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 | NCT02211469 | August 2014 | 28 September 2015 | A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male Subjects | A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male Subjects | Rheumatoid Arthritis | Drug: BMS-986104;Drug: Placebo | Bristol-Myers Squibb | Not recruiting | 18 Years | 49 Years | Male | 41 | Phase 1 | United States | |
537 | NCT02219191 | August 2014 | 16 December 2017 | Puerarin Versus Atorvastatin in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases | The Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases | Rheumatoid Arthritis | Drug: puerarin tablet 50 mg;Drug: Atorvastatin tablet 20 mg | Chengdu PLA General Hospital | Not recruiting | 18 Years | 75 Years | All | 150 | N/A | China | |
538 | NCT02219347 | August 2014 | 16 December 2017 | Biomarkers of Remission in Rheumatoid Arthritis (BioRRA) | Biomarkers of Remission in Rheumatoid Arthritis (BioRRA) | Rheumatoid Arthritis | Drug: DMARD cessation | Newcastle-upon-Tyne Hospitals NHS Trust | Newcastle University;Wellcome Trust | Not recruiting | 18 Years | N/A | All | 74 | N/A | United Kingdom |
539 | NCT02234960 | August 2014 | 14 November 2016 | Local, Non-Interventional Study of RoActemra (Tocilizumab) in Poland (ACT-POL): First-Line Treatment in Routine Clinical Practice of Participants With Rheumatoid Arthritis (RA) | TOCILIZUMAB IN FIRST LINE BIOLOGIC TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS IN ROUTINE CLINICAL PRACTICE IN POLAND - MULTICENTER, NON-INTERVENTIONAL, PROSPECTIVE, OBSERVATIONAL STUDY (ACT-POL) | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 102 | N/A | Poland | |
540 | NCT02264301 | August 2014 | 16 December 2017 | Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid Arthritis | The Effect of Qingkailing Injection on Corticosteroids Withdrawal Rate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Puerarin injection 400 mg;Drug: Qingkailing injection 40 ml | Chengdu PLA General Hospital | Recruiting | 18 Years | 75 Years | All | 150 | N/A | 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 |
541 | NCT02311855 | August 2014 | 16 December 2017 | Duration of Immune Response to Influenza Vaccination in Patients With RA | Duration of Immune Response to Influenza Vaccination in Patients With Rheumatoid Arthritis Receiving Treatment With Biologic Agents | Rheumatoid Arthritis | Biological: Influenza vaccine | Bassett Healthcare | New York State Department of Health | Not recruiting | 40 Years | 75 Years | All | 87 | Phase 4 | United States |
542 | NCT02305849 | July 25, 2014 | 15 July 2019 | A Study to Evaluate Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate (MTX) Treatment | Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to MTX | Rheumatoid Arthritis | Drug: Peficitinib;Drug: Placebo;Drug: Methotrexate | Astellas Pharma Inc | Not recruiting | 20 Years | N/A | All | 519 | Phase 3 | Japan | |
543 | EUCTR2013-005362-19-DE | 17/07/2014 | 17 July 2017 | Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB) | Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB) - TAVAB | Myasthenia Gravis Systemic Lupus Erythematosus Rheumatoid Arthritis ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Velcade® Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: BORTEZOMIB CAS Number: 179324-69-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3,5- | Charité - Universitätsmedizin Berlin | Authorised | Female: yes Male: yes | Phase 2 | Germany | ||||
544 | EUCTR2013-004148-49-LT | 14/07/2014 | 3 July 2017 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS | 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 MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Current Sponsor code: PF-06438179 Other descriptive name: Infliximab-Pfizer Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Other descriptive name: Infliximab-EU Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Pfizer Inc. | Not Recruiting | Female: yes Male: yes | 614 | Phase 3 | Poland;Brazil;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina | |||
545 | JPRN-UMIN000016928 | 2014/07/03 | 2 April 2019 | Targeted Ultrasound in Rheumatoid Arthritis | Rheumatoid arthritis | If DAS28 increased by >0.6 from baseline, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week. If DAS28 increased by >0.6 from baseline or total PD score is 4 or greater, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week. | Leeds University | Recruiting | 18years-old | Not applicable | Male and Female | 400 | Not selected | Japan,Europe | ||
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 |
546 | JPRN-UMIN000015175 | 2014/07/01 | 2 April 2019 | Head-to-head comparison of Subcutaneous Tocilizumab versus Abatacept for Rheumatoid arthritis : prospective, randomized trial. | Rheumatoid Arthritis | Subcutaneous Tocilizumab 162mg every other week. Subcutaneous Abatacept 125mg every week. | St.Marianna University School of Medicine | Recruiting | 20years-old | Not applicable | Male and Female | 120 | Not selected | Japan | ||
547 | NCT02011334 | July 2014 | 14 November 2016 | A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs. | A MULTICENTER, OPEN LABEL STUDY TO EVALUATE EFFICACY AND SAFETY OF TOCILIZUMAB GIVEN SUBCUTANEOUSLY IN MONOTHERAPY AND IN COMBINATION WITH NON-BIOLOGIC DMARDS IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS IN LATIN AMERICA | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 285 | Phase 3 | Argentina;Brazil;Colombia;Dominican Republic;Mexico;Venezuela;Ecuador;Uruguay | |
548 | NCT02053727 | July 2014 | 25 June 2018 | Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background | Pilot Study to Evaluate Subcutaneous Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background- a Pilot, Double-blind, Placebo-controlled, Randomized, Controlled Trial. | Rheumatoid Arthritis;Chronic Hepatitis B | Drug: Abatacept;Drug: Placebo | Suzanne Kafaja | Recruiting | 18 Years | N/A | All | 20 | N/A | United States | |
549 | NCT02141997 | July 2014 | 19 October 2017 | A Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Biological: adalimumab;Biological: ABT-122 | AbbVie | Not recruiting | 18 Years | 99 Years | All | 222 | Phase 2 | Australia;Bulgaria;Canada;Czech Republic;Germany;Hungary;New Zealand;Poland;Romania;Turkey;United States | |
550 | JPRN-UMIN000014311 | 2014/06/24 | 2 April 2019 | Examination of the clinical remission and functional remission in Infliximab using the increase-in-quantity protocol to TNF-alpha inhibitory drug resistance rheumatoid arthritis | rheumatoid arthritis | The quantity of Infliximab is increased. | Institute of Health Biosciences, The University of Tokushima Graduate School | Not Recruiting | 20years-old | 75years-old | Male and Female | 10 | 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 |
551 | ChiCTR-TRC-14004824 | 2014-06-23 | 18 April 2017 | Clinical studies on Ginsenoside C-K | Study on tolerability and pharmacokinetics of Ginsenoside C-K tablet in healthy volunteers after a single dose | rheumatoid arthritis | 7 groups:Seven different doses with ginsenoside compound K; | Institute of Clinical Pharmacology, Central South University | Not Recruiting | 18 | 45 | Both | 7 groups:77; | Phase 1 study | China | |
552 | ChiCTR-BOC-16008925 | 2014-06-10 | 18 April 2017 | Circulating Tfh subpopulation in very early rheumatoid arthritis | Circulating Bcl-6+ICOS+ Tfh subpopulation correlates with disease activity in very early rheumatoid arthritis | Rheumatoid Arthritis | RA patients:methotrexate;Healthy control (HC) individuals:Nil; | The First Hospital, Jilin University, Changchun | Not Recruiting | Both | RA patients:22;Healthy control (HC) individuals:15; | Other | China | |||
553 | JPRN-JapicCTI-142621 | 09/6/2014 | 2 April 2019 | CHS-0214 Phase III trial | A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate | Rheumatoid Arthritis | Intervention name : CHS-0214 Dosage And administration of the intervention : subcutaneous injection Control intervention name : Enbrel INN of the control intervention : Etanercept Dosage And administration of the control intervention : subcutaneous injection | DAIICHISANKYO Co.,Ltd. | Coherus Biosciences, Inc. | 20 | BOTH | 620 | Phase 3 | |||
554 | NCT02196558 | June 9, 2014 | 16 December 2017 | A Phase 1/2 Study of E6011 in Japanese Subjects With Rheumatoid Arthritis | A Phase 1/2 Study of Repeated Subcutaneous E6011 Administration in Japanese Subjects With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: E6011 | Eisai Co., Ltd. | Not recruiting | 20 Years | 64 Years | All | 37 | Phase 1/Phase 2 | Japan | |
555 | EUCTR2013-002790-22-HU | 02/06/2014 | 10 July 2015 | To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA) | An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE | Rheumatoid Arthritis MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Sarilumab Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 131.6- Product Name: Sarilumab Product Code: SAR153191 (REGN88) Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Sarilumab Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 175- | sanofi-aventis recherche & développement | Not Recruiting | Female: yes Male: yes | 120 | United States;Estonia;Czech Republic;Hungary;Argentina;Poland;Russian Federation;Chile | ||||
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 |
556 | ChiCTR1900026116 | 2014-06-01 | 30 September 2019 | The efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trial | The efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trial | rheumatoid arthritis | Experimental group:Prednisone+methotrexate+Hydrochloroquine;control group:placebo+methotrexate+Hydrochloroquine; | Central Hospital of Jinhua | Not Recruiting | 21 | 73 | Both | Experimental group:40;control group:40; | Phase 4 | China | |
557 | JPRN-UMIN000013546 | 2014/06/01 | 2 April 2019 | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus | rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis | take a glass of grapefruit juice every day do not take grapefruit juice | Department of Rheumatology and Clinical Immunology, Kyoto University Hospital | Not Recruiting | 16years-old | 80years-old | Male and Female | 20 | Not applicable | Japan | ||
558 | NCT01984268 | June 2014 | 5 September 2016 | ACTHAR for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate | Adenocorticotrophic Hormone for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: ACTHAR | Dartmouth-Hitchcock Medical Center | Mallinckrodt | Recruiting | 18 Years | 70 Years | Both | 60 | Phase 2 | United States |
559 | NCT02147587 | June 2014 | 11 June 2018 | A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate | A Randomized, Double-blind, Placebo-controlled, Phase 2 Study To Assess The Immune Response Following Administration Of Zoster Vaccine To Subjects With Rheumatoid Arthritis Receiving Tofacitinib (Cp-690,550) Or Placebo With Background Methotrexate Treatment | Rheumatoid Arthritis | Drug: Tofacitinib;Drug: Placebo | Pfizer | Not recruiting | 50 Years | N/A | All | 112 | Phase 2 | United States;United Kingdom | |
560 | NCT02151851 | June 2014 | 20 June 2016 | A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid Arthritis | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel Group, Randomized 24-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol (CZP) as Additional Medication to Methotrexate in Chinese Subjects With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate | Rheumatoid Arthritis | Biological: Certolizumab Pegol;Drug: Methotrexate;Other: Placebo | UCB Pharma SA, Belgium | Parexel | Not recruiting | 18 Years | N/A | Both | 431 | 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 |
561 | NCT02202395 | June 2014 | 16 December 2017 | Hydroxytriptolide in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate | A Radomized, Double-blind, and Placebo-controlled Multicenter Clinical Trial of Hydroxytriptolide, in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: LTS 0.25mg;Drug: LTS 0.5mg;Drug: LTS 1.0mg;Drug: Placebo | Shanghai Pharmaceuticals Holding Co., Ltd | Not recruiting | 35 Years | 65 Years | Female | 120 | Phase 1/Phase 2 | China | |
562 | NCT02277574 | June 2014 | 28 November 2016 | Assess Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis | A Randomized, Multi-Dose, Placebo-Controlled, Study of the Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: AMP-110;Other: Placebo | MedImmune LLC | Daiichi Sankyo Co., Ltd. | Not recruiting | 18 Years | 75 Years | Both | 29 | Phase 1 | United States |
563 | EUCTR2013-003984-72-LV | 30/05/2014 | 28 February 2019 | A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone. | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone. | Rheumatoid Arthritis (RA) MedDRA version: 17.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT 494 3mg Pharmaceutical Form: Capsule INN or Proposed INN: ABT 494 Current Sponsor code: ABT 494 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Name: ABT 494 12mg Pharmaceutical Form: Capsule INN or Proposed INN: ABT 494 Current Sponsor code: ABT-494 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | AbbVie Deutschland GmbH & Co. KG | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia | |||
564 | EUCTR2013-003413-18-GB | 13/05/2014 | 3 July 2017 | 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 | King’s College London | Guy's and St. Thomas' NHS Foundation Trust | Authorised | Female: yes Male: yes | 206 | Phase 2 | Netherlands;United Kingdom | ||
565 | NCT03604406 | May 8, 2014 | 9 September 2019 | The Immunogenicity and Safety of Zostavax® in Rheumatoid Arthritis Patients Using Abatacept | The Immunogenicity and Safety of Zostavax® in Rheumatoid Arthritis Patients Using Abatacept | Herpes Zoster;Inflammatory Disease;Rheumatoid Arthritis | Biological: Varicella Zoster Vaccine;Other: Placebo Injection | Kevin Winthrop | University of Alabama at Birmingham;Bristol-Myers Squibb | Recruiting | 50 Years | N/A | All | 50 | 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 |
566 | ChiCTR-TRC-14004520 | 2014-05-01 | 18 April 2017 | To study the signal pathways of Rheumatoid Arthritis Syndrome of Accumulated Dampness and intervention mechanism of Sanhuang Yilong Decoction based the theory that lung, spleen and kidney regulate water | To study the signal pathways of Rheumatoid Arthritis Syndrome of Accumulated Dampness and intervention mechanism of Sanhuang Yilong Decoction based the theory that lung, spleen and kidney regulate water metabolism | rheumatoid arthritis | two:Methotrexate, hydroxychloroquine sulfate pills and NSAIDs in both groups; Sanhuang Yinong decoction will be give in the experimental group;RA patients:NA; | General Hospital of Chengdu Military Region | Recruiting | 45 | 65 | Both | two:240;RA patients:40; | Phase 1 study | China | |
567 | NCT01967316 | May 2014 | 18 April 2016 | Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-TNF Users | A Pilot Study of the Safety and Effectiveness of the Live Zoster Vaccine in Anti-TNF Users | Rheumatoid Arthritis | Biological: Herpes Zoster Vaccine;Drug: Placebo | University of Alabama at Birmingham | Oregon Health and Science University | Recruiting | 50 Years | N/A | Both | 125 | Phase 2 | United States |
568 | NCT02105129 | May 2014 | 9 May 2016 | A Study of the Safety, Tolerability and Pharmacokinetics of HMPL-523 | A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL-523 | Rheumatoid Arthritis (RA) | Drug: HMPL-523;Drug: Placebo | Hutchison Medipharma Limited | Not recruiting | 18 Years | 45 Years | Male | 118 | Phase 1 | Australia | |
569 | NCT02115750 | May 2014 | 17 October 2016 | Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA) | A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate | Rheumatoid Arthritis | Drug: Etanercept;Drug: CHS-0214 | Coherus Biosciences, Inc. | Daiichi Sankyo Co., Ltd.;Daiichi Sankyo Co., Ltd. | Not recruiting | 18 Years | N/A | Both | 647 | Phase 3 | United States;Belarus;France;Germany;Hungary;Israel;Japan;Poland;Russian Federation;South Africa;Spain;United Kingdom |
570 | NCT02123264 | May 2014 | 4 March 2019 | Zoledronic Acid in Rheumatoid Arthritis | Randomized Clinical Trial on the Prevention of Radiographic Progression With Zoledronic Acid in Patients With Early Rheumatoid Arthritis and Low Disease Activity | Arthritis, Rheumatoid | Drug: Zoledronic acid | Carmen Gómez-Vaquero | Not recruiting | 18 Years | N/A | All | 28 | Phase 3 | 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 |
571 | NCT02151474 | May 2014 | 19 February 2015 | INCB047986 in Rheumatoid Arthritis | A Double-Blind, Placebo-Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28-Day Course of INCB047986 in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: INCB047986;Drug: Placebo | Incyte Corporation | Recruiting | 18 Years | N/A | Both | 60 | Phase 2 | United States | |
572 | NCT02157012 | May 2014 | 10 December 2018 | Evaluation of the Condition of Rheumatoid Arthritis After Treatment | Evaluation of the Condition After Xeljanz Treatment in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: The effectiveness of Xeljanz in rheumatoid arthritis patients | Shinshu University | Showa Inan General Hospital | Recruiting | 20 Years | 90 Years | All | 100 | Phase 4 | Japan |
573 | NCT02167139 | May 2014 | 16 December 2017 | A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Humira (adalimumab);Drug: SB5 (proposed biosimilar to adalimumab) | Samsung Bioepis Co., Ltd. | Not recruiting | 18 Years | 75 Years | All | 544 | Phase 3 | Lithuania;Poland | |
574 | NCT02927509 | May 2014 | 17 October 2016 | Evaluation of Tumour Necrosis Factor Alpha (TNFa) Blockers in Early Rheumatoid Arthritis in France | Rheumatoid Arthritis | Drug: TNF alpha blockers | Centre Hospitalier Universitaire de Nimes | Pfizer;Pfizer | Not recruiting | 18 Years | 70 Years | Both | 813 | N/A | ||
575 | EUCTR2013-003177-99-SE | 11/04/2014 | 17 October 2016 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Tofacitinib CAS Number: 540737-29-9 Current Sponsor code: CP-690,550-10 Other descriptive name: TOFACITINIB CITRATE CP-690550 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Tofacitinib CAS Number: 540737-29-9 Current Sponsor code: CP-690,550-10 Other descriptive name: TOFACITINIB CITRATE CP-690550 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Trade Name: Enbrel Product Name: Etanercept Pharmaceutical Form: Solution for injection INN or Proposed INN: ETANERCEPT CAS Number: 185243-69-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Pfizer Inc. 235 East 42nd Street, New York, 10017 | Authorised | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | Portugal;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden | |||
No. | 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 |
576 | EUCTR2013-003493-27-HU | 08/04/2014 | 14 April 2014 | Study with the aim to evaluate the safety, tolerability and efficacy of QAL964 in patients with Rheumatoid Arthritis who are treated with anti-rheumatic drug methotrexate but where the treatment does not sufficiently work. | A randomized, double-blind, placebo-controlled study to investigate the safety, tolerability and efficacy of orally administered QAL964 in patients with active rheumatoid arthritis on stable doses of methotrexate and with inadequate response to methotrexate - CQAL964B2201 | Rheumatoid Arthritis MedDRA version: 16.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: QAL964 Pharmaceutical Form: Capsule Current Sponsor code: QAL964 Other descriptive name: QAL964 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 10-25 Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Novartis Pharma Services AG | Authorised | Female: yes Male: yes | 42 | Hungary;Ukraine;Russian Federation | ||||
577 | EUCTR2013-005013-13-LT | 08/04/2014 | 16 November 2015 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: SB5 Other descriptive name: SB5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Trade Name: Humira® Product Name: Humira® Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: not applicable Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | Samsung Bioepis Co., Ltd. | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | ||||
578 | EUCTR2013-004555-21-AT | 07/04/2014 | 29 May 2017 | This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 19.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT- P10 Product Code: CT- P10 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Trade Name: Rituxan Product Name: Rituxan Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- | CELLTRION, Inc. | Not Recruiting | Female: yes Male: yes | 361 | Phase 3 | Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of | |||
579 | NCT02019472 | April 4, 2014 | 16 December 2017 | A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Parallel Group Study of Sirukumab Monotherapy Compared With HUMIRA® Monotherapy Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: adalimumab 40 mg;Biological: sirukumab 100 mg;Biological: sirukumab 50 mg;Drug: Placebo | Janssen Research & Development, LLC | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 559 | Phase 3 | United States;Bulgaria;Chile;Colombia;Germany;Hungary;Lithuania;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Ukraine;Argentina;Peru |
580 | JPRN-UMIN000013440 | 2014/04/01 | 2 April 2019 | To evaluate the efficacy and safety of subcutaneous and intravenous abatacept. | Rheumatoid arthritis | SC abatacept IV abatacept Extension of SC abatacept | Osaka Medical College | Not Recruiting | 20years-old | 80years-old | Male and Female | 50 | 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 |
581 | NCT02109289 | April 2014 | 16 December 2017 | Etanercept in Rheumatoid Arthritis and Vascular Inflammation | Pilot Open-label Study of the Effect of Etanercept on Vascular Inflammation in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis;Vascular Inflammation | Drug: etanercept | Innovaderm Research Inc. | Not recruiting | 18 Years | 80 Years | All | 5 | Phase 4 | Canada | |
582 | NCT02101073 | March 31, 2014 | 14 January 2019 | ALX-0061 Phase I Bioavailability Study in Healthy Volunteers | A Phase I, Open-Label Study Evaluating the Bioavailability of ALX-0061 After Subcutaneous and Intravenous Administration in Healthy Volunteers. | Rheumatoid Arthritis | Biological: ALX-0061 | Ablynx | Not recruiting | 18 Years | 55 Years | All | 70 | Phase 1 | Netherlands | |
583 | EUCTR2010-020992-21-DE | 25/03/2014 | 28 September 2015 | Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis | A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, Phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis. | Rheumatoid Arthritis MedDRA version: 17.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Masitinib Product Code: AB1010 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: masitinib mesylate CAS Number: 790-299-79-5 Current Sponsor code: AB1010 Other descriptive name: not applicable Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Methotrexate Product Name: Methotrexate Product Code: not applicable Pharmaceutical Form: Capsule, hard INN or Proposed INN: METHOTREXATE CAS Number: 59-05-2 Current Sponsor code: not applicable Other descriptive name: not applicable Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2,5 mg- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: Masitinib Product Code: AB1010 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: masitinib mesylate CAS Number: 790-299-79-5 Current Sponsor code: AB1010 Other descriptive name: not applicable Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | AB Science | Not Recruiting | Female: yes Male: yes | 140 | Phase 2b/3 | Serbia;United States;Philippines;Taiwan;Morocco;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Monaco;India;Czech Republic;Mexico;Argentina;Poland;Romania;South Africa;Germany;Tunisia;Bosnia and Herzegovina | |||
584 | EUCTR2013-005001-31-ES | 25/03/2014 | 19 September 2016 | Study on the ability of zoledronic acid to prevent worsening of radiographs of hands and feet of patients with rheumatoid arthritis diagnosed less than 2 years ago and who have few symptoms in their joints by making treatment with the drugs commonly used for the management of disease. | Randomized clinical trial on the prevention of radiographic progression with zoledronic acid in patients with early rheumatoid arthritis and low disease activity - Prevention of radiographic progression in rheumatoid arthritis with zoledronic acid | Rheumatoid arthritis MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Zoledronic acid Product Name: Zoledronic acid Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ZOLEDRONIC ACID CAS Number: 118072-93-8 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.8- | Dra. Carmen Gómez Vaquero (Servicio de Reumatología del Hospital Universiari de Bellvitge - Idibell) | Not Recruiting | Female: yes Male: yes | Phase 3 | Spain | ||||
585 | EUCTR2013-003780-65-IT | 24/03/2014 | 18 January 2016 | Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis | A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects with Moderate to Severe Active Rheumatoid Arthritis who have Experienced an Inadequate Response to TNF inhibitors | Rheumatoid Arthritis MedDRA version: 14.1 Level: LLT Classification code 10066578 Term: Progression of rheumatoid arthritis System Organ Class: 100000004859 MedDRA version: 14.1 Level: LLT Classification code 10060732 Term: Rheumatoid arthritis flare up System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CLAZAKIZUMAB Product Code: BMS-945429 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: CLAZAKIZUMAB CAS Number: 1236278-28-6 Current Sponsor code: BMS945429 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Bristol-Myers Squibb International Corporation | Not Recruiting | Female: yes Male: yes | 240 | Phase 2B | France;United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Australia;South Africa;Japan;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 |
586 | JPRN-UMIN000013362 | 2014/03/15 | 2 April 2019 | Examination of the remission maintenance effect by low dose etanercept after clinical remission in the rheumatoid arthritis. | Rheumatoid Arthritis | Methotrexate Etanercept | Takarazuka city hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 60 | Not selected | Japan | ||
587 | NCT02092467 | March 14, 2014 | 14 October 2019 | Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Arthritis, Rheumatoid | Drug: tofacitinib;Biological: adalimumab;Biological: etanercept | Pfizer | Not recruiting | 50 Years | N/A | All | 4414 | Phase 4 | United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;China;Colombia;Czechia;Finland;Hong Kong;Israel;Jordan;Lebanon;Malaysia;Mexico;Netherlands;New Zealand;Peru;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Czech Republic;Sweden | |
588 | EUCTR2013-004555-21-LV | 03/03/2014 | 22 May 2017 | This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 16.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT- P10 Product Code: CT- P10 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Trade Name: Rituxan Product Name: Rituxan Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- | CELLTRION, Inc. | Not Recruiting | Female: yes Male: yes | 361 | Phase 3 | Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Germany;Latvia;Korea, Republic of;Bosnia and Herzegovina | |||
589 | NCT02029599 | March 2014 | 19 October 2015 | The Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis | A Phase 2 Randomised, Double-blind, Placebo-controlled Multiple Ascending Dose Study Evaluate the Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Fang yi qing feng shi granule;Drug: placebo;Drug: Methotrexate;Drug: Acetaminophen tablets | Maoxiang Group Jilin Pharmaceutical Co., Ltd. | Not recruiting | 18 Years | 65 Years | Both | 240 | Phase 2 | China | |
590 | NCT02057250 | March 2014 | 16 December 2017 | To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis | A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy | RA | Drug: Sarilumab;Device: Auto-Injector Device (AID);Device: Pre-filled Syringe (PFS);Drug: Methotrexate;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Hydroxychloroquine | Sanofi | Regeneron Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 217 | Phase 3 | United States;Chile;Mexico;Poland;Russian Federation;South Africa;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 |
591 | NCT02066389 | March 2014 | 27 June 2016 | A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate (MTX) in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 With Background Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone | Rheumatoid Arthritis | Drug: ABT-494;Drug: Placebo | AbbVie | Not recruiting | 18 Years | 100 Years | Both | 300 | Phase 2 | United States;Bulgaria;Chile;Czech Republic;Hungary;Israel;Latvia;Mexico;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Turkey;Ukraine;Romania;Serbia | |
592 | NCT02097524 | March 2014 | 25 May 2015 | Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Sarilumab;Drug: Tocilizumab | Regeneron Pharmaceuticals | Sanofi | Not recruiting | 18 Years | N/A | Both | 105 | Phase 1 | United States | |
593 | EUCTR2013-004051-20-ES | 26/02/2014 | 6 November 2018 | NOT CONTROLLED STUDY TO ASSESS THE EFFICACY OF TOCILIZUMAB IN PATIENTS WITH MODERATE OR SEVERE RHEUMATOID ARTHRITIS WHO ARE CANDIDATES TO BE TREATED WITH A BIOLOGICAL THERAPY AS MONOTHERAPY | NOT CONTROLLED STUDY TO ASSESS THE EFFICACY OF TOCILIZUMAB IN PATIENTS WITH MODERATE OR SEVERE RHEUMATOID ARTHRITIS WHO ARE CANDIDATES TO BE TREATED WITH A BIOLOGICAL THERAPY AS MONOTHERAPY | RHEUMATOID ARTHRITIS;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra 20 mg/ml concentrado para solución para perfusión Pharmaceutical Form: Solution for infusion INN or Proposed INN: TOCILIZUMAB CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: ROACTEMRA Concentration unit: mg/kg milligram(s)/kilogram Concentration type: up to Concentration number: 800- | FUNDACIÓN ESPAÑOLA DE REUMATOLOGIA | Not Recruiting | Female: yes Male: yes | 122 | Phase 4 | Spain | |||
594 | NCT02065700 | February 25, 2014 | 22 July 2019 | Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Patients | A Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Filgotinib | Gilead Sciences | Galapagos NV | Not recruiting | 18 Years | N/A | All | 739 | Phase 2 | United States;Argentina;Australia;Belgium;Bulgaria;Chile;Colombia;Czechia;France;Germany;Guatemala;Hungary;Israel;Latvia;Mexico;Moldova, Republic of;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine;Czech Republic |
595 | EUCTR2013-004654-13-CZ | 12/02/2014 | 28 November 2016 | The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis | An Open-Label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 18.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: N/A CAS Number: 1446410-95-2 Current Sponsor code: ABP 501 Other descriptive name: ABP 501 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | Amgen Inc. | Not Recruiting | Female: yes Male: yes | 425 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;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 |
596 | EUCTR2013-002007-34-FI | 10/02/2014 | 10 October 2016 | Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs. | Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound. - TOZULTRA | Rheumatoid Arthritis MedDRA version: 18.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 Pharmaceutical Form: Solution for injection INN or Proposed INN: Tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 180- | Roche a/s | Not Recruiting | Female: yes Male: yes | 137 | Phase 3 | Finland;Denmark;Sweden | |||
597 | JPRN-UMIN000016844 | 2014/02/07 | 2 April 2019 | The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors | Rheumatoid arthritis | infliximab: standard strategy infliximab: aggressive strategy golimumab: standard strategy golimumab: aggressive strategy | Takarazuka city hospital | Recruiting | 20years-old | 90years-old | Male and Female | 80 | Not applicable | Japan | ||
598 | JPRN-JapicCTI-142505 | 01/2/2014 | 2 April 2019 | Phase III study of MRA-SC 162 mg/week | A Randomized, Double-blind, Parallel-group, Phase III Study of MRA-SC in Rheumatoid Arthritis Patients with Inadequate Response to Tocilizumab Subcutaneous Injection 162 mg every 2 weeks | Rheumatoid arthritis | Intervention name : MRA-SC INN of the intervention : tocilizumab Dosage And administration of the intervention : 162 mg QW Control intervention name : MRA-SC INN of the control intervention : tocilizumab Dosage And administration of the control intervention : 162 mg Q2W | Chugai Pharmaceutical Co., Ltd. | 20 | BOTH | 50 | Phase 3 | ||||
599 | NCT02001987 | February 2014 | 14 November 2016 | A Study Of RoActemra/Actemra (Tocilizumab) in Tocilizumab-Naive Patients With Rheumatoid Arthritis With Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) or Biologic Therapy | A Multicenter Open-Label Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Tocilizumab in Tocilizumab-Naive Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARD and/or Biologic Therapy | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 139 | Phase 3 | France | |
600 | NCT02078375 | February 2014 | 23 April 2019 | The PRESS RA: Protein and Resistance Exercise Supplementation Study for Rheumatoid Arthritis | The PRESS RA Study: Protein and Resistance Exercise Supplementation Study for Rheumatoid Arthritis | Rheumatoid Arthritis | Dietary Supplement: Protein;Dietary Supplement: Carbohydrate (Placebo);Other: Resistance Exercise Program | Johns Hopkins University | National Institute on Aging (NIA);American College of Rheumatology Research and Education Foundation | Not recruiting | 60 Years | 95 Years | All | 23 | 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 |
601 | NCT02173587 | February 2014 | 19 February 2015 | Study Evaluating the Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis | Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Dietary Supplement: Mussel oil capsules;Dietary Supplement: Corn oil capsules | Zhejiang University | Sir Run Run Shaw Hospital | Not recruiting | 18 Years | 75 Years | Both | 56 | N/A | China |
602 | NCT02434757 | February 2014 | 11 May 2015 | Addition of H.P. Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis | Addition of H. P Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis Inadequately Controlled With Biologic Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis | Drug: H.P. Acthar Gel | Ronald J. Rapoport, MD | Questcor Pharmaceuticals, Inc. | Recruiting | 18 Years | N/A | Both | 10 | N/A | United States |
603 | NCT02169544 | January 31, 2014 | 16 December 2017 | Post-marketing Study Assessing the Long-Term Safety of Abatacept | Post-marketing Study Assessing the Long-Term Safety of Abatacept | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 100000 | N/A | ||
604 | NCT02049138 | January 24, 2014 | 4 March 2019 | An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Rheumatoid Arthritis Subjects | A Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) With Upadacitinib (ABT-494) | Rheumatoid Arthritis | Drug: ABT-494 | AbbVie | Not recruiting | 18 Years | 100 Years | All | 494 | Phase 2 | United States;Belgium;Bulgaria;Chile;Czechia;Hungary;Israel;Latvia;Mexico;New Zealand;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Australia;Czech Republic | |
605 | EUCTR2012-003655-11-BE | 23/01/2014 | 30 April 2018 | Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life | A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: filgotinib Product Code: GLPG0634 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: INN - FILGOTINIB Current Sponsor code: GLPG0634 Other descriptive name: GLPG0634 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Product Name: Filgotinib Product Code: GS-6034 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: FILGOTINIB Current Sponsor code: GS-6034 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Gilead Sciences Inc. | Authorised | Female: yes Male: yes | 739 | Phase 2 | United States;Spain;Guatemala;Ukraine;Austria;Russian Federation;Israel;Chile;Colombia;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of | |||
No. | 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 |
606 | JPRN-UMIN000012364 | 2014/01/10 | 2 April 2019 | Drug registry study to evaluate the effectiveness of tramadol / acetaminophen combination tablets as pain management for patient with rheumatoid arthritis. | rheumatoid arthritis | Tramadol / acetaminophen combination tablets will be administrated by 1 tablets / time/ qid and every 4 hours for pain relief. Step by step dose up administration schedule over 4weeks will be applied at beginning of treatment as bellows; *Day1-Day7(1 tablet/day, after night meal) *Day8-Day14(1 tabletX2 times /day, after morning and night meal) *Day15-Day21(1 tabletX3 times /day, after morning, afternoon and night meal *Day22-Day30(1 tabletX4 times /day, after morning, night meal and before bedtime) Once dose reached to 1 tabletX4 times /day, then treatment will be continue up to 24 weeks. | Osaka City University Medical School, Department of Orthopedic Surgery | Not Recruiting | 25years-old | 75years-old | Male and Female | 31 | Not applicable | Japan | ||
607 | NCT01988506 | January 6, 2014 | 27 August 2018 | Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases | Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach | Rheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic Sclerosis | Drug: Interleukin 2 | Assistance Publique - Hôpitaux de Paris | Iltoo Pharma | Recruiting | 18 Years | N/A | All | 132 | Phase 2 | France |
608 | JPRN-JapicCTI-142497 | 01/1/2014 | 2 April 2019 | Phase 2b, Rheumatoid Arthritis Dose Ranging Study for Clazakizumab in Subjects who have Experienced an Inadequate Response to TNF inhibitors. | A Phase 2b, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects with Moderate to Severe Active Rheumatoid Arthritis who have Experienced an Inadequate Response to TNF inhibitors. | Rheumatoid Arthritis | Intervention name : Clazakizumab Dosage And administration of the intervention : Injection, 1 mg, 5 mg, 25 mg Control intervention name : null | Bristol-Myers K.K. | 18 | BOTH | 140 | Phase 2 | ||||
609 | NCT01988012 | January 2014 | 16 December 2017 | A Study of the Efficacy and Safety of Tocilizumab in Adults With Rheumatoid Arthritis. | An Open-label, Multicenter Study to Evaluate Disease Activity and Safety of Treatment With Actemra (Tocilizumab) Administered as Subcutaneous Injection in Adult RA Patients. | Rheumatoid Arthritis | Biological: tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 100 | Phase 3 | Israel | |
610 | NCT02017639 | January 2014 | 18 April 2016 | Sarilumab Effect on the Pharmacokinetics of Simvastatin | A Multi-center, Open-label, 2-treatment, Single-sequence Clinical Study to Evaluate the Effects of a Single 200 mg Subcutaneous Injection of Sarilumab on the Pharmacokinetics of a Single 40 mg Oral Dose of Simvastatin, With Optional 1-year Extension of Open Label Treatment of Sarilumab, in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: sarilumab SAR153191 (REGN88);Drug: simvastatin | Sanofi | Regeneron Pharmaceuticals | Not recruiting | 18 Years | 75 Years | Both | 19 | Phase 1 | United States;Korea, Republic of;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 |
611 | NCT02019602 | January 2014 | 16 December 2017 | A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta | A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol) | Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid Arthritis | Procedure: Blood sampling from mother;Procedure: Blood sampling from infant;Procedure: Blood sampling from umbilical cord;Biological: Certolizumab Pegol | UCB BIOSCIENCES, Inc. | PPD;Parexel | Not recruiting | 18 Years | N/A | All | 16 | Phase 1 | United States;France;Netherlands;Switzerland |
612 | NCT02031471 | January 2014 | 16 December 2017 | TOSCARA Study: A Study of Subcutaneous Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis Naïve to RoActemra/Actemra Treatment | TOSCARA: An Open-label, Single Arm Study to Evaluate the Efficacy, Safety and Tolerability of Tocilizumab (TCZ) Subcutaneous in TCZ-naïve Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 57 | Phase 3 | Belgium;Luxembourg | |
613 | EUCTR2014-004558-33-Outside-EU/EEA | 6 January 2015 | A Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis | A Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis | Juvenile Rheumatoid Arthritis MedDRA version: 17.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: Adalimumab Product Code: 331731-18-1 Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: Humira Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | Abbott Japan Co., Ltd. | Not Available | Female: yes Male: yes | 25 | Japan | |||||
614 | JPRN-UMIN000012690 | 2013/12/28 | 2 April 2019 | Study of Actemura Remission induction of RA and Sequential Maintenance of Remission by Reasonable cost Treatment | Rheumatoid Arthritis | tocilizumab+tacrolimus+Bucillamine tocilizumab | National hospital organization Chiba east national hospital Clinical Research Center | Not Recruiting | 20years-old | 99years-old | Male and Female | 60 | Not applicable | Japan | ||
615 | EUCTR2013-004006-26-DK | 18/12/2013 | 26 September 2016 | OPAL | Optical images for monitoring treatment changes in rheumatoid arthritis – a longitudinal study with Rheumascan | Detection of synovitis and tenosynovitis in the hands of patients with rheumatoid arthritis; Diagnostic performance of optical imaging in comparison with ultrasound and magnetic resonance imaging. MedDRA version: 16.1 Level: LLT Classification code 10067132 Term: Synovitis wrist System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ICG-Pulsion Pharmaceutical Form: Powder and solvent for solution for injection/infusion INN or Proposed INN: 2-{7-[1,1-dimethyl-3-(4-sulfobutyl)-benz[e]indolin-2-ylidene]-1,3,5-heptatrienyl}-1,1-dimethyl-3-(sulfobutyl)-1H-benz[e]-indolium hydroxide,inner salt CAS Number: 3599-32-4 Other descriptive name: INDOCYANINE GREEN Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- | Knowledge Centre for Rheumatology and Back Diseases | Not Recruiting | Female: yes Male: yes | 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 |
616 | EUCTR2013-002150-79-BE | 16/12/2013 | 22 August 2016 | A study to evaluate the efficacy and safety of tocilizumab subcutaneous in RA patients | TOSCARA: An open-label, single-arm study to evaluate the efficacy, safety and tolerability of tocilizumab (TCZ) subcutaneous in TCZ-naïve patients with active rheumatoid arthritis - TOSCARA | Rheumatoid Arthritis MedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-02 Pharmaceutical Form: Solution for injection INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Other descriptive name: TOCILIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 180- | N.V. Roche S.A. | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Belgium | |||
617 | JPRN-UMIN000018816 | 2013/12/05 | 2 April 2019 | Study on the relationship between arthritis and sleep disturbance | Study on the relationship between arthritis and sleep disturbance - Sleep study in arthritis | Rheumatoid Arthritis | Treatment with melatonin-mimetics, ramelteon. Treatment with biological disease-modifying anti-rheumatic drugs. | Shunichi Shiozawa | Rheumatic Diseases Center, Kohnan Kakogawa Hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 200 | Not applicable | Japan |
618 | JPRN-UMIN000012073 | 2013/12/01 | 2 April 2019 | Effects of Subcutaneous Actemura and MTX Blending in RA | rheumatoid arthritis | Adults with active RA (DAS28 >3.2) despite methotrexate prescription were randomly assigned to continue methotrexate with the addition of tocilizumab (MTX+TCZ) 162mg/body every other week for 52 weeks. Adults with active RA (DAS28 >3.2) despite methotrexate prescription were randomly assigned to switch to tocilizumab (TCZ) 162mg/body every other week for 52 weeks. | Department of Orthopaedic Surgery, Graduate School of Medicine, Osaka City University Medical School | Not Recruiting | 20years-old | 85years-old | Male and Female | 100 | Phase 4 | Japan | ||
619 | NCT01668966 | December 2013 | 14 November 2016 | A Long Term Extension Study of WA19926 (NCT01649804) of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid Arthritis | A Multicenter, Open-Label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 24 | Phase 3 | Brazil | |
620 | NCT02047604 | December 2013 | 16 December 2017 | (C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis | A Randomized, Double-blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients With Active Rheumatoid Arthritis With Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s). | Rheumatoid Arthritis | Drug: SAN-300;Drug: Placebo | Valeant Pharmaceuticals International, Inc. | Not recruiting | 18 Years | 75 Years | All | 41 | 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 |
621 | EUCTR2013-000114-38-DE | 29/11/2013 | 4 August 2015 | A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase: T cell REgulating Arthritis Trial 2b (TREAT 2b) | A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase: T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b) | Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tregalizumab Product Code: BT061 Pharmaceutical Form: Solution for injection INN or Proposed INN: Tregalizumab Current Sponsor code: BT061 Other descriptive name: A Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 12.5- INN or Proposed INN: Tregalizumab Current Sponsor code: BT061 Other descriptive name: B Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- INN or Proposed INN: Tregalizumab Current Sponsor code: BT061 Other descriptive name: C Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- INN or Proposed INN: Tregalizumab Current Sponsor code: BT061 Other descriptive name: D Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- INN or Proposed INN: Tregalizumab Current Sponsor code: BT061 Other descriptive name: E Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Biotest AG | Not Recruiting | Female: yes Male: yes | 304 | Phase 2b | Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden | |||
622 | NCT03736044 | November 25, 2013 | 19 November 2018 | Reconstitution of CD4+CD25highCD127low/-Tcell | Analysis of T Cell Population to Obtain a Free-drug Remission in Patients Affected by Rheumatoid Athritis in Remission Phase Induced by TNF-blocker Therapy | Rheumatoid Arthritis | Drug: TNF-blockers suspension in patients with rheumatoid arthritis | University Hospital of Ferrara | Not recruiting | 18 Years | N/A | All | 48 | N/A | ||
623 | EUCTR2013-002777-22-GB | 14/11/2013 | 16 November 2015 | Targeted Ultrasound in Rheumatoid Arthritis (TURA) | Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA | Rheumatoid Arthritis MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Humira Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine | Authorised | Female: yes Male: yes | 310 | France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom | ||||
624 | EUCTR2013-003658-26-NL | 13/11/2013 | 26 November 2013 | Individualised treatment strategy based on disease activity for early RA patients in usual clinical practice: The COBRA Cohort Study | Treat-to-target strategy for early RA patients in usual clinical practice: The COBRA Cohort Study - COBRA Cohort Study | Early Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Methotrexate Product Name: Methotrexate Pharmaceutical Form: Tablet INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 10-25 Trade Name: Prednison Product Name: Prednison Pharmaceutical Form: Tablet INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 10-60 Trade Name: Plaquenil Product Name: hydroxycholoquine Pharmaceutical Form: Tablet INN or Proposed INN: hydroxychloroquine sulfate CAS Number: 747-36-4 Other descriptive name: HYDROXYCHLOROQUINE SULFATE Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 400- Trade Name: Sulfasalazine Product Name: Sulfasalazine Pharmaceutical Form: Tablet INN or Proposed INN: Sulfasalazine Other descriptive name: SULFASALAZINE Concentration unit: g gram(s) Concentration type: up to Concentration number: 2- | VU University Medical Center | Authorised | Female: yes Male: yes | Netherlands | |||||
625 | JPRN-UMIN000012257 | 2013/11/12 | 2 April 2019 | Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial | osteoarthritis, rheumatoid arthritis, avascular necrosis of femoral condyle | A periarticular injection including methylprednisolone, ropivacaine, morphine, bosmin, and ketoprofen for pain after total knee arthroplasty A periarticular injection including ropivacaine, morphine, bosmin, and ketoprofen for pain after total knee arthroplasty | Nekoyama Miyao Hospital | Not Recruiting | 18years-old | Not applicable | Male and Female | 74 | 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 |
626 | EUCTR2013-003486-34-DK | 04/11/2013 | 14 March 2016 | Treatment of Tenosynovitis among rheumatoid arthritis patients | Systemic versus ultrasound-guided local glucocorticoid treatment, among rheumatoid arthritis patients with tenosynovitis - a randomized double blind study - SULTAN | MedDRA version: 16.0 Level: LLT Classification code 10042869 Term: Synovitis and tenosynovitis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Diprofos Depot Pharmaceutical Form: Solution for injection INN or Proposed INN: BETAMETHASONE ACIBUTATE CAS Number: 5534-05-4 Current Sponsor code: Glucocorticoid Other descriptive name: Binyrebarkhormon Concentration unit: mg/l milligram(s)/litre Concentration type: range Concentration number: 3,5-14 Trade Name: Natriumklorid 9mg/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: SODIUM CHLORIDE Current Sponsor code: Natriumklorid Other descriptive name: SODIUM CHLORIDE Concentration unit: mg/l milligram(s)/litre Concentration type: range Concentration number: 4,5-18 | Knowledge Centre for Rheumatology and Back Diseases | Not Recruiting | Female: yes Male: yes | Denmark | |||||
627 | NCT01855789 | November 2013 | 14 November 2016 | A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous Tocilizumab With Methotrexate in Participants With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Placebo;Drug: Tocilizumab;Drug: methotrexate | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 718 | Phase 3 | United States | ||
628 | NCT01951170 | November 2013 | 19 October 2017 | An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis | An Open-Label Study to Evaluate Non-Progression Of Structural Joint Damage Of Subcutaneous Tocilizumab In Patients With Moderate To Severe Active Rheumatoid Arthritis (Ac-Cute) | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 52 | Phase 3 | Australia | |
629 | NCT01980836 | November 2013 | 19 February 2015 | Effect of Tocilizumab to the Cellular Immune Response to Influenza Vaccine | The Effect of Tocilizumab on the Cellular Immune Response to Seasonal Influnza Vaccine in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis;Cellular Immune Response | Biological: Seasonal influenza vaccine | Tel-Aviv Sourasky Medical Center | Not recruiting | 18 Years | N/A | Both | 40 | Phase 4 | Israel | |
630 | NCT01990157 | November 2013 | 16 December 2017 | Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis | Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis in Which Methotrexate (MTX) Treatment is Not Effective | Rheumatoid Arthritis | Drug: TAB08 | Theramab LLC | Not recruiting | 18 Years | 65 Years | All | 18 | Phase 1/Phase 2 | Russian Federation | |
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 |
631 | NCT02005757 | November 2013 | 3 August 2015 | Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED) | Open Label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Mizoribine in Active Rheumatoid Arthritis Patients Unsuccessfully Treated With Disease-modifying Antirheumatic Drug | Rheumatoid Arthritis | Drug: Bredinin tablet 150mg;Drug: Bredinin tablet 50mg | Chong Kun Dang Pharmaceutical | Recruiting | 20 Years | 80 Years | Both | 60 | Phase 2 | Korea, Republic of | |
632 | NCT02027298 | November 2013 | 16 December 2017 | Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study | Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study | Primary Sjogren's Syndrome;Secondary Sjogren's Syndrome;Inflammatory Arthritis;Rheumatoid Arthritis | Drug: Abatacept | The Cleveland Clinic | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 0 | Phase 2 | United States |
633 | NCT02254655 | November 2013 | 29 January 2018 | The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis | The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis, a Controlled and Randomized Trial | Rheumatoid Arthritis | Drug: Puerarin injection 400 mg;Drug: Control | Chengdu PLA General Hospital | Not recruiting | 18 Years | 75 Years | All | 119 | Phase 2 | China | |
634 | NCT02293590 | November 2013 | 20 August 2018 | RICE: Remission by Intra-articular Injection Plus CErtolizumab | An Open Label, Randomised Study to Compare the Efficacy of Certolizumab Pegol (CZP) Plus a Dynamic or Fixed Dose Treatment Strategy in Patients With Rheumatoid Arthritis, a Phase II Study | Rheumatoid Arthritis | Drug: Certolizumab Pegol | Rüdiger B. Müller | UCB Pharma | Not recruiting | 18 Years | N/A | All | 43 | Phase 2 | Switzerland |
635 | EUCTR2012-004074-25-DE | 30/10/2013 | 23 July 2018 | Comparison of the effectiveness and safety of two different starting dosages of cortisone, compared to each other and to placebo, in early active rheumatoid arthritis | Comparison of the efficacy and safety of two different starting dosages of prednisolone in early active rheumatoid arthritis: a randomized, placebo controlled trial - CORRA | Early rheumatoid arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: PredniHEXAL® 5mg Tabletten Product Name: PredniHEXAL Pharmaceutical Form: Capsule, hard INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: PredniHEXAL® 5mg Tabletten Product Name: PredniHEXAL Pharmaceutical Form: Capsule, hard INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7,5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: PredniHEXAL® 10mg Tabletten Product Name: PredniHEXAL Pharmaceutical Form: Capsule, hard INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 10mg Tabletten Product Name: PredniHEXAL Pharmaceutical Form: Capsule, hard INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: PredniHEXAL® 20mg Tabletten Product Name: PredniHEXAL Pharmaceutical Form: Capsule, hard INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 20mg Tabletten Product Name: PredniHEXAL Pharmaceutical Form: Capsule, hard INN or Proposed INN: Prednisolon | Ruhr-Universität Bochum | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | 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 |
636 | EUCTR2013-002341-11-GB | 25/10/2013 | 4 August 2015 | This is a study in healthy subjects to look at the effect of tocilizumab (RoActemra) on a type of white blood cell | A SINGLE BLIND PHASE IV PHARMACODYNAMIC STUDY TO EVALUATE NEUTROPHIL DISTRIBUTION KINETICS AND FUNCTION FOLLOWING SINGLE-DOSE TOCILIZUMAB TREATMENT IN HEALTHY SUBJECTS | healthy volunteers (intended indication: Rheumatoid Arthritis) MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: TOCILIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann-La Roche Ltd | Not Recruiting | Female: no Male: yes | Phase 4 | United Kingdom | ||||
637 | EUCTR2013-000342-19-NL | 24/10/2013 | 5 September 2016 | A clinical trial where patients with Rheumatoid Arthritis are treated with the study drug tocilizumab, subcutaneous (injection in the skin), with or without other non-biological anti-rhematic drugs, to study the safety and efficacy of the drug. | MULTI-CENTER, OPEN LABEL, SINGLE ARM PHASE IIIB STUDY ON SAFETY AND EFFICACY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO NON-BIOLOGIC DMARDS - OSCAR | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 Pharmaceutical Form: Solution for injection INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: TOCILIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 162- | Roche Nederland B.V. | Not Recruiting | Female: yes Male: yes | Phase 3 | Netherlands | ||||
638 | JPRN-UMIN000012399 | 2013/10/16 | 2 April 2019 | Performance of Rheumascan in healthy subjects and patients with active rheumatoid arthritis | Rheumatoid arthritis | Patients with active rheumatoid arthritis (1)Assessment of tender and swollen joints by physical examination (2)Joint ultrasonography (assessment of active synovitis by grading and quantification of vascularity using power Doppler or color Doppler ultrasonography) in 22 joints of bilateral hands (3)Gadolinium-enhanced MRI of the hand with more severe arthritis (4)Examination by Rheumascan, a fluorescence optical imaging device using intravenous indocyanine green (ICG) Healthy subjects (1)Assessment of tender and swollen joints by physical examination (2)Joint ultrasonography (assessment of active synovitis by grading and quantification of vascularity using power Doppler or color Doppler ultrasonography) in 22 joints of bilateral hands (3)Examination by Rheumascan, a fluorescence optical imaging device using intravenous indocyanine green (ICG) | Tokyo Medical and Dental University | Diagnostic Imaging Center, Ochanomizu Surugadai Clinic | Not Recruiting | 20years-old | Not applicable | Male and Female | 9 | Not applicable | Japan | |
639 | EUCTR2013-001999-38-BE | 07/10/2013 | 17 August 2015 | A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy - Phase II study of TNF-K in Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TNF-Kinoid Product Code: TNF-K Pharmaceutical Form: Emulsion for injection INN or Proposed INN: not assigned yet Current Sponsor code: TNF-K Other descriptive name: TNF-Kinoid Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Emulsion for injection Route of administration of the placebo: Intramuscular use | Neovacs SA | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of | |||
640 | EUCTR2013-000054-22-GB | 01/10/2013 | 3 April 2017 | OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENT | OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENT - ACT-MOVE | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 Pharmaceutical Form: Solution for injection INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: Recombinant humanised anti-human monoclonal antibody directed against the IL-6R Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 180- | Roche Products Limited | Not Recruiting | Female: yes Male: yes | Phase 3 | 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 |
641 | JPRN-JapicCTI-132277 | 01/10/2013 | 2 April 2019 | AMG 162 Phase III study (DESIRABLE study) | A Confirmatory Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on DMARDs treatment (Phase III) | rheumatoid arthritis | Intervention name : AMG 162 INN of the intervention : Denosumab Dosage And administration of the intervention : Administer 60 mg every 6 months or every 3 months as a subcutaneous injection Control intervention name : Placebo Dosage And administration of the control intervention : Administer placebo as a subcutaneous injection | DAIICHISANKYO Co.,Ltd. | 20 | BOTH | 642 | Phase 3 | ||||
642 | JPRN-UMIN000011891 | 2013/10/01 | 2 April 2019 | Multicenter study of the effect of GoLimumab On the Remission Induction rate and bio-free remission maintenance rate in early rheumatoid Arthritis. | Rheumatoid Arthritis | Golimumab | St.Marianna University School of Medicine | Not Recruiting | 20years-old | 70years-old | Male and Female | 50 | Not selected | Japan | ||
643 | NCT01773681 | October 2013 | 10 December 2018 | Novel Imaging Markers for Rheumatoid Arthritis | Novel Imaging Markers for Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Cimzia;Device: Magnetic Resonance Imaging (MRI);Device: High-resolution peripheral quantitative computed tomography (HR-pQCT) | University of California, San Francisco | Not recruiting | 18 Years | N/A | All | 30 | N/A | United States | |
644 | NCT01947465 | October 2013 | 14 March 2016 | Immunogenicity and Safety of Vaccinations in Immunocompromised Persons | A Prospective Cohort Study in 6 Swiss Rheumatology Centres and 4 Travel Clinics on the Immunogenicity and Safety of Tetanus and Hepatitis A Vaccine in Patients With Rheumatoid Arthritis, Axial Spondyloarthritis and Vasculitis and Healthy Controls | Arthritis, Rheumatoid;Spondylarthritis;Vasculitis | Biological: Hepatitis A vaccine and tetanus vaccine | University of Zurich | University of Basel;Swiss Tropical & Public Health Institute;University of Bern;University Hospital, Geneva;Cantonal Hospital of St. Gallen;Cantonal Hospital of Aarau, Switzerland | Not recruiting | 18 Years | N/A | Both | 645 | N/A | Switzerland |
645 | NCT01960855 | October 2013 | 11 July 2016 | A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 Given With Methotrexate (MTX) in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy | Rheumatoid Arthritis | Drug: ABT-494;Drug: Placebo | AbbVie | Not recruiting | 18 Years | 100 Years | Both | 276 | Phase 2 | United States;Australia;Belgium;Czech Republic;Hungary;New Zealand;Poland;Puerto Rico;Spain;United Kingdom;Canada;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 |
646 | NCT01962337 | October 2013 | 19 February 2018 | Phase 1 Single and Multiple Dose Study of FPA008 in Healthy Volunteers and Rheumatoid Arthritis Subjects | A Phase 1, Randomized, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose Study of FPA008 in Healthy Volunteers and Subjects With Rheumatoid Arthritis | Healthy;Rheumatoid Arthritis | Drug: FPA008;Drug: Placebo | Five Prime Therapeutics, Inc. | Not recruiting | 21 Years | 70 Years | All | 66 | Phase 1 | Hungary;Netherlands;Poland | |
647 | NCT01962974 | October 2013 | 16 December 2017 | A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®) | A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®) | Arthritis, Rheumatoid | Biological: Golimumab 2 mg/kg IV | Janssen Biotech, Inc. | Not recruiting | 18 Years | 76 Years | All | 7 | Phase 3 | United States;Canada;Argentina;Brazil;Colombia;Mexico | |
648 | NCT01966718 | October 2013 | 19 October 2017 | Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies. | Repository Corticotropin Injection As Adjunctive Therapy In Patients With Rheumatoid Arthritis Who Have Failed At Least Three Biologic Therapies With Different Modes Of Action | Rheumatoid Arthritis | Drug: Repository corticotropin injection | Arthritis Treatment Center, Maryland | Not recruiting | 18 Years | 80 Years | All | 8 | Phase 4 | United States | |
649 | NCT01973569 | October 2013 | 16 December 2017 | AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Patients With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment | A Confirmatory Study of AMG 162 (Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment (Phase III) | Rheumatoid Arthritis | Drug: denosumab;Drug: placebo | Daiichi Sankyo, Inc. | Not recruiting | 20 Years | N/A | All | 667 | N/A | Japan | |
650 | NCT01975610 | October 2013 | 16 December 2017 | Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis | A Phase 2a, 4-Week Double-Blind, Proof-of-Concept Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CC-292;Drug: Placebo | Celgene | Not recruiting | 18 Years | 80 Years | Female | 47 | 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 |
651 | NCT01985464 | October 2013 | 15 July 2019 | Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid Arthritis | Feasibility Study of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UC-MSC) in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Umbilical cord mesenchymal stem cells | Translational Biosciences | Not recruiting | 18 Years | N/A | All | 20 | Phase 1/Phase 2 | Panama | |
652 | NCT02036931 | October 2013 | 21 January 2019 | A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System | A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System | Noninflammatory Degenerative Joint Disease;Rheumatoid Arthritis | Device: Metal on Polyethylene articulation;Drug: Ceramic on Polyethylene articulation;Device: Ceramic on Ceramic articulation | Zimmer Biomet | Not recruiting | 18 Years | N/A | All | 315 | Phase 1 | United States;France;Germany;Ireland;Netherlands;Spain | |
653 | NCT02538757 | October 2013 | 21 August 2017 | Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE) | Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-TNF Users (VERVE) | Arthritis;Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease;Inflammatory Arthritis | Biological: Herpes Zoster Vaccine;Drug: Placebo | University of Alabama at Birmingham | Oregon Health and Science University | Not recruiting | 50 Years | N/A | All | 125 | Phase 2 | United States |
654 | NCT01942174 | September 27, 2013 | 11 February 2019 | VACcination In Methotrexate Treated Rheumatoid Arthritis Patients | Lead Time of the Methotrexate Establishment and Vaccinal Protection Against the Pneumococcal Agent in Patients Affected With Rheumatoid Polyarthritis | Rheumatoid Arthritis | Biological: Prevenar 13;Biological: Pneumo23 / Pneumovax;Drug: Methotrexate - Immediate;Drug: Methotrexate - Delay | University Hospital, Montpellier | APHP (Hospital Cochin);Pfizer | Not recruiting | 18 Years | N/A | All | 276 | Phase 3 | France;Monaco |
655 | EUCTR2013-000359-42-GR | 12/09/2013 | 21 August 2017 | Not applicable | Multicenter, open label, phase IIIb study to evaluate the safety and tolerability of subcutaneous tocilizumab as monotherapy and/or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs in patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 16.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 Pharmaceutical Form: Solution for injection | ROCHE HELLAS S.A. | Not Recruiting | Female: yes Male: yes | Phase 3 | Greece | ||||
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 |
656 | EUCTR2012-005674-61-BE | 11/09/2013 | 21 August 2017 | Mesenchymal Precursor Cells (MPCs) for treatment of rheumatoid arthritis | A double-blind, randomized, placebo-controlled, multi-center, dose escalation study of a single intravenous infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in the treatment of biologic-naïve patients with rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Allogeneic Mesenchymal Precursor Cells Pharmaceutical Form: Suspension for injection Other descriptive name: ALLOGENEIC MESENCHYMAL PRECURSOR CELLS Concentration unit: Munit million units Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use | Mesoblast, Inc | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Serbia;Hungary;Estonia;Czech Republic;Poland;Belgium;Croatia;Latvia | |||
657 | NCT01907230 | September 10, 2013 | 25 March 2019 | Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis Patients | Propylactic Use of Entecavir for Biological Agents Associated Hepatitis B Virus Reactivation in Inflammatory Arthritis Patients: a Randomized Controlled Trial | Rheumatoid Arthritis;Hepatitis B Reactivation;Exposure to Hepatitis B Virus | Drug: Entecavir | Taipei Veterans General Hospital, Taiwan | Not recruiting | 20 Years | 90 Years | All | 115 | Phase 4 | Taiwan | |
658 | ChiCTR-ONRC-13003578 | 2013-09-01 | 18 April 2017 | Agkistrodon different formulations inflammatory and analgesic effects on rheumatoid arthritis clinical study | Agkistrodon different formulations inflammatory and analgesic effects on rheumatoid arthritis clinical study | Rheumatoid arthritis | The water decoction group of Agkistrodon:Taking the water decoction of Agkistrodon;Agkistrodon liquor:Taking Agkistrodon liquor agents;Agkistrodon pulvis:Taking the Agkistrodon pulvis;Control group:Taking placebo; | Zhejiang Chinese Medical University | Not Recruiting | 18 | 65 | Both | The water decoction group of Agkistrodon:30;Agkistrodon liquor:30;Agkistrodon pulvis:30;Control group:30; | Phase 1 study | China | |
659 | JPRN-JapicCTI-132209 | 01/9/2013 | 2 April 2019 | Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA (REASSURE-E) | A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Intervention name : AIN457 INN of the intervention : Secukinumab Dosage And administration of the intervention : Subjects will receive 150 mg secukinumab s.c. Control intervention name : null | Novartis Pharma K.K. | 18 | BOTH | 454 | Phase 3 | ||||
660 | NCT01787149 | September 2013 | 11 June 2018 | A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis | A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis | Combination With DMARDs | Drug: DMARDs | Mycenax Biotech Inc. | Not recruiting | 20 Years | N/A | All | 98 | Phase 3 | Taiwan | |
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 |
661 | NCT01911234 | September 2013 | 1 April 2019 | Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs' TNF-Kinoid in Adult Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Biological: TNF-Kinoid;Other: Placebo | Neovacs | Not recruiting | 18 Years | 75 Years | All | 143 | Phase 2 | Belgium;Georgia;Hungary;Lebanon;Macedonia, The Former Yugoslav Republic of;Moldova, Republic of;Poland;Russian Federation;Serbia;Ukraine;Czech Republic | |
662 | NCT01948388 | September 2013 | 28 January 2019 | The Effect of Corticotrophin (ACTH) in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients | Study of The Effect of Corticotrophin in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients From a Clinical and Structural Perspective As Measured by a Clinical Disease Activity Index Score and Bone Edema, Synovitis and Erosions on Magnetic Resonance Imaging | Rheumatoid Arthritis | Drug: corticotrophin 80 units | Gaylis, Norman B., M.D. | Not recruiting | 18 Years | N/A | All | 20 | Phase 4 | United States | |
663 | NCT01955603 | September 2013 | 19 February 2015 | A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis | A Randomised, Placebo-controlled, Double-blind Within Cohort, Dose Escalation, Multiple-dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered Subcutaneously to Subjects With Moderate to Severe Rheumatoid Arthritis | Inflammation;Rheumatoid Arthritis | Drug: NNC0215-0384;Drug: placebo | Novo Nordisk A/S | Not recruiting | 18 Years | 75 Years | Both | 24 | Phase 1 | Germany;Hungary;Poland;Russian Federation | |
664 | NCT02072200 | September 2013 | 19 October 2017 | Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE) | A New Modified-Release Tablet Formulation of Prednisone in Patients With Rheumatoid Arthritis- Multicenter, Phase IV, Interventional Study to Assess Reduction of Morning Stiffness | Rheumatoid Arthritis | Drug: Lodotra® | Mundipharma Korea Ltd | Not recruiting | 20 Years | 80 Years | All | 147 | Phase 4 | Korea, Republic of | |
665 | NCT02275299 | September 2013 | 19 February 2015 | Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis | A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod or Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Leflunomide;Drug: Iguratimod | Jiangsu Simcere Pharmaceutical Co., Ltd. | Recruiting | 18 Years | 70 Years | Both | 240 | 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 |
666 | NCT02600455 | September 2013 | 16 December 2017 | Use-Results Survey for ORENCIA® Subcutaneous Injection 125mg Syringe 1mL | Outline of Use-Results Survey for ORENCIA® Subcutaneous Injection 125mg Syringe 1mL | Rheumatoid Arthritis | Drug: Orencia | Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd | Not recruiting | 18 Years | N/A | All | 505 | N/A | Japan |
667 | NCT02600468 | September 2013 | 16 December 2017 | Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg | Outline of Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg | Rheumatoid Arthritis | Drug: Orencia | Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd | Not recruiting | 18 Years | N/A | All | 671 | N/A | |
668 | EUCTR2013-000525-31-GB | 27/08/2013 | 10 July 2015 | The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis | A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 16.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 Pharmaceutical Form: Solution for injection in pre-filled syringe Current Sponsor code: ABP 501 Other descriptive name: Biosimilar product to adalimumab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Trade Name: Humira Product Name: Adalimumab Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Other descriptive name: Humira Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | Amgen Inc | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | |||
669 | EUCTR2013-002429-52-ES | 23/08/2013 | 17 May 2016 | STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS | A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 Pharmaceutical Form: Solution for injection INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: TOCILIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 180- | Roche Farma S.A | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Spain;Ireland | |||
670 | EUCTR2011-005649-10-DE | 19/08/2013 | 10 July 2015 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 16.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 Pharmaceutical Form: Solution for injection INN or Proposed INN: mavrilimumab CAS Number: 1085337-57-0 Current Sponsor code: CAM-3001 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Trade Name: Simponi Product Name: Golimumab Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | MedImmune Ltd | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;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 |
671 | EUCTR2012-002181-12-SE | 19/08/2013 | 27 October 2014 | A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | Active rheumatoid arthritis MedDRA version: 16.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MK-8457 Product Code: MK-8457 Pharmaceutical Form: Capsule INN or Proposed INN: None Other descriptive name: MK-8457 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as | Not Recruiting | Female: yes Male: yes | 178 | Phase 2a | United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden | |||
672 | EUCTR2012-005733-37-CZ | 16/08/2013 | 8 August 2016 | A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SB2 (infliximab biosimilar) Product Code: SB2 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Current Sponsor code: SB2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Remicade® Product Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Samsung Bioepis Co., Ltd. | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | |||
673 | EUCTR2012-003654-86-HU | 15/08/2013 | 4 August 2015 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone | moderately to severely active rheumatoid arthritis MedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Proposed INN - FILGOTINIB Current Sponsor code: GLPG0634 Other descriptive name: GLPG0634 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: GLPG0634 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Proposed INN - FILGOTINIB Current Sponsor code: GLPG0634 Other descriptive name: GLPG0634 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: GLPG0634 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Propsoed INN - FILGOTINIB Current Sponsor code: GLPG0634 Other descriptive name: GLPG0634 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Galapagos NV | Not Recruiting | Female: yes Male: yes | 280 | Phase 2b | United States;Serbia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | |||
674 | EUCTR2012-005026-30-HU | 15/08/2013 | 2 September 2013 | A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 14.1 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB4 (etanercept biosimilar) Product Code: SB4 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT CAS Number: 185243-69-0 Current Sponsor code: SB4 Other descriptive name: TNFR:Fc Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Trade Name: Enbrel® Product Name: Enbrel® Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT CAS Number: 185243-69-0 Other descriptive name: TNFR:Fc Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Samsung Bioepis Co., Ltd. | Authorised | Female: yes Male: yes | 498 | Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | ||||
675 | NCT01856309 | August 7, 2013 | 1 October 2018 | Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (Sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) | Arthritis, Rheumatoid | Drug: Sirukumab 100 mg;Drug: Sirukumab 50 mg;Drug: Placebo | Janssen Research & Development, LLC | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 1822 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;France;Germany;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Ukraine;United Kingdom |
No. | 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 |
676 | EUCTR2013-000944-25-IT | 02/08/2013 | 22 December 2015 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with rheumatoid arthritis | A three year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in subjects with active rheumatoid arthritis - REASSURE-1 Extension | Rheumatoid arthritis MedDRA version: 16.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Secukinumab CAS Number: 1229022-83-6 Current Sponsor code: AIN457 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Novartis Farma S.p.A. | Not Recruiting | Female: yes Male: yes | 454 | Panama;United States;Thailand;Guatemala;Colombia;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Japan | ||||
677 | EUCTR2013-001569-17-IT | 02/08/2013 | 10 February 2014 | A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with other non-biological medicinal products in rheumatoid arthritis (RA) patients. | A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with methotrexate and/or other DMARDS in rheumatoid arthritis (RA) patients. | Rheumatoid Arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 Pharmaceutical Form: Solution for injection INN or Proposed INN: TOCILIZUMAB CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: TOCILIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 180- | Roche S.p.A. | Authorised | Female: yes Male: yes | Phase 3B | Italy | ||||
678 | NCT01394913 | August 2013 | 19 February 2015 | Comparison of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis | A Prospective, Double-blind, Randomized Study to Compare Efficacy of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Reumatocept (etanercept);Drug: Enbrel (etanercept) | EMS | Not recruiting | 18 Years | 70 Years | Both | 216 | Phase 3 | Brazil | |
679 | NCT01905735 | August 2013 | 19 February 2015 | A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis | A Multicentric,Double-blind,Placebo Controlled,Phase-2 Study to Assess the Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis . | Rheumatoid Arthritis. | Drug: Rhustoxicodendron 30;Drug: placebo | Healthcare Homoeo Charitable Society | Recruiting | 25 Years | 60 Years | Both | 60 | Phase 2 | India | |
680 | NCT01915537 | August 2013 | 19 February 2015 | Infliximab and Classic DMARDs in the Rheumatoid Arthritis Patients | A Prospective Cohort Study to Observe the Difference of Efficacy Between Infliximab With Methotrexate and Classic DMARDs in the Severe Rheumatoid Arthritis Patients With Poor Prognosis | Rheumatoid Arthritis(RA) | Drug: Infliximab group;Drug: Classic DMARDs treatment group | Zhang, Xiao, M.D. | Central South University;Tianjin Medical University General Hospital;Xijing Hospital | Not recruiting | 18 Years | 70 Years | Both | 170 | N/A | 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 |
681 | NCT01925157 | August 2013 | 12 October 2015 | A Study of LY3090106 in Healthy Participants and Participants With Rheumatoid Arthritis (RA) | A Single-Dose, Multicenter, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3090106 in Healthy Subjects and Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: LY3090106 - SQ;Biological: LY3090106 - IV;Biological: Placebo - SQ | Eli Lilly and Company | Not recruiting | 18 Years | 80 Years | Both | 43 | Phase 1 | Bulgaria;Moldova, Republic of;Poland;Romania;Hungary;United States | |
682 | NCT01936181 | August 2013 | 16 December 2017 | A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: Remicade (infliximab);Drug: SB2 (proposed biosimilar to infliximab) | Samsung Bioepis Co., Ltd. | Not recruiting | 18 Years | 75 Years | All | 584 | Phase 3 | Bulgaria;Lithuania | |
683 | NCT01932372 | July 26, 2013 | 11 November 2019 | Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis | XELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE) | Rheumatoid Arthritis | Drug: Tofacitinib (Xeljanz);Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc | Pfizer | Not recruiting | N/A | N/A | All | 10477 | N/A | Japan | |
684 | JPRN-JapicCTI-153073 | 01/7/2013 | 2 April 2019 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) | Rheumatoid arthritis | Intervention name : Sirukumab Dosage And administration of the intervention : 100 mg Intervention name : Sirukuma Dosage And administration of the intervention : 50mg Control intervention name : null | Janssen Pharmaceutical K.K. | 18 | BOTH | 280 | Phase 3 | ||||
685 | NCT01774877 | July 2013 | 19 February 2015 | A Clinical Study of Xin'an Medicine in the Treatment of Bi Syndrome | Efficacy and Safety of Xinfeng Capsule in the Treatment of Rheumatoid Arthritis (RA):A Randomized, Double-blind, Double-dummy, Multi-center Trial | Rheumatoid Arthritis | Drug: Xinfeng capsule;Drug: leflunomide | The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine | Ministry of Science and Technology of the People´s Republic of China | Not recruiting | 18 Years | 65 Years | Both | 304 | N/A | 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 |
686 | NCT01851070 | July 2013 | 11 June 2018 | A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFa Inhibitor | A Double-blind, Randomized, Placebo-controlled, Dose-escalation, Multi-center Study a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFa Inhibitor | Rheumatoid Arthritis | Drug: Allogeneic Mesenchymal Precursor Cells;Drug: Normal Saline | Mesoblast, Ltd. | PPD | Not recruiting | 18 Years | 80 Years | All | 48 | Phase 2 | United States;Australia |
687 | NCT01853033 | July 2013 | 16 December 2017 | A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis | A Study in Patients With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABT-122 | Rheumatoid Arthritis | Biological: ABT-122;Biological: Placebo | AbbVie | Not recruiting | 18 Years | 75 Years | All | 19 | Phase 1 | United States | |
