing TNF-Blockade + MTX to MTX+SSZ+HCQ in Patients With Early RA With an Inadequate Response to MTXRheumatoid ArthritisDrug: conventional DMARD combination;Biological: MTX plus anti-TNFKarolinska InstitutetNot recruiting18 YearsN/ABoth487Phase 4
1912NCT00116727October 200219 February 2015Rheumatoid 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 PfizerNot recruiting18 YearsN/ABoth5103N/AUnited States
1913NCT00121043October 200219 February 2015Evaluating Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using aSelf-Reported QuestionnaireAn Open Label, Randomized, Crossover Study to Assess Acceptability and Functionality of SimpleJectTM Vs Pre-Filled Syringe(s) Using Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using A Self-Reported QuestionnaireRheumatoid ArthritisDevice: SimpleJectTM;Drug: Kineret® (Anakinra)AmgenNot recruiting18 YearsN/ABothPhase 4
1914NCT00544154October 200219 February 2015Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid ArthritisEfficacy and Safety of CDP870 400 mg in Combination With Methotrexate Compared to Methotrexate Alone in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Are Partial Responders to MethotrexateArthritis, RheumatoidDrug: CDP870UCB PharmaNot recruiting18 Years75 YearsBoth247Phase 3
1915NCT00042406September 200219 February 2015Trial With HuMax-CD4 in Patients With Rheumatoid Arthritis Failing Treatment With Methotrexate and a TNF-alpha BlockerA Double-Blind, Placebo-Controlled, Randomized, Parallel Group Clinical Trial of Anti-CD4 Receptor Human Monoclonal Antibody (HuMax-CD4) in Patients With Active RA Failing Treatment With Methotrexate and TNF-alpha Blocking AgentsRheumatoid ArthritisDrug: HuMax-CD4Emergent Product Development Seattle LLCNot recruiting18 YearsN/ABoth75Phase 2/Phase 3United States;Canada
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1916NCT00049751September 200219 February 2015Study of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid ArthritisA Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: AdalimumabAbbottNot recruiting18 YearsN/ABoth3000Phase 3United States
1917NCT00055133September 200219 February 2015A Study Using Intravenous Paxceed™ to Treat Patients With Rheumatoid ArthritisA Phase 2 Open-Label Clinical Study Using Intravenous Paxceed™ to Treat Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Micellar Paclitaxel for InjectionAngiotech PharmaceuticalsNot recruiting21 Years70 YearsBoth50Phase 2United States
1918NCT00121056September 200219 February 2015REKinDLE: Registry With Enbrel® or Kineret® in a Database Using Longitudinal EvaluationsRegistry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations (REKinDLE)Rheumatoid ArthritisDrug: Enbrel®;Drug: Kineret®AmgenNot recruiting18 YearsN/ABothN/A
1919NCT00282412September 20028 August 2016Rheumatoid Arthritis:Tolerance Induction by Mixed ChimerismRheumatoid Arthritis: Tolerance Induction by Mixed ChimerismRheumatoid ArthritisBiological: Hematopoietic Stem Cell TransplantationNorthwestern UniversityNot recruiting18 Years60 YearsBoth4Phase 1United States
1920NCT00448383September 200219 February 2015A Study to Assess the Safety and Efficacy of Adalimumab When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid ArthritisAn Open-Label, Multi-Center Study to Assess the Safety and Efficacy of the Fully Human Anti-TNF-a Monoclonal Antibody Adalimumab (D2E7) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: adalimumabAbbottNot recruiting18 YearsN/ABoth6610Phase 3
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1921NCT00946686September 200216 December 2017To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting ConditionsA Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting ConditionsRheumatoid Arthritis;Psoriatic ArthritisDrug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical);Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)SandozNot recruiting18 YearsN/AAll52Phase 1
1922NCT00111423August 200219 February 2015Evaluating the Safety of Extended Treatment With Pegsunercept (PEG sTNF-RI)in Subjects With Rheumatoid Arthritis (RA)Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of Extended Treatment With Pegsunercept (PEG sTNF-RI) in Subjects With Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: Pegsunercept (PEG sTNF-RI)AmgenNot recruiting18 YearsN/ABoth216Phase 2
