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:172,標的パスウェイ数:213]
Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
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1 | NCT02903212 | March 2020 | 27 May 2019 | Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis | Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: Autologous apoptotic cells injection | Centre Hospitalier Universitaire de Besancon | Not recruiting | 18 Years | 80 Years | All | 22 | Phase 1/Phase 2 | ||
2 | NCT04086745 | January 2, 2020 | 11 November 2019 | A Study of Baricitinib in Participants With Rheumatoid Arthritis | A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Baricitinib;Drug: TNF Inhibitor | Eli Lilly and Company | Incyte Corporation | Not recruiting | 18 Years | N/A | All | 1300 | Phase 4 | |
3 | NCT04115423 | January 1, 2020 | 14 October 2019 | A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab | A 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 Database | Infection;Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab) | Sungkyunkwan University | Ministry of Food and Drug Safety, Korea | Not recruiting | 18 Years | N/A | All | 4540 | Phase 4 | |
4 | NCT04117165 | January 1, 2020 | 14 October 2019 | Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis | Assessment 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 Therapy | Diagnostic Test: Biotherapy Prescription with SinnoTest® software;Drug: Patient Current Care | University Hospital, Grenoble | Not recruiting | 18 Years | 70 Years | All | 180 | N/A | France | |
5 | NCT04115397 | January 2020 | 22 October 2019 | Bisphosphonates for the Treatment of Seropositive Musculoskeletal Complaints | Towards Efficient Prediction and Prevention of Rheumatoid Arthritis | Seropositive Muskuloskeletal Complaints | Drug: Zoledronic Acid;Drug: Placebo | Karolinska Institutet | Not recruiting | 18 Years | N/A | All | 80 | Phase 4 | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
6 | NCT04078191 | December 2019 | 16 September 2019 | Comparison 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 Arthritis | Drug: Tc 99m tilmanocept | Navidea Biopharmaceuticals | Not recruiting | 18 Years | N/A | All | 24 | Phase 2 | United Kingdom | |
7 | JPRN-jRCTs071190030 | 01/11/2019 | 5 November 2019 | Non-inferiority trial of efficacy after switching from Remicade to infliximab BS[CTH] in rheumatoid arthritis patients | Non-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 I | Rheumatoid arthritis | Rheumatoid 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 Kawakami | Recruiting | >= 20age old | Not applicable | Both | 80 | Phase 4 | none | |
8 | NCT04134728 | November 1, 2019 | 4 November 2019 | Efficacy 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) Inhibitors | A 24-week, Phase 3, Multicentre, Randomised, Double-blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Sarilumab, in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological DMARDs and/or Janus Kinase Inhibitors | Arthritis, Rheumatoid | Biological: GSK3196165;Biological: Sarilumab;Drug: Placebo to GSK3196165/ Sarilumab;Drug: csDMARDs | GlaxoSmithKline | Iqvia Pty Ltd | Not recruiting | 18 Years | N/A | All | 525 | Phase 3 | United States |
9 | NCT04130178 | October 25, 2019 | 28 October 2019 | Nerve Block of the Proximal Interphalangeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study | Nerve Block of the Proximal Interphalyngeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study | Rheumatoid Arthritis | Drug: Nerve block | Sohag University | Recruiting | 18 Years | N/A | All | 42 | N/A | Egypt | |
10 | NCT04120831 | October 7, 2019 | 22 October 2019 | TOLERA: Tolerance Enhancement in RA | Sequential B Cell/T Cell Therapy to Re-induce Humoral Immune TOLErance in ACPA- Positive Rheumatoid Arthritis A Prospective, Randomized Controlled Open Label Single-centre Clinical Trial in Adult Subjects With Active ACPA-positive Rheumatoid Arthritis Failing Methotrexate | Rheumatoid Arthritis | Drug: Abatacept Injection | University of Erlangen-Nürnberg Medical School | Recruiting | 18 Years | N/A | All | 20 | Phase 2 | Germany | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
11 | JPRN-JapicCTI-194932 | 01/10/2019 | 5 November 2019 | An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis | An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis | Intervention 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.Ltd | Recruiting | 20 | BOTH | 505 | Phase 3 | Japan | ||
12 | NCT04077567 | October 1, 2019 | 22 October 2019 | An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis | An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: TS-152 | Taisho Pharmaceutical Co., Ltd. | Recruiting | 20 Years | N/A | All | 505 | Phase 3 | Japan | |
13 | NCT03828344 | October 2019 | 11 February 2019 | Safety and Tolerability of a Single Intravenous Infusion of BX-U001 in Refractory Rheumatoid Arthritis | A 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 Arthritis | Rheumatoid Arthritis | Biological: hUC-MSC suspension;Biological: Placebo | Baylx Inc. | Not recruiting | 18 Years | 70 Years | All | 16 | Phase 1 | ||
14 | NCT04136262 | October 2019 | 4 November 2019 | Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis | Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis: a Randomized Controlled Trial | Rheumatoid Arthritis | Drug: Tripterygium wilfordii Hook F (TwHF);Drug: Methotrexate;Other: Dummy Tripterygium wilfordii Hook F (TwHF) | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Not recruiting | N/A | N/A | Female | 300 | Phase 2/Phase 3 | ||
15 | ChiCTR1900026257 | 2019-09-28 | 30 September 2019 | A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue | Efficacy, 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 trial | Rheumatoid 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 TCM | Not Recruiting | 18 | 70 | Both | High-dose experimental group :30;Low-dose experimental group:30;Control group :30; | Phase 2 | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
16 | NCT03971253 | September 2, 2019 | 28 October 2019 | Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis | Japan Post-Marketing Surveillance - Specified Drug Use-results Survey for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis | Rheumatoid Arthritis (RA) | Drug: Peficitinib | Astellas Pharma Inc | Recruiting | N/A | N/A | All | 3000 | Phase 4 | Japan | |
17 | NCT03895879 | September 2019 | 30 September 2019 | Use of Tocilizumab Drug Levels to Optimize Treatment in RA | Concentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients: a Randomised, Multicenter, Non-inferiority Trial (TODORA) | Rheumatoid Arthritis | Drug: Tocilizumab | Reade Rheumatology Research Institute | ZonMw: The Netherlands Organisation for Health Research and Development | Recruiting | 18 Years | N/A | All | 98 | Phase 4 | Netherlands |
18 | NCT03938701 | September 2019 | 26 August 2019 | Fluorescence Imaging of Disease Activity in IBD and Rheumatoid Arthritis Using OTL38 | Fluorescence 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 Study | IBD;Rheumatoid Arthritis | Drug: OTL38;Device: Fluorescence Imaging | University Medical Center Groningen | GlaxoSmithKline;On Target Laboratories, LLC;VU University Medical Center | Not recruiting | 18 Years | N/A | All | 30 | Phase 1 | Netherlands |
19 | NCT03976245 | September 2019 | 22 July 2019 | Advanced Therapeutics in Rheumatoid Arthritis (RA) | Advanced Therapeutics in Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Etanercept;Drug: tofacitinib | Lawson Health Research Institute | Academic Medical Organization of Southwestern Ontario | Not recruiting | 18 Years | N/A | All | 144 | Phase 4 | Canada |
20 | JPRN-JapicCTI-194928 | 26/8/2019 | 10 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 MJK101 | 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 MJK101 | Rheumatoid Arthritis | Intervention 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 GmbH | Recruiting | 20 | 75 | BOTH | 100 | Phase 3 | Japan | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
21 | NCT04004429 | August 26, 2019 | 11 November 2019 | A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease | A 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 Disease | Rheumatoid Arthritis | Drug: 50 mg AP1189;Drug: AP1189;Drug: Placebo | SynAct Pharma Aps | Recruiting | 18 Years | 85 Years | All | 90 | Phase 2 | Denmark | |
22 | ChiCTR1900025013 | 2019-08-08 | 27 August 2019 | Clinical observation of multiple dose use of tranexamic acid in patients with rheumatoid arthritis after total knee arthroplasty | Effects of multiple dose use of tranexamic acid on blood loss and inflammatory factors after total knee arthroplasty in patients with rheumatoid arthritis | Total knee arthroplasty | group 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 Medicine | Recruiting | 50 | 75 | Both | group 1:38;group 2:38; | Phase 4 | China | |
23 | ChiCTR1900024902 | 2019-08-01 | 27 August 2019 | A randomized, double-blind, prospective, controlled trial for Yishen-Tongbi-Tang in the treatment of active rheumatoid arthritis | A randomized, double-blind, prospective, controlled trial for Yishen-Tongbi-Tang in the treatment of active rheumatoid arthritis | Rheumatoid Arthritis | Experimental group:Traditional Chinese medicine (Yi-Shen Tong-Bi Tang);Positive control group:Methotrexate; | The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine | Not Recruiting | 18 | 65 | Both | Experimental group:50;Positive control group:50; | N/A | China | |
24 | NCT02418273 | August 1, 2019 | 16 December 2017 | Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders | Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot Study | Osteoporosis;Juvenile Rheumatoid Arthritis;Dermatomyositis;Polyarthritis;Systemic Lupus Erythematosis;Vasculitis;Glucocorticoid-induced Osteoporosis | Drug: denosumab | Indiana University | Not recruiting | 4 Years | 16 Years | All | 24 | Phase 1/Phase 2 | United States | |
25 | NCT04068246 | August 1, 2019 | 2 September 2019 | The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients | The 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 Arthritis | Drug: Metformin | Sadat City University | Recruiting | 18 Years | N/A | All | 100 | Early Phase 1 | Egypt | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
26 | ChiCTR1900025021 | 2019-07-25 | 27 August 2019 | Safety, Tolerance and Pharmacokinetics of Single Administration of Meloxicam Suspension Injection in Healthy Chinese Subjects | Safety, Tolerance and Pharmacokinetics of Single Administration of Meloxicam Suspension Injection in Healthy Chinese Subjects | Osteoarthritis, rheumatoid arthritis | A: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 University | Recruiting | Both | A:12;B:12;C:12;D:12; | Phase 1 | China | |||
27 | ChiCTR1900024261 | 2019-07-15 | 15 July 2019 | Efficacy and safety of sirolimus in new-onset rheumatoid arthritis: a prospective, double-blinded, randomized, placebo-controlled, monocentric study in China | Efficacy and safety of sirolimus in new-onset rheumatoid arthritis: a prospective, double-blinded, randomized, placebo-controlled, monocentric study in China | rheumatoid arthritis | A: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 University | Not Recruiting | 18 | 65 | Both | A:30;B:30; | Phase 4 | China | |
28 | NCT04018599 | July 15, 2019 | 30 September 2019 | Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS | A 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 Subjects | Rheumatoid 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 Uveitis | Drug: 40 mg MSB11022 | Fresenius Kabi SwissBioSim GmbH | PRA Health Sciences | Recruiting | 18 Years | 55 Years | All | 216 | Phase 1 | United States |
29 | NCT03813199 | July 4, 2019 | 29 July 2019 | Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis | Phase IIa Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose Study on ABX464 in Combination With Methotrexate (MTX), in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have Inadequate Response to MTX or/and to an Anti- Tumor Necrosis Factor Alpha (Tnfa) Therapy, or Intolerance to Anti-Tnfa Therapy | Rheumatoid Arthritis | Drug: ABX464 50mg;Drug: Matching Placebo;Drug: ABX464 100mg;Drug: Methotrexate | Abivax S.A. | Recruiting | 18 Years | 75 Years | All | 60 | Phase 2 | France | |
30 | NCT03656627 | June 27, 2019 | 22 October 2019 | Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Autoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative Colitis | Drug: Nivolumab | Alliance Foundation Trials, LLC. | Bristol-Myers Squibb | Recruiting | 18 Years | N/A | All | 72 | Phase 1 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
31 | NCT03912428 | June 14, 2019 | 1 July 2019 | Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis | Evaluation of Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis | Myositis | Drug: Celecoxib | National Institute of Mental Health (NIMH) | Recruiting | 18 Years | 99 Years | All | 47 | Phase 1 | United States | |
32 | NCT03970837 | June 5, 2019 | 22 October 2019 | Efficacy 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 DMARDs | Arthritis, Rheumatoid | Biological: GSK3196165;Drug: Tofacitinib;Drug: Placebo to GSK3196165;Drug: Placebo to Tofacitinib;Drug: csDMARDs | GlaxoSmithKline | Iqvia Pty Ltd | Recruiting | 18 Years | N/A | All | 1500 | Phase 3 | United States;Colombia |
33 | NCT03886038 | June 1, 2019 | 1 April 2019 | Subunit 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 Controls | Biological: Shingrix | Region Skane | Not recruiting | 18 Years | N/A | All | 150 | Phase 4 | Sweden | |
34 | NCT03619876 | June 2019 | 27 May 2019 | Effects of Abatacept on Myocarditis in Rheumatoid Arthritis | Effects of Abatacept on Myocarditis in Rheumatoid Arthritis | Rheumatoid Arthritis;Myocardial Inflammation | Drug: Abatacept;Drug: Adalimumab | Columbia University | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 20 | Phase 4 | United States |
35 | NCT04033809 | May 30, 2019 | 29 July 2019 | Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients | Effectiveness of High Fiber Multigrain Supplementation Among the Rheumatoid Arthritis Patients: A Randomized, Open Label Trial | Rheumatoid Arthritis | Dietary Supplement: Multigrain powder (S) | University of Science Malaysia | Not recruiting | 21 Years | N/A | All | 50 | N/A | Malaysia | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
36 | NCT03980483 | May 16, 2019 | 22 October 2019 | Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A 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 Methotrexate | Arthritis, Rheumatoid | Biological: GSK3196165;Drug: Tofacitinib 5 mg;Drug: Placebo to GSK3196165;Drug: Placebo to tofacitinib;Drug: Methotrexate;Drug: Folic (or folinic) acid | GlaxoSmithKline | Iqvia Pty Ltd | Recruiting | 18 Years | N/A | All | 1500 | Phase 3 | United States |
37 | NCT03823378 | May 13, 2019 | 3 June 2019 | A 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-105 | AbbVie | Recruiting | 18 Years | N/A | All | 50 | Phase 2 | Belgium;Canada;Czechia;Hungary;Poland;Spain;United Kingdom | |
38 | NCT03882008 | April 25, 2019 | 29 April 2019 | A Study to Evaluate Biomarkers to Predict Efficacy of Abatacept in Rheumatoid Arthritis | Phase IV Open-Label Study to Evaluate Biomarkers to Predict the Efficacy of Abatacept in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Abatacept | University of Washington | Bristol-Myers Squibb | Recruiting | 18 Years | N/A | All | 25 | Phase 4 | United States |
39 | NCT03915964 | April 25, 2019 | 11 November 2019 | A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis | A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Baricitinib;Drug: TNF Inhibitor | Eli Lilly and Company | Incyte Corporation | Recruiting | 18 Years | N/A | All | 2600 | Phase 4 | United 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 |
40 | EUCTR2018-003933-14-EE | 09/04/2019 | 30 April 2019 | A 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 NV | Authorised | Female: no Male: yes | 250 | Phase 2 | Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany;Latvia;Moldova, Republic of | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
41 | NCT03938636 | April 8, 2019 | 22 October 2019 | Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging | Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging | Rheumatoid Arthritis | Drug: TC99m-tilmanocept | Navidea Biopharmaceuticals | Recruiting | 18 Years | N/A | All | 105 | Phase 2 | United States | |
42 | NCT03816345 | April 4, 2019 | 11 November 2019 | Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable Cancer | A 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 Neoplasm | Biological: Nivolumab | National Cancer Institute (NCI) | Recruiting | 18 Years | N/A | All | 264 | Phase 1 | United States | |
43 | NCT03669367 | April 1, 2019 | 21 January 2019 | EFFECTS 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, Wrist | Drug: Abatacept Injection;Drug: hydroxycloroquina | Fundacion Clinic per a la Recerca Biomédica | Not recruiting | 18 Years | N/A | All | 98 | Phase 4 | ||
44 | NCT03700021 | April 2019 | 4 February 2019 | Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis | Single-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 Drugs | Rheumatoid Arthritis | Drug: Abatacept + csDMARD | New York University School of Medicine | Not recruiting | 18 Years | N/A | All | 25 | Phase 4 | United States | |
45 | NCT03823391 | March 27, 2019 | 9 September 2019 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis | A 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 Arthritis | Rheumatoid Arthritis (RA) | Drug: ABBV-3373;Drug: Placebo for ABBV-3373;Drug: Adalimumab;Drug: Placebo for adalimumab | AbbVie | Recruiting | 18 Years | 75 Years | All | 45 | Phase 1 | United States;Germany;Hungary;Israel;Netherlands;Poland;Puerto Rico | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
46 | NCT03885037 | March 20, 2019 | 4 November 2019 | Infliximab 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 Arthritis | Drug: Infliximab [infliximab biosimilar 3] | Pfizer | Recruiting | N/A | N/A | All | 300 | Phase 3 | Japan | |
47 | NCT04057118 | March 20, 2019 | 4 November 2019 | A 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 Therapies | Rheumatoid Arthritis | Drug: SKI-O-703;Drug: Placebo | Oscotec Inc. | Recruiting | 18 Years | N/A | All | 148 | Phase 2 | United States;Czechia;Poland;Russian Federation;Ukraine | |
48 | NCT03890302 | March 14, 2019 | 8 April 2019 | A Placebo-controlled Study to Evaluate the Safety, Movement Through, and Reaction of the Body to Single and Multiple Increasing Doses of FB704A | A Phase 1, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Single and Multiple Ascending Doses of FB704A | Rheumatoid Arthritis | Drug: FB704A;Drug: Placebo | Fountain Biopharma Inc. | Recruiting | 18 Years | 55 Years | All | 41 | Phase 1 | United States | |
49 | ChiCTR1900021808 | 2019-03-08 | 18 March 2019 | A 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 Subjects | A 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 Subjects | Active rheumatoid arthritis | 1:8 mg/kg QX003S ;2:Tocilizumab, 8 mg/kg; | JiangSu Qyuns Therapeutics Co., Ltd | Recruiting | 18 | 50 | Male | 1:43;2:43; | Phase 1 | China | |
50 | NCT03813771 | March 2019 | 4 February 2019 | Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification | Targeted 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 Arthritis | Drug: Benepali;Drug: Sulfasalazine;Drug: Methotrexate;Drug: Hydroxychloroquine | University of Leeds | Samsung Bioepis Co., Ltd. | Not recruiting | 18 Years | N/A | All | 106 | Phase 4 | United Kingdom |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
51 | NCT03858725 | February 26, 2019 | 18 March 2019 | Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteers | A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteer | Rheumatoid Arthritis | Drug: D569 Tab.;Drug: CKD-374 5mg Tab. | Chong Kun Dang Pharmaceutical | Recruiting | 19 Years | 54 Years | All | 36 | Phase 1 | Korea, Republic of | |
52 | NCT03852355 | February 25, 2019 | 1 April 2019 | the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis | the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis; a Randomized Controlled Trial | Rheumatoid Arthritis;Headache | Drug: Radiofrequency;Drug: Steroids | Assiut University | Recruiting | 18 Years | 60 Years | All | 60 | N/A | Egypt | |
53 | NCT03868072 | February 22, 2019 | 18 March 2019 | Study to Evaluate the Bioequivalence of Pfizer Korea Inc. XELJANZ 5Mg Tablet in Healthy Volunteers | An 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 Volunteers | Rheumatoid Arthritis | Drug: XELJANZ 5Mg Tablet;Drug: Chong Kun Dang Tofacitinib Tablet | Chong Kun Dang Pharmaceutical | Recruiting | 19 Years | N/A | All | 40 | Phase 1 | Korea, Republic of | |
54 | NCT03737708 | February 13, 2019 | 18 March 2019 | A 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 Trial | Rheumatoid Arthritis (RA) | Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abatacept | Astellas Pharma Korea, Inc. | Recruiting | 19 Years | 75 Years | All | 148 | Phase 4 | Korea, Republic of | |
55 | NCT03729349 | January 15, 2019 | 22 October 2019 | Golimumab for Adherence in Rheumatoid Arthritis | Golimumab for Adherence in Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: Golimumab | Janssen Inc. | Recruiting | 18 Years | 85 Years | All | 300 | Early Phase 1 | Canada | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
56 | NCT03863405 | January 9, 2019 | 3 June 2019 | Metformin Use in Rheumatoid Arthritis | The Effect of Metformin on the Clinical Outcome of Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Placebo Oral Tablet;Drug: Conventional DMARDs;Drug: Metformin | Ain Shams University | Future University in Egypt | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | Egypt |
57 | NCT03981900 | January 4, 2019 | 22 July 2019 | IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis | IDentification 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, Rheumatoid | Drug: Tofacitinib | Pfizer | Recruiting | 18 Years | N/A | All | 500 | Phase 1 | France | |
58 | EUCTR2018-000666-10-HU | 03/01/2019 | 28 February 2019 | A 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 therapy | 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 DMARDs | Rheumatoid Arthritis MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: ABBV-105 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. KG | Authorised | Female: yes Male: yes | 240 | Phase 2 | United States;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Spain;Germany;United Kingdom | |||
59 | NCT03896594 | December 24, 2018 | 15 April 2019 | A Multiple Dose of HL237 in Healthy Male Subject | A 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 Subject | Rheumatoid Arthritis | Drug: HL237;Drug: Placebo Oral Tablet | Hanlim Pharm. Co., Ltd. | Recruiting | 20 Years | 45 Years | Male | 36 | Phase 1 | Korea, Republic of | |
60 | NCT03652961 | December 21, 2018 | 14 January 2019 | Rheumatoid Arthritis Memory B Cells and Abatacept (RAMBA) | Rheumatoid Arthritis Memory B Cells and Abatacept (RAMBA) | Rheumatoid Arthritis | Drug: Abatacept | Dartmouth-Hitchcock Medical Center | New York University School of Medicine | Recruiting | 18 Years | N/A | All | 25 | Phase 4 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
61 | NCT03574545 | December 19, 2018 | 4 November 2019 | Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis | A Randomized, Open Label, Multiple Dose, Parallel Group Study to Assess the Safety and Pharmacokinetic Comparability of Two VAY736 Drug Products in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: VAY736 | Novartis Pharmaceuticals | Recruiting | 18 Years | 65 Years | All | 50 | Phase 1 | Germany;Jordan | |
62 | NCT03830203 | December 19, 2018 | 25 February 2019 | Comparative Study of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate | A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: BAT1806;Drug: Actemra(EU-licensed) | Bio-Thera Solutions | Recruiting | 18 Years | N/A | All | 612 | Phase 3 | China | |
63 | EUCTR2018-001690-25-PL | 11/12/2018 | 7 January 2019 | Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis | A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis | Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: CT-P17 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, Inc | Authorised | Female: yes Male: yes | 564 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Bosnia and Herzegovina | |||
64 | NCT03729674 | November 26, 2018 | 3 December 2018 | Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs | Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs | Rheumatoid Arthritis;Ankylosing Spondylitis;Ulcerative Colitis;Crohn's Disease | Drug: Biosimilar;Drug: Originator (legacy) drug | McGill University Health Center | Université 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 Group | Not recruiting | 18 Years | N/A | All | 800 | Phase 3 | |
65 | NCT03789292 | November 26, 2018 | 8 April 2019 | A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis | A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: CT-P17 SC;Biological: Humira SC | Celltrion | Not recruiting | 18 Years | 75 Years | All | 564 | Phase 3 | Bulgaria | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
66 | NCT03755466 | November 21, 2018 | 10 December 2018 | Examination of Efficacy and Safety of Baricitinib in RA Patients | Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib | Rheumatoid Arthritis | Drug: Baricitinib, olumiant®;Drug: Biologics;Drug: Tofacitinib 5 MG [Xeljanz] | Shinshu University | Recruiting | 20 Years | N/A | All | 90 | Phase 2 | Japan | |
67 | NCT03980639 | November 20, 2018 | 24 June 2019 | Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase | Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase | Rheumatoid Arthritis | Drug: patient treated with DMARD | University Hospital, Toulouse | Recruiting | 18 Years | N/A | All | 594226 | N/A | France | |
68 | NCT03852888 | November 14, 2018 | 11 March 2019 | Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant Patients | Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant Patients | Rheumatoid Arthritis | Biological: Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate level | CHU de Reims | Recruiting | 18 Years | N/A | All | 60 | N/A | France | |
69 | EUCTR2018-001690-25-HU | 13/11/2018 | 19 November 2018 | Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis | A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis | Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: CT-P17 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, Inc | Authorised | Female: yes Male: yes | 564 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Bosnia and Herzegovina | |||
70 | NCT03707535 | November 12, 2018 | 29 April 2019 | To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis | A 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 Arthritis | Rheumatoid Arthritis | Biological: CT-P13;Biological: Remicade | Celltrion | Recruiting | 18 Years | 75 Years | All | 270 | Phase 3 | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