688 | NCT01862224 | July 2013 | 19 February 2015 | A Synovial Biopsy Study of JNJ-38518168 in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Synovial Biopsy Study of JNJ-38518168 in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: JNJ-38518168;Drug: Placebo;Drug: Placebo / JNJ-38518168 | Janssen Research & Development, LLC | Not recruiting | 18 Years | 65 Years | Both | 21 | Phase 2 | United States;Moldova, Republic of | |
689 | NCT01890473 | July 2013 | 19 October 2017 | Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe | Phase Ib, Multicenter, Randomized, Open-Label, Parallel-Group Study to Characterize the Pharmacokinetics of a Single Dose of Abatacept 125 mg Administered Subcutaneously Using the BD Physioject™ Autoinjector or the UltraSafe Passive Needle Guard Prefilled Syringe | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 356 | Phase 1 | United States;Argentina;Mexico;Peru;South Africa | |
690 | NCT01893996 | July 2013 | 16 December 2017 | Study of Adalimumab to Lower Cardiovascular Risk in RA Patients With Well Controlled Joint Disease | Adalimumab to Mitigate Cardiovascular Risk in RA Patients With Well-Controlled Joint Disease | Rheumatoid Arthritis;Cardiovascular Disease | Drug: Adalimumab;Drug: Placebo | University of California, San Francisco | American College of Rheumatology Research and Education Foundation;AbbVie | Not recruiting | 18 Years | N/A | All | 60 | 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 |
691 | NCT01894516 | July 2013 | 3 August 2015 | Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Patients (DARWIN2) | Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks as Monotherapy to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (MTX) Alone | Rheumatoid Arthritis | Drug: GLPG0634;Drug: Placebo | Galapagos NV | Not recruiting | 18 Years | N/A | Both | 287 | Phase 2 | United States;Argentina;Australia;Austria;Bulgaria;Chile;Colombia;Germany;Guatemala;Hungary;Latvia;Mexico;Moldova, Republic of;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine | |
692 | NCT01927263 | July 2013 | 18 April 2016 | A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis | A Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis ?A Double-blind, Active Drug-controlled Study and Long-term Study? | Rheumatoid Arthritis | Biological: NI-071;Biological: Infliximab | Nichi-Iko Pharmaceutical Co.,Ltd. | Not recruiting | 20 Years | 75 Years | Both | 242 | Phase 3 | Japan | |
693 | NCT02236481 | July 2013 | 18 December 2018 | Clinical Study to Evaluate the Efficacy of Anakinra in Patients With Rheumatoid Arthritis and Diabetes | No-profit Study to Ensure Normal Clinical Practice, to Evaluate the Efficacy of Anakinra in Reducing the Glycated Haemoglobin in Patients Affected by Rheumatoid Arthritis and Diabetes; Randomized, Open Label, Parallel Group,Controlled Clinical Study | Diabetes Mellitus, Type 2;Arthritis, Rheumatoid | Drug: Anakinra;Drug: TNF alpha inhibitors | Prof. Roberto Giacomelli | Not recruiting | 18 Years | N/A | All | 41 | Phase 4 | Italy | |
694 | NCT02519387 | July 2013 | 19 October 2017 | Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity | Multicentre Study for Evaluation of the Efficacy and Safety of Buprenorphine Transdermal Patch (SOVENOR®) 5mg and 10mg in Patients With Non-malignant Pain of Moderate Intensity Due to Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain and Joint/Muscle Pain, When an Opioid is Necessary for Obtaining Adequate Analgesia | Osteoarthritis;Rheumatoid Arthritis;Lower Back Pain;Joint Pain;Muscle Pain | Drug: Buprenorphine Transdermal Patch | Mundipharma Pharmaceuticals Sdn. Bhd. | Not recruiting | 40 Years | N/A | All | 78 | Phase 4 | Malaysia | |
695 | NCT02894047 | July 2013 | 19 September 2016 | Study of the Influence of the Expression of the Calcium-sensitive Receptor (CaSR) by Monocytes in the Synovial Liquid on Structural Alterations in Patients Diagnosed With Rheumatoid Arthritis in the Previous Two Years | Study of the Influence of the Expression of the Calcium-sensitive Receptor (CaSR) by Monocytes in the Synovial Liquid on Structural Alterations in Patients Diagnosed With Rheumatoid Arthritis in the Previous Two Years | Arthritis, Rheumatoid | Biological: blood | Centre Hospitalier Universitaire, Amiens | Not recruiting | 18 Years | N/A | Both | 42 | 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 |
696 | EUCTR2012-003635-31-BE | 26/06/2013 | 17 August 2015 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. | moderately to severely active rheumatoid arthritis MedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Proposed INN - FILGOTINIB Current Sponsor code: GLPG0634 Other descriptive name: GLPG0634 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: GLPG0634 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Proposed INN - FILGOTINIB Current Sponsor code: GLPG0634 Other descriptive name: GLPG0634 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: GLPG0634 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Propsoed INN - FILGOTINIB Current Sponsor code: GLPG0634 Other descriptive name: GLPG0634 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Galapagos NV | Not Recruiting | Female: yes Male: yes | 595 | Phase 2b | United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | |||
697 | EUCTR2012-004482-40-ES | 18/06/2013 | 22 July 2013 | Evaluation of a protocol for the reduction of doses in patients with rheumatoid arthritis (RA) in clinical remission in treatment with biological therapies | Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis (RA) in persistent clinical remission in treatment with biological therapies: open, controlled study and randomized. | Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis in clinical remission at treatment with biologic therapies;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 3- Trade Name: HUMIRA Product Name: Adalimumab Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Trade Name: ENBREL Product Name: Etanercept Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT CAS Number: 185243-69-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: CIMZIA Product Name: Certolizumab Pegol Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: CERTOLIZUMAB PEGOL CAS Number: 428863-50-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Trade Name: SIMPONI Product Name: Golimumab Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: ORENCIA Product Name: Abatacept Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: ABATACEPT CAS Number: 332348-12-6 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 1000- Trade Name: RoActemra Product Name: Tocilizumab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: TOCILIZUMAB CAS Number: 375823-41-9 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 8- Product Name: Infliximab Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/kg milligram(s)/kilogram | FRANCISCO J. BLANCO GARCÍA | Authorised | Female: yes Male: yes | Spain | |||||
698 | NCT01881308 | June 17, 2013 | 30 September 2019 | Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis | REmission in Rheumatoid Arthritis - Assessing WIthrawal of Disease-modifying Antirheumatic Drugs in a Non-inferiority Design | Rheumatoid Arthritis | Drug: TNF inhibitors;Drug: Synthetic DMARD(s);Drug: Co-medication: Synthetic DMARDs | Diakonhjemmet Hospital | The Research Council of Norway;South-Eastern Norway Regional Health Authority | Not recruiting | 18 Years | 80 Years | All | 360 | Phase 4 | Norway |
699 | EUCTR2012-003686-17-SK | 05/06/2013 | 7 January 2019 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 Pharmaceutical Form: Tablet INN or Proposed INN: baricitinib Current Sponsor code: LY3009104 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 Pharmaceutical Form: Tablet INN or Proposed INN: baricitinib Current Sponsor code: LY3009104 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Eli Lilly and Company | Authorised | Female: yes Male: yes | 3000 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden | |||
700 | NCT01861782 | June 2013 | 19 February 2015 | Comparison Between Dead Sea Solar and Water Treatment to Sulfur Pool and Medicinal Mud Treatment in Patients With RA | Comparison Between Dead Sea Solar and Water Treatment to Sulfur Pool and Medicinal Mud Treatment in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Other: Dead Sea Solar and Water Treatment;Other: Sulfur Pool & Medicinal Mud | Soroka University Medical Center | Not recruiting | 18 Years | N/A | Both | 30 | N/A | Israel | |
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 |
701 | NCT01875991 | June 2013 | 19 October 2017 | Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept | An Open-label, Randomized, Crossover Study to Assess the Preference for Autoinjector A Versus Autoinjector B in Rheumatoid Arthritis and Plaque Psoriasis Subjects Treated With Etanercept | Rheumatoid Arthritis;Plaque Psoriasis | Drug: Etanercept via Autoinjector A;Drug: Etanercept via Autoinjector B | Amgen | Not recruiting | 18 Years | N/A | All | 217 | Phase 4 | United States;Canada | |
702 | NCT01878318 | June 2013 | 14 November 2016 | A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs | Open Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in the Hand of Patients With Moderate to Severe Rheumatoid Arthritis (RA) and Inadequate Response to Non-biological DMARDs | Rheumatoid Arthritis | Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 0 | Phase 4 | Venezuela | |
703 | NCT01885819 | June 2013 | 16 December 2017 | Autologous Adipose Tissue Stromal Vascular Fraction Cells for Rheumatoid Arthritis | Feasibility Study of Non-Expanded Autologous Adipose Tissue Derived Stromal Vascular Fraction Cells in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Autologous stromal vascular fraction cells | Translational Biosciences | Not recruiting | 18 Years | N/A | All | 0 | Phase 1/Phase 2 | Panama | |
704 | NCT01895309 | June 2013 | 16 December 2017 | A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: Enbrel (etanercept);Drug: SB4 (proposed biosimilar to etanercept) | Samsung Bioepis Co., Ltd. | Not recruiting | 18 Years | 75 Years | All | 596 | Phase 3 | Poland;United Kingdom | |
705 | NCT01901185 | June 2013 | 19 October 2017 | Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept | A Single-arm, Multicenter Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Electromechanical Autoinjector to Self-inject Etanercept | Rheumatoid Arthritis;Psoriatic Arthritis | Drug: Etanercept / Autoinjector A | Amgen | Not recruiting | 18 Years | N/A | All | 77 | Phase 3 | 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 |
706 | NCT01961271 | June 2013 | 19 October 2017 | Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain | Multicentre Study To Evaluate Efficacy And Safety Of Buprenorphine Transdermal Patch (Norspan) In Chronic Non-Malignant Pain Of Moderate To Severe Intensity Due To Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain And Joint / Muscle Pain, When Opioid Is Needed For Analgesia | Osteoarthritis;Rheumatoid Arthritis;Lower Back Pain;Joint Pain;Muscle Pain | Drug: Buprenorphine transdermal patch | Mundipharma Pte Ltd. | Mundipharma Korea Ltd;Mundipharma (Hong Kong) Ltd;Mundipharma Distribution GmBH (Philippine Branch) | Not recruiting | 18 Years | 80 Years | All | 114 | Phase 4 | Hong Kong;Korea, Republic of;Philippines |
707 | NCT02132234 | June 2013 | 19 February 2015 | Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis | Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis | Rheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Hypertension | Drug: Etanercept;Drug: Adalimumab;Drug: Certolizumab;Drug: Infliximab | Jagiellonian University | Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland | Recruiting | 18 Years | N/A | Both | 100 | Phase 4 | Poland |
708 | NCT01955733 | May 31, 2013 | 16 December 2017 | Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis | Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis: an Open-label Extension Trial | Arthritis, Rheumatoid | Drug: BI 695500 | Boehringer Ingelheim | Not recruiting | 18 Years | 82 Years | All | 91 | Phase 3 | United States;Belgium;Bulgaria;Germany;Greece;Netherlands;Poland;Portugal;Spain;Argentina;Brazil;Canada;Chile;Hungary;Ireland;Mexico;United Kingdom | |
709 | EUCTR2012-003686-17-IT | 29/05/2013 | 26 February 2018 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Pharmaceutical Form: Tablet INN or Proposed INN: baricitinib Current Sponsor code: LY3009104 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: baricitinib Product Code: LY3009104 Pharmaceutical Form: Tablet INN or Proposed INN: baricitinib Current Sponsor code: LY3009104 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Eli Lilly and Company | Authorised | Female: yes Male: yes | 3000 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden | |||
710 | JPRN-UMIN000014485 | 2013/05/24 | 2 April 2019 | Golimumab study for development of tight control and biologics-free condition. | rheumatoid arthritis | Treatment with Golimumab for patients with rheumatoid arthritis | Rheumatology, Internal MedicineJuntendo University School of Medicine, Juntendo Koshigaya Hospital | 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 |
711 | EUCTR2013-000337-13-DE | 13/05/2013 | 11 December 2017 | 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) | Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Cimzia Pharmaceutical Form: Suspension for injection in pre-filled syringe INN or Proposed INN: CERTOLIZUMAB PEGOL CAS Number: 428863-50-7 Current Sponsor code: UCB SA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Solution and suspension for suspension for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | Universitätsklinikum Erlangen | Authorised | Female: yes Male: yes | 156 | Phase 3 | Serbia;Portugal;Germany | |||
712 | NCT01357759 | May 2013 | 23 November 2015 | Safety and Tolerability of MORAb-022 in Healthy and Rheumatoid Arthritis Subjects | A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Trial of MORAb-022 in Healthy Subjects and Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MORAb-022 | Morphotek | Not recruiting | 18 Years | 75 Years | Both | 20 | Phase 1 | United States;Netherlands | |
713 | NCT01846975 | May 2013 | 16 March 2015 | Introducing a Single IV Abatacept Treatment in RA Patients Currently Receiving Weekly SC Abatacept to Simulate a Holiday | A Phase IV, Open Label Study Introducing a Single IV Treatment With Abatacept in Patients With Rheumatoid Arthritis Currently Receiving Weekly Injections of SC Abatacept to Simulate a Holiday or Patient Vacation | Rheumatoid Arthritis | Drug: IV Abatacept | Rüdiger B. Müller | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | Both | 49 | Phase 4 | Switzerland |
714 | NCT01873443 | May 2013 | 7 December 2015 | Long-Term Efficacy and Safety of CT-P10 in Patients With RA | An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1 | Rheumatoid Arthritis | Drug: Rituximab, MTX, folic acid | Celltrion | Not recruiting | 18 Years | 75 Years | Both | 87 | Phase 1 | Korea, Republic of | |
715 | NCT01927757 | May 2013 | 19 October 2017 | Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab | A Single Arm Trial to Evaluate the Efficacy of Etanercept in Moderate to Severe Rheumatoid Arthritis Patients Who Failed to Respond or Lost a Satisfactory Response to Treatment With Adalimumab When Used as Their First Biologic Agent | Moderate to Severe Rheumatoid Arthritis | Biological: Etanercept;Drug: Methotrexate | Amgen | Not recruiting | 18 Years | N/A | All | 90 | Phase 4 | United States;Canada;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 |
716 | NCT02035800 | May 2013 | 11 June 2018 | Bone Resorption, Osteoclastogenesis and Adalimumab | Bone Resorption, Osteoclastogenesis and Adalimumab | RheumatoId Arthritis | Drug: Adalimumab | Université de Sherbrooke | AbbVie | Recruiting | 18 Years | N/A | All | 120 | Phase 4 | Canada |
717 | NCT02350881 | May 2013 | 19 October 2017 | Mid-term Outcomes of First MTP Arthroplasty With Primus™ FGT Implant. | A Post-Market Observational Study to Evaluate Safety and Performance of Primus™ FGT Implant at a Minimum of 5 Years Follow-up | Hallux Limitus of Left Great Toe;Rheumatoid Arthritis;Arthritis of 1st Metatarsophalangeal Joint;Osteoarthritis;Bunion;Hallux Limitus of Right Great Toe | Device: Primus FGTI (Flexible Great toe Implant) | Tornier, Inc. | Not recruiting | 18 Years | N/A | All | 70 | N/A | Italy | |
718 | NCT02468791 | May 2013 | 17 November 2015 | MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis | A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Rituximab | Mabion SA | Recruiting | 18 Years | 80 Years | Both | 863 | Phase 3 | Bosnia and Herzegovina;Georgia;Poland;Serbia;Ukraine | |
719 | NCT04157010 | May 2013 | 11 November 2019 | Tocilizumab REMission in Early RA | Prospective, Single-centre, Open-Label, Randomised, Pilot Study Assessing the Changes in Expression of Janus Kinase/Signal Transducers and Activators of Transcription (JAK-STAT) and Speed & Depth of Remission Induced by Tocilizumab & Methotrexate Combination and Tocilizumab Monotherapy in Patients With Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Tocilizumab | University of Leeds | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 20 | Phase 4 | United Kingdom |
720 | EUCTR2012-004090-16-DE | 23/04/2013 | 10 July 2015 | Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy. | A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 655064 Pharmaceutical Form: Solution for injection Current Sponsor code: BI 655064 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 120- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Boehringer Ingelheim Pharma GmbH & Co. KG | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Poland;Spain;Netherlands;Germany;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 |
721 | EUCTR2012-004342-14-LT | 11/04/2013 | 28 August 2014 | A Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs | A Phase 2/3 Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: VX-509 Product Code: VX-509 Pharmaceutical Form: Tablet INN or Proposed INN: VX-509 Current Sponsor code: VX-509 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 40 | Phase 2/3 | United States;Estonia;Lithuania;Denmark;South Africa;Netherlands | |||
722 | NCT01758198 | April 11, 2013 | 16 December 2017 | Abatacept Post-marketing Clinical Study in Japan | A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Rheumatoid Arthritis | Biological: Abatacept;Drug: Placebo matching with Abatacept;Drug: Methotrexate | Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd | Not recruiting | 20 Years | N/A | All | 405 | Phase 4 | Japan |
723 | EUCTR2011-004017-17-GB | 08/04/2013 | 15 April 2013 | Tocilizumab and Remission in early rheumatoid arthritis | Prospective, Single-centre, Open-Label, Randomised, Pilot Study Assessing the changes in expression of JAK-STAT and Speed & Depth of Remission Induced by Tocilizumab & Methotrexate Combination and Tocilizumab Monotherapy in Patients with Early Rheumatoid Arthritis (TREMERA). - TREMERA | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: Tocilizumab Product Code: RoActemra Pharmaceutical Form: Concentrate and solvent for solution for infusion | The University of Leeds | Authorised | Female: yes Male: yes | 20 | United Kingdom | ||||
724 | EUCTR2012-003057-29-CZ | 02/04/2013 | 12 January 2015 | A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis. | A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XMAB®5871 IN PATIENTS WITH RHEUMATOID ARTHRITIS - XmAb®5871 Phase IIa, Ascending Multiple Dose Study in Rheumatoid Arthritis Patients | XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis. MedDRA version: 16.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: XmAb5871_10.0MG Product Code: XENP5871 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: XmAb®5871 Current Sponsor code: XENP5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 9.0-11.0 Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use Product Name: XmAb5871_3.0MG Product Code: XENP5871 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: XmAb®5871 Current Sponsor code: XENP5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 9.0-11.0 Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use Product Name: XmAb5871_1.0MG Product Code: XENP5871 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: XmAb®5871 Current Sponsor code: XENP5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 9.0-11.0 Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use Product Name: XmAb5871_0.3MG Product Code: XENP5871 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: XmAb®5871 Current Sponsor code: XENP5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 9.0-11.0 | Xencor Inc. | Not Recruiting | Female: yes Male: yes | 58 | Phase 2a | Hungary;Czech Republic;Slovakia | |||
725 | JPRN-JapicCTI-132121 | 01/4/2013 | 2 April 2019 | Abatacept Post-marketing Clinical Study in Japan | A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Rheumatoid Arthritis | Intervention name : Abatacept Dosage And administration of the intervention : 10 mg/kg IV / month Control intervention name : Placebo Dosage And administration of the control intervention : 0 mg/kg IV / month | Bristol-Myers Squibb K.K. | Ono Pharmaceutical Co.,LTD. | 20 | BOTH | 400 | 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 |
726 | JPRN-UMIN000009887 | 2013/04/01 | 2 April 2019 | Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6 | Rheumatoid Arthritis | When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha. If the initial concentration of serum TNF alpha is less than 1.1 pg/ml, we will raise the dose of infliximab to 6 mg/kg. When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha. If the initial concentration of serum TNF alpha is more than 1.1 pg/ml, we will raise the dose of infliximab to 10 mg/kg. | Department of Orthopaedic surgery, Tohoku University Hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 100 | Not applicable | Japan | ||
727 | NCT01547091 | April 2013 | 19 February 2015 | Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis | Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II | Rheumatoid Arthritis | Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs);Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs);Biological: UC-MSC+DMARDS | Alliancells Bioscience Corporation Limited | Recruiting | 18 Years | 70 Years | Both | 200 | Phase 1/Phase 2 | China | |
728 | NCT01764997 | April 2013 | 16 December 2017 | An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate | A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients With Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment With Adalimumab and MTX | Rheumatoid Arthritis | Drug: Sarilumab;Drug: Etanercept;Drug: Methotrexate;Drug: Placebo (for sarilumab);Drug: Placebo (for etanercept);Drug: Adalimumab | Sanofi | Regeneron Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 776 | Phase 3 | United States;Argentina;Australia;Brazil;Chile;Colombia;Czechia;Ecuador;Finland;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;New Zealand;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic |
729 | NCT01850680 | April 2013 | 19 February 2015 | Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered Sarilumab in Japanese Patients With Rheumatoid Arthritis Receiving Concomitant Methotrexate | Rheumatoid Arthritis | Drug: sarilumab SAR153191 (REGN88);Drug: placebo;Drug: methotrexate;Drug: folic acid | Sanofi | Regeneron Pharmaceuticals | Not recruiting | 20 Years | 65 Years | Both | 61 | Phase 1 | Japan |
730 | NCT01851278 | April 2013 | 19 February 2015 | Effectiveness Intraarticular Corticosteroid | Effectiveness and Tolerance Infiltration Intraarticular Corticosteroid According to Dose | Rheumatoid Arthritis | Drug: Triamcinolone hexacetonide | Federal University of São Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo | Recruiting | 18 Years | 65 Years | Both | 60 | N/A | Brazil |
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 |
731 | NCT01878123 | April 2013 | 10 October 2016 | Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis | A Randomized, Single-Dose, Placebo-Controlled, Study of the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: AMP-110;Other: Placebo | MedImmune LLC | Daiichi Sankyo Co., Ltd.;Daiichi Sankyo Co., Ltd. | Not recruiting | 18 Years | 75 Years | Both | 26 | Phase 1 | United States |
732 | JPRN-UMIN000010286 | 2013/03/21 | 2 April 2019 | Maintenance Trial by Orencia in Rheumatoid Arthritis | Rheumatoid Arthritis | Patients whose RA status is in low disease activity after 24 weeks of treatment with abatacept receive the reduced dosage of abatacept. | Hokkaido University Hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 150 | Not selected | Japan | ||
733 | EUCTR2012-005275-14-NO | 19/03/2013 | 28 November 2016 | Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs | Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs in a non-inferiority design - ARCTIC REWIND | Rheumatoid arthritis (RA) MedDRA version: 15.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Methotrexate Pfizer 2,5 mg tabletter Pharmaceutical Form: Tablet Trade Name: Methotrexate Pfizer 2,5 mg tabletter Pharmaceutical Form: Tablet Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte Pharmaceutical Form: Injection Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte Pharmaceutical Form: Injection Trade Name: Salazopyrin EN 500 mg enterotabletter Pharmaceutical Form: Tablet Trade Name: Salazopyrin EN 500 mg enterotabletter Pharmaceutical Form: Tablet Trade Name: Plaquenil 200 mg filmdrasjerte tabletter Pharmaceutical Form: Tablet Trade Name: Plaquenil 200 mg filmdrasjerte tabletter Pharmaceutical Form: Tablet Trade Name: Arava 20 mg filmdrasjerte tabletter Pharmaceutical Form: Tablet Trade Name: Arava 20 mg filmdrasjerte tabletter Pharmaceutical Form: Tablet Trade Name: ENBREL 25 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte. Pharmaceutical Form: Injection Trade Name: Cimzia 200 mg injeksjonsvæske, oppløsning Pharmaceutical Form: Injection Trade Name: Simponi 50 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte. Pharmaceutical Form: Injection Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning. Pharmaceutical Form: Infusion Trade Name: Humira 40 mg injeksjonsvæske, oppløsning, i ferdigfylt sprøyte Pharmaceutical Form: Injection | Diakonhjemmet Hospital AS | Authorised | Female: yes Male: yes | Phase 4 | Norway | ||||
734 | EUCTR2012-003644-71-ES | 12/03/2013 | 5 August 2014 | Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure | A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate. | Rheumatoid Arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel Product Name: Enbrel Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT CAS Number: 185243-69-0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for infusion in pre-filled syringe Route of administration of the placebo: Subcutaneous use | Pfizer Inc. | Not Recruiting | Female: yes Male: yes | 168 | France;Hong Kong;Czech Republic;Spain;Australia;Israel;Chile;Russian Federation;Netherlands;Germany;Colombia | ||||
735 | EUCTR2012-003629-40-CZ | 11/03/2013 | 11 April 2016 | An Efficacy And Safety Study of CNTO6785 In Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Randomized, Placebo-controlled Double-blind, Multicenter, Phase 2 Dose Ranging Study To Assess The Efficacy And Safety of CNTO6785 In Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 14.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: CNTO6785 Product Code: CNTO6785 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: CNTO6785 Current Sponsor code: CNTO6785 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Janssen-Cilag International NV | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Philippines;Czech Republic;Argentina;Thailand;Poland;Russian Federation;Colombia;China;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 |
736 | NCT01558089 | March 2013 | 19 October 2017 | Good EULAR Response In Patients With Early Rheumatoid Arthritis | Ability To Achieve A Good Eular Response In Patients With Moderate-to-severe Active Early Rheumatoid Arthritis Who Satisfy The New Acr/Eular Classification Criteria Receiving Etanercept + Mtx In Real World Clinical Practice In Greece | Rheumatoid Arthritis | Drug: etanercept;Drug: methotrexate | Pfizer | Not recruiting | 18 Years | N/A | All | 76 | N/A | Greece | |
737 | NCT01715896 | March 2013 | 19 October 2017 | A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis | A Phase 2 Exploratory Study of Mavrilimumab Versus Anti-tumor Necrosis Factor in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Golimumab 50 mg;Biological: Mavrilimumab 100 mg | MedImmune LLC | Not recruiting | 18 Years | 80 Years | All | 215 | Phase 2 | Argentina;Colombia;Czech Republic;France;Greece;Hungary;Israel;Mexico;Portugal;Russian Federation;Serbia;Slovakia;Spain;United Kingdom;Turkey | |
738 | NCT02843789 | March 2013 | 19 February 2018 | Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy | Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy | Arthritis, Rheumatoid | Drug: Tocilizumab | Centre Hospitalier Universitaire de Besancon | Not recruiting | 18 Years | 80 Years | All | 109 | Phase 4 | France | |
739 | EUCTR2012-002324-32-BE | 25/02/2013 | 16 August 2016 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Pharmaceutical Form: Tablet Current Sponsor code: LY3009104 Other descriptive name: baricitinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: baricitinib Product Code: LY3009104 Pharmaceutical Form: Tablet Current Sponsor code: LY3009104 Other descriptive name: baricitinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Pharmaceutical Form: Capsule INN or Proposed INN: METHOTREXATE CAS Number: 59-05-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten Pharmaceutical Form: Capsule INN or Proposed INN: METHOTREXATE CAS Number: 59-05-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Methotrexate 2.5mg Tablets Pharmaceutical Form: Capsule INN or Proposed INN: METHOTREXATE CAS Number: 59-05-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Methotrexate 2.5 mg tablets Pharmaceutical Form: Capsule INN or Proposed INN: METHOTREXATE CAS Number: 59-05-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Eli Lilly and Company | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden | |||
740 | JPRN-UMIN000010126 | 2013/02/25 | 23 April 2019 | Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease | Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease - Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD | Interstitial lung disease related to rheumatoid arthritis | In cases with UIP/NSIP pattern ILD, treatment is started with prednisolone and tacrolimus. For safety concern, the doses of tacrolimus should not exceed the dose approved in Japan and are adjusted to maintain blood trough levels less than 10 ng/ml. Prednisolone is started at the dose of 0.5 mg/kg/day and continued at the initial dose through 2-4 weeks, then reduced by 5 mg every 2-4 weeks. After the dose of prednisolone reaches 15 mg/day, it is reduced by 2.5 mg. After the dose of prednisolone reaches 10 mg, it is reduced by 1 mg every 4 weeks. The dose of prednisolone should be tapered to achieve 0.2 mg/kg/day at week 24. Prednisolone should be maintained at least 5 mg/day until month 12. Then prednisolone can be either continued, reduced or stopped later on. In cases with OP pattern ILD, prednisolone is started, tapered and maintained as mentioned in cases with UIP/NSIP pattern ILD. Methotrexate is started after the dose of prednisolone reaches 0.3 to 0.4 mg/kg/day. Methotrexate is increased to the maximal tolerable dose, but should not exceed 16 mg/week. Methotrexate should be used following the guideline published by Japan College of Rheumatology. If methotrexate is not feasible by any reason, it can be substituted by tacrolimus and tacrolimus should be used as mentioned in UIP/NSIP pattern ILD cases. | Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University | Not Recruiting | 20years-old | Not applicable | Male and Female | 34 | 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 |
741 | EUCTR2012-000609-58-BE | 20/02/2013 | 17 August 2015 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0109-0012A 100 mg/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A Current Sponsor code: NNC0109-0012 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Code: 0109-0012A 50 mg/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A Current Sponsor code: NNC0109-0012 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Code: 0109-0012A 25 mg/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A Current Sponsor code: NNC0109-0012 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Novo Nordisk A/S | Not Recruiting | Female: yes Male: yes | 268 | Phase 2b | United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Germany | |||
742 | EUCTR2012-000610-11-BE | 20/02/2013 | 17 August 2015 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate | Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0109-0012A 100 mg/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A Current Sponsor code: NNC0109-0012 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Code: 0109-0012A 50 mg/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A Current Sponsor code: NNC0109-0012 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Code: 0109-0012A 25 mg/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A Current Sponsor code: NNC0109-0012 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Novo Nordisk A/S | Not Recruiting | Female: yes Male: yes | 268 | Phase 2b | United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Germany | |||
743 | EUCTR2012-003536-23-CZ | 20/02/2013 | 4 August 2015 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | Rheumatoid Arthritis MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Sarilumab Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 131.6- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Product Name: Sarilumab Product Code: SAR153191 (REGN88) Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Sarilumab Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 175- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra Pharmaceutical Form: Solution for injection INN or Proposed INN: tocilizumab Other descriptive name: RoActemra Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use | sanofi-aventis recherche & développement | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden | ||||
744 | EUCTR2012-003724-20-HU | 19/02/2013 | 19 January 2015 | A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate. | A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone | Rheumatoid Arthritis MedDRA version: 17.0 Level: LLT Classification code 10042952 Term: Systemic rheumatoid arthritis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: IPI 145 Pharmaceutical Form: Capsule CAS Number: 1201438-56-3 Other descriptive name: IPI-145 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Code: IPI 145 Pharmaceutical Form: Capsule CAS Number: 1201438-56-3 Other descriptive name: IPI-145 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Code: IPI 145 Pharmaceutical Form: Capsule CAS Number: 1201438-56-3 Other descriptive name: IPI-145 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Infinity Pharmaceuticals, Inc | Not Recruiting | Female: yes Male: yes | 316 | Phase 2 | Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;Colombia;New Zealand | |||
745 | EUCTR2012-004090-16-ES | 19/02/2013 | 10 July 2015 | Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy. | A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 655064 Pharmaceutical Form: Solution for injection INN or Proposed INN: BI 655064 Current Sponsor code: BI 655064 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 120- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Boehringer Ingelheim España, S.A. | Not Recruiting | Female: yes Male: yes | 130 | Czech Republic;Spain;Australia;Netherlands;Germany;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 |
746 | EUCTR2012-005370-62-IT | 18/02/2013 | 7 January 2019 | clinical study to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes. | “No-profit” clinical study for the improvement of clinical practice, to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes; randomized, open label, parallel group, controlled clinical study. | rheumatoid arthritis and type 2 diabetes mellitus as comorbidity. MedDRA version: 14.1 Level: LLT Classification code 10037740 Term: RA System Organ Class: 100000004859 MedDRA version: 14.1 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: KINERET*SC 7SIR 100MG 0,67ML Pharmaceutical Form: Solution for injection INN or Proposed INN: ANAKINRA CAS Number: 143090-92-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | OSPEDALE CIVILE SAN SALVATORE, ASL 04, L'AQUILA | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | Italy | |||
747 | JPRN-UMIN000010033 | 2013/02/14 | 2 April 2019 | To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy | Rheumatoid Arthritis | Tocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks. | Daihei Kida | Not Recruiting | 20years-old | 75years-old | Male and Female | 20 | Not selected | Japan | ||
748 | EUCTR2011-006344-71-DE | 08/02/2013 | 8 August 2016 | Treatment with eggs of pig whipworm for patients with rheumatoid arthritis, who are insufficiently treated with methotrexate | Trichuris suis ova (TSO) as a additional therapy for rheumatoid arthritis patients with insufficient response to methotrexate. A prospective, double-blind, randomized, controlled monocenter study. | Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Trichuris suis ova Product Name: Trichuris suis ova Product Code: TSO Pharmaceutical Form: Oral suspension INN or Proposed INN: Trichuris suis ova Current Sponsor code: TSO Other descriptive name: Pig whipworm eggs Concentration unit: thousand organisms thousand organisms Concentration type: equal Concentration number: 2500- Pharmaceutical form of the placebo: Oral suspension Route of administration of the placebo: Oral use | Immanuel Krankenhaus Berlin | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Germany | |||
749 | NCT01768858 | February 5, 2013 | 11 February 2019 | Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice | Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice | Crohn´s Disease;Ulcerative Colitis;Plaque Psoriasis;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: Adalimumab | AbbVie | Raffeiner GmbH | Not recruiting | 18 Years | 99 Years | All | 96 | Phase 2 | Austria |
750 | EUCTR2011-003538-16-LT | 04/02/2013 | 10 July 2015 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Sarilumab Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 131.6- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Product Name: Sarilumab Product Code: SAR153191 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Sarilumab Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 175- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | sanofi-aventis recherche & développement | Not Recruiting | Female: yes Male: yes | 522 | United States;Portugal;Hong Kong;Taiwan;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand | ||||
No. | 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 |
751 | EUCTR2012-003194-25-LT | 04/02/2013 | 27 October 2014 | Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis | Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MabionCD20 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab Current Sponsor code: MabionCD20 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Trade Name: MabThera Product Name: MabThera Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Mabion S.A. | Not Recruiting | Female: yes Male: yes | 863 | Serbia;Poland;Ukraine;Croatia;Romania;Lithuania;Russian Federation;Georgia | ||||
752 | NCT01724931 | February 2013 | 1 June 2015 | Aminopterin Dose Finding Treatment for Methotrexate-Naïve Rheumatoid Arthritis | A Phase 2 Double-Blind, Placebo-Controlled, Randomized Dose Finding Study For The Efficacy And Safety Of Aminopterin In Methotrexate-Naive Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: LD-aminopterin;Drug: placebo | Syntrix Biosystems, Inc. | Not recruiting | 18 Years | N/A | Both | 175 | Phase 2 | Ukraine | |
753 | NCT01742468 | February 2013 | 19 October 2015 | Intervention With Long-chain n-3 Polyunsaturated Fatty Acids From Microalgae Oil in Patients With Rheumatoid Arthritis | Intervention With Products Enriched With Long Chain n-3 Polyunsaturated Fatty Acids (n-3 LC-PUFA) From Microalgae Oil in Patients With Rheumatoid Arthritis - Influence on Disease Activity and Inflammation Status | Rheumatoid Arthritis | Dietary Supplement: long-chain n-3 PUFA;Dietary Supplement: sunflower oil | University of Jena | German Federal Ministry of Education and Research | Not recruiting | 40 Years | 80 Years | Both | 38 | N/A | Germany |
754 | NCT01712399 | January 28, 2013 | 16 December 2017 | A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis | An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Mavrilimumab 100 mg | MedImmune LLC | Not recruiting | 19 Years | 79 Years | All | 409 | Phase 2 | Argentina;Bulgaria;Chile;Colombia;Czechia;Estonia;Germany;Greece;Hungary;Israel;Mexico;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Czech Republic | |
755 | EUCTR2012-002323-15-PL | 25/01/2013 | 2 February 2015 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON | Moderately to severely active rheumatoid arthritis MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Pharmaceutical Form: Tablet Current Sponsor code: LY3009104 Other descriptive name: baricitinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: baricitinib Product Code: LY3009104 Pharmaceutical Form: Tablet Current Sponsor code: LY3009104 Other descriptive name: baricitinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Eli Lilly and Company | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | United States;Greece;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | |||
No. | 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 |
756 | EUCTR2012-002535-28-GB | 21/01/2013 | 11 December 2017 | A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA | A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA | Rheumatoid Arthritis MedDRA version: 20.0 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: MabThera Pharmaceutical Form: Concentrate for solution for infusion Trade Name: RoActemra Product Name: RoActemra Pharmaceutical Form: Concentrate for solution for infusion | Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) | Authorised | Female: yes Male: yes | 160 | Phase 4 | Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom | |||
757 | EUCTR2012-004631-22-BE | 15/01/2013 | 7 October 2014 | TapERA: Tapering Etanercept in Reumatoid Artritis. | TapERA: Maintaining remission in RA while tapering Etanercept. - TapERA | reumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Enbrel Product Name: Enbrel Product Code: EMEA/H/C000262 Pharmaceutical Form: Solution for injection in pre-filled syringe | University Hospitals Leuven | Authorised | Female: yes Male: yes | Belgium | |||||
758 | NCT01715831 | January 15, 2013 | 16 December 2017 | A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488 | A Multicenter, Open-Label, Single-Arm Extension Study to Describe the Safety of Tocilizumab Treatment In Brazilian Patients With DMARDs Refractory Rheumatoid Arthritis Which Completed Studies ML21530 and MA21488 and Presenting an Indication of Maintaining the Tocilizumab Treatment | Arthritis, Rheumatoid | Drug: DMARDs;Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 26 | Phase 4 | Brazil | |
759 | EUCTR2012-002322-73-HU | 14/01/2013 | 7 December 2015 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis. | A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Pharmaceutical Form: Tablet Current Sponsor code: LY3009104 Other descriptive name: baricitinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: baricitinib Product Code: LY3009104 Pharmaceutical Form: Tablet Current Sponsor code: LY3009104 Other descriptive name: baricitinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Humira Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40/0.8- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Eli Lilly and Company | Not Recruiting | Female: yes Male: yes | 1280 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan | |||
760 | EUCTR2012-002339-27-HU | 14/01/2013 | 19 January 2015 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD | Moderately to severely active rheumatoid arthritis MedDRA version: 16.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Pharmaceutical Form: Tablet Current Sponsor code: LY3009104 Other descriptive name: baricitinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: baricitinib Product Code: LY3009104 Pharmaceutical Form: Tablet Current Sponsor code: LY3009104 Other descriptive name: baricitinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Eli Lilly and Company | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of | |||
No. | 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 |
761 | ChiCTR-TRC-13002981 | 2013-01-07 | 18 April 2017 | Effectiveness and safety of Chinese herbal medicine in low responders in patient population of rheumatoid arthritis under MTX-based conventional therapy | Effectiveness and safety of Chinese herbal medicine in low responders in patient population of rheumatoid arthritis under MTX-based conventional therapy | rheumatoid arthritis;M06.991 | A:GTT tablets, 10 mg 3 times a day after meals. Yi Shen Juan Bi (YSJB) ,1 pocket (8 g) 3 times a day after meals;B:Methotrexate (MTX)10 mg/week and Sulfasalazine (SSZ),at an initial dose of 0.5 g three times a day in the first week, from the second week the dose was 1.0g twice a day; | Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences | Not Recruiting | 18 | 70 | Both | A:110;B:110; | Post-market | ||
762 | NCT02089087 | January 7, 2013 | 15 April 2019 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients | A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CFZ533 in Healthy Subjects and Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Biological: CFZ533;Drug: Placebo | Novartis Pharmaceuticals | Not recruiting | 18 Years | 55 Years | All | 75 | Phase 1 | United States;Taiwan | |
763 | ChiCTR-TRC-13003948 | 2013-01-01 | 18 April 2017 | The evaluation of clinical curative effect of 'supplying of shen and nourishing sui' law of electroacupuncture combined with ZeLing joint swelling mixture in the treatment of rheumatoid arthritis with yin-deficiency of liver and kidney pattern | The evaluation of clinical curative effect of 'supplying of shen and nourishing sui' law of electroacupuncture combined with ZeLing joint swelling mixture in the treatment of rheumatoid arthritis with yin-deficiency of liver and kidney pattern | rheumatoid arthritis | Control:Methotrexate 10mg qw PO + Leflunomide 10mg qd PO ;EA combined with medicine group:M+L+SEA+ZJSM ; | Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine | Not Recruiting | 18 | 70 | Both | Control:60;EA combined with medicine group:60; | Other | China | |
764 | JPRN-UMIN000007404 | 2013/01/01 | 2 April 2019 | Open-label, multicenter, randomized controlled trials, for comparing remission induction rate of a dose-escalation therapy of methotrexate and an additional combination therapy with bucillamine for naive patients to over 8 mg/weekly of methotrexate. | Rheumatoid arthritis | Dose escalation of methotrexate Concomitant therapy of methotrexate and bucillamine | KONAMON Study Group | Recruiting | Not applicable | Not applicable | Male and Female | 90 | Not applicable | Japan | ||
765 | NCT01965132 | January 1, 2013 | 18 June 2018 | Korean College of Rheumatology Biologics Registry | Korean College of Rheumatology Biologics Registry | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: Biologic DMARD | Seoul National University Hospital | Recruiting | 18 Years | N/A | All | 3500 | 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 |
766 | NCT01389388 | January 2013 | 25 May 2015 | Effects of Rosuvastatin on Carotid Artery Plaques in Patients With Inflammatory Joint Disease | Cholesterol Plaques in Carotid and Coronary Arteries and the Effect of Rosuvastatin in Rheumatoid Arthritis, Ankylosing Spondylitis and Other Inflammatory Joint Diseases | Carotid Artery Plaque;Ankylosing Spondylitis;Rheumatoid Arthritis | Drug: Rosuvastatin | Diakonhjemmet Hospital | Not recruiting | 35 Years | 80 Years | Both | 114 | N/A | Norway | |
767 | NCT01721044 | January 2013 | 30 September 2019 | A Moderate to Severe Rheumatoid Arthritis Study | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors | Rheumatoid Arthritis | Drug: Placebo;Drug: Baricitinib;Drug: cDMARD | Eli Lilly and Company | Not recruiting | 18 Years | N/A | All | 527 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Puerto Rico;Spain;Switzerland;Turkey;United Kingdom;Croatia;India | |
768 | NCT01754935 | January 2013 | 19 February 2015 | A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX-509 Using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects With Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis | Drug: VX-509;Drug: VX-509 matching placebo | Vertex Pharmaceuticals Incorporated | Not recruiting | 18 Years | 65 Years | Both | 43 | Phase 2 | United States;Denmark;Estonia;Lithuania;Netherlands;South Africa | |
769 | NCT01765478 | January 2013 | 25 May 2015 | Safety,PK/PD, Food Effect Study of Orally Administered HM71224 in Healthy Adult Male Volunteers | A Phase1 Study, to Determine the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Doses of Orally Administered HM71224 in Healthy, Adult Male Volunteers | Rheumatoid Arthritis | Drug: HM71224 single ascending dose;Drug: HM71224 food effect;Drug: HM71224 Multiple ascending dose | Hanmi Pharmaceutical Company Limited | Not recruiting | 18 Years | 65 Years | Male | 62 | Phase 1 | Netherlands | |
770 | NCT01767844 | January 2013 | 19 February 2015 | Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients? | Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients? A Randomised Controlled Pilot Trial | Rheumatoid Arthritis | Dietary Supplement: Creatine;Dietary Supplement: Placebo | Bangor University | Not recruiting | 18 Years | N/A | Both | 43 | N/A | 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 |
771 | NCT01793519 | January 2013 | 11 November 2019 | Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis | Stopping Tumor Necrosis Factor-Alpha Inhibitors in Rheumatoid Arthritis (STARA) Clinical Trial | Rheumatoid Arthritis | Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Placebo | Georgetown University | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);University of Maryland, College Park;Washington D.C. Veterans Affairs Medical Center;Washington Hospital Center;Patient-Centered Outcomes Research Institute;Arthritis and Pain Associates of PG County;Arthritis & Rheumatism Associates, P.C.;Rheumatology Associates of Baltimore, L.L.C.;The Arthritis Clinic of Northern Virginia, P.C.;Arthritis and Rheumatic Disease Associates, P.C. | Recruiting | 18 Years | N/A | All | 290 | Phase 4 | United States |
772 | EUCTR2012-002323-15-IT | 18/12/2012 | 14 September 2015 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BARICITINIB Product Code: LY3009104 Pharmaceutical Form: Tablet Current Sponsor code: LY3009104 Other descriptive name: Baricitinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: BARICITINIB Product Code: LY3009104 Pharmaceutical Form: Tablet Current Sponsor code: LY3009104 Other descriptive name: Baricitinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | ELI LILLY AND COMPANY | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | United States;Greece;Spain;Turkey;Austria;Israel;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Australia;Netherlands;Japan;Korea, Republic of | |||
773 | JPRN-UMIN000009425 | 2012/12/06 | 2 April 2019 | A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient | Rheumatoid Arthritis | The dose of golimumab should be fixed as 50 mg/month for all period. Treat-to-target strategy might be achieved by MTX or other DMARDs for one year. The goal of treatment is low disease activity. Treat-to-target strategy will be started with 50 mg of golimumab for first 3 months and then 100 mg golimumab can be used for tight control of rheumatoid arthritis to achieve low disease activity (LDA). Also MTX or other DMARDs might be used for tight control. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is allowed. Total period is one year. Treat-to-target strategy will be started with 100 mg of golimumab for first 3 months. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is performed. If not, physicians should control the disease activity using MTX or other DMARDs. Total period is one year. | Osaka City University Medical School | Recruiting | 20years-old | Not applicable | Male and Female | 150 | Phase 4 | Japan | ||
774 | NCT01491815 | December 2012 | 18 December 2018 | Active Conventional Therapy Compared to Three Different Biologic Treatments in Early Rheumatoid Arthritis With Subsequent Dose Reduction | A Multicenter, Randomized, Open-label, Blinded-assessor, Phase 4 Study in Patients With Early Rheumatoid Arthritis to Compare Active Conventional Therapy Versus Three Biologic Treatments, and Two De-escalation Strategies in Patients Who Respond to Treatment | Rheumatoid Arthritis | Drug: Non-biological DMARD's;Biological: Cimzia;Biological: Orencia;Biological: RoActemra | Karolinska Institutet | Recruiting | 18 Years | N/A | All | 800 | Phase 4 | Sweden | |
775 | NCT01717846 | December 2012 | 23 May 2016 | Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid Arthritis | In Vivo Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and Antigen Presenting (APC) Cells in Rheumatoid Arthritis | Apoptotic DNA Damage;Rheumatoid Arthritis;T-cell Lymphocytosis | Drug: Group 1 or Orencia treated group;Other: Group 2 (DMARDS treated group) | University of California, Los Angeles | Bristol-Myers Squibb | Not recruiting | 18 Years | 85 Years | Both | 0 | 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 |
776 | NCT01721057 | December 2012 | 30 September 2019 | A Study in Moderate to Severe Rheumatoid Arthritis Participants | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Placebo;Drug: Baricitinib;Drug: cDMARD | Eli Lilly and Company | Not recruiting | 18 Years | N/A | All | 684 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Croatia;Czechia;Germany;Hungary;India;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Taiwan;United Kingdom;Czech Republic | |
777 | NCT01752855 | December 2012 | 19 October 2017 | Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab | A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab | Rheumatoid Arthritis | Biological: New formulation adalimumab | AbbVie (prior sponsor, Abbott) | Not recruiting | 18 Years | N/A | All | 88 | Phase 2 | United States;Belgium;Czech Republic;Germany;Puerto Rico;Romania;Slovakia | |
778 | NCT01759030 | December 2012 | 16 December 2017 | Study of Safety and Efficacy of BCD-020 Comparing to MabThera in Patients With Rheumatoid Arthritis | Double Blind Randomized Clinical Study Evaluating Efficacy and Safety of BCD-020 and MabThera in Patients With Rheumatoid Arthritis Who Had an Inadequate Response or Intolerance to Other DMARDs Including One or More TNF Inhibitor Therapies | Rheumatoid Arthritis | Drug: Rituximab | Biocad | Not recruiting | 18 Years | 80 Years | All | 181 | Phase 3 | Belarus;India;Russian Federation;Ukraine;Colombia | |
779 | NCT01770106 | December 2012 | 19 February 2015 | RA Denosumab on Bone Microstructure Study | Comparison of the Effect of Denosumab and Alendronate on Bone Density and Microarchitecture in Rheumatoid Arthritis Females With Low Bone Mass: A Randomized Controlled Trial | Rheumatoid Arthritis | Drug: Denosumab;Drug: Alendronate | Chinese University of Hong Kong | Not recruiting | 18 Years | 80 Years | Female | 40 | Phase 4 | Hong Kong | |
780 | JPRN-UMIN000011181 | 2012/11/19 | 2 April 2019 | Continuous epidural infusion versus periarticular multimodal drug injection in bilateral simultaneous total knee arthroplasty: a randomized controlled trial | Osteoarthritis of knee, rheumatoid arthritis | A continuous epidural infusion containing ropivacaine and morphine for pain after simultaneous bilateral total knee arthroplasty A periarticular multimodal drug injection including ropivacaine, morphine, bosmin, methylprednisolone, and ketoprofen for pain after simultaneous bilateral total knee arthroplasty | Nekoyama miyao hospital | Not Recruiting | 18years-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 |
781 | EUCTR2012-001618-40-CZ | 05/11/2012 | 6 January 2015 | Evaluation of the blood concentration of Tabalumab after the administration of Tabalumab using prefilled syringe or auto-injector in patients with Rheumathoid Arthritis that have not responded correctly to treatment with Methotrexate. | Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled syringe or Auto-Injector in Patients with Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate. | Rheumatoid Arthritis MedDRA version: 14.1 Level: LLT Classification code 10042952 Term: Systemic rheumatoid arthritis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tabalumab Product Code: LY2127399 Pharmaceutical Form: Solution for injection Other descriptive name: TABALUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- | Eli Lilly and Company | Not Recruiting | Female: yes Male: yes | 180 | United States;Czech Republic;Argentina;Poland;Russian Federation | ||||
782 | EUCTR2012-001760-30-IT | 05/11/2012 | 7 January 2013 | Evaluation effects of treatment with an inhibitor of the receptor of a protein (interleukin-6 IL-6)involved in inflammatory process, on the clinical response and on the changes from baseline in the biomarkers in patients with rheumatoid arthritis (RA)not responding adequately to Disease-modifying antirheumatic drugs (DMARDs) and/or to a first biological agent. | Evaluation effects of treatment with IL-6R inhibitor on clinical response and biomarkers in patients with rheumatoid arthritis (RA) not responding to DMARDs and/or a first biological agent. | Rheumatoid Arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: TOCILIZUMAB CAS Number: 375823-41-9 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Trade Name: RoActemra Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: TOCILIZUMAB CAS Number: 375823-41-9 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Trade Name: RoActemra Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: TOCILIZUMAB CAS Number: 375823-41-9 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Trade Name: RoActemra Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: TOCILIZUMAB CAS Number: 375823-41-9 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Trade Name: RoActemra Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: TOCILIZUMAB CAS Number: 375823-41-9 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Trade Name: RoActemra Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: TOCILIZUMAB CAS Number: 375823-41-9 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- | OSSERVATORIO EPIDEMIOLOGICO GISEA | Authorised | Female: yes Male: yes | Italy | |||||
783 | EUCTR2012-000609-58-GB | 01/11/2012 | 28 February 2019 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | Rheumatoid arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0109-0012A 100 mg/ml Pharmaceutical Form: Solution for injection Current Sponsor code: NNC0109-0012 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Code: 0109-0012A 50 mg/ml Pharmaceutical Form: Solution for injection Current Sponsor code: NNC0109-0012 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Code: 0109-0012A 25 mg/ml Pharmaceutical Form: Solution for injection Current Sponsor code: NNC0109-0012 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Novo Nordisk A/S | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany | |||
784 | JPRN-UMIN000009088 | 2012/11/01 | 2 April 2019 | Bio Logic MateTM clinical performance test for IFX Efficacy prediction | rheumatoid arthritis | IFX plus methotrexate | Bio Logic Mate Study Group | Not Recruiting | 20years-old | 75years-old | Male and Female | 150 | Not selected | Japan | ||
785 | NCT01689532 | November 2012 | 19 October 2017 | A Study of CNTO 136 (Sirukumab) Administered Subcutaneously in Japanese Patients With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine | A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously as Monotherapy, in Japanese Subjects With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine | Arthritis, Rheumatoid | Drug: Sirukumab 100 mg;Drug: Sirukumab 50 mg;Drug: Placebo | Janssen Pharmaceutical K.K. | GlaxoSmithKline | Not recruiting | 20 Years | N/A | All | 122 | 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 |
786 | NCT01709760 | November 2012 | 11 June 2018 | A Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With RA | A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate;Drug: ENIA11;Drug: Placebo | Mycenax Biotech Inc. | Not recruiting | 20 Years | N/A | All | 91 | Phase 3 | Taiwan | |
787 | NCT01711359 | November 2012 | 30 September 2019 | A Study in Participants With Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis | Drug: Baricitinib;Drug: Methotrexate;Drug: Baricitinib Placebo;Drug: MTX Placebo;Drug: Folic Acid | Eli Lilly and Company | Not recruiting | 18 Years | N/A | All | 588 | Phase 3 | United States;Argentina;Austria;Belgium;Brazil;Canada;Germany;Greece;India;Italy;Japan;Korea, Republic of;Mexico;Portugal;Puerto Rico;Russian Federation;South Africa;Sweden;United Kingdom | |
788 | NCT01725230 | November 2012 | 19 February 2015 | Assess the Pharmacokinetics of Rosuvastatin and Simvastatin When Administered Alone or in Combination With Fostamatinib | An Open-label, Non-randomized, 2-Period, Fixed Sequence, Single-center Study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily | Rheumatoid Arthritis | Drug: Fostamatinib;Drug: Rosuvastatin;Drug: Simvastatin | AstraZeneca | Not recruiting | 18 Years | 55 Years | Both | 42 | Phase 1 | United States | |
789 | NCT01741493 | November 2012 | 16 December 2017 | A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494 | A Study in Healthy Adult Volunteers and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Dosing of ABT-494 | Rheumatoid Arthritis | Drug: ABT-494;Drug: Placebo;Drug: Tofacitinib | AbbVie (prior sponsor, Abbott) | Not recruiting | 18 Years | 75 Years | All | 67 | Phase 1 | United States | |
790 | NCT01749787 | November 2012 | 19 February 2015 | Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis | A Phase Ib Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation, Safety and Tolerability Study of PRTX-100 in Combination With Methotrexate or Leflunomide in Patients With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: PRTX-100 at 1.5 mcg/kg;Drug: PRTX-100 at 3.0 mcg/kg;Drug: PRTX-100 at 6.0 mcg/kg;Drug: PRTX-100 at 12.0 mcg/kg;Drug: PRTX-100 at 240 mcg;Drug: Placebo;Drug: PRTX-100 at 420 mcg | Protalex, Inc. | Not recruiting | 18 Years | N/A | Both | 61 | 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 |
791 | NCT01679951 | October 31, 2012 | 25 March 2019 | A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate | A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Group, Dose Range Finding Study of JNJ-38518168 in Subjects With Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy | Rheumatoid Arthritis | Drug: Placebo;Drug: JNJ-38518168 (3 mg);Drug: JNJ-38518168 (10 mg);Drug: JNJ-38518168 (30 mg);Drug: Methotrexate | Janssen Research & Development, LLC | Not recruiting | 18 Years | 80 Years | All | 272 | Phase 2 | United States;Argentina;Chile;Colombia;Czechia;Hungary;Japan;Korea, Republic of;Latvia;Mexico;Poland;Romania;Russian Federation;Taiwan;Thailand;Ukraine;Czech Republic | |
792 | NCT01636843 | October 30, 2012 | 17 September 2018 | A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate | A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate | Inflammation;Rheumatoid Arthritis | Drug: NNC0109-0012;Drug: placebo | Novo Nordisk A/S | Not recruiting | 18 Years | 75 Years | All | 298 | Phase 2 | United States;Argentina;Belgium;Brazil;Czechia;France;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;Spain;Ukraine;Czech Republic | |
793 | NCT01741688 | October 26, 2012 | 16 December 2017 | An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid Arthritis | A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab | Rheumatoid Arthritis | Biological: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 16 | N/A | Peru | |
794 | EUCTR2010-021146-22-GB | 23/10/2012 | 29 October 2012 | Alemtuzumab and rheumatoid arthritis - a study to look at the function of the immune system | Alemtuzumab and rheumatoid arthritis - an immunisation study - Alemtuzumab and rheumatoid arthritis - an immunisation study | Rheumatoid Arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994; manufacturerd by Cambridge Therapeutic Antibody Centre, Burroughs Wellcome, Glaxo Wellcome) Product Name: Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994) | The Newcastle upon Tyne Hospitals NHS Foundation Trust | Authorised | Female: yes Male: yes | United Kingdom | |||||
795 | NCT01590966 | October 18, 2012 | 2 September 2019 | Scintigraphic Detection of the Biodistribution of Tumor Necrosis Factor With a Radiolabeled Anti-TNFa in Patients With Active Rheumatoid Arthritis and Active Axial and Peripheral Spondyloarthritis | Scintigraphic Detection of the Biodistribution of Tumor Necrosis Factor With a Radiolabeled Anti-TNFa in Patients With Active Rheumatoid Arthritis and Active Axial and Peripheral Spondyloarthritis | Axial and Peripheral Spondyloarthritis;Rheumatoid Arthritis | Drug: administration of Cimzia®;Drug: Immunoscintigraphy with radiolabeled Cimzia®. | University Hospital, Ghent | UCB Pharma SA | Not recruiting | 18 Years | 70 Years | All | 41 | Phase 3 | 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 |
796 | NCT01636557 | October 11, 2012 | 16 December 2017 | A Study to Evaluate the Effect of a Single Dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Patients With Rheumatoid Arthritis | A Phase I, Open-label, Drug Interaction Study to Evaluate the Effect of a Single-dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Subjects With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Sirukumab;Drug: Midazolam;Drug: Warfarin;Drug: Vitamin K;Drug: Omeprazole;Drug: Caffeine | Janssen Research & Development, LLC | Not recruiting | 18 Years | 65 Years | All | 12 | Phase 1 | Germany;Korea, Republic of;Moldova, Republic of;South Africa | |
797 | NCT01736189 | October 11, 2012 | 15 July 2019 | Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice | Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice (Combo Study; Adalimumab With High Dose MTX) | Rheumatoid Arthritis | Drug: Adalimumab | AbbVie (prior sponsor, Abbott) | Not recruiting | 16 Years | 99 Years | All | 346 | N/A | Japan | |
798 | JPRN-JapicCTI-132091 | 01/10/2012 | 2 April 2019 | A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFalpha Agents | A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFalpha Agents | Rheumatoid Arthritis | Intervention name : AIN457 INN of the intervention : secukinumab Dosage And administration of the intervention : subcutaneously 75mg, 150mg Control intervention name : null | Novartis Pharma K.K. | 18 | BOTH | 234 | Phase 3 | ||||
799 | JPRN-UMIN000008812 | 2012/10/01 | 2 April 2019 | Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) | Rheumatoid arthritis | tocilizumab monotherapy | Department of Rheumatology & Clinical Immunology Saitama Medical Center, Saitama Medical Universitity | Not Recruiting | 16years-old | 80years-old | Male and Female | 40 | Not selected | Japan | ||
800 | JPRN-UMIN000010315 | 2012/10/01 | 2 April 2019 | Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment | rheumatoid arthritis | In patients with clinical remission by adalimumab (DAS28-CRP <2.6) maintained over 24 weeks, to stop the Adalimumab. | Osaka City University Medical School | Metabolism, Endocrinology, and Molecular Medicine. Osaka City University Graduate School of Medicine. The center for rheumatic diseases. Nara Medical University. Rheumatology. Kitano Hospital. | Recruiting | 20years-old | Not applicable | Male and Female | 50 | 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 |
801 | JPRN-UMIN000018101 | 2012/10/01 | 2 April 2019 | Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study | Osteoarthritis, rheumatoid arthritis, osteonecrosis | To determine whether postoperative VTE is present and to evaluate the efficacy and safety of edoxaban for the prevention of patients undergoing TKA, OWHTO, or CWHTO, angiography of the pulmonary artery and deep veins of the lower limbs is performed in all patients on postoperative day 7. Levels of coagulation and fibrinolysis markers are evaluated on the preoperative day and on postoperative days 1, 3, 7, and 14. | Yokohama City University School of Medicine | Recruiting | Not applicable | Not applicable | Male and Female | 100 | Not selected | Japan | ||
802 | NCT01609205 | October 2012 | 11 June 2018 | Doppler Evaluation in RA Patients After Adalimumab. | Doppler Quantitative Evaluation and Follow-up Over 12 Months in RA Patients With Moderate and High Disease Activity Who Are Candidates for Biologic add-on Therapy With Adalimumab | Rheumatoid Arthritis | Biological: Adalimumab | Hamed Rezaei | Abbott | Not recruiting | 18 Years | N/A | All | 60 | Phase 4 | Sweden |
803 | NCT01619176 | October 2012 | 19 February 2015 | Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood | Non Inferiority Trial for the Study of Acupuncture on Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: methotrexate;Drug: non-steroidal anti-inflammatory drug (NSAID);Drug: leflunomide;Procedure: Acupuncture | Chinese Academy of Sciences | Shanghai GuangHua Hospital of integrated traditional and western medicine | Not recruiting | 18 Years | 65 Years | Female | 15 | N/A | China |
804 | NCT01709578 | October 2012 | 16 December 2017 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-a Antagonists | Rheumatoid Arthritis | Drug: Sarilumab;Drug: placebo;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide | Sanofi | Regeneron Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 546 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Ecuador;Germany;Greece;Guatemala;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic;Hong Kong |
805 | NCT01710358 | October 2012 | 30 September 2019 | A Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy | Rheumatoid Arthritis | Drug: Adalimumab;Drug: Baricitinib;Drug: Methotrexate;Drug: Adalimumab Placebo;Drug: Baricitinib Placebo | Eli Lilly and Company | Not recruiting | 18 Years | N/A | All | 1307 | Phase 3 | United States;Argentina;Belgium;Canada;China;Croatia;Czechia;France;Germany;Greece;Hungary;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Slovenia;South Africa;Spain;Switzerland;Taiwan;United Kingdom;Czech Republic;Netherlands | |
No. | 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 |
806 | NCT01730456 | October 2012 | 14 November 2016 | A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926 | A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 13 | Phase 3 | Macedonia, The Former Yugoslav Republic of | |
807 | NCT01734993 | October 2012 | 19 October 2017 | A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA). | A Multicenter, Open-Label Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 11 | Phase 3 | France | |
808 | NCT01789151 | October 2012 | 7 November 2016 | 99m-Technetium- Glucosamine in Arthritis | 99mTc-labelled D-Glucosamine in the Evaluation of Disease Activity in Patients With Degenerative and Inflammatory Rheumatic Conditions | Rheumatoid Arthritis;Ankylosing Spondylitis | Device: Technetium labelled glucosamine | University of Sydney | AbbVie | Not recruiting | 18 Years | 90 Years | Both | N/A | Australia | |
809 | NCT01871961 | October 2012 | 23 March 2015 | Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient | Evaluation of Rheumatoid Arthritis Patient Performance Using the Metoject® Prefilled Pen (Methotrexate 50 mg/mL, Prefilled Pen) for Subcutaneous Injection and Subsequent Pharmacokinetic Assessment of Drug Delivery | Rheumatoid Arthritis (RA) | Drug: Methotrexate (Metoject® prefilled pen) | medac GmbH | PPD (CRO) | Not recruiting | 16 Years | N/A | Both | 105 | Phase 1 | United States |
810 | NCT02915094 | October 2012 | 16 December 2017 | Kineret in the Treatment of Rheumatoid Arthritis | Kineret in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Anakinra | Swedish Orphan Biovitrum | Not recruiting | 18 Years | N/A | All | 30 | 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 |
811 | JPRN-jRCTs032180245 | 28/09/2012 | 7 October 2019 | Wear of 32mm OXINIUM head on XLPE: Multicenter RCT Study | Wear of 32mm Oxidized Zirconium (OXINIUM) head on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study - 32mmOX multicenter study | Hip osteoarthritis, Rheumatoid arthritis Hip osteoarthritis, Rheumatoid arthritis | Arm A: Oxidized zirconium alloy (OXINIUM) femoral head Arm B: Standard cobalt chromium alloy head Random allocation is registered automatically at the UMIN Internet Medical Research Data Center (INDICE) | Masanobu Saito | Not Recruiting | >= 20age old | <= 75age old | Both | 352 | Phase 4 | none | |
812 | EUCTR2011-006058-94-CZ | 26/09/2012 | 11 April 2016 | Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents | A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - REASSURE 2 | Rheumatoid arthritis MedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB CAS Number: 1229022-83-6 Current Sponsor code: AIN457 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB CAS Number: 1229022-83-6 Current Sponsor code: AIN457 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Portugal;Panama;United States;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of | |||
813 | NCT01711814 | September 26, 2012 | 3 June 2019 | A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study | A Phase 2 Open-Label, Noncomparative, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study | Arthritis, Rheumatoid | Drug: peficitinib | Astellas Pharma Global Development, Inc. | Janssen Biotech, Inc. | Not recruiting | 18 Years | N/A | All | 611 | Phase 2 | United States;Belgium;Bulgaria;Colombia;Czechia;Hungary;Mexico;Poland;Czech Republic |
814 | JPRN-UMIN000015297 | 2012/09/19 | 23 April 2019 | The feasibility study of accelated infliximab infusion from initial administration | The feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration | patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis) | Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure. | Chiba University Hospital | Recruiting | 20years-old | 70years-old | Male and Female | 54 | Phase 2 | Japan | |
815 | EUCTR2011-002894-48-GB | 14/09/2012 | 30 April 2019 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 MedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: BI 695500 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Trade Name: Rituxan Product Name: Rituxan Pharmaceutical Form: Injection INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Boehringer Ingelheim International GmbH | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | Bulgaria;Germany;Norway;Belgium;Brazil;Poland;Argentina;Canada;Mexico;Hungary;United Kingdom;Guatemala;Netherlands;South Africa;Peru;France;Italy;Chile;Russian Federation;Ireland;Ukraine;Spain;Greece;Estonia;United States;Portugal;Serbia;New Zealand;Sweden | |||
No. | 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 |
816 | JPRN-JapicCTI-132051 | 12/9/2012 | 23 April 2019 | Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis | Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis | Rheumatoid Arthritis | Intervention name : iguratimod (Careram) Dosage And administration of the intervention : Oral | Eisai Co., Ltd. | BOTH | 2000 | NA | |||||
817 | JPRN-JapicCTI-152782 | 12/9/2012 | 23 April 2019 | Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis | Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis | Rheumatoid Arthritis | Intervention name : Kolbet INN of the intervention : Iguratimod Dosage And administration of the intervention : Oral | Toyama Chemical Co., Ltd. (Current FUJIFILM Toyama Chemical Co., Ltd.) | BOTH | 2000 | NA | |||||
818 | NCT01694264 | September 1, 2012 | 16 December 2017 | Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFa | A Randomized, Double-blinded, Phase 3, Multicenter, Investigator-initiated Trial for Entecavir for Prophylaxis of Hepatitis B Virus (HBV) Reactivation in HBV Surface Antigen or Anti-HBc Positive Patients Undergoing Anti-TNFa Treatment | Chronic Hepatitis B;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Juvenile Idiopathic Arthritis | Drug: Entecavir;Drug: Placebo | Seoul National University Hospital | Konkuk University Medical Center;Kyungpook National University;Kyunghee University Medical Center;Kyung Hee University Hospital at Gangdong;Gachon University Gil Medical Center;Daegu Catholic University Medical Center;Eulji University Hospital;SMG-SNU Boramae Medical Center;The Catholic University of Korea;Severance Hospital;Ajou University School of Medicine;Ewha Womans University Mokdong Hospital;Inha University Hospital;Chonnam National University Hospital;Chonbuk National University Hospital;Chungnam National University Hospital;Hallym University Medical Center;Hanyang University;Dong-A University;Korea University Guro Hospital | Not recruiting | 16 Years | 85 Years | All | 43 | Phase 3 | Korea, Republic of |
819 | NCT01635686 | September 2012 | 19 February 2015 | Comparison the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers | A Randomized, Double-blind, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers | Rheumatoid Arthritis | Drug: DWP422 25mg;Drug: ENBREL 25MG PFS INJ. | Daewoong Pharmaceutical Co. LTD. | Not recruiting | 20 Years | 45 Years | Male | 38 | Phase 1 | Korea, Republic of | |
820 | NCT01640938 | September 2012 | 17 November 2015 | Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis | A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Secukinumab (AIN457) | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 259 | Phase 3 | United States;Brazil;Bulgaria;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Mexico;Russian Federation;Slovakia;Spain;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 |
821 | NCT01676701 | September 2012 | 11 June 2018 | Evaluation of Tabalumab Using Auto-Injector or Prefilled Syringe in Participants With Rheumatoid Arthritis (RA) | Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: Tabalumab Auto-Injector;Drug: Tabalumab Prefilled Syringe | Eli Lilly and Company | Not recruiting | 18 Years | N/A | All | 8 | Phase 3 | United States;Argentina;Czechia;Poland;Puerto Rico;Russian Federation;Czech Republic | |
822 | EUCTR2011-006070-73-DE | 28/08/2012 | 27 January 2014 | Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis | A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM | Rheumatoid arthritis MedDRA version: 15.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib 50 mg blue film-coated tablet Product Code: R935788 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fostamatinib disodium CAS Number: 914295-16-2 Current Sponsor code: R935788 sodium Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | AstraZeneca AB | Not Recruiting | Female: yes Male: yes | 130 | United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Bulgaria;South Africa;Germany | ||||
823 | EUCTR2012-000535-36-BE | 28/08/2012 | 21 August 2017 | A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety. | A multicenter, randomized, double-blind, double dummy, parallel design study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation compared to the currently approved adalimumab formulation in subjects with active rheumatoid arthritis. | Rheumatoid Arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Abbott GmbH & Co. KG | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Czech Republic;Slovakia;Puerto Rico;Poland;Belgium;Romania;Germany | |||
824 | NCT01643928 | August 16, 2012 | 16 December 2017 | Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04) | Extension Study Evaluating Treatment With Pf-05280586 Versus Rituximab In Subjects With Active Rheumatoid Arthritis Who Have Participated In Other Pf-05280586 Clinical Trials | Rheumatoid Arthritis | Biological: Rituximab-Pfizer (PF-05280586) x 3 courses;Biological: Rituximab-EU+ Rituximab-Pfizer x 2 Courses;Biological: Rituximab-US + Rituximab-Pfizer x 2 Courses | Pfizer | Not recruiting | 18 Years | N/A | All | 185 | N/A | United States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Switzerland;Ukraine | |
825 | NCT01604343 | August 2012 | 9 January 2017 | A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D) | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite DMARD Therapy | Arthritis, Rheumatoid | Drug: Placebo;Drug: Sirukumab | Janssen Research & Development, LLC | GlaxoSmithKline | Not recruiting | 18 Years | N/A | Both | 1670 | Phase 3 | United States;Bulgaria;Canada;Chile;Colombia;Croatia;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;South Africa;Taiwan;Ukraine;Argentina;Brazil;India;Peru |
No. | 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 |
826 | NCT01606761 | August 2012 | 2 November 2015 | A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T) | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | Arthritis, Rheumatoid | Drug: Placebo;Drug: Sirukumab | Janssen Research & Development, LLC | GlaxoSmithKline | Not recruiting | 18 Years | N/A | Both | 879 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Croatia;France;Germany;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;Spain;Taiwan;United Kingdom;Brazil;China |