1923NCT02093026August 200216 December 2017Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)An Open-label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera®/Rituxan®) in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Rituximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Folic AcidHoffmann-La RocheGenentech, Inc.Not recruiting21 YearsN/AAll465Phase 2United States;Australia;Belgium;Brazil;Canada;Czech Republic;Finland;Germany;Israel;Italy;Mexico;New Zealand;Poland;Spain;Sweden;United Kingdom
1924NCT00043732July 200219 February 2015Safety Study of SCIO-469 to Treat Patients With Active Rheumatoid Arthritis Receiving MethotrexateA Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study of SCIO-469 in Patients in Active Rheumatoid Arthritis Receiving MethotrexateRheumatoid ArthritisDrug: SCIO-469Scios, Inc.Not recruiting18 YearsN/ABoth120Phase 2United States
1925NCT00650026July 200219 February 2015Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid ArthritisMulticenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: adalimumabAbbottNot recruiting18 YearsN/ABothN/A
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1926NCT00042068June 200219 February 2015A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid ArthritisA Multi-center, Double-Blind, Randomized, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of Meloxicam (7.5, 15, and 22.5 mg) and Placebo in Patients With Rheumatoid ArthritisArthritis, RheumatoidDrug: MeloxicamBoehringer IngelheimNot recruiting18 Years80 YearsBoth1000Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;France;Germany;Hungary;Italy;Korea, Republic of;Russian Federation;Taiwan;Ukraine
1927NCT00034060April 200219 February 2015The Role of Cytokines on Growth Hormone Suppression in Premenopausal Women With Rheumatoid Arthritis and the Effect of Treatment With EtanerceptSuppression of the Growth Hormone/ Insulin-Like Growth Factor-1 (GH/IGF-1) Axis in Women With Rheumatoid ArthritisRheumatoid Arthritis;HealthyDrug: EtanerceptNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruitingN/AN/AFemale36Phase 2United States
1928NCT00034203April 200219 February 2015Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.Rheumatoid ArthritisDrug: efalizumabXOMA (US) LLCNot recruiting18 Years80 YearsBothPhase 2United States
1929NCT00038298April 200219 February 2015A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving MethotrexateA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Safety and Tolerability of AMG 719 in Subjects With Rheumatoid Arthritis Receiving MethothrexateRheumatoid ArthritisDrug: Placebo;Drug: AMG 719;Drug: AGM 719;Drug: placebo to AMG 719AmgenNot recruiting18 YearsN/ABoth53Phase 2United States
1930NCT00036153March 200219 February 2015Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid ArthritisA Randomized, Double-Blind Study to Assess the Efficacy of Tacrolimus (Prograf®)+ Methotrexate Vs. Placebo + Methotrexate in the Treatment of Rheumatoid Arthritis in Patients With Partial Response to MethotrexateRheumatoid ArthritisDrug: Tacrolimus (Prograf®);Drug: MethotrexateAstellas Pharma IncAstellas Pharma US, Inc.Not recruiting18 YearsN/ABoth210Phase 3United States;Canada
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1931NCT00451971March 200219 February 2015Objective Study in Rheumatoid ArthritisObjective Study in Rheumatoid ArthritisArthritis, RheumatoidDrug: LEFLUNOMIDESanofiNot recruiting18 Years75 YearsBoth249Phase 4Australia
1932NCT00959439March 200216 December 2017Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg)A Comparative Bioavailability Study of Naproxen Delayed-Release Tablets, 375mg.Rheumatoid Arthritis;OsteoarthritisDrug: Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.);Drug: Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)SandozNot recruiting21 Years50 YearsAll34Phase 1
1933NCT00029042January 200219 February 2015Infliximab to Treat Children With Juvenile Rheumatoid ArthritisA Randomized Double Blind Controlled Intra-Patient Dose Escalation Phase II Trial of Infliximab in Pediatric Patients With Refractory Juvenile Rheumatoid ArthritisJuvenile Rheumatoid ArthritisDrug: InfliximabNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruitingN/AN/ABoth48Phase 2United States
1934NCT00048321January 200219 February 2015ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid ArthritisISIS 104838-CS7, A Double-Blind, Placebo-Controlled, Randomized Trial of the Safety, Efficacy and Pharmacokinetic Profile of ISIS 104838 (TNF-Alpha Antisense Oligonucleotide) Subcutaneous Injections in Active Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: ISIS 104838Isis PharmaceuticalsNot recruiting18 YearsN/ABoth160Phase 2United States;Canada
