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 46. 悪性関節リウマチ [臨床試験数:1,999,薬物数:1,752(DrugBank:321),標的遺伝子数:167,標的パスウェイ数:86] 

Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. 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"    Synonyms (DrugBank) were also searched for.
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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
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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
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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_
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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
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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_
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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_
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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_
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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
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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
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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_
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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_
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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
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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_
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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_
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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_
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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
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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_
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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_
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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_
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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_
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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
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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_
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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
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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
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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_
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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_
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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_
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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_
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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_
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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_
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Last_Refreshed_
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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_
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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_
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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
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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_
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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_
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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_
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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
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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
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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_
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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_
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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_
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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_
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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_
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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_
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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_
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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
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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_
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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
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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_
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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_
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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
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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
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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_
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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
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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
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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_
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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_
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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_
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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_
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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_
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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_
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Last_Refreshed_
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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_
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Last_Refreshed_
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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_
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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_
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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_
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Last_Refreshed_
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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sponsor
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agemin
Inclusion_
agemax
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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
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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
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Target_
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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_
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agemin
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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_
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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_
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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
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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
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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
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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
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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
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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
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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
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sponsor
Recruitment_
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agemin
Inclusion_
agemax
Inclusion_
gender
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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
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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_
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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
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sponsor
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Status
Inclusion_
agemin
Inclusion_
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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_
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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_
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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_
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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_
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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_
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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_
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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_
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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_
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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_
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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_
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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_
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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_
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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_
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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
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536NCT02211469August 201428 September 2015A Randomized, Placebo-Contr