827 | NCT01636817 | August 2012 | 17 September 2018 | A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics | A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics | Inflammation;Rheumatoid Arthritis | Drug: NNC0109-0012;Drug: placebo | Novo Nordisk A/S | Not recruiting | 18 Years | 75 Years | All | 239 | Phase 2 | United States;Argentina;Belgium;Brazil;Czechia;France;Germany;Hungary;Italy;Mexico;Poland;Spain;United Kingdom;Czech Republic | |
828 | NCT01652937 | August 2012 | 19 February 2015 | BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BIIB057 in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis | Drug: BIIB057;Drug: Placebo | Biogen Idec | Not recruiting | 18 Years | N/A | Female | 0 | Phase 2 | Canada | |
829 | NCT01662063 | August 2012 | 19 October 2017 | A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA) | A Multicenter Open-Label, Long-Term Extension Study of WA22762 and NA25220 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tocilizumab | Genentech, Inc. | Not recruiting | 18 Years | N/A | All | 218 | Phase 3 | United States;Puerto Rico | |
830 | NCT01706926 | August 2012 | 19 October 2017 | A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis | A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Mavrilimumab 30 mg;Biological: Mavrilimumab 100 mg;Biological: Mavrilimumab 150 mg;Other: Placebo | MedImmune LLC | MedImmune Ltd | Not recruiting | 18 Years | 80 Years | All | 420 | Phase 2 | Argentina;Bulgaria;Chile;Colombia;Czech Republic;Estonia;Germany;Hungary;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;France;Mexico |
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 |
831 | NCT01746680 | August 2012 | 24 August 2015 | Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis | Phase IV STudy of Tacrobell in Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tacrolimus with Methotrexate | Chong Kun Dang Pharmaceutical | Not recruiting | 20 Years | N/A | Both | 111 | Phase 4 | Korea, Republic of | |
832 | NCT01870908 | August 2012 | 12 October 2015 | Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis Patients | Drug Use-result Survey to Assess the Safety and Efficacy of the Combination of Tacrolimus + Biological Agents in Daily Clinical Settings | Rheumatoid Arthritis | Drug: tacrolimus;Drug: biological agents | Astellas Pharma Inc | Not recruiting | N/A | N/A | Both | 664 | N/A | Japan | |
833 | JPRN-UMIN000008572 | 2012/07/31 | 2 April 2019 | The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients | Rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX) | Tacrolimus group patients receive daily the optimal dosage of tacrolimus within the range between 1.5-3.0 mg/day for 52 weeks. Etanercept group patient receive weekly subcutaneous injection of etanercept 50mg for 52 weeks. | Department of Rheumatology and infectious disease, Kitasato university school of medicine | 1)Kitasato institute medical center hospital 2)Kitasato institute hospital 3)Ishikawa internal medicine clinic | Recruiting | 20years-old | 70years-old | Male and Female | 80 | Not applicable | Japan | |
834 | NCT01705730 | July 31, 2012 | 10 September 2018 | A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy | Mon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in Monotherapy | Rheumatoid Arthritis | Drug: tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 71 | N/A | Belgium | |
835 | EUCTR2011-005648-93-EE | 19/07/2012 | 11 April 2016 | A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 Pharmaceutical Form: Solution for injection INN or Proposed INN: mavrilimumab CAS Number: 1085337-57-0 Current Sponsor code: CAM-3001 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | MedImmune Ltd | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;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 |
836 | JPRN-UMIN000010902 | 2012/07/11 | 2 April 2019 | A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty | Osteoarthritis of knee, rheumatoid arthritis, avascular necrosis | An epidural anesthesia containing 2mg/ml ropivacaine 100ml and 10mg/ml morphine 0.8ml for pain after total knee arthroplasty A periarticular multimodal drug injection including 7.5mg/ml ropivacaine, 10mg/ml morphine 0.8ml, bosmin 0.3mg, methylprednisolone 40mg, and ketoprofen 50mg for pain after total knee arthroplasty | Nekoyama miyao hospital | Not Recruiting | 18years-old | Not applicable | Male and Female | 100 | Not selected | Japan | ||
837 | EUCTR2011-005376-42-LV | 06/07/2012 | 15 July 2013 | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0114-0006B Pharmaceutical Form: Powder for solution for infusion Current Sponsor code: NNC0114-0006 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the placebo: Intravenous use | Novo Nordisk A/S | Not Recruiting | Female: yes Male: yes | 60 | Serbia;Hungary;Spain;Poland;Bulgaria;Russian Federation;Latvia | ||||
838 | NCT01554696 | July 6, 2012 | 11 June 2019 | A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate | A Phase 2b, Randomized, Double-blind, Parallel-group, Placebo Controlled, Dose-finding, Multi-center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis in Patients Who Have Had an Inadequate Response to Methotrexate | Arthritis, Rheumatoid | Drug: peficitinib;Drug: Placebo;Drug: methotrexate | Astellas Pharma Inc | Not recruiting | 18 Years | N/A | All | 379 | Phase 2 | United States;Belgium;Bulgaria;Colombia;Czechia;Hungary;Mexico;Poland;Czech Republic | |
839 | JPRN-UMIN000008404 | 2012/07/01 | 2 April 2019 | Extension of Tocilizumab Dose Intervals in Patients with Low to Moderate Disease Activity Rheumatoid Arthritis using IL-6 Serum Level as Starting Criteria. | rheumatoid arthritis | Extension of Tocilizumab Dose Intervals | Japan Labour Health and Welfare Organization, Yokohama Rosai Hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 50 | Not selected | Japan | ||
840 | JPRN-UMIN000033222 | 2012/07/01 | 2 April 2019 | Clinical Results of Prophylactic Iodine-supported Primary TKA for Compromised Cases | Osteoarthritis, Rheumatoid arthritis of knee joint | prophylactic iodine-suported primaru TKA | Fukui General Hospital | Not Recruiting | 50years-old | 90years-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 |
841 | NCT01640054 | July 2012 | 19 October 2017 | A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis | (OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia | Rheumatoid Arthritis | Drug: Fostamatinib | AstraZeneca | Not recruiting | 18 Years | N/A | All | 115 | Phase 2 | Hong Kong;Japan;Korea, Republic of;Taiwan;Thailand;Vietnam | |
842 | NCT01659242 | July 2012 | 19 February 2015 | Leflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis:an Ultrasound/Magnetic Resonance Imaging Study | Leflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis Patients With Active Disease Despite Methotrexate: an Ultrasound and Magnetic Resonance Imaging Study | Rheumatoid Arthritis | Drug: Methotrexate plus sulfasalazine;Drug: Leflunomide | Singapore General Hospital | Not recruiting | 21 Years | 65 Years | Both | 1 | Phase 4 | Singapore | |
843 | NCT01665430 | July 2012 | 19 February 2018 | A Long-Term Extension Study to WA19926 (NCT01007435) of Tocilizumab in Participants With Early, Moderate to Severe Rheumatoid Arthritis | A Multicenter, Open-Label, Single Arm, Long-Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 38 | Phase 3 | Poland | |
844 | NCT01793259 | July 2012 | 19 February 2015 | Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA) | An Open-label, Randomized, Two-period Cross-over Study of Repeated Subcutaneous Injections of Methotrexate 50mg/ml Solution Either by a Pre-filled Syringe (Reference) or by a Disposable Pre-filled Pen (Test) to Assess Patient's Preference and Self-injection Experience and to Compare the Local Tolerability in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: methotrexate prefilled pen;Drug: methotrexate prefilled syringe | medac GmbH | Not recruiting | 18 Years | 75 Years | Both | 120 | Phase 3 | Germany | |
845 | NCT01893151 | July 2012 | 19 February 2015 | Effectiveness of Iguratimod Versus Placebo to Treat Early Rheumatoid Arthritis on MRI | A Randomized, Double-blind Study to Evaluate the Efficacy of Iguratimod Versus Placebo in Patients With Rheumatoid Arthritis on Magnetic Resonance Imaging (MRI) | Rheumatoid Arthritis | Drug: Iguratimod;Drug: Iguratimod placebo | Jiangsu Simcere Pharmaceutical Co., Ltd. | Recruiting | 18 Years | 65 Years | Both | 200 | 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 |
846 | EUCTR2011-005260-20-GB | 28/06/2012 | 28 February 2019 | RoActemra® (tocilizumab) plus methotrexate (MTX) in stable dosage in comparison with RoActemra® plus reducing (tapering) MTX dosages in patients with severe rheumatoid arthritis (RA) that have inadequate responded to a trial of two disease modifying anti-rheumatic drugs (DMARDs), including MTX and have not been previously treated with a biologic agent, such as a TNF inhibitor. | Randomised, Phase IV, placebo-controlled, comparative study to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rheumatoid arthritis (RA) who have demonstrated an inadequate response to prior conventional disease-modifying anti-rheumatic drugs (DMARDs) treatment and have initiated RoActemra® (tocilizumab, TCZ) in combination with MTX. - ACT-TAPER | Adult Rheumatoid Arthritis (RA) MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Pharmaceutical Form: Capsule, hard INN or Proposed INN: Methotrexate Disodium CAS Number: 7413345 Other descriptive name: Methotrexate as methotrexate disodium Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Pharmaceutical Form: Capsule, hard INN or Proposed INN: Methotrexate Disodium CAS Number: 7413345 Other descriptive name: Methotrexate as methotrexate disodium Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Methotrexate 2.5mg Tablets Pharmaceutical Form: Tablet INN or Proposed INN: Methotrexate Disodium CAS Number: 7413345 Other descriptive name: Methotrexate as methotrexate disodium Concentration unit: mg milligram(s) Concentration type: equal | Roche Products Limited | Not Recruiting | Female: yes Male: yes | 618 | Phase 4 | United Kingdom | |||
847 | EUCTR2011-005204-15-AT | 20/06/2012 | 30 April 2019 | Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped? | Ultrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop | biological DMARDs may be stopped in RA patients treated with a combination of synthetic DMARD plus biological DMARDs which are in persistent clinical remission. Ultrasound may be useful to predict a disease flare in patients stopping biological DMARDs therapy. MedDRA version: 20.0 Level: LLT Classification code 10039076 Term: Rheumatoid arthritis and other inflammatory polyarthropathies System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Enbrel Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT CAS Number: 185243-69-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: Humira Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Trade Name: Cimzia Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: CERTOLIZUMAB PEGOL CAS Number: 428863-50-7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 200- Trade Name: Simponi Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Roactemra Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Other descriptive name: TOCILIZUMAB | Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und Immunologie | Authorised | Female: yes Male: yes | 110 | Phase 4 | Austria | |||
848 | NCT01565655 | June 19, 2012 | 11 June 2019 | A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Patients | Arthritis, Rheumatoid | Drug: peficitinib;Drug: Placebo | Astellas Pharma Global Development, Inc. | Not recruiting | 18 Years | N/A | All | 289 | Phase 2 | Hungary;Mexico;Poland;Bulgaria;Czechia;United States;Czech Republic | |
849 | EUCTR2011-001122-18-HU | 13/06/2012 | 10 June 2014 | A Study of the Effectiveness and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Under the Skin of Patients with Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 15.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CNTO 1959 Pharmaceutical Form: Lyophilisate for solution for injection Current Sponsor code: CNTO 1959 Other descriptive name: CNTO 1959 IgG Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Code: CNTO 1959 Pharmaceutical Form: Lyophilisate for solution for injection Current Sponsor code: CNTO 1959 Other descriptive name: CNTO 1959 IgG Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: Ustekinumab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Janssen-Cilag International NV | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Colombia;Hungary;Czech Republic;Mexico;Argentina;Singapore;Peru;Bulgaria | |||
850 | NCT01638013 | June 13, 2012 | 22 October 2019 | A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K | Open-label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase 2b Study or Phase 3 Study of ASP015K | Arthritis, Rheumatoid | Drug: peficitinib | Astellas Pharma Inc | Not recruiting | 20 Years | N/A | All | 843 | Phase 3 | Japan;Korea, Republic of;Taiwan | |
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 |
851 | EUCTR2009-017998-37-BE | 08/06/2012 | 2 May 2016 | Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy. | Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy. | Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis. Patients with an active Crohn's disease. MedDRA version: 19.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: HLT Classification code 10052775 Term: Spondyloarthropathies System Organ Class: 100000004859 MedDRA version: 19.0 Level: HLT Classification code 10039078 Term: Rheumatoid arthropathies System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia 200 mg solution for injection Product Name: Certolizumab pegol Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe INN or Proposed INN: CERTOLIZUMAB PEGOL CAS Number: 428863-50-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Product Name: 99mTc-S-HYNIC Certolizumab pegol Pharmaceutical Form: Solution for injection INN or Proposed INN: CERTOLIZUMAB PEGOL CAS Number: 428863-50-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- | Ghent University Hospital | Authorised | Female: yes Male: yes | Belgium | |||||
852 | NCT01611688 | June 4, 2012 | 16 December 2017 | First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis | First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis | Inflammation;Rheumatoid Arthritis | Drug: NNC0215-0384;Drug: placebo | Novo Nordisk A/S | Not recruiting | 18 Years | 75 Years | All | 36 | Phase 1 | Germany | |
853 | JPRN-UMIN000007806 | 2012/06/01 | 2 April 2019 | The feasibility study of accelated infliximab infusion during maintenance phase | patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis) | Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure. | Chiba University Hospital | Not Recruiting | Not applicable | Not applicable | Male and Female | 54 | Phase 2 | Japan | ||
854 | NCT01602302 | June 2012 | 3 September 2018 | Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis | Ultrasound as Biomarker for Withdrawal of Biological DMARDs in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept) | Medical University of Graz | Recruiting | 18 Years | 90 Years | All | 110 | Phase 4 | Austria | |
855 | NCT01664104 | June 2012 | 16 December 2017 | A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting | CRP and BMI Study: Evaluation in Real Life of Clinical Remission Rate and Correlation Between CRP and BMI in Patients Treated With Tocilizumab | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 151 | N/A | 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 |
856 | NCT02052375 | June 2012 | 19 February 2015 | A Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Multiple Dose Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate | Rheumatoid Arthritis;Pharmacokinetics of ASP2408 | Drug: ASP2408;Drug: Placebo | Astellas Pharma Global Development, Inc. | Not recruiting | 18 Years | 75 Years | Both | 24 | Phase 1 | United States | |
857 | EUCTR2012-000222-21-DE | 31/05/2012 | 13 May 2013 | Comparison of the patient's experience with the methotrexate pre-filled syringe and with the methrotexate pre-filled pen and preference of the patient for subcutaneous methotrexate injection. | An open-label, randomized, two-period cross-over study of repeated subcutaneous injections of methotrexate 50mg/ml solution either by a pre-filled syringe (reference) or by a disposable pre-filled pen (test) to assess patient’s preference and self-injection experience and to compare the local tolerability in patients with active rheumatoid arthritis - Preference MTX pre-filled syringe vs pre-filled pen in RA | Rheumatoid Arthritis MedDRA version: 15.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: metex® 50 mg/ml Injektionslösung, Fertigspritze Product Name: metex® 50 mg/ml Injektionslösung, Fertigspritze Product Code: 70930.00.00 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Methotrexate disodium CAS Number: 59-05-2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Product Name: methotrexate pre-filled pen Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: Methotrexate disodium CAS Number: 59-05-2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | medac Gesellschaft für klinische Spezialpräparate mbH | Not Recruiting | Female: yes Male: yes | Germany | |||||
858 | EUCTR2011-005634-19-HU | 30/05/2012 | 25 February 2013 | A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 Pharmaceutical Form: Solution for injection INN or Proposed INN: mavrilimumab CAS Number: 1085337-57-0 Current Sponsor code: CAM-3001 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | MedImmune Ltd | Authorised | Female: yes Male: yes | 280 | Phase 2b | Serbia;Estonia;Spain;Ukraine;Chile;Russian Federation;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Bulgaria;South Africa;Germany | |||
859 | EUCTR2011-006040-79-DK | 25/05/2012 | 8 January 2018 | A clinical trial with the aim to explore the efficacy and safety of adding tocilizumab to standard of care in patients withearly rheumatoid arth | The efficacy and safety of adding tocilizumab to methotrexate and intra-articular glucocorticosteroid treatment in early rheumatoid arthritis. A randomized, double-blinded, placebo-controlled trial. - DanACT Early | Adult Rheumatoid Arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® Pharmaceutical Form: Concentrate for solution for infusion Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | Aarhus University Hospital, Department of Rheumatology U | Not Recruiting | Female: yes Male: yes | 180 | Phase 4 | Denmark | |||
860 | EUCTR2011-004419-22-DE | 23/05/2012 | 21 September 2015 | Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate | A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension | Rheumatoid Arthritis MedDRA version: 16.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: VX-509 Product Code: VX-509 Pharmaceutical Form: Tablet Current Sponsor code: VX-509 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Serbia;United States;Estonia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Mexico;Argentina;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 |
861 | NCT01569152 | May 22, 2012 | 1 April 2019 | Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008) | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial With a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis (RA) | Drug: MK-8457 100 mg;Drug: Dose-Matched Placebo;Drug: Methotrexate | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 82 | Phase 2 | Canada;Chile;Denmark;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Moldova, Republic of;Peru;Poland;South Africa;Taiwan;United Kingdom;United States | |
862 | EUCTR2011-005448-87-HU | 14/05/2012 | 10 July 2015 | A STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S) COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH ETANERCEPT PLUS DMARD(S) | A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S) COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH ETANERCEPT PLUS DMARD(S) | Rheumatoid Arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel® 50 mg Solution for Injection in Pre-filled Syringe Pharmaceutical Form: Solution for injection INN or Proposed INN: ETANERCEPT CAS Number: 185243-69-0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | Not Recruiting | Female: yes Male: yes | 320 | United Arab Emirates;Philippines;Saudi Arabia;Taiwan;Slovakia;Thailand;Ukraine;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Romania;South Africa;China | ||||
863 | EUCTR2012-000139-21-AT | 14/05/2012 | 15 October 2018 | Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action | A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade Product Name: Remicade Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: millilitre(s)/gram Concentration type: up to Concentration number: 100-5 Trade Name: Orencia Product Name: Orencia Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ABATACEPT CAS Number: 332348-12-6 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 250- Trade Name: Ro-Actemra Product Name: Ro Actemra Pharmaceutical Form: Concentrate for solution for infusion CAS Number: 375823-41-9 Other descriptive name: TOCILIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Trade Name: Mabthera Product Name: Mabthera Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Orencia Product Name: Orencia Pharmaceutical Form: Solution for injection INN or Proposed INN: ABATACEPT CAS Number: 332348-12-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Trade Name: Ro-Actemra Product Name: Ro Actemra Pharmaceutical Form: Solution for injection CAS Number: 375823-41-9 Other descriptive name: TOCILIZUMAB Concentration unit: millilitre(s)/gram Concentration type: equal Concentration number: 162- | Medizinische Universität Wien, Universitätsklinik für Innere Medizin III | Not Recruiting | Female: yes Male: yes | Phase 4 | Czech Republic;Slovakia;Austria;Russian Federation;Switzerland | ||||
864 | EUCTR2012-000439-17-LT | 11/05/2012 | 23 September 2013 | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis | active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MK-8457 Product Code: MK-8457 Pharmaceutical Form: Tablet INN or Proposed INN: None Other descriptive name: MK-8457 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: MK-8457 Product Code: MK-8457 Pharmaceutical Form: Tablet INN or Proposed INN: None Other descriptive name: MK-8457 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | MERCK SHARP & DOHME CORP. | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Denmark;Peru;South Africa;Latvia;Germany;Japan;Moldova, Republic of | |||
865 | EUCTR2011-005008-14-HU | 10/05/2012 | 12 November 2012 | Not applicable | Randomized, Double blind, Placebo-controlled, Multicenter, Phase II Study to Compare Four Dose Regimens of GLPG0634 Versus Placebo, in Combination With Methotrexate, Administered for 4 Weeks in the Treatment of Subjects With Active Rheumatoid Arthritis who have an Inadequate Response to Methotrexate Alone | Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 Pharmaceutical Form: Capsule, hard Current Sponsor code: GLPG0634 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: GLPG0634 Pharmaceutical Form: Capsule, hard Current Sponsor code: GLPG0634 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Product Name: GLPG0634 Pharmaceutical Form: Capsule, hard Current Sponsor code: GLPG0634 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Product Name: GLPG0634 Pharmaceutical Form: Capsule, hard Current Sponsor code: GLPG0634 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Galapagos SASU | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;European Union;Ukraine;Russian Federation;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 |
866 | EUCTR2011-005021-48-HU | 04/05/2012 | 9 October 2012 | A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX) | A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO | adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TL011 Product Code: TL011 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: TL011 Current Sponsor code: TL011 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Trade Name: MabThera®, 100 mg concentrate for solution for infusion Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Teva Pharmaceutical Industries | Not Recruiting | Female: yes Male: yes | 544 | Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland | ||||
867 | EUCTR2011-006125-14-HU | 04/05/2012 | 23 February 2015 | A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS - FUNCTION LTE | A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS - FUNCTION LTE | Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: RoActemra Product Code: RO4877533 Pharmaceutical Form: Concentrate for solution for infusion | Roche (Magyarország) Kft. | Not Recruiting | Female: yes Male: yes | 241 | Hungary | ||||
868 | JPRN-UMIN000007786 | 2012/05/01 | 2 April 2019 | "Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis " | Rheumatoid Arthritis | infliximab plus methotrexate | Saitama Medical Center. Saitama Medical University | Not Recruiting | 20years-old | 75years-old | Male and Female | 40 | Not applicable | Japan | ||
869 | JPRN-UMIN000014484 | 2012/05/01 | 2 April 2019 | Saitama Actemra study for QOL in patients with Rheumatoid arthritis | rheumatoid arthritis | Treatment with Tocilizumab | Juntendo University, Juntendo Koshigaya Hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 40 | Not selected | Japan | ||
870 | NCT01548001 | May 2012 | 14 March 2016 | Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis | A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod Alone or Iguratimod in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Iguratimod;Drug: Methotrexate | Jiangsu Simcere Pharmaceutical Co., Ltd. | Not recruiting | 18 Years | 65 Years | Both | 910 | 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 |
871 | NCT01554917 | May 2012 | 14 March 2016 | A Study of Iguratimod in Patients With Active Rheumatoid Arthritis | A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Iguratimod | Jiangsu Simcere Pharmaceutical Co., Ltd. | Not recruiting | 18 Years | N/A | Both | 1759 | Phase 4 | China | |
872 | NCT01559103 | May 2012 | 2 March 2015 | Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients | A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (Anti-IL-6) | Rheumatoid Arthritis | Biological: MEDI5117;Biological: MEDI5117 Placebo | AstraZeneca | Not recruiting | 20 Years | 75 Years | Both | 39 | Phase 1 | United States;Germany;United Kingdom | |
873 | NCT01576549 | May 2012 | 11 June 2018 | A Study of LY2127399 in Rheumatoid Arthritis | An Exploratory Open-Label Biomarker Study of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Synovial Biopsies | Rheumatoid Arthritis | Drug: LY2127399 | Eli Lilly and Company | Not recruiting | 18 Years | N/A | All | 2 | Phase 2 | United States | |
874 | NCT01579006 | May 2012 | 19 October 2017 | Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis | A Multi National, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (Actemra) | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Clalit Health Services | Not recruiting | 18 Years | N/A | All | 184 | N/A | Israel |
875 | NCT01613079 | May 2012 | 19 February 2015 | Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis | Evaluation of Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of RA Patients With Clinical Efficacy and Safety. | Arthritis, Rheumatoid | Drug: Tripterygium wilfordii Hook F;Drug: Methotrexate | Peking Union Medical College Hospital | Not recruiting | 18 Years | 65 Years | Both | 201 | 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 |
876 | NCT01617005 | May 2012 | 19 October 2017 | A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs) | Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 50 | N/A | Montenegro | |
877 | NCT01617590 | May 2012 | 19 February 2015 | Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research | A 48-week, Multi-center, Randomized, Open-lable, Controlled Study to Assess the Response (ACR20) Using Different Disease-Modifying Antirheumatic Drugs Cycle Combination Regimen in Adult Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: leflunomide;Drug: methotrexate | Shanxi Medical University | Recruiting | 18 Years | 75 Years | Both | 500 | N/A | China | |
878 | NCT01638715 | May 2012 | 12 November 2018 | A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action | A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action | Rheumatoid Arthritis | Drug: Remicade;Drug: Orencia;Drug: Ro-Actemra;Drug: Mabthera | Medical University of Vienna | Not recruiting | 18 Years | 75 Years | All | 115 | Phase 4 | Austria;Czechia;Russian Federation;Switzerland;Czech Republic;Saudi Arabia | |
879 | NCT01664598 | May 2012 | 15 August 2016 | An Extension Study of WA19926 of the Long-Term Safety of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis | A Multicenter, Open-label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 49 | Phase 3 | Russian Federation | |
880 | NCT01668641 | May 2012 | 19 February 2015 | Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients | Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Compare Four Dose Regimens of GLPG0634 Versus Placebo, in Combination With Methotrexate, Administered for 4 Weeks in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone | Rheumatoid Arthritis | Drug: GLPG0634;Drug: Placebo | Galapagos NV | Not recruiting | 18 Years | 70 Years | Both | 91 | Phase 2 | Hungary;Moldova, Republic of;Russian Federation;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 |
881 | NCT01724268 | May 2012 | 19 February 2015 | Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient | Randomized Controlled Clinical Trial of Low Dose Corticosteroids vs Anti TNF Treatment in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient- a Pilot Study | RHEUMATOID ARTHRITIS | Drug: Pred + Meth;Drug: Anti TNF + Meth | Hamad Medical Corporation | Recruiting | 18 Years | N/A | Both | 80 | Phase 3 | Qatar | |
882 | JPRN-UMIN000018017 | 2012/04/23 | 2 April 2019 | Analysis for the reactivation of hepatitis B virus (HBV) in rheumatoid arthritis or psoriasis patients with past HBV infection treated with anti-tumor necrosis factor-alpha therapy | rheumatoid arthritis or psoriasis patients with past hepatitis B virus infection | The effect of preventive lamivudine, adefovir or entecavir on de novo HBV hepatitis. | Department of general internal medicine, Kyushu-University hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 70 | Not selected | Japan | ||
883 | EUCTR2011-004529-28-HU | 18/04/2012 | 29 April 2013 | A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis | A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available | Rheumatoid Arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-40346527-AAC - capsule - 50 mg Product Code: JNJ-40346527 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Not assigned CAS Number: --- Current Sponsor code: JNJ-40346527-AAC Other descriptive name: Not assigned Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Janssen-Cilag International NV | Not Recruiting | Female: yes Male: yes | 90 | Phase 2a | Czech Republic;Hungary;Argentina;Poland;Ukraine;Singapore;Chile;Bulgaria;Russian Federation;Korea, Republic of | |||
884 | EUCTR2011-001729-25-DE | 11/04/2012 | 16 November 2015 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 17.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 Pharmaceutical Form: Solution for injection INN or Proposed INN: CERTOLIZUMAB PEGOL CAS Number: 428863-50-7 Current Sponsor code: CDP870 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: Trexan Product Name: Methotrexate Pharmaceutical Form: Tablet INN or Proposed INN: METHOTREXATE CAS Number: 59-05-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- | UCB Pharma SA | Not Recruiting | Female: yes Male: yes | 800 | United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | ||||
885 | JPRN-UMIN000011087 | 2012/04/11 | 2 April 2019 | Efficacy of monthly minodronate for the treatment of osteoporosis associated with rheumatoid arthritis after previous treatment with bisphosphonates | Osteoporosis | Minodronic acid (50mg/month or 1mg/day) | Osaka University Graduate School of Medicine | Not Recruiting | 20years-old | Not applicable | Male and Female | 100 | 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 |
886 | JPRN-UMIN000007380 | 2012/04/01 | 2 April 2019 | Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis | rheumatoid arthritis | tocilizumab + methotrexate (10mg/week) high-dose methotrexate (stepwisely increased to 16mg/week) | Kinki University Faculty of Medicine, Division of Hematology and Rheumatology | Not Recruiting | 20years-old | 80years-old | Male and Female | 40 | Not selected | Japan | ||
887 | JPRN-UMIN000007432 | 2012/04/01 | 2 April 2019 | Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody. | rheumatoid arthritis | Infliximab and Methotrexate. Patient is treated with IFX 3mg/kg for 0, 2, or 6 weeks, and henceforth every 8 weeks till 46weeks. Disease activity is assessed every 4weeks (suitable) or every 8 weeks (indispensable), and if SDAI Score 3.3 or more, it will change into of 3mg/kg 4week or 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks. If not remission(SDAI Score 3.3 or more), after change into of 3mg/kg 4week interval medication, it will change into of 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks. | Keio University | Not Recruiting | 20years-old | 75years-old | Male and Female | 100 | Not selected | Japan | ||
888 | NCT01484561 | April 2012 | 19 October 2017 | A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis | A Phase 1, Randomized, Placebo-Controlled, Two-Period, Fixed Sequence Study To Evaluate The Effect Of CP-690,550 On Measured Glomerular Filtration Rate In Patients With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: CP-690,550 or Placebo;Drug: Placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 148 | Phase 1 | United States;Czech Republic;Germany;Korea, Republic of;Mexico;Poland;Russian Federation;Spain | |
889 | NCT01557374 | April 2012 | 25 February 2019 | TOward the Lowest Effective DOse of Abatacept or Tocilizumab | Tapering Abatacept or Tocilizumab in Rheumatoid Arthritis in Remission. An Evaluation of Disease Activity, Relapse Risk, Structural Progression and the Economic Impact of a Tapering Strategy | Rheumatoid Arthritis | Drug: Tocilizumab, Abatacept;Drug: Decrease Tocilizumab, Abatacept | Assistance Publique - Hôpitaux de Paris | Ministry of Health, France | Not recruiting | 18 Years | N/A | All | 232 | Phase 4 | France |
890 | NCT01569074 | April 2012 | 19 October 2017 | Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis | (OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate Therapy | Rheumatoid Arthritis | Drug: Fostamatinib;Drug: Placebo | AstraZeneca | Not recruiting | 18 Years | N/A | All | 163 | Phase 2 | Hong Kong;Japan;Korea, Republic of;Taiwan;Thailand;Vietnam | |
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 |
891 | NCT01579890 | April 2012 | 19 February 2015 | Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid Arthritis | A Non-blinded, Non-placebo Controlled, Compassionate Use, Open Treatment, Open-ended Program of the Safety of Pennsaid Topical Lotion (Diclofenac) in the Treatment of Osteo or Rheumatoid Arthritis | Osteoarthritis of the Hand | Drug: Diclofenac | Mallinckrodt | Nuvo Research Inc. | Not recruiting | N/A | N/A | Both | N/A | ||
892 | NCT01583959 | April 2012 | 19 February 2015 | Study of Different Doses of Folic Acid in Combination With Methotrexate in Rheumatoid Arthritis | Randomized Trial of 10 mg Versus 30 mg Per Week of Folic Acid in Combination With Methotrexate in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Folic Acid;Drug: Placebo | Postgraduate Institute of Medical Education and Research | Not recruiting | 18 Years | 75 Years | Both | 100 | Phase 4 | India | |
893 | NCT01655381 | April 2012 | 19 October 2017 | A Long-Term Extension Study of WA19926 on the Safety of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid Arthritis | A Multicenter, Open-label, Single Arm, Long-term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 15 | Phase 3 | France | |
894 | NCT02171143 | April 2012 | 19 February 2015 | A Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on Methotrexate | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on Methotrexate | Rheumatoid Arthritis;Pharmacokinetics of ASP2409 | Drug: ASP2409;Drug: Placebo | Astellas Pharma Global Development, Inc. | Not recruiting | 18 Years | 75 Years | Both | 58 | Phase 1 | United States | |
895 | NCT02818361 | April 2012 | 3 December 2018 | Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis | Topical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Topical tripterygium gel;Drug: Placebo gel | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Not recruiting | 18 Years | 65 Years | All | 70 | N/A | 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 |
896 | EUCTR2011-002392-41-HU | 28/03/2012 | 14 January 2013 | A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis. | A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 Pharmaceutical Form: Capsule INN or Proposed INN: Prednisolone CAS Number: 52438-85-4 Current Sponsor code: Prednisolone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.7- INN or Proposed INN: Dipyridamole CAS Number: 58-32-2 Current Sponsor code: Dipyridamole Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 180- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Dacortin ® Product Name: Prednisone Pharmaceutical Form: Capsule INN or Proposed INN: PREDNISONE CAS Number: 53-03-2 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 5.0-7.5 Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Zalicus, Inc. | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria | |||
897 | EUCTR2011-006001-10-IT | 19/03/2012 | 25 September 2012 | Efficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response | Efficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response - | Rheumatoid arthritis MedDRA version: 14.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MABTHERA*EV 1FL 50ML 500MG Pharmaceutical Form: Injection INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Current Sponsor code: NA Other descriptive name: NA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000- Trade Name: MABTHERA*EV 1FL 50ML 500MG Pharmaceutical Form: Injection INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Current Sponsor code: NA Other descriptive name: NA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- | A.O. UNIVERSITARIA INTEGRATA DI VERONA | Authorised | Female: yes Male: yes | 48 | Italy | ||||
898 | EUCTR2011-002275-41-CZ | 15/03/2012 | 18 March 2013 | A Study of Two Different Adalimumab Formulations in Adults with Rheumatoid Arthritis. | A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis. | Rheumatoid Arthritis. MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | Abbott GmbH & Co. KG | Not Recruiting | Female: yes Male: yes | 60 | Belgium;Czech Republic | ||||
899 | JPRN-UMIN000017230 | 2012/03/01 | 2 April 2019 | Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies) | Rheumatoid arthritis | Biologic treatment (tocilizumab) | Kyushu University | Recruiting | 20years-old | Not applicable | Male and Female | 60 | Not selected | Japan | ||
900 | NCT01649999 | March 1, 2012 | 22 July 2019 | A Study to Evaluate the Efficacy and Safety of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects | Phase 2b Study of ASP015K - A Double-Blind, Placebo-Controlled, Dose-Finding Study in Moderate to Severe Rheumatoid Arthritis Patients | Arthritis, Rheumatoid | Drug: peficitinib;Drug: Placebo | Astellas Pharma Inc | Not recruiting | 20 Years | 75 Years | All | 281 | 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 |
901 | NCT01526057 | March 2012 | 19 February 2015 | A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01) | A Randomized, Double-Blind, Study Comparing The Pharmacokinetics And Pharmacodynamics, And Assessing The Safety Of PF-05280586 And Rituximab In Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate Who Have Had An Inadequate Response To One Or More TNF Antagonist Therapies | Rheumatoid Arthritis | Biological: PF-05280586;Biological: MabThera;Biological: Rituxan | Pfizer | Not recruiting | 18 Years | N/A | Both | 222 | Phase 1/Phase 2 | United States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Taiwan | |
902 | NCT01565408 | March 2012 | 16 December 2017 | Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid Arthritis | Safety and Tolerability of NNC0114-0006 Following Multiple s.c. Dosing at Escalating Dose Levels in Subjects With Rheumatoid Arthritis | Inflammation;Rheumatoid Arthritis | Drug: NNC0114-0006;Drug: placebo | Novo Nordisk A/S | Not recruiting | 18 Years | 75 Years | All | 32 | Phase 1 | Germany;Russian Federation | |
903 | NCT01582880 | March 2012 | 4 November 2019 | Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis | The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis | Chemical Injuries;Unspecified Complication of Corneal Transplant;Autoimmune Diseases;Ocular Cicatricial Pemphigoid;Stevens Johnson Syndrome;Lupus Erythematosus, Systemic;Rheumatoid Arthritis;Other Autoimmune Diseases | Drug: Riboflavin | Joseph B. Ciolino, MD | Not recruiting | 18 Years | N/A | All | 1 | Phase 1/Phase 2 | United States | |
904 | NCT01612377 | March 2012 | 19 February 2015 | Long Term Safety Trial of z102 and Prednisone in Patients With Moderate to Severe Rheumatoid Arthritis | A Phase II, Double-blind, Controlled, Multi-center, Randomized, Long Term Safety Trial of z102 and Prednisone (5 mg or 7.5 mg) in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Prednisolone-Dipyridamole;Drug: Prednisone;Drug: prednisone | Zalicus | Not recruiting | 18 Years | N/A | Both | 18 | Phase 2 | Serbia | |
905 | NCT01626573 | March 2012 | 25 March 2019 | A Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis | A Double- Blind, Placebo Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Itacitinib;Drug: Itacitinib Placebo | Incyte Corporation | Not recruiting | 18 Years | 75 Years | All | 106 | Phase 2 | United States;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 |
906 | NCT01670045 | March 2012 | 19 October 2017 | A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis | A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 43 | N/A | Indonesia;Greece | |
907 | EUCTR2011-004171-36-CZ | 15/02/2012 | 21 August 2012 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe Rheumatoid Arthritis (RA) MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAIT101 Product Code: SAIT101 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Current Sponsor code: SAIT101 Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Trade Name: MabThera® Product Name: MabThera® Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Samsung Electronics Co. Ltd. | Not Recruiting | Female: yes Male: yes | 616 | Poland;Spain;Korea, Republic of;Romania;Mexico;Argentina;Taiwan;Canada;United Kingdom;Russian Federation;Czech Republic;Brazil;South Africa;Turkey;Switzerland;Hungary | ||||
908 | NCT01623752 | February 10, 2012 | 2 July 2018 | Prospective Evaluation of the Radiographic Efficacy of Enbrel | A Prospective Evaluation Of The Radiographic Efficacy Of Etanercept In Patients With Rheumatoid Arthritis Or Psoriatic Arthritis. | Rheumatoid Arthritis;Psoriasis Arthritis | Drug: Etanercept | Pfizer | Not recruiting | 18 Years | N/A | All | 1816 | Phase 2 | ||
909 | JPRN-UMIN000006702 | 2012/02/01 | 2 April 2019 | A parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid Arthritis | rheumatoid arthritis | Intensive treatment group Period: 24 weeks In the intensive treatment group, a patient starts treatment with MTX at 8mg/week. Dosage is increased to 0.25mg/kg/week by week 8 and is further increased to his or her maximum tolerable dosage by week 12. The maximum tolerable dosage is maintained until week 24. If a patient shows inadequate response to MTX and does not achieve SDAI(simplified disease activity index)emission or CDAI (linical disease activity index)remission by week 16, additional treatment with tacrolimus, bucillamine, sarazosulfapyridine, or biologics will be started as scheduled in the protocol. After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72. Conventional treatment group Period: 24 weeks In the control group, a patient starts treatment with MTX, tacrolimus, bucillamine, sarazosulfapyridine, or biologics by attending rheumatologists' discretion by week 24. Biologics are allowed on and after week 12. After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72. | Tokyo Medical and Dental University | Department of Pharmacovigilance | Not Recruiting | 20years-old | 70years-old | Male and Female | 290 | Not applicable | Japan | |
910 | JPRN-UMIN000007019 | 2012/02/01 | 2 April 2019 | Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's disease | Rheumatoid arthritis | tocilizumab monotherapy | Department of Rheumatology & Clinical Immunology,Saitama Medical Center, Saitama Medical Universitity | Not Recruiting | 16years-old | 70years-old | 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 |
911 | JPRN-UMIN000007205 | 2012/02/01 | 2 April 2019 | The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis | Rheumatoid arthritis | 1) Tacrolimus Oral administration of tacrolimus is started usually at a dose of 1.5 mg/day immediately after informed consent is obtained. The dose can be increased or decreased within the limits of 3 mg/day with taking into account symptoms, adverse reactions and so on. However, the administration of tacrolimus can be started at a dose of 0.5 or 1.0 mg/day in order to reduce adverse effects. | Juntendo University | Not Recruiting | 65years-old | Not applicable | Male and Female | 30 | Not selected | Japan | ||
912 | NCT01352858 | February 2012 | 17 September 2018 | Autologous Tolerogenic Dendritic Cells for Rheumatoid Arthritis (AutoDECRA) | Phase 1 Study of Autologous Tolerogenic Dendritic Cells for Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: TolDC;Drug: Arthroscopy & saline irrigation alone | Newcastle University | Arthritis Research UK;Newcastle-upon-Tyne Hospitals NHS Trust | Recruiting | 18 Years | N/A | All | 15 | Phase 1 | United Kingdom |
913 | NCT01395251 | February 2012 | 25 May 2015 | Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis | Phase II/III Study of Oral Prednisolone Test in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Prednisolone | Rheumazentrum Ruhrgebiet | Not recruiting | 18 Years | N/A | Both | 130 | Phase 2/Phase 3 | Germany | |
914 | NCT01438892 | February 2012 | 19 February 2015 | Impact Of RA Therapy Compliance On Patient-Reported Outcomes | Impact Of RA Therapy Compliance On Patient-Reported Outcomes | Rheumatoid Arthritis | Drug: tDMARDs;Drug: biodmards | Pfizer | Not recruiting | 18 Years | N/A | Both | 396 | N/A | United States | |
915 | NCT01534884 | February 2012 | 1 June 2015 | Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis | Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: rituximab | Celltrion | Not recruiting | 18 Years | 75 Years | Both | 154 | Phase 1 | 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 |
916 | NCT01562327 | February 2012 | 19 October 2017 | A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis | A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab Actemra | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 50 | N/A | Argentina | |
917 | NCT01567358 | February 2012 | 19 February 2015 | Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis | A Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate | Rheumatoid Arthritis | Biological: Infliximab | Nichi-Iko Pharmaceutical Co.,Ltd. | Not recruiting | 20 Years | 75 Years | Both | 14 | Phase 1 | Japan | |
918 | NCT01613027 | February 2012 | 19 October 2017 | An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis | A Multicenter Observational Study of the Response to Rituximab (MabThera®) in Seropositive Patients With Rheumatoid Arthritis With Inadequate Response or Intolerance to Treatment With One or More Tumor Necrosis Factor Inhibitors (TNFi) | Rheumatoid Arthritis | Biological: Rituximab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 135 | N/A | Greece | |
919 | NCT01646385 | February 2012 | 19 October 2017 | Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry | Long-term Safety and Efficacy of Etanercept in a UK Observational Cohort Study - a Retrospective Database Analysis of British Society of Rheumatology Biologics Registry (BSRBR) Data | Rheumatoid Arthritis | Drug: etanercept;Drug: non-biologic anti-rheumatic drugs | Pfizer | Not recruiting | 18 Years | N/A | All | 6393 | N/A | ||
920 | NCT01940926 | February 2012 | 16 December 2017 | 68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid Arthritis | Diagnostic Performance and Evaluation Efficacy of 68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: 68Ga-BNOTA-PRGD2 | Peking Union Medical College Hospital | Not recruiting | 18 Years | N/A | All | 50 | Early 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 |
921 | NCT02090556 | January 31, 2012 | 26 November 2018 | Long-term Experience With Abatacept SC in Routine Clinical Practice | Long-term Experience With Abatacept SC in Routine Clinical Practice | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | inVentiv Health Clinical;PharmaNet | Not recruiting | 18 Years | N/A | All | 2896 | N/A | Australia;Austria;France;Germany;Greece;Italy;Monaco;Netherlands;Spain;Switzerland;United Kingdom |
922 | EUCTR2011-002849-36-LV | 12/01/2012 | 28 September 2015 | A study of multiple different dosages of JNJ 39758979 and placebo in patients with active Rheumatoid Arthritis | A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ-39758979 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available | Rheumatoid Arthritis MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-39758979-AAC - enteric coated tablet - 10 mg Product Code: JNJ-39758979 Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: Not assigned CAS Number: Not assigned Current Sponsor code: JNJ-39758979-AAC Other descriptive name: Not assigned Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Gastro-resistant tablet Route of administration of the placebo: Oral use Product Name: JNJ-39758979-AAC - enteric coated tablet - 30 mg Product Code: JNJ-39758979 Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: Not assigned CAS Number: Not assigned Current Sponsor code: JNJ-39758979-AAC Other descriptive name: Not assigned Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Gastro-resistant tablet Route of administration of the placebo: Oral use Product Name: JNJ-39758979-AAC - enteric coated tablet - 100 mg Product Code: JNJ-39758979 Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: Not assigned CAS Number: Not assigned Current Sponsor code: JNJ-39758979-AAC Other descriptive name: Not assigned Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Gastro-resistant tablet Route of administration of the placebo: Oral use | Janssen-Cilag International NV | Not Recruiting | Female: yes Male: yes | 325 | Phase 2b | Japan;Latvia;Romania;Singapore;Malaysia;Poland;Argentina;Mexico;Czech Republic;Colombia;Chile;Russian Federation;Ukraine;United States | |||
923 | EUCTR2011-004468-31-GB | 06/01/2012 | 28 August 2012 | Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | Rheumatoid Arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT-P13 Product Code: CT-P13 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 | 617 | Poland;Philippines;Bosnia and Herzegovina;Spain;Romania;Mexico;Peru;Ukraine;Slovakia;United Kingdom;Lithuania;Austria;Latvia;Italy;Chile;Bulgaria;Colombia;Portugal | ||||
924 | ChiCTR-TRC-12001859 | 2012-01-01 | 18 April 2017 | Treatment of coronary heart disease in rheumatoid arthritis with leflunomide combined with ligustrazine in clinical research | Treatment of coronary heart disease in rheumatoid arthritis with leflunomide combined with ligustrazine in clinical research | coronary heart disease in rheumatoid arthritis | 1:leflunomide combined with ligustrazine;2:leflunomide combined with placebo; | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences | Not Recruiting | 18 | 65 | Both | 1:30;2:30; | Other | China | |
925 | JPRN-UMIN000012613 | 2012/01/01 | 2 April 2019 | Reduction or withdrawal of etanercept after remission with etanerceptin patients with rheumatoid arthritis patients. | rheumatoid arthritis | etanercept50mg/wk or25mg twice/wk reduction of etanercept to 25mg/wk arfter 3 months from remission | Dept. of orthopedic surgery, Osaka Medical College | Not Recruiting | 20years-old | 70years-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 |
926 | NCT01474291 | January 2012 | 19 October 2017 | An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice | Evaluation of Factors Influencing Use of RoActemra® as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLO | Rheumatoid Arthritis | Biological: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 608 | N/A | France;Monaco | |
927 | NCT01502423 | January 2012 | 19 October 2017 | A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab | A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Adalimumab | AbbVie (prior sponsor, Abbott) | Not recruiting | 18 Years | N/A | All | 61 | Phase 2 | Australia;Canada;Germany | |
928 | NCT01506661 | January 2012 | 16 December 2017 | Zostavax in Rheumatoid Arthritis | Immune Response to Varicella Zoster Vaccination (ZOSTAVAX) in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis;Varicella Zoster | Drug: Zostavax (varicella zoster virus) vaccine | Oklahoma Medical Research Foundation | Not recruiting | 50 Years | 80 Years | All | 20 | Phase 1 | United States | |
929 | NCT01519791 | January 2012 | 11 June 2018 | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Certolizumab Pegol;Other: Placebo;Biological: Methotrexate | UCB Pharma SA | Not recruiting | 18 Years | N/A | All | 880 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;Ireland;Italy;Mexico;Monaco;Netherlands;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom;Czech Republic | |
930 | NCT01521923 | January 2012 | 11 June 2018 | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Certolizumab Pegol + Methotrexate (MTX);Biological: Placebo + Methotrexate (MTX) | UCB Pharma | Not recruiting | 18 Years | N/A | All | 359 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;Ireland;Italy;Mexico;Monaco;Netherlands;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom;Czech Republic | |
No. | 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 |
931 | NCT01533714 | January 2012 | 19 February 2015 | The Long-term Safety and Efficacy of Olokizumab (CDP6038) With Active Rheumatoid Arthritis | Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety and Efficacy of CDP6038 Administered Subcutaneously to Asian Subjects With Active Rheumatoid Arthritis Who Completed Study RA0083 | Rheumatoid Arthritis | Biological: Olokizumab | UCB Pharma | Not recruiting | 20 Years | N/A | Both | 103 | Phase 2 | Japan;Korea, Republic of;Taiwan | |
932 | EUCTR2010-023782-22-ES | 16/12/2011 | 18 September 2012 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 14.0 Level: LLT Classification code 10066578 Term: Progression of rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 Pharmaceutical Form: Tablet CAS Number: 1044535-58-1 Current Sponsor code: PF-04171327 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Code: PF-04171327 Pharmaceutical Form: Tablet CAS Number: 1044535-58-1 Current Sponsor code: PF-04171327 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Code: PF-04171327 Pharmaceutical Form: Tablet CAS Number: 1044535-58-1 Current Sponsor code: PF-04171327 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Decortin Pharmaceutical Form: Capsule INN or Proposed INN: PREDNISONE CAS Number: 53-03-02 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Pfizer, S.L.U. | Authorised | Female: yes Male: yes | 315 | Phase 2 | Poland;United States;Spain;Romania;Korea, Republic of;Mexico;Canada;Serbia;Ukraine;Czech Republic;Russian Federation;Slovakia;India;South Africa;Bulgaria;Malaysia;Germany;Colombia;Hungary | |||
933 | EUCTR2011-000436-28-PL | 07/12/2011 | 18 March 2013 | A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis. | A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 Pharmaceutical Form: Capsule INN or Proposed INN: Z102 (Prednisolone and Dipyridamole). Current Sponsor code: Z102 (Prednisolone and Dipyridamole). Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 360- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Name: Prednisolone Product Code: Prednisolone Pharmaceutical Form: Capsule INN or Proposed INN: Prednisolone CAS Number: 52438-85-4 Current Sponsor code: Prednisolone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.7- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Name: Dipyridamole Product Code: Dipyridamole Pharmaceutical Form: Capsule INN or Proposed INN: Dipyridamole CAS Number: 58-32-2 Current Sponsor code: Dipyridamole Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 180- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Dacortin ® Pharmaceutical Form: Capsule INN or Proposed INN: PREDNISONE CAS Number: 53-03-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Zalicus, Inc. | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Serbia;Hungary;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Chile;Bulgaria;Russian Federation | |||
934 | NCT01511003 | December 5, 2011 | 20 August 2018 | A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs) | An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDs | Rheumatoid Arthritis | Drug: Tacrolimus | Astellas Pharma Inc | Astellas Pharma Korea, Inc. | Not recruiting | 20 Years | 75 Years | All | 128 | Phase 4 | Korea, Republic of |
935 | NCT01443364 | December 2011 | 16 December 2017 | Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis | Multicenter, Open Label Study to Evaluate the Predictability of Early Response to Certolizumab Pegol (in Combination With Methotrexate) as Confirmed at Week 52 in Subjects With Moderate-severe Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Biological: Certolizumab pegol | UCB Italy s.p.a. | Not recruiting | 18 Years | N/A | All | 132 | 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 |
936 | NCT01500278 | December 2011 | 16 December 2017 | Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate | A Multicenter, Single-blind, Randomized Parallel-group Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis Responding Inadequately to Methotrexate | Rheumatoid Arthritis | Biological: Certolizumab Pegol (CZP);Biological: Adalimumab (ADA);Drug: Methotrexate (MTX) | UCB Pharma SA | Parexel | Not recruiting | 18 Years | N/A | All | 915 | Phase 4 | Czechia;France;Germany;Greece;Hungary;Ireland;Italy;Mexico;Monaco;Poland;Portugal;Romania;Spain;Switzerland;United Kingdom;United States;Czech Republic;Canada;Bulgaria;Austria;Australia |
937 | NCT01326962 | November 30, 2011 | 16 December 2017 | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF | Tocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNF | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 28 | Phase 3 | Saudi Arabia | |
938 | EUCTR2011-005036-26-GB | 29/11/2011 | 28 August 2012 | A study to investigate what effects FX125L (taken by mouth) has on adults with chronic inflammatory diseases | An Exploratory Phase IIa Study to Investigate the Biological Activity of Oral FX125L in Adult Patients with Chronic Inflammatory Disease | Asthma Chronic obstructive pulmonary disease Rheumatoid arthritis Psoriasis MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: FX125L Pharmaceutical Form: Capsule Current Sponsor code: FX125L Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Funxional Therapeutics Ltd | Not Recruiting | Female: yes Male: yes | Phase 2a | United Kingdom | ||||
939 | ChiCTR-TRC-11001789 | 2011-11-14 | 18 April 2017 | Effect of TGP combined with MTX and LEF on liver function in RA patients: Clinical study protocol | Effect of TGP combined with MTX and LEF on liver function in RA patients: Clinical study protocol | Rheumatoid Arthritis | Treatment:TGP capsules (TGP) + methotrexate (MTX) + leflunom;Control:methotrexate(MTX) + leflunomide (LEF); | Anhui Provincial Hospital Department of Rheumatism | Not Recruiting | 18 | 65 | Both | Treatment:140;Control:140; | Post-market | China | |
940 | NCT01251120 | November 2011 | 19 October 2017 | A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis | A Pragmatic, Randomized, Parallel Group Study of the Effect on Disease Remission, Work Productivity and Tolerability of Tocilizumab in Combination With DMARDs and Individually Designed Best Practice DMARD Therapy in Patients With Early, Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: DMARD | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 2 | 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 |
941 | NCT01408602 | November 2011 | 19 February 2015 | A Study of Two Doses of MRC375 in Moderate to Severe Rheumatoid Arthritis Patients | A 24-week, Phase 2, Double-blind, Placebo-controlled, Randomized Study to Assess the Safety and Efficacy of 2 Doses of MRC375 in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MRC375;Drug: Matching Placebo;Drug: MRC375 150mg | Molecular Research Center, Inc. | Camargo Pharmaceutical Services;Clin Data Services;Harrison Clinical Research;BARC Global Central Laboratory;Bilcare Global Clinical Supplies | Not recruiting | 18 Years | N/A | Both | 300 | Phase 2 | United States |
942 | NCT01468077 | November 2011 | 19 October 2017 | A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment | Multicenter, Randomized, Parallel Group Study to Compare the Incidence of Tocilizumab Related Infusion Reactions in Patients With Moderate to Severe Active RA, When Infusion is Given Over 31 Minutes Compared to 1 Hour | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 47 | Phase 2 | Denmark;Iceland | |
943 | NCT01469013 | November 2011 | 30 September 2019 | Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of Baricitinib (LY3009104) in Japanese Patients With Active Rheumatoid Arthritis on Background Methotrexate Therapy | Arthritis, Rheumatoid | Drug: Placebo;Drug: Baricitinib;Drug: Methotrexate | Eli Lilly and Company | Not recruiting | 20 Years | 75 Years | All | 145 | Phase 2 | Japan | |
944 | NCT01592292 | November 2011 | 19 October 2017 | An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy | A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent | Rheumatoid Arthritis | Drug: Rituximab;Drug: Adalimumab;Drug: Etanercept;Drug: Infliximab | Hoffmann-La Roche | Not recruiting | 20 Years | N/A | All | 90 | N/A | Korea, Republic of | |
945 | NCT02243800 | November 2011 | 8 August 2016 | Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency | Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency | Rheumatoid Arthritis;Vitamin D Deficiency | Other: cholecalciferol versus placebo | University Hospital, Clermont-Ferrand | CRINEX Laboratory;BP 337 - 3 rue de Gentilly;92541 MONTROUGE Cedex FRANCE | Recruiting | 18 Years | N/A | Both | 164 | 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 |
946 | NCT01451203 | October 11, 2011 | 16 December 2017 | Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis | A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Patients With Early-stage Rheumatoid Arthritis Who Are Naïve to Methotrexate and Have Poor Prognostic Factors | Rheumatoid Arthritis | Drug: Placebo;Drug: CZP;Drug: methotrexate (MTX) | Astellas Pharma Inc | UCB Japan Co. Ltd. | Not recruiting | 20 Years | 64 Years | All | 319 | Phase 3 | Japan |
947 | NCT01548768 | October 10, 2011 | 15 July 2019 | RHYTHM (Formerly Escape II Myocardium) | RHYTHM (RHeumatoid Arthritis studY of THe Myocardium): How Rheumatoid Arthritis (RA) and Tumor Necrosis Factor (TNF) Inhibitors Affect the Myocardial Structure and Function. | Rheumatoid Arthritis | Drug: TNF inhibitors;Drug: DMARDs | Columbia University | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | N/A | All | 175 | Phase 4 | United States |
948 | NCT01292616 | October 2011 | 19 February 2015 | Effect of TNF-Inhibition Combined With Conventional DMARDs on Cervical Pannus in Patients With RA and Cervical Spine Involvement | Rheumatoid Arthritis | Drug: therapy with disease-modifying anti rheumatic drugs (DMARD) | University of Zurich | Recruiting | 18 Years | N/A | Both | 15 | N/A | Switzerland | ||
949 | NCT01359943 | October 2011 | 19 October 2017 | Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate | A Randomized, Double-blind, Placebo-controlled Study of Efficacy, Safety and Tolerability of Secukinumab at 12 Weeks Administered With an Intravenous (i.v.) or Subcutaneous (s.c.) Loading Regimen Compared to Placebo in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate | Rheumatoid Arthritis | Biological: secukinumab (AIN457);Drug: placebo | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 221 | Phase 2 | United States;Bulgaria;Canada;Hungary;Italy;Poland;Puerto Rico;Slovakia | |
950 | NCT01436370 | October 2011 | 19 October 2017 | TIV and High Dose TIV in Subjects With Rheumatoid Arthritis | A Phase II Study in Adults With Rheumatoid Arthritis Receiving TNF-alpha-inhibitor Therapy to Assess the Immunogenicity and Safety of Trivalent Inactivated Vaccine (TIV) and High Dose Trivalent Inactivated Vaccine (High-Dose TIV) Administered at Two Dosage Levels | Influenza | Biological: Trivalent inactivated influenza vaccine | National Institute of Allergy and Infectious Diseases (NIAID) | Not recruiting | 18 Years | 64 Years | All | 102 | 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 |
951 | NCT01439204 | October 2011 | 19 October 2017 | Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb | A Randomized, Open-label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of Abatacept (BMS-188667) Drug Products Using Active Pharmaceutical Ingredient Manufactured at Devens, MA Site Relative to Active Pharmaceutical Ingredient Manufactured at Lonza, New Hampshire (NH) in Healthy Subjects | Rheumatoid Arthritis | Biological: Abatacept (BMS-188667) | Bristol-Myers Squibb | Not recruiting | 18 Years | 55 Years | All | 223 | Phase 1 | United States | |
952 | NCT01463059 | October 2011 | 19 February 2015 | Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy | A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker Therapy | Rheumatoid Arthritis | Biological: Placebo;Biological: Olokizumab 60 mg;Biological: Olokizumab 120 mg;Biological: Olokizumab 240 mg | UCB Japan Co. Ltd. | Not recruiting | 20 Years | N/A | Both | 119 | Phase 2 | Japan;Korea, Republic of;Taiwan | |
953 | NCT01557322 | October 2011 | 19 October 2017 | Characterize Patients With Moderately Active Rheumatoid Arthritis (RA) | Evaluation of the Clinical Characteristics, Real-world Treatment Pathways, and Outcomes of Patients With Moderate Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: etanercept;Drug: methotrexate (MTX) | Pfizer | Not recruiting | 18 Years | N/A | All | 1754 | N/A | ||
954 | NCT01641952 | October 2011 | 19 October 2017 | An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent | Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program | Rheumatoid Arthritis | Drug: Rituximab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 505 | N/A | Romania | |
955 | NCT01954381 | October 2011 | 3 August 2015 | Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis | Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Device: transthoracic echocardiographic;Device: Doppler ultrasound.;Biological: blood samples | Assistance Publique Hopitaux De Marseille | Not recruiting | 18 Years | N/A | Both | 60 | 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 |
956 | NCT01961505 | October 2011 | 16 December 2017 | Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid Arthritis | A Randomized Controlled Study to Determine the Effects and Safety of Topical Compound Tripterygium Wilfordii Hook F in Patients With Active Rheumatoid Arthritis. | Active Rheumatoid Arthritis | Drug: Topical compound tripterygium;Drug: Placebo | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Not recruiting | 18 Years | 65 Years | All | 70 | N/A | ||
957 | NCT01245439 | September 2011 | 19 October 2017 | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis | Local Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 65 | Phase 3 | Turkey | |
958 | NCT01350804 | September 2011 | 19 October 2017 | Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor a (Anti-TNFa) Agents (CAIN457F2309 and CAIN457F2309E1) | A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents (CAIN457F2309) and A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2309E1) | Rheumatoid Arthritis | Biological: AIN457;Biological: Placebo;Biological: Abatacept | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 551 | Phase 3 | United States;Brazil;Bulgaria;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Mexico;Romania;Russian Federation;Slovakia;Spain | |
959 | NCT01359150 | September 2011 | 19 October 2017 | A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo | A Randomized, Double Blind, Placebo Controlled Phase 2 Study To Assess The Immune Response Following Administration Of Influenza And Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving Cp-690,550 Or Placebo Cp-690,550 With And Without Background Methotrexate | Rheumatoid Arthritis | Drug: CP-690,550;Drug: placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 223 | Phase 2 | United States;Poland | |
960 | NCT01374971 | September 2011 | 19 October 2017 | Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia) | Open-Label Pre and Post Treatment Arthroscopic Synovial Biopsy Study for the Assessment of Certolizumab Pegol Immunomodulatory Synovial Effects on Select Biomarkers and Gene Expression | Rheumatoid Arthritis | Drug: Certolizumab Pegol (CZP);Procedure: Arthroscopic synovial tissue biopsy | Nathan Wei, MD, FACP, FACR: | University of California, San Diego | Not recruiting | 18 Years | N/A | All | 12 | Phase 3 | 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 |
961 | NCT01393639 | September 2011 | 18 December 2018 | Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis | A Phase 2, Randomized, Double Blind Assessment Of Efficacy And Safety Of Pf 04171327(1, 5, 10, 15 Mg Dose, Daily) Compared To 5 Mg And 10 Mg Prednisone Daily And Placebo Daily In Subjects With Rheumatoid Arthritis Over An 8 Week Period Followed By A 4 Week Period Of Tapering Of Study Drug. | Rheumatoid Arthritis | Drug: PF-04171327;Drug: prednisone;Other: prednisone;Other: placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 323 | Phase 2 | United States;Bulgaria;Colombia;Czechia;Germany;Hungary;India;Korea, Republic of;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;Canada;Czech Republic | |
962 | NCT01399697 | September 2011 | 19 October 2017 | A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate | A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With MTX Versus Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 > 3,2) | Rheumatoid Arthritis | Drug: methotrexate;Drug: placebo;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 261 | Phase 4 | Spain | |
963 | NCT01404585 | September 2011 | 19 February 2015 | Proof-of-Concept Study With BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults With Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: Placebo;Drug: BMS-817399 | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | Both | 123 | Phase 2 | United States;Argentina;Korea, Republic of;Mexico;Russian Federation;South Africa;Spain | |
964 | NCT01417052 | September 2011 | 19 February 2015 | A Study to Determine the Safety and Efficacy of LX3305 in Subjects With Active Rheumatoid Arthritis | A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: 50 mg LX3305 QD;Drug: 100 mg LX3305 QD;Drug: 150 mg LX3305 QD;Drug: 200 mg LX3305 QD;Drug: 250 mg LX3305 QD;Drug: 300 mg LX3305 QD;Drug: 400 mg LX3305 QD;Drug: 250 mg LX3305 BID;Drug: 500 mg LX3305 QD;Drug: Placebo | Lexicon Pharmaceuticals | Not recruiting | 18 Years | 75 Years | Both | 10 | Phase 1 | United States | |
965 | NCT01446978 | September 2011 | 7 December 2015 | Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs | Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate | Vaccine Response Impaired | Biological: hepatitis A vaccine | Sormland County Council, Sweden | Not recruiting | 18 Years | N/A | Both | 150 | Phase 2 | 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 |
966 | NCT01462162 | September 2011 | 19 October 2017 | A Prospective Observational Study of Tocilizumab (RoActemra/Actemra) in Participants With Rheumatoid Arthritis | A Prospective Observational Study to Evaluate and Correlate the Impact of Treatment With Tocilizumab (RoActemra®) on Fatigue and Different Factors Influencing Fatigue in Participants With Rheumatoid Arthritis in Routine Clinical Practice | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 122 | N/A | Spain | |
967 | NCT01544101 | September 2011 | 19 February 2015 | A Nutritional Intervention for Arthritis | A Nutritional Intervention for Arthritis | Rheumatoid Arthritis | Other: Vegan Diet;Dietary Supplement: dietary supplement omega3 fatty acids aand vitamins | Physicians Committee for Responsible Medicine | Not recruiting | 18 Years | N/A | Both | 32 | N/A | United States | |
968 | NCT02076659 | September 2011 | 11 June 2018 | Combination Therapy of F8IL10 and Methotrexate in Rheumatoid Arthritis Patients | A Dose-finding, Pharmacokinetic Phase I Study of the Human Monoclonal Antibody-cytokine Fusion Protein F8IL10 (Dekavil) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: F8IL10;Drug: Methotrexate | Philogen S.p.A. | Not recruiting | 18 Years | 75 Years | All | 36 | Phase 1 | Italy | |
969 | NCT02164214 | September 2011 | 21 September 2015 | Does Etanercept Influence Tweak Modulation of Inflammation During Inflammatory Rheumatisms (Psoriatic Arthritis and Rheumatoid Arthritis)? | DOES ETANERCEPT INFLUENCE TWEAK MODULATION OF INFLAMMATION DURING INFLAMMATORY RHEUMATISMS (PSORIATIC ARTHRITIS AND RHEUMATOID ARTHRITIS)? | Inflammatory Rheumatism;Psoriatic Arthritis;Rheumatoid Arthritis | Drug: etanercept Treatment | Assistance Publique Hopitaux De Marseille | Not recruiting | 18 Years | N/A | Both | 60 | Phase 3 | France | |
970 | EUCTR2011-000102-21-CZ | 19/08/2011 | 23 February 2015 | Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents | A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1 | Rheumatoid arthritis MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: Secukinumab Current Sponsor code: AIN457 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Powder for solution for injection Route of administration of the placebo: Subcutaneous use Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use Trade Name: Orencia Product Name: Abatacept Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: ABATACEPT CAS Number: 332348-12-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 548 | Germany;Bulgaria;Romania;Brazil;Canada;Mexico;Hungary;Czech Republic;France;Italy;Colombia;Russian Federation;Spain;Slovakia;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 |
971 | EUCTR2010-023956-99-HU | 17/08/2011 | 4 August 2015 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to Methotrexate Pharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011) Revised Protocol 04 incorporating Protocol Amendment 12 | RHEUMATOID ARTHRITIS,NOS MedDRA version: 17.1 Level: LLT Classification code 10039076 Term: Rheumatoid arthritis and other inflammatory polyarthropathies System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CLAZAKIZUMAB Product Code: BMS-945429 Pharmaceutical Form: Solution for injection INN or Proposed INN: CLAZAKIZUMAB Current Sponsor code: BMS-945429 Other descriptive name: anti-IL-6 mAb Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: Humira Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40/0.8- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: Methotrexate Pharmaceutical Form: Tablet INN or Proposed INN: METHOTREXATE CAS Number: 59-05-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Methotrexate Pharmaceutical Form: Tablet INN or Proposed INN: METHOTREXATE CAS Number: 59-05-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Product Name: CLAZAKIZUMAB Product Code: BMS-945429 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: CLAZAKIZUMAB CAS Number: 1236278-28-6 Current Sponsor code: BMS945429 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- | Bristol-Myers Squibb International Corporation | Not Recruiting | Female: yes Male: yes | 677 | Phase 2B | Korea, Republic of;Japan;Germany;Netherlands;South Africa;Peru;Brazil;Belgium;Argentina;Canada;Mexico;Czech Republic;Hungary;France;Italy;Russian Federation;Spain;Taiwan;United States | |||
972 | EUCTR2011-002363-15-IS | 17/08/2011 | 19 January 2015 | A clinical trial with the aim to explore infusion reactions from Tocilizumab given either in 31 or 60 minutes to patients with moderate to severe rheumatoid arthritis. | Multicenter, randomized, parallel group study to compare the incidence of Tocilizumab related infusion reactions in patients with moderate to severe active RA, when infusion is given over 31 minutes compared to 1 hour. - ACT FAST | Adult Rheumatoid Arthritis MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® Pharmaceutical Form: Concentrate for solution for infusion | Roche a/s | Not Recruiting | Female: yes Male: yes | 56 | Denmark;Iceland | ||||
973 | NCT01331837 | August 2, 2011 | 16 December 2017 | A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors | A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Etanercept;Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 50 Years | N/A | All | 3080 | Phase 4 | United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Canada;Chile;Croatia;Czechia;Ecuador;France;Germany;Greece;Hungary;India;Israel;Italy;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Turkey;United Kingdom;Brazil;China;Czech Republic | |
974 | NCT01400516 | August 2011 | 16 December 2017 | Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial | Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial | Rheumatoid Arthritis | Drug: Teriparatide;Drug: calcium citrate;Drug: Vitamin D;Drug: TNF antagonist | Brigham and Women's Hospital | Eli Lilly and Company | Not recruiting | 45 Years | N/A | All | 26 | Phase 4 | United States |
975 | NCT01414101 | August 2011 | 19 February 2015 | Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ISIS 329993 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ISIS CRP Rx or Placebo | Isis Pharmaceuticals | Not recruiting | 18 Years | 75 Years | Both | 51 | Phase 2 | Canada;Russian Federation | |
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 |
976 | NCT01426789 | August 2011 | 19 October 2017 | A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients | A Multicenter, 12 Week, Randomized, Double-blind, Placebo-controlled Biomarker Study of Secukinumab (AIN457) in Rheumatoid Arthritis Patients Followed by an Open Label Extension | Rheumatoid Arthritis | Drug: Placebo;Drug: Secukinumab | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 100 | Phase 2 | United States;Belgium;Germany;Russian Federation;United Kingdom | |
977 | NCT01442545 | August 2011 | 19 February 2015 | A Study to Investigate How JNJ-39758979 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants | A Study to Investigate the Effect of Multiple Doses of JNJ 39758979 on Methotrexate Pharmacokinetics in Rheumatoid Arthritis Patients on a Stable Methotrexate Dose | Rheumatoid Arthritis | Drug: JNJ-39758979 / MTX | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Not recruiting | 18 Years | 75 Years | Both | 21 | Phase 1 | United States;Germany | |
978 | JPRN-UMIN000013750 | 2011/07/31 | 2 April 2019 | Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis | Rheumatoid arthritis, Periodontitis | IL-6 receptor inhibition group: Tocilizumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later. TNF inhibition group: Infliximab, Etanercept, and Adalimumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later. | Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences | Not Recruiting | Not applicable | Not applicable | Male and Female | 80 | Not selected | Japan | ||
979 | EUCTR2011-000275-13-HU | 29/07/2011 | 10 July 2015 | Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs | A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents | Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: Secukinumab Current Sponsor code: AIN457 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Powder for solution for injection Route of administration of the placebo: Subcutaneous use Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use | Novartis Pharma AG | Not Recruiting | Female: yes Male: yes | 630 | Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan | ||||
980 | EUCTR2011-001863-39-AT | 28/07/2011 | 7 April 2014 | A study of saftey and efficacy of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab Monotherapy in patients with mild to moderate rheumatoid arthritis, who have not adequately responded to their current treatment with MTX. | A multi-center study of the safety and effect on disease activity of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab monotheraphy in patients with mild to moderate rheumatoid arthritis, with inadequate response to MTX (defined as DAS 28 = 4,5 and > 2,6) - OPTIMISE | Mild to moderate rheumatoid arthritis MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: Tocilizumab Product Code: RO4877533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Trade Name: Methotrexat Lederle 2.5mg tablets Product Name: Methotrexat Product Code: RO0029893 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Methotrexate Disodium CAS Number: 7413345 Current Sponsor code: RO0029893 Other descriptive name: Methotrexate as methotrexate disodium Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Roche Austria GmbH | Not Recruiting | Female: yes Male: yes | Austria | |||||
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 |