1935NCT00246064December 200119 February 2015The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) ProtocolThe Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol. Tapering Methotrexate in Patients With Rheumatoid Arthritis Beginning Therapy With InfliximabArthritis, RheumatoidDrug: infliximabCentocor Ortho Biotech Services, L.L.C.Not recruiting18 Years80 YearsBoth210Phase 4
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1936NCT00035334October 200119 February 2015Study of the Safety and Efficacy of NC-503 in Secondary (AA) AmyloidosisA Phase II/III Study of the Safety and Efficacy of NC-503 in Patients Suffering From Secondary (AA) AmyloidosisSecondary (AA) Amyloidosis;Rheumatoid Arthritis;Nephrotic Syndrome;Familial Mediterranean Syndrome;Kidney Diseases;Gastrointestinal DiseasesDrug: NC-503 (Anti-amyloidotic (AA) Agent)Bellus Health IncFDA Office of Orphan Products DevelopmentNot recruiting18 YearsN/ABoth150Phase 2/Phase 3United States;Finland;France;Israel;Italy;Lithuania;Netherlands;Poland;Russian Federation;Spain;Turkey;United Kingdom
1937NCT00036374October 200119 February 2015A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid ArthritisA Randomized, Double-Blind Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate for the Treatment of Patients With Polyarticular Juvenile Rheumatoid ArthritisRheumatoid Arthritis, JuvenileDrug: InfliximabCentocor, Inc.Not recruiting4 Years18 YearsBoth123Phase 3United States
1938NCT00036387October 200119 February 2015A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Rheumatoid Arthritis.A Randomized, Double-blind Trial of the Safety of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis on Standard Disease-modifying Anti-Rheumatic Drug Background Therapy.Arthritis, RheumatoidDrug: InfliximabCentocor, Inc.Not recruiting18 YearsN/ABoth347Phase 3United States
1939NCT00116714October 200119 February 2015Rheumatoid 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 PfizerNot recruiting18 YearsN/ABoth4968N/AUnited States
1940NCT02180516October 200119 February 2015Safety 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 IngelheimNot recruitingN/AN/ABoth9984N/A
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1941NCT00144651August 200119 February 2015Study of MRA in Patients With Rheumatoid Arthritis (RA)An Open-label, Extension, Phase II Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Were Participated in Study MRA009JPRheumatoid ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNot recruiting20 YearsN/ABoth135Phase 2
1942NCT00537667August 200119 February 2015The SPECTRA StudyA Single Centre, Open-Label, Randomised, Study to Evaluate the Effect of Anakinra (r-metHuIL-1ra) Alone and in Combination With PEGylated Recombinant Methionyl Human Soluble Tumour Necrosis Factor Receptor Type I (PEG sTNF-RI) on Synovial Inflammation in Subjects With Rheumatoid Arthritis.Rheumatoid ArthritisDrug: anakinra;Drug: anakinra and PEG sTNF-R1AmgenNot recruiting18 YearsN/ABoth22Phase 2
1943NCT00524160July 200119 February 2015A Study of the Effect on Pain Control of Treatment With Fentanyl, Administered Through the Skin, in Patients With Rheumatoid Arthritis or OsteoarthritisOpen-Label Study To Assess The Effect On Pain Control Of Durogesic (Fentanyl Transdermic Therapeutic System) Treatment In Subjects With Rheumatoid Arthritis Or Osteoarthritis Of The Knee Or Hip.Arthritis;Osteoarthritis;Rheumatoid ArthritisDrug: Fentanyl transdermal patchJanssen Pharmaceutica N.V., BelgiumNot recruiting18 YearsN/ABoth264Phase 4
1944NCT00078806June 200119 February 2015Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid ArthritisPhase 3 Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid ArthritisJuvenile Rheumatoid ArthritisDrug: Enbrel;Drug: PlaceboAmgenImmunex CorporationNot recruiting2 Years18 YearsBoth75Phase 3United States;Canada
1945NCT00037700May 200119 February 2015Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid ArthritisRheumatoid ArthritisDrug: anakinra;Drug: pegsunerceptAmgenNot recruiting18 YearsN/ABothPhase 2United States