71 | ChiCTR1800019277 | 2018-11-01 | 5 November 2018 | The Zoledronic Acidameliorate theSecondary Osteoporosis in Rheumatoid Arthritis patients | The Zoledronic Acidameliorate theSecondary Osteoporosis in Rheumatoid Arthritis patients | Rheumatoid Arthritis | Control group:MTX;Treatment group 1:Zoledronate Acid(ZA);Treatment group 2:MTX+Zoledronate Acid; | Shanghai Traditional Medicine University Affiliated Guanghua Hospital | Recruiting | 18 | 65 | Both | Control group:22;Treatment group 1:22;Treatment group 2:22; | Other | China | |
72 | EUCTR2017-004226-15-DK | 26/10/2018 | 26 November 2018 | Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied. | CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art | Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0 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 Rheumatology | Authorised | Female: yes Male: yes | 180 | Phase 2 | Denmark | |||
73 | ChiCTR1900026079 | 2018-10-25 | 30 September 2019 | Wangbi capsule combined methotrexate tablets for treatment of Rheumatoid Arthritis: A Randomized,Double-blind,Single analog,Positive Drug Parallel-group controlled clinical study | Wangbi capsule combined methotrexate tablets for treatment of Rheumatoid Arthritis: A Randomized,Double-blind,Single analog,Positive Drug Parallel-group controlled clinical study | Rheumatoid Arthritis | Experimental group:Wangbi capsule combined methotrexate tablets;Control group:Simulation of Wangbi capsule combined methotrexate tablets; | Longhua Hospital Shanghai University of Traditional Chinese Medicine | Recruiting | 18 | 70 | Both | Experimental group:60;Control group:60; | Phase 4 | China | |
74 | NCT03718611 | October 22, 2018 | 22 July 2019 | To Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects | A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects | Rheumatoid Arthritis | Drug: BR9001;Drug: BR900A | Boryung Pharmaceutical Co., Ltd | Not recruiting | 19 Years | 50 Years | All | 36 | Phase 1 | Korea, Republic of | |
75 | NCT03682705 | October 8, 2018 | 14 October 2019 | A 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 DMARDs | Rheumatoid Arthritis (RA) | Drug: Upadacitinib;Drug: ABBV-105;Drug: Upadacitinib placebo;Drug: ABBV-105 placebo | AbbVie | Recruiting | 18 Years | N/A | All | 240 | Phase 2 | United States;Belgium;Canada;Czechia;Hungary;Poland;Puerto Rico;Spain;United Kingdom;Germany;Ireland | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
76 | JPRN-JapicCTI-184031 | 02/10/2018 | 7 October 2019 | A Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) Therapy | A Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) Therapy | Rheumatoid Arthritis (RA) | Intervention name : TS-152 INN of the intervention : ozoralizumab Dosage And administration of the intervention : Subcutaneous injection every 4 weeks Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Taisho Pharmaceutical co., LTD | Not Recruiting | 20 | BOTH | 135 | Phase 3 | Japan | ||
77 | NCT03511625 | October 2, 2018 | 7 October 2019 | The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis | The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot Study | Rheumatoid Arthritis | Drug: Acthar Injectable Product;Drug: Depo medrol | Attune Health Research, Inc. | Mallinckrodt | Recruiting | 18 Years | N/A | All | 6 | Phase 3 | United States |
78 | NCT03546335 | October 1, 2018 | 22 October 2018 | Zr-89 Cimzia PET Imaging Rheumatoid Arthritis | Zirconium-89 Certolizumab PET Imaging in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: 89Zr-DFO-CZP | University of California, San Francisco | Recruiting | 18 Years | N/A | All | 10 | Phase 1 | United States | |
79 | NCT03593837 | October 1, 2018 | 20 August 2018 | Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind,Placebo-controlled Trial Evaluating the Efficacy and Safety of Huang Qi GuiZhi Wu Wu Tang Granulesin Patients With Rheumatoid Arthritis | Huang Qi Gui Zhi Wu Wu Granule;Rheumatoid Arthritis | Drug: Huang qi gui zhi wu wu granule;Drug: Huang qi gui zhi wu wu granule placebo | Cui xuejun | Not recruiting | 18 Years | 80 Years | All | 100 | Phase 2/Phase 3 | ||
80 | NCT03770702 | October 1, 2018 | 18 December 2018 | Statins and ARBs on Rheumatoid Activity | Investigational and Comparative Study Between the Anti-inflammatory Effectof Both Angiotensin Reeptor Blockers and Statins on Rheumatoid Arthritis Disease Activity on Egyptian Patients | Rheumatoid Arthritis | Drug: Angiotensin receptor blockers;Drug: Statins | Sherief Abd-Elsalam | Recruiting | 18 Years | 65 Years | All | 45 | Phase 3 | Egypt | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
81 | NCT03770923 | October 1, 2018 | 18 December 2018 | Effect of Some Drugs on Rheumatoid Arithritis Activity | Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis | Rheumatoid Arthritis | Drug: Rupatadine;Drug: Montelukast | Sherief Abd-Elsalam | Recruiting | 18 Years | N/A | All | 75 | Phase 3 | Egypt | |
82 | NCT03660059 | September 27, 2018 | 16 September 2019 | A 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 MTX | Rheumatoid Arthritis (RA) | Drug: Peficitinib;Drug: Plaebo;Drug: Disease-modifying antirheumatic drugs (DMARDs) | Astellas Pharma China, Inc. | Recruiting | 18 Years | N/A | All | 375 | Phase 3 | China;Korea, Republic of;Taiwan | |
83 | ChiCTR1800018637 | 2018-09-26 | 10 October 2018 | Correlation between Human epididymis protein 4 and interstitial lung disease in patients with rheumatoid arthritis | Correlation between Human epididymis protein 4 and interstitial lung disease in patients with rheumatoid arthritis | rheumatoid arthritis | Gold 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 College | Recruiting | Both | Target condition:150;Difficult condition:100 | Diagnostic New Technique Clincal Study | China | |||
84 | NCT03691909 | September 25, 2018 | 2 September 2019 | A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Rheumatoid Arthritis | A 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 Arthritis | Rheumatoid Arthritis | Drug: HB-adMSC | Hope Biosciences | Not recruiting | 18 Years | 65 Years | All | 15 | Phase 1/Phase 2 | United States | |
85 | NCT03699293 | September 22, 2018 | 15 October 2018 | NSAIDs vs. Coxibs in the Presence of Aspirin | NSAIDs vs. Coxibs in the Presence of Aspirin: Effects on Platelet Function, Endothelial Function, and Biomarkers of Inflammation in Subjects With Rheumatoid Arthritis and Increased Cardiovascular Risk or Cardiovascular Disease | Rheumatoid Arthritis;Cardiovascular Diseases | Drug: celecoxib 200mg capsule;Drug: naproxen sodium 550mg tablet;Drug: Aspirin 81mg tablet | Inova Health Care Services | Recruiting | 18 Years | 75 Years | All | 30 | Phase 4 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
86 | EUCTR2018-001114-15-NL | 18/09/2018 | 28 February 2019 | Predicting the risk for rheumatoid arthritis with the help of a PET scan. | Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis. - Early diagnostics in RA | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: [18F]PEG-Folate Pharmaceutical Form: Solution for injection | VU Medical Center, department of Rheumatology | Authorised | Female: yes Male: yes | 60 | Phase 4 | Netherlands | |||
87 | JPRN-JapicCTI-184229 | 12/9/2018 | 16 July 2019 | 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- | 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 Arthritis | Intervention 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 Recruiting | BOTH | 2000 | NA | ||||
88 | NCT03701789 | September 11, 2018 | 22 October 2019 | Effect of Baricitinib Treatment on Peripheral Bone in RA | Evaluation of Bone Quality in Patients With Rheumatoid Arthritis Treated With Baricitinib: Single Centre, Mode of Action Study (BARE BONE) | Rheumatoid Arthritis;Bone Density;Finger Joints | Drug: Baricitinib | University of Erlangen-Nürnberg Medical School | Recruiting | 18 Years | 74 Years | All | 15 | Phase 3 | Germany | |
89 | JPRN-JapicCTI-184029 | 04/9/2018 | 7 October 2019 | A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy | A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy | Rheumatoid Arthritis (RA) | Intervention name : TS-152 INN of the intervention : ozoralizumab Dosage And administration of the intervention : Subcutaneous injection every 4 weeks Control intervention name : Placebo INN of the control intervention : Placebo Dosage And administration of the control intervention : Usage: Subcutaneous injection every 4 weeks, Dosage: No active ingredients contain | Taisho Pharmaceutical co., LTD | Not Recruiting | 20 | 75 | BOTH | 370 | Phase 2-3 | Japan | |
90 | NCT04079374 | September 3, 2018 | 22 October 2019 | Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel | Open, Randomized, Comparative, Multicenter Study in Parallel Groups of the Efficacy, Safety, Immunogenicity of Etanercept and Enbrel, Lyophilisates for Solution for Subcutaneous Injection, in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Etanercept;Drug: Enbrel | Joint Stock Company Farmak | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Recruiting | 18 Years | 75 Years | All | 160 | Phase 3 | Ukraine |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
91 | EUCTR2015-004386-91-PL | 26/08/2018 | 7 January 2019 | Study to explore and compare the effects of a new drug in combination with methotrexate therapy in people with early and established rheumatoid arthritis. | A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs | Rheumatoid Arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 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 Limited | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Poland;Germany | |||
92 | NCT03636984 | August 24, 2018 | 27 August 2018 | Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real World | Efficacy and Safety Study of Anbainuo in Chinese Patients With Rheumatoid Arthritis/ Ankylosing Spondylitis in the Real World: a Prospective, Open-label, Multi-center Observational Study | Rheumatoid Arthritis;Ankylosing Spondylitis | Drug: recombinant TNF-a receptor: IgG Fc fusion protein | Zhejiang Hisun Pharmaceutical Co. Ltd. | Not recruiting | 18 Years | N/A | All | 1000 | Phase 2/Phase 3 | ||
93 | NCT03535519 | August 7, 2018 | 26 August 2019 | Rheumatoid Arthritis Response to Methotrexate | Rheumatoid Arthritis Ultrasound Response to Methotrexate | Rheumatoid Arthritis | Drug: Methotrexate | Juan Carlos Nieto | Nordic Pharma SAS | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | Spain |
94 | NCT04066803 | August 1, 2018 | 2 September 2019 | Optimal MTX Dose With Folic Acid Randomized Case-control Trial | Safety and Efficacy of Optimal Methotrexate With Folic Acid in Patients With Rheumatoid Arthritis in Meizhou, Guangdong: a Randomized Case-control Study | Rheumatoid Arthritis | Drug: DMARDs;Drug: Folic Acid;Drug: MTX | Sun Yat-sen University | Shanghai Pharmaceuticals Holding Co., Ltd | Recruiting | 18 Years | 70 Years | All | 160 | Phase 4 | China |
95 | EUCTR2018-002368-18-ES | 25/07/2018 | 20 August 2018 | Phase 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 load | Phase 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 load | 1. 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) | Authorised | Female: yes Male: yes | 740 | Phase 4 | Spain | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
96 | NCT03618784 | July 11, 2018 | 26 August 2019 | Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis | A 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 Arthritis | Rheumatoid Arthritis | Biological: FURESTEM-RA Inj;Other: sterile saline | Kang Stem Biotech Co., Ltd. | Not recruiting | 19 Years | 80 Years | All | 33 | Phase 1/Phase 2 | Korea, Republic of | |
97 | EUCTR2017-004079-30-ES | 10/07/2018 | 23 July 2018 | Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology | Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU | Rhuematoid Arthritis MedDRA version: 20.0 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: MabThera 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) | Authorised | Female: yes Male: yes | 207 | Phase 3 | Portugal;Belgium;Spain;Italy | |||
98 | NCT03445871 | July 2, 2018 | 29 July 2019 | Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate | Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate | Rheumatoid Arthritis | Biological: Blood sample;Diagnostic Test: CRQ | Centre Hospitalier Universitaire de Saint Etienne | Recruiting | 18 Years | N/A | All | 60 | Phase 4 | France | |
99 | NCT03605251 | July 1, 2018 | 11 February 2019 | Efficacy 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 Methotrexate | Rheumatoid Arthritis | Drug: TAS5315 low dose;Drug: TAS5315 high dose;Drug: Placebos | Taiho Pharmaceutical Co., Ltd. | Recruiting | 20 Years | 64 Years | All | 90 | Phase 2 | Japan | |
100 | NCT02885597 | July 2018 | 23 July 2018 | Juanbi Pill for Rheumatoid Arthritis | Juanbi Pill Combined With Methotrexate for Rheumatoid Arthritis: Multi-center Random Controlled Clinical Trials | Juanbi Pill;Rheumatoid Arthritis | Drug: Juanbi pill;Drug: Juanbi pill placebo;Drug: Methotrexate | Cui xuejun | Shanghai Yueyang Integrated Medicine Hospital;Longhua Hospital;Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine | Recruiting | 18 Years | 80 Years | All | 120 | Phase 2/Phase 3 | China |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
101 | NCT03173040 | July 2018 | 23 July 2018 | The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis | The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis: a Study Protocol for a Multicenter, Randomized, Controlled Clinical Trial | Niu Bang Zi Pill;Rheumatoid Arthritis | Drug: NiuBangZi pill or NiuBangZi pill placebo | Cui xuejun | Shanghai Yueyang Integrated Medicine Hospital;Longhua Hospital;Shanghai Seventh People's Hospital | Recruiting | 18 Years | 80 Years | All | 100 | Phase 2/Phase 3 | China |
102 | NCT03589833 | July 2018 | 20 August 2018 | Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RA | Effectiveness and Safety of Tumor Necrosis Factor Receptor Fusion Protein(Yisaipu) Combined With Tripterygium Wilfordii for Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Tripterygium Wilfordii;Drug: Methotrexate;Drug: Yisaipu | Peking Union Medical College Hospital | Recruiting | 18 Years | 65 Years | All | 504 | Phase 2 | China | |
103 | NCT03084419 | June 26, 2018 | 29 July 2019 | APRIL (AbatacePt in Rheumatoid Arthritis-ILD) | Safety of Abatacept in Rheumatoid Arthritis Associated Interstitial Lung Disease: A Feasibility Trial | Rheumatoid Arthritis;Interstitial Lung Disease | Drug: Abatacept | Cambridge University Hospitals NHS Foundation Trust | Bristol-Myers Squibb | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United Kingdom |
104 | JPRN-UMIN000033059 | 2018/06/20 | 23 April 2019 | The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial | The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial - The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial | Osteoarthritis of the hip, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture | A 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 Hospital | Not Recruiting | 18years-old | Not applicable | Male and Female | 120 | Not selected | Japan | |
105 | NCT03550833 | June 13, 2018 | 30 September 2019 | Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model | Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model | Arthritis, Rheumatoid;Stress Disorder | Behavioral: Questionnaire;Biological: blood sample | University Hospital, Bordeaux | Not recruiting | 18 Years | N/A | All | 152 | Phase 3 | France | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
106 | NCT03606876 | June 13, 2018 | 28 January 2019 | Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects | A 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 Subjects | Rheumatoid Arthritis | Drug: BAT1806 injection | Bio-Thera Solutions | Not recruiting | 18 Years | 55 Years | Male | 138 | Phase 1 | China | |
107 | NCT03535402 | June 1, 2018 | 15 July 2019 | Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics | Measurement 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 Arthritis | Drug: Sarilumab | Gaylis, Norman B., M.D. | Recruiting | 18 Years | N/A | All | 20 | Phase 3 | United States | |
108 | NCT03559686 | May 30, 2018 | 15 July 2019 | Named 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 C87051 | Rheumatoid Arthritis | Drug: Certolizumab Pegol | UCB Biopharma S.P.R.L. | Not recruiting | 18 Years | N/A | All | Phase 3 | |||
109 | NCT03522415 | May 28, 2018 | 23 July 2018 | Study of Safety and Efficacy of HLX01+MTX in Patients With Rheumatoid Arthritis | A 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 Methotrexate | Moderately to Severely Active Rheumatoid Arthritis | Drug: HLX01;Drug: Methotrexate(MTX) | Shanghai Henlius Biotech | Recruiting | 18 Years | 75 Years | All | 267 | Phase 3 | China | |
110 | NCT03410056 | May 22, 2018 | 4 November 2019 | Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis | A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy | Rheumatoid Arthritis RA | Drug: AMG 592;Drug: Placebo | Amgen | Not recruiting | 18 Years | 70 Years | All | 153 | Phase 1/Phase 2 | United States;Bulgaria;Germany;Poland;Spain | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
111 | EUCTR2017-001944-36-ES | 21/05/2018 | 18 June 2018 | Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis | A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy | Rheumatoid Arthritis MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: AMG592 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 Inc | Authorised | Female: yes Male: yes | 137 | Phase 1;Phase 2 | United States;Czech Republic;Mexico;Poland;Spain;Romania;Australia;Bulgaria;Germany;New Zealand;United Kingdom | |||
112 | NCT03378219 | May 18, 2018 | 26 August 2019 | An Observational Study on Sarilumab-exposed Pregnancies | Kevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study | Rheumatoid Arthritis -Exposure During Pregnancy | Drug: Sarilumab SAR153191 (REGN88) | Sanofi | Regeneron Pharmaceuticals | Recruiting | N/A | N/A | Female | 300 | N/A | United States;Canada |
113 | NCT03508713 | May 13, 2018 | 11 June 2018 | Long-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 China | Rheumatoid Arthritis | Drug: disease modified antirheumatic drugs or biological agents | Nanfang Hospital of Southern Medical University | Southern Medical University, China | Not recruiting | 18 Years | N/A | All | 200 | Phase 3 | |
114 | EUCTR2017-004054-41-BE | 07/05/2018 | 3 September 2018 | COBRA-Slim with or without fast access to TNF blockade for remission induction in early RA | CareRA2020: Effectiveness of a combination of Methotrexate and a step down glucocorticoid regimen (COBRA-Slim) for remission induction in patients with early Rheumatoid Arthritis (RA), with or without fast access to 24 weeks of Tumor Necrosis Factor (TNF) blockade in insufficient responders, a randomized, multicenter, pragmatic trial. - CareRA2020 | early active Rheumatoid Arthritis, previously untreated with DMARDs MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: etanercept 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 Leuven | Authorised | Female: yes Male: yes | 440 | Phase 4 | Belgium | |||
115 | EUCTR2016-002569-68-GB | 04/05/2018 | 28 May 2018 | Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease | Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease: A feasibility study - APRIL | Rheumatoid-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 Trust | Authorised | Female: yes Male: yes | 30 | Phase 2 | United Kingdom | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
116 | NCT03492658 | May 2018 | 11 June 2018 | Abatacept 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 Diseases | Drug: Abatacept;Drug: Methotrexate | Leiden University Medical Center | Not recruiting | 18 Years | N/A | All | 46 | Phase 4 | ||
117 | NCT03435601 | April 18, 2018 | 11 June 2018 | A 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 Arthritis | Drug: Anifrolumab;Drug: Placebos | Josef Smolen, Univ. Prof. Dr. | Recruiting | 18 Years | 70 Years | All | 24 | Phase 2 | Austria | |
118 | NCT03493269 | April 16, 2018 | 22 October 2019 | A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Rheumatoid Arthritis (RA) or Psoriasis | A 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 Duration | Healthy Volunteers | Drug: BAY1834845;Other: Matching Placebo;Drug: Midazolam | Bayer | Recruiting | 18 Years | 65 Years | All | 88 | Phase 1 | Germany | |
119 | JPRN-UMIN000030575 | 2018/03/31 | 22 July 2019 | 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. - 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 arthritis | Patients 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, Limited | Recruiting | 20years-old | Not applicable | Male and Female | 44 | Not applicable | Japan | |
120 | NCT03478111 | March 30, 2018 | 30 September 2019 | CMAB008 With MTX Therapy in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis | A 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 Remicade | Rheumatoid Arthritis | Drug: CMAB008;Drug: MTX;Drug: Remicade | Shanghai Biomabs Pharmaceutical Co., Ltd. | Not recruiting | 18 Years | N/A | All | 390 | Phase 3 | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
121 | JPRN-UMIN000031890 | 2018/03/21 | 2 April 2019 | Triple-masked randomized comparison of 5mL or 20nL levobupivacaine to femoral triangle block for total knee arthroplasty | knee osteoarthritis or knee rheumatoid arthritis | Group 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 Hospital | Recruiting | 20years-old | 100years-old | Male and Female | 120 | Phase 3 | Japan | ||
122 | NCT03449758 | March 9, 2018 | 9 September 2019 | Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis | Effect 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 Inhibitors | Rheumatoid Arthritis | Drug: SARILUMAB;Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine | Sanofi | Regeneron Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 84 | Phase 4 | France |
123 | ChiCTR1800014584 | 2018-03-01 | 29 January 2018 | Clinical 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 arthritis | Experimental group:Asprin;Controlled group:Rivaroxaban; | Department of Orthopaedics, West China Hospital, Sichuan University | Not Recruiting | 70 | 100 | Both | Experimental group:90;Controlled group:30; | Other | China | |
124 | ChiCTR1800014872 | 2018-03-01 | 19 February 2018 | Role of parecoxib sodium in the multimodal analgesia after total knee arthroplasty | Safety and efficacy of parecoxib sodium in the multimodal analgesia after total knee arthroplasty: a prospective randomized controlled trial | osteoarthritis or rheumatoid arthritis | Experimental 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 Hospital | Not Recruiting | Both | Experimental group:50;Control group:50; | Post-market | China | |||
125 | JPRN-UMIN000031692 | 2018/03/01 | 7 October 2019 | Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty | Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty - Efficacy of intravenous acetaminophen injection for pain management after TKA | knee osteoarthritis rheumatoid arthritis | Study group:Fentanyl sustained intravenous administration given after operation end. And use the Intravenous acetaminophen 4 times per 6 hour.Dosage is 15 mg/kg for the patient less than 50 kg in weight and 1000 mg for the patient more than 50 kg in weight. Control group:Fentanyl sustained intravenous administration given after operation end. | Yamaguchi University | Recruiting | 20years-old | Not applicable | Male and Female | 60 | Not selected | Japan | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
126 | NCT03100253 | March 1, 2018 | 30 September 2019 | Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation | Open-label, Randomized Controlled Trial Comparing Tocilizumab to Anti-TNF Treatment and Discovery of Biomarkers for Treatment Selection in Rheumatoid Arthritis Patients With Inadequate Response to a First Anti-TNF | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Golimumab;Drug: Certolizumab Pegol | Mario Negri Institute for Pharmacological Research | Recruiting | 18 Years | N/A | All | 400 | Phase 4 | Italy | |
127 | NCT03470688 | March 1, 2018 | 11 June 2018 | Investigating the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents | An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology | Rheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis | Biological: Originator;Biological: Biosimilar | Opal Rheumatology Ltd. | Merck Sharp & Dohme Corp. | Recruiting | 18 Years | N/A | All | 5000 | Phase 4 | Australia |
128 | NCT03480529 | March 1, 2018 | 16 September 2019 | Monitoring the IMmUological TOXicity of Drugs | Monitoring the IMmUological TOXicity of Drugs | Arthritis;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Capillary Leak Syndrome;Hepatitis | Drug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom | Groupe Hospitalier Pitie-Salpetriere | Institut National de la Santé Et de la Recherche Médicale, France | Not recruiting | 18 Years | N/A | All | 662 | Early Phase 1 | France |
129 | EUCTR2017-004079-30-BE | 19/02/2018 | 30 April 2019 | Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology | Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU | Rheumatoid Arthritis MedDRA version: 20.0 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: MabThera 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 | 219 | Phase 3 | Portugal;Spain;Belgium;Italy | |||
130 | EUCTR2017-002878-38-NL | 07/02/2018 | 5 March 2018 | Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis | Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis - ASCARA | Patients 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 Center | Authorised | Female: yes Male: yes | 46 | Phase 4 | Netherlands | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
131 | NCT03455842 | February 1, 2018 | 11 February 2019 | The BCD-089 (aIL6R) in Patients With Active Rheumatoid Arthritis | International 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 Arthritis | Seropositive RA | Drug: placebo;Biological: BCD-089, 162 mg, s/c, q2w;Biological: BCD-089, 162 mg, s/c, qw | Biocad | Not recruiting | 18 Years | 80 Years | All | 105 | Phase 2 | Belarus;Russian Federation | |
132 | NCT04022525 | February 1, 2018 | 29 July 2019 | Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches | Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches | Rheumatoid Arthritis | Drug: Leflunomide 20Mg Tab | Assiut University | Not recruiting | 18 Years | N/A | All | 80 | Phase 1/Phase 2 | Egypt | |
133 | NCT01694693 | January 31, 2018 | 16 December 2017 | Description 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 Study | Description 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 Study | Rheumatoid Arthritis | Drug: Orencia | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 0 | N/A | ||
134 | NCT03430388 | January 31, 2018 | 6 May 2019 | Yellow Fever Vaccine in Patients With Rheumatic Diseases | Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area | Systemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile Dermatomyositis | Biological: Yellow Fever vaccine (17D) | University of Sao Paulo General Hospital | Not recruiting | 2 Years | 60 Years | All | 600 | N/A | Brazil | |
135 | EUCTR2017-002753-11-FI | 25/01/2018 | 30 April 2019 | The effect of the new anti-rheumatic drug tofacitinib on cytokine-induced inflammatory pathways in patients with rheumatoid arthritis | The effect of tofacitinib on the activity of JAK-STAT pathways in patients with rheumatoid arthritis (RA) - TofaSTAT17 | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Xeljanz Product Name: Xeljanz Product Code: PRD4862257 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 Hospital | Authorised | Female: yes Male: yes | 24 | Phase 4 | Finland | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