981 | NCT01382940 | July 26, 2011 | 16 December 2017 | A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis | A Multicenter, Open-label, Single-arm Study to Evaluate the Safety Administering Rituximab at a More Rapid Infusion Rate in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: rituximab;Drug: methotrexate;Drug: methylprednisolone;Drug: acetaminophen;Drug: antihistamine | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 351 | Phase 4 | United States | |
982 | EUCTR2011-001220-38-GB | 12/07/2011 | 2 October 2012 | A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis | A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension | Rheumatoid Arthritis MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Powder for solution for injection or infusion INN or Proposed INN: Secukinumab Current Sponsor code: AIN457 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Novartis Pharma Services AG | Authorised | Female: yes Male: yes | 350 | United States;Belgium;United Kingdom;Russian Federation;Germany | ||||
983 | JPRN-jRCTs032180273 | 11/07/2011 | 10 September 2019 | Wear of OXINIUM on XLPE: Multicenter RCT Study | Wear of Oxidized Zirconium (OXINIUM) on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study - 28mmOX multicenter study | Hip osteoarthritis, Rheumatoid arthritis Hip osteoarthritis, Rheumatoid arthritis | Arm A: Oxidized zirconium alloy (OXINIUM) femoral head Arm B: Standard cobalt chromium alloy head Random allocation is registered automatically at the UMIN Internet Medical Research Data Center (INDICE) | Haruhiko Akiyama | Not Recruiting | >= 20age old | <= 75age old | Both | 1308 | Phase 4 | none | |
984 | JPRN-JapicCTI-111628 | 01/7/2011 | 2 April 2019 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for Clazakizumab in Subjects Who Are Not Responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of Clazakizumab Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate. | Rheumatoid Arthritis | Intervention name : Clazakizumab Dosage And administration of the intervention : Injection, 25 mg, 100 mg, 200 mg Control intervention name : Methotrexate,Adalimumab Dosage And administration of the control intervention : Methotrexate:Oral,7.5 mg, Adalimumab:Injection,40mg | Bristol-Myers K.K. | 18 | BOTH | 406 | Phase 2 | ||||
985 | NCT01390441 | July 2011 | 19 October 2017 | A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002) | A Two-Part, Phase I Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of MK-8808 and to Compare the Pharmacokinetics of MK-8808 With EU-approved MabThera® and US-licensed Rituxan® in Patients With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Biological: MK-8808;Biological: MabThera® (rituximab);Drug: Methotrexate;Biological: Rituxan® (rituximab);Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Loratadine | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 65 Years | All | 100 | Phase 1 | Belarus;Bulgaria;Colombia;Georgia;Hungary;Italy;Philippines;Poland;Russian Federation;Singapore;Spain;Ukraine;United Kingdom;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 |
986 | NCT01410695 | July 2011 | 18 December 2018 | Masitinib in Refractory Active Rheumatoid Arthritis | A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic Drugs | Rheumatoid Arthritis (RA) | Drug: masitinib 3 mg;Drug: masitinib 6.0 mg;Drug: methotrexate;Drug: Placebo (methotrexate);Drug: Placebo (masitinib) | AB Science | Not recruiting | 18 Years | N/A | All | 324 | Phase 2/Phase 3 | Czechia;Czech Republic;France;United States | |
987 | NCT02433184 | July 2011 | 30 September 2019 | Very Early Versus Delayed Etanercept in Patients With RA | A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early Versus Delayed Etanercept in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Etanercept;Drug: Methotrexate;Drug: Sulfasalazine;Drug: Hydroxychloroquine | University of Leeds | Not recruiting | 18 Years | 80 Years | All | 120 | Phase 4 | United Kingdom | |
988 | EUCTR2010-019262-86-ES | 22/06/2011 | 2 October 2012 | Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa ______________________________________________ A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) | Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa ______________________________________________ A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) | Artritis Reumatoide _______________________ Rheumatoid Arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: SAR153191 Pharmaceutical Form: Solution for injection Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- | sanofi-aventis Recherche & Développement | Authorised | Female: yes Male: yes | 1500 | Hungary;Finland;Germany;Netherlands;Estonia;Spain;Greece;Lithuania;Austria | ||||
989 | EUCTR2011-000107-40-GB | 16/06/2011 | 4 February 2013 | A 12 weeks study to evaluate effect of revamilst in addition to methotrexate in rheumatiod arthritis patients. | A Phase IIb, 12 week Randomized, Double-Blind, Parallel Group, Placebo-Controlled study to evaluate Efficacy, Safety and Tolerability of 2, 4 and 6 mg of Revamilast in patients with Active Rheumatoid Arthritis who have had an inadequate response to Methotrexate. | Rheumatoid Arthritis MedDRA version: 15.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Revamilast Product Code: GRC 4039 Pharmaceutical Form: Tablet INN or Proposed INN: Revamilast Current Sponsor code: GRC 4039 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Revamilast Product Code: GRC 4039 Pharmaceutical Form: Tablet INN or Proposed INN: Revamilast Current Sponsor code: GRC 4039 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Revamilast Product Code: GRC 4039 Pharmaceutical Form: Tablet INN or Proposed INN: Revamilast Current Sponsor code: GRC 4039 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Glenmark Pharmaceuticals SA | Not Recruiting | Female: yes Male: yes | 406 | Phase 2b | Philippines;Poland;Sri Lanka;United Kingdom;India | |||
990 | EUCTR2008-001523-57-NO | 10/06/2011 | 19 March 2012 | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Abatacept CAS Number: 332348-12-6 Current Sponsor code: BMS-188667 Other descriptive name: CTLA4Ig Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- | Bristol Myers Squibb International Corporation | Authorised | Female: yes Male: yes | 100 | Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;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 |
991 | EUCTR2010-022504-42-GB | 07/06/2011 | 21 August 2012 | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients with Active Rheumatoid Arthritis on background Methotrexate Therapy | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients with Active Rheumatoid Arthritis on background Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: LY3009104 Product Code: LY3009104 Pharmaceutical Form: Capsule* INN or Proposed INN: Not available CAS Number: 1187595-84-1 Current Sponsor code: LY3009104 phosphate Other descriptive name: JAK1 / JAK2 Inhibtor Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: LY3009104 Product Code: LY3009104 Pharmaceutical Form: Capsule* INN or Proposed INN: Not available CAS Number: 1187595-84-1 Current Sponsor code: LY3009104 phosphate Other descriptive name: JAK1 / JAK2 Inhibtor Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Eli Lilly and Company | Authorised | Female: yes Male: yes | 270 | Phase 2b | Hungary;United Kingdom | |||
992 | EUCTR2011-000215-79-FR | 07/06/2011 | 30 April 2019 | Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRA | Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRA | Polyarthrite rhumatoïde | Trade Name: Roactemra Pharmaceutical Form: Solution for injection CAS Number: 375823-41-9 Other descriptive name: TOCILIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- | CHU de Clermont Ferrand | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | France | |||
993 | JPRN-UMIN000005590 | 2011/06/01 | 2 April 2019 | Maintenance of remission by tocilizumab mono-therapy after remission obtained by combination with methotrexate in patients with rheumatoid arthritis | Rheumatoid arthritis | Cessation of MTX (tocilizumab monotherapy) Continue MTX with tocilizumab | Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University | Not Recruiting | 20years-old | 75years-old | Male and Female | 40 | Not selected | Japan | ||
994 | NCT01215942 | June 2011 | 19 February 2015 | An Open Label Study for Patients With Rheumatoid Arthritis | A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: LY2127399 | Eli Lilly and Company | Not recruiting | 18 Years | N/A | Both | 1505 | Phase 3 | United States;Argentina;Australia;Brazil;Bulgaria;Colombia;Croatia;France;Germany;Greece;Hungary;India;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Sri Lanka;Taiwan;Ukraine;Italy;Peru | |
995 | NCT01351480 | June 2011 | 16 December 2017 | Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) Patients | Assessment of Structural Benefits of Injectable Abatacept as Measured by MRI in RA Patients Who Have Failed Prior Anti-Tumor Necrosis (TNF) Therapy and Correlated With Clinical Outcomes | Rheumatoid Arthritis | Biological: abatacept | Arthritis & Rheumatic Disease Specialties Research | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 34 | Phase 3 | 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 |
996 | NCT01355354 | June 2011 | 19 February 2015 | Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects | An Open-Label, Non-Randomised, 2-Period, Single Centre Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily | Healthy Volunteers;Rheumatoid Arthritis | Drug: Digoxin;Drug: Fostamatinib | AstraZeneca | Not recruiting | 18 Years | 45 Years | Both | 21 | Phase 1 | United Kingdom | |
997 | NCT01369745 | June 2011 | 19 October 2017 | A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis | A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Prednisolone;Drug: dipyridamole;Drug: Prednisone;Drug: Z102;Other: placebo | Zalicus | Not recruiting | 18 Years | N/A | All | 294 | Phase 2 | United States | |
998 | NCT01384422 | June 2011 | 19 February 2015 | Safety and Preliminary Efficacy of GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: GLPG0634 | Galapagos NV | Not recruiting | 18 Years | 70 Years | Both | 36 | Phase 2 | Moldova, Republic of | ||
999 | NCT01405118 | June 2011 | 19 February 2015 | Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers | A Phase 1, Open Labeled, Fixed Sequence Study To Estimate The Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers | Rheumatoid Arthritis | Drug: Metformin/CP-690,550 | Pfizer | Not recruiting | 18 Years | 55 Years | Both | 24 | Phase 1 | Belgium | |
1000 | NCT01450982 | June 2011 | 19 February 2015 | A Study to Investigate How JNJ-38518168 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants | A Study to Investigate the Effects of JNJ-38518168 on Methotrexate Pharmacokinetics in Rheumatoid Arthritis Participants on a Stable Methotrexate Dose | Rheumatoid Arthritis | Drug: JNJ-38518168 / MTX | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Not recruiting | 18 Years | 75 Years | Both | 20 | 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 |
1001 | EUCTR2010-022378-15-DE | 25/05/2011 | 22 October 2012 | A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis. | VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET | Rheumatoid arthritis MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (Immu-106) Pharmaceutical Form: Solution for injection INN or Proposed INN: Veltuzumab CAS Number: 728917-18-8 Current Sponsor code: hA20, IMMU-106 Other descriptive name: humanised anti-CD 20 antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 70-80 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Nycomed GmbH | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom | |||
1002 | EUCTR2011-003016-23-IT | 11/05/2011 | 27 January 2014 | Controlled randomized study on maintenance to low activity disease with low doses of SKA citokines compared with standard therapy | Controlled randomized study on maintenance to low activity disease with low doses of SKA citokines compared with standard therapy (DMARDS)of arthritis management - CIDAI STUDY | Rheumatoid Arthritis MedDRA version: 14.1 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Guna-Anti Interleukin 1 Product Code: NA Pharmaceutical Form: Oral drops INN or Proposed INN: NA CAS Number: NA Current Sponsor code: 36172 Other descriptive name: Guna-Antiinterleukin 1 alfa Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: .000000001- INN or Proposed INN: NA CAS Number: NA Current Sponsor code: 36172 Other descriptive name: Guna-Antiinterleukin 1 beta Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: .000000001- Product Name: Interleukin 10 Product Code: NA Pharmaceutical Form: Oral drops INN or Proposed INN: NA CAS Number: NA Current Sponsor code: 36247 Other descriptive name: Guna-Interleukin 10 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: .000000001- Product Name: Interleukin 4 Product Code: NA Pharmaceutical Form: Oral drops INN or Proposed INN: NA CAS Number: NA Current Sponsor code: 36241 Other descriptive name: Guna-Interleukin 4 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: .000000001- | GUNA SPA | Authorised | Female: yes Male: yes | Italy | |||||
1003 | EUCTR2009-015019-42-DE | 10/05/2011 | 27 October 2014 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 Pharmaceutical Form: Solution for injection INN or Proposed INN: Golimumab Current Sponsor code: CNTO148 Other descriptive name: Human anti-TNF-alpha monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Janssen Biologics B.V. | Not Recruiting | Female: yes Male: yes | 170 | United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Peru;Germany;Netherlands | ||||
1004 | EUCTR2009-016266-90-ES | 03/05/2011 | 11 September 2012 | Estudio aleatorizado, doble-ciego, controlado con placebo, multicéntrico, de dos partes, de búsqueda de dosis y confirmatorio, con un diseño operacionalmente adaptativo que evalúa la eficacia y seguridad de SAR153191 junto con metotrexato (MTX), en pacientes con artritis reumatoide activa con respuesta inadecuadada a la terapia con metotrexato __________________________________________________ A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY | Estudio aleatorizado, doble-ciego, controlado con placebo, multicéntrico, de dos partes, de búsqueda de dosis y confirmatorio, con un diseño operacionalmente adaptativo que evalúa la eficacia y seguridad de SAR153191 junto con metotrexato (MTX), en pacientes con artritis reumatoide activa con respuesta inadecuadada a la terapia con metotrexato __________________________________________________ A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY | Artritis Reumatoide _____________________________________ Rheumatoid Arthritis MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis ;Artritis Reumatoide _____________________________________ Rheumatoid Arthritis MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: SAR153191 Pharmaceutical Form: Solution for injection Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Code: SAR153191 Pharmaceutical Form: Solution for injection Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Code: SAR153191 Pharmaceutical Form: Solution for injection Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Pharmaceutical Form: Solution for injection Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Code: SAR153191 Pharmaceutical Form: Solution for injection Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Code: SAR153191 Pharmaceutical Form: Solution for injection Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Sanofi-aventis Recherche & Développement | Authorised | Female: yes Male: yes | 1740 | Portugal;Hungary;Finland;Germany;Czech Republic;Netherlands;Estonia;Spain;Greece;Austria;Lithuania | ||||
1005 | NCT01262118 | May 2011 | 19 October 2017 | Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid Arthritis | An Exploratory Phase 1, Fixed Sequence, Open-Label Study To Assess The Effects Of CP-690,550 On The Kinetics Of Cholesterol Flux Through The High Density Lipoprotein/Reverse Cholesterol Transport Pathway In Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CP-690,550 (tasocitinib) | Pfizer | Not recruiting | 18 Years | N/A | All | 69 | Phase 1 | United States;Hungary | |
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 |
1006 | NCT01283971 | May 2011 | 19 October 2017 | A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor | A Randomized, Open-label, Parallel-group Study of the Reduction of Signs and Symptoms During Treatment With Tocilizumab Versus Adalimumab, Both in Combination With MTX, in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to Treatment With Only One TNF Inhibitor | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: adalimumab;Drug: placebo to tocilizumab;Drug: placebo to adalimumab;Drug: methotrexate;Drug: folate | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 96 | Phase 4 | Germany;Greece;Italy;Netherlands;Puerto Rico;Russian Federation;Spain;Sweden;Denmark;Finland;France;United States;United Kingdom | |
1007 | NCT01328522 | May 2011 | 19 February 2015 | Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: SAR153191 (REGN88) | Sanofi | Regeneron Pharmaceuticals | Not recruiting | 18 Years | 75 Years | Both | 32 | Phase 1 | United States | |
1008 | NCT01329991 | May 2011 | 19 February 2015 | Phase 1b Study of PLX5622 in Rheumatoid Arthritis Patients Who Are Receiving Methotrexate | A Phase 1b Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Drug-Drug Interaction of PLX5622 in Patients With Rheumatoid Arthritis Who Are Receiving Methotrexate | Rheumatoid Arthritis | Drug: Placebo;Drug: PLX5622 | Plexxikon | Not recruiting | 18 Years | N/A | Both | 26 | Phase 1 | United States | |
1009 | NCT01347983 | May 2011 | 19 February 2015 | Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients | Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: Tocilizumab+Methotrexate(MTX) | Chugai Pharma Taiwan | Not recruiting | 20 Years | 75 Years | Both | 72 | Phase 3 | Taiwan | |
1010 | NCT01370902 | May 2011 | 19 February 2015 | Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis | A Randomised, Double-blind, Placebo-controlled, Single-dose and Multiple-dose, Dose-escalation Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis | Inflammation;Rheumatoid Arthritis | Drug: NNC 0141-0000-0100;Drug: placebo | Innate Pharma | Not recruiting | 18 Years | 75 Years | Both | 92 | Phase 1 | 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 |
1011 | NCT01404429 | May 2011 | 19 October 2017 | Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis | Randomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate | Postgraduate Institute of Medical Education and Research | Not recruiting | 18 Years | 65 Years | All | 100 | Phase 4 | India | |
1012 | NCT01405326 | May 2011 | 19 February 2015 | REstore Working Ability in RheumatoiD Arthritis | The Effect of Six Months Adalimumab Treatment on Sick Leaves and Retirement in Patients With Rheumatoid Arthritis Who Are at a Risk of Losing Their Ability to Work | Rheumatoid Arthritis | Biological: adalimumab | The Rheumatological Center of Helsinki | Abbott | Recruiting | 25 Years | 55 Years | Both | 160 | Phase 4 | Finland |
1013 | EUCTR2010-022224-77-GB | 27/04/2011 | 27 May 2013 | Open-label study to assess the safety and efficacy of CDP6038 in patients who completed RA0056 | A PHASE 2 MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0056 - RA0057 | Rheumatoid Arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CDP6038 Product Code: CDP6038 Pharmaceutical Form: Solution for injection INN or Proposed INN: Olokizumab CAS Number: 1007223-17-7 Current Sponsor code: CDP6038 Other descriptive name: Recombinant human Mab of IgG4 subtype Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | UCB Biosciences Inc | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | United Kingdom;Belgium;United States | |||
1014 | EUCTR2010-023692-26-GB | 07/04/2011 | 2 October 2012 | Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4) | (OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 | Rheumatoid arthritis MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib disodium Product Code: previously known as R935788 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fostamatinib disodium CAS Number: 914295-16-2 Other descriptive name: Fostamatinib disodium Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Humira Product Name: Humira Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Other descriptive name: Humira Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | AstraZeneca AB | Authorised | Female: yes Male: yes | 280 | Phase 2B | Hungary;Germany;Netherlands;Bulgaria;South Africa;United Kingdom;Czech Republic;Russian Federation;Slovakia;Canada;Ukraine;United States;Poland | |||
1015 | EUCTR2008-007346-63-GB | 05/04/2011 | 15 April 2013 | Reumap: An Open Label phase II study of Bovine Intestinal Alkaline Phosphatase (bIAP), An Inflammation modulating moiety, in RA patients - REUMAP | Reumap: An Open Label phase II study of Bovine Intestinal Alkaline Phosphatase (bIAP), An Inflammation modulating moiety, in RA patients - REUMAP | Rheumatoid Arthritis | Product Name: bIAP Product Code: EC 3.1.3.1 Pharmaceutical Form: Solution for injection INN or Proposed INN: bovine intesastinal alkaline phosphatase (bIAP) CAS Number: EC 3.1.3.1 Current Sponsor code: bIAP Other descriptive name: bIAP Concentration unit: IU international unit(s) Concentration type: range Concentration number: 800-1500 | Alloksys Life Sciences B.V. | Not Recruiting | Female: yes Male: yes | 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 |
1016 | JPRN-UMIN000005362 | 2011/04/01 | 2 April 2019 | Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs). | Patients with rheumatoid arthritis with anemia taking NSAIDs | Treatment with mesalazine | Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine | Not Recruiting | 20years-old | 70years-old | Male and Female | 13 | Not selected | Japan | ||
1017 | NCT01336218 | April 2011 | 19 February 2015 | Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects. | An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin | Rheumatoid Arthritis;Healthy Volunteers | Drug: fostamatinib;Drug: rifampicin | AstraZeneca | Not recruiting | 18 Years | 55 Years | Both | 15 | Phase 1 | United States | |
1018 | EUCTR2010-023910-30-GB | 23/03/2011 | 19 March 2012 | A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early versus Delayed Etanercept in patients with Rheumatoid Arthritis (VEDERA) - Very Early versus Delayed Etanercept in patients with RA (VEDERA) | A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early versus Delayed Etanercept in patients with Rheumatoid Arthritis (VEDERA) - Very Early versus Delayed Etanercept in patients with RA (VEDERA) | Rheumatoid Arthritis MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Enbrel 50mg pre-filled pen Product Name: Etanercept (Enbrel) Product Code: EU/1/99/126/020 Pharmaceutical Form: Solution for injection INN or Proposed INN: Etanercept CAS Number: 185243-69-0 Current Sponsor code: RR10/9592 Other descriptive name: Enbrel Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Trade Name: Enbrel 50mg pre-filled syringe Product Name: Etanercept (Enbrel) Product Code: EU/1/99/126/017 Pharmaceutical Form: Solution for injection INN or Proposed INN: Etanercept CAS Number: 185243-69-0 Current Sponsor code: RR10/9592 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | University of Leeds | Authorised | Female: yes Male: yes | 120 | United Kingdom | ||||
1019 | EUCTR2010-021020-94-DE | 10/03/2011 | 19 March 2012 | A randomized, double-blind, parallel-group, placebo- and active calibrator-controlled study assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a | A randomized, double-blind, parallel-group, placebo- and active calibrator-controlled study assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a | active rheumatoid arthritis MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Code: SAR153191 Pharmaceutical Form: Solution for injection Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: Simponi Pharmaceutical Form: Solution for injection INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Sanofi-aventis Recherche & Développement | Not Recruiting | Female: yes Male: yes | 250 | Hungary;Czech Republic;Germany;Spain;Italy | ||||
1020 | EUCTR2010-023469-22-NL | 09/03/2011 | 19 March 2012 | A phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis - ARA 290 in ARA | A phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis - ARA 290 in ARA | Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 12.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: ARA290 Product Code: ARA290 Pharmaceutical Form: Solution for infusion | LUMC | Authorised | Female: yes Male: yes | 12 | Phase 2 | 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 |
1021 | EUCTR2010-022865-81-CZ | 02/03/2011 | 29 July 2013 | Clinical trial to investigate the safety, efficacy, and absorption, distribution, and elimination of ALX-0061 compared to placebo in patients with rheumatoid arthritis | A phase I/II, multi-center, randomized, double-blind, placebo controlled study, with a single ascending dose part followed by a multiple ascending dose part, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of intravenous ALX-0061 in patients with rheumatoid arthritis - ALX-0061 phase I/II, single ascending dose and multiple ascending dose study in rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 Pharmaceutical Form: Solution for infusion Other descriptive name: ALX-0061 Nanobody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Ablynx NV | Not Recruiting | Female: yes Male: yes | 72 | Phase 1/2 | Czech Republic;Hungary | |||
1022 | NCT01313520 | March 1, 2011 | 16 December 2017 | A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136) | A Randomized Clinical Trial to Study the Effects of Infliximab on Clinical Efficacy and Hand and Wrist Magnetic Resonance Imaging (MRI) in Patients With Active Rheumatoid Arthritis (RA)(Protocol No. P08136) | Arthritis, Rheumatoid | Drug: Infliximab;Drug: Placebo | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 61 | Phase 2 | Moldova, Republic of;Romania | |
1023 | NCT01232569 | March 2011 | 19 October 2017 | A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis | A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tocilizumab 162 mg;Drug: Placebo | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 656 | Phase 3 | United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;Greece;Guatemala;Hungary;Israel;Malaysia;Mexico;New Zealand;Panama;Philippines;Poland;Russian Federation;South Africa;Spain;Switzerland;Thailand;Peru | |
1024 | NCT01276262 | March 2011 | 19 February 2015 | Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects | A Single-blind, Placebo-controlled, 2-period, Fixed Sequence Study to Determine the Effects of Coadministration of Fostamatinib 100 mg Twice Daily on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Subjects | Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction;Laymen Terminology Level of Oral Contraceptive in Blood, Oral Contraceptive, Rheumatoid Arthritis, Drug -Drug Interaction | Drug: fostamatinib;Drug: Microgynon® 30 (Oral contraceptive);Drug: Placebo | AstraZeneca | Not recruiting | 18 Years | 45 Years | Female | 22 | Phase 1 | United Kingdom | |
1025 | NCT01284569 | March 2011 | 14 January 2019 | Study to Assess Safety and Efficacy of Anti-Interleukin 6-receptor (IL6R) Nanobody in Rheumatoid Arthritis (RA) Patients | A Phase I/II, Randomised, Double-Blind, Placebo Controlled Study, Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Single and Multiple Intravenous Doses of ALX-0061 in Patients With RA | Rheumatoid Arthritis | Biological: ALX-0061;Biological: Placebo | Ablynx | Not recruiting | 18 Years | 80 Years | All | 65 | Phase 1/Phase 2 | Czechia;Hungary;Poland;Czech Republic;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 |
1026 | NCT01294397 | March 2011 | 16 December 2017 | Effects of Denosumab on the Pharmacokinetics of Etanercept | The Effects of Denosumab on the Pharmacokinetics of Etanercept in Postmenopausal Women With Low Bone Mineral Density and Rheumatoid Arthritis | Postmenopausal;Osteopenia;Rheumatoid Arthritis;Osteoporosis | Drug: Etanercept;Drug: Denosumab | Amgen | Not recruiting | 45 Years | 80 Years | Female | 19 | Phase 1 | United States | |
1027 | NCT01299961 | March 2011 | 19 October 2017 | Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis | Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: abatacept | University of California, Los Angeles | Not recruiting | 18 Years | N/A | All | 25 | Phase 3 | United States | |
1028 | NCT01301703 | March 2011 | 19 February 2015 | Vaccination Against Pertussis, Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis | The Efficacy and Safety of Vaccination Against Pertussis. Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) | Tel-Aviv Sourasky Medical Center | Not recruiting | 18 Years | 64 Years | Both | 100 | Phase 4 | Israel | |
1029 | NCT01309854 | March 2011 | 19 February 2015 | Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy Subjects | An Open-Label, Single Center Study to Assess the Pharmacokinetics of Pioglitazone in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily | Rheumatoid Arthritis;Healthy Volunteers;Pharmacokinetics;Pioglitazone;Drug-drug Interaction;Amount of Pioglitazone in Blood | Drug: fostamatinib;Drug: pioglitazone | AstraZeneca | Not recruiting | 18 Years | 55 Years | Both | 15 | Phase 1 | United States | |
1030 | NCT01311622 | March 2011 | 19 February 2015 | Effects of Administration of Fostamatinib on Blood Concentrations of Warfarin in Healthy Subjects | An Open-Label, Single Centre Study to Assess the Pharmacokinetics and Pharmacodynamics of Warfarin When Co-Administered With Fostamatinib in Healthy Subjects | Rheumatoid Arthritis;Healthy Subjects | Drug: warfarin;Drug: fostamatinib | AstraZeneca | Not recruiting | 18 Years | 55 Years | Both | 15 | Phase 1 | 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 |
1031 | NCT01313208 | March 2011 | 16 December 2017 | Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD Therapy | Rheumatoid Arthritis | Drug: etanercept;Drug: Placebo;Drug: DMARD Therapy | Amgen | Not recruiting | 18 Years | 80 Years | All | 210 | Phase 4 | United States;Canada | |
1032 | NCT01317797 | March 2011 | 19 October 2017 | A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid Arthritis | A Phase Ib Double-blind, Placebo-controlled, Randomized, Dose-escalating Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Subcutaneous Injections of MT203 in Patients With Mild to Moderate Rheumatoid Arthritis on Treatment With Methotrexate | Rheumatoid Arthritis | Drug: namilumab (MT203);Drug: Placebo | Takeda | Not recruiting | 18 Years | N/A | All | 24 | Phase 1 | Bulgaria;Netherlands | |
1033 | NCT01332994 | March 2011 | 19 October 2017 | A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis | Efficacy and Safety Study of a Sequential Therapy of Tocilizumab (TCZ) and, if Initially Inadequately Responded to Tocilizumab (TCZ), Followed by Rituximab (RTX) in DMARD-IR Patients With Rheumatoid Arthritis (MIRAI) | Rheumatoid Arthritis | Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 519 | Phase 3 | Germany | |
1034 | NCT01333878 | March 2011 | 19 February 2015 | Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage | An Open-Label, Pilot Trial to Assess the Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage Determined by Low Field Extremity MRI (eMRI) and X-ray | Rheumatoid Arthritis | Biological: Subcutaneous Abatacept | Orrin M Troum, M.D. and Medical Associates | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | Both | 12 | Phase 2/Phase 3 | United States |
1035 | NCT01353859 | March 2011 | 19 October 2017 | A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs | An Open Label, Local, Multicenter , Phase IIIb Interventional Study to Assess the Efficacy of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) in Indonesian Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 39 | Phase 3 | Indonesia;Greece | |
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 |
1036 | NCT01566201 | March 2011 | 19 February 2015 | Effects of Interleukin-1 Inhibition on Vascular and Left Ventricular Function in Rheumatoid Arthritis Patients With Coronary Artery Disease | The Effect of Inhibition of Interleukin-1 Activity on Vascular and Left Ventricular Function in Patients With Coronary Artery Disease and Coexistent Rheumatoid Arthritis | Rheumatoid Arthritis;Coronary Artery Disease;Inflammation | Drug: anakinra;Drug: placebo | University of Athens | Not recruiting | 18 Years | N/A | Both | 80 | N/A | Greece | |
1037 | EUCTR2010-020839-39-GB | 25/02/2011 | 28 August 2012 | Efficacy and safety of CDP6038 in patients with rheumatoid arthritis with an unsuccessful response to anti-TNF therapy | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITH AN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056 | Rheumatoid Arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olikizumab Product Code: CDP6038 Pharmaceutical Form: Solution for injection INN or Proposed INN: Olokizumab CAS Number: 1007223-17-7 Current Sponsor code: CDP6038 Other descriptive name: Recombinant human Mab of IgG4 subtype Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: Tocilizumab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RoActemra® CAS Number: 375823-41-9 Current Sponsor code: EU/1/08/492/001-6 Other descriptive name: TOCILIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | UCB Biosciences, Inc | Not Recruiting | Female: yes Male: yes | 220 | United Kingdom;United States | ||||
1038 | EUCTR2010-022206-40-HU | 23/02/2011 | 23 September 2013 | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy | Rheumatoid Arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: LY2127399 Product Code: LY2127399 Pharmaceutical Form: Solution for injection Current Sponsor code: LY2127399 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 120- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: LY2127399 Product Code: LY2127399 Pharmaceutical Form: Solution for injection Current Sponsor code: LY2127399 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Eli Lilly and Company | Not Recruiting | Female: yes Male: yes | 1002 | Phase 3 | Hungary;Poland;Lithuania;Bulgaria | |||
1039 | EUCTR2010-022205-17-HU | 18/02/2011 | 4 March 2013 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: LY2127399 Product Code: LY2127399 Pharmaceutical Form: Solution for injection Current Sponsor code: LY2127399 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 120- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: LY2127399 Product Code: LY2127399 Pharmaceutical Form: Solution for injection Current Sponsor code: LY2127399 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Eli Lilly and Company | Not Recruiting | Female: yes Male: yes | 990 | Phase 3 | Bulgaria;Lithuania;Poland;Hungary | |||
1040 | EUCTR2009-012615-18-FR | 16/02/2011 | 25 January 2016 | Efficacy and safety of cholecalciferol on rheumatoid arthritis activity in patients with vitamin D deficiency - SCORPION | Efficacy and safety of cholecalciferol on rheumatoid arthritis activity in patients with vitamin D deficiency - SCORPION | Rheumatoid arthritis (RA) MedDRA version: 12.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions | Trade Name: UVEDOSE Pharmaceutical Form: Oral solution INN or Proposed INN: COLECALCIFEROL CAS Number: 67-97-0 Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 100000- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use | CHU de Clermont-Ferrand | Not Recruiting | Female: yes Male: yes | 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 |
1041 | EUCTR2010-021558-21-HU | 08/02/2011 | 11 September 2012 | A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis | A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis ;Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: AK106-001616 Product Code: AK106-001616 Pharmaceutical Form: Capsule, hard CAS Number: 590416-75-4 Current Sponsor code: AK106-001616 (form B) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg Pharmaceutical Form: Capsule* INN or Proposed INN: naproxen CAS Number: 22204-53-1 Current Sponsor code: naproxen Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: AK106-001616 Product Code: AK106-001616 Pharmaceutical Form: Capsule, hard CAS Number: 590416-75-4 Current Sponsor code: AK106-001616 (form B) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Code: AK106-001616 Pharmaceutical Form: Capsule, hard CAS Number: 590416-75-4 Current Sponsor code: AK106-001616 (form B) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg Pharmaceutical Form: Capsule* INN or Proposed INN: naproxen CAS Number: 22204-53-1 Current Sponsor code: naproxen Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: AK106-001616 Product Code: AK106-001616 Pharmaceutical Form: Capsule, hard CAS Number: 590416-75-4 Current Sponsor code: AK106-001616 (form B) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Asahi Kasei Pharma Corporation | Not Recruiting | Female: yes Male: yes | 240 | Phase 2a | Hungary;Slovakia;Czech Republic;Germany;United Kingdom | |||
1042 | JPRN-UMIN000008164 | 2011/02/01 | 2 April 2019 | Restart for sustaining remission of rheumatoid arthritis in use of etanercept | Rheumatoid Arthritis | After the administration of etanercept (50mg/week), the dosage of etanercept will be discontinued when the low disease activity (DAS28-ESR<3.2) is achieved. If patients recur from low disease activity, same dose of etanercept will be administered again by the observation of every two months. This strategy will be maintained for two years. We must control the disease activity below the low disease activity using combined medicine except glucocorticoid if patients could not reach low disease activity after the administration of etanercept in three months. It will be considered to be a dropout if patients cannot reach low disease activity within six months. | Osaka City University Medical School | Recruiting | 20years-old | Not applicable | Male and Female | 50 | Phase 4 | Japan | ||
1043 | NCT01235507 | February 2011 | 19 October 2017 | A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER) | Actemra - Local Bosnian Open, Multicentric, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis After Inadequate Response to DMARDs | Rheumatoid Arthritis | Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 71 | Phase 3 | Bosnia and Herzegovina | |
1044 | NCT01254331 | February 2011 | 19 October 2017 | An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment | Open Label, Multicenter, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Monotherapy or in Combination With MTX in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non Biologic DMARDs | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 51 | Phase 3 | Tunisia | |
1045 | NCT01285752 | February 2011 | 8 August 2016 | A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Active comparator;Drug: AK106-001616 | Asahi Kasei Pharma Corporation | Not recruiting | 18 Years | 65 Years | Both | 240 | Phase 2 | Czech Republic;Germany;Hungary;Poland;Slovakia;Ukraine;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 |
1046 | NCT01292265 | February 2011 | 19 October 2017 | A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA) | A Phase 3b, Open Label, Multicenter, Exploratory Study to Assess Changes in Joint Inflammation Using Ultrasonography in Subjects With Rheumatoid Arthritis Treated for 12 Weeks With Certolizumab Pegol | Rheumatoid Arthritis | Biological: Certolizumab Pegol | UCB Pharma | Not recruiting | 18 Years | N/A | All | 3 | Phase 3 | United States | |
1047 | NCT01339481 | February 2011 | 19 February 2015 | A Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept | A Phase 0, Open-Label, Multi-Center, Observational Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept | Rheumatoid Arthritis | Drug: abatacept | Astellas Pharma Inc | Perseid Therapeutics LLC | Not recruiting | 18 Years | N/A | Both | 26 | N/A | United States |
1048 | NCT01765374 | February 2011 | 19 February 2015 | Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis | Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis | Rheumatoid Arthritis | Device: ESAOTE MyLab60;Drug: Rituximab | University Hospital, Rouen | Not recruiting | 18 Years | N/A | Both | 30 | Phase 4 | France | |
1049 | NCT02092961 | February 2011 | 19 October 2017 | Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study | A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Placebo or Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study | Rheumatoid Arthritis | Drug: Fostamatinib;Drug: Adalimumab;Drug: Placebo of Fostamatinib;Drug: Placebo of Adalimumab | AstraZeneca | Not recruiting | 18 Years | N/A | All | 198 | Phase 2 | United States;Bulgaria;Canada;Czech Republic;Germany;Hungary;Netherlands;Poland;Russian Federation;South Africa;United Kingdom | |
1050 | EUCTR2010-022049-88-DE | 05/01/2011 | 30 June 2014 | Efficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAI | Efficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAI | Rheumatoid Arthritis (RA) MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: RoActemra 20 mg/ml Concentrate for solution for infusion Product Name: Tocilizumab Product Code: RO4877533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Trade Name: Mabthera 500 mg Concentrate for solution for infusion Product Name: Rituximab Product Code: RO045-2294 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Current Sponsor code: RO045-2294 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Roche Pharma AG | Not Recruiting | Female: yes Male: yes | 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 |
1051 | NCT01202773 | January 2011 | 11 June 2018 | A Study in Participants With Rheumatoid Arthritis | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to One or More TNF-a Inhibitors (FLEX V) | Rheumatoid Arthritis | Drug: LY2127399;Drug: Placebo Q4W;Drug: Placebo Q2W | Eli Lilly and Company | Not recruiting | 18 Years | N/A | All | 456 | Phase 3 | United States;Argentina;Australia;Brazil;Colombia;France;Germany;Greece;Italy;Japan;Korea, Republic of;Malaysia;Mexico;New Zealand;Poland;Russian Federation;South Africa;Spain;Taiwan | |
1052 | NCT01207453 | January 2011 | 19 October 2017 | Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid Arthritis | Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Milnacipran;Drug: Placebo | Brigham and Women's Hospital | Forest Laboratories;National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 24 Years | N/A | All | 49 | Phase 4 | United States |
1053 | NCT01270035 | January 2011 | 19 February 2015 | Efficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate | Rheumatoid Arthritis | Drug: Adalimumab | Keio University | Saitama Medical University | Recruiting | N/A | N/A | Both | 40 | Phase 4 | Japan | |
1054 | NCT01274910 | January 2011 | 19 February 2015 | Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial | Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial | Rheumatoid Arthritis | Dietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA);Dietary Supplement: Capsules (Placebo) | Rabin Medical Center | Recruiting | 50 Years | 80 Years | Both | 60 | N/A | Israel | |
1055 | NCT01351805 | January 2011 | 22 July 2019 | Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain | Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain | Systemic Inflammatory Process;Knee Pain Chronic;Osteoarthritis;Rheumatoid Arthritis;Autoimmune Diseases | Drug: Fish Oil;Dietary Supplement: Vitamin D;Other: placebo pill | Brigham and Women's Hospital | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 50 Years | N/A | All | 25876 | 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 |
1056 | NCT01411215 | January 2011 | 19 October 2017 | A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department | A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department | Rheumatoid Arthritis;Ankylosing Spondylitis | Drug: Enbrel | Pfizer | Not recruiting | 18 Years | N/A | All | 160 | N/A | China | |
1057 | NCT01737944 | January 2011 | 19 October 2017 | Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration | Exposure, Safety and Local Tolerance Study Comparing 3 Routes of Methotrexate (MTX) Administration: Vibex-MTX Device, Subcutaneous (SC)and Intramuscular (IM) in Adult Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate (MTX) | Antares Pharma Inc. | Not recruiting | 18 Years | N/A | All | 38 | Phase 1/Phase 2 | United States | |
1058 | NCT02586246 | January 2011 | 23 November 2015 | Long-term Treatment Study of CDP870 Self-injection in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870 | Long-term Treatment Study of CDP870 Self-injection. A Multicenter, Open-label, Long-term Safety Study to Evaluate the Safety and Efficacy of CDP870 Self-injection Administered at a Dose of 200 mg Biweekly for 24 Weeks or Longer in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870 Administered Concomitantly With or Without Methotrexate (MTX) | Active Rheumatoid Arthritis | Drug: CDP870 | Astellas Pharma Inc | UCB Japan Co. Ltd. | Not recruiting | N/A | N/A | Both | 86 | Phase 3 | Japan |
1059 | EUCTR2011-001626-15-ES | 30 June 2014 | A study of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with rheumatoid arthritis with inadequate response to prior treatment with methotrexate and low disease activity with the combination de RoActemra/Actemra y methotrexate. | A multi-centre, randomized, double-blind study of the safety and efficacy of tocilizumab (TCZ) in combination with methotrexate (MTX), versus TCZ (placebo controlled) in patients with active rheumatoid arthritis (RA) with inadequate response to prior MTX treatment and low disease activity (DAS 28 ? 3.2) with the combination TCZ and MTX. | Rheumatoid arthritis MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Methotrexate Disodium CAS Number: 7413345 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Roche Farma, S.A. | Not Recruiting | Female: yes Male: yes | Spain | ||||||
1060 | NCT02675803 | December 20, 2010 | 21 January 2019 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of VAY736 in Rheumatoid Arthritis Patients | A Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VAY736 in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Biological: VAY736;Biological: VAY736 placebo | Novartis Pharmaceuticals | Not recruiting | 18 Years | 65 Years | All | 65 | Phase 1 | 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 |
1061 | EUCTR2010-021283-14-CZ | 15/12/2010 | 12 May 2014 | A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis | A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Anti-IL-20 (109-0012) Product Code: NNC 0109-0000-0012 Pharmaceutical Form: Powder for solution for injection Current Sponsor code: NNC 0109-0000-0012 Other descriptive name: Anti-IL-20 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Novo Nordisk A/S | Not Recruiting | Female: yes Male: yes | 66 | Portugal;Hungary;Czech Republic;Spain;Italy;United Kingdom | ||||
1062 | EUCTR2009-015898-12-NL | 10/12/2010 | 19 March 2012 | Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination with Methotrexate, Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination with Methotrexate, Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Patients with active rheumatoid arthritis and an inadequate response to Methotrexate MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: GLPG0259 Product Code: GLPG0259 Pharmaceutical Form: Capsule, hard CAS Number: 1195065-29-2 Current Sponsor code: GLPG0259 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: GLPG0259 Product Code: GLPG0259 Pharmaceutical Form: Capsule, hard CAS Number: 1195065-29-2 Current Sponsor code: GLPG0259 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: GLPG0259 Product Code: GLPG0259 Pharmaceutical Form: Capsule, hard CAS Number: 1195065-29-2 Current Sponsor code: GLPG0259 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6.25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: GLPG0259 Product Code: GLPG0259 Pharmaceutical Form: Capsule, hard CAS Number: 1195065-29-2 Current Sponsor code: GLPG0259 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Galápagos NV | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Netherlands;Belgium | |||
1063 | NCT01285310 | December 9, 2010 | 16 December 2017 | Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid Arthritis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study, To Compare the Efficacy and Safety of Two Doses of Apremilast (CC-10004) in Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: Apremilast 30 mg;Drug: Apremilast 20 mg;Drug: Placebo | Celgene | Not recruiting | 18 Years | N/A | All | 237 | Phase 2 | United States;Czechia;Poland;Spain;Czech Republic | |
1064 | EUCTR2010-021435-14-NL | 06/12/2010 | 19 March 2012 | Effects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis | Effects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis | rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 Pharmaceutical Form: Powder for solution for injection | Academisch Medisch Centrum Amsterdam | Authorised | Female: yes Male: yes | Netherlands | |||||
1065 | EUCTR2010-019871-31-GB | 01/12/2010 | 28 February 2019 | A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis | A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ETORICOXIB CAS Number: 202409-33-4 Current Sponsor code: MK-0663 Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ETORICOXIB CAS Number: 202409-33-4 Current Sponsor code: MK-0663 Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;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 |
1066 | NCT01142726 | December 2010 | 19 October 2017 | Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis | A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA | Rheumatoid Arthritis | Drug: Abatacept;Drug: Methotrexate;Drug: Abatacept placebo;Drug: Methotrexate placebo | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 511 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;Finland;France;Germany;Italy;Korea, Republic of;Mexico;Poland;Russian Federation;South Africa;Sweden;Norway | |
1067 | NCT01236118 | December 2010 | 19 October 2017 | A Study of LY2439821 in Rheumatoid Arthritis | An Open-Label Extension Study to Evaluate Safety and Tolerability of Multiple Subcutaneous Doses of LY2439821 in Japanese Patients With Rheumatoid Arthritis on Concomitant Methotrexate | Rheumatoid Arthritis | Drug: LY2439821 | Eli Lilly and Company | Not recruiting | 20 Years | N/A | All | 28 | Phase 1 | Japan | |
1068 | NCT01258712 | December 2010 | 19 February 2015 | Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients | Randomized, Placebo-controlled Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients | Rheumatoid Arthritis (RA) | Drug: Tocilizumab + methotrexate(MTX);Drug: Tocilizumab placebo + methotrexate(MTX) | Chugai Pharma Taiwan | Not recruiting | 20 Years | 75 Years | Both | 86 | Phase 3 | Taiwan | |
1069 | NCT01261403 | December 2010 | 12 March 2018 | Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Active Rheumatoid Arthritis | A Phase 2, Randomized, Double- Blind, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: PDA001;Drug: Vehicle Controlled Placebo | Celularity Incorporated | Celgene Corporation | Not recruiting | 18 Years | 75 Years | All | 26 | Phase 2 | United States |
1070 | NCT01270997 | December 2010 | 19 February 2015 | Randomized Double-blind Parallel Trial to Evaluate Equivalence in Efficacy and Safety of HD203 and Enbrel in RA Patients | A Multicenter Randomized Double-blind Active-controlled Parallel Group Phase ? Trial to Evaluate the Equivalence in Efficacy and Safety of HD203 and Enbrel in Combination With Methotrexate in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Etanercept | Hanwha Chemical | Not recruiting | 20 Years | N/A | Both | 294 | 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 |
1071 | EUCTR2010-021184-32-DE | 30/11/2010 | 24 October 2016 | GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy | A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies | Refractory rheumatoid arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NA Product Code: GP2013 Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: GP2013 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 1000- Trade Name: Mabthera Product Name: MabThera Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000- Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000- | Hexal AG | Not Recruiting | Female: yes Male: yes | 164 | Phase 2 | Germany;Bulgaria;Romania;Brazil;Belgium;Poland;Argentina;Hungary;France;India;Italy;United Kingdom;Austria;Turkey;Spain;Estonia | |||
1072 | EUCTR2010-020745-27-BE | 23/11/2010 | 21 August 2017 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (OSKIRA - 3) | A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3 | Rheumatoid Arthritis MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib disodium Product Code: FosD Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fostamatinib disodium CAS Number: 914295-16-2 Current Sponsor code: FosD Other descriptive name: Fostamatinib disodium Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | AstraZeneca AB | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany | |||
1073 | EUCTR2010-020892-22-BE | 23/11/2010 | 21 August 2017 | Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X) | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X | Rheumatoid Arthritis MedDRA version: 16.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib disodium Product Code: FosD Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fostamatinib disodium CAS Number: 914295-16-2 Current Sponsor code: FosD Other descriptive name: Fostamatinib disodium Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | AstraZeneca AB | Not Recruiting | Female: yes Male: yes | 2000 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | |||
1074 | JPRN-UMIN000004412 | 2010/11/01 | 2 April 2019 | Corticosteroid-sparing effect of Actemra in patients with Rheumatoid Arthritis refractory to anti-TNF agents, methotrexate and corticosteroid | rheumatoid arthritis | tocilizumab | General Internal Medicine, Tenri Hospital | Recruiting | 16years-old | 80years-old | Male and Female | 25 | Not applicable | Japan | ||
1075 | JPRN-UMIN000008756 | 2010/11/01 | 2 April 2019 | Abatacept-based approach to cure of RA | Rheumatoid Arthritis | Abatacept treatmentat month 12 MTX treatment at month 12 | University of Occupational and Environmental Health, Japan | Recruiting | 15years-old | Not applicable | 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 |
1076 | NCT01225393 | November 2010 | 14 November 2016 | A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis | A Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MLTA3698A;Drug: adalimumab;Drug: leflunomide;Drug: methotrexate;Drug: placebo | Genentech, Inc. | Not recruiting | 18 Years | 75 Years | Both | 211 | Phase 2 | Romania;Spain;Bulgaria;Chile;Germany;Hungary;Mexico;Peru;Poland;United States | |
1077 | NCT01225991 | November 2010 | 19 October 2017 | Milnacipran for Treatment of Pain in Older Adults With Rheumatoid Arthritis | An Open-label Trial of Milnacipran for the Treatment of Pain in Rheumatoid Arthritis (RA) in Older Adults | Rheumatoid Arthritis | Drug: Milnacipran | University of California, Los Angeles | Forest Laboratories | Not recruiting | 50 Years | N/A | All | 18 | Phase 4 | United States |
1078 | NCT01245790 | November 2010 | 19 February 2015 | A Study of Fostamatinib in Subjects With Impaired Kidney Function | An Open-label, Phase I Study to Assess the Pharmacokinetics of R406 in Subjects With Renal Impairment Compared to Healthy Subjects Following Administration of a Single Dose of Fostamatinib 150 mg | Rheumatoid Arthritis;Renal Impairment | Drug: fostamatinib | AstraZeneca | Not recruiting | 18 Years | N/A | Both | 24 | Phase 1 | United States | |
1079 | NCT01255761 | November 2010 | 11 June 2018 | A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects | Phase 4, Randomized, 52-Week Study To Evaluate Two Assessment Tools To Predict Treatment Success At 52 Weeks Based On A Treatment Decision At Week 12 In Subjects With Moderate To Severe Rheumatoid Arthritis Receiving Cimzia | Rheumatoid Arthritis | Biological: Certolizumab Pegol (CZP) | UCB Pharma | Not recruiting | 18 Years | N/A | All | 736 | Phase 4 | United States | |
1080 | NCT01287858 | November 2010 | 17 November 2015 | Study to Assess Safety, Tolerability, and Pharmacokinetics of Oral Doses for AC430 in Healthy Subjects | A Phase 1, Randomized, Double Blind, Placebo Controlled, Sequential, Ascending Single-Dose and Multiple-Dose First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AC430 in Healthy Subjects | Rheumatoid Arthritis | Drug: AC430 | Daiichi Sankyo Inc. | Not recruiting | 18 Years | 45 Years | Both | 88 | 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 |
1081 | NCT01618019 | November 2010 | 19 October 2017 | N-3 PUFA and Rheumatoid Arthritis in Korea | Effect of n-3 Polyunsaturated Fatty Acid Supplementation on Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Dietary Supplement: Omega-3 fatty acid;Dietary Supplement: Placebo | Hanyang University | Not recruiting | 18 Years | 80 Years | All | 109 | N/A | Korea, Republic of | |
1082 | EUCTR2008-006924-68-AT | 28/10/2010 | 17 October 2016 | Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573 | Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573 | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Actemra Product Code: RO4877533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- | F. Hoffmann-La Roche Ltd | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | France;Portugal;Hungary;Czech Republic;Spain;Austria;Netherlands;United Kingdom;Italy | |||
1083 | EUCTR2010-020743-12-GB | 26/10/2010 | 19 March 2012 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Fostamatinib disodium Product Code: FosD Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fostamatinib disodium CAS Number: 914295-16-2 Current Sponsor code: FosD Other descriptive name: Fostamatinib disodium Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | AstraZeneca AB | Authorised | Female: yes Male: yes | 900 | Phase 3 | Hungary;Germany;United Kingdom;Bulgaria;France;Estonia;Poland | |||
1084 | EUCTR2010-020744-35-GB | 26/10/2010 | 27 May 2013 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2) | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2 | Rheumatoid Arthritis MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib disodium Product Code: FosD Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fostamatinib disodium CAS Number: 914295-16-2 Current Sponsor code: FosD Other descriptive name: Fostamatinib disodium Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | AstraZeneca AB | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia | |||
1085 | NCT01362062 | October 26, 2010 | 16 December 2017 | Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy | A Study to Observe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti TNF Therapy. | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 110 | N/A | 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 |
1086 | EUCTR2010-018485-24-CZ | 20/10/2010 | 1 December 2014 | To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BT061 Product Code: BT061 Pharmaceutical Form: Solution for injection INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal Current Sponsor code: BT061 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal Current Sponsor code: BT061 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Biotest AG | Not Recruiting | Female: yes Male: yes | 128 | Hungary;Czech Republic;Spain;Latvia;Germany | ||||
1087 | EUCTR2010-019134-27-CZ | 19/10/2010 | 19 May 2014 | A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY | A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY | Rhuematoid Arthritis MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: CH-4051 Product Code: CH-4051 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Dipotassium Salt Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.3- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: CH-4051 Product Code: CH-4051 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Dipotassium Salt Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: CH-4051 Product Code: CH-4051 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Dipotassium Salt Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3.0- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Methotrexate Product Name: Methotrextate Pharmaceutical Form: Capsule, hard INN or Proposed INN: Methotrexate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Folic Acid Product Name: Folic Acid Pharmaceutical Form: Capsule, hard INN or Proposed INN: Folic Acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- | Chelsea Therapeutics, Inc | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Czech Republic;Bulgaria | |||
1088 | EUCTR2010-019871-31-FI | 18/10/2010 | 7 October 2014 | Etoricoxib and placebo in patients with rheumatoid arthritis | A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ETORICOXIB CAS Number: 202409-33-4 Current Sponsor code: MK-0663 Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ETORICOXIB CAS Number: 202409-33-4 Current Sponsor code: MK-0663 Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany | |||
1089 | EUCTR2010-020738-24-GB | 12/10/2010 | 19 March 2012 | To see whether for patients with established rheumatoid arthritis that have already achieved a good response to Tumour Necrosis Factor Inhibitor (TNF inhibitor) treatment, whether the treatment be tapered to a minimum dose without affecting the control of disease activity. | Optimising Treatment With Tumour Necrosis Factor Inhibitors In Rheumatoid Arthritis: Is Dose Tapering Practical In Good Responders? A “Proof Of Principle” And Exploratory Trial. (OPTTIRA) - OPTTIRA | Patients with established Rheumatoid arthritis MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Enbrel pre-filled pen Product Name: Etanercept Pharmaceutical Form: Solution for injection INN or Proposed INN: etanercept CAS Number: 185243690 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Humira Product Name: Adalimumab Pharmaceutical Form: Solution for injection INN or Proposed INN: Adalimumab CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Trade Name: Enbrel pre-filled syringe Product Name: Etanercept Pharmaceutical Form: Solution for injection INN or Proposed INN: etanercept CAS Number: 185243690 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | King's College London | Authorised | Female: yes Male: yes | 0 | United Kingdom | ||||
1090 | EUCTR2010-018646-31-SK | 11/10/2010 | 3 April 2017 | A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis | A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 12.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: CT-P13 Product Code: CT-P13 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Infliximab CAS Number: 170277-31-3 Current Sponsor code: CT-P13 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Remicade Product Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Current Sponsor code: Remicade Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | CELLTRION, Inc | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Portugal;Slovakia;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;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 |
1091 | EUCTR2010-021449-28-FR | 04/10/2010 | 19 March 2012 | Valeur prédictive de la concentration sérique d’Adalimumab (Humira) sur la réponse clinique dans la polyarthrite rhumatoïde - AFORA | Valeur prédictive de la concentration sérique d’Adalimumab (Humira) sur la réponse clinique dans la polyarthrite rhumatoïde - AFORA | Polyarthrite rhumatoïde MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: HUMIRA Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | CHRU de TOURS | Authorised | Female: yes Male: yes | France | |||||
1092 | NCT01034306 | October 2010 | 19 October 2017 | Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis | A Phase IIB Study of the Efficacy and Safety of Daily CF101 in Patients With Active Rheumatoid Arthritis and Elevated Baseline Expression Levels of Peripheral Blood Mononuclear Cell A3 Adenosine Receptors | Rheumatoid Arthritis | Drug: CF101;Drug: Placebo control | Can-Fite BioPharma | Not recruiting | 18 Years | 75 Years | All | 79 | Phase 2 | Bulgaria;Israel | |
1093 | NCT01098201 | October 2010 | 28 September 2015 | Certolizumab and Lower Extremity Lymph Flow in Rheumatoid Arthritis (RA) | The Effect of Certolizumab on Lower Extremity Lymph Flow in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Certolizumab | University of Rochester | Not recruiting | 18 Years | N/A | Both | 5 | Phase 4 | United States | |
1094 | NCT01149057 | October 2010 | 19 October 2017 | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS | An Open-Label Study to Evaluate the Efficacy and Safety Of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARDs and/or Biologic DMARDs | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Clalit Health Services | Not recruiting | 18 Years | N/A | All | 145 | Phase 4 | Israel |
1095 | NCT01164579 | October 2010 | 19 October 2017 | Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA) | An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tasocitinib plus Methotrexate;Drug: Tofacitinib plus placebo methotrexate;Drug: Placebo tofacitinib plus Methotrexate | Pfizer | Not recruiting | 18 Years | N/A | All | 109 | Phase 2 | United States;Argentina;Chile;Croatia;Czech Republic;Hungary;Mexico;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 |
1096 | NCT01185301 | October 2010 | 19 October 2017 | Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA) | A Double-Blind, Randomized, Parallel-Arm, Multicenter Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy With Adalimumab in Subjects With Early Rheumatoid Arthritis (CONCERTO) | Early Rheumatoid Arthritis | Biological: adalimumab;Drug: methotrexate | AbbVie (prior sponsor, Abbott) | Not recruiting | 18 Years | N/A | All | 395 | Phase 3 | United States;Argentina;Austria;Belgium;Canada;Czech Republic;Germany;Poland;Puerto Rico;Spain | |
1097 | NCT01185353 | October 2010 | 16 December 2017 | A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients With Active Rheumatoid Arthritis on Background Methotrexate Therapy | Arthritis, Rheumatoid | Drug: LY3009104;Drug: Placebo;Drug: Methotrexate | Eli Lilly and Company | Incyte Corporation | Not recruiting | 18 Years | 75 Years | All | 301 | Phase 2 | United States;Croatia;Czechia;Hungary;India;Mexico;Poland;Romania;Ukraine;Argentina;Czech Republic;Peru;United Kingdom |
1098 | NCT01214733 | October 2010 | 14 December 2015 | A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis | An Open Label Study of the Safety During Treatment With Tocilizumab (TCZ), in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 30 | Phase 3 | South Africa | |
1099 | NCT01217086 | October 2010 | 19 February 2015 | Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA) | Randomized, Double-blind, Parallel-group, Phase 3 Study | Rheumatoid Arthritis | Drug: Infliximab | Celltrion | Not recruiting | 18 Years | 75 Years | Both | 617 | Phase 3 | Korea, Republic of | |
1100 | NCT01221636 | October 2010 | 14 September 2015 | Pharmacokinetic Study to Compare the Blood Levels of Low vs High Metal Manufacture of Abatacept | A Study to Compare the Pharmacokinetics of Abatacept (BMS-188667) Drug Product Using Active Pharmaceutical Ingredient Manufactured With a High Concentration of Metals Relative to the Active Pharmaceutical Ingredient Manufactured With a Low Concentration of Metals | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | Not recruiting | 18 Years | 55 Years | Both | 0 | 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 |
1101 | NCT01264211 | October 2010 | 17 November 2015 | Safety and Efficacy of the Combination of Diacerein 100 mg Daily and MTX Versus MTX Alone in the Treatment of Early Rheumatoid Arthritis (RA) | A 6-month Pilot Randomised Double-blind Placebo-controlled Multicentre, Phase 2 Study | Rheumatoid Arthritis | Drug: Diacerein;Drug: Placebo | TRB Chemedica | Not recruiting | 18 Years | 65 Years | Both | 40 | Phase 2 | Thailand | |
1102 | NCT01781702 | October 2010 | 19 February 2015 | Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients | A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients | Pelubiprofen;Celebrex;Rheumatoid Arthritis | Drug: Pelubiprofen 30 mg;Drug: Celebrex 200 mg | Daewon Pharmaceutical Co., Ltd. | Not recruiting | 18 Years | 80 Years | Both | 120 | Phase 3 | ||
1103 | NCT02528292 | October 2010 | 31 August 2015 | Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Rheumatoid Arthritis | Phase 4 Study of Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Patients With Rheumatoid Arthritis Undergoing Treatment With Anti-TNF Therapy | Rheumatoid Arthritis | Procedure: Synovial biopsy;Drug: Anti-TNF therapy | Barts & The London NHS Trust | Not recruiting | 18 Years | N/A | Both | 24 | N/A | United Kingdom | |
1104 | ChiCTR1900024107 | 2010-09-29 | 1 July 2019 | A randomized, controlled, open label, multicenter clinical trial to evaluate the efficacy and safety of recombinant tumor necrosis factor receptor:Fc fusion protein (rhTNFR:Fc) with Methotrexate in active rheumatoid arthritis (ReABLE-II) | A randomized, controlled, open label, multicenter clinical trial to evaluate the efficacy and safety of recombinant tumor necrosis factor receptor:Fc fusion protein (rhTNFR:Fc) with Methotrexate in active rheumatoid arthritis (ReABLE-II) | Active Rheumatoid Arthritis | A:Treatment of Yisaipu combined with methotrexate for 52 weeks;B:Treatment of Yisaipu combined with methotrexate for the first 24 weeks and followed by methotrexate monotherapy;C:Methotrexate monotherapy for 52 weeks; | Chinese Academy of Medical Sciences & Peking Union Medical College Hospital | Not Recruiting | 18 | 60 | Both | A:30;B:30;C:30; | Phase 4 | China | |
1105 | EUCTR2010-019694-15-BE | 28/09/2010 | 21 August 2017 | Act-Alone : An open-label, single-arm study to describe glucocorticoid use in rheumatoid arthritis patients treated with Tocilizumab in daily clinical practice and to evaluate systematic glucocorticoid dose reduction once low disease activity is reached - ACT-Alone | Act-Alone : An open-label, single-arm study to describe glucocorticoid use in rheumatoid arthritis patients treated with Tocilizumab in daily clinical practice and to evaluate systematic glucocorticoid dose reduction once low disease activity is reached - ACT-Alone | Rheumatoid Arthritis in adult MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Medrol 4 mg tablets Pharmaceutical Form: Tablet CAS Number: 83-43-2 Other descriptive name: METHYLPREDNISOLONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Trade Name: Medrol A 16 mg tablets Pharmaceutical Form: Tablet CAS Number: 83-43-2 Other descriptive name: METHYLPREDNISOLONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 16- | N.V. Roche S.A. | Not Recruiting | Female: yes Male: yes | Phase 4 | 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 |
1106 | JPRN-UMIN000011789 | 2010/09/21 | 2 April 2019 | Usefulness of intravenous abatacept at an increased dose in rheumatoid arthritis patients with a poor prognosis | Rheumatoid arthritis | Administration of increased dose of abatacept to patients with rheumatoid arthritis previously treated with abatacept. | National Health Organization Nagoya Medical Center | Not Recruiting | Not applicable | Not applicable | Male and Female | 20 | Not applicable | Japan | ||
1107 | EUCTR2010-019935-37-FI | 15/09/2010 | 13 May 2013 | A pragmatic, randomized, parallel group study of the effect on disease remission, work productivity, and tolerability of tocilizumab in combination with DMARDs and individually designed best practice DMARD therapy in patients with early, moderate to severe Rheumatoid Arthritis | A pragmatic, randomized, parallel group study of the effect on disease remission, work productivity, and tolerability of tocilizumab in combination with DMARDs and individually designed best practice DMARD therapy in patients with early, moderate to severe Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 Pharmaceutical Form: Concentrate for solution for infusion CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: TOCILIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- | Roche Oy | Not Recruiting | Female: yes Male: yes | 160 | Finland | ||||
1108 | ChiCTR-TRC-10001014 | 2010-09-01 | 18 April 2017 | Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Method of Activating Blood Circulation by Removing Blood Stasis | Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Method of Activating Blood Circulation by Removing Blood Stasis | Rheumatoid Arthritis;M06.991 | Group A:observation group: Leflunomide Tablets, from the first day to the third day, 50mg, qd, po, then 20mg, qd, po. Ligustrazine Powder-Needle, 0.12g, solubling in 5% GS/NS 100ml, qd, iv, in 30 to 60 minutes. ;Group B:control group: Leflunomide Tablets, from the first day to the third day, 50mg, qd, po, then 20mg, qd, po. ; | Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences | Not Recruiting | 18 | 65 | Both | Group A:60;Group B:60; | Phase 1 study | China | |
1109 | NCT01116141 | September 2010 | 19 February 2015 | A Study of CH-4051 in Patients With Rheumatoid Arthritis (RA) | A Phase II, Multi-center, Randomized, Parallel Group, Double-blind, MTX Controlled Study to Assess the Clinical Efficacy, Safety and Tolerability of CH-4051 in Patients With Active RA Who Have Shown an Inadequate Response to MTX Monotherapy | Rheumatoid Arthritis | Drug: CH-4051;Drug: Methotrexate (MTX);Drug: Folic Acid | Chelsea Therapeutics | Not recruiting | 18 Years | 80 Years | Both | 250 | Phase 2 | ||
1110 | NCT01154647 | September 2010 | 19 February 2015 | Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes | Unraveling Impaired Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes: a Series of Experiments Targeting Brain Neurotransmission | Fatigue Syndrome, Chronic;Fibromyalgia;Arthritis, Rheumatoid | Drug: citalopram;Drug: 1 ml 0.9 % NaCl | Vrije Universiteit Brussel | Research Foundation Flanders;Universiteit Antwerpen;University Hospital, Antwerp;Artesis University College, Antwerp | Not recruiting | 18 Years | 65 Years | Female | 70 | 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 |
1111 | NCT01162421 | September 2010 | 19 October 2017 | A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis | Radiographic, Clinical and Patient Outcomes in a Multicenter, Open Label Phase IV Randomized Trial of Earlier Adalimumab Introduction Therapy Versus Later Introduction as Per Standard of Care After Initial Methotrexate Failure in Early Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Biological: adalimumab;Drug: Methotrexate | AbbVie (prior sponsor, Abbott) | Mount Sinai Hospital, Canada | Not recruiting | 18 Years | 99 Years | All | 77 | Phase 4 | Canada |
1112 | NCT01163747 | September 2010 | 19 October 2017 | A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA) | A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate | Rheumatoid Arthritis | Biological: tocilizumab;Drug: methotrexate;Biological: 23-Valent Pneumococcal Polysaccharide Vaccine;Biological: Tetanus Toxoid Adsorbed Vaccine | Genentech, Inc. | Not recruiting | 18 Years | 64 Years | All | 91 | Phase 4 | United States | |
1113 | NCT01184001 | September 2010 | 19 February 2015 | A Study To Evaluate The Effect Of Food On How Tasocitinib (CP-690,550) Is Absorbed And Moves Through The Body Following Oral Administration Of Tasocitinib (CP-690,550) Tablets To Healthy Subjects | A Phase 1, Randomized, 2-Period, 2-Sequence, Open Label, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On Pharmacokinetics Of Tasocitinib (CP-690,550) Tablets In Healthy Subjects | Rheumatoid Arthritis | Drug: Treatment A;Drug: Treatment B | Pfizer | Not recruiting | 21 Years | 55 Years | Both | 16 | Phase 1 | Singapore | |
1114 | NCT01185288 | September 2010 | 19 October 2017 | A Study to Determine the Effect of Methotrexate (MTX) Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Treated With Adalimumab (MUSICA) | A Multicenter, Double-Blind, Randomized, Parallel-Arm Study to Determine the Effect of Methotrexate Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis Treated With Adalimumab (MUSICA) | Rheumatoid Arthritis | Biological: Adalimumab;Drug: Methotrexate | AbbVie (prior sponsor, Abbott) | Not recruiting | 18 Years | N/A | All | 309 | Phase 4 | United States;Puerto Rico | |
1115 | NCT01208506 | September 2010 | 16 December 2017 | First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis | First Human Dose Trial of NNC0114-0000-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis | Inflammation;Rheumatoid Arthritis;Healthy | Drug: NNC0114-0000-0005;Drug: placebo | Novo Nordisk A/S | Not recruiting | 18 Years | 75 Years | All | 64 | Phase 1 | 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 |
1116 | NCT01213017 | September 2010 | 16 December 2017 | The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients | The Effect of Certolizumab Pegol in Combination With Methotrexate on MRI Synovitis and Bone Edema and Patient Reported Outcomes as Measured Using an Automated Visit Manager System in Moderate to Severe Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: certolizumab pegol | Oklahoma Medical Research Foundation | UCB Pharma | Not recruiting | 18 Years | N/A | All | 20 | Phase 3 | United States |
1117 | NCT01248780 | September 2010 | 19 October 2017 | Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: Golimumab;Drug: Placebo;Drug: Methotrexate (MTX) | Centocor, Inc. | Schering-Plough | Not recruiting | 18 Years | N/A | All | 264 | Phase 3 | China |
1118 | NCT01282528 | September 2010 | 19 February 2015 | Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis | Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis;Ultrasonography;Infliximab | Biological: infliximab | Peking Union Medical College Hospital | Shanghai Changzheng Hospital;First Hospital of China Medical University;Shenzhen People's Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Wenzhou Medical University;First People's Hospital of Foshan;West China Hospital | Recruiting | 18 Years | 65 Years | Both | 85 | Phase 4 | China |
1119 | EUCTR2010-019964-36-BE | 26/08/2010 | 21 August 2017 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2 | Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: CCX354-C Product Code: CCX354-C Pharmaceutical Form: Film-coated tablet Current Sponsor code: CCX354-C Other descriptive name: CCX354 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | ChemoCentryx, Inc. | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | Czech Republic;Hungary;Belgium;Germany | |||
1120 | EUCTR2010-018375-22-ES | 03/08/2010 | 19 March 2012 | A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), in patients with oderate to severe active rheumatoid arthritis. Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a tocilizumab IV en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa. | A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), in patients with oderate to severe active rheumatoid arthritis. Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a tocilizumab IV en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa. | Rheumatoid arthritis Artritis Reumatoide MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: tocilizumab 162mg/0.9ml jeringa SC Product Code: Ro 487-7533/F10 Pharmaceutical Form: Solution for injection INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 180- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann-La Roche Ltd. | Authorised | Female: yes Male: yes | 1200 | Germany;United Kingdom;Bulgaria;Spain;Italy;Lithuania | ||||
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 |
1121 | ChiCTR-TRC-10000989 | 2010-08-01 | 18 April 2017 | A 24 Week Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Chinese Medicines –the Second Trial | A 24 Week Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Chinese Medicines | rheumatoid arthritis;M06.991 | observation group:Methotrexate Tablets, once per week, for first tim;observation group:Leigongtengduogan Pian, 10mg per time, 3 times per day, Yishen Juanbi Wan, 8g per time, 3 times per day, for oral administration, after meals ;Total:; | The Ministry of Science and Technology of the People's Republic of China | Not Recruiting | 18 | 70 | Male | observation group:120;observation group:120;Total:240; | Post-market | China | |
1122 | JPRN-JapicCTI-101263 | 01/8/2010 | 2 April 2019 | DRIVE | A Dose-response Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on Methotrexate (MTX) to Validate Inhibitory Effect on Bone Erosion (Phase II) | Rheumatoid Arthritis | Intervention name : AMG 162 INN of the intervention : Denosumab Dosage And administration of the intervention : AMG 162 60 mg administered subcutaneously - Every 6 months/ Every 3 months/ Every 2 months Control intervention name : Placebo Dosage And administration of the control intervention : Subcutaneously for placebo | DAIICHISANKYO Co.,Ltd. | 20 | 75 | BOTH | 320 | Phase 2 | |||
1123 | NCT01184092 | August 2010 | 19 February 2015 | A Study To Compare The Amount Of Tasocitinib (CP-690,550) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Three Different Tablet Versions Of Tasocitinib (CP-690,550) | Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, Cross-Over, Bioequivalence Study Comparing Phase 2b, Phase 3 And Commercial Image Tablet Formulations Of Tasocitinib (CP-690,550) Under Fasted Conditions | Rheumatoid Arthritis | Drug: Treatment A;Drug: Treatment B;Drug: Treatment C | Pfizer | Not recruiting | 21 Years | 55 Years | Both | 24 | Phase 1 | Singapore | |
1124 | EUCTR2010-019261-28-DE | 26/07/2010 | 19 March 2012 | A randomised, single-dose, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC 0142-0000-0002 in subjects with active rheumatoid arthritis | A randomised, single-dose, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC 0142-0000-0002 in subjects with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: NNC 0142-0000-0002 Product Code: NNC 142-0002 Pharmaceutical Form: Powder and solvent for solution for injection Current Sponsor code: NNC 142-0002 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Novo Nordisk A/S | Not Recruiting | Female: yes Male: yes | 160 | Germany | ||||