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1946NCT02209779May 200119 February 2015Efficacy and Safety of Different Doses of BIRB 796 BS in Patients With Active Rheumatoid ArthritisA Randomised, Parallel, Double-blind, Placebo-controlled Study to Investigate Efficacy and Safety of Different Doses (5, 10, 20 and 30 mg) of BIRB 796 BS Administered Twice a Day Orally Over 4 Weeks in Patients With Active Rheumatoid Arthritis Who Have Failed at Least One DMARDArthritis, RheumatoidDrug: BIBR 796 BS;Drug: PlaceboBoehringer IngelheimNot recruiting18 Years75 YearsBoth167Phase 2
1947NCT02251210May 200119 February 2015Efficacy and Safety of BIIL 284 BS in Adult Patients With Active Rheumatoid ArthritisThree Month, Randomised, Double-blind, Double-dummy, Placebo-controlled, Multiple Dose-range Study of the Efficacy and Safety of BIIL 284 BS (5, 25 and 75 mg p.o. Once Daily) in Adult Patients With Active Rheumatoid ArthritisArthritis, RheumatoidDrug: BIIL 284 BS low dose;Drug: BIIL 284 BS medium dose;Drug: BIIL 284 BS high dose;Drug: PlaceboBoehringer IngelheimNot recruiting18 Years70 YearsBoth404Phase 2
1948NCT00014794April 200119 February 2015Positron Emission Tomography and Magnetic Resonance Imaging to Evaluate Synovial Blood Flow in Rheumatoid Arthritis PatientsH215O Positron Emission Tomography (PET) in the Assessment of Synovial Blood Flow in Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: 15-O labeled waterNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruitingN/AN/ABoth10Phase 1United States
1949NCT02693210February 20017 November 2016A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid ArthritisA Randomised, Double Dummy Controlled, Parallel Group Study of the Efficacy and Safety of MabThera (Rituximab) Alone or in Combination With Either Cyclophosphamide or Methotrexate, in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Rituximab;Other: Placebo Rituximab;Other: Placebo Methotrexate;Other: Placebo Cyclophosphamide;Drug: Methotrexate;Drug: CyclophosphamideHoffmann-La RocheNot recruiting21 YearsN/ABoth161Phase 2Australia;Belgium;Canada;Czech Republic;Germany;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
1950NCT00579644January 200122 January 2018Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate AloneTreatment of Early Rheumatoid Arthritis: Minocycline in Combination With Methotrexate Versus Methotrexate AloneRheumatoid ArthritisDrug: Combination of Minocycline and MTX or MTX alone;Drug: methotrexateUniversity of NebraskaNot recruiting19 Years75 YearsAll91Phase 3
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1951NCT00034853December 200019 February 2015Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)A 12 Week Double-blind Randomized Trial, With a 12 Week Open-label Extension, to Investigate the Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension Administered Twice Daily in Children With Juvenile Rheumatoid ArthritisArthritis, Juvenile RheumatoidDrug: meloxicam oral suspension;Drug: naproxen oral suspensionBoehringer IngelheimNot recruiting2 Years17 YearsBoth180Phase 3United States;Brazil;Mexico;Ukraine;Argentina
1952NCT00195663December 200019 October 2017Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid ArthritisA Prospective Multi-Centre Randomised, Double-Blind, Active Comparator-Controlled, Parallel-Groups Study Comparing the Fully Human Monoclonal Anti-TNFa Antibody Adalimumab Given Every Second Week With Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate Administered Over 2 Years in Patients With Early Rheumatoid Arthritis (PREMIER).Early Rheumatoid ArthritisBiological: Adalimumab;Drug: Methotrexate;Biological: Adalimumab placebo;Drug: Methotrexate placeboAbbVie (prior sponsor, Abbott)Not recruiting18 YearsN/AAll799Phase 3United States;Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Slovakia;Spain;Sweden;Switzerland;United Kingdom
1953NCT00162266October 200019 October 2017Abatacept With Methotrexate- Phase IIBA Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Two Different Doses of BMS-188667 Administered Intravenously to Subjects With Active Rheumatoid Arthritis While Receiving MethotrexateRheumatoid ArthritisDrug: Abatacept (BMS-188667);Drug: PlaceboBristol-Myers SquibbNot recruiting18 YearsN/AAll524Phase 2United States;Argentina;Australia;Belgium;Canada;France;Germany;Ireland;Netherlands;South Africa;United Kingdom