136 | NCT03227419 | January 22, 2018 | 3 September 2018 | Abatacept vs Tocilizumab for the Treatment of RA in TNF Alpha Inhibitor Inadequate Responders | 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 | Arthritis, Rheumatoid | Drug: Tocilizumab Prefilled Syringe;Drug: Abatacept Prefilled Syringe | Lille Catholic University | Recruiting | 18 Years | N/A | All | 224 | Phase 4 | France | |
137 | NCT03368235 | January 18, 2018 | 4 November 2019 | Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis | A 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 | Drug: AZD9567;Drug: Prednisolone | AstraZeneca | Recruiting | 18 Years | 80 Years | All | 40 | Phase 2 | Denmark;Netherlands;Sweden | |
138 | JPRN-UMIN000030828 | 2018/01/15 | 2 April 2019 | The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis. | Rheumatoid Arthritis Osteoporosis | zoledronic acid denosumab | Osaka City University Graduate School of Medicine | Recruiting | 20years-old | Not applicable | Male and Female | 500 | Not selected | Japan | ||
139 | EUCTR2017-003259-40-ES | 04/01/2018 | 8 January 2018 | Periodontitis 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 Canarias | Authorised | Female: yes Male: yes | 120 | Phase 4 | Spain | |||
140 | NCT02955212 | January 3, 2018 | 30 September 2019 | A 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: Placebo | AbbVie | Not recruiting | 18 Years | N/A | All | 338 | Phase 3 | Brazil;China;Korea, Republic of | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
141 | JPRN-UMIN000030237 | 2018/01/01 | 2 April 2019 | Additional postoperative intravenous tranexamic acid administration versus placebo administration for patients treated with intraoperative combined intravenous and intra-articular tranexamic acid in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial | Osteoarthritis of the knee, rheumatoid arthritis, avascular necrosis | Additional 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 Hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 100 | Not selected | Japan | ||
142 | NCT02795299 | January 2018 | 23 July 2018 | Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFa Antagonist Failed in Rheumatoid Arthritis | Phase 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 Antagonist | Rheumatoid Arthritis | Drug: Gerilimzumab;Drug: Methotrexate;Drug: Folic Acid;Drug: Placebo | Bird Rock Bio, Inc. | Techtrials Pesquisa e Tecnologia Ltda;Pharmagenix | Not recruiting | 18 Years | 80 Years | All | 0 | Phase 2 | |
143 | JPRN-jRCTs031180050 | 26/12/2017 | 10 September 2019 | Hydroxychloroquine for Japanese patients with rheumatoid arthritis | Efficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritis | Rheumatoid arthritis;D001172 | Treatment with hydroxychloroquine for 24 weeks | Yuko Kaneko | Recruiting | >= 18age old | Not applicable | Both | 120 | Phase 2-3 | None | |
144 | NCT03798028 | December 26, 2017 | 21 January 2019 | The Safety and Effects of Mesenchymal Stem Cell (MSCs) in the Treatment of Rheumatoid Arthritis | The Effects and Safety of Mesenchymal Stem Cells in the Treatment of Moderate/Severe Rheumatoid Arthritis, a Multicenter Randomized Controlled Clinical Study | Rheumatoid Arthritis | Biological: UC-MSCs | Xijing Hospital | Changhai Hospital;Southwest Hospital, China | Recruiting | 18 Years | 70 Years | All | 250 | N/A | China |
145 | EUCTR2017-001970-41-DK | 21/12/2017 | 24 September 2018 | Dose reduction and withdrawal of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months multi-centre trial | Dose reduction and discontinuation of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months randomised, open label, parallel-group, multi-centre trial - The BIODOPT trial (BIOlogical Dose OPTimisation) | Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis MedDRA version: 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 Kristensen | Authorised | Female: yes Male: yes | 180 | Phase 4 | Denmark | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
146 | NCT03457792 | December 19, 2017 | 11 June 2018 | A Study of Abatacept in Participants That Only Recently Started to Develop Rheumatoid Arthritis | Abatacept in Early-Stage Rheumatoid Arthritis Patients: Longterm Experience and Efficacy in Routine Clinical Practice | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | Recruiting | 18 Years | N/A | All | 400 | N/A | Germany | |
147 | NCT03186417 | December 15, 2017 | 22 July 2019 | Mesenchymal Stem Cells in Early Rheumatoid Arthritis | Cell-Based Therapy in Rheumatoid Arthritis: Proof of Concept Phase 1 Trial | Rheumatoid Arthritis | Biological: 2 million hMSC/kg;Biological: 4 million hMSC/kg;Biological: 6 million hMSC/kg;Biological: placebo | MetroHealth Medical Center | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Recruiting | 18 Years | 80 Years | All | 20 | Phase 1 | United States |
148 | EUCTR2017-001717-92-AT | 11/12/2017 | 7 January 2019 | A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in patients with rheumatoid arthritis who have a high interferon signature (TarIFNiRA) | A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in RA patients with a high IFN signature (TarIFNiRA) - TarIFNiRA | High IFN siganture in patients with rheumatoid arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab (MEDI-546) 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 Vienna | Authorised | Female: yes Male: yes | 24 | Phase 2 | Austria;Italy;Switzerland | |||
149 | EUCTR2017-001944-36-PL | 23/11/2017 | 15 October 2018 | Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis | A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy | Rheumatoid Arthritis MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: 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 Inc | Authorised | Female: yes Male: yes | 137 | Phase 1;Phase 2 | United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;New Zealand;United Kingdom | |||
150 | NCT03334851 | November 17, 2017 | 30 September 2019 | Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis | A 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 ARTHRITIS | Systemic Lupus Erythematosus;Rheumatoid Arthritis | Drug: PF-06835375;Drug: Placebo | Pfizer | Recruiting | 18 Years | 70 Years | All | 112 | Phase 1 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
151 | NCT03911830 | November 11, 2017 | 23 April 2019 | Aerobic Exercise Program Followed by Cold Water Immersion: Effects on Arthritis Patients Arterial Stiffness | Effects of an Aerobic Exercise Program on Cycloergometer Followed by Cold Water Immersion Recovery in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis;Cryotherapy Effect;Physical Activity | Other: Exercise followed cold water immersion | Centre Hospitalier Universitaire de Besancon | Not recruiting | 20 Years | 80 Years | All | 18 | N/A | France | |
152 | EUCTR2017-003425-15-DK | 10/11/2017 | 11 December 2017 | Patients 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, Rigshospitalet | Authorised | Female: yes Male: yes | 100 | Phase 4 | Denmark | |||
153 | NCT03357471 | November 3, 2017 | 10 September 2018 | Study 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 Disease | A 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 Disease | Moderate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's Disease | Drug: e-Device | UCB Biopharma S.P.R.L. | Not recruiting | 18 Years | N/A | All | 70 | Phase 3 | United States | |
154 | EUCTR2017-000384-32-BG | 02/11/2017 | 30 April 2019 | Phase IIb in Rheumatoid Arthritis | A Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A | Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Evobrutinib Product Code: M2951 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 KGaA | Authorised | Female: yes Male: yes | 363 | Phase 2 | Serbia;United States;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;Bulgaria;South Africa;Germany;Japan | |||
155 | JPRN-UMIN000029797 | 2017/11/02 | 23 April 2019 | Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial | Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial - Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial | Osteoarthritis of the hip, Avascular necrosis of the femoral head, Rheumatoid arthritis | The 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 Hospital | Not Recruiting | 18years-old | Not applicable | Male and Female | 40 | Not selected | Japan | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
156 | NCT03329885 | November 2, 2017 | 20 August 2018 | A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Patients and Patients With Average to Very Serious Psoriasis | A 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 Psoriasis | Rheumatoid Arthritis;Psoriasis;Ankylosing Spondylitis;Inflammatory Bowel Diseases;Nonalcoholic Steatohepatitis | Other: Placebo;Drug: BMS-986251 | Bristol-Myers Squibb | Not recruiting | 18 Years | 70 Years | All | 38 | Phase 1/Phase 2 | Netherlands | |
157 | NCT03387423 | November 2, 2017 | 11 November 2019 | Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis | ESCALATE-RA A NON-INTERVENTIONAL STUDY OF CRITICAL FACTORS FOR ESCALATING DRUG TREATMENT IN PATIENTS TREATED WITH TOFACITINIB FOR MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS | Arthritis, Rheumatoid | Drug: Tofacitinib | Pfizer | Recruiting | 18 Years | N/A | All | 1500 | N/A | Germany | |
158 | JPRN-JapicCTI-173747 | 01/11/2017 | 16 July 2019 | Specific 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 Arthritis | Intervention 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. | Recruiting | BOTH | 1000 | NA | ||||
159 | JPRN-UMIN000029759 | 2017/11/01 | 2 April 2019 | Percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty as a component of multimodal pain management: a randomized control trial | Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis | Percutaneous 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 Hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 32 | Not selected | Japan | ||
160 | NCT03440892 | November 1, 2017 | 18 March 2019 | Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients | Longitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of Survivin | Rheumatoid Arthritis | Drug: methotrexate;Drug: sulfasalazine;Drug: abatacept;Drug: tocilizumab;Drug: tofacitinib/baricitinib | Vastra Gotaland Region | Recruiting | 20 Years | N/A | All | 2500 | N/A | Sweden | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
161 | NCT02647762 | October 30, 2017 | 14 October 2019 | CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid Arthritis | A Phase 3, Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CF101 1 mg;Drug: CF101 2 mg;Drug: Placebo;Drug: MTX | Can-Fite BioPharma | Recruiting | 18 Years | 75 Years | All | 525 | Phase 3 | Bosnia and Herzegovina;Canada;Israel;Moldova, Republic of;Poland;Romania;Serbia | |
162 | NCT03324412 | October 28, 2017 | 16 December 2017 | Efficacy and Safety of TwHF and MTX in Patients With Rheumatoid Arthritis | A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of TwHF and MTX Treating Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Treatment of MTX;Drug: Treatment of MTX and TwHF | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Not recruiting | 45 Years | 70 Years | All | 216 | Phase 2/Phase 3 | ||
163 | NCT03337815 | October 28, 2017 | 16 December 2017 | A Specification Clinical Application Research of Tripterygium Wilfordii Treating Rheumatoid Arthritis | A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of Tripterygium Wilfordii Treating Rheumatoid Arthritis and Establish A Prediction Model | Rheumatoid Arthritis | Drug: Treatment of MTX and TwHF placebo;Drug: Treatment of TwHF and MTX placebo | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Recruiting | 45 Years | 70 Years | All | 264 | Phase 2/Phase 3 | China | |
164 | NCT03163966 | October 5, 2017 | 8 January 2018 | A Study of the EP4 Antagonist CR6086 in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-controlled, Dose Response, Phase II, Multicentre Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Oral CR6086 Administered at the Doses of 30, 90 or 180 mg Bid for 12 Weeks in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis | Rheumatoid Arthritis, DMARD-naive and Early Disease Patients | Drug: CR6086;Drug: Methotrexate;Drug: Placebo | Rottapharm Biotech | Recruiting | 18 Years | N/A | All | 240 | Phase 2 | Czechia | |
165 | JPRN-UMIN000029003 | 2017/10/01 | 2 April 2019 | Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial | Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis | Percutaneous 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 Hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 40 | Not selected | Japan | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
166 | NCT03254589 | October 1, 2017 | 26 August 2019 | Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis | Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis | Rheumatoid Arthritis;Stiffness, Aortic;Endothelial Dysfunction;Cardiovascular Risk Factor | Drug: Methotrexate;Drug: Sulfasalazine;Drug: Other DMARDs | Flinders University | University of South Australia;medac GmbH | Recruiting | 18 Years | N/A | All | 124 | Phase 4 | Australia |
167 | NCT03257852 | September 29, 2017 | 11 November 2019 | A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate | A Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate | Rheumatoid Arthritis (RA) | Drug: ASP5094;Drug: Placebo;Other: Methotrexate therapy | Astellas Pharma Inc | Not recruiting | 20 Years | N/A | All | 66 | Phase 2 | Japan | |
168 | EUCTR2016-004300-65-BE | 26/09/2017 | 20 August 2018 | 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®). | 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 TRIS | rheumatoid 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 Hospital | Authorised | Female: yes Male: yes | 120 | Phase 4 | Belgium | |||
169 | EUCTR2017-000384-32-CZ | 26/09/2017 | 11 June 2018 | Phase IIb in Rheumatoid Arthritis | A Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A | Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Evobrutinib Product Code: M2951 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 KGaA | Authorised | Female: yes Male: yes | 363 | Phase 2 | Japan;Germany;Bulgaria;South Africa;Poland;Brazil;Argentina;Mexico;Czech Republic;Colombia;Chile;Russian Federation;Ukraine;United States;Serbia | |||
170 | NCT03233230 | September 18, 2017 | 15 July 2019 | Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis | A 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 | Rheumatoid Arthritis | Drug: Evobrutinib;Drug: Placebo;Drug: Methotrexate | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Not recruiting | 18 Years | 75 Years | All | 390 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Chile;Colombia;Czechia;Mexico;Poland;Russian Federation;Serbia;South Africa;Ukraine;Germany;Hungary;Romania;Slovakia;Spain |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
171 | EUCTR2017-000838-64-SE | 11/09/2017 | 16 October 2017 | An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone | A 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 AB | Authorised | Female: yes Male: yes | 40 | Phase 2 | Denmark;Netherlands;Sweden | |||
172 | NCT03262740 | September 11, 2017 | 12 March 2018 | The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients | The Effect of BMS-986195 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects | Rheumatoid Arthritis | Drug: BMS-986195;Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol) | Bristol-Myers Squibb | Not recruiting | 18 Years | 40 Years | Female | 58 | Phase 1 | United States | |
173 | EUCTR2016-004834-11-BG | 04/09/2017 | 28 February 2019 | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CR6086 Product Code: CR6086Z 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 | 240 | Phase 2 | Moldova, Republic of;United Kingdom;Bulgaria;Denmark;Romania;Poland;Argentina;Czech Republic | |||
174 | NCT03241446 | September 2017 | 15 October 2018 | Pharmacokinetics 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 Arthritis | Arthritis, Rheumatoid | Drug: Tilmanocept | Navidea Biopharmaceuticals | Not recruiting | 30 Years | 65 Years | All | 0 | Phase 1 | ||
175 | NCT03254966 | September 2017 | 16 December 2017 | Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients | Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Safety and Efficacy of SHR0302 in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: SHR0302;Drug: Placebo | Jiangsu HengRui Medicine Co., Ltd. | Not recruiting | 18 Years | 70 Years | All | 170 | Phase 2 | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
176 | EUCTR2017-000947-41-FR | 18/08/2017 | 16 October 2017 | ORENCIA VERSUS ROACTEMRA BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS. | ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPEN-LABELED, SUPERIORITY TRIAL. - SUNSTAR | Adults patients suffering from rheumatoid arthritis and in adequate response to a first line of treatment with a TNF alpha inhibitor. MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ORENCIA 125 mg, solution injectable en seringue préremplie 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 Lille | Authorised | Female: yes Male: yes | Phase 4 | France | ||||
177 | NCT03160001 | August 15, 2017 | 18 December 2018 | Niclosamide With Etanercept in Rheumatoid Arthritis | Adjuvant Use of Niclosamide With Etanercept in Rheumatoid Arthritis: Experimental and Clinical Study | Rheumatoid Arthritis (RA) | Drug: Placebo;Drug: Niclosamide;Drug: Etanercept | Faiq Gorial | Not recruiting | 18 Years | N/A | All | 110 | Phase 1/Phase 2 | Iraq | |
178 | NCT03245515 | August 15, 2017 | 18 January 2018 | A Study of BMS-986195 in Healthy Male Subjects | Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects | Rheumatoid Arthritis | Drug: BMS-986195 | Bristol-Myers Squibb | Not recruiting | 18 Years | 55 Years | Male | 24 | Phase 1 | Netherlands | |
179 | NCT03156023 | August 14, 2017 | 4 November 2019 | Multiple Ascending Doses of AMG 570 in Subjects With Rheumatoid Arthritis | A 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 Arthritis | Rheumatoid Arthritis | Drug: AMG 570;Drug: Placebo | Amgen | Not recruiting | 18 Years | 75 Years | All | 34 | Phase 1 | United States;Germany | |
180 | NCT03327454 | August 10, 2017 | 5 November 2018 | Benepali® PEN Patient Satisfaction Survey | Non-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled Pen | Rheumatoid Arthritis;Spondyloarthropathies | Biological: Benepali | Biogen | Not recruiting | 18 Years | N/A | All | 500 | N/A | Germany | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
181 | NCT03188081 | August 4, 2017 | 23 July 2018 | A 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) Abatacept | A 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 SC | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | Recruiting | 18 Years | N/A | All | 300 | N/A | Italy | |
182 | NCT03155347 | August 2, 2017 | 4 November 2019 | An 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) Therapy | A 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 Therapy | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: MTX;Drug: Placebo Matched to MTX;Drug: Placebo Matched to Tocilizumab | Hoffmann-La Roche | Recruiting | 18 Years | 70 Years | All | 300 | Phase 3 | China | |
183 | NCT03215407 | August 1, 2017 | 16 December 2017 | The Comparative Study of Intra-articular Injection of Tocilizumab and Compound Betamethasone | The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee | Rheumatoid Arthritis of Knee | Drug: Intra-articular Tocilizumab;Drug: Intra-articular Compound Betamethasone | Chinese PLA General Hospital | Not recruiting | 18 Years | 65 Years | All | 60 | Phase 4 | ||
184 | NCT03250767 | August 1, 2017 | 30 September 2019 | Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement | A 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 Replacement | Osteo Arthritis Shoulders;Traumatic Arthritis;Rheumatoid Arthritis | Device: Integra Titan Modular Shoulder System 2.5 | Integra LifeSciences Corporation | Recruiting | 18 Years | N/A | All | 140 | Phase 1/Phase 2 | United States | |
185 | JPRN-UMIN000028376 | 2017/07/26 | 2 April 2019 | Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis | rheumatoid arthritis | Combination of anti-rheumatic therapy and denosumab Anti-rheumatic therapy alone | Hokkaido Medical Center for Rheumatic Diseases | Recruiting | 20years-old | 75years-old | Male and Female | 30 | Not selected | Japan | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
186 | NCT02541955 | July 20, 2017 | 9 September 2019 | Use of Acthar in Rheumatoid Arthritis (RA) Related Flares | Use of Acthar in Rheumatoid Arthritis Related Flares | Rheumatoid Arthritis (RA) | Drug: Acthar | Dr. Veena Ranganath | Recruiting | 18 Years | N/A | All | 40 | Phase 4 | United States | |
187 | EUCTR2016-004834-11-DK | 06/07/2017 | 30 April 2019 | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CR6086 Product Code: CR6086Z 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 | 240 | Phase 2 | Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom | |||
188 | NCT03120949 | July 4, 2017 | 18 December 2018 | Evaluation 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 Arthritis | Rheumatoid Arthritis | Drug: Olokizumab 64 mg SC q4w;Drug: Olokizumab 64 mg SC q2w;Drug: Methotrexate | R-Pharm | Quintiles, Inc.;OCT Clinical Trials;Mene Research | Recruiting | 18 Years | N/A | All | 1880 | Phase 3 | United States;Argentina;Brazil;Bulgaria;Colombia;Czechia;Estonia;Germany;Hungary;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Romania;Russian Federation;Taiwan;United Kingdom |
189 | NCT03189017 | July 3, 2017 | 26 August 2019 | A Phase I Study of ICP-022 in Healthy Subjects | A 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 Dose | Systemic Lupus Erythematosus;Rheumatoid Arthritis | Drug: ICP-022;Drug: Placebos | Innocare Pharma Australia Pty Ltd | Not recruiting | 18 Years | 55 Years | Male | 64 | Phase 1 | Australia | |
190 | NCT03285191 | July 3, 2017 | 27 August 2018 | Subject Insights to Understand Rheumatoid Arthritis (RA) | Patient Interviews to Better Understand Disease Experience and Unmet Treatment Needs in Rheumatoid Arthritis | Arthritis, Rheumatoid | Other: Numerical rating scale;Other: Real-time data capture app | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 30 | Phase 1/Phase 2 | United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
191 | ChiCTR-IPR-17011566 | 2017-07-01 | 12 June 2017 | The efficacy and safety of sirolimus in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China | The efficacy and safety of sirolimus in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China | Rheumatoid Arthritis;M05.901 | Sirolimus group: Sirolimus; Non-Sirolimus group:Glucocorticoids and Immunosuppressant; | the Second Hospital of Shanxi Medical University | Recruiting | 18 | 65 | Both | Sirolimus group:200; Non-Sirolimus group:100; | Post-market | China | |
192 | NCT03394131 | July 1, 2017 | 23 July 2018 | ?Efficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients | Treatment of Carpal Tunnel in Rheumatoid Arthritis | Treatment Resistant Carpal Tunnel in RA Patients | Drug: Hylase;Drug: Insulin;Other: saline | Assiut University | Recruiting | 20 Years | 80 Years | All | 90 | N/A | Egypt | |
193 | ChiCTR-INR-17011772 | 2017-06-27 | 3 July 2017 | The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agents | The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agents | Rheumatoid Arthritis | test 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 Hospital | Recruiting | 18 | 65 | Both | test group:80;Control group:40; | New Treatment Measure Clinical Study | China | |
194 | NCT03278470 | June 26, 2017 | 27 August 2018 | A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject | A 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 Subject | Rheumatoid Arthritis | Drug: HL237;Drug: Placebo Oral Tablet | Hanlim Pharm. Co., Ltd. | Not recruiting | 20 Years | 45 Years | Male | 57 | Phase 1 | Korea, Republic of | |
195 | NCT03239080 | June 19, 2017 | 11 February 2019 | Effect of Denosumab in Erosion Healing in RA | Effect of RANKL Inhibition on Healing of Bone Erosion in Rheumatoid Arthritis Using HR-pQCT | Rheumatoid Arthritis | Drug: Denosumab;Other: Placebo | Chinese University of Hong Kong | Not recruiting | 18 Years | N/A | All | 110 | Phase 2 | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
196 | EUCTR2015-005309-35-GB | 16/06/2017 | 28 February 2019 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) 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-Pharm | Authorised | Female: yes Male: yes | 1880 | Phase 3 | United 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 | |||
197 | JPRN-UMIN000027719 | 2017/06/12 | 2 April 2019 | Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy. | rheumatoid arthritis/remission | add-on iguratimod tapering MTX continuing the treatment | Osaka Medical College | Recruiting | 20years-old | 100years-old | Male and Female | 100 | Not selected | Japan | ||
198 | EUCTR2016-000569-21-FR | 08/06/2017 | 28 February 2019 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 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 | 423 | Phase 3 | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | |||
199 | NCT03100734 | June 1, 2017 | 15 July 2019 | Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel | A Multicentre Observational Study to Evaluate the Real-Life Effectiveness of Benepali® Following Transition From Enbrel® in Patients With Rheumatoid Arthritis (RA) and Axial Spondyloarthritis (axSpA) - The BENEFIT Study | Rheumatoid Arthritis;Axial Spondyloarthritis | Biological: Benepali;Biological: Enbrel | Biogen | Samsung Bioepis Co., Ltd. | Not recruiting | 18 Years | N/A | All | 585 | N/A | Germany |
200 | NCT03139136 | May 30, 2017 | 26 August 2019 | Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis | A 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 Methotrexate | Rheumatoid Arthritis | Drug: MBS2320;Drug: Placebo | Modern Biosciences plc | Not recruiting | 18 Years | 75 Years | All | 121 | Phase 2 | Georgia;Moldova, Republic of;Romania | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
201 | NCT03193957 | May 15, 2017 | 16 December 2017 | An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis | An 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 Arthritis | Rheumatoid Arthritis | Drug: Etanercept;Device: Autoinjector | Samsung Bioepis Co., Ltd. | Not recruiting | 18 Years | 55 Years | All | 50 | Phase 2 | Poland | |
202 | NCT03131973 | May 13, 2017 | 8 January 2018 | Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin | Effects 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 Participants | Rheumatoid Arthritis | Drug: BMS-986195;Drug: Methotrexate;Drug: Leucovorin;Drug: Caffeine;Drug: Montelukast;Drug: Flurbiprofen;Drug: Omeprazole;Drug: Midazolam;Drug: Digoxin;Drug: Pravastatin | Bristol-Myers Squibb | Not recruiting | 18 Years | 50 Years | All | 26 | Phase 1 | United States | |