1125 | EUCTR2009-017051-10-NL | 13/07/2010 | 19 March 2012 | Metabolic adverse events before and after glucocorticoid pulse therapy in rheumatoid arthritis | Metabolic adverse events before and after glucocorticoid pulse therapy in rheumatoid arthritis | Patients with rheumatoid arthritis, who suffer from a exacerbation of disease can be included in this study. Exacerbation is defined as a Disease Activity Score of 5.1 or higher. Patients will be excluded if they suffer from diabetes (irrespective of medication) or if they have a contra-indication for dexamethason use. MedDRA version: 12.0 Level: LLT Classification code 10060732 Term: Rheumatoid arthritis flare up | Trade Name: Dexamethason Product Name: dexamethason Pharmaceutical Form: Intravenous infusion | UMC Utrecht | Authorised | Female: yes Male: yes | 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 |
1126 | EUCTR2009-012041-35-BE | 02/07/2010 | 7 October 2014 | A phase II, randomized, double-blind, controlled study to evaluate the immune responses, safety and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis who have relapsed despite anti-TNFa biological therapy | A phase II, randomized, double-blind, controlled study to evaluate the immune responses, safety and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis who have relapsed despite anti-TNFa biological therapy - TNF-K-003 | Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TNF-Kinoid Product Code: TNF-K Pharmaceutical Form: Emulsion for injection INN or Proposed INN: Not assigned yet Current Sponsor code: TNF-K Other descriptive name: N.A. Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 360- Pharmaceutical form of the placebo: Emulsion for injection Route of administration of the placebo: Intramuscular use | Neovacs SA | Authorised | Female: yes Male: yes | 48 | Phase 2 | France;Argentina;Belgium;Croatia;Romania;Chile;Bulgaria | |||
1127 | JPRN-UMIN000003807 | 2010/07/01 | 2 April 2019 | A study for comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis | Rheumatoid Arthritis | Combination therapy of three DMARDs (bucillamine, salazosulphapyridine and methotrexate) Combination therapy of TNF-bloking biologics and methotrexate | Japan Association of Rheumatologists in Private Practice | Not Recruiting | Not applicable | Not applicable | Male and Female | 160 | Not applicable | Japan | ||
1128 | JPRN-UMIN000003880 | 2010/07/01 | 2 April 2019 | Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area | Rheumatoid arthritis | DAS28>3.2 at 24 weeks Switching to another biologics DAS28>3.2 at 24 weeks Dose up of MTX or addition of other DMARDs DAS28<=3.2 at 24 weeks 40 mg of Adalimumab every two week DAS28<=3.2 at 24 weeks 40 mg of Adalimumab every four week | Osaka City University Medical School | Higashi Sumiyoshi Morimoto Hospital, Yodogawa Christian Hospital, Kitade Hospital, Shirahama Hamayu Hospital | Recruiting | 20years-old | Not applicable | Male and Female | 100 | Not applicable | Japan | |
1129 | NCT01147341 | July 2010 | 19 October 2017 | Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia | Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response By Switching to Certolizumab Pegol (Cimzia)? A Phase IV, Randomized, Multi-Center, Double-Blind, Twelve-Week Study Followed by a 12-Week Open-Label Phase | Rheumatoid Arthritis | Drug: Cimzia;Drug: Placebo | Michael Schiff, MD | UCB Pharma | Not recruiting | 18 Years | 75 Years | All | 37 | Phase 4 | United States |
1130 | NCT01593332 | July 2010 | 19 February 2015 | Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis | DMARD Resistant Rheumatoid Arthritis | Drug: Rituximab | Mashhad University of Medical Sciences | Roche Pharma AG | Not recruiting | 19 Years | 75 Years | Both | 44 | Phase 4 | Iran, Islamic 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 |
1131 | EUCTR2009-013758-33-SE | 17/06/2010 | 27 January 2014 | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 Pharmaceutical Form: Solution for injection INN or Proposed INN: CERTOLIZUMAB PEGOL CAS Number: 428863-50-7 Current Sponsor code: CDP870 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | UCB Pharma S.A. | Not Recruiting | Female: yes Male: yes | 36 | Denmark;Netherlands;Sweden | ||||
1132 | EUCTR2009-012055-19-IE | 16/06/2010 | 19 March 2012 | A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis | A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: GSK315234 Injection 100mg/mL Product Code: GSK315234 Pharmaceutical Form: Injection* Current Sponsor code: GSK315234 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Intravenous use | GlaxoSmithKline Research & Development Limited | Not Recruiting | Female: yes Male: yes | 45 | United Kingdom;Belgium;France;Ireland | ||||
1133 | EUCTR2010-019873-13-BE | 07/06/2010 | 21 August 2017 | Comparative study of the clinical response and cardiorespiratory endurance in early rheumatoid arthritis patients treated with Tociluzimab or Methotrexate Addendum protocol : Global gene expression profiles in synovial biopsies from early rheumatoid arthritis patients treated with Tocilizumab or Methotrexate - TOMERA | Comparative study of the clinical response and cardiorespiratory endurance in early rheumatoid arthritis patients treated with Tociluzimab or Methotrexate Addendum protocol : Global gene expression profiles in synovial biopsies from early rheumatoid arthritis patients treated with Tocilizumab or Methotrexate - TOMERA | early rheumatoid arthritis MedDRA version: 12.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions | Trade Name: RoActemra Product Name: Tocilizumab Pharmaceutical Form: Solution for infusion | UCL Cliniques Universitaires Saint Luc | Not Recruiting | Female: yes Male: yes | Phase 2 | Belgium | ||||
1134 | EUCTR2008-005708-18-GB | 04/06/2010 | 19 March 2012 | Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excess | Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excess | Rheumatoid arthritis, SLE, Polymyalgia rheumatica, Disthyroid eye disease, Cushing's syndrome | Trade Name: Glucophage (metformin) Product Name: Metformin Pharmaceutical Form: Tablet | Queen Mary University of London | Authorised | Female: yes Male: yes | United Kingdom | |||||
1135 | NCT01132118 | June 2010 | 19 October 2017 | Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis | Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis | Rheumatoid Arthritis;Insulin Resistance | Drug: Hydroxychloroquine | Brigham and Women's Hospital | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | N/A | All | 30 | Phase 3 | 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 |
1136 | NCT01143337 | June 2010 | 19 October 2017 | Efficacy and Safety Study of MP-435 in Combination With Methotrexate (MTX) in Patients With Rheumatoid Arthritis | A Multicenter Randomized, Double-blind, Placebo-controlled Study of MP-435 in Combination With MTX in Patients With Rheumatoid Arthritis - Exploratory Study | Rheumatoid Arthritis | Drug: MP-435(dose1) + Methotrexate;Drug: Placebo + Methotrexate | Mitsubishi Tanabe Pharma Corporation | Not recruiting | 20 Years | 75 Years | All | 112 | Phase 2 | Japan | |
1137 | NCT01146652 | June 2010 | 15 October 2018 | Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND) | A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: SAR153191 (REGN88) | Sanofi | Regeneron Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 2000 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Brazil;Canada;Chile;Colombia;Czechia;Ecuador;Estonia;Finland;Germany;Greece;Guatemala;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;South Africa;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Czech Republic |
1138 | EUCTR2009-017163-42-SE | 18/05/2010 | 22 May 2017 | Pain modulation in RA – Influence of adalimumab. A randomized, placebo-controlled study using functional magnetic resonance imaging - PARADE | Pain modulation in RA – Influence of adalimumab. A randomized, placebo-controlled study using functional magnetic resonance imaging - PARADE | Rheumatoid arthritis (RA) The overall aim with this project is to investigate central pain mechanisms in RA and healthy controls, and in RA how these are influenced by autonomic neural regulation and TNF-blockade with Humira. | Trade Name: Humira Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Subcutaneous use | Karolinska Institute | Not Recruiting | Female: yes Male: yes | Phase 4 | Sweden | ||||
1139 | EUCTR2010-019438-28-SE | 17/05/2010 | 19 March 2012 | Vaccination against TBE in patients who use immunosuppressive drugs | Vaccination against TBE in patients who use immunosuppressive drugs | TBE vaccin in patients using immunosuppressive drugs MedDRA version: 12.1 Level: LLT Classification code 10046859 Term: Vaccination MedDRA version: 12.1 Level: LLT Classification code 10037153 Term: Psoriasis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10054980 Term: Immunosuppressant drug therapy | Trade Name: FSME-IMMUN Pharmaceutical Form: Suspension for injection CAS Number: 0 Other descriptive name: TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED) Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2,4- | Mälarsjukhuset Eskilstuna | Authorised | Female: yes Male: yes | Sweden | |||||
1140 | EUCTR2009-015845-21-GB | 13/05/2010 | 7 August 2012 | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Humira® Product Code: RO 551-6922 Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: RO 551-6922 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | F. Hoffmann-La Roche Ltd. | Authorised | Female: yes Male: yes | 300 | Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;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 |
1141 | EUCTR2009-015740-42-DE | 12/05/2010 | 23 March 2015 | A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSION RETRO – REduction of Therapy in RA patients in Ongoing remission, Reduzierung der Therapie bei RA-Patienten in Remission - RETRO | A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSION RETRO – REduction of Therapy in RA patients in Ongoing remission, Reduzierung der Therapie bei RA-Patienten in Remission - RETRO | Rheumatoid arthritis MedDRA version: 17.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Prednisolon Product Code: Prednisolon Pharmaceutical Form: Tablet INN or Proposed INN: PREDNISOLONE CAS Number: 50-24-8 Trade Name: Humira Pharmaceutical Form: Injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Product Name: Azathioprin Pharmaceutical Form: Coated tablet CAS Number: 446-86-6 Current Sponsor code: 52424.00.00 Other descriptive name: AZATHIOPRINE Concentration unit: mg/kg milligram(s)/kilogram Trade Name: Immunosporin Product Name: Immunosporin Pharmaceutical Form: Tablet INN or Proposed INN: CICLOSPORIN CAS Number: 59865-13-3 Trade Name: Cimzia Product Name: Cimzia Pharmaceutical Form: Injection INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Current Sponsor code: EU/1/09/544/001-002 Concentration unit: mg milligram(s) Trade Name: Enbrel Product Name: Enbrel Pharmaceutical Form: Injection INN or Proposed INN: ETANERCEPT CAS Number: 185243690 Current Sponsor code: EU/1/99/126/016 Concentration unit: mg milligram(s) Product Name: Quensyl Pharmaceutical Form: Tablet CAS Number: 747-36-4 Other descriptive name: HYDROXYCHLOROQUINE SULFATE Concentration unit: mg/kg milligram(s)/kilogram Trade Name: REMICADE Product Name: Remicade Pharmaceutical Form: INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Current Sponsor code: EU/1/99/116/001 Concentration unit: mg/kg milligram(s)/kilogram Trade Name: Lantarel Product Name: Lantarel Pharmaceutical Form: Injection INN or Proposed INN: METHOTREXATE SODIUM CAS Number: 15475-56-6 Current Sponsor code: 9709.01.01 Other descriptive name: Lantarel Concentration unit: mg milligram(s) Trade Name: Arava Product Name: Arava Pharmaceutical Form: Tablet INN or Proposed INN: LEFLUNOMIDE CAS Number: 75706-12-6 Current Sponsor code: EU 1/99/118/007 – 008 Other descriptive name: Arava Concentration unit: mg milligram(s) Product Name: Metex 2,5mg Pharmaceutical Form: Tablet INN or Proposed INN: METHOTREXATE SODIUM CAS Number: 15475-56-6 Other descriptive name: Metex 2,5mg | Universitätsklinkum Erlangen | Authorised | Female: yes Male: yes | Phase 3 | Germany | ||||
1142 | EUCTR2009-015950-39-DE | 12/05/2010 | 25 January 2016 | Rituximab-Treatment in Addition to Leflunomide in Patients with active rheumatoid arthritis | Addition of Rituximab to Leflunomide in patients with active rheumatoid arthritis - AMARA | Active rheumatoid arthritis (RA) Patients who have had an inadequate response to disease modifying anti-rheumatic drugs (not more than 3 DMARDs including leflunomide, not more than one anti-TNF failure) and currently have active disease despite at least 3-month treatment with leflunomide. Active disease is defined as DAS 28 > 3.2 and at least swollen joint count (SJC) = 3 and tender joint count (TJC) = 3 included in the 28 joint count. MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera® Product Name: Rituximab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | Johann Wolfgang Goethe-Universität Frankfurt/M. | Not Recruiting | Female: yes Male: yes | Germany | |||||
1143 | EUCTR2010-018331-18-GB | 12/05/2010 | 17 June 2013 | A 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy | A 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy | Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: R04877533 Other descriptive name: TOCILIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- | F. Hoffmann-La Roche Ltd. | Not Recruiting | Female: yes Male: yes | United Kingdom | |||||
1144 | NCT01101555 | May 12, 2010 | 16 December 2017 | Repeat Dose Subcutaneous Rhumatoid Arthritis Efficacy Study | A Randomised, Single-blind, Placebo-controlled, Study Toevaluate the Safety, Tolerability, Pharmacodynamics Andpharmacokinetics of Repeat Subcutaneous Administration Ofotelixizumab in Subjects With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: subcutanious administration;Other: Placebo | GlaxoSmithKline | Not recruiting | 18 Years | 75 Years | All | 28 | Phase 1 | Russian Federation | |
1145 | JPRN-UMIN000003615 | 2010/05/01 | 2 April 2019 | Evaluation of the effectiveness of three nonbiologic DMARDs [salazosulfapyridine(SSZ), bucillamine(BUC), methotrexate(MTX)] combination therapy for early RA | RA(Rheumatoid Arthritis) | Using 3 DMARDs(Salazosulfapyridine, Bucillamine, and Methotrexate) for 24 months | St Luke's International Hospital | Recruiting | 20years-old | 80years-old | Male and Female | 20 | 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 |
1146 | NCT01059448 | May 2010 | 13 April 2015 | Safety and Efficacy of AMG 827 in Subjects With RA | A Long-Term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: AMG 827 | Amgen | Not recruiting | N/A | N/A | Both | 211 | Phase 2 | United States;Bulgaria;Canada;Czech Republic;Latvia;Mexico;Poland;United Kingdom | |
1147 | NCT01090570 | May 2010 | 23 March 2015 | Safety, Pharmacokinetic (PK), Pharmcodynamic (PD), and Drug-Drug Interaction of PLX3397 in Patients With Rheumatoid Arthritis Who Are Receiving Methotrexate | Rheumatoid Arthritis | Drug: PLX3397 | Plexxikon | Not recruiting | 18 Years | N/A | Both | 0 | Phase 1 | United States | ||
1148 | NCT01163617 | May 2010 | 19 October 2017 | The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients | A Multicenter, Randomized, Open-Label Study of the Injection Time and Usability of the Physiolis Syringe and Autoinjector in Injection-Experienced Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Device: Adalimumab delivered in current syringe;Device: Adalimumab delivered in Physiolis syringe;Device: Adalimumab delivered in current autoinjector;Device: Adalimumab delivered in Physiolis autoinjector | AbbVie (prior sponsor, Abbott) | Not recruiting | 18 Years | N/A | All | 85 | Phase 2 | United States | |
1149 | NCT01245452 | May 2010 | 19 February 2015 | Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or Methotrexate | Comparative Study of the Clinical Response and Cardiorespiratory Endurance in Early Rheumatoid Arthritis Patients Treated With Tocilizumab or Methotrexate Addendum Protocol : Global Gene Expression Profiles in Synovial Biopsies | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Methotrexate | Patrick Durez | Not recruiting | 18 Years | 70 Years | Both | 30 | N/A | Belgium | |
1150 | NCT01250548 | May 2010 | 19 February 2015 | The Controlled Trial of Apremilast for Rheumatoid Arthritis Treatment (CARAT) | The Controlled Trial of Apremilast for Rheumatoid Arthritis Treatment | Rheumatoid Arthritis | Biological: apremilast;Other: Placebo | Baylor Research Institute | Not recruiting | 18 Years | N/A | Both | 34 | 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 |
1151 | NCT01253265 | May 2010 | 19 October 2017 | A Study in Rheumatoid Arthritis | Multiple-Dose, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2439821 in Japanese Patients With Rheumatoid Arthritis on Concomitant Methotrexate Treatment | Rheumatoid Arthritis | Drug: LY2439821;Drug: Placebo | Eli Lilly and Company | Not recruiting | 20 Years | 75 Years | All | 32 | Phase 1 | Japan | |
1152 | NCT01253291 | May 2010 | 19 February 2015 | A Study of Japanese Rheumatoid Arthritis Patients | An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate | Rheumatoid Arthritis | Drug: LY2127399 | Eli Lilly and Company | Not recruiting | 20 Years | 75 Years | Both | 32 | Phase 1 | Japan | |
1153 | NCT01077531 | April 28, 2010 | 16 December 2017 | Safety, Pharmacodynamics and Pharmacokinetics of GSK2136525 Repeat Dose in Rheumatoid Arthritis | A Randomized, Placebo-controlled, Single-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of Otelixizumab in Rheumatoid Arthritis Subjects | Arthritis, Rheumatoid | Drug: Otelixizumab;Drug: Matching placebo | GlaxoSmithKline | Not recruiting | 18 Years | 75 Years | All | 12 | Phase 1 | Russian Federation;Spain;United Kingdom | |
1154 | EUCTR2009-017379-90-IT | 27/04/2010 | 14 September 2015 | Characterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - ND | Characterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - ND | RA patients fulfilling the 1987 ACR criteria who discontinued a first antibody TNF-i (Infliximab or Adalimumab) because of secondary inefficacy MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Pharmaceutical Form: Solution for injection INN or Proposed INN: ETANERCEPT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | AZIENDA OSPEDALIERA SENESE | Not Recruiting | Female: yes Male: yes | Italy | |||||
1155 | EUCTR2009-011791-30-GB | 14/04/2010 | 21 August 2012 | A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis | A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: NNC151-0000 Product Code: NNC0151-0000-0000 Pharmaceutical Form: Powder for solution for injection Current Sponsor code: NNC0151-0000-0000 Other descriptive name: Anti-C5aR Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Novo Nordisk A/S | Authorised | Female: yes Male: yes | 48 | Hungary;Germany;Czech Republic;Russian Federation;United Kingdom;Ukraine;Denmark;Romania;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 |
1156 | EUCTR2010-018696-21-FR | 14/04/2010 | 19 March 2012 | Etude de l’évolution de la réponse immunitaire Th17 chez des patients atteints de polyarthrite rhumatoïde et traités par tocilizumab après échec des autres thérapies - TOCI 17 | Etude de l’évolution de la réponse immunitaire Th17 chez des patients atteints de polyarthrite rhumatoïde et traités par tocilizumab après échec des autres thérapies - TOCI 17 | Polyarthrite rhumatoïde MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: RoACTEMRA Product Name: TOCILIZUMAB Pharmaceutical Form: Solution for injection | CHU DIJON | Authorised | Female: yes Male: yes | France | |||||
1157 | EUCTR2009-015835-34-IT | 09/04/2010 | 3 April 2017 | VITAMIN D EFFECT ON T LYMPHOCYTES AND OSTEOCLASTOGENESIS IN RHEUMAOID ARTHRITIS - ND | VITAMIN D EFFECT ON T LYMPHOCYTES AND OSTEOCLASTOGENESIS IN RHEUMAOID ARTHRITIS - ND | Rheumatoid Arthritis MedDRA version: 12.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid | Trade Name: DIBASE*IM OS 2F 1ML 300000UI/M Pharmaceutical Form: Solution for injection INN or Proposed INN: Colecalciferol Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 300000- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Oral use | AZIENDA OSPEDALIERA ORDINE MAURIZIANO | Not Recruiting | Female: yes Male: no | Phase 3 | Italy | ||||
1158 | NCT01021735 | April 2010 | 8 June 2015 | Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic Therapy | Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic Therapy | Rheumatoid Arthritis | Drug: etanercept or adalimumab;Drug: Rituximab | University of Glasgow | Arthritis Research Campaign;NHS Lothian;NHS Grampian;NHS Tayside;NHS Borders;NHS Fife | Not recruiting | 18 Years | N/A | Both | 302 | Phase 4 | United Kingdom |
1159 | NCT01060098 | April 2010 | 30 March 2015 | T Cells and TNF: The Impact of TNF Blockade | T Cells and TNF: The Impact of TNF Blockade on Effector T Cell Populations in Rheumatoid Arthritis and Other Conditions Treated With Anti-TNFalpha Agents | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: anti-TNF therapy (etanercept or adalimumab) | Imperial College London | Not recruiting | 18 Years | 80 Years | Both | 52 | N/A | United Kingdom | |
1160 | NCT01067430 | April 2010 | 19 February 2015 | Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA) | Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: Etoricoxib;Drug: Diclofenac | Northumbria Healthcare NHS Foundation Trust | Not recruiting | 18 Years | N/A | Both | 20 | 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 |
1161 | NCT01151644 | April 2010 | 19 February 2015 | Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases | Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases | Rheumatoid Arthritis;Spondyloarthritis;Systemic Lupus Erythematosus (SLE);Dermatomyositis (DM);DMixed Connective Tissue Disease;Systemic Vasculitis;Systemic Sclerosis (SSc);Sjögren's Syndrome;Antiphospholipid Syndrome;Juvenile Idiopathic Arthritis;Juvenile SLE;Juvenile DM | Biological: Anti-pandemic H1N1 influenza vaccine | University of Sao Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo | Not recruiting | N/A | N/A | Both | 5000 | Phase 4 | Brazil |
1162 | NCT01287533 | April 2010 | 19 February 2015 | Efficacy of Monthly Ibandronate in Women With RA and Reduced Bone Mineral Density Receiving Long-term Steroids | Efficacy of Monthly Ibandronate in Women With Rheumatoid Arthritis and Reduced Bone Mineral Density Receiving Long-term Glucocorticoids | Rheumatoid Arthritis;Osteoporosis;Osteopenia | Drug: Ibandronate;Drug: Placebo | Yeong-Wook Song | Not recruiting | 18 Years | 75 Years | Female | 167 | Phase 4 | Korea, Republic of | |
1163 | NCT01313858 | April 2010 | 19 October 2017 | A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554) | Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis | Arthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, Ankylosing | Drug: Simponi®;Drug: Methotrexate | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 1613 | N/A | Germany | |
1164 | EUCTR2009-015636-15-HU | 25/03/2010 | 19 March 2012 | Rheumatoid arthritis | An Open-label Extension Study to Assess the Long-term Safety and Tolerability of ATN-103 in Subjects With Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ATN-103 Product Code: ATN-103 Pharmaceutical Form: Powder for solution for injection Current Sponsor code: ATN-103 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Russian Federation;Germany;Canada;Switzerland;Belgium;Japan;United States;South Africa | ||||
1165 | EUCTR2009-015653-20-NL | 08/03/2010 | 19 March 2012 | Prospective study on the effects of etanercept treatment in patients with rheumatoid arthritis who are naïve for TNF-alpha blocking therapy and patients who do not respond (anymore) to prior treatment with other anti-TNF-alpha medication - Not applicable | Prospective study on the effects of etanercept treatment in patients with rheumatoid arthritis who are naïve for TNF-alpha blocking therapy and patients who do not respond (anymore) to prior treatment with other anti-TNF-alpha medication - Not applicable | rheumatoid arthritis MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: etanercept Product Name: Etanercept Pharmaceutical Form: Injection* INN or Proposed INN: METHOTREXATE CAS Number: 59-05-2 Current Sponsor code: ETN-cohortRA2009 Other descriptive name: methotrexate Concentration unit: mg milligram(s) Concentration type: range Concentration number: 5-30 | Authorised | Female: yes Male: yes | 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 |
1166 | NCT01197066 | March 2010 | 30 September 2019 | Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis | A Phase ? Multicenter, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Certolizumab Pegol as Additional Medication to Methotrexate, in Patients With Active Rheumatoid Arthritis Who Participated in Study 101-KOA-0801i | Rheumatoid Arthritis | Drug: Certolizumab Pegol | Korea Otsuka Pharmaceutical Co., Ltd. | Not recruiting | 18 Years | N/A | All | 110 | Phase 3 | Korea, Republic of | |
1167 | NCT01256736 | March 2010 | 19 February 2015 | To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis | Prospective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 Study | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: DMARDs | JW Pharmaceutical | Not recruiting | 18 Years | N/A | Both | 89 | Phase 3 | Korea, Republic of | |
1168 | NCT01610791 | March 2010 | 19 October 2017 | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION) | A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study) | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 121 | Phase 3 | Morocco | |
1169 | NCT02010216 | March 2010 | 19 October 2017 | A Study of RoActemra/Actemra (Tocilizumab) in Adult Patients With Rheumatoid Arthritis (SVOBODA Programme) | Non-Randomized Phase IV Trial on Efficacy and Safety of Actemra in the Treatment of Adult Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 23 | Phase 4 | Kazakhstan | |
1170 | NCT01063062 | February 28, 2010 | 16 December 2017 | A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE) | A Single-arm, Open-label, Multicenter Study of Tocilizumab Monotherapy or in Combination With Methotrexate to Assess Safety and the Efficacy in Reducing Disease Activity in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs (PICTURE) | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: Methotrexate | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 107 | 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 |
1171 | EUCTR2009-016789-10-NL | 19/02/2010 | 19 March 2012 | Efficacy of the H1N1 Flu (swine flu) vaccination in patients with Rheumatoid Arthritis treated with rituximab | Efficacy of the H1N1 Flu (swine flu) vaccination in patients with Rheumatoid Arthritis treated with rituximab | To assess the efficacy of A/H1N1 vaccination in patients treated with rituximab therapy | Trade Name: Focetria Trade Name: Pandemrix, | Div KIR AMC | Authorised | Female: yes Male: yes | Netherlands | |||||
1172 | EUCTR2009-017325-19-FI | 11/02/2010 | 19 March 2012 | “The effect of Six months Adalimumab Treatment on Sick Leaves and retirement in Patients with rheumatoid Arthritis who are at risk of losing their ability to work” | “The effect of Six months Adalimumab Treatment on Sick Leaves and retirement in Patients with rheumatoid Arthritis who are at risk of losing their ability to work” | Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: HUMIRA Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Route of administration of the placebo: Subcutaneous use | Helsingin reumakeskus | Authorised | Female: yes Male: yes | Finland | |||||
1173 | EUCTR2009-016987-34-SE | 09/02/2010 | 27 May 2013 | . | PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS | Moderate to severe active Rheumatoid Arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: CP-690,550 Pharmaceutical Form: Film-coated tablet CAS Number: 540737-29-9 Current Sponsor code: CP-690,550 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Methotrexate Sodium Pharmaceutical Form: Tablet INN or Proposed INN: METHOTREXATE SODIUM CAS Number: 15475-56-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Philippines;Taiwan;Slovakia;Thailand;Costa Rica;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Australia;Peru;Korea, Republic of;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden | |||
1174 | EUCTR2009-012566-32-CZ | 05/02/2010 | 19 March 2012 | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Rheumatoid arthritis (RA) MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: AMG 827 Product Code: AMG 827 Pharmaceutical Form: Solution for injection INN or Proposed INN: AMG 827 Current Sponsor code: AMG 827 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 70- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Amgen Inc | Not Recruiting | Female: yes Male: yes | 240 | Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland | ||||
1175 | NCT00979771 | February 2010 | 16 December 2017 | A Study to Investigate the Ability of GSK706769 to Maintain Clinical Remission After Withdrawal of Enbrel in Rheumatoid Arthritis Patients | A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Ability of GSK706769 to Maintain Clinical Remission After Withdrawal of Enbrel in Patients With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: GSK706769;Drug: Placebo | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 0 | Phase 2 | 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 |
1176 | NCT01038674 | February 2010 | 16 December 2017 | Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis | A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Dose-escalation, Phase 1 Trial of Anti-IL-20 in Subjects With Rheumatoid Arthritis | Inflammation;Rheumatoid Arthritis | Drug: anti-IL-20;Drug: placebo | Novo Nordisk A/S | Not recruiting | 18 Years | 75 Years | All | 16 | Phase 1 | Belgium;Poland | |
1177 | NCT01052194 | February 2010 | 19 February 2015 | A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis | A 12-week, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Placebo;Drug: VX-509 | Vertex Pharmaceuticals Incorporated | Not recruiting | 18 Years | 75 Years | Both | 206 | Phase 2 | United States;Belgium;Croatia;Germany;Hungary;Poland;Puerto Rico;Romania;Russian Federation;Serbia | |
1178 | NCT01059864 | February 2010 | 19 October 2017 | Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550 | Phase 2 Study Of The Effects Of Open-Label CP-690,550 And Double-Blind Atorvastatin On Lipids In Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CP-690,550;Drug: Atorvastatin;Drug: Atorvastatin Placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 111 | Phase 2 | United States;Korea, Republic of | |
1179 | NCT01063803 | February 2010 | 19 February 2015 | Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis | An Open-Label Extension Study To Assess The Long-term Safety And Tolerability Of ATN-103 In Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ATN-103 | Ablynx | Not recruiting | 18 Years | 80 Years | Both | 266 | Phase 2 | United States;Canada;Hungary;Japan;Russian Federation;Serbia;South Africa;Switzerland | |
1180 | NCT01111357 | February 2010 | 19 February 2015 | Study of Human Leukocyte Antigen (HLA) Polymorphisms in Patients With Rheumatoid Arthritis | Study of HLA Polymorphisms in French West-Indian Patients With Rheumatoid Arthritis : A Case Control Study | Rheumatoid Arthritis | Biological: Collect of 10 ml of peripheric blood for DNA extraction | Centre Hospitalier Universitaire de Fort-de-France | Not recruiting | 18 Years | N/A | Both | 200 | N/A | Martinique | |
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 |
1181 | NCT01123070 | February 2010 | 19 February 2015 | TL011 in Severe, Active Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis;Biological: MabThera infusions | Teva Pharmaceutical Industries | Not recruiting | 18 Years | 80 Years | Both | 48 | Phase 1/Phase 2 | Czech Republic;Hungary;Italy;Spain;United Kingdom;Germany | ||
1182 | NCT01754805 | January 22, 2010 | 24 June 2019 | A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Patients With Rheumatoid Arthritis | A Phase 1b, Open-Label, Single Sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: peficitinib;Drug: methotrexate | Astellas Pharma Inc | Not recruiting | 18 Years | 65 Years | All | 15 | Phase 1 | United States | |
1183 | EUCTR2008-007185-33-DE | 12/01/2010 | 19 March 2012 | A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103 Administered to Subjects With Active Rheumatoid Arthritis on a Background of Methotrexate | A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103 Administered to Subjects With Active Rheumatoid Arthritis on a Background of Methotrexate | Rheumatoid arthritis MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: ATN-103 Product Code: ATN-103 Pharmaceutical Form: Powder for solution for injection Current Sponsor code: ATN-103 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Powder for solution for injection Route of administration of the placebo: Subcutaneous use | Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company | Not Recruiting | Female: yes Male: yes | 240 | Phase 1/2 | Hungary;United Kingdom;Germany;Netherlands;Belgium | |||
1184 | EUCTR2009-010582-23-DE | 04/01/2010 | 24 February 2014 | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | Rheumatoid arthritis MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Golimumab Current Sponsor code: CNTO 148 Other descriptive name: Human anti TNF-alpha monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 12.5- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Product Name: Golimumab liquid in prefilled pen Product Code: CNTO 148 Pharmaceutical Form: Solution for injection INN or Proposed INN: Golimumab Current Sponsor code: CNTO 148 Other descriptive name: Human anti TNF-alpha monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Janssen Biologics B.V. | Not Recruiting | Female: yes Male: yes | 400 | Phase 3b | Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden | |||
1185 | NCT00752154 | January 2010 | 19 February 2015 | Curcumin in Rheumatoid Arthritis | Curcumin in Rheumatoid Arthritis - ACross-Over Pilot Study | Rheumatoid Arthritis | Drug: Curcumin (Longvida™) | University of California, Los Angeles | Recruiting | 18 Years | N/A | Both | 40 | Phase 0 | 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 |
1186 | NCT00995449 | January 2010 | 19 October 2017 | Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis | A Phase 2, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of the Anti-GM-CSF Monoclonal Antibody KB003 in Subjects With Active Rheumatoid Arthritis and Inadequate Prior Treatment Outcome From Biologic Therapy | Rheumatoid Arthritis | Biological: KB003;Other: Placebo Comparator | KaloBios Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 9 | Phase 2 | United States | |
1187 | NCT01039688 | January 2010 | 11 June 2018 | Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX | Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: CP-690,550;Drug: Disease-modifying antirheumatic drug | Pfizer | Not recruiting | 18 Years | 99 Years | All | 956 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;Colombia;Costa Rica;Czechia;Dominican Republic;Germany;Hungary;India;Korea, Republic of;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Puerto Rico;Russian Federation;Slovakia;Spain;Sweden;Taiwan;Thailand;Ukraine;Czech Republic | |
1188 | NCT01071798 | January 2010 | 19 October 2017 | An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis | A Prospective, Multi-center, Non-interventional Observational Study to Evaluate the Safety and Effectiveness of MabThera® (Rituximab) Within the First 6 Months (in Case of Re-therapy the First 12 Months) of Treatment in Patients With Severe Active Rheumatoid Arthritis in Routine Care | Rheumatoid Arthritis | Drug: Rituximab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 1653 | N/A | Germany;United States | |
1189 | NCT01089023 | January 2010 | 19 October 2017 | A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis | Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and the Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti- TNF Therapy. | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 95 | Phase 4 | Bahrain;Iran, Islamic Republic of;Kuwait;Qatar;United Arab Emirates | |
1190 | NCT01198509 | January 2010 | 19 October 2017 | Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA) | Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA) | Rheumatoid Arthritis;Psoriatic Arthritis;Periodontal Disease | Drug: doxycycline;Drug: vancomycin | New York University School of Medicine | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Memorial Sloan Kettering Cancer Center | Not recruiting | 18 Years | 70 Years | All | 178 | 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 |
1191 | NCT02368093 | January 2010 | 19 October 2017 | Efficacy Study of Dextromethorphan to Treat Rheumatoid Arthritis | A Double-blind, Placebo-controlled, Therapeutic Trial With Antitussive Drug-Dextromethorphan: Aimed to Determine Its Therapeutic Effect in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Dextromethorphan hydrobromide | Taichung Veterans General Hospital | TSH Biopharm Corporation Limited | Not recruiting | 18 Years | N/A | All | 48 | N/A | |
1192 | NCT02731560 | January 2010 | 18 April 2016 | Rituximab (RTX) for Disease Modifying Anti Rheumatic Drug (DMARD) Non-responders in Pakistan: The Pakistan Rituximab Study (PARIS) | Efficacy and Safety of Rituximab in Pakistani Patients With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Rituximab | Prof. Abid Z. Farooqi | Aga Khan University;Fatima Memorial Hospital;Fauji Foundation Hospital, Rawalpindi | Not recruiting | 18 Years | 80 Years | Both | 74 | Phase 4 | |
1193 | EUCTR2009-014735-20-LV | 29/12/2009 | 11 February 2013 | A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints. | A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH | Rheumatoid Arthritis MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: mavrilimumab CAS Number: 1085337-57-0 Current Sponsor code: CAM-3001 Other descriptive name: anti-GM-CSF receptor alpha Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | MedImmune Ltd | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Hungary;Estonia;Czech Republic;Poland;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Japan | |||
1194 | NCT00950989 | December 2009 | 12 September 2016 | AMG 827 in Rheumatoid Arthritis Subjects With Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: AMG 827 70 mg;Drug: AMG 827 140 mg;Drug: AMG 827 210 mg;Drug: Placebo;Drug: Stable weekly dose of methotrexate | Amgen | Not recruiting | 18 Years | 70 Years | Both | 240 | Phase 2 | Bulgaria;Canada;Czech Republic;Hungary;Latvia;Mexico;Poland;United Kingdom;United States | |
1195 | NCT01000441 | December 2009 | 19 February 2015 | Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis | Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: infliximab, etanercept, adalimumab;Drug: abatacept, rituximab or tocilizumab | University Hospital, Strasbourg, France | Recruiting | 18 Years | N/A | Both | 300 | Phase 4 | France;Monaco | |
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 |
1196 | NCT01001832 | December 2009 | 19 October 2017 | Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese Patients | A Phase II/III, Multicenter, Randomized, Double-Blind, Double-Dummy Study to Assess Similarity of the Efficacy, Pharmacokinetics, Safety and Immunogenicity of Abatacept Administered Subcutaneously or Intravenously in Japanese Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: Intravenous (IV) abatacept;Drug: Subcutaneous (SC) abatacept | Bristol-Myers Squibb | Not recruiting | 20 Years | N/A | All | 118 | Phase 2/Phase 3 | Japan | |
1197 | NCT01008852 | December 2009 | 19 February 2015 | Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis | Randomized, Parallel, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate | Active Rheumatoid Arthritis | Drug: SBI-087;Drug: Placebo | Pfizer | Emergent Product Development Seattle LLC | Not recruiting | 18 Years | N/A | Both | 210 | Phase 2 | United States;Argentina;Canada;Chile;Hungary;Japan;Mexico;Poland;Serbia;Spain;Greece;Turkey |
1198 | NCT01023256 | December 2009 | 19 October 2017 | Safety and Preliminary Efficacy of MOR103 in Patients With Active Rheumatoid Arthritis | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of MOR103 Administered Intravenously to Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MOR103 | MorphoSys AG | Not recruiting | 18 Years | N/A | All | 96 | Phase 1/Phase 2 | Bulgaria;Germany;Netherlands;Poland;Ukraine | |
1199 | NCT01027728 | December 2009 | 19 February 2015 | Study to Evaluate Safety and Efficacy of CCX 354-C in Subjects With Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CCX 354-C | ChemoCentryx | Not recruiting | 18 Years | 75 Years | Both | 24 | Phase 1/Phase 2 | Belgium;Romania | |
1200 | NCT01029613 | December 2009 | 31 August 2015 | Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating Biomarkers | Adalimumab in Rheumatoid Arthritis. An Investigation of Changes in Disease Activity and Course of Joint Destruction by Use of 3 Tesla Whole-Body MRI, Dedicated 3 Tesla MRI and CT of the Hand, and Soluble Biomarkers | Rheumatoid Arthritis | Drug: Adalimumab | Glostrup University Hospital, Copenhagen | Not recruiting | 18 Years | 85 Years | Both | 40 | 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 |
1201 | NCT01044498 | December 2009 | 19 October 2017 | A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis | An Open-label, Multi-center, One Sequence Cross-over Drug Interaction Study to Investigate the Effect of Tocilizumab (TCZ, RO4877533) on the Pharmacokinetics and Pharmacodynamics of an Oral Contraceptive (OC) in Female Patients With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Ortho-Novum® 1/35 | Hoffmann-La Roche | Not recruiting | 18 Years | 44 Years | Female | 46 | Phase 3 | United States | |
1202 | EUCTR2009-016055-22-FI | 27/11/2009 | 27 October 2014 | Immuunipuutteisten matkailijoiden A-hepatiittisuojaus | Immuunipuutteisten matkailijoiden A-hepatiittisuojaus | Terveet vapaaehtoiset ja vapaaehtoiset potilaat, joilla on diagnosoitu nivelreuma. MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Epaxal Product Name: Epaxal Pharmaceutical Form: Solution for injection | HY, HUS | Not Recruiting | Female: yes Male: yes | Finland;Sweden | |||||
1203 | EUCTR2009-012424-87-GB | 26/11/2009 | 19 March 2012 | T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNF | T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNF | Rheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 12.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis MedDRA version: 12.0 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis | Trade Name: Enbrel Pharmaceutical Form: Solution for injection INN or Proposed INN: etanercept CAS Number: 185243690 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Humira Pharmaceutical Form: Solution for injection INN or Proposed INN: adalimumab CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Trade Name: Enbrel Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: etanercept CAS Number: 185243690 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: Enbrel Pharmaceutical Form: Solution for injection INN or Proposed INN: Etanercept CAS Number: 185243690 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- | Imperial College London South Kensington London | Authorised | Female: yes Male: yes | United Kingdom | |||||
1204 | EUCTR2009-009696-34-DE | 23/11/2009 | 24 April 2012 | A Study in Patients with Rheumatoid Arthritis | A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients with Active Rheumatoid Arthritis on Concomitant DMARD Therapy | Rheumatoid Arthritis MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY2439821 Product Code: LY2439821 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: N.A. Current Sponsor code: LY2439821 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 48- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Eli Lilly and Company | Not Recruiting | Female: yes Male: yes | 648 | Phase 2 | India;Russian Federation;Germany;Peru;Taiwan;Argentina;Romania;Korea, Republic of;Chile;Poland | |||
1205 | EUCTR2009-012185-32-IT | 23/11/2009 | 7 January 2013 | Open label, multicentric phase IIIb study to evaluate the effect of tocilizumab in combination with DMARDs in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by dedicated magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis (RA) - ND | Open label, multicentric phase IIIb study to evaluate the effect of tocilizumab in combination with DMARDs in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by dedicated magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis (RA) - ND | Moderate to severe active rheumatoid arthritis (RA), who are inadequate responders to DMARDs. MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Tocilizumab Product Code: Ro487-7533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RoActemra CAS Number: 375823-41-9 Current Sponsor code: Ro487-7533 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- | ROCHE | Not Recruiting | Female: yes Male: yes | Phase 3b | 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 |
1206 | EUCTR2009-012204-42-IE | 13/11/2009 | 19 March 2012 | A randomized, double-blind, placebo-controlled, parallel group study to investigate the ability of GSK706769 to maintain clinical efficacy after withdrawal of Enbrel in patients with rheumatoid arthritis | A randomized, double-blind, placebo-controlled, parallel group study to investigate the ability of GSK706769 to maintain clinical efficacy after withdrawal of Enbrel in patients with rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: GSK706769 Product Code: GSK706769 Pharmaceutical Form: Film-coated tablet CAS Number: 880356-67-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | GlaxoSmithKline Research & Development Limited | Not Recruiting | Female: yes Male: yes | 50 | Belgium;Ireland | ||||
1207 | EUCTR2009-014296-40-DE | 12/11/2009 | 10 December 2012 | PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS | PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS | Rheumatoid arthritis MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: not applicable Product Code: CP-690,550 Pharmaceutical Form: Film-coated tablet CAS Number: 540737-29-9 Current Sponsor code: CP-690,550-10 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | Not Recruiting | Female: yes Male: yes | 396 | Phase 3 | France;Belgium;Spain;Ireland;Austria;Germany;United Kingdom;Italy | |||
1208 | EUCTR2009-013223-37-CZ | 10/11/2009 | 12 December 2016 | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: PF-04171327 Product Code: PF-04171327 Pharmaceutical Form: Tablet Current Sponsor code: PF-04171327 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: PF-04171327 Product Code: PF-04171327 Pharmaceutical Form: Tablet Current Sponsor code: PF-04171327 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Pharmaceutical Form: Capsule* INN or Proposed INN: Prednisone CAS Number: 53-03-2 Other descriptive name: Decortin® Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Pfizer Inc. | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | Hungary;Czech Republic;Spain | |||
1209 | EUCTR2009-013316-12-NL | 10/11/2009 | 1 December 2014 | A multi-center, randomized, double blind, placebo controlled study to evaluate remission in DMARD and biological naïve early reumatoid arthritis (RA) subjects treated with tocilizumab (TCZ) plus tight control methotrexate (MTX) treatment, TCZ monotherapy or tight control MTX monotherapy. - U-Act-Early | A multi-center, randomized, double blind, placebo controlled study to evaluate remission in DMARD and biological naïve early reumatoid arthritis (RA) subjects treated with tocilizumab (TCZ) plus tight control methotrexate (MTX) treatment, TCZ monotherapy or tight control MTX monotherapy. - U-Act-Early | Rheumatoid Arthritis MedDRA version: 15.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: RoActemra Pharmaceutical Form: Concentrate for solution for infusion Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Methotrexate 'Lederle' 2,5mg tablets Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Roche Nederland B.V. | Not Recruiting | Female: yes Male: yes | Netherlands | |||||
1210 | EUCTR2007-006129-29-DE | 03/11/2009 | 27 January 2014 | A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis | A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis - MOR103 Rheumatoid Arthritis PoC Study | Rheumatoid arthritis MedDRA version: 13.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MOR103 Product Code: MOR103 Pharmaceutical Form: Solution for infusion Current Sponsor code: MOR103 Other descriptive name: Human Recombinant IgG1, lambda Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 8-12 Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | MorphoSys AG | Not Recruiting | Female: yes Male: yes | 89 | Poland;Ukraine;Bulgaria;Netherlands;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 |
1211 | EUCTR2009-014824-40-CZ | 03/11/2009 | 19 March 2012 | An open label follow on study to evaluate the long-term safety, tolerability and efficacy of ART621 following fortnightly administration for 48 weeks in patients with rheumatoid arthritis concomitantly taking methotrexate. | An open label follow on study to evaluate the long-term safety, tolerability and efficacy of ART621 following fortnightly administration for 48 weeks in patients with rheumatoid arthritis concomitantly taking methotrexate. | Rheumatoid arthritis | Product Code: ART621 Pharmaceutical Form: Solution for injection Current Sponsor code: ART621 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | Arana Therapeutics Ltd | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic | ||||
1212 | JPRN-UMIN000002744 | 2009/11/01 | 2 April 2019 | Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuation | rheumatoid arthritis | tocilizumab plus methotrexate tocilizumab | Keio University | Not Recruiting | 20years-old | 75years-old | Male and Female | 300 | Not selected | Japan | ||
1213 | NCT00844714 | November 2009 | 19 October 2017 | Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy | Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy | Endothelial Function;Rheumatoid Arthritis;Inflammation | Drug: Rituxan | University of California, San Francisco | Genentech, Inc. | Not recruiting | 18 Years | N/A | All | 20 | N/A | United States |
1214 | NCT00976599 | November 2009 | 19 October 2017 | A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis | An Exploratory Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Pharmacodynamics Of CP-690,550, Administered Orally Twice Daily (BID) For 4 Weeks, In Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CP-690,550 + methotrexate;Drug: Placebo + Methotrexate | Pfizer | Not recruiting | 18 Years | N/A | All | 29 | Phase 2 | United States | |
1215 | NCT01006681 | November 2009 | 19 February 2015 | Vaccination Against Influenza H1N1 in Rheumatic Diseases | Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Immunomodulatory Drugs | Influenza;Rheumatic Diseases | Biological: Focetria (Monovalent MF59-Adjuvanted vaccine) | Tel-Aviv Sourasky Medical Center | Not recruiting | 18 Years | 65 Years | Both | 400 | Phase 2 | ||
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 |
1216 | NCT01007175 | November 2009 | 19 February 2015 | Study Evaluating Multiple Ascending Doses Of ATN-103 In Japanese Subjects With Rheumatoid Arthritis | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Clinical Efficacy Of ATN-103 Administered To Japanese Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate | Rheumatoid Arthritis | Biological: ATN-103 10 mg q4wks;Biological: ATN-103 30 mg q4wks;Biological: ATN-103 80 mg q4wks;Biological: ATN-103 10 mg q8wks;Biological: ATN-103 80 mg q8wks | Ablynx | Not recruiting | 20 Years | 75 Years | Both | 60 | Phase 1/Phase 2 | Japan | |
1217 | NCT01009879 | November 2009 | 19 February 2015 | Human Tumor Necrosis Factor Alpha (TNFa)-Induced Pre-B Cell Bone Marrow Emigrants | Human TNFa-Induced Pre-B Cell Bone Marrow Emigrants | Rheumatoid Arthritis | Drug: Etanercept | University of Pittsburgh | Amgen | Not recruiting | 18 Years | N/A | Both | 0 | Phase 4 | United States |
1218 | NCT01010581 | November 2009 | 19 February 2015 | SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-Controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: SC12267 (4SC-101);Drug: Placebo;Drug: Methotrexate;Drug: Folic Acid | 4SC AG | Not recruiting | 18 Years | N/A | Both | 266 | Phase 2 | Bulgaria;Czech Republic;Poland;Romania | |
1219 | EUCTR2008-005450-20-BE | 29/10/2009 | 19 March 2012 | The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME) | The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME) | Rheumatoid arthritis MedDRA version: 12.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Remicade (infliximab) Pharmaceutical Form: Intravenous infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Other descriptive name: remicade Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 10- Trade Name: Humira (adalimumab) Pharmaceutical Form: Injection* INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Trade Name: Enbrel (etanercept) Pharmaceutical Form: Injection* INN or Proposed INN: ETANERCEPT CAS Number: 185243690 Other descriptive name: Enbrel Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Mabthera (rituximab) Pharmaceutical Form: Intravenous infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Other descriptive name: Mabthera Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000- Trade Name: Orencia (abatacept) Pharmaceutical Form: Intravenous infusion INN or Proposed INN: ABATACEPT CAS Number: 332348-12-6 Other descriptive name: Orencia Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000- | Radboud University Nijmegen Medical Centre, department of Rheumatic Diseases | Authorised | Female: yes Male: yes | 261 | Belgium | ||||
1220 | EUCTR2008-008954-22-NL | 27/10/2009 | 19 March 2012 | Non Steroidal Anti-Inflammatory Drugs and the antiplatelet effects of acetylsalicylic acid - NSAIDs and ASA research | Non Steroidal Anti-Inflammatory Drugs and the antiplatelet effects of acetylsalicylic acid - NSAIDs and ASA research | This is a healthy volunteer trial. Indications of the IMP's in the context of this trial are: Elevated risk on cardiovascular event Rheumatoid arthritis | Trade Name: Naproxen Pch Tablet 500mg Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Ibuprofen Pch Tablet 600mg Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Diclofenac Natrium Pch Retard Tablet Mga 75mg Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Meloxicam Cf Tablet 7,5mg Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Acetylsalicylzuur Cardio Pch Disp Tablet 80mg Pharmaceutical Form: Tablet | Medisch Spectrum Twente | Authorised | Female: yes Male: yes | 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 |
1221 | EUCTR2009-012118-27-NL | 27/10/2009 | 19 March 2012 | A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy | A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy | JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis. MedDRA version: 9.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions | Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet Product Code: GFI 38518168-AEK-B-007 Pharmaceutical Form: Over encapsulated tablet Current Sponsor code: JNJ-38518168 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Over encapsulated tablet Route of administration of the placebo: Oral use | Janssen-Cilag International NV | Not Recruiting | Female: yes Male: yes | 90 | Phase 2a | Czech Republic;United Kingdom;Netherlands;Spain | |||
1222 | EUCTR2009-012759-12-GB | 14/10/2009 | 19 March 2012 | A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. | A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. | Rheumatoid Arthritis MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Methotrexate Disodium CAS Number: 7413345 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | F. Hoffmann-La Roche Ltd. | Authorised | Female: yes Male: yes | 1128 | Hungary;Portugal;Finland;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Sweden | ||||
1223 | EUCTR2009-014394-41-DK | 12/10/2009 | 12 December 2016 | Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers. Whole-Body MRI in Rheumatoid Arthritis Protocol (WRAP) | Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers. Whole-Body MRI in Rheumatoid Arthritis Protocol (WRAP) | Reumatoid artritis MedDRA version: 12.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid | Trade Name: Humira Product Name: Humira Product Code: Adalimummab Pharmaceutical Form: Injection* INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: Humira Other descriptive name: Adalimumab Concentration unit: 1X 100 milligrams/millilitre Concentration type: equal Concentration number: 40-40 | Hvidovre Hospital | Not Recruiting | Female: yes Male: yes | Phase 4 | Denmark | ||||
1224 | EUCTR2009-012218-30-PT | 06/10/2009 | 5 November 2012 | A randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 weeks after initiation of treatment in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to non-biological DMARDs - PORTRAIT | A randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 weeks after initiation of treatment in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to non-biological DMARDs - PORTRAIT | Men and women > 18 years of age with RA who are currently experiencing an inadequate clinical response to a stable dose of non-biologic DMARDs (at least 12 weeks) and with MRI documented synovitis of dominant hand. | Trade Name: RoActemra Pharmaceutical Form: Concentrate for solution for infusion | Roche Farmacêutica Química, Lda. | Not Recruiting | Female: yes Male: yes | Portugal | |||||
1225 | EUCTR2009-011137-26-DE | 05/10/2009 | 27 January 2014 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 Pharmaceutical Form: Solution for injection INN or Proposed INN: Golimumab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Product Name: Golimumab Product Code: SCH 900259 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Golimumab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Schering-Plough Research Institute, A Division of Schering Corporation | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;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 |
1226 | NCT00929864 | October 2009 | 19 October 2017 | Abatacept Versus Adalimumab Head-to-Head | A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Abatacept;Drug: Adalimumab | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 869 | Phase 3 | United States;Argentina;Canada;Chile;Peru | |
1227 | NCT00938587 | October 2009 | 18 December 2018 | A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis | A Phase 2a, Randomized, Double-Blind, Active And Placebo-Controlled Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: PF-04171327 10 mg;Other: Prednisone Placebo;Drug: PF-04171327 25 mg;Drug: Prednisone 5 mg;Other: Placebo for PF-04171327;Other: Placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 86 | Phase 2 | United States;Czechia;Hong Kong;Hungary;Korea, Republic of;Russian Federation;Serbia;Singapore;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic | |
1228 | NCT00960440 | October 2009 | 19 October 2017 | Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors | Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors | Arthritis, Rheumatoid | Drug: CP-690,550;Drug: Placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 399 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Ireland;Italy;Korea, Republic of;Puerto Rico;Spain;Taiwan;United Kingdom | |
1229 | NCT00993317 | October 2009 | 19 October 2017 | A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis | A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 24-week Study to Assess the Efficacy and Safety of Certolizumab Pegol as Additional Medication to MTX in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate | Rheumatoid Arthritis | Drug: Placebo of CDP870;Drug: CDP870 200mg;Drug: Methotrexate | Korea Otsuka Pharmaceutical Co., Ltd. | Not recruiting | 18 Years | 75 Years | All | 127 | Phase 3 | Korea, Republic of | |
1230 | NCT00996203 | October 2009 | 19 October 2017 | A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs. | Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ) | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: DMARDs (disease-modifying antirheumatic drugs) | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 201 | Phase 4 | Russian Federation | |
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 |
1231 | NCT01002716 | October 2009 | 19 February 2015 | Cell Immunity Response to Vaccination Against Influenza in Patients With Rheumatoid Arthritis | Cell Immunity Response to Vaccination Against Influenza in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Agrippal S1 (Influenza vaccination) | Tel-Aviv Sourasky Medical Center | Recruiting | 18 Years | 90 Years | Both | 90 | Phase 4 | Israel | |
1232 | NCT01123655 | October 2009 | 14 December 2015 | Phase 1 Trial of Type II Collagen (CII) APL A12 in Rheumatoid Arthritis Patients | Phase 1 Trial of CII APL A12 in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: APL A12 | VA Office of Research and Development | Not recruiting | 18 Years | 85 Years | Both | 22 | Phase 1 | United States | |
1233 | NCT01211834 | October 2009 | 19 February 2015 | Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD Therapy | Rheumatoid Arthritis | Drug: tocilizumab;Drug: DMARDs;Drug: Placebo | JW Pharmaceutical | Not recruiting | 18 Years | N/A | Both | 90 | Phase 3 | Korea, Republic of | |
1234 | NCT01873625 | October 2009 | 19 February 2015 | Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Affected Knee Osteoarthritis by Rheumatoid Arthritis | Resurfacing Articular Cartilage With Mesenchymal Stem Cells Transplantation in Patients With Knee Joint Osteoarthritis Affected by Rheumatoid Arthritis: Randomized Triple Blind Clinical Trial Phase II/III (ACRCT) | Rheumatoid Arthritis | Biological: mesenchymal cell transplantation;Biological: placebo | Royan Institute | Not recruiting | 10 Years | 65 Years | Both | 60 | Phase 2/Phase 3 | Iran, Islamic Republic of | |
1235 | EUCTR2009-011000-34-DE | 30/09/2009 | 19 March 2012 | A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate | A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate | Moderate to severe Rheumatoid Arthritis. MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: AIN457 Pharmaceutical Form: Powder for solution for injection Current Sponsor code: AIN457 Other descriptive name: rhumAb to Il-17A (IgG1-k-class) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Powder for solution for injection Route of administration of the placebo: Subcutaneous use | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 200 | Hungary;Slovakia;Czech Republic;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 |
1236 | EUCTR2009-012953-39-CZ | 02/09/2009 | 19 March 2012 | A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: SC12267 Product Code: SC12267 Pharmaceutical Form: Film-coated tablet Current Sponsor code: SC12267 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 35- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Metex 2,5mg Tabletten Pharmaceutical Form: Tablet INN or Proposed INN: METHOTREXATE CAS Number: 59-05-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Trade Name: Metex 7,5mg Tabletten Pharmaceutical Form: Tablet INN or Proposed INN: METHOTREXATE CAS Number: 59-05-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7.5- Trade Name: Metex 10mg Tabletten Pharmaceutical Form: Tablet INN or Proposed INN: METHOTREXATE CAS Number: 59-05-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | 4SC AG | Not Recruiting | Female: yes Male: yes | 244 | Phase 2 | Czech Republic;Bulgaria;Poland | |||
1237 | NCT00913458 | September 2009 | 19 October 2017 | Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis | A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate | Active Rheumatoid Arthritis;Arthritis, Rheumatoid;Rheumatoid Arthritis | Drug: etanercept | Pfizer | Not recruiting | 18 Years | N/A | All | 306 | Phase 4 | France;Germany;Ireland;Italy;Monaco;Netherlands;Poland;Qatar;Romania;Russian Federation;Spain;Switzerland;United Kingdom | |
1238 | NCT00959036 | September 2009 | 19 February 2015 | Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis | A Seamless, Phase 1/2, Multiple Ascending Dose, Proof Of Concept Study Of ATN-103 Administered To Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate | Active Rheumatoid Arthritis | Drug: ATN-103;Drug: Placebo;Drug: Methotrexate | Ablynx | Not recruiting | 18 Years | 80 Years | Both | 252 | Phase 1/Phase 2 | United States;Belgium;Canada;Germany;Hungary;Russian Federation;Serbia;South Africa;Switzerland | |
1239 | NCT00969527 | September 2009 | 19 February 2015 | Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis | Assessment of the Efficacy of Oncoxin+Viusid Administration in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Dietary Supplement: Oncoxin + Viusid;Dietary Supplement: Placebo | Catalysis SL | Not recruiting | 18 Years | N/A | Both | 86 | Phase 3 | Cuba | |
1240 | NCT00973479 | September 2009 | 19 October 2017 | An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFalpha Monoclonal Antibody, Administered Intravenously, in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Arthritis, Rheumatoid | Drug: Golimumab;Other: Placebo;Drug: methotrexate (MTX) | Centocor, Inc. | Schering-Plough | Not recruiting | 18 Years | N/A | All | 592 | Phase 3 | United States;Argentina;Australia;Colombia;Hungary;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Poland;Russian Federation;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 |
1241 | NCT00975130 | September 2009 | 16 December 2017 | Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2) | An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2) | Arthritis, Rheumatoid | Biological: SC golimumab;Biological: IV golimumab | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 3366 | Phase 3 | Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czech Republic;Denmark;Ecuador;Finland;France;Germany;Greece;Guatemala;Hungary;Ireland;Israel;Italy;Korea, Republic of;Mexico;Monaco;Netherlands;Norway;Panama;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Turkey;United Kingdom | |
1242 | NCT00984815 | September 2009 | 19 October 2017 | Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment | Open-Label Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-Steroidal Anti-Inflammatory Drug Treatment | Osteoarthritis;Rheumatoid Arthritis;Chronic Low Back Pain;Chronic Regional Pain Syndrome;Chronic Soft Tissue Pain | Drug: HZT-501 | Horizon Pharma Ireland, Ltd., Dublin Ireland | Not recruiting | 40 Years | 80 Years | All | 86 | Phase 3 | United States | |
1243 | NCT00993668 | September 2009 | 19 October 2017 | Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines | A Phase 4, Randomized, Single-blind, Placebo-controlled, Multicenter Study to Evaluate the Immunogenicity of Pneumococcal and Influenza Vaccines in Adult Subjects With Rheumatoid Arthritis Receiving Certolizumab Pegol or Placebo | Rheumatoid Arthritis | Other: Placebo;Biological: Certolizumab pegol | UCB Pharma | Not recruiting | 18 Years | N/A | All | 224 | Phase 4 | United States | |
1244 | NCT01075477 | September 2009 | 14 November 2016 | An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab) | Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines | Rheumatoid Arthritis | Drug: rituximab [Mabthera/Rituxan] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 151 | N/A | Finland;United States | |
1245 | NCT01253226 | September 2009 | 5 November 2018 | A Study for Japanese Participants With Rheumatoid Arthritis (RA) | Multiple-Dose, Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate | Rheumatoid Arthritis | Drug: LY2127399 (Tabalumab);Drug: Placebo | Eli Lilly and Company | Not recruiting | 20 Years | 75 Years | All | 32 | Phase 1 | 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 |
1246 | EUCTR2009-010813-57-DE | 28/08/2009 | 19 March 2012 | A multicenter, randomized, double-blind, placebo-controlled, single dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of intravenous and subcutaneous CDP6038 in male and female subjects with rheumatoid arthritis on a stable dose of methotrexate. | A multicenter, randomized, double-blind, placebo-controlled, single dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of intravenous and subcutaneous CDP6038 in male and female subjects with rheumatoid arthritis on a stable dose of methotrexate. | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: CDP6038 Product Code: CDP6038 Pharmaceutical Form: Solution for injection CAS Number: 1007223-17-7 Current Sponsor code: CDP6038 Other descriptive name: recombinant human Mab of IgG4 subtype Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: CDP6038 Product Code: CDP6038 Pharmaceutical Form: Solution for injection CAS Number: 1007223-17-7 Current Sponsor code: CDP6038 Other descriptive name: recombinant human Mab of IgG4 subtype Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use | UCB Celltech | Not Recruiting | Female: yes Male: yes | 72 | Germany | ||||
1247 | EUCTR2009-011206-42-CZ | 18/08/2009 | 19 March 2012 | A Randomized, Double Blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients with Active Rheumatoid Arthritis with Inadequate Response to Any Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy including Biologics | A Randomized, Double Blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients with Active Rheumatoid Arthritis with Inadequate Response to Any Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy including Biologics | Active Rheumatoid Arthritis MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: INCB028050 phosphate Product Code: INCB028050 Pharmaceutical Form: Capsule* Current Sponsor code: INCB028050 phosphate Other descriptive name: INCB028050 phosphate salt Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: INCB028050 phosphate Product Code: INCB028050 Pharmaceutical Form: Capsule* Current Sponsor code: INCB028050 phosphate Other descriptive name: INCB028050 phosphate salt Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: INCB028050 phosphate Product Code: INCB028050 Pharmaceutical Form: Capsule* Current Sponsor code: INCB028050 phosphate Other descriptive name: INCB028050 phosphate salt Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Incyte Corporation | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Czech Republic | |||
1248 | EUCTR2009-012705-19-HU | 17/08/2009 | 19 March 2012 | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201 | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201 | Rheumatoid Arthritis (RA) MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: | Product Name: LX3305 Dihydrate Product Code: LX3305 Pharmaceutical Form: Capsule, hard INN or Proposed INN: None as of yet CAS Number: 1078151-47-9 Current Sponsor code: LX3305 Dihydrate Other descriptive name: LX3305 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: LX3305 Dihydrate Product Code: LX3305 Pharmaceutical Form: Capsule, hard INN or Proposed INN: None as of yet CAS Number: 1078151-47-9 Current Sponsor code: LX3305 Dihydrate Other descriptive name: LX3305 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Lexicon Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 104 | Phase 2 | Hungary;Czech Republic;Bulgaria | |||
1249 | EUCTR2009-010516-15-HU | 14/08/2009 | 10 February 2014 | Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate | Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid arthritis (seropositive) MedDRA version: 9.1 Level: LLT Classification code 10040107 Term: Seropositive rheumatoid arthritis | Product Name: SBI-087 Product Code: SBI-087 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: n/a CAS Number: n/a Current Sponsor code: SBI-087 Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 160- Pharmaceutical form of the placebo: Powder for solution for injection Route of administration of the placebo: Subcutaneous use | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | Not Recruiting | Female: yes Male: yes | 200 | Hungary;Greece;Poland;Spain | ||||
1250 | JPRN-UMIN000002340 | 2009/08/01 | 2 April 2019 | Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET) | Rheumatoid Arthritis | Treatment with higher dosages of infliximab (3-10 mg/Kg) Every 2 months Follow-up to 54 weeks Treatment with one of other biologics (etanercept, adalimumab, tocilizumab) in standard protocol Follow-up to 54 weeks | Department of Rheumatosurgery, Osaka City University Medical School | Not Recruiting | 20years-old | Not applicable | Male and Female | 60 | 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 |
1251 | NCT03681639 | August 1, 2009 | 28 October 2019 | Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component | A Multi-Centre, Prospective Study to Obtain Survival and Clinical Outcome Data on the Zimmer Hip Resurfacing System Utilising the Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component | Avascular Necrosis of Hip;Osteoarthritis, Hip;Rheumatoid Arthritis;Inflammatory Arthritis;Post-traumatic; Arthrosis | Diagnostic Test: Serum Metal ion levels determined to monitor changes in chromium and cobalt levels | Zimmer Biomet | Not recruiting | 18 Years | 65 Years | All | 225 | N/A | Germany | |
1252 | NCT00929357 | August 2009 | 19 October 2017 | Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment | A Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice. | Rheumatoid Arthritis | Drug: DMARDs or Biologics | Pfizer | Not recruiting | 18 Years | N/A | All | 156 | N/A | Denmark | |
1253 | NCT00965653 | August 2009 | 14 November 2016 | A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis | Open-label, Multicenter, Randomized, Parallel Study to Investigate pk, pd, Efficacy and Safety of Tocilizumab (TCZ, RO4877533) Following Subcutaneous Administration of TCZ 162 mg Weekly or Every Other Week in Combination With Methotrexate in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: folic acid;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | 75 Years | Both | 29 | Phase 1 | Canada;New Zealand;Spain;United Kingdom | |
1254 | NCT01224041 | August 2009 | 18 January 2016 | Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate | Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study | Rheumatoid Arthritis | Drug: Tacrolimus | Astellas Pharma Inc | Astellas Pharma Korea, Inc. | Not recruiting | 18 Years | 75 Years | Both | 78 | Phase 4 | Korea, Republic of |
1255 | NCT01870128 | August 2009 | 19 February 2015 | Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial | Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial | Rheumatoid Arthritis | Drug: Combination Steroid;Drug: Methotrexate;Drug: Combination | All India Institute of Medical Sciences, New Delhi | Not recruiting | 18 Years | 60 Years | Both | 60 | 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 |
1256 | EUCTR2008-002623-85-NL | 27/07/2009 | 11 February 2013 | A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE | A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE | Moderate to severe early Rheumatoid Arthritis (RA). (Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Enbrel 25mg PFS Product Name: Enbrel (Etanercept) Product Code: 0881 Pharmaceutical Form: Injection* INN or Proposed INN: Etanercept Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Subcutaneous use Trade Name: Enbrel 50mg PFS Product Name: Enbrel (Etanercept) Product Code: 0881 Pharmaceutical Form: Injection* INN or Proposed INN: Etanercept Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Subcutaneous use Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate 2.5mg Tablets Pharmaceutical Form: Tablet INN or Proposed INN: METHOTREXATE CAS Number: 59052 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development | Not Recruiting | Female: yes Male: yes | 300 | France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden | ||||
1257 | ChiCTR-TRC-09000472 | 2009-07-20 | 18 April 2017 | Weekly dose of leflunomide for the treatment of early rheumatoid arthritis | Weekly dose of leflunomide for the treatment of early rheumatoid arthritis: a multicentre, open, randomized clincal trial | Rheumatoid arthritis | Group A:leflunomide 10mg,orally taken once daily for 24 weeks;Group B:leflunomide 50mg, orally taken weekly for 24 weeks; | People's Hospital, Peking University | Not Recruiting | 18 | 65 | Both | Group A:160;Group B:160; | Post-market | China | |
1258 | ChiCTR-TRC-09000473 | 2009-07-20 | 18 April 2017 | Efficacy and safety of Alendronate on Structural Benefit and Inflammation in Rheumatoid Arthritis(RA): A randomized, open, placebo-controlled, multicentre clinical trial. | Efficacy and safety of Alendronate on Structural Benefit and Inflammation in Rheumatoid Arthritis(RA): A randomized, open, placebo-controlled, multicentre clinical trial. | Rheumatoid Arthritis | Group B:MTX 7.5-20mg, orally taken once weekly for 48 week;Group A:MTX7.5-20mg, orally taken once weekly combined Alendronate Sodium 70mg,orally taken once weekly for 48 weeks ; | People's Hospital, Peking University | Not Recruiting | 18 | Both | Group B:160;Group A:160; | Post-market | China | ||
1259 | EUCTR2009-010955-29-NL | 13/07/2009 | 19 March 2012 | Prevention of clinically manifest rheumatoid arthritis by B cell directed therapy in the earliest phase of the disease. | Prevention of clinically manifest rheumatoid arthritis by B cell directed therapy in the earliest phase of the disease. | Pre-clinical RA patients with a high risk on developing the disease. | Trade Name: MabThera 500 mg (10mg/ml) Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab CAS Number: 174722-31 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use | Division of Clinically Immunology and Rheumatology, AMC | Authorised | Female: yes Male: yes | Netherlands | |||||
1260 | JPRN-UMIN000002169 | 2009/07/01 | 2 April 2019 | Safety and efficacy of 3 DMARDs for 2 years of treatment in patients with early rheumatoid arthritis | Rheumatoid Arthritis | Salazosulfapyridine Bucillamine | Higashi-Hiroshima Memorial Hospital | Not Recruiting | 20years-old | 80years-old | Male and Female | 60 | 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 |
1261 | NCT00903383 | July 2009 | 19 October 2017 | Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate | A Phase 2, Multi-center, Randomized, Double Blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy | Rheumatoid Arthritis | Drug: LX3305 low dose;Drug: LX3305 mid dose;Drug: LX3305 high dose;Drug: Placebo | Lexicon Pharmaceuticals | Not recruiting | 18 Years | 75 Years | All | 208 | Phase 2 | United States;Bulgaria;Czech Republic;Hungary;Poland;Serbia | |
1262 | NCT00965757 | July 2009 | 19 October 2017 | A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate | A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: T-614;Drug: Placebo | Eisai Co., Ltd. | Toyama Chemical Co., Ltd. | Not recruiting | 20 Years | 69 Years | All | 253 | Phase 3 | Japan |
1263 | EUCTR2009-012141-34-GB | 29/06/2009 | 19 March 2012 | Randomised Controlled Trial of the Use of Topical Application of Tranexamic Acid in Primary Total Hip Replacement. - (TRANX-H) | Randomised Controlled Trial of the Use of Topical Application of Tranexamic Acid in Primary Total Hip Replacement. - (TRANX-H) | Blood loss in total hip replacement in patient with ostoearthritis and rheumatoid arthritis. | Trade Name: Cyklokapron® Product Name: Cyklokapron® Product Code: NA Pharmaceutical Form: Injection* Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Local use (Noncurrent) | University Hospital of North Tees and Hartlepool | Not Recruiting | Female: yes Male: yes | 150 | United Kingdom | ||||
1264 | EUCTR2008-002381-55-ES | 16/06/2009 | 19 March 2012 | Evaluación de la Eficacia de Rituximab en pacientes con Artritis Reumatoide a través de la medición, por Resonancia Magnética de Mano, de los parámetros clínicos de la enfermedad. Estudio RESONAR. Efficacy of rituximab in patients with Rheumatoid Arthritis, by measurement of disease parameters through magnetic resonance of the hand. RESONAR study. | Evaluación de la Eficacia de Rituximab en pacientes con Artritis Reumatoide a través de la medición, por Resonancia Magnética de Mano, de los parámetros clínicos de la enfermedad. Estudio RESONAR. Efficacy of rituximab in patients with Rheumatoid Arthritis, by measurement of disease parameters through magnetic resonance of the hand. RESONAR study. | Pacientes con artritis reumatoide (AR) activa refractarios a uno o más fármacos antiTNF (definido por un DAS28>3,2). MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: MABTHERA 500 mg concentrado para solución para perfusión Pharmaceutical Form: Intravenous infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Other descriptive name: RITUXIMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use | ROCHE FARMA, S.A. | Not Recruiting | Female: yes Male: yes | Spain | |||||
1265 | JPRN-JapicCTI-090764 | 01/6/2009 | 23 April 2019 | Long-Term Treatment Study of Ocrelizumab for Rheumatoid Arthritis | Long-Term Treatment Study of Ocrelizumab for Rheumatoid Arthritis | Rheumatoid Arthritis | Intervention name : Ocrelizumab Dosage And administration of the intervention : 500 mg will be administered by intravenous infusion on Day 1 and Day 15. Repeat courses of therapy with ocrelizumab may be administered basically every 24 weeks, a minimum interval of 12 weeks, between courses. | Chugai Pharmaceutical Co., Ltd. | 20 | BOTH | 200 | Phase 3 | ||||