1954NCT00162279October 200019 February 2015The Study of Abatacept in Combination With EtanerceptA Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Intravenous Infusions of BMS-188667 (10 mg/kg) Given Monthly in Combination With Subcutaneous Injections of Etanercept (25mg)Given Twice Weekly to Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: AbataceptBristol-Myers SquibbNot recruiting18 YearsN/ABoth141Phase 2United States
1955NCT00393471October 200019 February 2015Study 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 PfizerNot recruiting18 YearsN/AMale615Phase 3Australia;Austria;Belgium;Czech Republic;Denmark;Finland;France;Germany;Greece;Israel;Italy;Netherlands;Norway;Poland;Portugal;Romania;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1956NCT00006292September 200019 February 2015Infliximab for the Treatment of Early Rheumatoid ArthritisRandomized Double Blind Active Treatment Controlled Trial of the Anti-TNF-Alpha Antibody Infliximab in Patients With Erosive Rheumatoid ArthritisRheumatoid ArthritisDrug: InfliximabNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruitingN/AN/ABoth60Phase 2United States
1957NCT00279747September 200019 February 2015A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension 0.25mg/kg and 0.125 mg/kg Administered Once Daily in Comparison to Naproxen Oral Suspension 5mg/kg Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis.Arthritis, Juvenile RheumatoidDrug: meloxicam 0.25 mg/kg;Drug: meloxicam 0.125 mg/kg;Drug: naproxen 10 mg/kgBoehringer IngelheimNot recruiting2 Years16 YearsBoth226Phase 3Austria;Belgium;France;Germany;Italy;Russian Federation;United Kingdom
1958NCT00037648July 200019 February 2015Juvenile Rheumatoid ArthritisA Randomized, Multi-center, Blinded, Placebo-controlled Study With an Open-label Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuIL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid ArthritisJuvenile Chronic ArthritisDrug: Anakinra;Drug: PlaceboAmgenNot recruiting2 Years17 YearsBoth86Phase 2United States
1959NCT00195650July 200019 October 2017Long Term Open Label Continuation StudyA Multi-Center Continuation Study of the Human Anti-TNF Antibody D2E7 Administered as a Subcutaneous Injection in Patients With Rheumatoid ArthritisRheumatoid ArthritisBiological: AdalimumabAbbottNot recruiting18 YearsN/AAll846Phase 3United States;Canada
1960NCT00078793June 200019 February 2015Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid ArthritisPhase IV Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid ArthritisJuvenile Rheumatoid ArthritisDrug: Enbrel®AmgenImmunex CorporationNot recruiting2 Years18 YearsBoth600N/AUnited States;Canada
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1961NCT00233571June 200019 February 2015A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid ArthritisA Multi-Centre Open Label Continuation Study With Subcutaneous D2E7 (Adalimumab) for Patients With Rheumatoid Arthritis Who Completed a Preceding Clinical Study With D2E7 (Adalimumab)Rheumatoid ArthritisBiological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW)AbbottNot recruiting18 YearsN/ABoth796Phase 3
1962NCT00138983May 200019 February 2015Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol.Rheumatoid Arthritis;Polymyalgia Rheumatica;Giant Cell Arteritis;Polymyositis;Wegener’s GranulomatosisDrug: Alendronate versus alfacalcidol (1-alpha OH vitamin D)UMC UtrechtDutch Health Care Insurance BoardNot recruiting18 Years90 YearsBoth200Phase 3Netherlands
1963NCT00132418April 200019 February 2015Study of Enbrel in Rheumatoid Arthritis (RA) Subjects With Comorbid DisordersDouble-blind, Randomized, Placebo-controlled Study of Enbrel (Etanercept) in the Treatment of Rheumatoid Arthritis Subjects With Comorbid DisordersRheumatoid ArthritisDrug: Enbrel;Drug: PlaceboAmgenImmunex CorporationNot recruiting18 YearsN/ABoth564Phase 4United States
1964NCT00006055March 200019 February 2015Autologous 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 CenterNot recruiting1 Year55 YearsBoth10N/AUnited States
1965NCT00195702February 200019 October 2017Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Rheumatoid Arthritis Patients Currently Receiving Treatment With MethotrexateRheumatoid ArthritisBiological: Adalimumab;Drug: PlaceboAbbottNot recruiting18 YearsN/AAll619Phase 3United States;Canada