203 | EUCTR2016-005017-45-HU | 12/05/2017 | 18 June 2018 | A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 19.1 Level: LLT Classification code 10040107 Term: Seropositive rheumatoid arthritis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NI-0101 Product Code: NI-0101 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 | 81 | Phase 2 | Bosnia and Herzegovina;United Kingdom;Moldova, Republic of;Bulgaria;Georgia;Poland;Hungary;Serbia | |||
204 | EUCTR2016-005017-45-BG | 11/05/2017 | 28 February 2019 | A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 20.0 Level: LLT Classification code 10040107 Term: Seropositive rheumatoid arthritis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NI-0101 Product Code: NI-0101 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 | 81 | Phase 2 | Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina | |||
205 | NCT03241108 | May 10, 2017 | 27 August 2018 | Study of an Anti-TLR4 mAb in Rheumatoid Arthritis | Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an Anti-Toll Like Receptor 4 Monoclonal Antibody in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Other: Placebo;Drug: NI-0101 | NovImmune SA | Not recruiting | 18 Years | N/A | All | 90 | Phase 2 | Bosnia and Herzegovina;Bulgaria;Georgia;Hungary;Moldova, Republic of;Poland;Serbia | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
206 | NCT03086343 | May 9, 2017 | 22 October 2019 | A 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 placebo | AbbVie | Not recruiting | 18 Years | N/A | All | 657 | Phase 3 | United 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 | |
207 | EUCTR2016-001825-15-BE | 08/05/2017 | 28 February 2019 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 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 York | Not Recruiting | Female: yes Male: yes | 680 | Phase 3;Phase 4 | United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | |||
208 | NCT02808871 | April 7, 2017 | 7 October 2019 | Phase 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 Disease | Drug: Pirfenidone;Drug: Placebo | Ivan O. Rosas | Recruiting | 18 Years | 85 Years | All | 270 | Phase 2 | United States;Australia;Canada;United Kingdom | |
209 | NCT02908490 | April 1, 2017 | 25 February 2019 | Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis? | Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis? | Arthritis, Rheumatoid;Atherosclerosis | Drug: Sildenafil;Other: Placebo | Kimberly Liang | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | United States | |
210 | NCT03275025 | April 1, 2017 | 22 July 2019 | A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis | A 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 Arthritis | Drug: YRA-1909 low dose;Drug: YRA-1909 mid dose;Drug: YRA-1909 high dose;Drug: Placebo | Yungjin Pharm. Co., Ltd. | Recruiting | 19 Years | 80 Years | All | 200 | Phase 2 | Korea, Republic of | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
211 | NCT03291457 | March 30, 2017 | 22 October 2019 | A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice | A Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Glucocorticoid Agent | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 101 | Phase 3 | Belgium | |
212 | NCT03178955 | March 27, 2017 | 24 June 2019 | Circadian RA Study in Rheumatoid Arthritis Subjects | The Effects of Biologic Therapy With Disease Activity and Circadian Rhythm | Rheumatoid Arthritis | Drug: Etanercept | University of California, Davis | Not recruiting | 18 Years | 80 Years | All | 0 | Phase 1 | United States | |
213 | NCT03348046 | March 23, 2017 | 12 March 2018 | Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan | Post-Authorization Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan | Rheumatoid Arthritis | Drug: Biosimilar Infliximab | Hikma Pharmaceuticals LLC | INC Research | Recruiting | 18 Years | N/A | All | 40 | N/A | Jordan |
214 | NCT03245320 | March 20, 2017 | 4 February 2019 | Clinical Evaluation of the TITAN™ Total Shoulder System | A Post-Market Observational Study to Evaluate Performance and Safety of the TITAN™ Total Shoulder System | Arthritis;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, Shoulder | Device: Integra TITAN™ Total Shoulder Generation 1.0 | Integra LifeSciences Corporation | Not recruiting | 18 Years | N/A | All | 50 | Phase 1 | United States | |
215 | NCT03755258 | March 16, 2017 | 10 December 2018 | Trial of Ginsenoside Compound K (GCK) Tablet in Patients With Rheumatoid Arthritis | A Phase Ib Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GCK in Rheumatoid Arthritis Patients | Early Rheumatoid Arthritis | Drug: GCK 100 mg + Placebo 200 mg;Drug: GCK 200 mg + Placebo 100 mg;Drug: GCK 300 mg;Drug: Placebo 300mg | Zhejiang Hisun Pharmaceutical Co. Ltd. | Recruiting | 18 Years | 65 Years | All | 128 | Phase 1 | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
216 | NCT03110094 | March 13, 2017 | 11 June 2018 | Investigation of Immunological and Pharmacological Factors for Response to Adalimumab in Rheumatoid Arthritis | Investigation of Immunological and Pharmacological Factors for Response to Adalimumab in Rheumatoid Arthritis, With Analysis of CD4 + Follicular Helper T Subpopulations | Rheumatoid Arthritis | Other: Adalimumab;Other: Healthy volunteers | Rennes University Hospital | Recruiting | 18 Years | N/A | All | 60 | N/A | France | |
217 | EUCTR2015-005307-83-LV | 03/03/2017 | 30 April 2019 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) 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-Pharm | Authorised | Female: yes Male: yes | 1575 | Phase 3 | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of | |||
218 | NCT03082573 | March 3, 2017 | 16 December 2017 | Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar Gel | Open-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 DMRADs | Rheumatoid Arthritis | Drug: H.P. Acthar gel | Iraj Sabahi Research Inc. | Mallinckrodt | Recruiting | 21 Years | N/A | All | 30 | Phase 4 | United States |
219 | EUCTR2016-002126-36-AT | 01/03/2017 | 10 December 2018 | A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors | A randomized, double-blind, placebo-controlled, multi-center, three-part phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors | Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RO7123520 Product Code: RO7123520/F03-01 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 Ltd | Not Recruiting | Female: yes Male: yes | 204 | Phase 2 | United States;Spain;Guatemala;Austria;Chile;Colombia;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;Germany | |||
220 | NCT03025308 | February 28, 2017 | 4 November 2019 | Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis | A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis | RheumatoId Arthritis | Drug: Filgotinib;Drug: Placebo to match filgotinib | Gilead Sciences | Galapagos NV | Not recruiting | 18 Years | N/A | All | 2731 | Phase 3 | United 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. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
221 | NCT03161457 | February 27, 2017 | 23 July 2018 | A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid Arthritis | A 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) Therapy | Rheumatoid Arthritis;Arthritis, Rheumatoid | Biological: JHL1101;Biological: MabThera | JHL Biotech, Inc. | Recruiting | 18 Years | 80 Years | All | 150 | Phase 1 | Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;Lithuania;Poland;Russian Federation;Taiwan;Ukraine;United Kingdom | |
222 | JPRN-UMIN000026137 | 2017/02/15 | 5 November 2019 | Intravenous 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 total knee arthroplasty: randomized controlled trial - Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral TKA: randomized controlled trial | Osteoarthritis of the knee Rheumatoid arthritis | The 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 Hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 32 | Not selected | Japan | |
223 | NCT03667131 | February 13, 2017 | 26 November 2018 | Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis. | Effect of Prophylactic Treatment With Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis Patients. | Rheumatoid Arthritis | Drug: Enalapril Maleate;Drug: Placebo | University of Guadalajara | Not recruiting | 18 Years | 80 Years | Female | 59 | Phase 2 | Mexico | |
224 | ChiCTR-IPR-17010325 | 2017-01-31 | 18 April 2017 | The efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trial | The efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trial | rheumatic disease;M05.901 | Metformin 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 University | Not Recruiting | 18 | 65 | Both | Metformin Group:100;Non-Metformin Group:100;Metformin combined with Coenzyme Q10 Group:100; | Post-market | China | |
225 | NCT02997605 | January 31, 2017 | 4 February 2019 | Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients | Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission. | RheumatoId Arthritis | Drug: GlucoCorticoid | University Hospital, Toulouse | Recruiting | 18 Years | N/A | All | 122 | Phase 4 | France | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
226 | NCT03052322 | January 31, 2017 | 1 July 2019 | MSB11022 in Moderate to Severe Rheumatoid Arthritis | A 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 | Moderate to Severe Rheumatoid Arthritis | Drug: MSB11022;Drug: EU-Humira | Fresenius Kabi SwissBioSim GmbH | Not recruiting | 18 Years | N/A | All | 288 | Phase 3 | Czech Republic;United Kingdom;Poland;Hungary;Germany;Czechia;Bulgaria | |
227 | EUCTR2013-003413-18-NL | 30/01/2017 | 12 March 2018 | Arthritis prevention with abatacept | Arthritis Prevention In the Pre-clinical Phase of RA with Abatacept. - APIPPRA | The target population for therapeutic intervention will be subjects who carry serum autoantibodies (antibodies to citrullinated protein antigens – ACPA; rheumatoid factor – RF) and who have joint pains (arthralgia) but no joint swelling. These subjects are deemed to be at highest risk of developing rheumatoid arthritis. MedDRA version: 20.0 Level: PT Classification code 10003239 Term: Arthralgia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ORENCIA 125 mg solution for 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 Center | Authorised | Female: yes Male: yes | 206 | Phase 2 | Netherlands;United Kingdom | |||
228 | NCT03028467 | January 24, 2017 | 27 August 2018 | Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid Arthritis | A 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 Methotrexate | Arthritis, Rheumatoid | Drug: GSK3196165 Dose 1;Drug: GSK3196165 Dose 2;Drug: GSK3196165 Dose 3;Drug: Methotrexate;Drug: Placebo;Drug: Folic acid | GlaxoSmithKline | Not recruiting | 20 Years | N/A | All | 15 | Phase 2 | Japan | |
229 | NCT03085940 | January 20, 2017 | 16 December 2017 | Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis | Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Hydroxychloroquine;Drug: Placebo | Indonesia University | Not recruiting | 18 Years | N/A | All | 37 | N/A | Indonesia | |
230 | NCT02984943 | January 19, 2017 | 4 November 2019 | The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis | The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis: A Pilot Study | RheumatoId Arthritis | Device: Hyperbaric Oxygen | David Grant U.S. Air Force Medical Center | Not recruiting | 18 Years | N/A | All | 14 | N/A | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
231 | NCT03112213 | January 12, 2017 | 18 December 2018 | Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment | CONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis) | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: NSAIDs | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 135 | Phase 3 | Germany | |
232 | EUCTR2015-003140-39-PL | 09/01/2017 | 10 September 2018 | A Study to EValuate the Efficacy and Safety of JTE-051 on Subjects with Active Rheumatoid Arthritis (MOVE-RA) | A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis (MOVE-RA) - MOVE-RA | Rheumatoid Arthritis (RA) MedDRA version: 20.0 Level: LLT Classification code 10040107 Term: Seropositive rheumatoid arthritis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JTE-051 Product Code: JTE-051 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 Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Russian Federation;Bulgaria;Colombia | |||
233 | ChiCTR-IPR-17010307 | 2017-01-01 | 18 April 2017 | The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China | The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China | Rheumatoid Arthritis;M05.901 | Rapamycin group:Rapamycin;Non-rapamycin group :conventional glucocorticoids and DMARDs; | the Second Hospital of Shanxi Medical University | Recruiting | 18 | 65 | Both | Rapamycin group:200;Non-rapamycin group :100; | Post-market | China | |
234 | NCT03855007 | January 1, 2017 | 11 March 2019 | The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment | Prospective Clinical Study to Observe the Efficacy and Safety of Iguratimod in Rheumatoid Arthritis and Early Rheumatoid Arthritis Patients for 6 Months Treatment in China | Arthritis, Rheumatoid | Drug: Iguratimod;Drug: MTX;Drug: HCQ;Drug: Pred | Qilu Hospital of Shandong University | Recruiting | 16 Years | 90 Years | All | 200 | Phase 4 | China | |
235 | NCT02865434 | January 2017 | 1 April 2019 | Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA | An 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 Controls | Arthritis, Rheumatoid | Drug: 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 View | Navidea Biopharmaceuticals | Not recruiting | 18 Years | N/A | All | 39 | Phase 1/Phase 2 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
236 | NCT03016884 | January 2017 | 5 February 2018 | Safety and Tolerability of Herpes Zoster Vaccine Rheumatologic Patients | Safety and Tolerability of Herpes Zoster Vaccine in Patients With Rheumatoid Arthritis Immunized Prior to Biologics and Tofacitinib Therapy Initiation | Herpes Zoster | Biological: Zostavax vaccine | HaEmek Medical Center, Israel | Recruiting | 50 Years | N/A | All | 250 | Phase 4 | Israel | |
237 | NCT03288584 | January 2017 | 16 July 2018 | Effects of Interleukin-6 Inhibition on Vascular, Endothelial and Left Ventricular Function in Rheumatoid Arthritis | The Effect of Inhibition of Interleukin-6 Activity on Vascular, Endothelial and Left Ventricular Function in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis;Inflammation | Drug: Tocilizumab (Actemra®);Drug: Other biological agent;Drug: Corticosteroid and non-biological agents. | University of Athens | Recruiting | 18 Years | 80 Years | All | 60 | Phase 1 | Greece | |
238 | NCT02965599 | December 27, 2016 | 8 April 2019 | Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Rheumatoid Arthritis | A 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 Arthritis | Arthritis, Rheumatoid | Drug: Placebo;Drug: GSK3117391 | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 3 | Phase 1/Phase 2 | Mexico;Poland;Romania | |
239 | EUCTR2016-000569-21-GB | 23/12/2016 | 28 February 2019 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 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 | 423 | Phase 3 | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | |||
240 | NCT02969044 | December 20, 2016 | 29 January 2018 | Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate | A 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 Methotrexate | Rheumatoid Arthritis | Drug: Placebo;Drug: PF-06651600 | Pfizer | Not recruiting | 18 Years | 75 Years | All | 74 | Phase 2 | United States;Bulgaria;Czechia;Georgia;Germany;Hungary;Poland;Serbia;Slovakia | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
241 | EUCTR2014-004704-29-CZ | 15/12/2016 | 1 October 2018 | This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 710 Product Code: ABP 710 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 Recruiting | Female: yes Male: yes | 550 | Phase 3 | United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany | |||
242 | NCT02862574 | December 15, 2016 | 16 December 2017 | Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis | Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Andecaliximab;Drug: Placebo;Drug: Methotrexate;Drug: TNF Inhibitor | Gilead Sciences | Not recruiting | 18 Years | 80 Years | All | 15 | Phase 2 | United States;Australia;Hungary;Taiwan | |
243 | EUCTR2016-002852-26-CZ | 07/12/2016 | 17 September 2018 | MSB11022 in moderately to severely active rheumatoid arthritis | A multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA | moderately to severely active rheumatoid arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: adalimumab Product Code: MSB11022 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 KGaA | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom | |||
244 | EUCTR2015-003140-39-BG | 05/12/2016 | 20 August 2018 | A Study to EValuate the Efficacy and Safety of JTE-051 in Subjects with Active Rheumatoid Arthritis (MOVE-RA) | A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis (MOVE-RA) - MOVE-RA | Rheumatoid Arthritis (RA) MedDRA version: 20.0 Level: LLT Classification code 10040107 Term: Seropositive rheumatoid arthritis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JTE-051 Product Code: JTE-051 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 Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Russian Federation;Bulgaria;Colombia | |||
245 | NCT02760433 | December 2016 | 18 December 2018 | Evaluation 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 Disease | A 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 | Rheumatoid Arthritis | Drug: Olokizumab q4w;Drug: Olokizumab q2w;Drug: Placebo q2w | R-Pharm | Quintiles, Inc.;OCT Clinical Trials;Mene Research | Recruiting | 18 Years | N/A | All | 350 | Phase 3 | United States;Argentina;Brazil;Colombia;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Russian Federation;Turkey;Czech Republic |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
246 | NCT02982083 | December 2016 | 12 December 2016 | Clinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid Arthritis | Clinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Placebo Oral Tablet;Drug: Raloxifene hydrochloride | Sara Saeidi Shahri | Not recruiting | 50 Years | N/A | Female | 40 | N/A | ||
247 | NCT02990806 | December 2016 | 11 November 2019 | A 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 Arthritis | Rheumatoid Arthritis (RA) | Biological: NI-071;Biological: Infliximab | Nichi-Iko Pharmaceutical Co., Ltd. | Not recruiting | 18 Years | 75 Years | All | 683 | Phase 3 | United States;Czechia;Poland;Puerto Rico;Russian Federation;Spain;Ukraine;United Kingdom | |
248 | NCT03016260 | December 2016 | 16 December 2017 | RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFa BIologicals in Rheumatoid Arthritis | Proof-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 Arthritis | Biological: Infliximab;Biological: Adalimumab;Biological: Etanercept;Biological: Golimumab;Biological: Certolizumab Pegol;Biological: Infliximab biosimilar;Biological: Etanercept biosimilar | TcLand Expression S.A. | European Commission | Recruiting | 18 Years | N/A | All | 720 | N/A | Czechia;France;Israel;Netherlands;Turkey;Czech Republic |
249 | NCT03337165 | December 2016 | 30 September 2019 | Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis | Safety/Efficacy of Intra-articular Administration of Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis | Musculoskeletal Diseases;Joint Disease;Arthritis;Arthritis, Rheumatoid;Rheumatic Diseases;Connective Tissue Diseases;Autoimmune Diseases;Immune System Diseases | Biological: tolerogenic dendritic cells | Russian Academy of Medical Sciences | Not recruiting | 18 Years | 75 Years | All | 10 | Phase 1 | Russian Federation | |
250 | NCT02983227 | November 30, 2016 | 4 November 2019 | A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350 (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 Arthritis | RheumatoId Arthritis | Drug: GDC 0853 | Genentech, Inc. | Not recruiting | 18 Years | 76 Years | All | 497 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Colombia;Mexico;Poland;Russian Federation;Serbia;Ukraine;Chile;Korea, Republic of | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
251 | NCT02986139 | November 29, 2016 | 22 July 2019 | Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis | A 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 Arthritis | Arthritis, Rheumatoid; Arthritis, Psoriatic | Drug: Commercial Formulation Etanercept;Drug: New Formulation Etanercept | Amgen | Not recruiting | 18 Years | N/A | All | 111 | Phase 3 | United States;Puerto Rico | |
252 | NCT02960490 | November 26, 2016 | 28 October 2019 | A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics | A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics | Rheumatoid Arthritis | Drug: E6011;Drug: Placebo | Eisai Co., Ltd. | Not recruiting | 18 Years | 75 Years | All | 64 | Phase 2 | Japan | |
253 | EUCTR2016-000933-37-HU | 24/11/2016 | 22 May 2017 | Study 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. KG | Authorised | Female: yes Male: yes | 313 | Phase 3 | Portugal;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 | |||
254 | EUCTR2014-005368-13-DE | 22/11/2016 | 23 July 2018 | A 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 Limited | Authorised | Female: yes Male: yes | 282 | Phase 1;Phase 3 | United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of | |||
255 | JPRN-UMIN000026819 | 2016/11/21 | 23 April 2019 | A randomized controlled trial of low-dose Enoxaparin versus low-dose Edoxavan for prevention of venous thromboembolism after total hip arthroprasty in elderly or underweight or moderate renal insufficient patients. | A randomized controlled trial of low-dose Enoxaparin versus low-dose Edoxavan for prevention of venous thromboembolism after total hip arthroprasty in elderly or underweight or moderate renal insufficient patients. - A RCT of anticoagulant agents for prevention of VTE after THA in elderly or underweight or moderate renal insufficient patients. | osteoarthritis of the hip, osteonecrosis of the femoral head, femoral neck fracture, rheumatoid arthritis, rapidly destructive coxarthropathy, septic arthritis of the hip | Dose: Edoxaban group; Edoxaban 15mg per day Enoxaparin gropu; Enoxaparin 2000 IU per day Intervention period: for 10 days after the surgery | Department of Orthopaedic Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences | Recruiting | 20years-old | Not applicable | Male and Female | 80 | Not selected | Japan | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
256 | NCT02874092 | November 15, 2016 | 22 July 2019 | Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis | Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MTX therapy;Drug: Ticagrelor | NYU Langone Health | Not recruiting | 18 Years | N/A | All | 9 | Phase 4 | United States | |
257 | EUCTR2015-005800-27-PL | 08/11/2016 | 5 March 2018 | Study of a new drug’s effect in people with severe rheumatoid arthritis who have not responded sufficiently well to treatment with DMARDs | A randomised, multi-center, double blind (sponsor open), placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK3117391 in subjects with moderate to severe, active rheumatoid arthritis | Rheumatoid Arthritis (RA) MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GSK3117391 Product Code: GSK3117391 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 Ltd | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Poland;Romania;Russian Federation | |||
258 | EUCTR2016-002908-15-NL | 08/11/2016 | 18 April 2017 | REDO study: Research into the effects of lower doses rituximab in patients with rheumatoid arthritis | REDO study: RhEumatoid arthritis REtreatment with ultra-low dose Rituximab: Disease Outcome after Dose Optimization - REDO | Rheumatoid arthritis MedDRA version: 19.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Pharmaceutical Form: Infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 | Sint Maartenskliniek | Authorised | Female: yes Male: yes | Phase 4 | Netherlands | ||||
259 | NCT02919761 | November 7, 2016 | 11 November 2019 | Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis | A Multicenter, 2 Part Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease | Arthritis, Rheumatoid | Drug: Acthar;Drug: Placebo | Mallinckrodt | Not recruiting | 18 Years | N/A | All | 259 | Phase 4 | United States;Argentina;Mexico;Peru;Puerto Rico;Colombia | |
260 | NCT02960438 | November 2, 2016 | 28 October 2019 | A Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Methotrexate | A Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Methotrexate | Rheumatoid Arthritis | Drug: E6011;Drug: Placebo | Eisai Co., Ltd. | Not recruiting | 18 Years | 75 Years | All | 190 | Phase 2 | Japan | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
261 | ChiCTR-INR-16009546 | 2016-11-01 | 18 April 2017 | The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis | The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis | rheumatoid arthritis;M05.901 | IL-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 University | Recruiting | 18 | 65 | Both | IL-2 group:15;IL-2 + IL-6 antagonist group:15;non IL-2 or IL-6 antagonist group:15; | New Treatment Measure Clinical Study | China | |
262 | ChiCTR-IPR-16009029 | 2016-11-01 | 18 April 2017 | Clinical Study of the Bone Protection Effect of Biqi Capsule for Treatment of Rheumatoid Arthritis | Clinical Study of the Bone Protection Effect of Biqi Capsule for Treatment of Rheumatoid Arthritis | Rheumatoid arthritis | RA: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 Medicine | Not Recruiting | 18 | 65 | Both | RA:the experimental group:60;RA:the control group:60;OA:The traditional Chinese group:60;OA:The western medicine control group:60; | Post-market | China | |
263 | NCT02996500 | November 2016 | 12 November 2018 | Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate | A 12 Week Randomized, Double-blind, Double Dummy, Parallel Group, Active And Placebo-controlled, Multicenter Study To Assess The Efficacy And Safety Profile Of Pf-06650833 In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate | Rheumatoid Arthritis | Drug: PF-06650833;Drug: Placebo;Drug: Tofacitinib | Pfizer | Not recruiting | 18 Years | 75 Years | All | 269 | Phase 2 | United States;Australia;Bosnia and Herzegovina;Bulgaria;Croatia;Czechia;Georgia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Taiwan;Ukraine | |
264 | NCT03011281 | November 2016 | 16 December 2017 | Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis | Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tofacitinib | Hanyang University | Recruiting | 19 Years | N/A | All | 378 | N/A | Korea, Republic of | |
265 | NCT03067870 | November 2016 | 18 June 2018 | Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid Arthritis | Transplantation of Autologous Purified Bone Marrow Derived Specific Populations of Stem Cells and Mesenchymal Stem Cells in Patients With Rheumatoid Arthritis | RheumatoId Arthritis;Osteoarthritis, Knee;Osteoarthritis, Hip | Biological: Stem Cell Transplantation | Stem Cells Arabia | Not recruiting | 17 Years | 75 Years | All | 100 | Phase 1 | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