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 |
1266 | NCT00848354 | June 2009 | 19 October 2017 | Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy | A Randomized, Open-label Study In The Latin America Region Comparing The Safety And Efficacy Of Etanercept With Conventional Dmard Therapy In Subjects With Rheumatoid Arthritis. | Rheumatoid Arthritis | Biological: Phase 1: Etanercept;Drug: Phase 1: Methotrexate;Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX;Drug: Phase 1: Conventiaonal DMARD | Pfizer | Amgen | Not recruiting | 18 Years | 69 Years | All | 429 | Phase 4 | Argentina;Chile;Colombia;Mexico;Panama;Brazil;Ecuador;Spain;Venezuela |
1267 | NCT00883896 | June 2009 | 19 February 2015 | Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis | A Randomized, Parallel, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of ILV-094 Administered Subcutaneously To Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate | Rheumatoid Arthritis | Other: Placebo;Drug: ILV-094 | Pfizer | Not recruiting | 18 Years | N/A | Both | 195 | Phase 2 | United States;Belgium;Colombia;Croatia;Germany;Hungary;Japan;Mexico;Netherlands;Romania;Russian Federation;Denmark | |
1268 | NCT00927927 | June 2009 | 19 October 2017 | First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis | A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single and Multiple Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0142-0002 Administered Subcutaneously to Subjects With Rheumatoid Arthritis | Inflammation;Rheumatoid Arthritis | Drug: NNC0142-0002;Drug: placebo | Janssen Research & Development, LLC | Not recruiting | 18 Years | 75 Years | All | 65 | Phase 1 | Germany | |
1269 | NCT00947492 | June 2009 | 19 February 2015 | Monitoring Epstein-Barr Virus (EBV) Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs | Monitoring EBV Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs ; Orencia* (Abatacept) and RoActemra* (Tocilizumab). | Rheumatoid Arthritis | Biological: Venous blood sample | Assistance Publique Hopitaux De Marseille | Not recruiting | 18 Years | N/A | Both | 60 | N/A | France | |
1270 | EUCTR2008-008337-11-SE | 27/05/2009 | 19 November 2012 | PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS | PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: CP-690,550 Pharmaceutical Form: Film-coated tablet CAS Number: 540737-29-9 Current Sponsor code: CP-690,550 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Pfizer Inc. | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;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 |
1271 | EUCTR2008-007788-17-CZ | 20/05/2009 | 24 July 2012 | PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS - | CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: CP-690,550 Product Code: CP-690,550 Pharmaceutical Form: Film-coated tablet CAS Number: 540737-29-9 Current Sponsor code: CP-690,550-10 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Pfizer Inc. | Not Recruiting | Female: yes Male: yes | 611 | Phase 3 | Germany;Czech Republic;Bulgaria | ||||
1272 | EUCTR2008-008338-35-CZ | 20/05/2009 | 10 July 2015 | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: CP-690,550 Pharmaceutical Form: Film-coated tablet CAS Number: 540737-29-9 Current Sponsor code: CP-690,550 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Humira Product Name: Humira Pharmaceutical Form: Solution for injection CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Pfizer Inc. | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom | |||
1273 | EUCTR2008-004875-23-BE | 18/05/2009 | 11 August 2014 | An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis | An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: LY2127399 Pharmaceutical Form: Powder for solution for injection Current Sponsor code: LY2127399 Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 48- | Eli Lilly and Company | Not Recruiting | Female: yes Male: yes | 236 | France;Hungary;Poland;Belgium;Austria;Germany | ||||
1274 | EUCTR2008-007023-26-CZ | 18/05/2009 | 26 June 2012 | PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | CP 690,550 is being studied as a disease modifying antirheumatic drug for the treatment of moderate to severe active rheumatoid arthritis in adults. MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: CP-690,550 Pharmaceutical Form: Film-coated tablet CAS Number: 540737-29-9 Current Sponsor code: CP-690,550 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Pfizer Inc. | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Czech Republic;Bulgaria;Poland | |||
1275 | EUCTR2009-011105-17-IT | 17/05/2009 | 19 March 2012 | A single-arm, open-label study of early improvement of anemia and fatigue during treatment with tocilizumab (TCZ) in combination with non biologic DMARDs, in adult patients with moderate to severe active rheumatoid arthritis. - Anemia Fatigue | A single-arm, open-label study of early improvement of anemia and fatigue during treatment with tocilizumab (TCZ) in combination with non biologic DMARDs, in adult patients with moderate to severe active rheumatoid arthritis. - Anemia Fatigue | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Tocilizumab Product Code: Ro 487-7533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RoActemra CAS Number: 375823-41-9 Current Sponsor code: Ro 487-7533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- | ROCHE | Not Recruiting | Female: yes Male: yes | 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 |
1276 | EUCTR2007-006657-63-FI | 08/05/2009 | 3 September 2012 | Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA) | Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA | Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Enbrel 25 mg powder and solvent for solution for injection Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT CAS Number: 185243-69-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Powder and solvent for solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: Enbrel 50 mg powder and solvent for solution for injection Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT CAS Number: 185243-69-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Powder and solvent for solution for injection Route of administration of the placebo: Subcutaneous use | Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom | Not Recruiting | Female: yes Male: yes | 72 | Hungary;Finland;Iceland;Denmark;Norway;Sweden | ||||
1277 | EUCTR2009-011520-53-SK | 04/05/2009 | 18 April 2016 | Evaluation of Adherence and Persistence to Tocilizumab in combination with Methotrexate or Tocilizumab Monotherapy in patients with moderate to severe active rheumatoid arthritis in local environment | Evaluation of Adherence and Persistence to Tocilizumab in combination with Methotrexate or Tocilizumab Monotherapy in patients with moderate to severe active rheumatoid arthritis in local environment | moderate to severe active rheumatoid arthritis | Trade Name: RoActemra® Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Other descriptive name: RoActemra Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal | Roche Slovensko s.r.o. | Not Recruiting | Female: yes Male: yes | Slovakia | |||||
1278 | ChiCTR-TRC-12003871 | 2009-05-01 | 18 April 2017 | Phase II of Tong Luo Hua Shi Capsules in Rheumatoid Arthritis | A Multi-center, Randomized, Double-blind, Phase II Study Evaluating the Safety and Efficacy of Tong Luo Hua Shi Capsules in Participants with Rheumatoid Arthritis | Rheumatoid arthritis | A:2 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary;B:3 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary;C:4 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary;D:4 pieces placebo; | The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Not Recruiting | 18 | 68 | Both | A:60;B:60;C:60;D:60; | Phase 1+Phase 2 | China | |
1279 | NCT00279461 | May 2009 | 10 August 2015 | Vitamin D Deficiency Causes Immune Dysfunction and Enables or Perpetuates the Development of Rheumatoid Arthritis | Vitamin D Deficiency Causes Immune Dysfunction and Enables or Perpetuates the Development of Rheumatoid Arthritis: Clinical Trial and Investigations on Dendritic Cells | Arthritis, Rheumatoid;Vitamin D Deficiency | Drug: Placebo in arm A and Vitamin D in arm B;Drug: vitamin D 3 for arm A ,and matching placebo for arm B | Indiana University | Not recruiting | 18 Years | N/A | Both | 0 | Phase 2 | United States | |
1280 | NCT00838565 | May 2009 | 19 February 2015 | Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis | Phase I, Randomized, Patient and Investigator-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Intravenously Administered Doses of PF-04236921 in Patients With Rheumatoid Arthritis Receiving Methotrexate | Rheumatoid Arthritis | Drug: Placebo;Drug: dose level 1;Drug: dose level 2;Drug: dose level 3;Drug: dose level 4 | Pfizer | Not recruiting | 18 Years | 70 Years | Both | 41 | Phase 1 | United States;Korea, Republic of;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 |
1281 | NCT00853385 | May 2009 | 19 October 2017 | A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis | Phase 3 Randomized, Double-Blind, Active Comparator, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate | Rheumatoid Arthritis | Drug: CP 690,550;Drug: CP-690,550;Other: Placebo;Biological: Biologic TNFi | Pfizer | Not recruiting | 18 Years | N/A | All | 717 | Phase 3 | United States;Australia;Bosnia and Herzegovina;Bulgaria;Canada;Chile;Costa Rica;Croatia;Czech Republic;Denmark;Dominican Republic;Finland;Germany;Korea, Republic of;Mexico;Philippines;Poland;Slovakia;Spain;Thailand;United Kingdom | |
1282 | NCT00856544 | May 2009 | 19 October 2017 | A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications | Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS | Arthritis, Rheumatoid | Drug: CP-690,550;Drug: Placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 795 | Phase 3 | United States;Australia;Chile;China;Colombia;Croatia;Denmark;Finland;Germany;Greece;Malaysia;Mexico;Poland;Russian Federation;Slovakia;Spain;Sweden;Thailand;United Kingdom;Venezuela | |
1283 | NCT00888745 | May 2009 | 19 February 2015 | A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis | A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: placebo;Drug: PRO283698 | Genentech, Inc. | Not recruiting | 18 Years | 75 Years | Both | 65 | Phase 1 | United States;Hungary;United Kingdom | |
1284 | NCT00891020 | May 2009 | 19 October 2017 | A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDs | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: Nonbiologic DMARDs of investigator's choice | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 886 | Phase 3 | United States;Puerto Rico;United Kingdom | |
1285 | NCT00902369 | May 2009 | 8 August 2016 | A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: AK106-001616;Drug: Placebo;Drug: Active comparator | Asahi Kasei Pharma Corporation | Not recruiting | 18 Years | 65 Years | Both | 130 | Phase 2 | Czech Republic;Germany;Hungary;Lithuania;Romania;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 |
1286 | NCT00902486 | May 2009 | 10 September 2018 | INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs | A Randomized, Double-blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients With Active RA With Inadequate Response to Any Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including Biologics | Rheumatoid Arthritis | Drug: INCB028050;Drug: Placebo | Incyte Corporation | Not recruiting | 18 Years | N/A | All | 127 | Phase 2 | United States;Czechia;Czech Republic | |
1287 | NCT00920608 | May 2009 | 19 February 2015 | A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients | A Phase I, Multi-centre, Open-label, Fixed-sequence Study to Assess the Pharmacokinetics of Methotrexate Alone and When Co-administered With AZD9056 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: AZD9056;Drug: Methotrexate | AstraZeneca | Not recruiting | 18 Years | 70 Years | Both | 12 | Phase 1 | ||
1288 | EUCTR2008-006917-25-DE | 24/04/2009 | 19 March 2012 | A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). | A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). | Patients with active rheumatoid arthritis who are on a stable dose of methotrexate | Trade Name: Ribazen Product Name: Tranilast Pharmaceutical Form: Tablet INN or Proposed INN: Tranilast CAS Number: 53902-12-8 Current Sponsor code: None Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Ribazen Product Name: Tranilast Pharmaceutical Form: Tablet INN or Proposed INN: Tranilast CAS Number: 53902-12-8 Current Sponsor code: None Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Product Name: methotrexate Pharmaceutical Form: Tablet INN or Proposed INN: METHOTREXATE CAS Number: 59052 | Nuon Therapeutics, Inc. | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United Kingdom;Czech Republic;Germany;Bulgaria;Poland | |||
1289 | EUCTR2008-008309-23-FR | 24/04/2009 | 19 March 2012 | Etude clinique comparative en double aveugle versus placebo sur la rapidité d’action du tocilizumab sur le soulagement des patients atteints de polyarthrite rhumatoïde active avec réponse inadéquate aux DMARDs et/ou aux biothérapies. - TORPEDO | Etude clinique comparative en double aveugle versus placebo sur la rapidité d’action du tocilizumab sur le soulagement des patients atteints de polyarthrite rhumatoïde active avec réponse inadéquate aux DMARDs et/ou aux biothérapies. - TORPEDO | Polyarthrite rhumatoïde active modérée à sévère de moins de 10 ans d'ancienneté, avec réponse inadéquate au méthotrexate (MTX) et/ou à un autre DMARD et/ou à au moins un anti-TNF MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: RoActemra Product Code: RO487-7533/F01-F05 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tolicizumab CAS Number: 357823-41-9 Current Sponsor code: RO4877533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Concentrate for solution for injection Route of administration of the placebo: Intravenous use | ROCHE | Authorised | Female: yes Male: yes | France | |||||
1290 | EUCTR2008-004875-23-PL | 22/04/2009 | 15 May 2012 | An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis | An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: LY2127399 Product Code: NA Pharmaceutical Form: Powder for solution for injection Current Sponsor code: LY2127399 Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 48- | Eli Lilly and Company | Not Recruiting | Female: yes Male: yes | 236 | Hungary;Germany;Belgium;France;Austria;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 |
1291 | EUCTR2008-006075-75-DE | 22/04/2009 | 19 March 2012 | A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis | A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: AK106-001616 Pharmaceutical Form: Capsule, hard CAS Number: 590416-75-4 Current Sponsor code: AK106-001616 (form B) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg Pharmaceutical Form: Capsule* INN or Proposed INN: naproxen CAS Number: 22204-53-1 Current Sponsor code: naproxen Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Asahi Kasei Pharma Corporation | Not Recruiting | Female: yes Male: yes | 130 | Phase 2a | Hungary;Czech Republic;United Kingdom;Germany | |||
1292 | NCT01081717 | April 14, 2009 | 15 July 2019 | Golimumab Safety and Surveillance Program Using the Ingenix NHI Database | A Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis Treated With Golimumab and Other Types of Biological and Systemic Non Biological Treatments | Rheumatoid Arthritis;Arthritis, Psoriatic;Ankylosing Spondylitis | Drug: systemic non-biological treatments;Biological: anti-TNF biologics;Biological: golimumab;Biological: non-anti-TNF biologics;Other: general population | Janssen Biotech, Inc. | Not recruiting | N/A | 99 Years | All | 1064 | N/A | United States | |
1293 | EUCTR2009-011044-20-GB | 08/04/2009 | 19 March 2012 | A Single-Centre, Double-blind, Double-dummy, Randomised, Placebo Controlled, Four Period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600mg and 150mg) on QT/QTc Interval, Compared to Placebo, using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers | A Single-Centre, Double-blind, Double-dummy, Randomised, Placebo Controlled, Four Period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600mg and 150mg) on QT/QTc Interval, Compared to Placebo, using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers | rheumatoid arthritis MedDRA version: 9.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions | Product Code: AZD5672 Pharmaceutical Form: Tablet Current Sponsor code: AZD5672 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Avelox® Product Name: Avelox- Moxifloxacin Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | AstraZeneca AB | Not Recruiting | Female: no Male: yes | 64 | United Kingdom | ||||
1294 | JPRN-JapicCTI-090751 | 01/4/2009 | 2 April 2019 | A study of Adalimumab in Japanese subjects with Rheumatoid Arthritis | A Phase 3 Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis | Intervention name : adalimumab INN of the intervention : adalimumab Dosage And administration of the intervention : 40 mg every other week, subcutaneous Control intervention name : Placebo Dosage And administration of the control intervention : every other week, subcutaneous | Abbott Japan Co., Ltd. | Eisai Co., Ltd. | 20 | BOTH | 300 | Phase 3 | |||
1295 | JPRN-UMIN000004271 | 2009/04/01 | 2 April 2019 | Upper gastrointestinal endoscopic findings in Japanese with rheumatoid arthritis (RA) receiving long-term NSAIDs therapy, and the usefulness of switching to selective COX-2 inhibitor celecoxib | Rheumatoid arthritis (RA) NSAIDs-induced gastrointestinal mucosal injury | Japanese rheumatic patients who have been treated with NSAIDs for twelve or more weeks are switched to CEL (400mg/day). Upper GI endoscopy is conducted before and after administration of CEL. Patients with ulcers at the enrollment are switched to CEL (400mg/day) with famotidine (20mg/day) after healing of their pre-existing ulcers following treatment. | Hoshigaoka Koseinenkin Hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 100 | 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 |
1296 | NCT00763139 | April 2009 | 19 October 2017 | Inflammation and Insulin Resistance in Rheumatoid Arthritis | Inflammation and Insulin Resistance in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Pioglitazone;Drug: Placebo | Vanderbilt University | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | N/A | All | 34 | N/A | United States |
1297 | NCT00887770 | April 2009 | 19 February 2015 | A Study to Investigate the Potential for AZD5672 to Affect the Electrical Conduction Pathways in the Heart | A Single-centre, Double-blind, Double-dummy, Randomised, Placebo-controlled, Four-period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600 mg and 150 mg) on QT/QTc Interval, Compared to Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers | Rheumatoid Arthritis | Drug: AZD5672;Drug: Moxifloxacin;Drug: placebo | AstraZeneca | Quintiles Limited | Not recruiting | 18 Years | 45 Years | Male | 64 | Phase 1 | United Kingdom |
1298 | NCT00928317 | April 2009 | 19 February 2015 | Dose Ranging Study of ART621 in Subjects Diagnosed With Rheumatoid Arthritis Taking Methotrexate | Multi-Centre Randomised Double-Blind Pbo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability, Efficacy, PK and Immunogenicity of Multiple Doses of ART621 for 3 Months in Patients With Rheumatoid Arthritis Taking Methotrexate | Rheumatoid Arthritis | Drug: ART621;Drug: Placebo | Arana Therapeutics Ltd | Not recruiting | 18 Years | 80 Years | Both | 13 | Phase 2 | United States;Argentina;Australia;Czech Republic;India;Malaysia;New Zealand;Poland | |
1299 | NCT00931086 | April 2009 | 19 February 2015 | Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99 | An Expanded Access Trial of Belimumab Antibody (Monoclonal Anti-BLyS Antibody) in Patients With Rheumatoid Arthritis (RA) Who Were Previously Treated Under HGS Protocol LBRA99 | Rheumatoid Arthritis | Drug: belimumab | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Not recruiting | 18 Years | N/A | Both | Phase 4 | United States | |
1300 | NCT01075711 | April 2009 | 19 February 2015 | Determine the Improvement in Activity Status/Quality of Life (QoL) of Patients With Rheumatoid Arthritis (RA) During Treatment With Lodotra (Prednisone) | Non-interventional Study for Determining the Improvement in the Activity Status / Life Quality of Patients With Rheumatoid Arthritis Being Treated With the Tempus Tablet | Arthritis, Rheumatoid | Drug: Prednisone | Merck KGaA | Merck Serono GmbH, Germany | Not recruiting | 18 Years | N/A | Both | 2728 | 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 |
1301 | EUCTR2008-006930-92-CZ | 31/03/2009 | 19 March 2012 | A multi-centre randomised, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of ART621 following multiple dose administration for 3 months in patients with rheumatoid arthritis concomitantly taking methotrexate | A multi-centre randomised, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of ART621 following multiple dose administration for 3 months in patients with rheumatoid arthritis concomitantly taking methotrexate | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: ART621 Pharmaceutical Form: Solution for injection Current Sponsor code: ART621 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Arana Therapeutics Ltd | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic | ||||
1302 | EUCTR2008-003011-12-GB | 30/03/2009 | 19 March 2012 | Prospective Randomised Double-Blind Placebo Controlled Study Assessing the Efficacy of Tocilizumab with Synovial Analysis in Patients with Rheumatoid Arthritis - TOCRA | Prospective Randomised Double-Blind Placebo Controlled Study Assessing the Efficacy of Tocilizumab with Synovial Analysis in Patients with Rheumatoid Arthritis - TOCRA | Rheumatoid Arthritis | Trade Name: RoActemra®EV Product Code: PRD82321 Product Name: Tocilizumab Product Code: RO4877533 Pharmaceutical Form: Concentrate for solution for infusion Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | University of Leeds | Authorised | Female: yes Male: yes | 30 | United Kingdom | ||||
1303 | EUCTR2008-006936-37-HU | 25/03/2009 | 19 March 2012 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid Arthritis (RA) MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: ILV-094 Product Code: ILV-094 Pharmaceutical Form: Powder for injection* Current Sponsor code: ILV-094 Other descriptive name: Recombinant human anti IL-22 monoclonal antibody IgG1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Powder for injection* Route of administration of the placebo: Subcutaneous use | Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development | Not Recruiting | Female: yes Male: yes | 180 | Hungary;Germany;Netherlands;Belgium | ||||
1304 | NCT00687193 | March 2009 | 19 October 2017 | Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARD | Arthritis, Rheumatoid | Drug: Placebo;Drug: CP-690,550 | Pfizer | Not recruiting | 20 Years | 70 Years | All | 318 | Phase 2 | Japan | |
1305 | NCT00808210 | March 2009 | 14 November 2016 | A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab | A PHASE II RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN COMBINATION WITH METHOTREXATE, COMPARED TO INFLIXIMAB PLUS METHOTREXATE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS CURRENTLY RESPONDING INADEQUATELY TO ETANERCEPT OR ADALIMUMAB | Rheumatoid Arthritis | Drug: infliximab;Drug: methotrexate;Drug: methylprednisolone;Drug: ocrelizumab;Drug: sham | Genentech, Inc. | Not recruiting | 18 Years | N/A | Both | 28 | 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 |
1306 | NCT00837434 | March 2009 | 18 December 2018 | Anti-TNF Agents for the Treatment of Rheumatoid Arthritis | A Partially Blinded, Randomized, Multi-Center, Phase IV Trial to Evaluate Mechanism of Action of Anti-TNF Agents in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Etanercept;Drug: Adalimumab | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Not recruiting | 18 Years | 75 Years | All | 63 | Phase 4 | United States |
1307 | NCT00847613 | March 2009 | 19 October 2017 | A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate | Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate | Arthritis, Rheumatoid | Drug: CP-690,550;Drug: Placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 800 | Phase 3 | United States;Australia;Brazil;Bulgaria;Canada;Colombia;Czech Republic;Greece;India;Japan;Korea, Republic of;Mexico;Poland;Taiwan;Ukraine;Venezuela | |
1308 | NCT00850343 | March 2009 | 19 October 2017 | Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients | A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered Without Coadministration of Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-003) | Rheumatoid Arthritis | Drug: Certolizumab pegol | Astellas Pharma Inc | UCB Japan Co. Ltd. | Not recruiting | 20 Years | 74 Years | All | 208 | Phase 3 | Japan |
1309 | NCT00851318 | March 2009 | 19 October 2017 | Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients | A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered in Combination With Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-001) | Rheumatoid Arthritis | Drug: Certolizumab pegol;Drug: Methotrexate | Astellas Pharma Inc | UCB Japan Co. Ltd. | Not recruiting | 20 Years | 74 Years | All | 285 | Phase 3 | Japan |
1310 | NCT00870467 | March 2009 | 19 October 2017 | A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis | A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Double-blind adalimumab;Drug: Double-blind Placebo;Biological: Open-label Adalimumab;Biological: Open-labelAdalimumabRescue | Abbott | Eisai Co., Ltd. | Not recruiting | 20 Years | N/A | All | 334 | 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 |
1311 | NCT00871767 | March 2009 | 19 February 2015 | AZD5672 Bioavailability Study in Healthy Male and Female Subjects | An Open-Label, Randomized, 4 Period Crossover, Replicate Study to Assess the Relative Bioavailability of the Phase III and Phase IIb Formulations of AZD5672 in Healthy Male and Female Subjects | Rheumatoid Arthritis | Drug: AZD5672 | AstraZeneca | Not recruiting | 18 Years | 55 Years | Both | 24 | Phase 1 | United Kingdom | |
1312 | NCT00882024 | March 2009 | 19 February 2015 | Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA) | A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast With Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients With Active Rheumatoid Arthritis (RA) | Active Rheumatoid Arthritis | Drug: Tranilast;Drug: Placebo | Nuon Therapeutics, Inc. | Not recruiting | 18 Years | 75 Years | Both | 250 | Phase 2 | United States;Argentina;Bulgaria;Czech Republic;Germany;Mexico;Serbia;United Kingdom | |
1313 | NCT02721004 | March 2009 | 21 July 2016 | Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With Rheumatoid Arthritis | Documentation of the Efficacy and Safety of RoActemra in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | N/A | N/A | Both | 592 | N/A | Austria | |
1314 | EUCTR2008-006443-39-ES | 23/02/2009 | 24 April 2012 | Estudio piloto de fase II multicéntrico, aleatorizado, en grupos paralelos para comparar la incidencia de las reacciones a la infusión de Tocilizumab en pacientes con AR moderada a grave cuando la infusión se realiza en 1 hora frente a 31 minutos. | Estudio piloto de fase II multicéntrico, aleatorizado, en grupos paralelos para comparar la incidencia de las reacciones a la infusión de Tocilizumab en pacientes con AR moderada a grave cuando la infusión se realiza en 1 hora frente a 31 minutos. | Pacientes adultos con artritis reumatoide (AR) activa moderada o grave que son respondedores inadecuados a los tratamientos con FAMEs no biológicos o con anti-TNFs. MedDRA version: 9 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Tocilizumab Product Code: RO04877533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Tocilizumab Current Sponsor code: RO4877533 Other descriptive name: RoActemra Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- | Roche Farma, S.A. | Not Recruiting | Female: yes Male: yes | Spain | |||||
1315 | EUCTR2008-004894-16-DE | 12/02/2009 | 19 March 2012 | Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy | Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: LY2127399 Pharmaceutical Form: Powder for solution for injection Current Sponsor code: LY2127399 Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 48- Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Subcutaneous use | Eli Lilly and Company limited | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | Hungary;Czech Republic;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 |
1316 | NCT00754572 | February 2009 | 19 October 2017 | A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis | A Single-arm, Open-label Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 418 | Phase 3 | Argentina;Brazil;Chile;Colombia;Costa Rica;Ecuador;Mexico;Peru;Uruguay;Venezuela | |
1317 | NCT00777816 | February 2009 | 18 January 2016 | Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis | A Blinded, Placebo-controlled, Study of the Safety and Pharmacokinetics of XOMA 052 Administered to Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: XOMA 052;Drug: Placebo | XOMA (US) LLC | Not recruiting | 18 Years | 75 Years | Both | 18 | Phase 2 | United States | |
1318 | NCT00814307 | February 2009 | 19 October 2017 | A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis | Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: CP-690,550;Drug: Placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 611 | Phase 3 | United States;Brazil;Bulgaria;Chile;Colombia;Czech Republic;Dominican Republic;Germany;India;Malaysia;Mexico;Philippines;Poland;Puerto Rico;Russian Federation;Ukraine | |
1319 | NCT00837811 | February 2009 | 11 June 2018 | An Open Label Extension Study in Participants With Rheumatoid Arthritis | An Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis. | Rheumatoid Arthritis | Biological: LY2127399 | Eli Lilly and Company | Not recruiting | 18 Years | N/A | All | 182 | Phase 2 | United States;Australia;Austria;Belgium;Brazil;Canada;Chile;Germany;Hungary;India;Mexico;Poland;Puerto Rico;Romania;Argentina;Czech Republic;France;Slovakia;Ukraine | |
1320 | NCT00847886 | February 2009 | 19 October 2017 | Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: LX3305;Drug: LX3305 Placebo;Drug: Methotrexate | Lexicon Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 15 | 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 |
1321 | NCT00851240 | February 2009 | 19 February 2015 | BTT-1023 in Rheumatoid Arthritis | A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Repeated Intravenous Doses of BTT-1023 in Patients With Rheumatoid Arthritis - a Double-blind Randomized Placebo-controlled Sequential Group Trial | Rheumatoid Arthritis | Drug: BTT-1023;Drug: Placebo | Biotie Therapies Corp. | Not recruiting | 18 Years | 75 Years | Both | 24 | Phase 1 | Bulgaria | |
1322 | NCT00854685 | February 2009 | 19 February 2015 | Dose Optimisation Study of ART621 in Subjects Diagnosed With Rheumatoid Arthritis Taking Methotrexate | A Factorial-design, Randomised, Double-blind, Placebo-controlled, Dose Optimisation Study to Investigate the Safety, Efficacy, Immunogenicity and Pharmacokinetics of ART621 Following Multiple Dose Administration in Subjects Diagnosed With Rheumatoid Arthritis Concomitantly Taking Methotrexate | Rheumatoid Arthritis | Drug: ART621;Drug: Placebo | Arana Therapeutics Ltd | Trident Clinical Research Pty Ltd | Not recruiting | 18 Years | 80 Years | Both | 27 | Phase 2 | Sri Lanka |
1323 | NCT01447264 | February 2009 | 19 February 2015 | Effectiveness of Water Exercises on Isokinetic Muscle Strength | Comparison of the Effectiveness Between Land and Water Exercises on Isokinetic Muscle Strength of Lower Limbs in Women With Rheumatoid Arthritis: a Randomized Controlled Trial | Rheumatoid Arthritis | Procedure: Land exercises;Procedure: Water exercises | Federal University of São Paulo | Department of Medicine | Not recruiting | 40 Years | 65 Years | Female | 100 | Phase 3 | Brazil |
1324 | EUCTR2008-004754-33-SK | 29/01/2009 | 13 March 2017 | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug Therapy | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug Therapy | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: BG00012 Pharmaceutical Form: Capsule, hard CAS Number: 624497 Other descriptive name: Dimeythl Fumarate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 120- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Biogen Idec Limited | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | Czech Republic;Slovakia;Poland | |||
1325 | EUCTR2008-005525-11-ES | 29/01/2009 | 18 April 2012 | Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato. A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate. | Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato. A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate. | Artritis reumatoide Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: MABTHERA 500 mg concentrado para solución para perfusión Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Current Sponsor code: Ro 45-2294 Other descriptive name: RITUXIMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use Product Name: tocilizumab Product Code: RO4877533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab Current Sponsor code: Ro4877533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | F Hoffmann-La Roche Ltd | Authorised | Female: yes Male: yes | 81 | United Kingdom;Germany;Netherlands;France;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 |
1326 | EUCTR2008-007225-39-BE | 06/01/2009 | 5 June 2018 | A 2 year follow up to assess the effectiveness in daily practice of different treatment strategies for early Rheumatoid Arthritis patients. | A 2 year prospective multicentre randomised controlled trial comparing effectiveness in daily practice of different treatment strategies for early RA - CareRA | early active Rheumatoid Arthritis, previously untreated with DMARDS MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Ledertrexate Pharmaceutical Form: Tablet INN or Proposed INN: methotrexate CAS Number: 7413-34-5 Other descriptive name: METHOTREXATE DISODIUM Concentration unit: mg milligram(s) Concentration type: range Concentration number: 7.5-20 Trade Name: Salazopyrine Pharmaceutical Form: Tablet INN or Proposed INN: SULFASALAZINE CAS Number: 599-79-1 Concentration unit: g gram(s) Concentration type: range Concentration number: 1-3 Trade Name: Arava Pharmaceutical Form: Coated tablet INN or Proposed INN: LEFLUNOMIDE CAS Number: 75706-12-6 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 10-20 | University Hospitals Leuven | Not Recruiting | Female: yes Male: yes | 400 | Phase 4 | Belgium | |||
1327 | NCT00825409 | January 2009 | 19 February 2015 | Safety and Effectiveness Study of Ascension's PyroCarbon Radial Head Compared to Ascension's Metal Radial Head | Safety and Effectiveness Study of Ascension's PyroCarbon Radial Head Compared to Ascension's Metal Radial Head to Treat Arthritis, Fractures of the Radial Head, Relief of Symptoms After Radial Head Resection, or Revision of a Failed Radial Head Implant. | Degenerative Arthritis;Post-Traumatic Arthritis;Rheumatoid Arthritis | Device: Carbon Modular Radial Head;Device: Metal Radial Head | Ascension Orthopedics, Inc. | Recruiting | 18 Years | 85 Years | Both | 203 | N/A | United States | |
1328 | NCT00838058 | January 2009 | 19 February 2015 | A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis. | An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy Volunteers | Rheumatoid Arthritis;Healthy Volunteers | Drug: CE-224,535;Drug: CE 224,535 | Pfizer | Not recruiting | 18 Years | 55 Years | Both | 11 | Phase 1 | United States | |
1329 | NCT00858780 | January 2009 | 19 October 2017 | Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA | Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA) | Rheumatoid Arthritis | Drug: Etanercept;Drug: Placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 91 | Phase 4 | Denmark;Finland;Hungary;Iceland;Norway;Sweden | |
1330 | NCT01426347 | January 2009 | 16 December 2017 | Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis | Vitamin Therapy in Rheumatoid Arthritis | Rheumatoid Arthritis;Vitamin D Deficiency | Drug: Placebo sugar pill;Drug: Ergocalciferol | Johns Hopkins University | Not recruiting | 18 Years | 75 Years | All | 139 | 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 |
1331 | NCT02405234 | January 2009 | 16 December 2017 | Ascension PyroCarbon Radial Head Study | Safety and Effectiveness Study of Ascension PyroCarbon Radial Head Compared to Ascension Metal Radial Head | Degenerative Arthritis;Radial Head Fracture;Rheumatoid Arthritis | Device: Carbon Modular Radial Head replacement;Device: Metal Radial Head replacement | Integra LifeSciences Corporation | Not recruiting | 18 Years | 85 Years | All | 78 | N/A | United States | |
1332 | NCT02779114 | January 2009 | 30 May 2016 | RETRO (REduction of Therapy in RA Patients in Ongoing Remission) | A Phase 3, Multicenter, Randomized, Open, Prospective, Controlled, Parallel Group Study of Reduction of Therapy in Patients With Rheumatoid Arthritis in Ongoing Remission. | Rheumatoid Arthritis | Drug: Control group;Other: Reduction group 1;Other: Reduction group 2 | University of Erlangen-Nürnberg Medical School | Recruiting | 18 Years | N/A | Both | 318 | Phase 3 | Germany | |
1333 | NCT02809833 | January 2009 | 19 October 2017 | Use of Tocilizumab for Rheumatoid Arthritis (RA) in Daily Routine | Tocilizumab for the Treatment of Rheumatoid Arthritis: Findings on The Use of Tocilizumab in Daily Clinical Routine | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 850 | N/A | Germany | |
1334 | NCT00848120 | December 31, 2008 | 16 December 2017 | A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis | An Open Label Study to Evaluate the Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 29 | Phase 3 | Philippines | |
1335 | EUCTR2008-002046-27-DE | 08/12/2008 | 24 April 2012 | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: GSK1841157 Pharmaceutical Form: Concentrate for solution for injection Current Sponsor code: GSK1841157 Other descriptive name: HuMax-CD20 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Subcutaneous use | GlaxoSmithKline Research & Development Ltd | Not Recruiting | Female: yes Male: yes | 70 | Phase 1/2A | Germany;Belgium;France;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 |
1336 | EUCTR2008-004931-39-PL | 08/12/2008 | 19 March 2012 | A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80 mg, 160 mg, and 320 mg ALD518 versus Placebo Administered as Multiple Intravenous Infusions to Patients with Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate. | A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80 mg, 160 mg, and 320 mg ALD518 versus Placebo Administered as Multiple Intravenous Infusions to Patients with Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate. | Active Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: ALD518 Product Code: ALD518 Pharmaceutical Form: Intravenous infusion Current Sponsor code: ALD518 Other descriptive name: ALD518 monoclonal antibody (anti IL-6 mAb) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80- Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use | Alder Biopharmaceuticals, Inc | Not Recruiting | Female: yes Male: yes | 120 | Poland | ||||
1337 | ChiCTR-TRC-10001060 | 2008-12-01 | 18 April 2017 | Efficacy and safety of infliximab in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial | Efficacy and safety of infliximab in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial | rheumatoid arthritis;M05.901 | infliximab:intravenous injections of infliximab (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy;placebo:intravenous injections of placebo (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy; | People's Hospital, Beijing University; Shanghai Changzheng Hospital | Not Recruiting | 18 | 65 | Both | infliximab:0;placebo:0; | Phase 3 study | China | |
1338 | NCT00767325 | December 2008 | 19 October 2017 | A Rheumatoid Arthritis Study to Assess Early Response to Abatacept+MTX as Defined by Improvement of Synovitis Measures by Power Doppler Ultrasonography | Multi-Center, Open Label Study to Assess Early Response to Abatacept With Background Methotrexate Using Power Doppler Ultrasonography in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: Abatacept;Drug: Methotrexate | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 104 | Phase 3 | Denmark;France;Germany;Hungary;Italy;Norway;Spain;United Kingdom | |
1339 | NCT00805116 | December 2008 | 17 May 2016 | Marine Oils and Arthritis | Whale Oil Versus Cod Liver Oil in Rheumatoid Arthritis | Rheumatoid Arthritis | Dietary Supplement: Whale blubber oil;Dietary Supplement: Cod liver oil | National Institute of Nutrition and Seafood Research, Norway | Not recruiting | 18 Years | N/A | Both | 7 | N/A | Norway | |
1340 | NCT00810836 | December 2008 | 19 February 2015 | Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of BG00012 When Given With Methotrexate to Subjects With Active RA Who Have Had an Inadequate Response to Conventional Disease-Modifying Anti-rheumatic Drug Therapy | Rheumatoid Arthritis | Drug: BG00012;Drug: placebo | Biogen Idec | Not recruiting | 18 Years | 75 Years | Both | 153 | Phase 2 | Australia;Canada;Czech Republic;India;Poland;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 |
1341 | NCT00815906 | December 2008 | 19 February 2015 | Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis | An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: SBI-087 | Pfizer | Emergent Product Development Seattle LLC | Not recruiting | 20 Years | 70 Years | Both | 20 | Phase 1 | Japan |
1342 | NCT00818064 | December 2008 | 16 December 2017 | Safety and Tolerability of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis | A Randomised, Double-blind, Placebo-controlled, Single- Dose, Dose-escalation Trial of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis | Inflammation;Rheumatoid Arthritis;Healthy | Drug: anti-IL-20;Drug: placebo | Novo Nordisk A/S | Not recruiting | 18 Years | 75 Years | All | 32 | Phase 1 | Netherlands | |
1343 | NCT01011959 | December 2008 | 19 February 2015 | A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Parallel-group Study of the Safety and Tolerability of REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate | Rheumatoid Arthritis | Biological: REGN88 | Regeneron Pharmaceuticals | Sanofi | Not recruiting | 18 Years | N/A | Both | 60 | Phase 1 | United States |
1344 | NCT01179971 | December 2008 | 19 February 2015 | n-3 and n-6 Fatty Acids in Rheumatoid Arthritis | Incorporation of n-3 Long Chain Polyunsaturated Fatty Acids and Gamma Linolenic Acid in Plasma Lipids, Cholesteryl Esters, and Erythrocyte Membranes and Their Influence on Disease Activity in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Dietary Supplement: Fish oil, gamma-linolenic acid | Charite University, Berlin, Germany | University of Jena | Not recruiting | 18 Years | 80 Years | Both | 60 | Phase 2 | |
1345 | EUCTR2008-006256-22-FR | 21/11/2008 | 19 March 2012 | Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy. | Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy. | rheumatoid arthritis requiring anti-TNF alpha treatment MedDRA version: 9.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions | Trade Name: remicade Pharmaceutical Form: Intravenous infusion INN or Proposed INN: infliximab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Trade Name: humira Pharmaceutical Form: Injection* INN or Proposed INN: adalimumab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Trade Name: enbrel Pharmaceutical Form: Injection* INN or Proposed INN: etanercept Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- | CHU Saint-Etienne | Authorised | Female: yes Male: yes | 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 |
1346 | NCT00771030 | November 2008 | 14 November 2016 | Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis | A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: AMG 827;Other: Placebo | Amgen | Not recruiting | 18 Years | 70 Years | Both | 40 | Phase 1/Phase 2 | Canada;Mexico;United States | |
1347 | NCT00783536 | November 2008 | 19 February 2015 | A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid Arthritis | An Randomized, Open Label, Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate With DMARD Therapy in Subjects With Active Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Etanercept + Methotrexate;Drug: DMARDS | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | 80 Years | Both | 402 | Phase 4 | Mexico | |
1348 | NCT00791921 | November 2008 | 19 October 2017 | Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA) | A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated. | Rheumatoid Arthritis | Drug: CDP870;Drug: Placebo of CDP870 | Otsuka Pharmaceutical Co., Ltd. | UCB Japan Co. Ltd. | Not recruiting | 20 Years | 74 Years | All | 230 | Phase 3 | Japan |
1349 | NCT00791999 | November 2008 | 19 October 2017 | Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA) | A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Pharmacokinetics and Safety of CDP870 as add-on Medication to MTX in Japanese Active RA Patients Who Have an Incomplete Response to MTX. | Rheumatoid Arthritis | Drug: CDP870 400mg;Drug: CDP870 200mg;Drug: CDP870 100mg;Drug: Placebo of CDP870 | Otsuka Pharmaceutical Co., Ltd. | UCB Japan Co. Ltd. | Not recruiting | 20 Years | 74 Years | All | 316 | Phase 2/Phase 3 | Japan |
1350 | NCT00796705 | November 2008 | 19 October 2017 | Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA) | Switching Anti-TNF-alpha Agents in Patients With RA With An Inadequate Response to TNF-alpha Inhibition | Rheumatoid Arthritis | Drug: Adalimumab;Drug: Adalimumab placebo;Drug: Etanercept | National Institute of Allergy and Infectious Diseases (NIAID) | Not recruiting | 18 Years | N/A | All | 13 | 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 |
1351 | NCT00901550 | November 2008 | 19 February 2015 | The Chinese University of Hong Kong Early Arthritis Study | The Chinese University of Hong Kong Early Arthritis Study | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Infliximab | Chinese University of Hong Kong | Not recruiting | 18 Years | 80 Years | Both | 40 | N/A | China | |
1352 | NCT00948610 | November 2008 | 16 December 2017 | Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy | Sleep & Immune Mechanisms in Rheumatoid Arthritis: Remicade Substudy | Rheumatoid Arthritis | Drug: Remicade | University of California, Los Angeles | National Heart, Lung, and Blood Institute (NHLBI) | Not recruiting | 18 Years | 85 Years | All | 20 | N/A | United States |
1353 | NCT00773461 | October 31, 2008 | 16 December 2017 | A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis. | A Randomized, Double Blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With DMARD Therapy, in Patients With Active Rheumatoid Arthritis and Inadequate Response to Current DMARD Therapy | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo | Hoffmann-La Roche | Not recruiting | 18 Years | 70 Years | All | 209 | Phase 3 | China | |
1354 | EUCTR2008-005320-81-AT | 21/10/2008 | 19 March 2012 | A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2 | A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2 | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: ACZ885 Product Code: ACZ885 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Canakinumab Current Sponsor code: ACZ885 Other descriptive name: Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 200 | Germany;Spain;Austria | ||||
1355 | EUCTR2008-000742-30-HU | 18/10/2008 | 19 March 2012 | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: R935788 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fostamatinib Disodium CAS Number: 914295-16-2 Current Sponsor code: R935788 sodium hexahydrate Other descriptive name: R788 Sodium, R788 Na, R788 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: R935788 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fostamatinib Disodium CAS Number: 914295-16-2 Current Sponsor code: R935788 sodium hexahydrate Other descriptive name: R788 Sodium, R788 Na, R788 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Rigel Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 420 | Phase 2 | Hungary;Bulgaria;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 |
1356 | EUCTR2008-001847-20-ES | 17/10/2008 | 28 August 2014 | Estudio aleatorizado, controlado con placebo, para evaluar la seguridad y eficacia de añadir tocilizumab (TCZ) a metotrexato (MTX) frente al cambio a TCZ (controlado con placebo), con la posibilidad de añadir otros fármacos antirreumáticos modificadores de la enfermedad (FAMEs), en pacientes con artritis reumatoide activa que tienen una respuesta inadecuada al tratamiento previo con MTX. | Estudio aleatorizado, controlado con placebo, para evaluar la seguridad y eficacia de añadir tocilizumab (TCZ) a metotrexato (MTX) frente al cambio a TCZ (controlado con placebo), con la posibilidad de añadir otros fármacos antirreumáticos modificadores de la enfermedad (FAMEs), en pacientes con artritis reumatoide activa que tienen una respuesta inadecuada al tratamiento previo con MTX. | Artritis reumatoide MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Tocilizumab Product Code: RO04877533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab Current Sponsor code: RO4877533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets Pharmaceutical Form: Tablet INN or Proposed INN: METOTREXATO SODIO Other descriptive name: METHOTREXATE SODIUM Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | F Hoffmann-La Roche Ltd | Not Recruiting | Female: yes Male: yes | 470 | France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden | ||||
1357 | EUCTR2007-003288-36-NL | 15/10/2008 | 18 April 2012 | A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART | A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Remicade Product Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Centocor BV | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria | |||
1358 | EUCTR2008-005212-40-SE | 14/10/2008 | 19 March 2012 | Pain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSING | Pain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSING | Rheumatoid arthritis (RA) The overall aim with this project is to investigate central pain mechanisms in RA and healthy controls, and in RA how these are influenced by autonomic neural regulation and TNF-blockade with Remicade. MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10060016 Term: Alpha tumor necrosis factor MedDRA version: 9.1 Level: LLT Classification code 10029817 Term: Nuclear magnetic resonance imaging brain MedDRA version: 9.1 Level: LLT Classification code 10053689 Term: Cardiovascular autonomic function test | Trade Name: Remicade Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Infliximab Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Karolinska Institute | Authorised | Female: yes Male: no | Sweden | |||||
1359 | EUCTR2008-004398-16-SE | 08/10/2008 | 16 September 2013 | A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable RA Patients in Clinical remission - ADMIRE | A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable RA Patients in Clinical remission - ADMIRE | Adalimumab has the indication for life-long treatment of RA but can adalimumab be discontinued in patients who are in stable clinical remission (DAS28<2.6) with retained low disease activity or will the RA symptoms relapse? If relapse occurs, how is the response if adalimumab is reinstituted? MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Humira Product Name: Humira Pharmaceutical Form: Injection INN or Proposed INN: Adalimumab Current Sponsor code: ABT-Humira Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | Abbott Scandinavia AB | Not Recruiting | Female: yes Male: yes | 50 | Sweden | ||||
1360 | EUCTR2007-000830-38-FR | 07/10/2008 | 19 March 2012 | A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. | A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Certolizumab pegol Product Code: CDP870 Pharmaceutical Form: Solution for injection INN or Proposed INN: Certolizumab pegol CAS Number: 428863-50-7 Current Sponsor code: CDP870 Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 200- | UCB Pharma S.A. | Authorised | Female: yes Male: yes | 132 | Phase 3B | Germany;France;Italy;Poland;Austria | |||
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 |
1361 | ChiCTR-TRC-10000850 | 2008-10-01 | 18 April 2017 | Phase III clinical trial of Iguratimodin rheumatoid arthritis | Phase III clinical trial of Iguratimodin rheumatoid arthritis | rheumatoid arthritis | 3:Experimental group: Iguratimod tablet, nimesulide dummy tablet; positive control group: taking nimesulide and Iguratimod dummy tablet; placebo group: taking Iguratimod dummy tablet and nimesulide dummy tablet. ; | Anhui Medical University | Not Recruiting | 18 | 65 | Both | 3:600; | Phase 3 study | China | |
1362 | NCT00768053 | October 2008 | 19 October 2017 | Evaluation of EULAR-RAID Score in Rheumatoid Arthritis Patients | Open-Label Study To Evaluate The EULAR-RAID Score, Rheumatoid Arthritis Impact Of Disease Score, In Rheumatoid Arthritis Patients Eligible To Etanercept And Who Will Receive Etanercept | Rheumatoid Arthritis | Drug: Etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | Lincoln Medical and Mental Health Center;Umanis;SODIA;depolabo | Not recruiting | 18 Years | N/A | All | 108 | Phase 4 | France;Monaco |
1363 | NCT00771329 | October 2008 | 19 February 2015 | BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB023 (Anti-TWEAK) Administered to Subjects With Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: BIIB023;Other: Placebo (sterile normal saline) | Biogen Idec | Not recruiting | 18 Years | 65 Years | Both | 53 | Phase 1 | United States;Russian Federation;Ukraine | |
1364 | NCT00771420 | October 2008 | 19 February 2015 | A Single Dose Study of the CAM-3001 in Patients With Rheumatoid Arthritis | A Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CAM-3001 in Patients With Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: CAM-3001;Other: Placebo | MedImmune Ltd | Not recruiting | 18 Years | 70 Years | Both | 38 | Phase 1 | Germany | |
1365 | NCT00779220 | October 2008 | 7 April 2015 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis | A Randomized, Double-blind, Parallel-group, Study to Evaluate the Efficacy, Safety and PK/PD of Ocrelizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy | Rheumatoid Arthritis | Drug: placebo;Drug: methotrexate;Drug: ocrelizumabu 50mg;Drug: ocrelizumabu 200mg;Drug: ocrelizumab 500mg | Chugai Pharmaceutical | Not recruiting | 20 Years | N/A | Both | 152 | 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 |
1366 | NCT00785928 | October 2008 | 19 February 2015 | A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy | Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy | Rheumatoid Arthritis | Biological: LY2127399;Drug: Placebo | Eli Lilly and Company | Not recruiting | 18 Years | 75 Years | Both | 158 | Phase 2 | United States;Argentina;Australia;Chile;Germany;Hungary;India;Mexico;Poland;Romania;Slovakia;Ukraine;Brazil;Canada;Czech Republic | |
1367 | NCT00867516 | October 2008 | 16 December 2017 | Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis | A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80,160 and 320mg ALD518 Versus Placebo Administered as Multiple IV Infusions to Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate | Arthritis, Rheumatoid | Biological: ALD518;Biological: Infusion without ALD518` | Vitaeris INC | Not recruiting | 18 Years | 80 Years | All | 127 | Phase 2 | Canada;Georgia;India;Poland;Russian Federation;Serbia | |
1368 | EUCTR2008-001282-28-NL | 23/09/2008 | 19 March 2012 | Influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune diseases treated with immunosuppressive therapy - Vaccinations in rheumatic autoimmune diseases | Influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune diseases treated with immunosuppressive therapy - Vaccinations in rheumatic autoimmune diseases | Rheumatic autoimmune diseases including rheumatoid arthritis and poly or dermatomyositis. | Trade Name: Influvac Pharmaceutical Form: INN or Proposed INN: Influvac Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 0,5- Trade Name: Pneumovax 23 Pharmaceutical Form: INN or Proposed INN: Pneumovax 23 Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 0,5- Trade Name: HBvaxpro Pharmaceutical Form: INN or Proposed INN: HBVAXPRO Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 10- | Radboud University Nijmegen Medical Centre | Authorised | Female: yes Male: yes | Netherlands | |||||
1369 | EUCTR2008-001241-26-HU | 18/09/2008 | 19 March 2012 | A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate - n.a. | A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate - n.a. | Active rheumatoid arthritis, functional class II-III MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: BT061 (CD4 monoclonal antibody) Product Code: BT971 Pharmaceutical Form: Solution for infusion INN or Proposed INN: BT061 (CD4 monoclonal antibody) Concentration unit: mg milligram(s) Concentration type: equal Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Biotest AG | Not Recruiting | Female: yes Male: yes | 110 | Hungary;Bulgaria | ||||
1370 | EUCTR2008-001105-42-BE | 16/09/2008 | 26 November 2013 | A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG | A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: LY2127399 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: LY2127399 Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use | Eli Lilly and Company | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;Poland;Belgium;Austria;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 |
1371 | EUCTR2008-004126-16-FI | 05/09/2008 | 19 March 2012 | Local Open-Label Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARDs | Local Open-Label Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARDs | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: tocilizumab Product Code: RO4877533 (TCZ) Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab Current Sponsor code: RO 4877533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: -20 | Roche Oy | Not Recruiting | Female: yes Male: yes | Finland | |||||
1372 | NCT00706797 | September 2008 | 19 October 2017 | Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects | An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) Added to Methotrexate in Comparison With Usual Treatment in Subjects With Moderate Rheumatoid Arthritis Disease Activity | Rheumatoid Arthritis | Drug: etanercept (EnbrelTM);Drug: methotrexate | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | All | 141 | Phase 4 | Czech Republic;France;Germany;Hungary;Italy;Poland;Spain;Turkey;United Kingdom;Austria;Croatia;United States | |
1373 | NCT00717808 | September 2008 | 8 June 2015 | Effects of Tranilast on Pharmacokinetics of Methotrexate (MTX) in Patients With Rheumatoid Arthritis (RA) | A Phase 1, Blinded, Randomised, Crossover Pilot Study to Investigate the Safety, Tolerability and Pharmacokinetics of Tranilast in Patients With Rheumatoid Arthritis on Methotrexate | Rheumatoid Arthritis | Drug: Tranilast;Drug: Placebo comparator | Imperial College London | Nuon Therapeutics, Inc. | Not recruiting | 18 Years | 75 Years | Both | 0 | Phase 1 | United Kingdom |
1374 | NCT00724672 | September 2008 | 8 June 2015 | A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521) | Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Rheumatoid Arthritis During Different Forms of Anti-Tumor Necrosis-Alpha Treatments. | Rheumatoid Arthritis | Drug: etanercept;Drug: infliximab;Drug: adalimumab | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | Both | 0 | N/A | ||
1375 | NCT00746512 | September 2008 | 19 October 2017 | A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088) | A Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Access the Effects of Oral Prednisone on Clinical Efficacy and the Power Doppler Ultrasound Signal of Synovium in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Prednisone 15 mg;Drug: Placebo Tablets;Drug: Prednisone 7.5 mg;Drug: Placebo Over-Encapsulated Tablets | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 45 | Phase 1 | 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 |
1376 | NCT00753454 | September 2008 | 19 October 2017 | Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA) | A Phase IIIb, Multi-center Open-label, Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With Methotrexate in Patients With Active Rheumatoid Arthritis Who Participated in C87077. | Rheumatoid Arthritis | Drug: Certolizumab pegol | UCB Pharma | Not recruiting | 18 Years | N/A | All | 168 | Phase 3 | United States;Canada | |
1377 | NCT00780793 | September 2008 | 19 February 2015 | Spacing of TNF-blocker Injections in Rheumatoid Arthritis Study | Effect of TNF-blocker Injections Spacing on Rheumatoid Arthritis Inflammatory Activity in Patients in Clinical Remission or Low Disease Activity | Rheumatoid Arthritis | Drug: progressive spacing of TNF-blocker injections;Drug: DMARD maintenance | Assistance Publique - Hôpitaux de Paris | French Society of Rheumatology | Not recruiting | 18 Years | N/A | Both | 250 | Phase 4 | France |
1378 | NCT00814866 | September 2008 | 7 November 2016 | Bone Resorption, Osteoclastogenesis and Adalimumab | Bone Resorption, Osteoclastogenesis and Adalimumab | Rheumatoid Arthritis | Drug: Adalimumab | Université de Sherbrooke | Abbott | Not recruiting | 18 Years | N/A | Both | 28 | N/A | Canada |
1379 | NCT01026519 | September 2008 | 19 February 2015 | A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis | A Single-dose, Double-Blind, Placebo-Controlled, Parallel Group Safety, Tolerability and Pharmacodynamic Study of Subcutaneous REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate | Rheumatoid Arthritis | Drug: REGN88;Other: Placebo | Regeneron Pharmaceuticals | Sanofi | Not recruiting | 18 Years | N/A | Both | 32 | Phase 1 | Russian Federation |
1380 | EUCTR2008-000105-11-DE | 19/08/2008 | 19 March 2012 | Effectiveness after 4 and 24 weeks and safety of tocilizumab in patients with active RA - TAMARA - Tocilizumab And DMARDs: Achievements in Rheumatoid Arthritis | Effectiveness after 4 and 24 weeks and safety of tocilizumab in patients with active RA - TAMARA - Tocilizumab And DMARDs: Achievements in Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: RoActemra Product Name: Tocilizumab Product Code: RO4877533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- | Roche Pharma AG | Not Recruiting | Female: yes Male: yes | 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 |
1381 | EUCTR2006-000923-32-GB | 13/08/2008 | 19 March 2012 | A randomised, double-blind, placebo-controlled, Bayesian adaptive dose finding study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat intravenous infusions GSK315234A in patients with active rheumatoid arthritis (RA) | A randomised, double-blind, placebo-controlled, Bayesian adaptive dose finding study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat intravenous infusions GSK315234A in patients with active rheumatoid arthritis (RA) | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: GSK315234 Product Code: GSK315234 Pharmaceutical Form: Injection* Current Sponsor code: GSK315234 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Intravenous use | GlaxoSmithKline Research & Development Ltd | Not Recruiting | Female: yes Male: yes | 112 | United Kingdom | ||||
1382 | NCT00718718 | August 11, 2008 | 16 December 2017 | A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Phase 2, 2-Part, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept, Dose-finding Study Evaluating the Efficacy and Safety of CNTO 136 Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Arthritis, Rheumatoid | Drug: CNTO 136 100 mg;Drug: CNTO 136 50 mg;Drug: CNTO 136 25 mg;Drug: Placebo;Drug: Methotrexate | Centocor, Inc. | Not recruiting | 18 Years | N/A | All | 187 | Phase 2 | United States;Hungary;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Argentina;Taiwan;Ukraine | |
1383 | NCT00828997 | August 2008 | 18 December 2018 | Effects of Different Antirheumatic Treatments of Arthritis on Antibody Response Following Vaccination Using Prevenar® | Effects of Different Anti-rheumatic Treatments of Arthritis on Antibody Response Following Pneumococcal Vaccination Using Prevenar® | Rheumatoid Arthritis;Spondylarthropathy | Biological: Prevenar vaccination | Region Skane | Lund University | Not recruiting | 18 Years | N/A | All | 505 | Phase 4 | Sweden |
1384 | EUCTR2007-007888-24-FR | 31/07/2008 | 19 March 2012 | Open-label Study to Evaluate the EULAR-RAID Score, Rheumatoid Arthritis Impact of Disease Score, in Rheumatoid Arthritis Patients Eligible to Etanercept and Who Will Receive Etanercept. - RAINBOW | Open-label Study to Evaluate the EULAR-RAID Score, Rheumatoid Arthritis Impact of Disease Score, in Rheumatoid Arthritis Patients Eligible to Etanercept and Who Will Receive Etanercept. - RAINBOW | RHEUMATOID ARTHRITIS | Trade Name: ENBREL Pharmaceutical Form: Injection* INN or Proposed INN: ETANERCEPT CAS Number: 185243690 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Wyeth Pharmaceuticals France | Authorised | Female: yes Male: yes | 107 | France | ||||
1385 | ChiCTR-TCC-12002824 | 2008-07-10 | 18 April 2017 | Traditional Chinese and anti-rheumatic drugs for the treatment of rheumatoid arthritis | Integration of Traditional Chinese and Western Medicine treat rheumatoid witharthritis: A prospective, randomized, controlled trial | rheumatoid arthritis with peptic ulcer | Acupuncture treatment:ARD treatment and concomitant ginger-partitioned moxibustion of the Zusanli acupoint. ;ARD treatment:esomeprazole magnesium enteric-coated tablets ,celecoxib capsules and methotrexate tablets ;Combined therapy:ARD treatment and concomitant ginger-partitioned moxibustion of the Zusanli acupoint + oral Shanhuang Wuji decoction ; | Hospital of Chengdu Military Area Command PLA | Not Recruiting | 45 | 65 | Both | Acupuncture treatment:20;ARD treatment:20;Combined therapy:20; | Other | 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 |
1386 | JPRN-UMIN000001240 | 2008/07/01 | 2 April 2019 | The efficacy of tocilizumab to patients with rheumatoid arthritis refractory to anti-TNF agents: the open trial | rheumatoid arthritis | Tocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks for 3 years | Division of Rheumatology & Clinical Immunology, Jichi Medical University | Not Recruiting | 20years-old | Not applicable | Male and Female | 20 | Not selected | Japan | ||
1387 | JPRN-UMIN000001798 | 2008/07/01 | 2 April 2019 | Prevention of cartilage destruction in rheumatoid arthritis by etanercept (PRECEPT study) | Rheumatoid arthritis | Injection of etanercept by 50 mg/week for one year Injection of etanercept by 25 mg/week for one year | Team RA, Rheumatosurgery, Osaka City University Medical School | Not Recruiting | 20years-old | 80years-old | Male and Female | 100 | Not applicable | Japan | ||
1388 | JPRN-UMIN000002421 | 2008/07/01 | 2 April 2019 | Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis | rheumatoid arthritis | tocilizumab Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab | AA amyloidosis clinical research conference | Recruiting | 20years-old | Not applicable | Male and Female | 40 | Not selected | Japan | ||
1389 | NCT00712114 | July 2008 | 19 February 2015 | Safety, Tolerance, Pharmacokinetics and Activity of HE3286 in Patients With Rheumatoid Arthritis | A Phase I/II, Open Label, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Potential Anti-Inflammatory Activity of HE3286 When Administered Orally for 29 Days to Patients With Rheumatoid Arthritis on a Stable Dose of Methotrexate | Rheumatoid Arthritis | Drug: HE3286 | Harbor Therapeutics | Not recruiting | 18 Years | 75 Years | Both | 14 | Phase 1/Phase 2 | United States | |
1390 | NCT00713544 | July 2008 | 19 October 2017 | A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis | A Randomised, Double Blind, Placebo Controlled, Phase IIb Dose Ranging Study (With Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate. | Rheumatoid Arthritis | Drug: AZD5672;Drug: Etanercept;Drug: Placebo | AstraZeneca | Not recruiting | 18 Years | N/A | All | 373 | Phase 2 | Bulgaria;Colombia;Czech Republic;Hungary;Italy;Latvia;Malta;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Ukraine;Argentina;Netherlands;Peru | |
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 |
1391 | NCT00714493 | July 2008 | 19 October 2017 | RESTART C0168Z05 Rheumatoid Arthritis Study | A Phase 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) or Adalimumab (HUMIRA). | Rheumatoid Arthritis | Biological: Infliximab | Centocor Ortho Biotech Services, L.L.C. | Schering-Plough | Not recruiting | 18 Years | N/A | All | 203 | Phase 4 | United States;Austria;Canada;Finland;France;Germany;Israel;Netherlands;Spain;United Kingdom;Belgium |
1392 | NCT00717236 | July 2008 | 19 October 2017 | Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis | A Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: Certolizumab pegol (CZP);Other: Placebo | UCB Pharma | Not recruiting | 18 Years | N/A | All | 1648 | Phase 3 | United States;Canada;France;Germany;Italy;Netherlands;Spain | |
1393 | NCT00718588 | July 2008 | 19 February 2015 | A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MTRX1011A in Patients With Rheumatoid Arthritis | A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial, With a Single Ascending-Dose Stage Followed by a Multiple Ascending-Dose Stage, of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous MTRX1011A in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MTRX1011A | Genentech, Inc. | Not recruiting | 18 Years | 80 Years | Both | 66 | Phase 1 | United States | |
1394 | NCT00729209 | July 2008 | 19 February 2015 | A Study of ARRY-371797 in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ARRY-371797, p38 inhibitor; oral;Drug: Placebo | Array BioPharma | Not recruiting | 18 Years | N/A | Both | 28 | Phase 1 | United States | ||
1395 | NCT00782600 | July 2008 | 19 February 2015 | Study of Controlled Release Formulations of CE-224,535 Against the Immediate Release Formulation in Normal Volunteers | A Phase 1, Randomized, 4-Period, 4-Sequence Cross-Over Study Of The Pharmacokinetics Of 3 Durations Of Release Of A Controlled Release Formulation And A Single Dose Of An Immediate Release Oral Suspension Of CE-224,535 In Normal Healthy Volunteers | Rheumatoid Arthritis | Drug: suspension IR;Drug: CR 1;Drug: CR 2;Drug: CR 3 | Pfizer | Not recruiting | 18 Years | 55 Years | Both | 16 | 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 |
1396 | NCT01055899 | July 2008 | 19 February 2015 | Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate | Rheumatoid Arthritis | Biological: REGN88 | Regeneron Pharmaceuticals | Sanofi | Not recruiting | 18 Years | N/A | Both | 15 | Phase 1 | United States |
1397 | EUCTR2007-006150-25-FR | 24/06/2008 | 11 September 2012 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis ;Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: TRU-015 Pharmaceutical Form: Intravenous infusion Current Sponsor code: TRU-015 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use Trade Name: Decortin 5mg tablets Pharmaceutical Form: Tablet INN or Proposed INN: PREDNISONE CAS Number: 53032 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Solu-Medrone 125mg Pharmaceutical Form: Powder for solution for injection CAS Number: 2375033 Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use Pharmaceutical Form: Intravenous infusion Current Sponsor code: TRU-015 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use Trade Name: Decortin 5mg tablets Pharmaceutical Form: Tablet INN or Proposed INN: PREDNISONE CAS Number: 53032 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Solu-Medrone 125mg Pharmaceutical Form: Powder for solution for injection CAS Number: 2375033 Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | Authorised | Female: yes Male: yes | 216 | Hungary;Germany;Netherlands;Belgium;France;Austria | ||||
1398 | EUCTR2007-006527-13-BG | 18/06/2008 | 19 March 2012 | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients with Active Rheumatoid Arthritis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients with Active Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: CF101 Pharmaceutical Form: Tablet INN or Proposed INN: methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-ß-Dribofuronamide Current Sponsor code: CF101 Other descriptive name: IB-MECA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.1- INN or Proposed INN: methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-ß-Dribofuronamide Current Sponsor code: CF101 Other descriptive name: IB-MECA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Can-Fite BioPharma Ltd. | Not Recruiting | Female: yes Male: yes | 228 | Phase 2 | Bulgaria | |||
1399 | EUCTR2008-000587-17-GB | 18/06/2008 | 19 March 2012 | Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy | Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy | Rheumatoid arthritis. MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Actemra Product Code: RO4877533 (TCZ) Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab Current Sponsor code: RO4877533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- | F. Hoffmann-La Roche Ltd | Not Recruiting | Female: yes Male: yes | 1500 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece | ||||
1400 | EUCTR2008-000743-34-BE | 18/06/2008 | 26 November 2013 | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: R935788 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fostamatinib Disodium CAS Number: 914295-16-2 Current Sponsor code: R935788 sodium hexahydrate Other descriptive name: R788 Sodium, R788 Na, R788 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Rigel Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | France;Belgium;Germany;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 |
1401 | EUCTR2007-003508-36-HU | 17/06/2008 | 21 August 2012 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Lodotra® Pharmaceutical Form: Tablet INN or Proposed INN: Prednisone CAS Number: 53-03-2 Concentration unit: MBq/mg megabecquerel(s)/milligram Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Nitec Pharma AG | Not Recruiting | Female: yes Male: yes | 350 | Hungary;Germany;United Kingdom | ||||
1402 | EUCTR2007-001625-10-HU | 16/06/2008 | 3 July 2012 | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | RHEUMATOID ARTHRITIS MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Etanercept Pharmaceutical Form: Injection* INN or Proposed INN: ETANERCEPT CAS Number: 185243690 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Wyeth Pharmaceuticals France | Not Recruiting | Female: yes Male: yes | 700 | Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria | ||||
1403 | NCT00686868 | June 13, 2008 | 16 December 2017 | Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients | Clinical Phase I/IIA Study of Subcutaneously Administration of Ofatumumab in Rheumatoid Arthritis Patients on Stable Dose Methotrexate | Arthritis, Rheumatoid | Other: placebo;Drug: ofatumumab | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 35 | Phase 1 | United States;Australia;Belgium;France;Italy;New Zealand;Poland;Russian Federation;Spain;Canada;Germany;Hungary;Netherlands | |
1404 | EUCTR2007-001377-28-FR | 11/06/2008 | 19 March 2012 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously, -- AND who developed adverse events (AEs) corresponding to pre-specified newly diagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1 Level: LLT Classification code 10061664 Term: Autoimmune disorder MedDRA version: 9.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic MedDRA version: 9.1 Level: LLT Classification code 10047888 Term: Wegener's granulomatosis MedDRA version: 9.1 Level: LLT Classification code 10002817 Term: Antiphospholipid syndrome MedDRA version: 9.1 Level: LLT Classification code 10040767 Term: Sjogren's syndrome MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease MedDRA version: 9.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative MedDRA version: 9.1 Level: LLT Classification code 10003827 Term: Autoimmune hepatitis MedDRA version: 9.1 Level: LLT Classification code 10049046 Term: Autoimmune thyroiditis MedDRA version: 9.1 Level: LLT Classification code 10003822 Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1 Level: LLT Classification code 10034697 Term: Pernicious anemia MedDRA version: 9.1 Level: LLT Classification code 10028417 Term: Myasthenia gravis MedDRA version: 9.1 Level: LLT Classification code 10018620 Term: Goodpasture's syndrome MedDRA version: 9.1 Level: LLT Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | Merck Serono International S.A. | Authorised | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | |||
1405 | EUCTR2007-005464-26-GB | 05/06/2008 | 11 March 2013 | Devlopment of Heart and blood vessel problems in patients with conditions which cause long-term, widespread, inflammation in the body. | The role of inflammatory biomarkers in pathophysiology of cardiovascular dysfunction in systemic inflammatory conditions- Part II - Inflammatory Biomarkers and Cardiovascular Function - Part II | Rheumatoid Arthritis MedDRA version: 14.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: up to Concentration number: 3- Trade Name: Enbrel Pharmaceutical Form: Solution for injection INN or Proposed INN: ETANERCEPT CAS Number: 185243-69-0 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 50- Trade Name: Humira Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Trade Name: Cimzia Product Name: Cimzia Pharmaceutical Form: Solution for injection INN or Proposed INN: CERTOLIZUMAB PEGOL CAS Number: 428863-50-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- | Kings College London | Guys and St Thomas'NHS Foundation Trust | Authorised | Female: yes Male: yes | 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 |
1406 | EUCTR2008-000170-20-FR | 03/06/2008 | 19 March 2012 | A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with Rheumatoid Arthritis Having an Inadequate Response to Methotrexate. Pharmacogenetics Blood Sample Amendment 01 (version 1.0, dated 19-Dec-2007); Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008) | A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with Rheumatoid Arthritis Having an Inadequate Response to Methotrexate. Pharmacogenetics Blood Sample Amendment 01 (version 1.0, dated 19-Dec-2007); Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008) | subjects with rheumatoid arthritis (RA) who are on background therapy with methotrexate (MTX) MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: BMS-582949 Pharmaceutical Form: Tablet Current Sponsor code: BMS-582949 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Bristol Myers Squibb International Corporation | Authorised | Female: yes Male: yes | 240 | Czech Republic;France;Spain | ||||
1407 | JPRN-JapicCTI-080587 | 01/6/2008 | 2 April 2019 | Safety, Efficacy and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis | A Multicenter, Open-label Study of Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis | Juvenile Rheumatoid Arthritis (JRA) | Intervention name : adalimumab INN of the intervention : adalimumab Dosage And administration of the intervention : adalimumab 20 mg for chldren with body weight < 30 kg; adalimumab 40 mg for chldren with body weight >= 30 kg Control intervention name : null | Abbott Japan Co., Ltd. | Eisai Co., Ltd. | 4 | 17 | BOTH | 25 | Phase 3 | ||
1408 | NCT00147966 | June 2008 | 19 October 2017 | Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study) | Assessment of the Immunomodulatory Effects of Rituximab in Seropositive Rheumatoid Arthritis Using Arthroscopic Synovial Biopsies | Rheumatoid Arthritis | Drug: rituximab | University of California, San Diego | Genentech, Inc. | Not recruiting | 18 Years | 75 Years | All | 24 | Phase 2 | United States |
1409 | NCT00654368 | June 2008 | 19 October 2017 | CAMEO: Canadian Methotrexate and Etanercept Outcome Study | Canadian Methotrexate and Etanercept Outcome Study: An Open Label Randomized Trial of Etanercept and Methotrexate Versus Etanercept Alone in the Treatment of Rheumatoid Arthritis (CAMEO) | Rheumatoid Arthritis | Biological: Etanercept;Drug: Methotrexate | Amgen | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | All | 258 | Phase 4 | Canada |
1410 | NCT00689728 | June 2008 | 19 February 2015 | A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFa Inhibitor Therapy | A Phase 2 Study of Multiple Intravenous Doses of LY2127399 in Patients With Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy | Arthritis, Rheumatoid | Biological: LY2127399;Drug: Placebo | Eli Lilly and Company | Not recruiting | 18 Years | 75 Years | Both | 100 | Phase 2 | United States;Argentina;Austria;Belgium;Brazil;Canada;Germany;Mexico;Poland;Puerto Rico;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 |
1411 | NCT00700986 | June 2008 | 19 February 2015 | Cross-over Study to Investigate Retinal Function Following Administration of a Single Dose of AZD9056 | A Randomised, Double-Blind, Placebo-Controlled, 2-Period Cross-Over Study in Healthy Male Volunteers, to Investigate Retinal Function Following a Single 800mg Oral Dose of AZD9056 | Rheumatoid Arthritis | Drug: AZD9056;Drug: Placebo | AstraZeneca | Not recruiting | 18 Years | 65 Years | Male | 12 | Phase 1 | United Kingdom | |
1412 | NCT00711074 | June 2008 | 19 February 2015 | Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers | An Open-Label, Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of [14C]AZD5672 in Healthy Male Volunteers | Rheumatoid Arthritis | Drug: AZD5672 | AstraZeneca | Not recruiting | 50 Years | N/A | Male | 4 | Phase 1 | United Kingdom | |