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1966NCT00279760January 200026 September 2016Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid ArthritisA Pilot, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of LEA29Y and CTLA4Ig Administered Intravenously to Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: Belatacept;Drug: AbataceptBristol-Myers SquibbNot recruiting18 Years65 YearsBoth210Phase 1/Phase 2United States;Belgium;Canada;France;Germany;Ireland;Netherlands;Switzerland;United Kingdom
1967NCT02247375January 200019 February 2015Pharmacokinetics, Safety and Efficacy of BIIL 284 BS in Patients With Rheumatoid Arthritis (RA)A Double-blind, Randomized, Three Parallel Group Placebo-controlled Study to Investigate Pharmacokinetics, Effect on Expression of CD11b/CD18 (Mac-1), as Well as Safety and Efficacy of Two Oral Doses of BIIL 284 BS (Dosage: 25 mg Daily, 150 mg Daily) in Patients With Rheumatoid Arthritis Over Two WeeksArthritis, RheumatoidDrug: Low dose of BIIL 284 BS tablets;Drug: High dose of BIIL 284 BS tablets;Drug: PlaceboBoehringer IngelheimNot recruiting18 Years65 YearsBoth26Phase 1
1968NCT00579878December 199919 February 2015Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid ArthritisTriple III Comparison of Leflunomide Alone Versus Two DMARD Combinations (Leflunomide-Hydroxychloroquine-Sulfasalazine or Methotrexate-Hydroxychloroquine-Sulfasalazine) in the Treatment of Rheumatoid ArthritisRheumatoid ArthritisDrug: Leflunomide;Drug: Methotrexate-Sulfasalazine-Hydroxychloroquine;Drug: Leflunomide-Sulfasalazine-HydroxychloroquineUniversity of NebraskaNot recruiting19 Years80 YearsBoth70Phase 3United States
1969NCT00012506October 199919 February 2015The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid ArthritisUveitis;Arthritis, Juvenile RheumatoidDrug: TNFR:FcNational Eye Institute (NEI)Recruiting2 Years18 YearsBothPhase 3United States
1970NCT02932644October 199924 October 2016Vitamin D and Cardiovascular Events in Rheumatoid ArthritisAssociation Between Baseline Vitamin D Metabolite Levels and Risk of Cardiovascular Events in Rheumatoid Arthritis Patients. A Cohort Study With Patient-record Evaluated Outcomes.Rheumatoid Arthritis;Cardiovascular DiseaseOther: Baseline serum vitamin D level at or above 50 nmol/l;Other: Baseline serum vitamin D level below 50 nmol/lOdense University HospitalThe Danish Rheumatism Association;University of Southern Denmark;Region of Southern Denmark;Pfizer;Odense Patient Explorative data Network (OPEN);The Danish Rheumatism Association;University of Southern Denmark;Region of Southern Denmark;Pfizer;Odense Patient Explorative data Network (OPEN)Not recruiting18 Years75 YearsBoth160N/A
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1971NCT00000435September 199919 February 2015dnaJ 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)Not recruiting18 Years85 YearsBoth160Phase 2United States
1972NCT00000401July 199919 February 2015Oral Collagen for Rheumatoid ArthritisOpen Label Multicenter Induction of CII Tolerance in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Oral bovine type II collagenUniversity of TennesseeNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 Years80 YearsBoth110Phase 2United States
1973NCT00001862February 199919 February 2015TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid ArthritisThe Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid ArthritisJuvenile Rheumatoid Arthritis;UveitisDrug: EnbrelNational Eye Institute (NEI)Not recruitingN/AN/ABoth15Phase 2United States
1974NCT00356590December 199819 October 2017Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012Rheumatoid ArthritisBiological: EtanerceptAmgenImmunex CorporationNot recruiting18 YearsN/AAll468Phase 3Canada;United States
1975NCT00209859October 199819 February 2015Methotrexate and Cyclosporine in Treatment of Early Rheumatoid ArthritisCombination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis.Rheumatoid ArthritisDrug: Methotrexate;Drug: Intraarticular betamethasone;Drug: Cyclosporine/placebo-cyclosporineHvidovre University HospitalNot recruiting18 Years75 YearsBoth160Phase 4Denmark
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1976NCT00001677June 199819 February 2015Methotrexate Alone Versus Combination of Methotrexate and Subcutaneous Fludarabine for Severe Rheumatoid Arthritis: Safety, Tolerance and EfficacyMethotrexate Alone Versus Combination of Methotrexate and Subcutaneous Fludarabine for Severe Rheumatoid Arthritis: Safety, Tolerance and EfficacyArthritis, Rheumatoid;SynovitisDrug: Methotrexate;Drug: FludarabineNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruitingN/AN/ABoth40Phase 2United States