266 | NCT02819726 | October 31, 2016 | 18 December 2018 | PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis | 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) | Rheumatoid Arthritis | Biological: SAIT101;Biological: MabThera;Biological: Rituxan;Biological: Rituxan/SAIT101 | Archigen Biotech Limited | Not recruiting | 18 Years | 80 Years | All | 294 | Phase 1 | United States;Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;India;Korea, Republic of;Mexico;Poland;Spain | |
267 | NCT03061838 | October 27, 2016 | 29 July 2019 | Safety, 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 Arthritis | Rheumatoid Arthritis | Drug: MabThera®;Drug: Ritumax® | Biointegrator LLC | Not recruiting | 18 Years | N/A | All | 8 | Phase 1 | Russian Federation | |
268 | NCT02858492 | October 17, 2016 | 26 November 2018 | Safety 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 Arthritis | Arthritis, Rheumatoid | Drug: GSK2982772 60 mg;Drug: Placebo | GlaxoSmithKline | Not recruiting | 18 Years | 75 Years | All | 52 | Phase 1/Phase 2 | Germany;Italy;Poland;Russian Federation;Spain;United Kingdom | |
269 | EUCTR2016-000498-19-BG | 13/10/2016 | 10 December 2018 | A Study of Patients Previously Enrolled in Study GA29350 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Rheumatoid Arthritis | A PHASE II OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA29350 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939 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. | Authorised | Female: yes Male: yes | 580 | Phase 2 | Serbia;United States;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of | |||
270 | EUCTR2016-002061-54-IT | 13/10/2016 | 7 January 2019 | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases. | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases. Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) | Rheumatoid arthritis, seronegative spondylo arthritis, Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0 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. GEMELLI | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Italy | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
271 | JPRN-jRCTs041180071 | 13/10/2016 | 7 October 2019 | T-ReX study | Tocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study | Rheumatoid arthritis | At 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 Kojima | Not Recruiting | >= 20age old | Not applicable | Both | 51 | N/A | none | |
272 | NCT02937701 | October 10, 2016 | 21 January 2019 | Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab | 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 | Arthritis, Rheumatoid | Drug: ABP 710;Drug: Infliximab | Amgen | Not recruiting | 18 Years | 80 Years | All | 558 | Phase 3 | United States;Australia;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Spain;Czech Republic | |
273 | NCT03403140 | October 6, 2016 | 29 January 2018 | Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 ) | Multicenter Extension Study To 104 Weeks To Asses The Efficacy, Safety And Immunogenicity Of Enerceptan® In Combination With Methotrexate For The Treatment Of Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Etanercept | Gema Biotech S.A. | QUID-Quality in Drugs and Devices Latin American Consulting SRL | Not recruiting | 19 Years | 99 Years | All | 141 | Phase 3 | Argentina |
274 | EUCTR2015-004858-17-NL | 05/10/2016 | 10 October 2016 | REMission INDuction in very early Rheumatoid Arthritis | REMission INDuction in very early Rheumatoid Arthritis - REMINDRA | Very early Rheumatoid arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Methotrexate Product Name: Methotrexate Product Code: MTX 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) | Authorised | Female: yes Male: yes | Phase 4 | Netherlands | ||||
275 | NCT03364088 | October 1, 2016 | 4 February 2019 | Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia | Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia, a Randomized Controlled Trial | Knee Osteoarthritis;Arthropathy of Knee Joint;Knee Pain Chronic;Rheumatoid Arthritis;Anesthesia | Procedure: 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 Palanne | Helsinki University Central Hospital;Helsinki University;Finland | Not recruiting | 18 Years | 75 Years | All | 402 | N/A | Finland |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
276 | NCT02805010 | October 2016 | 12 December 2016 | Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously | A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously in Chinese Healthy Subjects | Rheumatoid Arthritis (RA) | Drug: Abatacept;Other: Placebo | Jiangsu Simcere Pharmaceutical Co., Ltd. | Bristol-Myers Squibb | Not recruiting | 18 Years | 45 Years | Both | 22 | Phase 1 | |
277 | NCT02881307 | October 2016 | 9 September 2019 | Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet | Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet | Rheumatoid Arthritis;Overweight | Dietary Supplement: Whey Protein&Prebiotic Supplement;Behavioral: Dietary Counseling;Behavioral: Dietary recommendations | Dr. Veena Ranganath | Recruiting | 18 Years | N/A | All | 60 | N/A | United States | |
278 | NCT02927522 | October 2016 | 17 October 2016 | Donepezil Attenuate Postoperative Cognitive Dysfunction | Donepezil Attenuate Postoperative Cognitive Dysfunction in Aged Patients- A Multi-center, Case Control, Randomized Clinical Trail | Osteoarthritis;Femoral Head Necrosis;Rheumatoid Arthritis | Drug: Donepezil;Drug: Placebo | RenJi Hospital | Shanghai Sixth Hospital;Shanghai Guanghua Hospital;Sanya People's Hospital;Shanghai Sixth Hospital;Shanghai Guanghua Hospital;Sanya People's Hospital | Not recruiting | 65 Years | N/A | Both | 550 | Phase 3 | |
279 | NCT02936180 | October 2016 | 27 August 2018 | Standard Versus High Dose Inactivated Influenza Vaccine in RA | Improving Influenza Immunization Responses in Rheumatoid Arthritis: A Strategy To Enhance Protection Against A Preventable Cause Of Death In An At Risk Population? | Rheumatoid Arthritis | Biological: HD-TIV;Biological: SD-QIV | McGill University Health Center | The Arthritis Society, Canada | Not recruiting | 18 Years | N/A | All | 280 | Phase 4 | Canada |
280 | NCT02037737 | September 30, 2016 | 19 February 2018 | Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting | Impact 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 Study | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 153 | N/A | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
281 | NCT02648035 | September 22, 2016 | 8 April 2019 | EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis | Multicenter, 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 Arthritis | Biological: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 200 | Phase 1 | Greece | |
282 | EUCTR2014-004904-31-BE | 21/09/2016 | 20 August 2018 | A 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 Recruiting | Female: yes Male: yes | 156 | Phase 4 | Belgium;Netherlands | |||
283 | NCT02885181 | September 21, 2016 | 16 December 2017 | Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects With Active Rheumatoid Arthritis on Background Therapy With Methotrexate | Rheumatoid Arthritis | Drug: GS-9876;Drug: Filgotinib;Drug: GS-9876 placebo;Drug: Filgotinib placebo;Drug: Methotrexate | Gilead Sciences | Not recruiting | 18 Years | 75 Years | All | 83 | Phase 2 | United States;Bulgaria;Czechia;Georgia;Moldova, Republic of;Poland;Ukraine;Czech Republic;Hungary | |
284 | NCT02919475 | September 14, 2016 | 27 August 2018 | Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis | 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) | Rheumatoid Arthritis | Drug: Placebo;Drug: JTE-051 | Akros Pharma Inc. | Not recruiting | 18 Years | 75 Years | All | 260 | Phase 2 | United States;Argentina;Bulgaria;Colombia;Mexico;Peru;Poland;Romania;Russian Federation;Ukraine | |
285 | NCT03147248 | September 12, 2016 | 26 August 2019 | A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA | A 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 RA | Rheumatoid Arthritis | Biological: Infliximab | Celltrion | Not recruiting | 18 Years | 75 Years | All | 412 | Phase 3 | Korea, Republic of | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
286 | NCT02833350 | September 9, 2016 | 30 September 2019 | Safety 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 Arthritis | Drug: GDC-0853;Drug: Adalimumab;Drug: Folic Acid;Drug: MTX;Drug: Placebo | Genentech, Inc. | Not recruiting | 18 Years | 75 Years | All | 578 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Colombia;Korea, Republic of;Mexico;Poland;Russian Federation;Serbia;Ukraine;Chile | |
287 | NCT02831855 | September 1, 2016 | 1 April 2019 | Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis | Drug: Placebo;Drug: Methotrexate;Drug: CP-690,550 | Pfizer | Not recruiting | 18 Years | N/A | All | 695 | Phase 4 | United States;Australia;Belgium;Bulgaria;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Philippines;Poland;Russian Federation;Slovakia;South Africa;Spain;United Kingdom | |
288 | NCT02666443 | September 2016 | 12 September 2016 | Low Dose Dexamethasone in Supraclavicular Blocks | Low Dose Dexamethasone as an Adjuvant to Supraclavicular Brachial Plexus Blocks: A Prospective Randomized, Double Blinded, Control Study | Rheumatoid Arthritis;Osteoarthritis;Nerve Entrapment;Ligament Injury | Drug: Intravenous Dexamethasone 1 mg;Drug: Peri-neural Dexamethasone 1 mg;Drug: Control intervention (no dexamethasone) | University of Calgary | Recruiting | 18 Years | 80 Years | Both | 306 | N/A | Canada | |
289 | NCT02897011 | September 2016 | 7 November 2016 | 2-week dc of MTX and Influenza Vaccination in RA | Effect of Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial | Rheumatoid Arthritis;Influenza;Methotrexate | Drug: Methotrexate | Seoul National University Hospital | Recruiting | 18 Years | 65 Years | Both | 318 | N/A | Korea, Republic of | |
290 | NCT02930343 | September 2016 | 14 October 2019 | Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy | Comparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control Trial | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid;Drug: Sulfasalazine | Jawaharlal Institute of Postgraduate Medical Education & Research | Not recruiting | 18 Years | 65 Years | All | 136 | Phase 3 | India | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
291 | NCT03016013 | September 2016 | 10 September 2018 | A 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 Arthritis | Biological: Placebo plus MTX;Biological: RC18 160 mg plus MTX | RemeGen | Recruiting | 18 Years | 65 Years | All | 480 | Phase 3 | China | |
292 | JPRN-UMIN000027242 | 2016/08/31 | 2 April 2019 | the effect of tofacitinib on bone mineral density in patients with rheumatoid arthritis | to determine the effect of tofacitinib on bone | tofacitinib | Division of rheumatology, hiroshima clinic | Hatta clinic Sky clinic Toyohira hospital | Not Recruiting | 18years-old | 90years-old | Male and Female | 50 | Phase 4 | Japan | |
293 | EUCTR2016-000912-13-DE | 30/08/2016 | 12 November 2018 | 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. | 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 Ltd | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Poland;Spain;Romania;Germany;Italy;United Kingdom | |||
294 | NCT02889796 | August 30, 2016 | 15 July 2019 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: Adalimumab;Drug: Placebo to match adalimumab;Drug: MTX | Gilead Sciences | Galapagos NV | Not recruiting | 18 Years | N/A | All | 1759 | Phase 3 | United 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 |
295 | EUCTR2016-000335-40-BG | 23/08/2016 | 20 August 2018 | A 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 Recruiting | Female: yes Male: yes | 600 | Phase 2 | Serbia;United States;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
296 | EUCTR2016-002125-11-LV | 23/08/2016 | 29 August 2016 | Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis | A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: CT-P13 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, Inc | Authorised | Female: yes Male: yes | 258 | Phase 1;Phase 3 | Hungary;Estonia;Czech Republic;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina | |||
297 | NCT02628028 | August 22, 2016 | 6 May 2019 | A Study of LY3337641 in Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects With Rheumatoid Arthritis: The RAjuvenate Study | Rheumatoid Arthritis | Drug: LY3337641;Drug: Placebo | Eli Lilly and Company | Not recruiting | 18 Years | 65 Years | All | 286 | Phase 2 | United States;Argentina;Australia;Austria;Italy;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Slovakia;South Africa;Spain;Germany | |
298 | ChiCTR-IIR-16008693 | 2016-08-20 | 18 April 2017 | Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously | A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously in Chinese Healthy Subjects | Rheumatoid Arthritis | Abatacept Group:Single dose of abatacept;Placebo Group:Single dose of placebo; | The First Hospital, Jilin University | Not Recruiting | 18 | 45 | Both | Abatacept Group:20;Placebo Group:2; | Phase 1 study | China | |
299 | NCT02705989 | August 18, 2016 | 11 February 2019 | Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects | A 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 Subjects | Rheumatoid Arthritis | Drug: BMS-986195;Other: Placebo | Bristol-Myers Squibb | Not recruiting | 18 Years | 55 Years | All | 439 | Phase 1 | Australia | |
300 | EUCTR2016-000393-37-BG | 08/08/2016 | 26 September 2016 | A study to test the effectiveness of bimekizumab as a treatment for rheumatoid arthritis, to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body. | A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY/TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE INTRAVENOUS DOSES OF BIMEKIZUMAB (UCB4940) ADMINISTERED TO SUBJECTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | RHEUMATOID ARTHRITIS MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Bimekizumab Product Code: UCB4940 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 Sprl | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;United Kingdom | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
301 | EUCTR2016-001532-35-HU | 08/08/2016 | 30 October 2017 | A 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 Limited | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | Hungary;Bulgaria | |||
302 | NCT02886728 | August 8, 2016 | 3 June 2019 | Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Rheumatoid Arthritis | Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: MTX;Drug: Placebo to match MTX | Gilead Sciences | Galapagos NV | Not recruiting | 18 Years | N/A | All | 1252 | Phase 3 | United 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 |
303 | NCT03775824 | August 1, 2016 | 30 September 2019 | Faecal Analyses in Rheumatoid Arthritis Therapy | Faecal Analyses in Rheumatoid Arthritis Therapy: An Prospective Observational Study of the Intestinal Microbiome in Patients With Rheumatoid Arthritis Receiving Immunosuppressive Therapy | Rheumatoid Arthritis | Drug: MTX start;Drug: TNF start | Region Skane | Not recruiting | 18 Years | N/A | All | 50 | N/A | ||
304 | NCT02722694 | August 2016 | 26 September 2016 | A Phase 3 Study of Abatacept in Chinese Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | A 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 Methotrexate | Rheumatoid Arthritis (RA) | Drug: Subcutaneous(SC) Abatacept;Other: Placebo;Drug: Methotrexate | Jiangsu Simcere Pharmaceutical Co., Ltd. | Bristol-Myers Squibb | Recruiting | 18 Years | N/A | Both | 360 | Phase 3 | China |
305 | NCT02892370 | August 2016 | 19 September 2016 | Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects | An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR0302 and Mass Balance in Healthy Volunteers | Rheumatoid Arthritis | Drug: SHR0302 | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | 18 Years | 45 Years | Male | 14 | Phase 1 | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
306 | NCT02940561 | August 2016 | 31 October 2016 | BE Study in Patients - Methotrexate Tablets | A 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 Arthritis | Drug: Methotrexate - Amneal;Drug: Methotrexate - DAVA | Amneal Pharmaceuticals, LLC | Accutest Research Laboratories (I) Pvt. Ltd. | Recruiting | 18 Years | 65 Years | Both | 48 | Phase 1 | India |
307 | NCT02784106 | July 31, 2016 | 11 June 2018 | Safety and Efficacy Study of M2951 in Participants With Rheumatoid Arthritis | Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects With Rheumatoid Arthritis on Stable Methotrexate Therapy | Rheumatoid Arthritis | Drug: Placebo;Drug: M2951 | EMD Serono Research & Development Institute, Inc. | Merck KGaA | Not recruiting | 18 Years | 75 Years | All | 65 | Phase 2 | United States;Germany |
308 | JPRN-JapicCTI-163317 | 28/7/2016 | 16 July 2019 | Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors | Rheumatoid Arthritis | Intervention 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 Recruiting | 18 | 120 | BOTH | 408 | Phase 2 | Japan, Asia except Japan, North America, South America, Europe, Oceania | |
309 | EUCTR2016-000064-42-SK | 27/07/2016 | 31 October 2016 | Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis | Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A | Rheumatoid Arthritis MedDRA version: 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 KGaA | Authorised | Female: yes Male: yes | 64 | Phase 2 | Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria | |||
310 | NCT02873936 | July 27, 2016 | 25 March 2019 | Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Rheumatoid Arthritis | Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: csDMARDs | Gilead Sciences | Galapagos NV | Not recruiting | 18 Years | N/A | All | 449 | Phase 3 | United States;Argentina;Australia;Belgium;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Poland;Spain;Switzerland;United Kingdom;Italy;Netherlands |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
311 | NCT02867306 | July 25, 2016 | 25 March 2019 | A Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis | A Phase 1 Open-label, Single-sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ASP1707;Drug: methotrexate (MTX) | Astellas Pharma Global Development, Inc. | Not recruiting | 18 Years | 65 Years | All | 10 | Phase 1 | Moldova, Republic of | |
312 | ChiCTR-IPR-16008793 | 2016-07-15 | 18 April 2017 | A multi center, randomized, double blind, positive parallel controlled clinical study of Zhengqing Fengtongning sustained release tablets in the treatment of rheumatoid arthritis | A multi center, randomized, double blind, positive parallel controlled clinical study of Zhengqing Fengtongning sustained release tablets in the treatment of rheumatoid arthritis | Rheumatoid arthritis | experimental 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 University | Recruiting | 18 | 75 | Both | experimental group:80; control group:80;The combined treatment group:80; | Post-market | China | |
313 | EUCTR2015-003433-10-GB | 05/07/2016 | 18 April 2017 | ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis | GP17-302 A randomized, double-blind, parallel-group, multicenter study to demonstrate similar efficacy and to compare safety and immunogenicity of GP2017 and Humira® in patients with moderate to severe active rheumatoid arthritis - ADMYRA trial | rheumatoid arthritis MedDRA version: 19.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Adalimumab Product Code: GP2017 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, AG | Authorised | Female: yes Male: yes | 308 | Phase 3 | Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of | |||
314 | NCT02683421 | July 2016 | 9 January 2017 | Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT Imaging | Evaluation of Subcutaneous (SC) Injected Tc 99m Tilmanocept Localization in Active Rheumatoid Arthritis (RA) Subjects by SPECT and SPECT/CT Imaging | Rheumatoid Arthritis | Drug: tilmanocept | Navidea Biopharmaceuticals | Not recruiting | 21 Years | N/A | Both | 18 | Phase 1 | United States | |
315 | NCT02585258 | June 30, 2016 | 10 September 2018 | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the Cost-effectiveness and Safety of Additional Low-dose Glucocorticoid in Treatment Strategies for Elderly Patients With Rheumatoid Arthritis | RheumatoId Arthritis | Drug: Prednisolone;Other: Placebo | VU University Medical Center | European Commission | Recruiting | 65 Years | N/A | All | 500 | Phase 4 | Finland;Germany;Hungary;Italy;Netherlands;Portugal;Romania;Slovakia |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
316 | NCT02765074 | June 30, 2016 | 20 May 2019 | Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of Subcutaneous Tocilizumab in Rheumatoid Arthritis | Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of 12 Months Subcutaneous Tocilizumab in Rheumatoid Arthritis Phase IV Prospective Multicentrique Study | Rheumatoid Arthritis | Drug: subcutaneous tocilizumab | Centre Hospitalier Régional d'Orléans | Rennes University Hospital | Recruiting | 18 Years | 85 Years | All | 60 | Phase 4 | France |
317 | NCT03106259 | June 29, 2016 | 19 February 2018 | Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj | Observational 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 Inj | Rheumatoid Arthritis | Drug: FURESTEM-RA Inj. | Kang Stem Biotech Co., Ltd. | Not recruiting | 19 Years | 80 Years | All | 9 | N/A | Korea, Republic of | |
318 | EUCTR2015-003376-75-ES | 23/06/2016 | 4 July 2016 | A 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 MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 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. KG | Authorised | Female: yes Male: yes | 600 | Phase 3 | Serbia;United States;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;European Union;Mexico;Puerto Rico;Argentina;Australia;Japan;New Zealand | |||
319 | NCT03333681 | June 20, 2016 | 25 March 2019 | Evaluation of Stem Cell Therapy Effects on the Immune Response in Rheumatoid Arthritis Patients | Evaluation 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 Patients | Rheumatoid Arthritis | Biological: Autologous mesenchymal stem cells | Mashhad University of Medical Sciences | Not recruiting | 35 Years | 60 Years | Female | 15 | Phase 1 | ||
320 | NCT02799472 | June 15, 2016 | 15 July 2019 | Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis | A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination With Methotrexate Therapy in Subjects With Active Rheumatoid Arthritis Despite Treatment With DMARDs | Arthritis, Rheumatoid | Drug: GSK3196165;Drug: Placebo;Drug: MTX;Drug: Folic (or folinic) acid | GlaxoSmithKline | Parexel | Not recruiting | 18 Years | N/A | All | 39 | Phase 2 | United States;Germany;Poland |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
321 | NCT03762824 | June 14, 2016 | 18 December 2018 | Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease | Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response. | Rheumatoid Arthritis;Systemic Lupus;Sjögren Syndrome;Systemic Vasculitis;Spondyloarthritis | Biological: 23-valent pneumococcal polysaccharide vaccine;Biological: 13-valent pneumococcal conjugate vaccine | Region Skane | Not recruiting | 18 Years | N/A | All | 300 | Phase 4 | ||
322 | EUCTR2015-005308-27-CZ | 07/06/2016 | 27 August 2018 | Study 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 Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 | Moderately to Severely Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) 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-Pharm | Authorised | Female: yes Male: yes | 350 | Phase 3 | United States;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Germany;Colombia;Korea, Republic of | |||
323 | JPRN-UMIN000021929 | 2016/06/01 | 7 October 2019 | Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis | Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT Study | Rheumatoid arthritis | Discontinuation of infliximab | Chiba University | Not Recruiting | 18years-old | Not applicable | Male and Female | 200 | Not selected | Japan | |
324 | NCT02804204 | June 2016 | 25 February 2019 | Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF | Analysis 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 Arthritis | Rheumatoid Arthritis | Drug: Anti-TNF | Hospital Universitari Vall d'Hebron Research Institute | UCB Pharma | Recruiting | 18 Years | N/A | All | 200 | Phase 2 | Spain |
325 | NCT02804581 | June 2016 | 27 June 2016 | Gum Arabic as Immunomodulator In Rheumatoid Arthritis Patients | Potential Role of Gum Arabic as Immunomodulator In Sudanese Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Dietary Supplement: Gum Arabic | Lamis Kaddam | University of Khartoum;Military hospital | Recruiting | 20 Years | 50 Years | Both | 45 | Phase 2 | Sudan |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
326 | EUCTR2016-002035-15-FI | 20/05/2016 | 13 June 2016 | Outcome after total knee endoprosthesis under general or regional anesthesia, a randomized study | Outcome after total knee arthroplasty under general or spinal anesthesia, a randomized study - Outcome after total knee arthroplasty under general or spinal anesthesia | Patients undego total knee arthroplasty operation in general or spinal anaesthesia because of osteoarthritis, rheumatoid arthritis or other degenerative condition of the knee MedDRA version: 19.0 Level: LLT Classification code 10031174 Term: Osteoarthrosis System Organ Class: 100000004859 MedDRA version: 19.0 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 Hospital | Authorised | Female: yes Male: yes | Phase 4 | Finland | ||||
327 | NCT02659150 | May 18, 2016 | 14 January 2019 | Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid Arthritis | A Multicenter, Open-Label, Proof-of-Activity Study of the Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: tocilizumab | Massachusetts General Hospital | Brigham and Women's Hospital | Recruiting | 50 Years | 75 Years | Female | 21 | Phase 4 | |
328 | NCT02792699 | May 17, 2016 | 22 October 2018 | Study to Assess if ABP798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Rituximab | 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 | Arthritis, Rheumatoid | Drug: ABP 798;Drug: Rituximab | Amgen | Not recruiting | 18 Years | 80 Years | All | 311 | Phase 3 | United States;Bulgaria;Estonia;Germany;Hungary;Poland;Canada | |
329 | EUCTR2014-004719-36-BG | 14/05/2016 | 9 January 2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A 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) 1 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: CDP6038 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-Pharm | Authorised | Female: yes Male: yes | 420 | Phase 3 | Belarus;Turkey;Russian Federation;Bulgaria | |||
330 | NCT02780388 | May 12, 2016 | 10 September 2018 | A Phase 1b Study of MEDI4920 in Subjects With Adult-onset Rheumatoid Arthritis | A 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 Arthritis | Adult Onset Rheumatoid Arthritis | Biological: MEDI4920;Other: Placebo | MedImmune LLC | Not recruiting | 18 Years | 70 Years | All | 57 | Phase 1 | United States;Poland | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
331 | JPRN-UMIN000022364 | 2016/05/10 | 2 April 2019 | Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis | Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis - Effectiveness of minodronate in osteoporotic patients with rheumatoid arthritis | Osteoprotic patients with rheumatoid arthritis | The 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 Medicine | Not Recruiting | 50years-old | 100years-old | Male and Female | 140 | Not applicable | Japan | |