1413 | NCT02151409 | June 2008 | 16 December 2017 | Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects | A Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Trial of Anti-C5aR Antibody (NNC 0151-0000-0000) Administered by i.v. Infusion or s.c. Injection in Healthy Subjects. | Inflammation;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Healthy | Drug: NNC 0151-0000-0000;Drug: placebo | Novo Nordisk A/S | Not recruiting | 18 Years | 55 Years | Male | 60 | Phase 1 | Netherlands | |
1414 | EUCTR2007-001625-10-ES | 28/05/2008 | 3 July 2012 | Estudio abierto y aleatorizado para evaluar la eficacia radiológica y la seguridad de Enbrel® (etanercept) añadido a metotrexato en comparación con el tratamiento habitual en pacientes con artritis reumatoide moderada An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | Estudio abierto y aleatorizado para evaluar la eficacia radiológica y la seguridad de Enbrel® (etanercept) añadido a metotrexato en comparación con el tratamiento habitual en pacientes con artritis reumatoide moderada An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | Artritis reumatoide RHEUMATOID ARTHRITIS MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Enbrel Pharmaceutical Form: Injection* INN or Proposed INN: ETANERCEPT CAS Number: 185243690 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Wyeth Pharmaceuticals France | Authorised | Female: yes Male: yes | 700 | Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria | ||||
1415 | EUCTR2007-007859-14-HU | 22/05/2008 | 19 March 2012 | A 12-WEEK, PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF ARRY-438162, ADMINISTERED ORALLY DAILY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS INCOMPLETELY RESPONSIVE TO METHOTREXATE | A 12-WEEK, PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF ARRY-438162, ADMINISTERED ORALLY DAILY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS INCOMPLETELY RESPONSIVE TO METHOTREXATE | Active Rheumatoid Arthritis incompletely responsive to methotrexate MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: ARRY-438162 Pharmaceutical Form: Film-coated tablet Current Sponsor code: ARRY-438162 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: ARRY-438162 Pharmaceutical Form: Film-coated tablet Current Sponsor code: ARRY-438162 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Array BioPharma Inc. | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | 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 |
1416 | EUCTR2008-000327-25-ES | 19/05/2008 | 19 March 2012 | ESTUDIO DE FASE 2A ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y DE GRUPOS PARALELOS DE CE-224,535, UN ANTAGONISTA DEL RECEPTOR P2X7, EN EL TRATAMIENTO DE LOS SIGNOS Y SÍNTOMAS DE LA ARTRITIS REUMATOIDE EN PACIENTES CON UN CONTROL INADECUADO CON METROTEXATO A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7 RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELY CONTROLLED ON METHOTREXATE | ESTUDIO DE FASE 2A ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y DE GRUPOS PARALELOS DE CE-224,535, UN ANTAGONISTA DEL RECEPTOR P2X7, EN EL TRATAMIENTO DE LOS SIGNOS Y SÍNTOMAS DE LA ARTRITIS REUMATOIDE EN PACIENTES CON UN CONTROL INADECUADO CON METROTEXATO A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7 RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELY CONTROLLED ON METHOTREXATE | Artritis Reumatoide MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: CE-224,535 Pharmaceutical Form: Tablet CAS Number: 724424-43-5 Current Sponsor code: CE-224,535 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125 mg- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | PFIZER S.A. | Authorised | Female: yes Male: yes | 78 | Phase 2A | Czech Republic;Spain;Poland | |||
1417 | EUCTR2007-007539-14-SK | 16/05/2008 | 13 March 2017 | A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE | A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: AZD5672 Product Code: AZD5672 Pharmaceutical Form: Tablet Current Sponsor code: AZD5672 Other descriptive name: AZD5672 Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: AZD5672 Product Code: AZD5672 Pharmaceutical Form: Tablet Current Sponsor code: AZD5672 Other descriptive name: AZD5672 Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Enbrel Product Name: Enbrel Pharmaceutical Form: Solution for injection INN or Proposed INN: Etanercept Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | AstraZeneca AB | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | Hungary;Czech Republic;Slovakia;Poland;Bulgaria;Latvia;Malta;Italy | |||
1418 | EUCTR2007-006288-56-AT | 14/05/2008 | 10 July 2015 | Methotrexat-Polyglutamate als Marker fuer das klinische Outcome in der Therapie der rheumatoiden Arthritis | Methotrexat-Polyglutamate als Marker fuer das klinische Outcome in der Therapie der rheumatoiden Arthritis | Rheumatoid Arthritis | Trade Name: Ebetrexat Pharmaceutical Form: Tablet INN or Proposed INN: METHOTREXATE CAS Number: 59052 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 15-25 | Ludwig Boltzmann Cluster für Rheumatologie, Balneologie und Rehabilitation | Not Recruiting | Female: yes Male: yes | Austria | |||||
1419 | EUCTR2007-005905-23-DE | 13/05/2008 | 19 March 2012 | A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing | A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Pharmaceutical Form: Solution for injection INN or Proposed INN: Adalimumab CAS Number: 331731-18-1 Other descriptive name: ABT-Humira Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: Humira 40 mg solution for injection in pre-filled syringe Pharmaceutical Form: Solution for injection INN or Proposed INN: Adalimumab CAS Number: 331731-18-1 Other descriptive name: ABT-Humira Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | Abbott GmbH & Co. KG | Not Recruiting | Female: yes Male: yes | 424 | United Kingdom;Germany | ||||
1420 | NCT00665626 | May 2008 | 16 December 2017 | Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis (Taski-3) | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients With Rheumatoid Arthritis Who Have Failed at Least One Biologic | Rheumatoid Arthritis | Drug: Fostamatinib disodium (R935788);Drug: Placebo | Rigel Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 219 | Phase 2 | United States;Belgium;Colombia;France;Germany;Italy;Peru;Brazil | |
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 |
1421 | NCT00665925 | May 2008 | 19 October 2017 | Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate | Rheumatoid Arthritis | Drug: Fostamatinib disodium (R935788);Drug: Placebo | Rigel Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 457 | Phase 2 | United States;Bulgaria;Colombia;Mexico;Poland;Romania;Israel | |
1422 | NCT00667758 | May 2008 | 19 February 2015 | Gonadotropin-Releasing Hormone (GnRH)-Antagonist Therapy in Rheumatoid Arthritis | Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial | Rheumatoid Arthritis | Drug: Cetrorelix;Drug: Placebo | Betanien Hospital | Norwegian Foundation for Health and Rehabilitation;University of Oslo | Not recruiting | 18 Years | N/A | Both | 104 | Phase 2 | Norway |
1423 | NCT00690573 | May 2008 | 19 October 2017 | Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis | A Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis | Juvenile Rheumatoid Arthritis | Biological: Adalimumab | Abbott | Eisai Co., Ltd. | Not recruiting | 4 Years | 17 Years | All | 25 | Phase 3 | Japan |
1424 | NCT00727987 | May 2008 | 19 February 2015 | A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CNTO 148;Drug: Placebo;Drug: Methotrexate (MTX) | Janssen Pharmaceutical K.K. | Mitsubishi Tanabe Pharma Corporation | Not recruiting | 20 Years | 74 Years | Both | 269 | Phase 3 | Japan |
1425 | NCT00771251 | May 2008 | 17 November 2015 | A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA) | A Study of Golimumab (CNTO148) Monotherapy in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CNTO 148;Drug: Placebo | Janssen Pharmaceutical K.K. | Mitsubishi Tanabe Pharma Corporation;Mitsubishi Tanabe Pharma Corporation | Not recruiting | 20 Years | 74 Years | Both | 311 | 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 |
1426 | NCT01224418 | May 2008 | 19 February 2015 | A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate | Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study | Rheumatoid Arthritis | Drug: Tacrolimus | Astellas Pharma Inc | Astellas Pharma Korea, Inc. | Not recruiting | 18 Years | 75 Years | Both | 50 | Phase 4 | Korea, Republic of |
1427 | EUCTR2007-004399-38-EE | 18/04/2008 | 26 June 2012 | A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: CRx-102 Pharmaceutical Form: Capsule* INN or Proposed INN: Prednisolone CAS Number: 50-24-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.9 and 1.8- INN or Proposed INN: Dipyridamole CAS Number: 58-32-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 180- Product Code: CRx-102 Pharmaceutical Form: Capsule* INN or Proposed INN: Prednisolone CAS Number: 50-24-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.9 and 1.8- INN or Proposed INN: Dipyridamole CAS Number: 58-32-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 90 - | CombinatoRx, Incorporated | Not Recruiting | Female: yes Male: yes | 616 | United Kingdom;Estonia;Lithuania | ||||
1428 | NCT00658047 | April 2008 | 19 February 2015 | A Study to Assess CH1504 in Patients With Active Rheumatoid Arthritis | A Phase II, Multi-center, Randomized, Double-blind, Methotrexate Controlled Study to Assess the Clinical Efficacy, Safety, and Tolerability of CH-1504 in Subjects With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: CH-1504;Drug: Methotrexate (MTX) | Chelsea Therapeutics | Not recruiting | 18 Years | 80 Years | Both | 201 | Phase 2 | Canada | |
1429 | NCT00661661 | April 2008 | 19 October 2017 | Long-Term, Open-Label Study Of CP-690,550 For Treatment Of Rheumatoid Arthritis In Japan | A Long-term, Open-label Study Of Cp-690,550 to Confirm The Safety Following Long Term Administration Of Cp-690,550 In The Treatment Of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CP-690,550 | Pfizer | Not recruiting | 20 Years | N/A | All | 487 | Phase 3 | Japan | |
1430 | NCT00673920 | April 2008 | 16 December 2017 | A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given As a Single Infusion or Dual Infusion Compared With Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy | Rheumatoid Arthritis | Drug: methotrexate;Drug: ocrelizumab;Drug: placebo | Genentech, Inc. | Roche Pharma AG | Not recruiting | 18 Years | N/A | All | 314 | Phase 3 | 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 |
1431 | NCT00674635 | April 2008 | 12 December 2016 | Phase II Study Evaluating the Safety and Efficacy of GSK315234A in Patients With Rheumatoid Arthritis | A Randomized, Double-blind, Placebo-controlled, Bayesian Adaptive Dose Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Intravenous Infusions GSK315234A in Patients With Active Rheumatoid Arthritis (RA) | Arthritis, Rheumatoid | Drug: GSK3152314A;Drug: Placebo | GlaxoSmithKline | Not recruiting | 18 Years | 75 Years | Both | 135 | Phase 2 | Australia;New Zealand;Russian Federation;Serbia;Ukraine;Former Serbia and Montenegro;United Kingdom | |
1432 | NCT02622503 | April 2008 | 9 January 2017 | A Study on Rheumatoid Arthritis Patients Treated With Rituximab | Retrospective Data Collection on Rheumatoid Arthritis (RA) Patients Treated With Rituximab in Finland. | Rheumatoid Arthritis | Drug: Rituximab | Hoffmann-La Roche | Not recruiting | N/A | N/A | Both | 81 | N/A | Finland | |
1433 | EUCTR2007-000593-24-GB | 28/03/2008 | 19 March 2012 | An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis. | An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis. | Rheumatoid Arthritis. MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Enbrel Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Etanercept CAS Number: 185243-69-0 Other descriptive name: Enbrel Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Humira Pharmaceutical Form: Solution for injection INN or Proposed INN: adalimumab CAS Number: 331731-18-1 Other descriptive name: Humira Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | F. Hoffmann-La Roche Ltd | Authorised | Female: yes Male: yes | 52 | United Kingdom;Sweden | ||||
1434 | EUCTR2007-002066-35-HU | 28/03/2008 | 19 March 2012 | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: CP-690,550 Pharmaceutical Form: Tablet CAS Number: 540737-29-9 Current Sponsor code: CP-690,550 Other descriptive name: CP-690,550-10 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: CP-690,550 Pharmaceutical Form: Tablet CAS Number: 540737-29-9 Current Sponsor code: CP-690,550 Other descriptive name: CP-690,550-10 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Humira® 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab Pharmaceutical Form: Injection* INN or Proposed INN: Humira® Current Sponsor code: Adalimumab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Subcutaneous use | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | Not Recruiting | Female: yes Male: yes | 350 | Phase 2B | Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece | |||
1435 | EUCTR2007-000896-41-HU | 27/03/2008 | 18 April 2012 | A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate | A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate | Rheumatoid arthritis | Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 Pharmaceutical Form: Injection* Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 Pharmaceutical Form: Injection* Trade Name: Methotrexate Product Name: Methotrexate Pharmaceutical Form: Tablet | Wyeth Pharmaceuticals France | Not Recruiting | Female: yes Male: yes | 900 | Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;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 |
1436 | EUCTR2007-005759-41-FR | 19/03/2008 | 19 March 2012 | A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an inadequate Response to Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an inadequate Response to Methotrexate Therapy | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913/F03 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ocrelizumab CAS Number: 637334-45-3 Current Sponsor code: RO 496-4913/F03 Other descriptive name: RhuMAb 2H7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann-La Roche Ltd | Authorised | Female: yes Male: yes | 300 | United Kingdom;Germany;France;Spain;Italy | ||||
1437 | NCT01000610 | March 17, 2008 | 16 December 2017 | A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate | An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate | Rheumatoid Arthritis | Drug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisolone | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 18 | Phase 4 | Tunisia | |
1438 | EUCTR2007-006539-29-SE | 14/03/2008 | 19 March 2012 | Effects of different anti-rheumatic treatments of arthritis on antibody response following pneumococcal vaccination using Prevenar | Effects of different anti-rheumatic treatments of arthritis on antibody response following pneumococcal vaccination using Prevenar | Patients with rheumatic diseases (rheumatoid arthritis and spondyloarthripaties) who are going to be vaccinated with Prevenar vaccine in order to study the serological responses to two pneumococcal serotypes and to study the impact of different treatment modalities on serological responses. | Trade Name: Prevenar vaccine Product Name: Prevenar vaccine Pharmaceutical Form: Injection* INN or Proposed INN: 7-valent Pneumococcal Conjugate vaccine | Dept of Rheumatology, Lund University Hospital, Lund, Sweden | Authorised | Female: yes Male: yes | 500 | Sweden | ||||
1439 | EUCTR2007-003623-20-ES | 12/03/2008 | 19 March 2012 | Estudio de los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide (Estudio TESICE-AR). Study of the B-cell-targeted therapy (rituximab) effects on the synovial tissue inmunopathology and peripheral blood B cells in rheumatoid arthritis (TESICE-AR study). | Estudio de los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide (Estudio TESICE-AR). Study of the B-cell-targeted therapy (rituximab) effects on the synovial tissue inmunopathology and peripheral blood B cells in rheumatoid arthritis (TESICE-AR study). | Se estudiaran los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide. MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Mabthera Product Name: Rituximab Pharmaceutical Form: Intravenous infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 | Dr. Juan D. Cañete Crespillo, Hospital Clínic de Barcelona | Authorised | Female: yes Male: yes | Spain | |||||
1440 | EUCTR2007-002536-29-FR | 03/03/2008 | 18 September 2012 | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Atacicept Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: Humira Product Name: Adalimumab Pharmaceutical Form: Solution for injection | Merck Serono International | Authorised | Female: yes Male: yes | 264 | Phase 2 | Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;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 |
1441 | NCT00565409 | March 2008 | 19 October 2017 | Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis | A Randomized, Double-Blind Study Comparing the Safety & Efficacy of Once-Weekly Etanercept 50 mg, Etanercept 25 mg, & Placebo in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Etanercept;Drug: Methotrexate;Drug: Placebo | Pfizer | Not recruiting | 18 Years | 70 Years | All | 834 | Phase 4 | Australia;Austria;Belgium;Chile;Colombia;Czech Republic;Former Serbia and Montenegro;France;Germany;Hungary;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;Spain;Sweden;Taiwan;United Kingdom;Brazil;Korea, Democratic People's Republic of;Serbia | |
1442 | NCT00605735 | March 2008 | 19 February 2015 | PoC in Rheumatoid Arthritis With Methotrexate | A Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects With Rheumatoid Arthritis Having an Inadequate Response to Methotrexate | Rheumatoid Arthritis, NOS | Drug: BMS-582949;Drug: Placebo | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | Both | 121 | Phase 2 | United States;Argentina;Czech Republic;France;Korea, Republic of;Mexico;Spain;Taiwan;Brazil | |
1443 | NCT00620685 | March 2008 | 19 November 2018 | A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking Methotrexate | A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Safety And Pharmacokinetic Profile Of 1 And 5 Mg Ph-797804 Administered Once Daily In Subjects With Rheumatoid Arthritis Who Are Taking Oral Methotrexate | Arthritis, Rheumatoid | Drug: Placebo;Drug: PH-797804 | Pfizer | Not recruiting | 18 Years | N/A | All | 27 | Phase 2 | United States | |
1444 | NCT00628095 | March 2008 | 19 February 2015 | Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of CE-224,535, An Antagonist Of The P2x7 Receptor, In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis In Subjects Who Are Inadequately Controlled On Methotrexate | Arthritis, Rheumatoid | Drug: CE-224,535;Drug: Placebo | Pfizer | Not recruiting | 18 Years | N/A | Both | 100 | Phase 2/Phase 3 | United States;Chile;Czech Republic;Korea, Republic of;Mexico;Poland;Spain | |
1445 | NCT00634933 | March 2008 | 19 October 2017 | Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate | Arthritis, Rheumatoid | Drug: TRU-015;Drug: Methylprednisolone;Drug: Prednisone | Pfizer | Trubion Pharmaceuticals/Emergent BioSolutions Inc. | Not recruiting | 18 Years | N/A | All | 222 | Phase 2 | United States;Belgium;Canada;France;Germany;Hungary;Mexico;Netherlands;Romania;Serbia;Austria |
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 |
1446 | NCT00641225 | March 2008 | 19 February 2015 | Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid Arthritis | An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: SBI-087 | Pfizer | Emergent Product Development Seattle LLC | Not recruiting | 18 Years | 70 Years | Both | 62 | Phase 1 | United States;Canada |
1447 | NCT00650767 | March 2008 | 19 October 2017 | A Study of ARRY-438162 in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ARRY-438162, MEK inhibitor; oral;Drug: Placebo | Array BioPharma | Not recruiting | 18 Years | N/A | All | 201 | Phase 2 | United States;Argentina;Brazil;Hungary;Peru;Poland;Romania | ||
1448 | NCT00664521 | March 2008 | 19 October 2017 | Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III) | A Randomized, Double-blind, Placebo Controlled, Multi-centre, Exploratory, Pilot, Phase II Trial of 150mg Atacicept Given Subcutaneously in Combination With Rituximab in Subjects With Rheumatoid Arthritis. | Rheumatoid Arthritis | Biological: Rituximab;Drug: Atacicept;Drug: Placebo matched to atacicept | Merck KGaA | Not recruiting | 18 Years | N/A | All | 27 | Phase 2 | France;Netherlands;Sweden;United Kingdom;Finland | |
1449 | NCT00664820 | March 2008 | 16 December 2017 | Effects of Probiotics on Rheumatoid Arthritis Patients | Effects of Probiotics on Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Dietary Supplement: Probiotic capsules containing Lactobacillus rhamnosus GR-1 and L. reuteri RC-14 | Lawson Health Research Institute | University of Western Ontario, Canada;St. Joseph's Health Care London | Not recruiting | 18 Years | 80 Years | All | 50 | N/A | Canada |
1450 | NCT02109666 | March 2008 | 16 December 2017 | Long Term Experience With Abatacept in Routine Clinical Practice | Long Term Experience With Abatacept in Routine Clinical Practice | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 2364 | N/A | Austria;Belgium;Canada;Czech Republic;Denmark;France;Germany;Greece;Ireland;Italy;Netherlands;Spain;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 |
1451 | EUCTR2007-000828-40-FR | 26/02/2008 | 19 March 2012 | A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076 | A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076 | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Certolizumab pegol Product Code: CDP870 Pharmaceutical Form: Solution for injection INN or Proposed INN: Certolizumab pegol Current Sponsor code: CDP870 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 200-+/- 15 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | UCB Pharma S.A. | Authorised | Female: yes Male: yes | 170 | Phase 3B | Germany;France;Italy;Poland;Austria | |||
1452 | EUCTR2006-006562-42-GB | 21/02/2008 | 19 March 2012 | An Observational and Exploratory Study to determine the effect of anti TNF Biologic Treatment in Rheumatoid Cachexia | An Observational and Exploratory Study to determine the effect of anti TNF Biologic Treatment in Rheumatoid Cachexia | Cachexia in patients with Rheumatoid arthritis. MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Enbrel Product Name: Etanercept 50mg Pharmaceutical Form: Powder and solvent for solution for injection | Derby Hospitals NHS Foundation Trust | Authorised | Female: yes Male: yes | 32 | United Kingdom | ||||
1453 | EUCTR2004-002132-26-GB | 19/02/2008 | 2 October 2012 | A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of ocrelizumab (Ro 496-4913, PRO70769, rhuMAb 2H7) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/A | A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of ocrelizumab (Ro 496-4913, PRO70769, rhuMAb 2H7) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/A | Rheumatoid Arthritis | Product Name: Ocrelizumab / rhuMAb 2H7 Product Code: Ro 496-4913 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Ocrelizumab CAS Number: N/A Current Sponsor code: Ro 496-4913 Other descriptive name: rhuMAb 2H7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann-La Roche Limited | Authorised | Female: yes Male: yes | 160 | Phase 1/2 | United Kingdom;Spain | |||
1454 | EUCTR2007-003647-75-NL | 07/02/2008 | 12 June 2012 | A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis | A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis | Rheumatoid arthritis. MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: TACI-Fc5 Pharmaceutical Form: Solution for injection INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 25-150 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: Mabthera Product Name: Rituximab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: rituximab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Merck Serono International | Authorised | Female: yes Male: yes | 90 | Phase 2 | Sweden;France;Finland;United Kingdom;Netherlands | |||
1455 | NCT00556894 | February 2008 | 19 October 2017 | Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CF101 | Can-Fite BioPharma | Not recruiting | 18 Years | 75 Years | All | 230 | Phase 2 | Bulgaria;Czech Republic;Israel;Poland;Serbia;Ukraine;Former Serbia and Montenegro | |
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 |
1456 | NCT00639834 | February 2008 | 19 February 2015 | Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis | A Phase 1, Multicenter, Single-dose, Dose-escalation, Safety and Tolerability Study of MDX-1342 (Anti-CD19 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: MDX-1342 | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | Both | 26 | Phase 1 | United States;Germany;Hungary;Ukraine;United Kingdom;Poland | |
1457 | NCT01017367 | February 2008 | 19 February 2015 | Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (RA) | Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: MDX-1100;Drug: Placebo | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | Both | 70 | Phase 2 | Romania;Ukraine | |
1458 | NCT01072058 | February 2008 | 19 February 2015 | Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker | Prospective Evaluation of Heart Function by Echocardiographic Study, Pro-brain Natriuretic Peptide Type B and Troponin T in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker | Arthritis, Rheumatoid;Spondylitis, Ankylosing | Drug: TNF blockers (infliximab, adalimumab, etanercept) | University of Sao Paulo | Not recruiting | 18 Years | 70 Years | Both | 100 | Phase 4 | Brazil | |
1459 | EUCTR2007-006729-28-GB | 25/01/2008 | 19 March 2012 | Is a single dose intramuscular (IM) triamcinolone acetonide injection more effective in treating symptomatic flare in established rheumatoid arthritis than equivalent dose of oral prednisolone? - Treatment comparison for symptomatic flare in RA | Is a single dose intramuscular (IM) triamcinolone acetonide injection more effective in treating symptomatic flare in established rheumatoid arthritis than equivalent dose of oral prednisolone? - Treatment comparison for symptomatic flare in RA | The objective of this study is to compare the efficacy of equivalent doses of IM triamcinolone acetonide and oral prednisolone in controlling a symptomatic flare in patients with established RA. MedDRA version: 9.1 Level: LLT Classification code 10060732 Term: Rheumatoid arthritis flare up | Trade Name: Kenalog Product Name: Triamcinolone acetonide Pharmaceutical Form: Injection* INN or Proposed INN: TRIAMCINOLONE ACETONIDE CAS Number: 76255 Concentration unit: IU/mg international unit(s)/milligram Concentration type: equal Concentration number: 80- Trade Name: Prednisolone Product Name: Prednisolone Pharmaceutical Form: Coated tablet INN or Proposed INN: PREDNISOLONE CAS Number: 50248 Concentration unit: IU/mg international unit(s)/milligram Concentration type: equal Concentration number: 5- | Trafford NHS Trust | Not Recruiting | Female: yes Male: yes | 58 | United Kingdom | ||||
1460 | EUCTR2007-000012-90-GB | 23/01/2008 | 9 January 2017 | The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial | The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial | The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamlined safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Anti-Inflammatory Drug (NSAID) therapy when used to treat pain and inflammation in osteoarthritis or rheumatoid arthritis patients who are free from ischaemic heart disease, cerebrovascular disease, peripheral arterial disease, and moderate or severe heart failure. MedDRA version: 13.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 13.1 Level: PT Classification code 10041591 Term: Spinal osteoarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Celebrex Pharmaceutical Form: Tablet Trade Name: Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses Pharmaceutical Form: Tablet | University of Dundee | Not Recruiting | Female: yes Male: yes | Phase 4 | Denmark;Netherlands;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 |
1461 | ChiCTR-CCC-10001054 | 2008-01-01 | 18 April 2017 | Circulating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid Arthritis | Circulating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid Arthritis | ra | 1:none;2:Infliximab ; | National Sciences Foundation of China | Not Recruiting | 28 | 58 | Both | 1:39;2:39; | Pilot study | China | |
1462 | ChiCTR-TRC-09000383 | 2008-01-01 | 18 April 2017 | Efficacy and safety of recombinant human IL-1 receptor antagonist in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial | Efficacy and safety of recombinant human IL-1 receptor antagonist in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial | rheumatoid arthritis;M05.901 | placebo:daily subcutaneous injections of placebo, with concurrent MTX therapy ;anakinra:daily subcutaneous injections of anakinra (80 mg), with concurrent MTX therapy; | Xi-jing Hospital, the 4th Military Medical University, Shanghai Changzheng Hospital | Not Recruiting | 18 | 65 | Both | placebo:10;anakinra:30; | Phase 3 study | China | |
1463 | NCT00611455 | January 1, 2008 | 16 December 2017 | Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy | A Double-blind, Randomized, Placebo Controlled, Parallel Group, Multi-center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Adult Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy | Arthritis, Rheumatoid | Drug: ofatumumab;Drug: Placebo | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 265 | Phase 3 | Argentina;Australia;Belgium;Chile;Czechia;Hungary;Peru;Poland;Romania;Russian Federation;South Africa;Spain;United Kingdom;Czech Republic | |
1464 | NCT00655824 | January 1, 2008 | 16 December 2017 | Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403 | An Open-label, International, Multi-center, Phase II, Extension Trial Investigating Long-term Efficacy and Safety of Repeated Treatment Courses of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Adult Patients With Active Rheumatoid Arthritis Who Previously Received Ofatumumab or Placebo | Arthritis, Rheumatoid | Drug: ofatumumab | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 124 | Phase 2 | United States;Denmark;Hungary;Poland;United Kingdom | |
1465 | NCT00559585 | January 2008 | 19 October 2017 | Methotrexate-Inadequate Response Study | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate | Rheumatoid Arthritis (RA) | Drug: Subcutaneous (SC) Abatacept;Drug: Intravenous (IV) Abatacept | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 2492 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Chile;France;Germany;Greece;Hungary;India;Ireland;Italy;Korea, Republic of;Mexico;Netherlands;Peru;Poland;Russian Federation;South Africa;Taiwan;Turkey;United Kingdom;Austria;Spain | |
No. | 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 |
1466 | NCT00603512 | January 2008 | 19 October 2017 | Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan | A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Confirm Dose Responsiveness Following 12 Weeks of the Administration of CP-690,550 (4 Doses) or Placebo in Subjects With Active Rheumatoid Arthritis Inadequately Controlled With Methotrexate Alone | Arthritis, Rheumatoid | Drug: Placebo;Drug: CP-690,550 | Pfizer | Not recruiting | 20 Years | 70 Years | All | 140 | Phase 2 | Japan | |
1467 | NCT00603525 | January 2008 | 19 October 2017 | Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-a Antagonist Therapy | A Double-blind, Randomized, Placebo Controlled, Parallel Group, Multi-center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Patients With Active Rheumatoid Arthritis Who Have Previously Had an Inadequate Response to One or More TNF Antagonist Therapies | Arthritis, Rheumatoid | Drug: Ofatumumab;Drug: Placebo | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 169 | Phase 3 | Argentina;Denmark;France;Germany;Italy;Korea, Republic of;Netherlands;Norway;Peru;Spain;Sweden;United Kingdom | |
1468 | NCT00741104 | January 2008 | 16 December 2017 | A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417) | A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients | Rheumatoid Arthritis | Drug: Infliximab | Merck Sharp & Dohme Corp. | Not recruiting | N/A | N/A | All | 363 | Phase 4 | ||
1469 | EUCTR2008-000744-13-DE | 27 January 2014 | An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study | An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: R935788 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fostamatinib Disodium CAS Number: 914295-16-2 Current Sponsor code: R935788 sodium hexahydrate Other descriptive name: R788 Sodium, R788 Na, R788 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Product Name: R935788 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fostamatinib Disodium CAS Number: 914295-16-2 Current Sponsor code: R935788 sodium hexahydrate Other descriptive name: R788 Sodium, R788 Na, R788 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | AstraZeneca AB | Not Recruiting | Female: yes Male: yes | 800 | France;Belgium;Bulgaria;Germany;Italy | |||||
1470 | NCT01362153 | December 26, 2007 | 16 December 2017 | A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA) | An Open-label Randomized Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of Subcutaneous and Intravenous Administrations of Golimumab to Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Golimumab | Centocor, Inc. | Not recruiting | 18 Years | 99 Years | All | 49 | 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 |
1471 | EUCTR2007-002951-18-NL | 10/12/2007 | 19 March 2012 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Ofatumumab CAS Number: 679 818-59-8 Current Sponsor code: HuMax-CD20 Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 20- Route of administration of the placebo: Intravenous use | Genmab A/S | Not Recruiting | Female: yes Male: yes | 236 | Phase 3 | Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden | |||
1472 | EUCTR2007-004878-31-DK | 10/12/2007 | 2 June 2014 | An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 | An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Ofatumumab CAS Number: 679 818-59-8 Current Sponsor code: HuMax-CD20 Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 20- | GlaxoSmithKline Research & Development Ltd | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Hungary;Denmark;United Kingdom | |||
1473 | NCT00547521 | December 2007 | 19 October 2017 | Phase IIIB Subcutaneous Abatacept Monotherapy Study | A Phase IIIb, Multi-center, Stratified, Open-Label Study to Evaluate the Immunogenicity, Steady State Trough Level, and Safety of Subcutaneous Abatacept (BMS-188667) in Subjects With Rheumatoid Arthritis Administered With or Without Background Methotrexate | Rheumatoid Arthritis (RA) | Drug: abatacept;Drug: Methotrexate (MTX) | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 119 | Phase 3 | United States;Australia;Mexico;South Africa;Brazil;Canada;Peru | |
1474 | NCT00576433 | December 2007 | 14 November 2016 | A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor. | An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor | Rheumatoid Arthritis | Drug: Methotrexate;Drug: rituximab [MabThera/Rituxan] | Hoffmann-La Roche | Not recruiting | 18 Years | 80 Years | Both | 60 | Phase 4 | Russian Federation | |
1475 | NCT00576706 | December 2007 | 19 February 2015 | PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity | A Phase III, Randomized, Double-dummy, Double Blind, Misoprostol-comparative Clinical Trial to Evaluate the Efficacy and Safety of Mucosta® Tablet in the Prevention of NSAID-induced Gastrointestinal Complications | Rheumatoid Arthritis;Osteoarthritis;Ankylosing Spondylitis | Drug: Rebamipide;Drug: Misoprostol | Korea Otsuka Pharmaceutical Co.,Ltd. | Not recruiting | 19 Years | N/A | Both | 396 | 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 |
1476 | NCT00580229 | December 2007 | 20 August 2018 | A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis. | A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: prednisone | University of South Florida | Not recruiting | 18 Years | 80 Years | All | 50 | Phase 2/Phase 3 | United States | |
1477 | NCT00580840 | December 2007 | 19 October 2017 | Dosing Flexibility Study in Patients With Rheumatoid Arthritis | A Phase IIIb Open-label run-in Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety/Efficacy of Certolizumab Pegol Administered Concomitantly With Stable-dose Methotrexate in Patients With Active Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: Certolizumab pegol;Other: Placebo | UCB Pharma | Not recruiting | 18 Years | N/A | All | 333 | Phase 4 | United States;Canada;France;Austria | |
1478 | NCT00647270 | December 2007 | 19 October 2017 | Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing | A Multi-center, Randomized, Double-blind,Placebo-controlled Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing | Rheumatoid Arthritis | Drug: adalimumab;Drug: Placebo | Abbott | Not recruiting | 18 Years | N/A | All | 420 | Phase 3 | United States;Australia;Canada;Germany;Puerto Rico;United Kingdom | |
1479 | NCT00963703 | December 2007 | 19 February 2015 | Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis | Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes | Rheumatoid Arthritis | Drug: Rituximab | University of Manitoba | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 15 | N/A | Canada |
1480 | NCT01231321 | December 2007 | 19 October 2017 | A Study of Adalimumab When Added to Inadequate Standard Anti-rheumatic Therapy in Patients With Active Rheumatoid Arthritis | An Open-label, Prospective, Multi-Centre Study to Assess the Safety and Efficacy of Adalimumab (Humira®) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: adalimumab | Abbott | Not recruiting | 18 Years | N/A | All | 100 | Phase 3 | Russian Federation | |
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 |
1481 | EUCTR2007-001585-33-LT | 13/11/2007 | 7 October 2014 | A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE | A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE | Rheumatoid arthritis (RA) MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: MabThera 500mg Product Name: MabThera 500mg Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Route of administration of the placebo: Intravenous use | F. Hoffman-La Roche Ltd. | Not Recruiting | Female: yes Male: yes | 180 | France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia | ||||
1482 | NCT00533897 | November 2007 | 19 October 2017 | Phase IIIB Subcutaneous Missed Dose Study | A Phase IIIb, Multi-Center, Randomized, Withdrawal Study to Evaluate the Immunogenicity and Safety of Subcutaneous Administered Abatacept in Adults With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Abatacept;Drug: Placebo | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 270 | Phase 3 | United States;Argentina;Canada;Mexico;South Africa;Brazil | |
1483 | NCT00554853 | November 2007 | 19 October 2017 | PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease | Peroxisome Proliferator-activated Receptor-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease | Rheumatoid Arthritis | Drug: pioglitazone;Drug: Sublingual nitroglycerine | University of Michigan | National Heart, Lung, and Blood Institute (NHLBI) | Not recruiting | 21 Years | 100 Years | All | 143 | Phase 3 | United States |
1484 | NCT00578305 | November 2007 | 19 October 2017 | A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate | A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate | Rheumatoid Arthritis | Biological: Rituximab;Drug: Placebo;Drug: Methylprednisolone;Drug: Methotrexate;Drug: Folic acid or folate | Hoffmann-La Roche | Not recruiting | 18 Years | 80 Years | All | 185 | Phase 3 | Argentina;Brazil;Canada;Czech Republic;Denmark;Estonia;France;Germany;Greece;Latvia;Lithuania;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Switzerland;Turkey;Former Serbia and Montenegro;United Kingdom | |
1485 | NCT00664573 | November 2007 | 19 February 2015 | Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Patients | Assessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202. | Rheumatoid Arthritis | Biological: Baminercept alfa (BG9924) | Biogen Idec | Not recruiting | 18 Years | 75 Years | Both | 339 | Phase 2 | Argentina;Brazil;Hungary;Mexico;Poland;Romania;Russian Federation;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 |
1486 | NCT01245361 | November 2007 | 19 February 2015 | A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial Benefit | A Comparative Study Of A 6-Month Infliximab (Remicade®) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis (RA) : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. | Undifferentiated Arthritis | Drug: Infliximab;Drug: sodium chloride | Patrick Durez | Not recruiting | N/A | N/A | Both | 30 | N/A | Belgium | |
1487 | EUCTR2007-003069-42-EE | 31/10/2007 | 19 March 2012 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA) | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA) | RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: CRx-102 Pharmaceutical Form: Capsule* INN or Proposed INN: Prednisolone CAS Number: 52438-85-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.9 and 1.8- INN or Proposed INN: Dipyridamole CAS Number: 58-32-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 180- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: Prednisolone Pharmaceutical Form: Capsule* INN or Proposed INN: Prednisolone CAS Number: 52438-85-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.9 and 1.8- Product Name: Dipyridamole Pharmaceutical Form: Capsule* INN or Proposed INN: Dipyridamole CAS Number: 58-32-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 180- Product Code: CRx-102 Pharmaceutical Form: Capsule* INN or Proposed INN: Prednisolone CAS Number: 52438-85-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.9 and 1.8- INN or Proposed INN: Dipyridamole CAS Number: 58-32-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 90 - Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | CombinatoRx, Incorporated | Not Recruiting | Female: yes Male: yes | 616 | Hungary;United Kingdom;Estonia;Lithuania | ||||
1488 | NCT00535782 | October 31, 2007 | 16 December 2017 | A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis | A Mechanism of Action Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) on Lipids, Arterial Stiffness, and Markers of Atherogenic Risk in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA). | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Placebo;Drug: Methotrexate | Hoffmann-La Roche | Not recruiting | 18 Years | 75 Years | All | 132 | Phase 3 | United States;Canada;Puerto Rico;United Kingdom | |
1489 | EUCTR2007-001035-58-ES | 30/10/2007 | 19 March 2012 | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATE ESTUDIO EN FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y EN GRUPOS PARALELOS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE MARAVIROC (UK 427,857) EN EL TRATAMIENTO DE LA ARTRITIS REUMATOIDE EN PACIENTES QUE RECIBEN METOTREXATO - N/A | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATE ESTUDIO EN FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y EN GRUPOS PARALELOS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE MARAVIROC (UK 427,857) EN EL TRATAMIENTO DE LA ARTRITIS REUMATOIDE EN PACIENTES QUE RECIBEN METOTREXATO - N/A | ARTRITIS REUMATOIDE RHEUMATOID ARTHRITIS MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Maraviroc Product Code: UK-427,857 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Maraviroc CAS Number: 376348-65-1 Current Sponsor code: UK-427,857 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Pfizer, S. A. | Authorised | Female: yes Male: yes | 114 | Phase 2 | Portugal;Spain;Italy | |||
1490 | EUCTR2006-006591-37-BE | 25/10/2007 | 7 October 2014 | A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis | A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis | Trade Name: Enbrel Product Name: Pre-filled syringe Pharmaceutical Form: Solution for injection INN or Proposed INN: ETANERCEPT CAS Number: 185243690 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Product Name: Enbrel Auto Injector Pharmaceutical Form: Solution for injection INN or Proposed INN: ETANERCEPT CAS Number: 185243690 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Wyeth Pharmaceuticals France | Not Recruiting | Female: yes Male: yes | 264 | Greece;Belgium;Austria | ||||
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 |
1491 | NCT00502853 | October 25, 2007 | 16 December 2017 | A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis. | Pilot Study to Evaluate the Effect of Mabthera in Combination With MTX in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Magnetic Resonance Imaging (MRI) in the Hand of Patients With Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate | Hoffmann-La Roche | Not recruiting | 18 Years | 75 Years | All | 10 | Phase 4 | Italy | |
1492 | EUCTR2007-002945-18-CZ | 15/10/2007 | 19 March 2012 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - Clinical efficacy and safety of ofatumumab in RA patients receiving background nonbiologic DMARDs | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - Clinical efficacy and safety of ofatumumab in RA patients receiving background nonbiologic DMARDs | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Ofatumumab CAS Number: 679 818-59-8 Current Sponsor code: HuMax-CD20 Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 20- Route of administration of the placebo: Intravenous use | Genmab A/S | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Czech Republic | |||
1493 | EUCTR2007-000733-19-GB | 02/10/2007 | 19 March 2012 | A Phase 2B, Blinded Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA202 | A Phase 2B, Blinded Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA202 | Rheumatoid arthritis (RA) MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: BG9924 Pharmaceutical Form: Powder for solution for injection Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Biogen Idec Ltd | Not Recruiting | Female: yes Male: yes | 380 | Phase 2B | Hungary;United Kingdom | |||
1494 | EUCTR2007-000734-38-GB | 02/10/2007 | 19 March 2012 | An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA203 | An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA203 | Rheumatoid arthritis (RA) MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: BG9924 Pharmaceutical Form: Powder for solution for injection Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Biogen Idec Ltd | Not Recruiting | Female: yes Male: yes | 120 | United Kingdom | ||||
1495 | ChiCTR-TRC-11001755 | 2007-10-01 | 18 April 2017 | Phase II of Tu Fu Ling Tablets in Rheumatoid Arthritis | A Multi-center, Randomized, Double-blind, Double-dummy, Phase II Study Evaluating the Safety and Efficacy of Tu Fu Ling Tablets in Participants with Rheumatoid Arthritis | Rheumatoid Arthritis | A:Tu Fu Ling Tablets, 200mg Bid. Other: Placebo;B:Tu Fu Ling Tablets, 100mg Tid. Other: Placebo. ;C:Leflunomide Tablets, 20mg Qd. Other: Placebo; | The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Not Recruiting | 18 | 65 | Both | A:80;B:80;C:80; | Phase 2 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 |
1496 | JPRN-UMIN000000837 | 2007/10/01 | 2 April 2019 | Combination effect of bucillamine and salazosulphapyridine on rheumatoid arthritis; Prospective randomized controlled study | Rheumatoid arthritis | Bucillamine mono-therapy(It's possible to choose the combination therapy with salazosulphapyridine at 6 months after the start of the treatment) Salazosulphapyridine mono-therapy(It's possible to choose the combination therapy with bucillamineat 6 months after the start of the treatment) Combination therapy of bucillamine and salazosulphapyridine (over the study period) | BASIC study group | Recruiting | 20years-old | 75years-old | Male and Female | 180 | Not applicable | Japan | ||
1497 | NCT00531817 | October 2007 | 19 October 2017 | A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Placebo;Drug: Permitted DMARDs | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 619 | Phase 3 | United States;Puerto Rico | |
1498 | NCT00550043 | October 2007 | 19 October 2017 | A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis | A Double-blind, Placebo-controlled Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: INCB018424;Drug: Placebo | Incyte Corporation | Not recruiting | 18 Years | 70 Years | All | 50 | Phase 2 | United States;Poland | |
1499 | NCT00551707 | October 2007 | 19 October 2017 | Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Superiority of CRx-102 Over Each of Its Components When Given to Subjects With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: CRx-102 (2.7/180);Drug: prednisolone;Drug: dipyridamole;Drug: placebo;Drug: CRx-102 (2.7/360) | Zalicus | Not recruiting | 18 Years | N/A | All | 51 | Phase 2 | United States;Argentina;Canada;Estonia;Hungary;Lithuania;Mexico;Poland;Romania;Russian Federation;Serbia;South Africa | |
1500 | NCT00554606 | October 2007 | 16 December 2017 | Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis | A 54-week, Phase II, Multi-center, Open-label Extension Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1B Monoclonal Antibody) in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ACZ885 | Novartis | Not recruiting | 18 Years | 75 Years | All | 115 | Phase 2 | United States;Belgium;Germany;Italy;Netherlands;Russian Federation;Spain;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 |
1501 | NCT00595517 | October 2007 | 19 October 2017 | Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer | A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use | Gastric Ulcer;Duodenal Ulcer;Rheumatoid Arthritis;Osteoarthritis;Lumbago | Drug: Esomeprazole 20 mg | AstraZeneca | Not recruiting | 20 Years | N/A | All | 395 | Phase 3 | Japan | |
1502 | NCT00626275 | October 2007 | 19 October 2017 | Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Participants With Rheumatoid Arthritis | A Phase 2a Randomized, Placebo- and Active-Controlled, Single-Dose, 3-Period, Crossover Study Followed by a Randomized, Placebo-Controlled, 14-Day, Parallel-Group Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ADL5859;Drug: Naproxen;Drug: Placebo | Cubist Pharmaceuticals LLC | Not recruiting | 18 Years | 75 Years | All | 46 | Phase 2 | United States | |
1503 | NCT00934648 | October 2007 | 19 October 2017 | A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate | An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate | Rheumatoid Arthritis | Drug: rituximab [MabThera/Rituxan];Drug: methotrexate | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 15 | Phase 4 | Morocco | |
1504 | NCT02699892 | October 2007 | 19 October 2017 | Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis | Post Marketing Non Interventional Clinical Research of Administration of Rituximab in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Rituximab | Hoffmann-La Roche | Not recruiting | 18 Years | 80 Years | All | 130 | N/A | Serbia | |
1505 | EUCTR2007-004694-26-BE | 17/09/2007 | 7 October 2014 | A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA | A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA | Patient with undifferentiated arthritis and the presence of anti-CCP antibodies are at high risk to develop RA MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Remicade Product Name: REMICADE® (Infliximab) Product Code: - Pharmaceutical Form: Powder for infusion* Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Saint-Luc Universitary Hospital | Authorised | Female: yes Male: yes | 30 | 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 |
1506 | EUCTR2006-006127-40-GB | 16/09/2007 | 19 March 2012 | Cerebral Blood Flow following TNF-alpha Antagonism in Rheumatoid Arthritis - a Pilot Study - TNF/CBF in RA | Cerebral Blood Flow following TNF-alpha Antagonism in Rheumatoid Arthritis - a Pilot Study - TNF/CBF in RA | Rheumatoid arthritis MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Humira Product Name: Humira 40mg solution for injection in pre-filled syringe (adalimumab) Pharmaceutical Form: Solution for injection INN or Proposed INN: recombinant human monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40mg in 0.8ml- | Newcastle-upon-Tyne Hospitals NHS Foundation Trust | Authorised | Female: yes Male: yes | United Kingdom | |||||
1507 | EUCTR2007-001665-15-ES | 14/09/2007 | 2 February 2015 | Estudio de extensión abierto, multicéntrico, de fase II, de 54 semanas de duración, para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide. | Estudio de extensión abierto, multicéntrico, de fase II, de 54 semanas de duración, para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide. | Artritis Reumatoide MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: ACZ885 Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Canakinumab (proposed) Current Sponsor code: ACZ885 Other descriptive name: ACZ885 Drug Substance Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Novartis Farmaceutica S.A. | Not Recruiting | Female: yes Male: yes | 179 | Belgium;Spain;Netherlands;Germany;Italy | ||||
1508 | EUCTR2007-002752-42-FR | 13/09/2007 | 19 March 2012 | FAKIR : Variabilité pharmacocinétique et de la relation pharmacocinétique-phamacodynamique de l'infliximab (Remicade®) dans la polyarthrite rhumatoide - FAKIR | FAKIR : Variabilité pharmacocinétique et de la relation pharmacocinétique-phamacodynamique de l'infliximab (Remicade®) dans la polyarthrite rhumatoide - FAKIR | Polyarthrite rhumatoïde MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Remicade® Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277313 Concentration unit: mg/kg/h milligram(s)/kilogram/hour Concentration type: range Concentration number: 1,5-3 | CHRU de Tours | Authorised | Female: yes Male: yes | France | |||||
1509 | EUCTR2007-002950-42-LT | 13/09/2007 | 19 March 2012 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Ofatumumab CAS Number: 679 818-59-8 Current Sponsor code: HuMax-CD20 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Route of administration of the placebo: Intravenous use | Genmab A/S | Not Recruiting | Female: yes Male: yes | 248 | Phase 3 | Hungary;United Kingdom;Czech Republic;Spain;Poland;Lithuania | |||
1510 | EUCTR2007-002976-32-NL | 06/09/2007 | 19 March 2012 | COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis. | COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis. | Patients with early rheumatoid arthritis wil be treated with a combination therapy: COBRA according to BEST or a modified COBRA schedule (COBRA-light). | Trade Name: Prednisone Pharmaceutical Form: Tablet Trade Name: Methotrexate Pharmaceutical Form: Tablet Trade Name: Sulphasalazine Pharmaceutical Form: Tablet | TIPharma | Authorised | Female: yes Male: yes | 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 |
1511 | NCT00539760 | September 5, 2007 | 16 December 2017 | A Phase I Rheumatoid Arthritis Study in Healthy Volunteers | A Phase I, Randomized, Observer- and Subject-Blind, Placebo-Controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1827771 in Healthy Volunteers | Arthritis, Rheumatoid | Drug: GSK1827771;Drug: Placebo | GlaxoSmithKline | Not recruiting | 18 Years | 55 Years | All | 45 | Phase 1 | United States | |
1512 | EUCTR2006-005640-81-GB | 04/09/2007 | 19 March 2012 | A PLACEBO CONTROLLED STUDY OF THE EFFECT OF EXTENDED TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: - EXXTRA | A PLACEBO CONTROLLED STUDY OF THE EFFECT OF EXTENDED TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: - EXXTRA | Rheumatoid arthritis | Trade Name: Mabthera Product Name: Mabthera Product Code: Rituximab Pharmaceutical Form: Concentrate for solution for infusion Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Methylprednisolone Product Name: Methylprednisolone Pharmaceutical Form: Powder for infusion* Other descriptive name: Methylprednisolone Concentration unit: mg milligram(s) Concentration type: range Concentration number: 200-300 | University of Leeds | Authorised | Female: yes Male: yes | 60 | United Kingdom | ||||
1513 | NCT00411424 | September 2007 | 19 February 2015 | Safety, Tolerability and Efficacy Study of the New Medication ASK8007 to Treat Patients With Rheumatoid Arthritis | Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Initial Efficacy of ASK8007 in Comparison With Placebo in Patients With Active Rheumatoid Arthritis - a Randomized, Double Blind, Placebo-controlled, Combined Single Dose Escalation and Multiple Dose Study | Rheumatoid Arthritis | Drug: ASK8007;Drug: Placebo | Astellas Pharma Inc | Not recruiting | 18 Years | N/A | Both | 54 | Phase 1/Phase 2 | Belgium;Hungary;Ireland;Netherlands;Spain;United Kingdom;France | |
1514 | NCT00550446 | September 2007 | 19 October 2017 | A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis | A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Adalimumab;Drug: CP-690-550;Drug: CP-690,550;Drug: Placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 386 | Phase 2 | United States;Brazil;Bulgaria;Chile;Croatia;Czech Republic;Germany;Greece;Hungary;Italy;Korea, Republic of;Mexico;Romania;Slovakia;Ukraine | |
1515 | NCT00613106 | September 2007 | 19 October 2017 | Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216) | Double-Blind Follow-On Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg)in Subjects Who Have Completed Participation in Horizon Protocol HZ-CA-301 (NCT00450658)or Horizon Protocol HZ-CA-303 (NCT00450216) | Osteoarthritis;Rheumatoid Arthritis;Chronic Low Back Pain;Chronic Regional Pain Syndrome;Chronic Soft Tissue Pain | Drug: HZT-501;Drug: Ibuprofen | Horizon Pharma Ireland, Ltd., Dublin Ireland | Not recruiting | 40 Years | 81 Years | All | 179 | Phase 3 | 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 |
1516 | NCT00660647 | September 2007 | 7 December 2015 | Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA) | Optimized Treatment Algorithm in Early Rheumatoid Arthritis: Methotrexate and Intra-articular Glucocorticosteroid Plus Adalimumab or Placebo in the Treatment of Early Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Adalimumab;Drug: Placebo | University of Aarhus | Abbott;Meda Pharmaceuticals;Aarhus University Hospital | Not recruiting | 18 Years | N/A | Both | 180 | Phase 3 | Denmark |
1517 | EUCTR2006-003054-26-CZ | 31/08/2007 | 19 March 2012 | A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid Arthritis - NA | A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid Arthritis - NA | Rheumatoid arthritis (RA) MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: TAK-783 Pharmaceutical Form: Tablet Current Sponsor code: TAK-783 Concentration unit: % percent Concentration type: range Concentration number: 90-110 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Takeda Global R&D (Europe) Ltd | Not Recruiting | Female: yes Male: yes | 230 | Hungary;Czech Republic;Latvia | ||||
1518 | EUCTR2007-001420-12-BE | 23/08/2007 | 7 October 2014 | A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine | A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: AZD9056 hydrochloride Product Code: AZD9056 Pharmaceutical Form: Tablet Current Sponsor code: AZD9056 Other descriptive name: None Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: AZD9056 hydrochloride Product Code: AZD9056 Pharmaceutical Form: Tablet Current Sponsor code: AZD9056 Other descriptive name: None Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Enbrel Product Name: Enbrel Pharmaceutical Form: Solution for injection INN or Proposed INN: Etanercept Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | AstraZeneca AB | Not Recruiting | Female: yes Male: yes | 360 | Phase 2b | France;Czech Republic;Poland;Belgium;Sweden | |||
1519 | EUCTR2007-000734-38-BE | 17/08/2007 | 11 November 2013 | An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA203 | An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA203 | Rheumatoid arthritis (RA) MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: BG9924 Pharmaceutical Form: Solution for injection Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Biogen Idec Ltd | Not Recruiting | Female: yes Male: yes | 120 | Belgium;United Kingdom | ||||
1520 | EUCTR2007-001754-11-IT | 03/08/2007 | 19 March 2012 | Pilot study to evaluate the effect of Rituximab in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis. - ND | Pilot study to evaluate the effect of Rituximab in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis. - ND | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Mabthera Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- | ROCHE | Not Recruiting | Female: yes Male: yes | 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 |
1521 | NCT00505089 | August 2007 | 19 February 2015 | Efficacy and Safety of Subcutaneous Versus Intravenous ACZ885 in Adult Patients With Established Rheumatoid Arthritis | An Exploratory, Open Label Pharmacokinetic - Pharmacodynamic Study to Compare Subcutaneous Versus Intravenous Administration of ACZ885 in Adult Patients With Established Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ACZ885 | Novartis | Not recruiting | 18 Years | 75 Years | Both | 11 | Phase 1/Phase 2 | Belgium;Germany;Netherlands;Poland | |
1522 | NCT00511329 | August 2007 | 11 June 2018 | Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease | Growth and the Effect of Genotropin in Chronically Ill Children With Juvenile Rheumatoid Arthritis and With Crohn's Disease | Arthritis, Juvenile Rheumatoid;Crohn Disease | Drug: somatropin [rDNA origin] for injection | Nationwide Children's Hospital | Pfizer | Not recruiting | 5 Years | 17 Years | All | 10 | Phase 2/Phase 3 | United States |
1523 | NCT00517543 | August 2007 | 19 February 2015 | A Study to Examine the Effect of Particle Size on Bioequivalence and Bioavailability | A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 | Chronic Obstructive Pulmonary Disease (COPD);Rheumatoid Arthritis;Atherosclerosis | Drug: GW856553 | GlaxoSmithKline | Not recruiting | 18 Years | 60 Years | Both | 36 | Phase 1 | United States | |
1524 | NCT00520572 | August 2007 | 19 October 2017 | A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA) | A Randomised, Double-Blind (With Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients With Active Disease Receiving Background Methotrexate or Sulphasalazine | Rheumatoid Arthritis | Drug: AZD9056;Drug: Etanercept;Drug: Placebo | AstraZeneca | Not recruiting | 18 Years | N/A | All | 385 | Phase 2 | United States;Argentina;Australia;Belgium;Canada;Czech Republic;France;Mexico;Poland;Romania;Russian Federation;Slovakia;Hungary;Sweden | |
1525 | NCT00523328 | August 2007 | 19 February 2015 | BG9924 in Combination With Methotrexate Extension of Study 104RA203 | An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects With Rheumatoid Arthritis Who Previously Participated in Study 104RA203 | Rheumatoid Arthritis | Drug: BG9924 | Biogen Idec | Not recruiting | 18 Years | 75 Years | Both | 72 | Phase 2 | United States;Belgium;Canada;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 |
1526 | NCT00538902 | August 2007 | 19 October 2017 | Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate | A Multi-center Randomized, Phase 2/3, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Safety and Efficacy of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate | Rheumatoid Arthritis | Biological: Placebo;Biological: Adalimumab 80 mg;Biological: Adalimumab 40 mg | Abbott | Not recruiting | 18 Years | N/A | All | 302 | Phase 2/Phase 3 | China | |
1527 | NCT00542789 | August 2007 | 19 October 2017 | Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID | A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use | Gastric Ulcer;Duodenal Ulcer;Rheumatoid Arthritis;Osteoarthritis;Lumbago | Drug: Esomeprazole;Drug: Placebo | AstraZeneca | Not recruiting | 20 Years | N/A | All | 343 | Phase 3 | Japan | |
1528 | NCT00550355 | August 2007 | 19 February 2015 | Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis | A Randomized, Subject and Investigator-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Intravenously Administered Doses of PD-0360324 in Patients With Rheumatoid Arthritis Receiving Methotrexate | Arthritis, Rheumatoid | Drug: PD 0360324;Drug: Placebo | Pfizer | Not recruiting | 21 Years | 70 Years | Both | 78 | Phase 1 | United States;Argentina;Bulgaria;Czech Republic;Mexico;Poland;Slovakia;Spain | |
1529 | NCT00597818 | August 2007 | 19 February 2015 | Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury | A Multi-center, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone for the Prevention of NSAID-induced Gastroduodenal Injury in Patients With Osteoarthritis and/or Rheumatoid Arthritis Patients | NSAID-induced Gastroduodenal Injury;Ulcers;Rheumatoid Arthritis;Osteoarthritis | Drug: Cobiprostone;Drug: Placebo | Sucampo Pharmaceuticals, Inc. | Not recruiting | 40 Years | 70 Years | Both | 120 | Phase 2 | United States | |
1530 | NCT03414502 | August 2007 | 6 May 2019 | Treatment of Rheumatoid Arthritis With Methotrexate: Predictors of Response | Treatment of Rheumatoid Arthritis With Methotrexate: Predictors of Response | Rheumatoid Arthritis | Drug: Methotrexate | University of Nebraska | Recruiting | 19 Years | N/A | All | 300 | Phase 3 | 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 |
1531 | EUCTR2006-005147-28-DE | 25/07/2007 | 23 May 2016 | MTX-IR Phase III | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. | Rheumatoid Arthritis (RA) MedDRA version: 15.0 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ocrelizumab Product Code: RO 496-4913 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ocrelizumab Current Sponsor code: RO 496-4913 Other descriptive name: RhuMAb 2H7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann-La Roche Ltd | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | France;Greece;Spain;Belgium;Austria;Germany;United Kingdom | |||
1532 | NCT00502840 | July 23, 2007 | 16 December 2017 | A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor. | An Open Label Study to Evaluate the Safety of Re-treatment With MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent (Extension Study to ML19070). | Rheumatoid Arthritis | Drug: rituximab [MabThera/Rituxan] | Hoffmann-La Roche | Not recruiting | 18 Years | 75 Years | All | 193 | Phase 3 | Germany | |
1533 | EUCTR2006-003698-29-AT | 18/07/2007 | 7 August 2012 | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis (RA) | Product Name: AMG 108 Product Code: AMG 108 Pharmaceutical Form: Solution for injection Current Sponsor code: AMG 108 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Amgen Inc. | Not Recruiting | Female: yes Male: yes | 784 | Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden | ||||
1534 | EUCTR2006-004666-14-DE | 17/07/2007 | 19 March 2012 | An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available | An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available | Rheumatoid Arthritis MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: ACZ885 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Canakinumab (proposed) Current Sponsor code: ACZ885 Other descriptive name: ACZ885 Drug Substance Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 32 | Germany | ||||
1535 | EUCTR2007-000886-40-CZ | 17/07/2007 | 5 December 2016 | Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER | Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER | patients with a diagnosis of early active rheumatoid arthritis in the previous 6 months, naïves of previous treatment by a DMARD and who need to be treated by a DMARD MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: ARAVA® Pharmaceutical Form: Coated tablet INN or Proposed INN: LEFLUNOMIDE CAS Number: 75706126 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Trade Name: ARAVA® Pharmaceutical Form: Coated tablet INN or Proposed INN: LEFLUNOMIDE CAS Number: 75706126 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Trade Name: ARAVA® Pharmaceutical Form: Coated tablet INN or Proposed INN: LEFLUNOMIDE CAS Number: 75706126 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | sanofi-aventis groupe | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Czech Republic;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 |
1536 | EUCTR2006-004834-33-LT | 05/07/2007 | 20 February 2017 | A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust | A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust | Rheumatiod Arthritis MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Rob 803 Product Code: Rob 803 6.25mg capsule Pharmaceutical Form: Capsule* Current Sponsor code: Rob 803 Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6.25- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: Rob 803 Product Code: Rob 803 12.5mg capsule Pharmaceutical Form: Capsule* Current Sponsor code: Rob 803 Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: Rob 803 Product Code: Rob 803 15mg capsule Pharmaceutical Form: Capsule* Current Sponsor code: Rob 803 Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: Rob 803 Product Code: Rob 803 25mg capsule Pharmaceutical Form: Capsule* Current Sponsor code: Rob 803 Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | OxyPharma AB | Not Recruiting | Female: yes Male: yes | 224 | Phase 2 | Poland;Belgium;Lithuania;Bulgaria;Latvia;United Kingdom | |||
1537 | ChiCTR-TRC-09000377 | 2007-07-01 | 18 April 2017 | Multicentered Clinical Evaluation Studies on Treating Active Rheumatoid Arthritis by the Method of Clearing Heat and Promoting Blood Flow | Multicentered Clinical Evaluation Studies on Treating Active Rheumatoid Arthritis by the Method of Clearing Heat and Promoting Blood Flow | rheumatoid arthritis | Group of MTX:Methotrexate Tablets: 10mg 1/w ;Group of Both MTX and Herbs:The Formula of Clearing Away Damp-heat and Promoting Blood Flow: 200ml bid; Methotrexate Tablets: 10mg 1/w ;Group of Herbs:The Formula of Clearing Away Damp-heat and Promoting Blood Flow: 200ml bid ; | China Academy of Chinese Medical Science Guang'an Men Hospital | Not Recruiting | 18 | 65 | Both | Group of MTX:76;Group of Both MTX and Herbs:77;Group of Herbs:77; | Post-market | China | |
1538 | NCT00405275 | July 2007 | 19 October 2017 | Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy | CSP #551 - Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: Etanercept;Drug: methotrexate;Drug: Sulfasalazine;Drug: Hydroxychloroquine;Drug: Placebo, triple;Drug: Placebo, etanercept | VA Office of Research and Development | Canadian Institutes of Health Research (CIHR);Rheumatoid Arthritis Investigational Network (RAIN);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | N/A | All | 353 | N/A | United States;Canada |
1539 | NCT00503139 | July 2007 | 16 December 2017 | Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan | Enbrel Special Use Result Surveillance | Rheumatoid Arthritis | Drug: Enbrel (etanercept) | Pfizer | Not recruiting | 10 Years | N/A | All | 684 | Phase 4 | Japan | |
1540 | NCT00504777 | July 2007 | 19 October 2017 | A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents. | An Open Label Study to Evaluate the Safety, and Effect on Treatment Response, of MabThera in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One or More Anti-TNF Agents. | Rheumatoid Arthritis | Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 36 | Phase 4 | Taiwan | |
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 |
1541 | NCT00555230 | July 2007 | 19 February 2015 | Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis | Effects of HMG-coA Reductase Inhibitor on Progression of Carotid Intima-Media Thickness and Arterial Stiffness in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Rosuvastatin;Drug: Placebo | Chinese University of Hong Kong | Not recruiting | 18 Years | 75 Years | Both | 150 | Phase 2 | China | |
1542 | NCT00664716 | July 2007 | 19 February 2015 | Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Patients | Assessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy. | Rheumatoid Arthritis | Biological: Placebo;Biological: baminercept alfa;Biological: Baminercept alfa | Biogen Idec | Not recruiting | 18 Years | 75 Years | Both | 391 | Phase 2 | Argentina;Brazil;Hungary;Mexico;Poland;Romania;Russian Federation;United Kingdom | |
1543 | EUCTR2006-006746-33-DE | 28/06/2007 | 19 March 2012 | Re-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IR | Re-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IR | Rheumatoid arthritis MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung Product Name: MabThera Product Code: Ro 45-2294 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab CAS Number: 174722-31 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Roche Pharma AG | Not Recruiting | Female: yes Male: yes | 240 | Germany | ||||
1544 | EUCTR2007-000760-24-CZ | 21/06/2007 | 7 November 2016 | Activity and safety of oral administration of SSR150106XB for the reduction of inflammation in patients with active rheumatoid arthritis (RA): A 4-week, multi-center, randomized, double-blind, placebo-controlled parallel group study of 90 µg administrered once daily and 90µg once every other day - ACCORD-RA | Activity and safety of oral administration of SSR150106XB for the reduction of inflammation in patients with active rheumatoid arthritis (RA): A 4-week, multi-center, randomized, double-blind, placebo-controlled parallel group study of 90 µg administrered once daily and 90µg once every other day - ACCORD-RA | Patients with active rheumatoid arthritis MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: SSR150106XB Product Code: SSR150106XB Pharmaceutical Form: Oral solution INN or Proposed INN: NA CAS Number: 335267-09-9 Current Sponsor code: SSR150106XB Other descriptive name: NA Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use | sanofi-aventis recherche & développement | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | Czech Republic | |||
1545 | EUCTR2006-005137-38-FR | 19/06/2007 | 19 March 2012 | A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis. | A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis. | Rheumatoid Arthritis MedDRA version: 6.0 Level: LLT Classification code 10039073 Term: | Trade Name: Enbrel Product Name: Enbrel Pre-filled syringe Pharmaceutical Form: Solution for injection INN or Proposed INN: ETANERCEPT CAS Number: 185243690 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Product Name: Enbrel Auto Injector Product Code: Auto Injector Pharmaceutical Form: Solution for injection INN or Proposed INN: ETANERCEPT CAS Number: 185243690 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Wyeth Pharmaceuticals France | Authorised | Female: yes Male: yes | 724 | Finland;Germany;United Kingdom;Denmark;France;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 |
1546 | EUCTR2006-005330-20-BE | 07/06/2007 | 25 September 2012 | anti TNF-IR phase III | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-a therapy. - | Rheumatoid arthritis MedDRA version: 14.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ocrelizumab Product Code: RO 496-4913 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ocrelizumab Current Sponsor code: RO 496-4913 Other descriptive name: RhuMAb 2H7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann-La Roche Ltd | Authorised | Female: yes Male: yes | 800 | Phase 3 | Hungary;Germany;Netherlands;Slovenia;Belgium;France;Spain;Italy;Sweden | |||
1547 | EUCTR2006-004140-23-CZ | 06/06/2007 | 10 July 2015 | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | Rheumatoid arthritis MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: Not Applicable Pharmaceutical Form: Solution for injection INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Bulgaria;Germany;Netherlands;United Kingdom;Italy;Sweden | |||
1548 | EUCTR2006-004666-14-BE | 04/06/2007 | 11 November 2013 | An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available | An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available | Rheumatoid Arthritis MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: ACZ885 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Canakinumab (proposed) Current Sponsor code: ACZ885 Other descriptive name: ACZ885 Drug Substance Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 32 | Belgium;Germany | ||||
1549 | NCT00422227 | June 2007 | 19 October 2017 | Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region | A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Etanercept , Methotrexate;Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | 70 Years | All | 300 | Phase 4 | Hong Kong;India;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand | |
1550 | NCT00447759 | June 2007 | 13 May 2019 | The Standard Care Versus Celecoxib Outcome Trial | Phase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID's | Osteoarthritis;Rheumatoid Arthritis | Drug: Celecoxib;Drug: Diclofenac | University of Dundee | University of Glasgow;University of Nottingham | Not recruiting | 60 Years | N/A | All | 7297 | Phase 4 | Denmark;Netherlands;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 |
1551 | NCT00462345 | June 2007 | 19 October 2017 | A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies. | An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Treatment Response in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies | Rheumatoid Arthritis | Drug: rituximab;Drug: Methotrexate;Drug: Corticosteroid or NSAID;Dietary Supplement: Folate | Hoffmann-La Roche | Not recruiting | 18 Years | 80 Years | All | 40 | Phase 4 | Korea, Republic of | |
1552 | NCT00650156 | June 2007 | 16 December 2017 | Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis | A Randomized, Parallel-group, Open-Label, Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis. | Rheumatoid Arthritis | Biological: adalimumab | AbbVie | Not recruiting | 18 Years | N/A | All | 24 | Phase 1 | China | |
1553 | NCT00896168 | June 2007 | 19 October 2017 | An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis | A Multi-Center, Pre-Marketing Clinical Trial to Evaluate the Efficacy and Safety of Infliximab Treatment on Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Infliximab;Drug: Methotrexate | Xian-Janssen Pharmaceutical Ltd. | Not recruiting | 18 Years | 65 Years | All | 234 | Phase 4 | ||
1554 | EUCTR2007-000082-38-DK | 24/05/2007 | 8 August 2016 | The OPERA Study. Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis. A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development. - The OPERA Study | The OPERA Study. Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis. A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development. - The OPERA Study | In early RA methotrexate and intra-articular glucocorticoid in combination with adalimumab is better than methotrexate and intra-articular glucocorticoid in achieving control of the disease as assessed by DAS28 < 3.2. MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Humira (adalimumab) Product Name: Humira® (adalimumab) Product Code: 2593 Pharmaceutical Form: Injection* INN or Proposed INN: Adalimumab | Aarhus University Hospital, Denmark | Not Recruiting | Female: yes Male: yes | 180 | Phase 4 | Denmark | |||
1555 | NCT00476996 | May 15, 2007 | 26 August 2019 | A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-a Therapy (SCRIPT) | A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-a Therapy | Rheumatoid Arthritis | Drug: Leflunomide;Drug: Methotrexate;Drug: Ocrelizumab;Drug: Placebo | Genentech, Inc. | Roche Pharma AG | Not recruiting | 18 Years | N/A | All | 836 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Japan;Mexico;Netherlands;New Zealand;Panama;Peru;Poland;Slovakia;Slovenia;Spain;Sweden;Switzerland;Taiwan |
No. | 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 |
1556 | EUCTR2007-001190-28-GB | 09/05/2007 | 4 December 2018 | Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT | Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Methotrexate Product Code: Methotrexate Pharmaceutical Form: Tablet INN or Proposed INN: METHOTREXATE CAS Number: 59052 Current Sponsor code: Methotrexate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Product Name: Sulfasalazine Product Code: Sulfasalazine Pharmaceutical Form: Tablet INN or Proposed INN: SULFASALAZINE CAS Number: 599791 Current Sponsor code: SULFASALAZINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Product Name: Hydroxychloroquine Product Code: Hydroxychloroquine Pharmaceutical Form: Tablet INN or Proposed INN: Hydroxychloroquine CAS Number: 118423 Current Sponsor code: Hydroxychloroquine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Product Name: Ciclosporin Product Code: Ciclosporin Pharmaceutical Form: Tablet INN or Proposed INN: Ciclosporin CAS Number: 59865133 Current Sponsor code: Ciclosporin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Product Name: Leflunomide Product Code: Leflunomide Pharmaceutical Form: Tablet INN or Proposed INN: Leflunomide CAS Number: 75706126 Current Sponsor code: Leflunomide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Product Name: Sodium aurothiomalate (intramuscular gold) Product Code: Sodium aurothiomalate (intramuscular gold) Pharmaceutical Form: Injection* INN or Proposed INN: Sodium aurothiomalate CAS Number: 12244574 Current Sponsor code: Sodium aurothiomalate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Product Name: methylprednisolone Product Code: methylprednisolone Pharmaceutical Form: Injection* INN or Proposed INN: Methylprednisolone CAS Number: 83432 Current Sponsor code: Methylprednisolone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Product Name: Prednisolone | King's College London | Not Recruiting | Female: yes Male: yes | 190 | Phase 4 | United Kingdom | |||