1977NCT00001614July 199719 February 2015The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid ArthritisThe Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid ArthritisArthritis, Juvenile Rheumatoid;UveitisDrug: Chicken type II collagenNational Eye Institute (NEI)Not recruitingN/AN/ABoth13Phase 1United States
1978NCT00278551June 199719 February 2015Stem Cell Support in Patients With Rheumatoid ArthritisImmune Ablation and Hematopoietic Stem Cell Support in Patients With Rheumatoid Arthritis and High Risk FactorsRHEUMATOID ARTHRITISBiological: Immune ablation and hematopoietic stem cell transplantRichard Burt, MDNot recruiting18 Years60 YearsBoth10Phase 1United States
1979NCT00357903April 199716 December 2017Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical TrialsOpen-Label Extension Treatment With Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) for Participating Patients in Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) Clinical TrialsRheumatoid ArthritisBiological: EtanerceptAmgenImmunex CorporationNot recruiting4 YearsN/AAll639Phase 3Canada;United States
1980NCT00269867March 199719 February 2015Infliximab Plus Methotrexate for the Treatment of Rheumatoid ArthritisA Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate TreatmentRheumatoid ArthritisDrug: Placebo;Drug: Infliximab 3 mg/kg;Drug: Infliximab 10 mg/kgCentocor, Inc.Not recruiting18 Years75 YearsBoth428Phase 3
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1981NCT00000395September 19969 January 2017Antifolate Effectiveness in ArthritisMechanisms of Antifolate Efficacy in ArthritisRheumatoid Arthritis;Adjuvant ArthritisDrug: Methotrexate;Dietary Supplement: Folinic acid;Dietary Supplement: Folic acidUniversity of Alabama at BirminghamNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Dietary Supplements (ODS)Not recruiting18 Years85 YearsBoth40Phase 2United States
1982NCT00000429June 199619 February 2015Calcium Supplements for Bone Health in Juvenile Rheumatoid ArthritisCalcium Supplementation for Bone Mineralization in Juvenile Rheumatoid Arthritis (JRA)Juvenile Rheumatoid ArthritisDrug: Calcium carbonateChildren's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting6 Years18 YearsBoth192Phase 2United States
1983NCT00570934March 199517 October 2016Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRAEffect of Supplementation With 2000 International Units (IU) Vitamin D, 1gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid ArthritisJuvenile Rheumatoid ArthritisDietary Supplement: Cholecalciferol;Dietary Supplement: Calcium;Dietary Supplement: Calcium and cholecalciferol;Drug: PlaceboUniversity of Missouri-ColumbiaNot recruiting3 Years15 YearsBoth24Phase 3United States
1984NCT00004420September 19947 April 2015Study of Gammalinolenic Acid for Juvenile Rheumatoid ArthritisJuvenile Rheumatoid ArthritisDrug: gamma-Linolenic acidFDA Office of Orphan Products DevelopmentUniversity of Massachusetts, WorcesterNot recruiting1 Year15 YearsBoth50N/A
1985JPRN-JapicCTI-05001623 April 2019A controlled, randomized trial of MRA monotherapy in patients with rheumatoid arthritis(RA)A controlled, randomized trial of MRA monotherapy in patients with rheumatoid arthritis(RA)RAIntervention name : MRA (tocilizumab)
Dosage And administration of the intervention : Intravenous infusion		Chugai Pharmaceutical Co., Ltd.20Phase 3
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1986JPRN-JapicCTI-05001823 April 2019Double-blind, parallel-group, controlled Phase 3 study of MRA in rheumatoid arthritis(RA)Double-blind, parallel-group, controlled Phase 3 study of MRA in rheumatoid arthritis(RA)RAIntervention name : MRA (tocilizumab)
Dosage And administration of the intervention : Intravenous infusion		Chugai Pharmaceutical Co., Ltd.2074Phase 3
1987JPRN-JapicCTI-05014623 April 2019Clinical Study to assess the efficacy and safety of increased dose of TA-650 in patients with Rheumatoid ArthritisClinical Study to assess the efficacy and safety of increased dose of TA-650 in patients with Rheumatoid ArthritisRheumatoid ArthritisIntervention name : TA-650 (Infliximab)
Dosage And administration of the intervention : Intravenous drip infusion		Mitsubishi Tanabe Pharma Corporation2075BOTHPhase 3
1988JPRN-JapicCTI-07047923 April 2019A 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-alpha 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-alpha therapy.Rheumatoid arthritisIntervention name : Ocrelizumab