332 | NCT02760316 | May 2, 2016 | 16 December 2017 | A 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 Control | Rheumatoid Arthritis | Drug: 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 mg | AstraZeneca | Not recruiting | 18 Years | 55 Years | All | 64 | Phase 1 | Germany;United Kingdom | |
333 | NCT01815411 | May 2016 | 11 June 2018 | Effect of Andosan in Patients With Rheumatoid Arthritis | Effect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Dietary Supplement: Mushroom extract | Egil Johnson | ImmunoPharma AS | Not recruiting | 19 Years | 75 Years | All | 10 | N/A | Norway |
334 | NCT02538341 | May 2016 | 15 April 2019 | Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial) | Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial) | Rheumatoid Arthritis;Inflammatory Arthritis;Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease | Biological: Herpes Zoster Vaccine;Drug: Placebo | University of Alabama at Birmingham | Oregon Health and Science University | Not recruiting | 50 Years | N/A | All | 617 | Phase 2 | United States |
335 | NCT02665910 | May 2016 | 2 May 2016 | Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients | A Phase I, Randomized, Placebo-Controlled, Multiple Doses Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Patients With RA | Rheumatoid Arthritis | Drug: SHR0302;Drug: SHR0302 placebo comparator | Jiangsu HengRui Medicine Co., Ltd. | Not recruiting | 18 Years | 70 Years | Both | 48 | Phase 1 | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
336 | NCT02760368 | May 2016 | 18 December 2018 | Evaluation 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 Disease | A 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 | Rheumatoid Arthritis | Drug: Olokizumab q4w;Drug: Olokizumab q2w;Drug: Placebo q2w | R-Pharm | Quintiles, Inc.;OCT Clinical Trials;Mene Research | Not recruiting | 18 Years | N/A | All | 428 | Phase 3 | Bulgaria;Russian Federation;Turkey |
337 | NCT02760407 | May 2016 | 18 December 2018 | Evaluation 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 Disease | A 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 | Rheumatoid Arthritis | Drug: Olokizumab 64mg q4w;Drug: Olokizumab 64mg q2w;Drug: Adalimumab 40mg q2w;Drug: Placebo q2w | R-Pharm | Quintiles, Inc.;OCT Clinical Trials | Recruiting | 18 Years | N/A | All | 1575 | Phase 3 | United 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 |
338 | NCT02762123 | May 2016 | 26 September 2016 | A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates | Effects of Concomitant Administration of BMS-986142 on the Single-dose Pharmacokinetics of Probe Substrates for CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-gp in Healthy Subjects | Rheumatoid Arthritis | Drug: BMS-986142 200mg;Drug: BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin);Drug: BMS-986142 350mg | Bristol-Myers Squibb | Not recruiting | 18 Years | 50 Years | Both | 28 | Phase 1 | United States | |
339 | NCT02770794 | May 2016 | 23 May 2016 | Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis | Multicenter 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 Activity | Arthritis, Rheumatoid | Drug: Infliximab | Chiba University | Not recruiting | 18 Years | N/A | Both | 200 | Phase 4 | ||
340 | NCT02603146 | April 27, 2016 | 28 October 2019 | Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis | Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis | Healthy Participants;Rheumatoid Arthritis (RA) Prevention | Drug: Hydroxychloroquine;Drug: HCQ Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Recruiting | 18 Years | N/A | All | 200 | Phase 2 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
341 | NCT02714881 | April 2016 | 23 July 2018 | Lipids, Inflammation, and CV Risk in RA | Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis | Rheumatoid Arthritis;Cardiovascular Disease | Radiation: Stress myocardial perfusion PET;Drug: certolizumab | Brigham and Women's Hospital | Recruiting | 35 Years | 90 Years | All | 75 | N/A | United States | |
342 | NCT02715908 | April 2016 | 16 July 2018 | A 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-ECCL002 | Rheumatoid Arthritis | Drug: LBEC0101 | LG Life Sciences | Not recruiting | 20 Years | 75 Years | All | 148 | Phase 3 | Korea, Republic of | |
343 | NCT02722044 | April 2016 | 11 June 2018 | Usability of an AI for M923 in Subjects With Moderate to Severe RA | An 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 Arthritis | Biological: M923;Device: Autoinjector | Momenta Pharmaceuticals, Inc. | Not recruiting | 18 Years | N/A | All | 33 | Phase 3 | United States | |
344 | NCT02746380 | April 2016 | 16 December 2017 | A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Multi-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 MTX | Arthritis, Rheumatoid | Drug: LBAL;Drug: Humira® | LG Life Sciences | Mochida Pharmaceutical Company, Ltd. | Not recruiting | 20 Years | 75 Years | All | 380 | Phase 3 | Japan;Korea, Republic of |
345 | NCT02573012 | March 29, 2016 | 11 November 2019 | Study to Compare the Efficacy of Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Participants | Prospective, Multicentre, Placebo-controlled, Double-blind Interventional Study to Compare the Efficacy of Maintenance Treatment With Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: Placebo matched to prednisone;Drug: Prednisone;Biological: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 314 | Phase 4 | France;Germany;Italy;Russian Federation;Serbia;Tunisia;Egypt;Switzerland;Turkey | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
346 | NCT02679001 | March 24, 2016 | 20 August 2018 | A 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 TREATMENT | Rheumatoid Arthritis | Drug: TNF inhibitor/TCZ | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 200 | Phase 1/Phase 2 | Sweden | |
347 | NCT02720523 | March 22, 2016 | 28 October 2019 | A 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 csDMARDs | A 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 csDMARDs | Rheumatoid Arthritis | Drug: Placebo;Drug: Upadacitinib | AbbVie | Not recruiting | 18 Years | N/A | All | 197 | Phase 2/Phase 3 | Japan | |
348 | NCT02682823 | March 21, 2016 | 12 November 2018 | Tocilizumab Real-Life Human Factors (RLHFs) Validation Study | Tocilizumab Real-Life Human Factors Validation Study | Rheumatoid Arthritis | Device: AI-1000 G2;Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 91 | Phase 4 | United States | |
349 | EUCTR2015-002523-26-HU | 08/03/2016 | 11 April 2016 | Effects 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 Alapítvány | Authorised | Female: yes Male: yes | Hungary | |||||
350 | NCT01961310 | March 8, 2016 | 11 June 2018 | Evaluation of the Intestinal Microbiota and Bacterial Translocation in Patients With Rheumatoid Arthritis | Evaluation of the Intestinal Microbiota and Bacterial Translocation in Patients With Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: Plasma analysis for bacterial translocation;Biological: Stool analysis | Centre Hospitalier Universitaire de Nimes | Not recruiting | 18 Years | N/A | All | 55 | N/A | France | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
351 | NCT02547493 | March 3, 2016 | 11 June 2018 | Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients | Comparison of Humoral Response to Conjugate Pneumococcal Vaccine and Polysaccharide Pneumococcal Vaccine in Rheumatoid Arthritis (RA) Patients Treated With Abatacept | Rheumatoid Arthritis | Biological: pneumococcal polysaccharide vaccine;Biological: pneumococcal conjugate vaccine;Drug: Abatacept | University Hospital, Montpellier | Bristol-Myers Squibb | Recruiting | 18 Years | 85 Years | All | 80 | N/A | France;Monaco |
352 | NCT02706951 | March 2, 2016 | 18 March 2019 | A 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 MTX | Rheumatoid Arthritis | Drug: Methotrexate;Drug: ABT-494;Drug: ABT-494 matching placebo;Drug: Methotrexate matching placebo | AbbVie | Not recruiting | 18 Years | 99 Years | All | 648 | Phase 3 | United 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 | |
353 | JPRN-UMIN000021492 | 2016/03/01 | 2 April 2019 | To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients. | Rheumatoid arthritis | switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients. | Inoue Hospital | Not Recruiting | 18years-old | Not applicable | Male and Female | 40 | Not selected | Japan | ||
354 | NCT02636829 | March 2016 | 26 September 2016 | Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory Arthritis | Validation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory Arthritis | Multiple Sclerosis;Rheumatoid Arthritis | Other: QALCIMUM questionnaire;Other: Determination of calcium intake by a dietician interview | Centre Hospitalier Universitaire de Nimes | Not recruiting | 18 Years | 69 Years | Both | 100 | N/A | France | |
355 | NCT02652299 | March 2016 | 25 March 2019 | Fibrocytes in Early and Longstanding Rheumatoid Arthritis | Fibrocytes in Early and Longstanding Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Synovial biopsy | Odense University Hospital | Not recruiting | 18 Years | N/A | All | 60 | N/A | Denmark | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
356 | NCT02714634 | March 2016 | 11 April 2016 | Clinical Trial Evaluating Methotrexate + Biologic Versus Methotrexate, Salazopyrine and Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate | Randomized Controlled Clinical Trial Evaluating Methotrexate + Biologic Versus Methotrexate, Salazopyrine and Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate | Rheumatoid Arthritis;Insufficient Response to Methotrexate. | Drug: Methotrexate + biologic administration;Drug: methotrexate + salazopyrine + hydroxychloroquine administration | University Hospital, Strasbourg, France | Not recruiting | 18 Years | N/A | Both | 286 | Phase 4 | ||
357 | NCT02728934 | February 25, 2016 | 11 November 2019 | Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis | Comparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: Golimumab Intravenous (IV);Biological: Infliximab;Biological: Biosimilar Infliximab | Janssen Scientific Affairs, LLC | Not recruiting | 18 Years | N/A | All | 1279 | N/A | United States | |
358 | EUCTR2015-002924-17-BE | 24/02/2016 | 23 July 2018 | A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid Arthritis | A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis | Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nanocort 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 FZE | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Belgium;Netherlands | |||
359 | NCT02698657 | February 23, 2016 | 15 July 2019 | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate | A 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 Methotrexate | Rheumatoid Arthritis (RA) | Drug: ASP5094;Drug: Placebo | Astellas Pharma Global Development, Inc. | Not recruiting | 18 Years | 65 Years | All | 30 | Phase 1 | United States;Poland | |
360 | NCT02706873 | February 23, 2016 | 25 March 2019 | A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ABT-494 matching placebo;Drug: Methotrexate;Drug: Methotrexate matching placebo;Drug: ABT-494 | AbbVie | Not recruiting | 18 Years | 99 Years | All | 1002 | Phase 3 | United States;Argentina;Australia;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Guatemala;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Kazakhstan;Latvia;Lithuania;Mexico;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Slovenia;South Africa;Spain;Switzerland;Taiwan;Tunisia;Turkey;Ukraine;United Kingdom;Czech Republic;Finland;Malaysia;Netherlands | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
361 | NCT02638948 | February 16, 2016 | 20 August 2018 | Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors | Rheumatoid Arthritis | Drug: BMS-986142;Drug: Placebo;Drug: Methotrexate | Bristol-Myers Squibb | Not recruiting | 18 Years | 120 Years | All | 536 | Phase 2 | United States;Argentina;Austria;Brazil;Canada;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;South Africa;Spain;Taiwan;Belgium | |
362 | NCT02683564 | February 2016 | 23 February 2016 | BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM Study | A Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM Study | Rheumatoid Arthritis | Drug: BOW015;Drug: Remicade | Epirus Biopharmaceuticals (Switzerland) GmbH | Not recruiting | 18 Years | 80 Years | Both | 548 | Phase 3 | ||
363 | NCT03332719 | February 2016 | 16 December 2017 | Efficacy, Safety and Immunogenicity of Enerceptan Compared to Enbrel in Rheumatoid Arthritis | Multicentric Evaluator-blinded Randomized Non-inferiority Study, to Asses the Compared Efficacy, Safety and Immunogenicity of Enerceptan® With Enbrel® in Combination With Methotrexate for the Treatment of Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Etanercept;Drug: Methotrexate | Gema Biotech S.A. | QUID-Quality in Drugs and Devices Latin American Consulting SRL | Not recruiting | 19 Years | 99 Years | All | 168 | Phase 3 | Argentina |
364 | NCT03355872 | February 2016 | 9 October 2018 | A 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 DMARDs | A 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 DMARDs | Rheumatoid Arthritis | Drug: HLX01 | Shanghai Henlius Biotech | Not recruiting | 18 Years | 65 Years | All | 194 | Phase 1/Phase 2 | ||
365 | EUCTR2014-004868-38-GR | 26/01/2016 | 14 March 2016 | A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis. | A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel Product Name: Enbrel 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. | Authorised | Female: yes Male: yes | 720 | United States;Hungary;Czech Republic;Canada;Greece;Argentina;Spain;Bulgaria | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
366 | NCT02925351 | January 25, 2016 | 11 November 2019 | Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory Diseases | The Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory Diseases | Autoimmune Disease;Crohn Disease;Inflammatory Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Takayasu Arteritis | Procedure: Computed Tomography;Radiation: Fluorine F 18 Clofarabine;Procedure: Positron Emission Tomography | Jonsson Comprehensive Cancer Center | National Cancer Institute (NCI) | Not recruiting | 18 Years | N/A | All | 8 | N/A | United States |
367 | NCT02640612 | January 22, 2016 | 18 December 2018 | Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis | Long-term Assessment of Safety, Efficacy, Pharmacokinetics and Immunogenicity of BI 695501 in Patients With Rheumatoid Arthritis (RA): an Open-label Extension Trial for Patients Who Have Completed Trial 1297.2 and Are Eligible for Long-term Treatment With Adalimumab | Arthritis, Rheumatoid | Drug: BI 695501 | Boehringer Ingelheim | Not recruiting | 18 Years | 80 Years | All | 430 | Phase 3 | United States;Bulgaria;Chile;Estonia;Germany;Hungary;Korea, Republic of;Malaysia;Poland;Russian Federation;Serbia;Spain;Thailand;Ukraine | |
368 | JPRN-UMIN000018931 | 2016/01/17 | 2 April 2019 | Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial | Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis | 1000 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 Hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 50 | Not selected | Japan | ||
369 | EUCTR2014-004673-16-DE | 12/01/2016 | 30 April 2018 | Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis. | Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients | Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 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 Ltd | Not Recruiting | Female: yes Male: yes | 226 | Phase 4 | Serbia;France;Egypt;Lebanon;Turkey;Russian Federation;Germany;Italy;Switzerland | |||
370 | EUCTR2015-003332-13-SK | 12/01/2016 | 8 February 2016 | A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 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. KG | Authorised | Female: yes Male: yes | 600 | Phase 3 | Serbia;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. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
371 | NCT02742597 | January 12, 2016 | 8 January 2018 | Patient-Centred Innovations for Persons With Multimorbidity - Ontario | Patient-Centred Innovations for Persons With Multimorbidity - Ontario | Hypertension;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;Multimorbidity | Behavioral: TIP / IMPACT Plus Care Coordination | Lawson Health Research Institute | Western 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 Hospital | Not recruiting | 18 Years | 80 Years | All | 1980 | N/A | Canada |
372 | EUCTR2012-002009-23-HU | 07/01/2016 | 3 July 2017 | Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis | A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA | Moderate to severe active rheumatoid arthritis MedDRA version: 18.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GP2015 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 AG | Not Recruiting | Female: yes Male: yes | 366 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Latvia | |||
373 | EUCTR2015-002634-41-HU | 07/01/2016 | 11 December 2017 | Long-term study of BI695501 in patients with active rheumatoid arthritis | Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab | Rheumatoid arthritis MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695501 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 GmbH | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of | |||
374 | NCT02636907 | January 6, 2016 | 16 December 2017 | Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe | Assessment 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 Syringe | Arthritis, Rheumatoid | Drug: BI 695501 Autoinjector;Drug: BI 695501 Prefilled syringe | Boehringer Ingelheim | Not recruiting | 18 Years | 80 Years | All | 77 | Phase 2 | United States;Poland;Ukraine | |
375 | NCT02321930 | January 2016 | 16 December 2017 | Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients | Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: tofacitinib 5mg po bid | University of California, Los Angeles | Not recruiting | 18 Years | N/A | All | 25 | Phase 4 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
376 | NCT02626026 | January 2016 | 10 October 2016 | Safety 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 Arthritis | Drug: GS-4059;Drug: Placebo | Gilead Sciences | Not recruiting | 18 Years | 65 Years | Both | 42 | Phase 1 | United States | |
377 | NCT02643823 | January 2016 | 13 June 2016 | Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis | Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: hUC-MSC + DMARDs;Drug: DMARDs | Shenzhen Hornetcorn Bio-technology Company, LTD | Futian People's Hospital | Recruiting | 18 Years | 80 Years | Both | 40 | Phase 1 | China |
378 | NCT02762838 | January 2016 | 24 June 2019 | Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | International 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 Arthritis | Rheumatoid Arthritis | Biological: BCD-055;Biological: Remicade®;Drug: Methotrexate;Drug: Folic acid | Biocad | Not recruiting | 18 Years | 75 Years | All | 426 | Phase 3 | Belarus;India;Russian Federation | |
379 | NCT02878161 | January 2016 | 29 August 2016 | Predictability Studies on the Efficacy of TNF-a Inhibitors in Chinese RA From Real World | Screening Protein Predictive of Response to Tumor Necrosis Factor-a Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal Pathway | Rheumatoid Arthritis | Drug: methotrexate(necessary);Biological: infliximab;Biological: etanercept;Biological: adalimumab;Drug: leflunomide (permitted, not necessary);Drug: NSAIDs (permitted,not necessary);Drug: Glucocorticoids (permitted,not necessary) | Fen Li | Recruiting | 18 Years | 75 Years | Both | 240 | Phase 4 | ||
380 | NCT02608112 | December 31, 2015 | 5 November 2018 | Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year | Subcutaneous 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 Year | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 291 | Phase 1 | France | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
381 | NCT02644499 | December 31, 2015 | 14 October 2019 | Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis | Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid | Jawaharlal Institute of Postgraduate Medical Education & Research | Not recruiting | 18 Years | N/A | All | 186 | Phase 4 | India | |
382 | EUCTR2015-003333-95-SK | 18/12/2015 | 6 November 2018 | A 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. KG | Authorised | Female: yes Male: yes | 1500 | Phase 3 | Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand;Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain | |||
383 | EUCTR2015-004173-32-DK | 18/12/2015 | 30 April 2019 | Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. | Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. A randomized and investigator initiated study. | Rheumatic diseases MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000005156 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Enbrel 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 Hospital | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Denmark | |||
384 | NCT02675426 | December 17, 2015 | 18 March 2019 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Rheumatoid Arthritis | Drug: Placebo;Drug: ABT-494 | AbbVie | Not recruiting | 18 Years | 99 Years | All | 661 | Phase 3 | United 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 | |
385 | EUCTR2015-003334-27-SK | 11/12/2015 | 6 November 2018 | A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 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. KG | Authorised | Female: yes Male: yes | 975 | Phase 3 | Portugal;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. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
386 | NCT02680067 | December 8, 2015 | 29 April 2019 | NIR Fluorescence Imaging of Lymphatic Transport Using ICG | Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green | Rheumatoid Arthritis | Drug: Indocyanine Green;Device: MultiSpectral Imaging System | University of Rochester | National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Recruiting | 18 Years | 89 Years | All | 30 | Phase 1 | United States |
387 | ChiCTR-IPR-15007368 | 2015-12-01 | 18 April 2017 | Clinical Research for the Effect of Chinese and Western Medicine on Treating Rheumatoid Arthritis | Comparative Study on the Influences of Gut Microbiota of Chinese and Western Medicine for Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | 1:HuaYuTongBiFang;2:HuaYuTongBiFang+MTX;3:ZhengQingFengTongNing Pills+MTX;4:Methotrexate; | Guangdong Provincial Hospital of Chinese Medicine | Not Recruiting | 18 | 65 | Male | 1:96;2:96;3:96;4:96; | Pilot study | China | |
388 | NCT02629159 | December 1, 2015 | 25 February 2019 | A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate | 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) | Rheumatoid Arthritis | Drug: Placebo for Adalimumab;Drug: ABT-494;Drug: Adalimumab;Drug: Placebo for ABT-494 | AbbVie | Not recruiting | 18 Years | N/A | All | 1629 | Phase 3 | United 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 | |
389 | NCT02944799 | December 2015 | 22 October 2018 | Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis | Alendronate 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 Mass | Rheumatoid Arthritis;Osteoporosis | Drug: Placebo;Drug: Alendronate;Drug: Calcium;Drug: Vitamin D | University of Aarhus | Recruiting | 18 Years | N/A | All | 160 | Phase 2 | Denmark | |
390 | NCT02758769 | November 30, 2015 | 16 December 2017 | Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings | Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings | Rheumatoid Arthritis | Biological: ORENCIA Subcutaneous Injection | Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd | Recruiting | 20 Years | N/A | All | 300 | N/A | Japan |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
391 | NCT02557100 | November 19, 2015 | 26 August 2019 | Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis | A 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 Drugs | Rheumatoid Arthritis | Drug: Abatacept;Drug: Adalimumab;Drug: Methotrexate | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 120 | Phase 4 | United States;Algeria;Canada;Mexico | |
392 | NCT02512575 | November 18, 2015 | 9 October 2018 | A 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 Arthritis | Drug: AZD9567 Monohydrat;Drug: Placebo oral suspension/ Placebo capsule;Drug: Prednisolone | AstraZeneca | Not recruiting | 18 Years | 55 Years | Male | 72 | Phase 1 | Germany | |
393 | EUCTR2015-002809-12-HU | 17/11/2015 | 2 October 2017 | A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: YLB113 Product Code: YLB113 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 Ltd | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Czech Republic;Hungary;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India | |||
394 | EUCTR2013-000337-13-PT | 13/11/2015 | 12 February 2018 | Prediction 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) - PreCePRA | Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy MedDRA version: 20.0 Level: LLT Classification code 10040107 Term: Seropositive rheumatoid arthritis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Cimzia 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 Erlangen | Authorised | Female: yes Male: yes | 156 | Phase 3 | Serbia;United States;Portugal;Germany | |||
395 | JPRN-UMIN000018848 | 2015/11/01 | 5 November 2019 | Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis | Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis - Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis | Rheumatoid arthritis | control: 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 Hospital | Not Recruiting | Not applicable | Not applicable | Male and Female | 900 | Not applicable | Japan | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
396 | NCT02534896 | November 2015 | 26 November 2018 | To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis | To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis | Active Rheumatoid Arthritis | Drug: Sunpharma1505 1;Drug: Sunpharma1505 2;Drug: Reference1505 | Sun Pharma Global FZE | Not recruiting | 18 Years | 90 Years | All | 330 | Phase 3 | Belgium;Netherlands | |
397 | NCT02543931 | November 2015 | 12 December 2016 | Curcuma Longa L in Rheumatoid Arthritis | Phase Ib Randomized, Double-Blind, Placebo-Controlled Study of Meriva in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Meriva;Drug: placebo | University of Arizona | Vanderbilt University;National Center for Complementary and Integrative Health (NCCIH);National Institutes of Health (NIH) | Not recruiting | 18 Years | N/A | Both | 3 | Phase 1 | United States |
398 | NCT02723760 | November 2015 | 11 April 2016 | 99mTc-3PRGD2 SPECT/CT in Rheumatoid Arthritis Patients | Clinical Study of 99mTc-3PRGD2 SPECT/CT in Diagnosis and Efficacy Evaluation of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: 99mTc-3PRGD2 | First Affiliated Hospital of Fujian Medical University | Recruiting | 20 Years | 70 Years | Both | 40 | Phase 0 | China | |
399 | NCT02552940 | October 31, 2015 | 11 June 2018 | An 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 Practice | A 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 PRACTICE | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | nv Roche sa | Not recruiting | 18 Years | N/A | All | 140 | N/A | Belgium;Luxembourg |
400 | ChiCTR-OPB-15007284 | 2015-10-30 | 18 April 2017 | Characterization of linkage between symbiotic gut microbes and fatty acid metabolism in rheumatoid arthritis patients | Characterization of linkage between symbiotic gut microbes and fatty acid metabolism in rheumatoid arthritis patients | Rheumatoid Arthritis | RA group1:Doxycycline;RA group 2:Placebo; | Hong Kong Baptist University | Recruiting | 18 | 80 | Both | RA group1:20;RA group 2:20; | Pilot study | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
401 | EUCTR2015-001246-28-BE | 19/10/2015 | 16 November 2015 | Ultrasound 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) - TOVERA | Rheumatoid Arthritis MedDRA version: 18.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: RoActemra Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe | Cliniques Universitaires Saint-Luc, Université catholique de Louvain | Authorised | Female: yes Male: yes | Belgium | |||||
402 | EUCTR2015-000581-58-CZ | 14/10/2015 | 15 October 2018 | A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action | A Randomized, Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Remicade Product Name: Remicade 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 Praha | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | Czech Republic | |||
403 | NCT02534311 | October 13, 2015 | 12 March 2018 | A 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 Level | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 60 | N/A | Slovakia | |
404 | NCT02778789 | October 2015 | 7 October 2019 | Comparing the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers | Non 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 Arthritis | Drug: Tocilizumab;Drug: TNF-alpha Inhibitor | University of Erlangen-Nürnberg Medical School | Not recruiting | 18 Years | N/A | All | 66 | N/A | Germany | |
405 | NCT02780323 | October 2015 | 16 December 2017 | Study to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis | A 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 Arthritis | Rheumatoid Arthritis | Drug: CELBESTA® placebo;Drug: CELEBREX® placebo;Drug: CELEBREX®;Drug: CELBESTA® | Dong-A ST Co., Ltd. | Recruiting | 19 Years | N/A | All | 158 | Phase 4 | Korea, Republic of | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
406 | NCT02882087 | October 2015 | 15 April 2019 | A 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 Arthritis | A 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 Arthritis | Moderate and Severe Rheumatoid Arthritis | Drug: RC18 160 mg plus MTX;Drug: Placebo plus MTX | RemeGen | Not recruiting | 18 Years | 65 Years | All | 60 | Phase 2 | China | |
407 | EUCTR2015-003638-28-DK | 30/09/2015 | 30 April 2019 | Treatment 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. - ALOSTRA | Rheumatoid arthritis and osteoporosis MedDRA version: 20.0 Level: LLT Classification code 10031289 Term: Osteoporosis, unspecified System Organ Class: 100000004859 MedDRA version: 20.0 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 Hospital | Authorised | Female: yes Male: yes | 160 | Phase 2 | Denmark | |||
408 | EUCTR2015-002284-42-FI | 18/09/2015 | 28 September 2015 | The 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 activit | INTENT: 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) - INTENT | rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specify | Trade 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 | READE | Authorised | Female: yes Male: yes | 1650 | Phase 1 | Finland | |||
409 | NCT02605642 | September 10, 2015 | 18 March 2019 | Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade | PERSIST: 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 Arthritis | Drug: CT-P13 | Pfizer | Hospira, now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | All | 351 | Phase 3 | Bulgaria;Canada;Czechia;Germany;Greece;Spain;United Kingdom;Czech Republic;France;Italy |
410 | NCT02535832 | September 2015 | 24 June 2019 | Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA) | Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA) | Rheumatoid Arthritis;Insulin Resistance | Drug: Pioglitazone;Drug: Placebo | University of Alabama at Birmingham | Recruiting | 35 Years | 65 Years | All | 36 | Phase 1 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
411 | NCT02553018 | September 2015 | 16 December 2017 | Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe | A 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, Rheumatoid | Drug: Methotrexate | Nordic Pharma SAS | Not recruiting | 18 Years | N/A | All | 278 | Phase 3 | France | |
412 | NCT02565810 | September 2015 | 16 December 2017 | An Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis | An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Adalimumab PFS and Pen | Samsung Bioepis Co., Ltd. | Not recruiting | 18 Years | 55 Years | All | 49 | Phase 2 | Poland | |
413 | NCT02717988 | September 2015 | 12 March 2018 | Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of SKI-O-703 in Healthy Volunteers | A 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 Volunteers | Rheumatoid Arthritis | Drug: SKI-O-703 capsule;Drug: Placebo capsule | Oscotec Inc. | PPD | Not recruiting | 18 Years | 55 Years | All | 48 | Phase 1 | United States |
414 | NCT02748785 | September 2015 | 7 November 2016 | MTX Discontinuation and Vaccine Response | Effect of Methotrexate Discontinuation on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial | Arthritis, Rheumatoid | Drug: Methotrexate;Biological: Seasonal Influenza vaccine | Seoul National University Hospital | Not recruiting | 18 Years | N/A | Both | 277 | Phase 4 | Korea, Republic of | |
415 | NCT02764515 | September 2015 | 16 December 2017 | Kunxian for the Treatment of Rheumatoid Arthritis | Comparison of the Efficacy and Safety of Kunxian Capsule and Methotrexate for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Kunxian Capsule;Drug: Methotrexate | Chinese SLE Treatment And Research Group | CHENLIJI Pharmaceutical Company,Guangzhou Pharmaceutical Group;CHINESE RHEUMATISM DATA CENTER | Recruiting | 40 Years | 70 Years | All | 428 | Phase 4 | China |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
416 | JPRN-UMIN000027241 | 2015/08/31 | 2 April 2019 | the change of IMT of carotide artery in RA with treatment of tocilizumab | rheumatoid arthritis | tofacitinib | hiroshima clinic | Not Recruiting | 18years-old | 80years-old | Male and Female | 50 | Not applicable | Japan | ||
417 | NCT02504268 | August 31, 2015 | 22 October 2019 | Effects of Abatacept in Patients With Early Rheumatoid Arthritis | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive | Rheumatoid Arthritis | Drug: Abatacept;Drug: Methotrexate;Other: Abatacept Placebo;Other: Methotrexate Placebo | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 1067 | Phase 3 | United 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 | |
418 | NCT02350426 | August 12, 2015 | 16 December 2017 | A Study to Assess Inflammation in Rheumatoid Arthritis Using Molecular Imaging Techniques | An Adaptive Design Open Label Pilot Study in Rheumatoid Arthritis Patients to Assess Inflammation Using Molecular Imaging Techniques | Arthritis, Rheumatoid | Other: Gadobutrol;Other: 18F-FDG;Other: 18F-GE-180 | GlaxoSmithKline | Cambridge University Hospitals NHS Foundation Trust | Not recruiting | 30 Years | 85 Years | All | 10 | Phase 1 | United Kingdom |
419 | JPRN-JapicCTI-153081 | 01/8/2015 | 16 July 2019 | Effects of Abatacept in Patients With Early Rheumatoid Arthritis | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive | Rheumatoid Arthritis | Intervention 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 Recruiting | 18 | BOTH | 1000 | Phase 3 | |||
420 | NCT02451748 | August 2015 | 29 April 2019 | IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA | IL-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 CIMZIA | Rheumatoid Arthritis | Other: 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 Chicago | UCB Pharma | Not recruiting | 18 Years | N/A | All | 32 | Phase 4 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
421 | NCT02797769 | August 2015 | 21 July 2016 | A 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 Databases | Rheumatoid Arthritis | Drug: Other Biologics;Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 75000 | N/A | ||
422 | NCT02481180 | July 31, 2015 | 22 July 2019 | Tolerance, Pharmacokinetics and Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis) | An Open, Dose Escalation, Multiple Dose Study to Assess Tolerance?Pharmacokinetics?Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis) | Rheumatoid Arthritis | Drug: T0001;Drug: Enbrel | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Not recruiting | 18 Years | 65 Years | All | 36 | Phase 1 | China | |
423 | EUCTR2015-000665-30-GB | 30/07/2015 | 27 August 2018 | Coherus Open-Label Safety Extension Study | An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES | Rheumatoid 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 Recruiting | Female: yes Male: yes | 447 | Phase 3 | France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;Italy;United Kingdom | |||
424 | NCT02504671 | July 23, 2015 | 15 April 2019 | Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid Arthritis | 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 | Arthritis, Rheumatoid | Drug: GSK3196165;Drug: MTX;Drug: Folic acid;Drug: Placebo | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 222 | Phase 2 | Bulgaria;Canada;Czechia;Estonia;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic | |
425 | EUCTR2012-003876-38-DE | 21/07/2015 | 28 November 2016 | Clinical 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 past | 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® - ASSIST-RT | Rheumatoid Arthritis MedDRA version: 19.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GP2013 Product Code: GP2013 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 Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Hungary;Poland;Germany | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
426 | NCT02242474 | July 2015 | 20 August 2018 | Anti-TNFa Use During Elective Foot and Ankle Surgery in Patients With Rheumatoid Arthritis | Prospective 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 Arthritis | Drug: Anti-TNF suspended perioperatively;Drug: Anti-TNFa continued perioperatively | CHU de Quebec-Universite Laval | Recruiting | 18 Years | N/A | All | 660 | Phase 4 | Canada | |
427 | NCT02467504 | July 2015 | 23 November 2015 | Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis | A 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 Arthritis | Rheumatoid Arthritis | Drug: hrIL-2 active;Drug: hrIL-2 placebo;Drug: MTX;Drug: Folic Acid;Drug: Loxoprofen | Peking University People's Hospital | Monash University;Beijing ShuangLu Pharmaceutical Co., Ltd. | Recruiting | 18 Years | 70 Years | Both | 60 | Phase 2 | China |
428 | NCT02480946 | July 2015 | 16 December 2017 | Safety and Tolerability Study of MBS2320 in Healthy Subjects and Subjects With Rheumatoid Arthritis | A 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 Methotrexate | Arthritis, Rheumatoid | Drug: MBS2320;Drug: Placebo;Drug: Methotrexate | Modern Biosciences plc | Covance | Not recruiting | 18 Years | 70 Years | All | 105 | Phase 1 | United Kingdom |
429 | NCT02486939 | July 2015 | 16 December 2017 | A 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 Psoriasis | Drug: CHS-0214 | Coherus Biosciences, Inc. | Daiichi Sankyo Co., Ltd.;Shire | Not recruiting | 18 Years | N/A | All | 359 | Phase 3 | Japan |
430 | NCT02514772 | July 2015 | 16 December 2017 | GP2013 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 Arthritis | Biological: GP2013 - A Proposed biosimilar rituximab;Biological: Originator rituximab - Rituxan ® or MabThera ® | Sandoz | Hexal AG | Not recruiting | 18 Years | N/A | All | 107 | Phase 3 | United States;Germany;Hungary;Poland |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
431 | NCT02518620 | July 2015 | 26 August 2019 | An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis | A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects With Moderate to Severe Rheumatoid Arthritis Who Have Completed One of the Preceding Phase IIb Studies With ALX-0061 | Rheumatoid Arthritis | Biological: ALX-0061 | Ablynx | Not recruiting | 18 Years | 74 Years | All | 406 | Phase 2 | Belgium;Bulgaria;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Macedonia, The Former Yugoslav Republic of | |
432 | NCT02531178 | July 2015 | 11 April 2016 | A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABBV-257 in Subjects With Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABBV-257 | Rheumatoid Arthritis | Biological: ABBV-257;Biological: Placebo | AbbVie | Not recruiting | 18 Years | 75 Years | Both | 8 | Phase 1 | Germany | |
433 | NCT02598466 | July 2015 | 15 February 2016 | Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South Africa | Patient-Reported Efficacy of Subcutaneous Abatacept in Rheumatoid Arthritis: An Evaluation Of Patients In a Compassionate Use Programme in South Africa | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | Hexor, South Africa | Not recruiting | 18 Years | N/A | Both | 69 | N/A | |
434 | NCT02480153 | June 25, 2015 | 4 February 2019 | A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02). | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis | Biological: PF-06410293;Biological: Adalimumab | Pfizer | Not recruiting | 18 Years | N/A | All | 597 | Phase 3 | United 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 | |
435 | EUCTR2014-003453-34-EE | 18/06/2015 | 29 January 2018 | Study 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 Limited | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
436 | NCT02405780 | June 10, 2015 | 5 March 2018 | A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients | 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 | Arthritis, Rheumatoid | Drug: FKB327;Drug: Humira® | Fujifilm Kyowa Kirin Biologics Co., Ltd. | Not recruiting | 18 Years | N/A | All | 645 | Phase 3 | United States;Canada;Chile;Czechia;Germany;Peru;Poland;Romania;Russian Federation;Spain;Ukraine;Bulgaria;Czech Republic | |
437 | EUCTR2015-000538-31-DE | 01/06/2015 | 4 August 2015 | Application into the joint of opioids in chronic arthritis of the knee joint | NEUORIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the knee joint - Neuroimpa - knee joint | chronic arthritis of the knee joint effusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA. MedDRA version: 18.0 Level: LLT Classification code 10067624 Term: Knee arthritis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Morphine Hexal 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 Berlin | Authorised | Female: yes Male: yes | Germany | |||||
438 | NCT02402686 | May 20, 2015 | 11 November 2019 | Non-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 Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 353 | N/A | Hungary | |
439 | EUCTR2014-004904-31-NL | 19/05/2015 | 5 September 2016 | A 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. | Authorised | Female: yes Male: yes | Phase 4 | Netherlands | ||||
440 | JPRN-UMIN000017440 | 2015/05/18 | 7 October 2019 | In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study. | In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study. - RAXEL study | Rheumatoid arthritis | for 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 immunology | Not Recruiting | 18years-old | 90years-old | Male and Female | 134 | Phase 4 | Japan | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
441 | EUCTR2014-000110-61-CZ | 11/05/2015 | 19 February 2018 | Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE | Rheumatoid Arthritis MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: FKB327 PFS 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 Recruiting | Female: yes Male: yes | 680 | Phase 3 | Bulgaria;Germany;United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru | |||
442 | EUCTR2014-003034-42-HU | 08/05/2015 | 10 September 2018 | An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis | A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061 | Rheumatoid Arthritis (RA) MedDRA version: 18.1 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 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 NV | Not Recruiting | Female: yes Male: yes | 501 | Phase 2 | Serbia;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | |||
443 | EUCTR2014-005418-45-SE | 04/05/2015 | 22 May 2017 | Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) | Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE | Rheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Plaquenil 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 Bengtsson | Solveig Wållberg-Jonsson | Not Recruiting | Female: yes Male: yes | Phase 2 | Sweden | |||
444 | NCT02404558 | May 2015 | 11 April 2016 | Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis | An 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 Arthritis | Rheumatoid Arthritis | Drug: sarilumab SAR153191 (REGN88);Drug: tocilizumab | Sanofi | Regeneron Pharmaceuticals | Not recruiting | 20 Years | N/A | Both | 30 | Phase 1 | Japan |
445 | NCT02456844 | May 2015 | 8 February 2016 | Study to Investigate the Effect of BMS-986142 on the Pharmacokinetics (PK) of Methotrexate and Probe Substrate Cocktail in Healthy Patients | Effects 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 Subjects | Rheumatoid Arthritis | Drug: Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142;Drug: Methotrexate, Leucovorin and BMS-986142 | Bristol-Myers Squibb | Not recruiting | 18 Years | 50 Years | Both | 24 | Phase 1 | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
446 | NCT02460393 | May 2015 | 8 January 2018 | A Trial With Humanized TNFa Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy Subjects | A 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 Subjects | Rheumatoid Arthritis | Drug: Humanized TNFa monoclonal antibody;Other: placebo | Shenyang Sunshine Pharmaceutical Co., LTD. | Not recruiting | 18 Years | 45 Years | All | 72 | Phase 1 | China | |
447 | NCT02566967 | May 2015 | 15 July 2019 | An 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 Perspective | An 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 Target | Rheumatoid Arthritis | Drug: tofacitinib | Norman B. Gaylis, MD | Not recruiting | 18 Years | N/A | All | 20 | Phase 3 | United States | |
448 | EUCTR2014-003307-30-HU | 16/04/2015 | 22 May 2017 | Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis | A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIMEKIZUMAB Product Code: UCB4940 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 SA | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Czech Republic;Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Moldova, Republic of | |||
449 | NCT02387762 | April 2015 | 8 April 2019 | ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate | A 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 Methotrexate | Rheumatoid Arthritis | Drug: acalabrutinib;Drug: Placebo | Acerta Pharma BV | Not recruiting | 18 Years | 75 Years | All | 31 | Phase 2 | United States | |
450 | NCT02423538 | April 2015 | 1 February 2016 | First-in-Human Single Ascending Dose of SHR0302 | A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy Volunteers | Rheumatoid Arthritis | Drug: SHR0302;Drug: SHR0302 placebo comparator | Jiangsu HengRui Medicine Co., Ltd. | Not recruiting | 18 Years | 45 Years | Both | 64 | Phase 1 | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
451 | NCT02499315 | April 2015 | 17 May 2016 | Study to Evaluate the Safety, Tolerability, and Action of AMG 357 in Females With Rheumatoid Arthritis | A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 357 in Female Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: AMG 357;Drug: Placebo | Amgen | Not recruiting | 25 Years | 70 Years | Female | 32 | Phase 1 | United States | |
452 | NCT02800811 | April 2015 | 8 August 2016 | Safety, Tolerability, PK, PD, and Immunogenicity of Single and Multiple Ascending Intravenous Doses of FR104 | Randomized, 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 Subjects | Rheumatoid Arthritis;Complication of Transplant | Drug: FR104;Drug: Placebo | OSE Immunotherapeutics | Not recruiting | 18 Years | 60 Years | Both | 64 | Phase 1 | Belgium | |
453 | ChiCTR-IPR-15006107 | 2015-03-30 | 18 April 2017 | The clinical trial of tolerance of Ginsenoside compound K | To study the pharmacokinetics and tolerance of Ginsenoside compound K tablet in healthy volunteers after multiple dosing administration | rheumatoid arthritis | three groups:Ginsenoside compound K is administrated after single dose or multiple doses; | Institute of Clinical Pharmacology, Central South University | Not Recruiting | 18 | 45 | Male | three groups:12; | Phase 1 study | China | |
454 | JPRN-UMIN000016950 | 2015/03/27 | 2 April 2019 | Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept | rheumatoid arthritis | Infliximab or adalimumab or golimumab | Osaka Medical College | Not Recruiting | 20years-old | Not applicable | Male and Female | 50 | Not selected | Japan | ||
455 | EUCTR2015-000089-72-IT | 26/03/2015 | 19 February 2018 | abatacept in obese and overweight RA patiens | FAT GENE EXPRESSION IN OVERWEIGHT AND OBESE PATIENTS WITH PERSISTENTLY ACTIVE RHEUMATOID ARTHRITIS TREATED WITH ABATACEPT AND CLINICAL RESPONSE | MedDRA version: 17.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ORENCIA Product Name: Orencia abatacept Pharmaceutical Form: Solution for injection | Policlinico Gemelli-CIC- UCSC | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | Italy | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
456 | NCT02486302 | March 24, 2015 | 5 February 2018 | A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis. | A Prospective, Multicenter Non-interventional Study To Evaluate The Efficacy Of Enbrel (Registered) (Etanercept) Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis With Particular Focus On The Clinical Status Improvements Still Observable After 12 Weeks Of Treatment | Rheumatoid Arthritis;Psoriatic Arthritis;Axial Spondyloarthritis;Plaque Psoriasis | Drug: Etanercept | Pfizer | Not recruiting | 18 Years | N/A | All | 1535 | N/A | Germany | |
457 | EUCTR2014-001471-31-HU | 23/03/2015 | 13 June 2016 | This 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. KG | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;New Zealand | |||
458 | EUCTR2014-003033-26-BE | 23/03/2015 | 12 September 2016 | A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis (RA) MedDRA version: 18.0 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 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 NV | Not Recruiting | Female: yes Male: yes | 330 | Phase 2 | Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | |||
459 | EUCTR2014-004419-35-GB | 18/03/2015 | 17 August 2015 | Inhibition of Co-Stimulation in Rheumatoid Arthritis | Inhibition 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 Board | University of Glasgow | Authorised | Female: yes Male: yes | 25 | United Kingdom | |||
460 | EUCTR2013-005524-42-NL | 10/03/2015 | 28 November 2016 | STAtins 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 | Reade | Authorised | Female: yes Male: yes | Phase 4 | Netherlands | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
461 | NCT02304354 | March 9, 2015 | 7 October 2019 | Relationship 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 Arthritis | Drug: Rituximab | University Hospital, Tours | Not recruiting | 18 Years | N/A | All | 70 | Phase 3 | France | |
462 | JPRN-UMIN000015433 | 2015/03/01 | 2 April 2019 | Safety study of methotrexate low-dose once daily administration in rheumatoid arthritis patients | rheumatoid arthritis | methotrexate | Department of Medical Pharmaceutics , Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama | Recruiting | 20years-old | Not applicable | Male and Female | 35 | Not selected | Japan | ||
463 | NCT02287922 | March 2015 | 26 August 2019 | A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate | Rheumatoid Arthritis | Biological: ALX-0061;Biological: Placebo;Biological: Tocilizumab | Ablynx | Not recruiting | 18 Years | 74 Years | All | 251 | Phase 2 | United 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 | |
464 | NCT02353780 | March 2015 | 11 June 2019 | Mechanistic Studies of B- and T-Cell Function in RA Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept | Mechanistic Studies of B- and T-Cell Function in Rheumatoid Arthritis Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept | Rheumatoid Arthritis (RA) | Drug: TNF Antagonist (enbrel, humire, remicade, cimzia, symponi);Drug: Abatacept;Drug: Tocilizumab | Dr. Larry W. Moreland | Genentech, Inc.;Bristol-Myers Squibb | Not recruiting | 18 Years | 64 Years | All | 10 | Phase 4 | United States |
465 | NCT02414984 | March 2015 | 16 December 2017 | Registry for Analysis of Compliance in Colombian Participants With Rheumatoid Arthritis Exposed to Golimumab | Registry of Patients With Rheumatoid Arthritis Exposed to Golimumab (Go-Compl-Ar): Review and Analysis of Compliance in Colombia | Rheumatoid Arthritis | Biological: Golimumab | Janssen-Cilag, S.A. | Not recruiting | 18 Years | N/A | All | 37 | N/A | Colombia | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
466 | NCT02620189 | March 2015 | 14 December 2015 | Th17 Responses Evaluated in RA Patients on Inhibitors of TNFa | A Study to Investigate the Role of IL-17 and Th17 Pathway Activation in RA Patients With Inadequate Response to Anti-TNFa Therapies | Rheumatoid Arthritis | Drug: Anti-TNF Biologics Therapy | Queen Mary University of London | Recruiting | 18 Years | N/A | Both | 50 | N/A | United Kingdom | |
467 | NCT02638259 | February 21, 2015 | 1 October 2018 | Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis | A Randomized, Double-blind, Parallel-group Phase III Study to Demonstrate Equivalent Efficacy and to Compare Safety & Immunogenicity of GP2015 and Enbrel® (EU Authorized) in Patients With Moderate to Severe, Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: GP2015 | Sandoz | Not recruiting | 18 Years | N/A | All | 376 | Phase 3 | United States;Bulgaria;Czechia;Estonia;Germany;Hungary;Italy;Latvia;Lithuania;Mexico;Poland;Russian Federation;Serbia;Slovakia;Spain;United Kingdom;Czech Republic | |
468 | NCT02373813 | February 20, 2015 | 4 November 2019 | Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission | A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: etanercept pre-filled syringe sq injection;Drug: Oral methotrexate;Drug: Placebo for etanercept sq injection;Drug: Placebo for methotrexate | Amgen | Not recruiting | 18 Years | N/A | All | 371 | Phase 3 | United States;Argentina;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Italy;Mexico;Poland;Portugal;South Africa;Spain;Czech Republic | |
469 | EUCTR2014-002945-23-GB | 18/02/2015 | 11 April 2016 | A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI. | A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. | Rheumatoid Arthritis (RA) MedDRA version: 18.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Namilumab Product Code: MT203 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 Recruiting | Female: yes Male: yes | 36 | Phase 2 | Estonia;Czech Republic;Spain;Russian Federation;United Kingdom | |||