Dosage And administration of the intervention : Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26.		Chugai Pharmaceutical Co., Ltd.20BOTHPhase 3
1989JPRN-JapicCTI-08053123 April 2019A 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) UseGastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, LumbagoIntervention name : esomeprazole
Dosage And administration of the intervention : Oral		AstraZeneca20BOTHPhase 3
1990JPRN-JapicCTI-08056523 April 2019A 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) UseGastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, LumbagoIntervention name : esomeprazole
Dosage And administration of the intervention : Oral		AstraZeneca20BOTHPhase 3
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1991JPRN-JapicCTI-08065023 April 2019Dose-Response Study of Ocrelizumab for Rheumatoid Arthritis.Dose-Response Study of Ocrelizumab for Rheumatoid Arthritis.Rheumatoid ArthritisIntervention name : Ocrelizumab
Dosage And administration of the intervention : 50mg,200mg,500mg twice as an IV infusion on Days1 and 15
Control intervention name : Placebo
Dosage And administration of the control intervention : administered twice as an IV infusion on Days1 and 15		Chugai Pharmaceutical Co., Ltd.20BOTHPhase 2
1992JPRN-JapicCTI-11160123 April 2019A 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 agentsRheumatoid ArthritisIntervention name : Secukinumab
INN of the intervention : Secukinumab
Dosage And administration of the intervention : s.c. i.v.		Novartis Pharma K.K.18BOTHPhase 3
1993JPRN-JapicCTI-12184323 April 2019OSKIRA-Asia-1A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate TherapyRheumatoid ArthritisIntervention name : Fostamatinib
Dosage And administration of the intervention : 100mg twice daily for 12 weeks
Intervention name : Fostamatinib
Dosage And administration of the intervention : 75mg twice daily for 12 weeks
Intervention name : Fostamatinib
Dosage And administration of the intervention : 50mg twice daily for 12 weeks
Intervention name : Fostamatinib
Dosage And administration of the intervention : 100mg twice daily for 4 weeks, followed by150mg once daily up to Week 12
Control intervention name : Placebo
Dosage And administration of the control intervention : twice daily for 12 weeks		AstraZeneca18BOTHPhase 2
1994JPRN-JapicCTI-12199023 April 2019OSKIRA-Asia-1XA Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in AsiaRheumatoid ArthritisIntervention name : Fostamatinib
Dosage And administration of the intervention : 100mg once daily		AstraZeneca18BOTHPhase 2
1995JPRN-JapicCTI-13212523 April 2019A 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 TherapyA 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 TherapyRheumatoid 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 : Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous injection every 2 weeks through Week 50
Control intervention name : Adalimumab
Dosage And administration of the control intervention : Adalimumab administered by SC injection every 2 weeks through Week 50		Eli Lilly Japan K.K.18BOTHPhase 3
No.TrialIDDate_
enrollement		Last_Refreshed_
on		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1996JPRN-JapicCTI-13213416 July 2019A 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 DrugsRheumatoid 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.Not Recruiting18BOTHPhase 3
1997JPRN-JapicCTI-13213823 April 2019A 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 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 ArthritisRheumatoid ArthritisIntervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.		Eli Lilly Japan K.K.18BOTHPhase 3
1998JPRN-JapicCTI-13215616 July 2019A 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 InhibitorsA 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 InhibitorsRheumatoid ArthritisIntervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.		Eli Lilly Japan K.K.Recruiting18BOTHPhase 3
1999JPRN-JapicCTI-14240516 July 2019A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid ArthritisRheumatoid ArthritisIntervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily
Intervention name : placebo
Dosage And administration of the intervention : Placebo administered orally once daily		Eli Lilly Japan K.K.Not Recruiting18BOTHPhase 3

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