470 | EUCTR2013-005418-37-DE | 05/02/2015 | 29 January 2018 | A 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. | Authorised | Female: yes Male: yes | 87 | Phase 2 | Germany;Italy;Switzerland | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
471 | EUCTR2013-004569-16-HU | 03/02/2015 | 8 August 2016 | A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis | A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | 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 10017 | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany | |||
472 | JPRN-JapicCTI-152979 | 01/2/2015 | 2 April 2019 | Dose 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 Arthritis | Intervention 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. | 20 | BOTH | 108 | Phase 2 | ||||
473 | NCT02332590 | February 2015 | 28 October 2019 | Efficacy 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 Arthritis | Rheumatoid Arthritis | Drug: Sarilumab;Drug: Adalimumab;Drug: Placebo (for sarilumab);Drug: Placebo (for adalimumab) | Sanofi | Regeneron Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 369 | Phase 3 | United States;Chile;Czechia;Germany;Hungary;Israel;Korea, Republic of;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic;France |
474 | NCT02357069 | February 2015 | 18 January 2016 | A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate Similarity of Efficacy and Safety of LBEC0101 50mg Subcutaneous Weekly Injection to Enbrel® 50mg Subcutaneous Weekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX | Arthritis, Rheumatoid | Drug: Enbrel;Drug: LBEC0101 | LG Life Sciences | Mochida Pharmaceutical Company, Ltd. | Not recruiting | 20 Years | 75 Years | Both | 372 | Phase 3 | Japan;Korea, Republic of |
475 | NCT02373202 | February 2015 | 9 January 2017 | A 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 Arthritis | Rheumatoid Arthritis | Drug: sarilumab SAR153191 (REGN88);Drug: non-MTX DMARDs (e.g. sulfasalazine, leflunomide, bucillamine, tacrolimus, or mizoribin);Drug: sulfasalazine;Drug: leflunomide;Drug: bucillamine;Drug: tacrolimus;Drug: mizoribin | Sanofi | Regeneron Pharmaceuticals | Not recruiting | 20 Years | N/A | Both | 91 | Phase 3 | Japan |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
476 | NCT02390700 | February 2015 | 28 November 2016 | Observational Study of Golimumab Intravenous Infusion | Golimumab Intravenous Infusion Registry (GO-IV) | Rheumatoid Arthritis | Biological: Golimumab Intravenous | Janssen Inc. | Not recruiting | 18 Years | N/A | Both | 78 | Phase 4 | Canada | |
477 | NCT02466581 | February 2015 | 18 December 2018 | Dose Reduction for Early Rheumatoid Arthritis 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 in the NORD-STAR Study and Have Reached Stable Low Disease Activity | Rheumatoid Arthritis | Drug: Sulphasalazine + Hydroxychloroquine OR Prednisolone;Biological: Cimzia;Biological: Orencia;Biological: RoActemra | Karolinska Institutet | Recruiting | 18 Years | N/A | All | 500 | Phase 4 | Sweden | |
478 | NCT02633332 | February 2015 | 28 December 2015 | Use 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 Treatments | Rheumatoid Arthritis;Autoimmune Diseases;Disorder of Synovium;Sjogren's Syndrome;Acute and Chronic Inflammation;Disorder of Pleura and Pleural Cavity;Felty's Syndrome;Rheumatoid Nodules | Drug: Vitamin D3;Drug: Lipitor®;Drug: Acycloguanosine;Drug: Tetracycline;Drug: methotrexate;Drug: etanercept | Università Popolare Homo & Natura | Not recruiting | 18 Years | 75 Years | Both | 15 | Phase 1 | Italy | |
479 | EUCTR2014-002541-22-CZ | 26/01/2015 | 9 January 2017 | Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis | A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH | Rheumatoid Arthritis MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) 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 & développement | Not Recruiting | Female: yes Male: yes | 540 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Puerto Rico;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of | |||
480 | EUCTR2014-000109-11-DE | 22/01/2015 | 16 August 2016 | Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC | Rheumatoid Arthritis MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: FKB327 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 Recruiting | Female: yes Male: yes | 730 | Phase 3 | United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
481 | EUCTR2014-003255-54-CZ | 21/01/2015 | 11 June 2018 | A study evaluating the effects of RGB-03 and MabThera combined with Methotrexate in patients with Rheumatoid Arthritis | A Double-blind, Randomised, Comparative Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Evaluation of RGB-03 and MabThera® Combined with Methotrexate in Rheumatoid Arthritis Patients | Rheumatoid arthritis MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RGB-03 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 Plc | Not Recruiting | Female: yes Male: yes | 142 | Phase 1;Phase 3 | Hungary;Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Romania;Austria;Russian Federation;Israel;Germany | |||
482 | NCT03719469 | January 20, 2015 | 5 November 2018 | Circulating microRNAs as Novel Prognosis Biomarkers for Rheumatoid Arthritis | Circulating microRNAs Expression as Predictors of Clinical Response in Rheumatoid Arthritis Patients Treated With Green Tea | Rh Disease | Dietary Supplement: Green tea group | King Saud University | Not recruiting | 18 Years | 85 Years | All | 150 | N/A | ||
483 | ChiCTR-IPR-15005787 | 2015-01-15 | 18 April 2017 | The effect of food on the pharmacokinetics of Ginsenoside C-K | To study the effect of food on pharmacokinetics of Ginsenoside C-K tablet in healthy volunteers | rheumatoid arthritis | Two groups:Ginsenoside compound K is administrated after taking food versus fasting; | Institute of Clinical Pharmacology, Central South University | Not Recruiting | 18 | 45 | Both | Two groups:24; | Phase 1 study | China | |
484 | NCT02309359 | January 2015 | 26 August 2019 | A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination With Methotrexate, in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Biological: ALX-0061;Other: Placebo;Drug: Methotrexate | Ablynx | Not recruiting | 18 Years | 74 Years | All | 345 | Phase 2 | United 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 | |
485 | NCT02371096 | January 2015 | 2 March 2015 | Comparative Pharmacokinetic Trial of RGB-03 and MabThera | Rheumatoid Arthritis | Drug: MabThera (rituximab);Drug: RGB-03 | Gedeon Richter Plc. | Not recruiting | 18 Years | 75 Years | Both | Phase 1 | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
486 | NCT02744196 | January 2015 | 5 February 2018 | Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC BIOCAD) With Methotrexate in First Line Biological Therapy of Patients With Active Rheumatoid Arthritis | Multicenter 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 Arthritis | Rheumatoid Arthritis | Biological: Acellbia;Drug: Placebo;Drug: Methotrexate | Biocad | Not recruiting | 18 Years | 80 Years | All | 159 | Phase 3 | ||
487 | NCT02837978 | January 2015 | 25 February 2019 | The Clinical Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months Treatment | Prospective Clinical Study to Observe the Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months Treatment in China | Arthritis, Rheumatoid | Drug: Tacrolimus;Drug: MTX | Qiang Shu | Recruiting | 18 Years | 80 Years | All | 100 | Phase 4 | China | |
488 | NCT02927535 | January 2015 | 17 October 2016 | Evaluation of TNFa Blockers Monotherapy in Early Rheumatoid Arthritis in France | Rheumatoid Arthritis | Drug: TNF blockers monotherapy | Centre Hospitalier Universitaire de Nimes | Pfizer;Pfizer | Not recruiting | 18 Years | 70 Years | Both | 813 | N/A | ||
489 | EUCTR2015-002466-22-Outside-EU/EEA | 28 December 2015 | A 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 Arthritis | A 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 Arthritis | Juvenile 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 Inc | Not Available | Female: yes Male: yes | 90 | United States;Australia;Canada;Costa Rica;New Zealand | |||||
490 | JPRN-UMIN000012650 | 2014/12/31 | 2 April 2019 | In vivo kinematic analysis of total knee arthroplasty with 3-dimensional registration technique. | osteoarthritis or rheumatoid arthritis of the knee joint | Fluoroscopy 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 College | Recruiting | 20years-old | 90years-old | Male and Female | 60 | Not selected | Japan | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
491 | EUCTR2014-003529-16-GB | 16/12/2014 | 4 December 2018 | Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology | Stratification of Biologic Therapies for RA by Pathobiology (STRAP): A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP | Rheumatoid Arthritis MedDRA version: 20.0 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: MabThera 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 | 219 | Phase 3 | United Kingdom | |||
492 | JPRN-UMIN000020663 | 2014/12/16 | 2 April 2019 | A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib. | Rheumatoid arthritis | Period :12 months Patients take Tofacitinib 5mg twice a day. | Kyusyu University Hospital Medicine and biosystemic science | Not Recruiting | 20years-old | Not applicable | Male and Female | 20 | Not applicable | Japan | ||
493 | JPRN-UMIN000015794 | 2014/12/15 | 2 April 2019 | Efficacy of monthly sodium risedronate for the treatment of corticosteroid induced osteoporosis in patients with rheumatoid arthritis (multicenter, double-blind, randomized, placebo-controlled, parallel-group study ) | osteoporosis, rheumatoid arthritis | monthly risedronate sodium 75mg for 6 months monthly placebo for 6 months | Division of rheumatology, endcrinology and nephrology, Hokkaido University Graduate School of Medicine | Not Recruiting | 20years-old | Not applicable | Male and Female | 165 | Phase 4 | Japan | ||
494 | NCT02198651 | December 15, 2014 | 27 August 2018 | A 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 | A 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 Diseases | Drug: Adalimumab;Other: Placebo | AbbVie | Not recruiting | 18 Years | 99 Years | All | 149 | Phase 4 | United States;Australia;Austria;Canada;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom | |
495 | EUCTR2014-000993-20-SE | 04/12/2014 | 5 February 2018 | Dosing of glucocorticoid (triamcinolone hexacetonid) when injecting knee joints of rheumatic diseases | Dosing of intraarticular triamcinolone hexacetonid for knee synovitis in chronic polyarthritis | Psoriatic arthritis and rheumatoid arthritis with synovitis of the knee;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: triamcinolone hexacetonide (Lederspan) Product Name: triamcinolone hexacetonid (Lederspan) Product Code: 9512 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 Gävleborg | Not Recruiting | Female: yes Male: yes | 160 | Phase 4 | Sweden | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
496 | ChiCTR1800014846 | 2014-12-01 | 12 February 2018 | Effect of preemptive analgesia with parecoxib sodium on multimodal analgesia in primary unilateral total hip arthroplasty | Effect of preemptive analgesia with parecoxib sodium on multimodal analgesia in primary unilateral total hip arthroplasty: A prospective randomized double-blind controlled trial | osteonecrosis of the femoral head, femoral neck fracture, developmental dysplasia of hip, osteoarthritis, rheumatoid arthritis or ankylosing spondylitis | Experiment 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 Hospital | Not Recruiting | Both | Experiment group:50;Control Group:50; | Post-market | China | |||
497 | NCT02260791 | December 2014 | 16 December 2017 | A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients | A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate | Arthritis, Rheumatoid | Drug: FKB327;Drug: Humira® | Fujifilm Kyowa Kirin Biologics Co., Ltd. | Not recruiting | 18 Years | N/A | All | 728 | Phase 3 | United States;Bulgaria;Canada;Chile;Czechia;Germany;Peru;Poland;Romania;Russian Federation;Spain;Ukraine;Czech Republic;Serbia | |
498 | NCT02328027 | December 2014 | 11 June 2018 | 99mTc-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 Spondylitis | Rheumatoid Arthritis;Ankylosing Spondylitis | Drug: 99mTc-rhAnnexin V-128 | Advanced Accelerator Applications | Not recruiting | 18 Years | N/A | All | 16 | Phase 1/Phase 2 | Switzerland | |
499 | NCT02876874 | December 2014 | 29 August 2016 | Relationship Between the Activity of Rheumatoid Arthritis and Lymph Node Morphology and Lymphatics Drainage | the Relationship Between the Activity of Rheumatoid Arthritis(RA) and Popliteal/Epitrochlear Lymph Node Morphology and the Drainage of Hand/Foot Superficial Lymphatic Vessels | Rheumatoid Arthritis;Lymph Node Mass;Lymphatic Vessel; Dilatation | Drug: indocyanine green(ICG) | Shanghai University of Traditional Chinese Medicine | Recruiting | 18 Years | 65 Years | Both | 21 | N/A | China | |
500 | EUCTR2014-001114-26-GB | 25/11/2014 | 28 February 2019 | A 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 dose | A 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. KG | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
501 | EUCTR2014-002374-36-SE | 19/11/2014 | 1 December 2014 | A study with dose de-escalation of coventional or biologic treatments in early rheeumatoid arthritis in patients with low disease activity. | A multicenter, randomized, open-label, blinded-assessor, follow-up, phase 4 study in patients with rheumatoid arthritis who have completed the initial treatment part (active conventional therapy versus three biologic treatments) in the NORD-STAR study and have reached stable low disease activity - CO-STAR | Rheumatoid arthritis (RA) MedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia 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, ClinTRID | Authorised | Female: yes Male: yes | 500 | Phase 4 | Sweden | |||
502 | NCT02281552 | November 18, 2014 | 16 December 2017 | A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis | A 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 Methotrexate | Rheumatoid Arthritis | Drug: Tofacitinib | Pfizer | Not recruiting | 20 Years | N/A | All | 209 | Phase 3 | Japan | |
503 | JPRN-UMIN000015616 | 2014/11/04 | 2 April 2019 | Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction | rheumatoid arthritis | Adalimumab plus Methotrexate Tocilizumab plus Methotrexate | Biologic Mate Study Group | Not Recruiting | 20years-old | 75years-old | Male and Female | 300 | Not selected | Japan | ||
504 | NCT02030028 | November 2014 | 18 March 2019 | ACTH Gel Therapy in Rheumatoid Arthritis | Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ACTHAR gel | Dr. Larry W. Moreland | Mallinckrodt | Recruiting | 18 Years | 100 Years | All | 20 | N/A | United States |
505 | NCT02287610 | November 2014 | 16 December 2017 | A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis | A 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 Setting | Rheumatoid Arthritis | Drug: RAYOS (delayed-release prednisone) | Horizon Pharma Ireland, Ltd., Dublin Ireland | Not recruiting | 18 Years | N/A | All | 75 | N/A | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
506 | NCT02293902 | November 2014 | 9 January 2017 | A 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 Therapy | Rheumatoid Arthritis | Drug: sarilumab SAR153191 (REGN88);Other: placebo;Drug: methotrexate;Drug: folic acid | Sanofi | Regeneron Pharmaceuticals | Not recruiting | 20 Years | 75 Years | Both | 243 | Phase 3 | Japan |
507 | NCT02296775 | November 2014 | 19 February 2015 | Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: DRL_RI;Biological: Rituxan;Biological: MabThera | Dr. Reddy's Laboratories Limited | Recruiting | 18 Years | 65 Years | Both | 276 | Phase 1/Phase 2 | India;Ukraine | ||
508 | NCT02342977 | November 2014 | 5 September 2016 | Effects 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 Necrosis | Drug: Placebo;Drug: Lacosamide | Indiana University School of Medicine | VA Office of Research and Development | Not recruiting | 18 Years | 70 Years | Both | 0 | Phase 2 | United States |
509 | NCT02551575 | November 2014 | 27 June 2016 | Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid Arthritis | Efficacy and Safety of Qingre Huoxue Comprehensive Therapy in the Treatment of Rheumatoid Arthritis (RA): A Randomized, Double-blind, Double-dummy, Multi-center Trial | Rheumatoid Arthritis | Drug: Treatment of MTX and HCQ;Drug: Treatment of TCM;Drug: Integrative Medicine | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Not recruiting | 18 Years | 65 Years | Both | 468 | Phase 2/Phase 3 | China | |
510 | EUCTR2014-000352-29-CZ | 27/10/2014 | 8 January 2018 | A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02). | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab-Pfizer Product Code: PF-06410293 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 Recruiting | Female: yes Male: yes | 560 | Phase 3 | Serbia;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. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
511 | EUCTR2014-001299-79-DK | 06/10/2014 | 2 October 2017 | Pnemococcal vaccination of rheumatoid arthritis patients in biological treatment | Pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy - Immunovax_RA | Immunoresponse on pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy MedDRA version: 18.0 Level: LLT Classification code 10069594 Term: Pneumococcal immunization System Organ Class: 100000004865 ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Prevenar 13 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 Hospital | Not Recruiting | Female: yes Male: yes | Phase 3 | Denmark | ||||
512 | JPRN-UMIN000015217 | 2014/10/01 | 2 April 2019 | Identification 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 | Identification 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. | Abatacept | Yokohama City University Graduate School of Medicine | Recruiting | 20years-old | Not applicable | Male and Female | 40 | Not applicable | Japan | |
513 | JPRN-UMIN000015462 | 2014/10/01 | 2 April 2019 | Clinical study on drug holiday with regulated rheumatoid arthritis activity after treatment with tofacitinib (Xanadu study) | Rheumatoid arthritis | Continue current treatment Tofacitinib discontinuation MTX discontinuation | School of Medicine, University of Occupational and Environmental Health, Japan | Recruiting | 18years-old | Not applicable | Male and Female | 400 | Not selected | Japan | ||
514 | NCT02102594 | October 2014 | 10 December 2018 | Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB) | Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB) | Myasthenia Gravis;Systemic Lupus Erythematosus;Rheumatoid Arthritis | Drug: Bortezomib | Charite University, Berlin, Germany | Prof. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology);NeuroCure Clinical Research Center, Charite, Berlin | Recruiting | 18 Years | 75 Years | All | 18 | Phase 2 | Germany |
515 | NCT02148640 | October 2014 | 16 December 2017 | The NOR-SWITCH Study | A 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 STUDY | Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis Chronic | Drug: Innovator infliximab;Drug: Biosimilar infliximab | Diakonhjemmet Hospital | South-Eastern Norway Regional Health Authority | Not recruiting | 18 Years | N/A | All | 482 | Phase 4 | Norway |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
516 | NCT02150473 | October 2014 | 16 December 2017 | The Effect of Adalimumab Plus Methotrexate (MTX) Versus Placebo Plus MTX on Cartilage in (RA) Patients | Delayed Gadolinium-enhanced Magnetic Resonance (MR) Imaging of Cartilage - A Pilot Study to Measure the Effect of Adalimumab Plus MTX Versus Placebo Plus MTX on Cartilage in Early RA Patients | Rheumatoid Arthritis | Drug: Adalimumab;Drug: Placebo | Heinrich-Heine University, Duesseldorf | Abbott | Not recruiting | 18 Years | 80 Years | All | 21 | Phase 3 | Germany |
517 | NCT02221258 | October 2014 | 17 October 2016 | Safety 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 Arthritis | Rheumatoid Arthritis | Biological: FURESTEM-RA Inj. | Kang Stem Biotech Co., Ltd. | Not recruiting | 19 Years | 80 Years | Both | 9 | Phase 1 | Korea, Republic of | |
518 | NCT02265705 | October 2014 | 25 March 2019 | A 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 Therapy | Rheumatoid Arthritis | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | Not recruiting | 18 Years | N/A | All | 290 | Phase 3 | Argentina;Brazil;China | |
519 | NCT02270632 | October 2014 | 5 December 2016 | A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX | 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. | Rheumatoid Arthritis | Drug: F8IL10;Drug: MTX;Drug: Placebo | Philogen S.p.A. | Recruiting | 18 Years | 74 Years | Both | 87 | Phase 2 | Germany;Italy;Switzerland | |
520 | NCT02500498 | October 2014 | 3 August 2015 | Safety Profile of Nulojix in Home Infusion Settings | Safety Profile of Nulojix in Home Infusion Settings | Rheumatoid Arthritis | Drug: Nulojix | Bristol-Myers Squibb | BiologicTx, LLC | Not recruiting | 18 Years | N/A | Both | 37 | N/A | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
521 | EUCTR2012-002945-40-DE | 22/09/2014 | 14 November 2016 | BI695501 compared to adalimumab in patients with active rheumatoid arthritis | Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Rheumatoid arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695501 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 GmbH | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | United States;Serbia;Estonia;Thailand;Spain;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of | |||
522 | EUCTR2013-005418-37-IT | 15/09/2014 | 23 March 2015 | A 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. | Authorised | Female: yes Male: yes | 87 | Phase 2 | Germany;Italy | |||
523 | EUCTR2013-002805-76-CZ | 11/09/2014 | 2 October 2017 | A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis. | A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) NEXUS. | Rheumatoid Arthritis (RA) MedDRA version: 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 Recruiting | Female: yes Male: yes | 108 | Phase 2 | Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Japan;United Kingdom | |||
524 | JPRN-UMIN000014624 | 2014/09/01 | 2 April 2019 | Effects of postoperative administration of celecoxib on postoperative pain management in patients after total knee arthroplasty. A randomized controlled study. | Osteoarthritis, Rheumatoid arthritis | Administration 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 Tsukuba | Not Recruiting | 20years-old | Not applicable | Male and Female | 120 | Phase 4 | Japan | ||
525 | NCT01717859 | September 2014 | 20 May 2019 | Musculoskeletal Ultrasound in Predicting Early Dose Titration With Tocilizumab | Musculoskeletal Ultrasound in Predicting Early Dose Titration With Tocilizumab | Rheumatoid Arthritis | Drug: Tocilizumab | University of California, Los Angeles | Genentech, Inc. | Not recruiting | 18 Years | N/A | All | 74 | Phase 4 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
526 | NCT02154425 | September 2014 | 11 June 2018 | A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers | A 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 Arthritis | Procedure: Breast milk sampling;Biological: Certolizumab Pegol | UCB BIOSCIENCES, Inc. | PPD;Parexel | Not recruiting | 18 Years | N/A | Female | 17 | Phase 1 | United States;Netherlands;Switzerland;France |
527 | NCT02246257 | September 2014 | 10 December 2018 | Early Rheumatoid Arthritis COR Intervention | Multifactorial Intervention to Prevent Cardiovascular Disease in Patients With Early Rheumatoid Arthritis | Rheumatoid Arthritis;Cardiovascular Diseases | Other: Simvastatin;Other: Losartan;Other: Metformin;Other: Outpatient rheumatology department;Other: Refered to general practice | MD, PhD, Annemarie Lyng Svensson | Recruiting | 18 Years | N/A | All | 300 | N/A | Denmark | |
528 | EUCTR2013-005543-90-HU | 26/08/2014 | 4 December 2018 | This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body, and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 798 Product Code: ABP 798 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 Inc | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | United States;Estonia;Hungary;Canada;Poland;Bulgaria;Germany | |||
529 | NCT02222493 | August 26, 2014 | 11 June 2018 | A 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 Methotrexate | Rheumatoid Arthritis | Biological: PF-06438179;Biological: Infliximab | Pfizer | Not recruiting | 18 Years | N/A | All | 650 | Phase 3 | United 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 | |
530 | NCT02202837 | August 12, 2014 | 16 December 2017 | Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice | Defining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Rheumatoid Arthritis Patients Treated With Etanercept (Enbrel (Registered)) | Rheumatoid Arthritis | Drug: etanercept | Pfizer | Not recruiting | 18 Years | N/A | All | 135 | N/A | Belgium | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
531 | NCT02308163 | August 8, 2014 | 15 July 2019 | A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDs | Phase 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 DMARDs | Rheumatoid Arthritis | Drug: peficitinib;Drug: Placebo;Biological: Etanercept | Astellas Pharma Inc | Not recruiting | 20 Years | N/A | All | 509 | Phase 3 | Japan;Korea, Republic of;Taiwan | |
532 | ChiCTR-RNC-14004887 | 2014-08-01 | 18 April 2017 | The pharmacogenomics study on Methotrexate in treating rheumatoid arthritis | The pharmacogenomics study on Methotrexate in treating rheumatoid arthritis | rheumatoid arthritis | Case series:Methotrexate; | The people's hospital, Yichun City | Recruiting | 18 | 65 | Case series:400; | Post-market | China | ||
533 | JPRN-UMIN000014737 | 2014/08/01 | 2 April 2019 | The 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 arthritis | Denosumab 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 Center | Not Recruiting | 50years-old | 90years-old | Male and Female | 286 | Not selected | Japan | ||
534 | NCT02176876 | August 2014 | 3 August 2015 | Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid Arthritis | A Phase 1b, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: GS-5745;Drug: Placebo to match GS-5745 | Gilead Sciences | Not recruiting | 18 Years | 70 Years | Both | 18 | Phase 1 | Czech Republic;Hungary | |
535 | NCT02187055 | August 2014 | 16 December 2017 | An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate | A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis | Rhematoid Arthritis | Drug: Tofacitinib with methotrexate;Drug: Tofacitinib without methotrexate;Biological: Adalimumab with methotrexate | Pfizer | Not recruiting | 18 Years | N/A | All | 1132 | Phase 4 | United States;Argentina;Australia;Bosnia and Herzegovina;Bulgaria;Canada;Chile;Czech Republic;Estonia;France;Israel;Korea, Republic of;Latvia;Lithuania;Mexico;Peru;Philippines;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Thailand;Turkey;United Kingdom;Croatia | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
536 |