1557 | EUCTR2006-005036-24-SE | 04/05/2007 | 7 August 2012 | A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A | A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A | Rheumatoid arthritis MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: CP-690,550 Pharmaceutical Form: Tablet CAS Number: 540737-29-9 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1- Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: CP-690,550 Pharmaceutical Form: Tablet CAS Number: 540737-29-9 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1- Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Pfizer Ltd - Ramsgate Road, Sandwich CT139NJ, UK. | Not Recruiting | Female: yes Male: yes | 483 | Phase 2B | Hungary;Czech Republic;Bulgaria;Sweden | |||
1558 | NCT00420199 | May 2007 | 19 October 2017 | A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | A Phase IIIB Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess Short-term Changes in Synovitis and Structural Damage Outcomes in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate, Treated With Abatacept Versus Placebo on a Background Therapy With Methotrexate | Active Rheumatoid Arthritis | Drug: Abatacept;Drug: Placebo | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 50 | Phase 3 | Belgium;Germany;Netherlands;Spain;Sweden;United Kingdom;Austria | |
1559 | NCT00443430 | May 2007 | 19 October 2017 | Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis | Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA) | Juvenile Chronic Polyarthritis;Juvenile Idiopathic Arthritis;Juvenile Rheumatoid Arthritis | Drug: methotrexate;Drug: methotrexate - etanercept - prednisolone arm | Seattle Children's Hospital | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Amgen | Not recruiting | 2 Years | 17 Years | All | 85 | Phase 4 | United States |
1560 | NCT00455208 | May 2007 | 19 February 2015 | A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis | Study Evaluating Cura-100 in Rheumatoid Arthritis and Osteoarthritis | Rheumatoid Arthritis;Osteoarthritis | Drug: Cura-100 | Cura Biotech LLC | Not recruiting | 20 Years | 50 Years | Both | 20 | 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 |
1561 | NCT00504595 | May 2007 | 19 October 2017 | Safety and Efficacy of ACZ885 in Adult Patients With Established Rheumatoid Arthritis | A 12-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR20) and to Determine a Biomarker Profile in Adult Patients With Established Rheumatoid Arthritis Responding to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) as Compared to Healthy Subjects Exposed to ACZ885 | Rheumatoid Arthritis | Drug: ACZ885 (investigational);Drug: Placebo | Novartis | Not recruiting | 18 Years | 75 Years | All | 80 | Phase 2 | Russian Federation;Spain;Switzerland;Turkey | |
1562 | NCT00578565 | May 2007 | 19 October 2017 | Rituximab in Rheumatoid Arthritis Lung Disease | Rituximab for the Treatment of Rheumatoid Arthritis-Associated Interstitial Pneumonia: A Pilot Study | Rheumatoid Arthritis;Interstitial Pneumonia | Drug: Rituximab | Eric Matteson | Genentech, Inc.;National Center for Research Resources (NCRR) | Not recruiting | 18 Years | 80 Years | All | 10 | Phase 3 | United States |
1563 | NCT00760669 | May 2007 | 19 October 2017 | An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants | Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients | Spondylitis, Ankylosing;Arthritis, Rheumatoid;Psoriasis;Arthritis, Psoriatic | Drug: Infliximab; observational study;Drug: Methotrexate | Janssen Korea, Ltd., Korea | Not recruiting | N/A | N/A | All | 1061 | Phase 4 | Korea, Republic of | |
1564 | EUCTR2007-000491-16-ES | 30/04/2007 | 2 February 2015 | Estudio de extensión abierto de 76 semanas de duración para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide activa - not available | Estudio de extensión abierto de 76 semanas de duración para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide activa - not available | Artritis Reumatoide MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: ACZ885 Product Code: ACZ885 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Canakinumab (proposed) Current Sponsor code: ACZ885 Other descriptive name: ACZ885 Drug Substance Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Novartis Farmacéutica, S.A. | Not Recruiting | Female: yes Male: yes | Belgium;Spain;Austria;Germany | |||||
1565 | EUCTR2005-002660-29-HU | 20/04/2007 | 19 March 2012 | A Phase 1b/2 Multiple-Dose Safety and Pharmacokinetic/Pharmacodynamic Study of LY2189102 in Patients with Rheumatoid Arthritis | A Phase 1b/2 Multiple-Dose Safety and Pharmacokinetic/Pharmacodynamic Study of LY2189102 in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis | Product Name: Anti IL-1ß antibody Product Code: LY2189102 Pharmaceutical Form: Powder for solution for infusion Current Sponsor code: LY2189102 Other descriptive name: Anti IL-1ß antibody, subclass IgG4 Concentration unit: mg milligram(s) Concentration type: not less then Concentration number: 20- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Eli Lilly and Company Limited | Not Recruiting | Female: yes Male: yes | 135 | Phase 1b/2 | Hungary;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 |
1566 | EUCTR2006-005466-39-GB | 12/04/2007 | 19 March 2012 | A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy | A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy | Rheumatoid arthritis (RA) MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: BG9924 Pharmaceutical Form: Powder for solution for injection Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Biogen Idec Ltd | Authorised | Female: yes Male: yes | 380 | Phase 2b | Hungary;United Kingdom | |||
1567 | EUCTR2006-005467-26-GB | 12/04/2007 | 19 March 2012 | A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapy | A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapy | Rheumatoid Arthritis MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: BG9924 Pharmaceutical Form: Powder for solution for injection Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Biogen Idec Ltd | Authorised | Female: yes Male: yes | 120 | Phase 2b | United Kingdom | |||
1568 | EUCTR2006-004669-32-ES | 09/04/2007 | 2 February 2015 | Estudio multicéntrico, de fase II, aleatorizado, doble ciego, controlado con placebo, de 12 semanas de duración, para evaluar la respuesta al tratamiento (ACR20) y para determinar un perfil de biomarcadores en pacientes adultos con artritis reumatoide establecida respondedores a ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) comparado con sujetos sanos expuestos a ACZ885 - not available | Estudio multicéntrico, de fase II, aleatorizado, doble ciego, controlado con placebo, de 12 semanas de duración, para evaluar la respuesta al tratamiento (ACR20) y para determinar un perfil de biomarcadores en pacientes adultos con artritis reumatoide establecida respondedores a ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) comparado con sujetos sanos expuestos a ACZ885 - not available | Artritis reumatoide establecida MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: ACZ885 Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Canakinumab (proposed) Current Sponsor code: ACZ885 Other descriptive name: ACZ885 Drug Substance Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Powder and solvent for solution for infusion Route of administration of the placebo: Intravenous use | Novartis Farmacéutica S.A | Not Recruiting | Female: yes Male: yes | 80 | Spain | ||||
1569 | EUCTR2006-004139-31-BE | 03/04/2007 | 15 July 2013 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Humira Pharmaceutical Form: Injection* INN or Proposed INN: Adalimumab Current Sponsor code: ABT-Humira Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Subcutaneous use Trade Name: Metex® Pharmaceutical Form: Tablet Current Sponsor code: Methotrexate disodium Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2,5- | Abbott GmbH & Co. KG | Not Recruiting | Female: yes Male: yes | 1000 | France;Hungary;Czech Republic;Greece;Spain;Belgium;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||||
1570 | NCT00409838 | April 2007 | 19 October 2017 | A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate | A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept Administered Intravenously in Korean Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate | Rheumatoid Arthritis | Drug: Abatacept;Drug: Methotrexate;Drug: Placebo | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 113 | 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 |
1571 | NCT00414661 | April 2007 | 19 October 2017 | Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550 | A Prospective Observational Study To Evaluate Long-Term Safety And Functional Status Of Subjects With Rheumatoid Arthritis Previously Enrolled In Studies Of CP-690,550 | Arthritis, Rheumatoid | Drug: CP-690,550 | Pfizer | Not recruiting | 18 Years | N/A | All | 162 | N/A | United States;Argentina;Brazil;Bulgaria;Canada;Chile;Czech Republic;Dominican Republic;Finland;Greece;Hungary;India;Italy;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Slovakia;Spain;Ukraine;Australia;Austria;Belgium;Costa Rica;Romania;Sweden | |
1572 | NCT00446784 | April 2007 | 19 February 2015 | Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis | A Phase 1, Double Blind Study Of The Safety And Pharmacokinetics Of Multiple Doses Of CE 224,535 In Subjects With Rheumatoid Arthritis Receiving Methotrexate | Arthritis, Rheumatoid | Drug: CE-224,535;Drug: Methotrexate | Pfizer | Not recruiting | 18 Years | N/A | Both | 20 | Phase 1 | United States | |
1573 | NCT00484237 | April 2007 | 19 February 2015 | A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis | A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Safety and Efficacy of Etanercept 10 mg Twice Weekly and 25 mg Once Weekly in Japanese Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 20 Years | 75 Years | Both | 80 | Phase 3 | Japan | |
1574 | NCT00989235 | April 2007 | 19 October 2017 | Substudy - Low Dose of Abatacept in Subjects With Rheumatoid Arthritis | A Phase 3B, Multi-Center, Randomized, Double-blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate-naïve Early Erosive Rheumatoid Arthritis Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate - Low Dose Sub-Study | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 108 | Phase 3 | ||
1575 | EUCTR2006-006373-25-ES | 23/03/2007 | 25 September 2012 | ESTUDIO OBSERVACIONAL PROSPECTIVO PARA EVALUAR LA SEGURIDAD A LARGO PLAZO Y EL ESTADO FUNCIONAL DE SUJETOS CON ARTRITIS REUMATOIDE INCLUIDOS PREVIAMENTE EN ESTUDIOS DE CP-690,550 A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A | CP-690,550 se está desarrollando como fármaco antirreumático modificador de la enfermedad (FARME) para el tratamiento de la artritis reumatoide (AR). CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: CP-690,550 Pharmaceutical Form: Tablet | Pfizer, S.A. | Not Recruiting | Female: yes Male: yes | 300 | Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;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 |
1576 | EUCTR2006-001553-10-BE | 20/03/2007 | 11 November 2013 | A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204 | A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204 | Early Rheumatoid Arthritis in adults MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: ACZ885 Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: ACZ885 Drug Substance Current Sponsor code: ACZ885 Other descriptive name: ACZ885 Drug Substance Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Powder and solvent for solution for infusion Route of administration of the placebo: Intravenous use | Novartis Pharma Services AG | Authorised | Female: yes Male: yes | 92 | Phase 2 | Belgium;Netherlands;Germany;Italy | |||
1577 | NCT04144101 | March 1, 2007 | 4 November 2019 | Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis | Comparison of Lower Dosage of Etoricoxib Versus Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis: A Single-center, Parallel-group, Randomized Controlled Pilot Study | Rheumatoid Arthritis | Drug: Etoricoxib;Drug: Aceclofenac | Chung Shan Medical University | Not recruiting | 20 Years | 80 Years | All | 40 | Phase 4 | ||
1578 | NCT00462072 | March 2007 | 19 October 2017 | Centocor Microarray Study of Patients | Microarray Analysis of Peripheral Blood and Tissues of Patients With Immune Mediated Inflammatory Diseases | Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Crohn's Disease | Drug: Infliximab | University of Rochester | Centocor, Inc. | Not recruiting | 12 Years | N/A | All | 31 | Phase 4 | United States |
1579 | NCT00487825 | March 2007 | 19 October 2017 | Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis | A 26-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR50) and to Determine a Biomarker Profile in Responders to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) Plus MTX as Compared to MTX Alone in Early Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: Canakinumab (investigational);Drug: Placebo;Drug: Methotrexate (MTX) | Novartis | Not recruiting | 18 Years | 75 Years | All | 78 | Phase 2 | United States;Belgium;Germany;Italy;Netherlands;Spain | |
1580 | NCT00913432 | March 2007 | 18 December 2018 | Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis | A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF Alpha | Rheumatoid Arthritis | Drug: masitinib | AB Science | Not recruiting | 18 Years | N/A | All | 20 | Phase 2 | ||
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 |
1581 | EUCTR2006-006380-22-DE | 22/02/2007 | 19 March 2012 | Biological dosimetry in radiation synovectomy of small finger joints with Erbium [169Er] citrate - ER-MM1 biological dosimetry | Biological dosimetry in radiation synovectomy of small finger joints with Erbium [169Er] citrate - ER-MM1 biological dosimetry | Patients with rheumatoid arthritis or seronegative spondylarthropathy with at least one inflamed finger joint (MCP, PIP, DIP) referred for RSO with with Erbium [169Er]citrate MedDRA version: 8.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions | Trade Name: ERMM-1 Pharmaceutical Form: Solution for injection INN or Proposed INN: erbium citrate Concentration unit: MBq/ml megabecquerel(s)/millilitre Concentration type: equal Concentration number: 111- | CIS bio international | Authorised | Female: yes Male: yes | Germany | |||||
1582 | NCT00413699 | February 5, 2007 | 16 December 2017 | Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis | A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: CP-690,550 | Pfizer | Not recruiting | 18 Years | N/A | All | 4553 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Costa Rica;Croatia;Czechia;Denmark;Dominican Republic;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Korea, Republic of;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Czech Republic;United States Minor Outlying Islands | |
1583 | NCT00418717 | February 2007 | 19 October 2017 | Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RA | An Open-label, Multicenter, Dose-regimen Study Evaluating the Efficacy and Safety of Etanercept 50 mg Once-weekly Dose in Japanese Subjects With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 20 Years | 75 Years | All | 42 | Phase 3 | Japan | |
1584 | NCT00425932 | February 2007 | 19 February 2015 | Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid Arthritis | Impact of Rituximab on Magnetic Resonance Imaging Evidence of Synovitis and Bone Lesions in Patients With Moderate or Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Rituximab | Gaylis, Norman B., M.D. | Oklahoma Medical Research Foundation;Genentech, Inc. | Not recruiting | 18 Years | 80 Years | Both | 60 | Phase 2 | United States |
1585 | NCT00427934 | February 2007 | 19 October 2017 | Maraviroc in Rheumatoid Arthritis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Maraviroc in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate | Arthritis, Rheumatoid | Drug: Maraviroc;Drug: Maraviroc Placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 128 | Phase 2 | United States;Australia;Germany;India;Italy;Mexico;Portugal;Spain;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 |
1586 | NCT00458146 | February 2007 | 19 February 2015 | A Phase 2 Study to Evaluate the Efficacy and Safety of 60mg of MM-093 in Patients With Active Rheumatoid Arthritis | A Phase 2, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 60mg of MM-093 Versus Placebo in Patients With Active Rheumatoid Arthritis on Stable Doses of Methotrexate | Rheumatoid Arthritis | Drug: MM-093 | Merrimack Pharmaceuticals | Not recruiting | 18 Years | 80 Years | Both | 100 | Phase 2 | United States | |
1587 | NCT00461448 | February 2007 | 19 February 2015 | A Pilot Study of Potassium Supplementation for Adult Patients With Rheumatoid Arthritis | Pilot Study of Potassium Supplementation in the Treatment of Rheumatoid Arthritis: a 4-Week, Randomized, Double-Blind, Placebo-Controlled Trial | Rheumatoid Arthritis | Dietary Supplement: Potassium supplement | Shahid Beheshti Medical University | Not recruiting | 18 Years | 60 Years | Both | 36 | Phase 1 | Iran, Islamic Republic of | |
1588 | EUCTR2006-003983-73-CZ | 17/01/2007 | 1 May 2012 | A Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid arthritis MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: RWJ-445380 Capsules 50 mg Product Code: RWJ-445380-002 Pharmaceutical Form: Capsule* CAS Number: 400797-45-7 Current Sponsor code: RWJ-445380-002 Other descriptive name: JNJ-16240159-AAC Concentration unit: % (W/W) percent weight/weight Concentration type: range Concentration number: 45 mg-55 mg Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: RWJ-445380 capsule 100 mg Product Code: RWJ-445380-002 Pharmaceutical Form: Capsule* CAS Number: 400797-45-7 Current Sponsor code: RWJ-445380-002 Other descriptive name: JNJ-16240159-AAC Concentration unit: % (W/W) percent weight/weight Concentration type: range Concentration number: 90 mg-110 mg Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: RWJ-445380 capsules 150 mg Product Code: RWJ-445380-002 Pharmaceutical Form: Capsule* CAS Number: 400797-45-7 Current Sponsor code: RWJ-445380-002 Other descriptive name: JNJ-16240159-AAC Concentration unit: % (W/W) percent weight/weight Concentration type: range Concentration number: 135 mg-165 mg Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Janssen-Cilag International N.V. | Not Recruiting | Female: yes Male: yes | 240 | Phase 2a | Germany;Czech Republic | |||
1589 | EUCTR2006-006275-21-GB | 10/01/2007 | 19 March 2012 | A Randomised, Pragmatic, Open-label study of Adalimumab versus Etanercept for Rheumatoid Arthritis. - Adalimumab versus Etanercept for RA | A Randomised, Pragmatic, Open-label study of Adalimumab versus Etanercept for Rheumatoid Arthritis. - Adalimumab versus Etanercept for RA | Rheumatoid Arthritis MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Humira Pharmaceutical Form: Injection Trade Name: Enbrel Pharmaceutical Form: Injection | University Hospital Birmingham NHS Foundation Trust | Authorised | Female: yes Male: yes | United Kingdom | |||||
1590 | NCT00413660 | January 2007 | 19 October 2017 | Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis | A Phase 2B, Randomized, Double Blind, Placebo-Controlled, Multicenter Study To Compare 6 Dose Regimens Of CP-690,550 Vs. Placebo, Each Combined With Methotrexate, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate Alone | Arthritis, Rheumatoid | Drug: CP-690,550;Other: placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 509 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Chile;Czech Republic;Hungary;Mexico;Poland;Slovakia;Spain;Sweden;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 |
1591 | NCT00424502 | January 2007 | 19 October 2017 | A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker. | An Open-label Study to Evaluate the Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition. | Rheumatoid Arthritis | Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 20 | Phase 4 | Hungary | |
1592 | NCT00427804 | January 2007 | 19 October 2017 | Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption | Tumor Necrosis Factor-a Induces Vitamin D Resistance in Small Intestinal Calcium Absorption | Rheumatoid Arthritis;Crohn's Disease | Drug: calcitriol | Atlanta VA Medical Center | Emory University | Not recruiting | 18 Years | 50 Years | Male | 9 | N/A | United States |
1593 | NCT00443651 | January 2007 | 16 December 2017 | A Study of the Safety of Rituximab in Combination With Other Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis | An Open-Label, Prospective Study of the Safety of Rituximab in Combination With Other Disease-Modifying Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Rituximab;Drug: Anti-inflammatory drugs | Genentech, Inc. | Biogen | Not recruiting | 18 Years | 80 Years | All | 578 | Phase 3 | United States |
1594 | NCT00716248 | January 2007 | 19 February 2015 | Bucillamine Study of Holding Remission After Infliximab Dose-off | The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate | Rheumatoid Arthritis | Drug: bucillamine;Drug: methotrexate | Saitama Medical University | Keio University | Not recruiting | 20 Years | N/A | Both | 40 | Phase 4 | Japan |
1595 | NCT02886689 | January 2007 | 12 September 2016 | C.O.R.P.U.S.: Observational Cohort of Adult and Child Inflammatory Arthritis in France | C.O.R.P.U.S. : Observational Cohort of Active Rheumatoid Arthritis, Spondylarthropathy and Idiopathic Juvenile Arthritis in France | Arthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Arthitis, Juvenile Idiopathic | Drug: TNF-alpha antagonist and other biotherapy | Central Hospital, Nancy, France | Not recruiting | 3 Years | 75 Years | Both | 5400 | 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 |
1596 | EUCTR2007-003591-19-DE | 1 May 2012 | AN OPEN, COMPARATIVE, WITHIN PATIENT CONTROLLED MULTICENTRE STUDY OF REPEATED SUBCUTANEOUS INJECTIONS OF METHOTREXATE 50MG/ML AND 10MG/ML TO COMPARE PATIENT SATISFACTION AND LOCAL TOLERABILITY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS - MTX 50 versus 10mg/ml | AN OPEN, COMPARATIVE, WITHIN PATIENT CONTROLLED MULTICENTRE STUDY OF REPEATED SUBCUTANEOUS INJECTIONS OF METHOTREXATE 50MG/ML AND 10MG/ML TO COMPARE PATIENT SATISFACTION AND LOCAL TOLERABILITY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS - MTX 50 versus 10mg/ml | Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: Methotrexate 50mg/ml solution for injection, pre-filled syringe Pharmaceutical Form: Solution for injection INN or Proposed INN: Methotrexate disodium CAS Number: 7413345 Other descriptive name: Methotrexate disodium Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Trade Name: Metex 10 mg/ml Injektionslösung, Fertigspritze Pharmaceutical Form: Solution for injection INN or Proposed INN: methotrexate disodium CAS Number: 7413345 Other descriptive name: Methotrexate disodium Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | medac Gesellschaft für klinische Spezialpräparate mbH | Not Recruiting | Female: yes Male: yes | Germany | ||||||
1597 | EUCTR2006-005386-19-BE | 19/12/2006 | 7 October 2014 | Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini | Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini | Rheumatoid arthritis refractory to TNF blockers patients MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: MabThera Pharmaceutical Form: Solution for infusion | Cliniques Universitaires Saint-Luc | Authorised | Female: yes Male: yes | Belgium | |||||
1598 | EUCTR2005-005664-88-GB | 08/12/2006 | 19 March 2012 | Prospective Study of Mycobacterium Tuberculosis Specific Cellular immune Responses in Iatrogenically Immunosuppressed Patients: those undergoing TNF-alpha blockade or Awaiting Renal Trasnplants: A Potential New Method For Accurate Diagnosis of Latent Tuberculosis Infection in Clinical Practice - Diagnosis of Latent TB Infection in Anti-TNF alpha or Dialysis | Prospective Study of Mycobacterium Tuberculosis Specific Cellular immune Responses in Iatrogenically Immunosuppressed Patients: those undergoing TNF-alpha blockade or Awaiting Renal Trasnplants: A Potential New Method For Accurate Diagnosis of Latent Tuberculosis Infection in Clinical Practice - Diagnosis of Latent TB Infection in Anti-TNF alpha or Dialysis | Renal failure and iatrogenic immunosuppression associated with solid organ transplantation or TNF alpha blockade in rheumatoid arthritis ICD 10 codes included: N18 Z94.0 M05 M06 M07 M45 | Trade Name: Tuberculin PPD RT 23 SSI for mantoux testing Product Name: Tuberculin PPD RT 23 SSI for mantoux testing Product Code: 1 Pharmaceutical Form: Injection* | University of Oxford | Authorised | Female: yes Male: yes | 520 | United Kingdom | ||||
1599 | EUCTR2006-003577-27-EE | 01/12/2006 | 19 March 2012 | A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS. - na | A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS. - na | Treatment of rheumatoid arthritis (RA) MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: PH-797804 Pharmaceutical Form: Capsule* CAS Number: 586414-48-4 Current Sponsor code: PH-797804 Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Code: PH-797804 Pharmaceutical Form: Capsule* CAS Number: 586414-48-4 Current Sponsor code: PH-797804 Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Code: PH-797804 Pharmaceutical Form: Capsule* CAS Number: 586414-48-4 Current Sponsor code: PH-797804 Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Pfizer Luxembourg SARL Branch Office Estonia | Not Recruiting | Female: yes Male: yes | 290 | Phase 2A | Czech Republic;Estonia;Spain | |||
1600 | NCT00383188 | December 2006 | 19 February 2015 | An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis | A 12-Week, Phase 2A, Randomized, Double-Blind, Placebo-Controlled Study To Investigate The Safety, Pharmacokinetics, And Efficacy Of PH-797804, Administered Orally Once Daily In Subjects With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: placebo;Drug: PH-797804 | Pfizer | Not recruiting | 18 Years | N/A | Both | 305 | Phase 2 | Australia;Brazil;Chile;Czech Republic;Estonia;India;Korea, Republic of;Peru;Poland;Russian Federation;South Africa;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 |
1601 | NCT00392951 | December 2006 | 19 November 2018 | Sirolimus for Autoimmune Disease of Blood Cells | Sirolimus for Patients With Chronic and/or Refractory Autoimmune Cytopenias: A Pilot Series | Autoimmune Pancytopenia;Autoimmune Lymphoproliferative Syndrome (ALPS);Evans Syndrome;Idiopathic Thrombocytopenic Purpura;Anemia, Hemolytic, Autoimmune;Autoimmune Neutropenia;Lupus Erythematosus, Systemic;Inflammatory Bowel Disease;Rheumatoid Arthritis | Drug: sirolimus | Children's Hospital of Philadelphia | Not recruiting | 1 Year | 30 Years | All | 30 | Phase 1/Phase 2 | United States | |
1602 | NCT00406419 | December 2006 | 16 December 2017 | A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE) | A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment | Rheumatoid Arthritis | Drug: methotrexate;Drug: ocrelizumab;Drug: placebo | Genentech, Inc. | Roche Pharma AG | Not recruiting | 18 Years | N/A | All | 1015 | Phase 3 | United States |
1603 | NCT00413452 | December 2006 | 19 February 2015 | Etanercept SFP in RA Patients | Open-Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: Etanercept | Amgen | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Both | 224 | Phase 3 | United States;Canada |
1604 | NCT00425321 | December 2006 | 19 February 2015 | Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: RWJ-445380 100 mg;Drug: RWJ-445380 200 mg;Drug: RWJ-445380 300 mg;Drug: Placebo | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Not recruiting | 18 Years | N/A | Both | 259 | Phase 2 | United States;Argentina;Brazil;Czech Republic;Germany;Mexico;Poland | |
1605 | NCT00430495 | December 2006 | 19 October 2017 | A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I) | A Randomized, Double-blind, Placebo-controlled, Multicentre, Phase II Dose-finding Study of Atacicept Given Subcutaneously in Subjects With Rheumatoid Arthritis and Inadequate Response to TNFa Antagonist Therapy | Rheumatoid Arthritis | Drug: Atacicept;Drug: Placebo matched to atacicept | EMD Serono | Merck KGaA | Not recruiting | 18 Years | N/A | All | 256 | Phase 2 | United States;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 |
1606 | NCT00440492 | December 2006 | 19 February 2015 | Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis | An Open-Label Study To Evaluate The Potential Pharmacokinetic Interaction Between PLA-695 And Methotrexate When Coadministered Orally To Adult Subjects With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: PLA-695 | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | 75 Years | Both | Phase 1 | United States;Canada | ||
1607 | NCT00484289 | December 2006 | 19 October 2017 | A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis | A Phase III, Multi-center, Open-label, Uncontrolled, Long-term Study to Evaluate the Safety of Abatacept (BMS-188667) in Japanese Subjects With Rheumatoid Arthritis Having Completed Clinical Studies IM101-071, IM101-034, and Also Special DMARD Failures | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | Not recruiting | 20 Years | N/A | All | 217 | Phase 3 | Japan | |
1608 | EUCTR2006-003142-42-DE | 30/11/2006 | 19 March 2012 | A Randomized, Double Blind, Placebo-controlled, Proof of Concept Study to evaluate Efficacy, Safety and Pharmacokinetics of two Different Doses of SC12267 (20mg, 35 mg) in Patients with Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-controlled, Proof of Concept Study to evaluate Efficacy, Safety and Pharmacokinetics of two Different Doses of SC12267 (20mg, 35 mg) in Patients with Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 8.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Product Code: SC12267 Pharmaceutical Form: Film-coated tablet Concentration unit: mg milligram(s) Concentration type: equal Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | 4SC AG | Not Recruiting | Female: yes Male: yes | 120 | Germany | ||||
1609 | EUCTR2006-002216-10-CZ | 27/11/2006 | 19 March 2012 | A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER | A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER | Rheumatoid Arthritis MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: PG-760564 Product Code: PG-760564 Pharmaceutical Form: Capsule* Current Sponsor code: PG-760564 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Procter & Gamble Pharmaceuticals | Not Recruiting | Female: yes Male: yes | 270 | Hungary;United Kingdom;Czech Republic;Netherlands | ||||
1610 | EUCTR2005-003632-22-ES | 22/11/2006 | 29 May 2012 | A study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with rheumatoid arthritis. | An open-label, exploratory study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with active rheumatoid arthritis | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab CAS Number: 174722-31 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | F. Hoffmann-La Roche Ltd. | Authorised | Female: yes Male: yes | 3 | 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 |
1611 | NCT00072982 | November 2006 | 19 February 2015 | Treatment of Rheumatoid Arthritis With Marine and Botanical Oils | Treatment of Rheumatoid Arthritis With Marine and Botanical Oils | Rheumatoid Arthritis | Drug: fish oil;Drug: borage seed oil;Drug: combination fish oil and borage seed oil | National Center for Complementary and Integrative Health (NCCIH) | Not recruiting | 18 Years | 85 Years | Both | 156 | Phase 3 | United States | |
1612 | NCT00395577 | November 2006 | 19 February 2015 | A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702 | A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 When Administered Concomitantly With Methotrexate | Rheumatoid Arthritis | Drug: VX-702 | Vertex Pharmaceuticals Incorporated | Not recruiting | 18 Years | 75 Years | Both | 120 | Phase 2 | Bulgaria;Croatia;Former Serbia and Montenegro;Poland;Russian Federation;Slovenia | |
1613 | NCT00396812 | November 2006 | 19 October 2017 | Rituximab for the Treatment of Early Rheumatoid Arthritis (RA) | An Open Label, Single Arm, Single Center, Phase I/II Trial of Rituximab (a Monoclonal Antibody to CD20) for the Treatment of Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Rituximab | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Not recruiting | 18 Years | N/A | All | 4 | Phase 1/Phase 2 | United States |
1614 | NCT00424346 | November 2006 | 19 October 2017 | Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis | A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) With Three Different Dose Regimens in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate Including 76-week and 96-week Extensions | Rheumatoid Arthritis | Drug: Canakinumab;Drug: Placebo | Novartis | Not recruiting | 18 Years | N/A | All | 274 | Phase 2 | United States;Austria;Belgium;Canada;Germany;Spain;Finland | |
1615 | NCT00589485 | November 2006 | 16 December 2017 | Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement | Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement | Osteoarthritis;Rheumatoid Arthritis;Traumatic Arthritis;Knee Arthritis | Device: Simplex® Bone Cement;Device: Cobalt™ Bone Cement | Zimmer Biomet | New Lexington Clinic | Not recruiting | 18 Years | N/A | All | 0 | 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 |
1616 | NCT00761514 | November 2006 | 19 October 2017 | Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira | Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira as Their First Anti-TNF Monoclonal Antibody (VIVIR) | Rheumatoid Arthritis | Drug: Humira (adalimumab) | Abbott | Not recruiting | 18 Years | N/A | All | 14 | Phase 4 | Puerto Rico | |
1617 | NCT02079532 | November 2006 | 19 October 2017 | A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor | An Open-label Study to Evaluate the Safety of MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent | Rheumatoid Arthritis | Drug: rituximab [MabThera] | Hoffmann-La Roche | Not recruiting | 18 Years | 75 Years | All | 302 | Phase 3 | Germany | |
1618 | EUCTR2006-004715-22-SI | 26/10/2006 | 19 March 2012 | A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 when Administered Concomitantly with Methotrexate | A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 when Administered Concomitantly with Methotrexate | Rheumatoid Arthritis | Product Code: VX-702 Pharmaceutical Form: Tablet Current Sponsor code: VX-702 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Slovenia | |||
1619 | EUCTR2006-003843-22-IT | 24/10/2006 | 7 January 2013 | prospeCtive study on intensive early rheumatoid arthritis treatment with adalimUmab: induction of REmission and maintenance - 'CURE' A Phase IV multicenter, randomized, double-blind study | prospeCtive study on intensive early rheumatoid arthritis treatment with adalimUmab: induction of REmission and maintenance - 'CURE' A Phase IV multicenter, randomized, double-blind study | rheumatoid arthritis MedDRA version: 14.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T Pharmaceutical Form: Solution for injection INN or Proposed INN: Adalimumab Concentration unit: mg milligram(s) Concentration number: 40- Trade Name: METHOTREXATE*100CPR 2,5MG Pharmaceutical Form: Tablet INN or Proposed INN: Methotrexate CAS Number: 59-05-2 Concentration unit: mg milligram(s) Concentration number: 2.5- Trade Name: DELTACORTENE FORTE*10CPR 25MG Pharmaceutical Form: Tablet INN or Proposed INN: Prednisone CAS Number: 53-03-2 Concentration unit: mg milligram(s) Concentration number: 25- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | OSPEDALE POLICLINICO S. MATTEO | Authorised | Female: yes Male: yes | Phase 4 | Italy | ||||
1620 | EUCTR2006-004673-98-HU | 16/10/2006 | 19 March 2012 | Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker | Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker | To investigate the efficacy of treatment with Rituximab (MabThera®) in patients with active RA whose current treatment with one or more TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalimumab - Humira®) alone or in combination with MTX is insufficient measured by DAS28 activity index. | Trade Name: MabThera 500 mg concentrate for solution for infusion Pharmaceutical Form: Concentrate for solution for infusion | Roche (Hungary) Ltd. | Not Recruiting | Female: yes Male: yes | 20 | Hungary | ||||
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 |
1621 | NCT00346216 | October 4, 2006 | 16 December 2017 | Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen | A Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen | Arthritis, Rheumatoid | Drug: celecoxib;Drug: Ibuprofen;Drug: Naproxen | Pfizer | The Cleveland Clinic | Not recruiting | 18 Years | N/A | All | 24081 | Phase 4 | United States;Australia;Brazil;Canada;Colombia;Costa Rica;Hong Kong;Mexico;Panama;Peru;Philippines;Taiwan;Ukraine |
1622 | EUCTR2006-000363-28-GB | 03/10/2006 | 19 March 2012 | DIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA Study | DIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA Study | Rheumatoid arthritis and Psoriatic arthritis | Trade Name: Remicade Product Name: Infliximab Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Infliximab Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 3- Trade Name: Enbrel Product Name: Etanercept Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Etanercept Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- | Greater Glasgow Health Board | Glasgow University | Authorised | Female: yes Male: yes | 40 | United Kingdom | |||
1623 | JPRN-UMIN000000512 | 2006/10/01 | 2 April 2019 | Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate | Rheumatoid Arthritis | If the score of DAS28 is under 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, doses of methotrexate will reduced to 2mg/w. When the score of DAS28 increses, tacrolimus will be administered instead of methotrexate. Period of observation is 32 weeks. If the score of DAS28 is over 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, tacrolimus will be administered. Period of observation is 32 weeks. | Rheumatosurgery, Osaka City University Medical School | Not Recruiting | Not applicable | Not applicable | Male and Female | 30 | Not applicable | Japan | ||
1624 | NCT00393146 | October 2006 | 25 May 2015 | A Study To Investigate The Effect Of 28 Days Of Dosing With GW856553 On Patients With Rheumatoid Arthritis | A Randomized, Double Blind, Placebo Controlled Study to Investigate the Safety and Tolerability and Clinical Activity of 28 Days of Oral Repeat Dosing With GW856553 at 7.5mg BID in Subjects With Active Rheumatoid Arthritis on Stable Anti-rheumatic Therapy. | Arthritis, Rheumatoid | Drug: GW856553 | GlaxoSmithKline | Not recruiting | 18 Years | N/A | Both | 57 | Phase 2 | Romania;Russian Federation;Spain | |
1625 | NCT00399282 | October 2006 | 19 February 2015 | Omega-3 and Vitamin E Supplementation in Patients With Rheumatoid Arthritis | Comparison of the Effects of Simultaneous Administration of Vitamin E and Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Omega-3 and Vitamin E supplementation | Shahid Beheshti Medical University | Not recruiting | 16 Years | 75 Years | Both | 75 | Phase 1 | Iran, Islamic 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 |
1626 | NCT00749645 | October 2006 | 4 July 2016 | Efficacy Study of FANG(30) for Active Rheumatoid Arthritis in Adult Patients | Clinical Phase II Pilot Study of the Efficacy of FANG(30) to Treat Active Rheumatoid Arthritis in Adult Patients | Arthritis, Rheumatoid | Drug: FANG(30);Drug: Placebo | Juan C. Bertoglio, MD | Fondo Nacional de Desarrollo Científico y Tecnológico, Chile | Not recruiting | 18 Years | 70 Years | Both | 60 | Phase 2 | Chile |
1627 | EUCTR2006-005391-40-IT | 25/09/2006 | 27 January 2014 | Study on the effect of intra-articular infiltrations of aulogous platelet gel as inhibitor of erosion in rheumatoid arthritis patients - ND | Study on the effect of intra-articular infiltrations of aulogous platelet gel as inhibitor of erosion in rheumatoid arthritis patients - ND | Patients with Rheumatoid Arthritis Level: PT Classification code 10039073 | Product Name: Platelet Rich Plasma Pharmaceutical Form: Solution for injection Current Sponsor code: PRPIN AR2006 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical Form: Solution for injection INN or Proposed INN: Triamcinolone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | AZIENDA OSPEDALIERA SENESE | Not Recruiting | Female: yes Male: yes | Italy | |||||
1628 | EUCTR2006-001000-37-DE | 19/09/2006 | 19 March 2012 | Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRST | Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRST | Rheumatoid arthritis MedDRA version: 8.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung Product Name: MabThera Product Code: Ro 45-2294 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab CAS Number: 174722-31 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Roche Pharma AG | Not Recruiting | Female: yes Male: yes | 300 | Germany | ||||
1629 | EUCTR2006-001428-38-GB | 18/09/2006 | 19 March 2012 | Remission Induction in Very Early Rheumatoid Arthritis (RIVERA): a comparison of etanercept plus methotrexate plus steroid with standard therapy - RIVERA | Remission Induction in Very Early Rheumatoid Arthritis (RIVERA): a comparison of etanercept plus methotrexate plus steroid with standard therapy - RIVERA | Patients with early inflamatory arthritis (duration of symptoms of < 12 weeks) who are at very high risk of the development of rheumatoid arthritis (seropositivity for Rheumatoid factor and anti-CCP antibody) | Trade Name: Enbrel Pharmaceutical Form: Solution for injection Trade Name: Methorexate Pharmaceutical Form: Tablet Trade Name: Depo-Medrone Pharmaceutical Form: Solution for injection Trade Name: Salazopyrin En-Tabs Pharmaceutical Form: Tablet Trade Name: Plaquenil Pharmaceutical Form: Tablet | University Hospitals Birmingham NHS Foundation Trust | Authorised | Female: yes Male: yes | 20 | United Kingdom | ||||
1630 | NCT00361335 | September 2006 | 19 October 2017 | A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: Golimumab;Drug: Methotrexate;Drug: Placebo | Centocor, Inc. | Schering-Plough | Not recruiting | 18 Years | N/A | All | 643 | Phase 3 | United States;Argentina;Australia;Colombia;Germany;Hungary;Latvia;Lithuania;Malaysia;Malta;Mexico;New Zealand;Peru;Poland;Ukraine;Belgium;Russian Federation |
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 |
1631 | NCT00361634 | September 2006 | 19 October 2017 | Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) to Measure Response to Etanercept in Rheumatoid Arthritis | DCE-MRI of the Wrist to Measure Short-Term Responses in Rheumatoid Arthritis Subjects Treated With Etanercept | Rheumatoid Arthritis | Drug: Etanercept | Amgen | Not recruiting | 18 Years | N/A | All | 14 | Phase 1 | United States;United Kingdom | |
1632 | NCT00367211 | September 2006 | 19 February 2015 | Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. | A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. | Osteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis | Drug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole);Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole) | POZEN | Not recruiting | 18 Years | N/A | Both | 400 | Phase 3 | United States | |
1633 | NCT00369473 | September 2006 | 9 January 2017 | Long-Term Assessment of Safety and Physical Function With AMG 108 in RA | A Long-Term Assessment of Safety and Physical Function With AMG 108 Subcutaneous Monthly Treatment in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: AMG 108 | Amgen | Not recruiting | 18 Years | N/A | Both | 690 | Phase 2 | Australia;Belgium;Canada;Czech Republic;Estonia;France;Hungary;Ireland;Italy;Latvia;Mexico;Netherlands;Poland;Puerto Rico;Slovakia;Spain;United Kingdom;United States | |
1634 | NCT00488475 | September 2006 | 19 October 2017 | Observational Trial With Enbrel | A 1 Year Observational Study of the Use of Etanercept in Routine German Clinical Practice to Treat Rheumatoid Arthritis Patients: a Health Economic, Safety and Effectiveness Evaluation | Rheumatoid Arthritis | Drug: etanercept | Pfizer | Not recruiting | 18 Years | N/A | All | 4945 | N/A | Germany | |
1635 | NCT00588393 | September 2006 | 19 February 2015 | FolateScan in Autoimmune Disease | Study of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory Diseases | Rheumatoid Arthritis;Osteoarthritis;Multiple Sclerosis;Crohn's Disease;Systemic Lupus Erythematosus | Drug: FolateScan (Technetium Tc 99mEC20) | Mayo Clinic | Endocyte | Not recruiting | 18 Years | N/A | Both | 75 | 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 |
1636 | NCT01126541 | September 2006 | 19 October 2017 | SMART Study: A Study of Re-treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on Anti-TNF Alfa Therapy | A Comparative Study to Assess the Effect of Retreatment With 2 Doses of MabThera on Disease Activity Score in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to antiTNF-alfa Therapy.(SMART) | Rheumatoid Arthritis | Drug: rituximab | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 224 | Phase 3 | France | |
1637 | NCT01308255 | September 2006 | 11 November 2019 | Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA) | A Multi-centre Randomised Double Blind Placebo Controlled Study Comparing Two Regimens of Combination Therapy in Early DMARD Naive Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: Infliximab;Drug: Methylprednisolone;Drug: Methotrexate;Dietary Supplement: Folic acid | University of Leeds | Not recruiting | 18 Years | 80 Years | All | 112 | Phase 4 | United Kingdom | |
1638 | EUCTR2006-002645-37-HU | 25/08/2006 | 19 March 2012 | A Phase II randomized double-blind placebo-controlled Study of KC706 in patients with rheumatoid arthritis inadequately controlled with a stable dose of methotrexate | A Phase II randomized double-blind placebo-controlled Study of KC706 in patients with rheumatoid arthritis inadequately controlled with a stable dose of methotrexate | Active rheumatoid arthritis (RA), patients taking stable doses of methotrexate MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: KC706 Product Code: KR002524 Pharmaceutical Form: Capsule* CAS Number: 848144-15-0 Current Sponsor code: KC706 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Kémia, Inc. | Authorised | Female: yes Male: yes | 150 | Phase 2 | Hungary | |||
1639 | NCT02006706 | August 10, 2006 | 16 December 2017 | A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy | An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure | Rheumatoid Arthritis | Drug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisolone | Hoffmann-La Roche | Not recruiting | 18 Years | 80 Years | All | 15 | Phase 3 | Serbia | |
1640 | EUCTR2005-006165-14-GB | 03/08/2006 | 19 March 2012 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NA | A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NA | Rheumatoid Arthritis MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: MLN3897 Product Code: N/A Pharmaceutical Form: Capsule* INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: MLN3897 Other descriptive name: AVE9897 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10 - Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Methotrexate(MTX) administration is at the discretion of the rheumatologist and no tradename is fixed by the protocol. Product Name: Methotrexate Product Code: N/A Pharmaceutical Form: Tablet INN or Proposed INN: Methotrexate CAS Number: N/A Current Sponsor code: N/A Other descriptive name: N/A Concentration unit: mg milligram(s) Concentration type: range Concentration number: 7.5-25 | Millennium Pharmaceuticals Inc, | Authorised | Female: yes Male: yes | 186 | Phase 2a | Czech Republic;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 |
1641 | JPRN-C000000452 | 2006/08/01 | 2 April 2019 | Remission Induction of Very Early Rheumatoid Arthritis with Methotrexate and Etanercept | rheumatoid arthritis | methotrexate 8mg/week methotrexate 8mg/week and etanercept(25mg x1-2/week) for 3 months methotrexate 8mg/week and etanercept(25mgx1-2/week) for 6 months | Johoku Biological Summit | Not Recruiting | Not applicable | Not applicable | Male and Female | 50 | Phase 4 | Japan | ||
1642 | NCT00302952 | August 2006 | 16 December 2017 | Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis | A Double Blind, Placebo Controlled, Phase II, Randomized Study of Lovastatin Therapy in the Treatment of Mildly Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Lovastatin;Drug: Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Not recruiting | 18 Years | 70 Years | All | 64 | Phase 2 | United States |
1643 | NCT00326339 | August 2006 | 19 February 2015 | Treatment of Arthritis With Syk Kinase Inhibition (TASKI-1) | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Dose Ranging Study to Evaluate Up to Three Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate | Rheumatoid Arthritis | Drug: R788;Drug: Placebo | Rigel Pharmaceuticals | Not recruiting | 18 Years | 75 Years | Both | 189 | Phase 2 | United States;Mexico | |
1644 | NCT00369928 | August 2006 | 19 October 2017 | Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate | A Multicenter, Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG-760564 in Adult Patients With RA Receiving Methotrexate | Rheumatoid Arthritis | Drug: PG-760564;Drug: Placebo dose | Procter and Gamble | Not recruiting | 18 Years | 70 Years | All | 254 | Phase 2 | United States;Czech Republic;Hungary;Netherlands;Poland;United Kingdom | |
1645 | NCT00732875 | August 2006 | 16 December 2017 | A Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methorexate (Extension Part)(Study P05645)(COMPLETED) | A Placebo-controlled, Double-blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment (Open-label Extension Part) | Arthritis, Rheumatoid | Biological: Infliximab + methotrexate (MTX) | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 75 Years | All | 92 | Phase 3 | ||
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 |
1646 | EUCTR2006-004062-13-IT | 18/07/2006 | 19 March 2012 | Randomised, open label, no profit, clinical, multicenter study of phase II and IIIB to assess efficacy and tolerability of oxycodone/paracetamol compared to anti-inflammatory non-steroidal drugs FANS and corticosteroid, in patients suffering moderate to severe chronic pain due to rheumatoid arthritis. - Do.R.A. | Randomised, open label, no profit, clinical, multicenter study of phase II and IIIB to assess efficacy and tolerability of oxycodone/paracetamol compared to anti-inflammatory non-steroidal drugs FANS and corticosteroid, in patients suffering moderate to severe chronic pain due to rheumatoid arthritis. - Do.R.A. | RHEUMATOID ARTHRITIS MedDRA version: 6.1 Level: PT Classification code 10039073 | Trade Name: DEPALGOS*20+325MG 28CPR RP Pharmaceutical Form: Film-coated tablet INN or Proposed INN: OXICODONE DC.IT CAS Number: 76-42-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- INN or Proposed INN: PARACETAMOLO DC.IT FU CAS Number: 103-90-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | A.U.S.L. RIMINI | Not Recruiting | Female: yes Male: yes | 149 | Phase 2 | Italy | |||
1647 | NCT01272908 | July 18, 2006 | 16 December 2017 | A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET) | Rituximab Phase IIIb Open-label, Multi-centre Assessment of Safety and Effectiveness in Patients With RA Following an Inadequate Response to One Prior Anti-TNF Inhibitor (RESET) | Rheumatoid Arthritis | Drug: rituximab | Hoffmann-La Roche | Not recruiting | 18 Years | 80 Years | All | 120 | Phase 3 | Canada;Sweden | |
1648 | NCT00369187 | July 2006 | 19 February 2015 | Study of a Large Protein Molecule Administered With Escalating Doses of Recombinant Human Hyaluronidase | Rheumatoid Arthritis | Drug: large protein molecule | Halozyme Therapeutics | Not recruiting | 18 Years | N/A | Both | 15 | Phase 4 | United States | ||
1649 | NCT00445770 | July 2006 | 19 October 2017 | Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis | A Randomized, Double-Blind, Multicenter, Comparative Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Etanercept;Drug: Methotrexate | Pfizer | Not recruiting | 20 Years | 75 Years | All | 550 | Phase 3 | Japan | |
1650 | NCT00555542 | July 2006 | 19 February 2015 | An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid Arthritis | B Cell Depletion Therapy in Rheumatoid Arthritis: An Analysis of Peripheral Blood T Cell Subsets | Rheumatoid Arthritis | Drug: rituximab | Chinese University of Hong Kong | Not recruiting | 21 Years | 70 Years | Both | 10 | 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 |
1651 | NCT01685424 | June 30, 2006 | 16 December 2017 | Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1) | Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated Analysis | Osteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis;Gout;Arthritis | Drug: Etoricoxib | Merck Sharp & Dohme Corp. | Not recruiting | N/A | N/A | All | 79189 | N/A | United States | |
1652 | EUCTR2004-001234-17-GB | 15/06/2006 | 1 May 2012 | Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable | Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable | Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients MedDRA version: 8.0 Level: LLT Classification code 10039073 | Trade Name: Celebrex Product Name: Celebrex Product Code: not applicable Pharmaceutical Form: Capsule* INN or Proposed INN: Celecoxib CAS Number: N/A Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Voltrarol SR Product Name: Voltrarol SR Product Code: Not Applicable Pharmaceutical Form: Tablet INN or Proposed INN: Diclofenac sodium CAS Number: N/A Current Sponsor code: Not applicable Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Losec Product Name: Losec Product Code: not applicable Pharmaceutical Form: Capsule* INN or Proposed INN: Omeprazole CAS Number: N/A Current Sponsor code: Not applicable Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Pfizer Limited | Not Recruiting | Female: yes Male: yes | 4402 | Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden | ||||
1653 | EUCTR2006-001359-36-NL | 02/06/2006 | 19 March 2012 | Effects of low-dose aspirin taken at bedtime on pathophysiologic mechanisms underlying hypertension in subjects with grade 1 essential hypertension: the Aspirin In Reduction of Tension (ASPIRETENSION) study - ASPIRETENSION | Effects of low-dose aspirin taken at bedtime on pathophysiologic mechanisms underlying hypertension in subjects with grade 1 essential hypertension: the Aspirin In Reduction of Tension (ASPIRETENSION) study - ASPIRETENSION | Patients should have grade 1 essential hypertension (140/90-159/99 mmHg), but free of history of any cardiovascular events, diabetes mellitus type 1 or 2 or rheumatoid arthritis. | Trade Name: Ascal(r) / carbasalate calcium Pharmaceutical Form: Oral powder Pharmaceutical form of the placebo: Oral powder Route of administration of the placebo: Oral use | Leiden University Medical Center | Authorised | Female: yes Male: yes | 15 | Netherlands | ||||
1654 | NCT00280917 | June 2006 | 19 October 2017 | Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CF101 | Can-Fite BioPharma | Not recruiting | 18 Years | 75 Years | All | 254 | Phase 2 | United States;Bulgaria;Israel;Poland;Romania;Serbia;Ukraine;Former Serbia and Montenegro | |
1655 | NCT00345748 | June 2006 | 19 February 2015 | A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate | A Phase II, Multi-center, Randomized, Double-Blind, Placebo Controlled, Dose Response Study to Evaluate the Safety and Efficacy of Two Different Doses of Abatacept (BMS-188667) Administered Intravenously to Japanese Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate | Rheumatoid Arthritis | Drug: Abatacept;Drug: Placebo | Bristol-Myers Squibb | Not recruiting | 20 Years | N/A | Both | 194 | 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 |
1656 | NCT00424294 | June 2006 | 19 October 2017 | A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of CP-195543 And Celecoxib Dual Therapy In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis In Subjects Who Are Inadequately Controlled On Methotrexate | Arthritis, Rheumatoid | Drug: CP-195,543;Drug: celecoxib;Drug: Methotrexate | Pfizer | Not recruiting | 18 Years | N/A | All | 70 | Phase 2 | United States | |
1657 | NCT00439062 | June 2006 | 19 February 2015 | Treatment of Rheumatoid Arthritis With Roxithromycin | Treatment of Rheumatoid Arthritis With Roxithromycin | Rheumatoid Arthritis | Drug: Roxithromycin | Nazilli State Hospital | Not recruiting | 18 Years | 70 Years | Both | 100 | Phase 4 | Turkey | |
1658 | NCT00443950 | June 2006 | 19 February 2015 | Study Evaluating the Efficacy and Safety of Etanercept in Chinese Subjects With Rheumatoid Arthritis | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Etanercept in Chinese Subjects With Active Rheumatoid Arthritis Receiving Methotrexate | Arthritis, Rheumatoid | Drug: Etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Both | 150 | Phase 3 | China | |
1659 | EUCTR2006-000854-32-AT | 29/05/2006 | 19 March 2012 | Rituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-Blockers | Rituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-Blockers | Rheumatoid Arthritis | Trade Name: Rituximab - MabThera Product Name: Rituximab MabThera Product Code: no Pharmaceutical Form: Solution for infusion | Vienna Medical University | Not Recruiting | Female: yes Male: yes | 20 | Austria | ||||
1660 | EUCTR2005-001742-16-GB | 26/05/2006 | 21 August 2012 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | Active rheumatoid arthritis (RA) | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 Pharmaceutical Form: Solution for injection INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50 and-100 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 Pharmaceutical Form: Solution for injection INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50 and-100 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Centocor B.V. | Not Recruiting | Female: yes Male: yes | 420 | Germany;United Kingdom;Netherlands;Spain;Austria | ||||
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 |
1661 | EUCTR2004-003295-10-GB | 17/05/2006 | 3 September 2012 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis - NA | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis - NA | Active Rheumatoid Arthritis (methotrexate [MTX]-naïve) | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 Pharmaceutical Form: Solution for injection INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50 and-100 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA Pharmaceutical Form: Tablet INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 Pharmaceutical Form: Solution for injection INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50 and-100 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Centocor BV | Not Recruiting | Female: yes Male: yes | 600 | Hungary;United Kingdom;Spain;Italy | ||||
1662 | NCT00298272 | May 2006 | 19 October 2017 | Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid Arthritis | A Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Tolerability and Safety of Rituximab When Given in Combination With Methotrexate and Etanercept (Enbrel) or Methotrexate and Adalimumab (Humira) in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: IDEC-C2B8 (rituximab);Drug: Placebo;Drug: Methotrexate;Drug: Etanercept;Drug: Adalimumab;Drug: Methylprednisolone;Dietary Supplement: Folate | Biogen | Hoffmann-La Roche;Genentech, Inc. | Not recruiting | 18 Years | 65 Years | All | 54 | Phase 2 | United States |
1663 | NCT00380601 | May 2006 | 19 February 2015 | Phase?Open-label Study of MRA for Rheumatoid Arthritis(RA) | An Open-label, Phase? Study to Evaluate the Efficacy and Safety of MRA in Patients With RA | Rheumatoid Arthritis | Drug: MRA(Tocilizumab) | Chugai Pharmaceutical | Not recruiting | 20 Years | N/A | Both | 20 | Phase 3 | Japan | |
1664 | NCT00497614 | May 2006 | 19 February 2015 | Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA) | 18F-FDG Positron Emission Tomography to Study the Response to Adalimumab in Rheumatoid Arthritis. A Monocentric Pilot Study | Rheumatoid Arthritis | Drug: adalimumab | University Hospital, Tours | Not recruiting | 18 Years | 75 Years | Both | 8 | N/A | France | |
1665 | NCT01078571 | May 2006 | 19 October 2017 | Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis | Safety and Effectiveness of Adalimumab (HUMIRA®) in Patients Diagnosed With Rheumatoid Arthritis (DALI Study) | Rheumatoid Arthritis | Biological: adalimumab (HUMIRA®) | Abbott | Not recruiting | 18 Years | N/A | All | 705 | N/A | 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 |
1666 | EUCTR2004-001930-18-EE | 17/04/2006 | 21 August 2012 | A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RA | A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RA | RHEUMATOID ARTHRITIS | Trade Name: Persantin 100 mg and Product Code: CRx-102 Pharmaceutical Form: Tablet INN or Proposed INN: prednisolone & dipyridamole CAS Number: N/A Current Sponsor code: CRx-102 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1 and 100- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | CombinatoRx, Inc | Not Recruiting | Female: yes Male: yes | 60 | Estonia | ||||
1667 | EUCTR2005-003558-83-CZ | 07/04/2006 | 19 March 2012 | A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - AMG 108 | A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - AMG 108 | Rheumatoid arthritis (RA) | Product Name: AMG 108 Product Code: AMG 108 Pharmaceutical Form: Solution for injection Current Sponsor code: AMG 108 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Amgen Inc. | Not Recruiting | Female: yes Male: yes | 784 | United Kingdom;Czech Republic;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden | ||||
1668 | EUCTR2005-005013-37-GB | 06/04/2006 | 19 March 2012 | A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA | A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA | Early Rheumatoid Arthritis | Trade Name: Remicade Product Name: Remicade Product Code: Infliximab Pharmaceutical Form: Powder for solution for infusion Trade Name: Mextrex Product Name: Methotrexate Product Code: Mextrex Pharmaceutical Form: Tablet INN or Proposed INN: n/a CAS Number: n/a Current Sponsor code: n/a Other descriptive name: Methotrexate Concentration unit: mol/mg mole(s)/milligram Concentration type: equal Concentration number: 10- Trade Name: Ferrograd Folic Tablets Product Name: Folic Acid Product Code: Ferrograd Pharmaceutical Form: Tablet INN or Proposed INN: n/a CAS Number: n/a Current Sponsor code: n/a Other descriptive name: Folic Acid Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 350- Trade Name: Solu-Medrone 2 Gram Product Name: Methylprednisolone Product Code: Solu-Medrone 2 Gram Pharmaceutical Form: Powder for injection* INN or Proposed INN: n/a CAS Number: n/a Current Sponsor code: n/a Other descriptive name: Methylprednisolone Concentration unit: g gram(s) Concentration type: equal Concentration number: 2- Trade Name: Solu-Medrone 2 Gram Product Name: Methylprednisolone Product Code: Solu-Medrone 2 Gram Pharmaceutical Form: Powder for infusion* INN or Proposed INN: n/a CAS Number: n/a Current Sponsor code: n/a Other descriptive name: Methylprednisolone Concentration unit: g gram(s) Concentration type: equal Concentration number: 2- | University of Leeds | Authorised | Female: yes Male: yes | 112 | United Kingdom | ||||
1669 | NCT00303563 | April 2006 | 14 November 2016 | A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis | A Randomized, Double-blind Study to Compare the Effect of RO4402257 Monotherapy and Methotrexate Monotherapy on Disease Response in Patients With Active Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: P38 Inhibitor (4);Drug: Placebo | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 204 | Phase 2 | United States;Canada;Croatia;Czech Republic;France;Italy;Mexico;Romania;Serbia;South Africa;Spain;Taiwan;Former Serbia and Montenegro | |
1670 | NCT00319917 | April 2006 | 19 February 2015 | A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients | FK506 Phase 4 Study: A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients | Rheumatoid Arthritis | Drug: tacrolimus;Drug: placebo | Astellas Pharma Inc | Not recruiting | 20 Years | 64 Years | Both | 123 | 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 |
1671 | EUCTR2004-003296-36-DE | 29/03/2006 | 21 August 2012 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy - NA | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy - NA | Active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 Pharmaceutical Form: Solution for injection INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50 and-100 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA Pharmaceutical Form: Tablet INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 Pharmaceutical Form: Solution for injection INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50 and-100 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Centocor B.V. | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Germany | ||||
1672 | EUCTR2005-004582-41-GB | 24/03/2006 | 19 March 2012 | Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RA | Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RA | Active Rheumatoid Arthritis | Trade Name: Mabthera Product Name: Mabthera Product Code: Rituximab Pharmaceutical Form: Concentrate for solution for infusion Trade Name: Arava Product Name: Arava Product Code: Leflunomide Pharmaceutical Form: Film-coated tablet Trade Name: Solu-Medrone 2 Gram Product Name: Solu-Medrone 2mg Product Code: Methylprednisolone Pharmaceutical Form: Powder for injection* | University of Leeds | Authorised | Female: yes Male: yes | 15 | United Kingdom | ||||
1673 | EUCTR2005-003558-83-GB | 21/03/2006 | 19 March 2012 | A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis (RA) | Product Code: AMG 108 Pharmaceutical Form: Solution for injection Current Sponsor code: AMG 108 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Amgen Inc. | Authorised | Female: yes Male: yes | 784 | Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden | ||||
1674 | EUCTR2004-003771-37-HU | 03/03/2006 | 19 March 2012 | A double-blind, randomized, placebo controlled, dose escalation, multi-center phase I/II trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with active rheumatoid arthritis who have previously failed one or more disease modifying anti-rheumatic drugs. - HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II | A double-blind, randomized, placebo controlled, dose escalation, multi-center phase I/II trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with active rheumatoid arthritis who have previously failed one or more disease modifying anti-rheumatic drugs. - HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II | Active Rheumatoid Arthritis MedDRA version: 7.0 Level: LLT Classification code 10039073 | Product Name: HuMax-CD20 Product Code: HuMax-CD20 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: N/A CAS Number: 679818-59-8 Current Sponsor code: HuMax-CD20 Other descriptive name: Human monoclonal antibody directed against CD20 on B-cells Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Genmab A/S | Not Recruiting | Female: yes Male: yes | 230 | Phase 1/2 | Hungary | |||
1675 | NCT00293826 | March 2006 | 19 February 2015 | A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: AMG 108;Drug: Placebo | Amgen | Not recruiting | 18 Years | 70 Years | Both | 813 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Czech Republic;Estonia;France;Hungary;Ireland;Italy;Latvia;Mexico;Netherlands;Poland;Slovakia;Spain;Sweden;United Kingdom;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 |
1676 | NCT00308282 | March 2006 | 19 February 2015 | A Multi-Site Study to Evaluate the Safety and Effect of Study Drug on Patients With Rheumatoid Arthritis | Phase II Study of Safety and Efficacy of Intravenous LY2127399 in Patients With Rheumatoid Arthritis Treated With Methotrexate | Arthritis, Rheumatoid | Drug: LY2127399;Drug: Placebo | Eli Lilly and Company | Not recruiting | 18 Years | 75 Years | Both | 126 | Phase 2 | Romania | |
1677 | NCT00394589 | March 2006 | 16 December 2017 | Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3) | Randomised Controlled Trial Evaluating Strategies to Optimize Disease Activity Control in RA Patients Treated With Infliximab in Clinical Practice. | Rheumatoid Arthritis | Drug: Infliximab Control;Drug: Infliximab Increased Frequency;Drug: Infliximab Increased Dose | Merck Sharp & Dohme Corp. | Integrated Therapeutics Group | Not recruiting | 18 Years | N/A | All | 43 | Phase 3 | Austria;Belgium;Denmark;France;Germany;Netherlands;Sweden;Turkey |
1678 | NCT00603993 | March 2006 | 19 October 2017 | Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis | A Non-Randomized, Open-Label, Roll-Over Study With Self Injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Adalimumab | Abbott | Abbott Japan Co.,Ltd;Eisai Co., Ltd. | Not recruiting | 20 Years | N/A | All | 88 | Phase 3 | Japan |
1679 | EUCTR2004-004995-35-GB | 24/02/2006 | 1 May 2012 | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | ACTIVE RHEUMATOID ARTHRITIS | Trade Name: Paroxetine hydrochloride 10 & 20 mg and Prednisolone 1 mg BP Product Name: N/A Product Code: CRx-139 Pharmaceutical Form: Tablet INN or Proposed INN: Paroxetine & Prednisolone CAS Number: N/A Current Sponsor code: CRx-139 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10 & 20 and-1 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | CombinatoRx, Inc. | Authorised | Female: yes Male: yes | 220 | Phase 2 | Czech Republic;Germany;United Kingdom;Denmark;Italy | |||
1680 | NCT00286689 | February 3, 2006 | 18 December 2018 | Effects of Growth Hormone in Chronically Ill Children | Hurler Syndrome;Cerebral Palsy;Juvenile Rheumatoid Arthritis;Crohn Disease;HIV Infections | Drug: Growth Hormone;Procedure: Whole body Protein turnover;Procedure: DEXA scan | University of Texas Southwestern Medical Center | Not recruiting | 3 Years | 17 Years | All | 0 | 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 |
1681 | EUCTR2005-005295-32-GB | 01/02/2006 | 18 April 2012 | Trial in rheumatoid arthritis of lisinopril (TRALIS) - TRALIS | Trial in rheumatoid arthritis of lisinopril (TRALIS) - TRALIS | Rheumatoid arthritis | Trade Name: Lisinopril Product Name: Lisinopril Product Code: N/A Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Research and Development Department, Addenbrookes NHS Foundation Trust | Authorised | Female: yes Male: yes | 200 | United Kingdom | ||||
1682 | NCT00287794 | February 2006 | 19 February 2015 | Quality of Sleep in Patients With Rheumatoid Arthritis | Study on the Quality of Sleep in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: diazepam, melatonin | Kobe University | Recruiting | 17 Years | N/A | Both | 1000 | Phase 1 | Japan | |
1683 | NCT00296257 | February 2006 | 19 February 2015 | Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114 | A Phase 2, Multi-Centre, Randomised, Double Blind, Placebo Controlled Study Evaluating the Efficacy, Safety and Pharmacokinetics of Two Doses of a Candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg Once Daily), Administered in Combination With Ongoing Methotrexate Treatment in Patients With Active Rheumatoid Arthritis. | Rheumatoid Arthritis (RA) | Drug: SMP-114 | Dainippon Sumitomo Pharma Europe LTd. | Not recruiting | 18 Years | N/A | Both | 312 | Phase 2 | Czech Republic;Germany;Hungary;Netherlands;Poland;United Kingdom | |
1684 | NCT00299546 | February 2006 | 19 October 2017 | A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s) | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis and Previously Treated With Biologic Anti- TNFa Agent(s) | Arthritis, Rheumatoid | Drug: Placebo;Biological: Golimumab 50 mg;Biological: Golimumab 100 mg | Centocor, Inc. | Schering-Plough | Not recruiting | 18 Years | N/A | All | 461 | Phase 3 | United States;Australia;Austria;Canada;Finland;Germany;Netherlands;New Zealand;Spain;United Kingdom;France;Switzerland |
1685 | NCT00422383 | February 2006 | 19 October 2017 | A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA) | A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate. | Rheumatoid Arthritis | Drug: rituximab [MabThera/Rituxan] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 378 | Phase 3 | Australia;Belgium;Brazil;Canada;China;Finland;France;Germany;Hungary;Italy;Netherlands;New Zealand;Slovakia;South Africa;Spain;Taiwan;Thailand;United Kingdom;Switzerland;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 |
1686 | NCT00502996 | February 2006 | 19 October 2017 | A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis. | Multicenter Non-Comparative Expanded Access Program of to Assess Safety of Rituximab (Mab Anti Cd-20) in Patients With Rheumatoid Arthritis (Ser) | Rheumatoid Arthritis | Drug: Methotrexate;Drug: rituximab [MabThera/Rituxan] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 246 | Phase 3 | Argentina;Brazil;Chile;Colombia;Ecuador;El Salvador;Mexico;Peru;Uruguay;Venezuela | |
1687 | EUCTR2005-003694-25-ES | 27/01/2006 | 19 March 2012 | Ensayo randomizado, doble ciego, con doble enmascaramiento, de grupos paralelos para evaluar la eficacia y seguridad de RO4402257 como monoterapia en comparación con la monoterapia de metotrexato para pacientes con artritis reumatoide activa (AR) A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis (RA). | Ensayo randomizado, doble ciego, con doble enmascaramiento, de grupos paralelos para evaluar la eficacia y seguridad de RO4402257 como monoterapia en comparación con la monoterapia de metotrexato para pacientes con artritis reumatoide activa (AR) A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis (RA). | Artritis Reumatoide Rheumatoid Arthritis | Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Pharmaceutical Form: Film-coated tablet Current Sponsor code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Pharmaceutical Form: Film-coated tablet Current Sponsor code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Pharmaceutical Form: Film-coated tablet Current Sponsor code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Methotrexate Sodium 2.5mg Tablets Product Name: Methotrexate Sodium 2.5mg Tablets Product Code: PL 00095/5079R Pharmaceutical Form: Tablet Other descriptive name: Methotrexate Sodium 2.5mg Tablets Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | F. Hoffmann-La Roche Ltd | Authorised | Female: yes Male: yes | 200 | Czech Republic;Spain;Italy | ||||
1688 | NCT00282308 | January 23, 2006 | 16 December 2017 | A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate | A Phase II, Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate | Rheumatoid Arthritis | Drug: Rituximab;Drug: Methotrexate;Drug: Methylprednisone;Biological: C. albicans;Biological: Tetanus toxoid adsorbed booster vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine;Biological: Keyhole limpet hemocyanin | Genentech, Inc. | Not recruiting | 18 Years | 65 Years | All | 103 | Phase 2 | United States | |
1689 | EUCTR2005-002395-15-FI | 09/01/2006 | 28 October 2013 | A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis. | A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis. | Rheumatoid arthritis | Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab CAS Number: 174722-31 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use Product Name: Methotrexate Product Code: Methotrexate Pharmaceutical Form: Tablet INN or Proposed INN: methotrexate | F. Hoffmann-La Roche Ltd. | Not Recruiting | Female: yes Male: yes | 853 | Phase 3 | Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden | |||
1690 | EUCTR2005-004385-16-GB | 03/01/2006 | 18 April 2012 | CIRCADIAN VARIATIONS IN CYTOKINES AND THE EFFECT OF TIMED RELEASE TABLET PREDNISONE IN RHEUMATOID ARTHRITIS | CIRCADIAN VARIATIONS IN CYTOKINES AND THE EFFECT OF TIMED RELEASE TABLET PREDNISONE IN RHEUMATOID ARTHRITIS | Rheumatoid arthritis | Product Name: Prednisone Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: Prednisone CAS Number: 53-03-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5 - | United Bristol Healthcare NHS Trust | Authorised | Female: yes Male: yes | 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 |
1691 | NCT03496831 | January 1, 2006 | 11 June 2018 | Predicting Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological Drugs | Development of a Prediction Model for the Risk of Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological Drugs | Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis | Drug: Biologic Agents | Simon Krabbe | University of Aarhus;Zealand University Hospital;University of Southern Denmark | Not recruiting | 18 Years | N/A | All | 7500 | Phase 2 | |
1692 | NCT00234234 | January 2006 | 19 February 2015 | Predictors of the Response to Adalimumab in Rheumatoid Arthritis | Predictors of the Response to Adalimumab in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Adalimumab | University Hospital, Rouen | Not recruiting | 18 Years | N/A | Both | 200 | Phase 4 | France | |
1693 | NCT00254293 | January 2006 | 19 October 2017 | Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA) | A Study to Assess the Steady-State Trough Serum Concentration, Safety, and Immunogenicity of Abatacept (BMS-188667) Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Who Are Receiving Disease Modifying Ant-Rheumatic Drugs (DMARDs) | Rheumatoid Arthritis | Drug: Abatacept or Placebo (both as IV & SC Solution);Drug: Abatacept or Placebo (both as IV & SC solution);Drug: Abatacept | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 87 | Phase 1/Phase 2 | United States | |
1694 | NCT00264147 | January 2006 | 19 October 2017 | Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED) | A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Parallel-Group, 12-Week Study to Assess the Clinically Effective Dose Range of Etoricoxib and to Assess Its Safety and Tolerability in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: etoricoxib;Drug: Comparator: placebo;Drug: Comparator: diclofenac | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 761 | Phase 2 | Canada;Colombia;Puerto Rico;Switzerland;United States | |
1695 | NCT00266227 | January 2006 | 19 October 2017 | A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Retreatment With Rituximab in Subjects With Rheumatoid Arthritis Receiving Background Methotrexate | Rheumatoid Arthritis | Drug: placebo;Drug: rituximab;Drug: methotrexate;Drug: folate | Genentech, Inc. | Not recruiting | 18 Years | 80 Years | All | 559 | Phase 3 | 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 |
1696 | NCT00299104 | January 2006 | 16 December 2017 | A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis | A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: placebo;Drug: rituximab | Genentech, Inc. | Hoffmann-La Roche | Not recruiting | 18 Years | 80 Years | All | 755 | Phase 3 | United States |
1697 | NCT00346294 | January 2006 | 19 February 2015 | An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-Injector in Subjects With Rheumatoid Arthritis | An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-Injector in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Other: Etanercept | Amgen | Immunex Corporation | Not recruiting | 18 Years | N/A | Both | 115 | Phase 4 | United States |
1698 | NCT00379990 | January 2006 | 19 February 2015 | A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days. | A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Synovial Thickness and Vascularity of 28 Days Repeat Dosing of GW274150 or 7.5mg Prednisolone in RA Subjects. | Arthritis, Rheumatoid | Drug: GW274150;Drug: Prednisolone;Other: Placebo | GlaxoSmithKline | Not recruiting | 18 Years | N/A | Both | 48 | Phase 2 | Serbia;United Kingdom | |
1699 | NCT00422942 | January 2006 | 19 October 2017 | A Pharmacokinetic and Pharmacodynamic Study of MabThera (Rituximab) Plus Methotrexate in Patients With Rheumatoid Arthritis (RA) | An Open-label, Exploratory Study of the Pharmacokinetic and Pharmacodynamic Activity of MabThera in Combination With Methotrexate in Synovial Tissue and in Peripheral Blood of Patients With Active Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate | Hoffmann-La Roche | Not recruiting | 18 Years | 80 Years | All | 3 | Phase 2 | Netherlands;Spain | |
1700 | NCT00724243 | January 2006 | 19 October 2017 | Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED) | Remicade Treatment Registry in Rheumatoid Arthritis I | Rheumatoid Arthritis | Drug: Infliximab | Merck Sharp & Dohme Corp. | Not recruiting | N/A | N/A | All | 33 | N/A | 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 |
1701 | NCT02922192 | January 2006 | 17 October 2016 | Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis | Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis | Rheumatoid Arthritis;Inflammatory Bowel Disease;Psoriasis;Psoriatic Arthritis;Ankylosing Spondylitis | Drug: TNF-a antagonists, non-TNFs, DMARD non-biologics | Biologics & Biosimilars Collective Intelligence Consortium | HealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Group Health Cooperative;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta;Pfizer;UPMC;HealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Group Health Cooperative;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta;Pfizer;UPMC | Not recruiting | 18 Years | N/A | Both | 100000 | N/A | |
1702 | EUCTR2005-004530-40-AT | 30/12/2005 | 22 April 2013 | Induction of remission in RA patients at low disease activity by additional Infliximab-therapy | Induction of remission in RA patients at low disease activity by additional Infliximab-therapy | Patients with a diagnose of rheumatoid arthritis according to ACR-criteria at least 1 year (max. 10 years) prior to start of therapy with active disease: DAS 28 between 2,8 and 3,5 and a change in DAS 28 score <0.6 during the last 6 weeks before inclusion. | Trade Name: Remicade Product Name: Remicade Pharmaceutical Form: Powder and solvent for solution for infusion | AESCA Pharma Ges.m.b.H | Not Recruiting | Female: yes Male: yes | 160 | Austria | ||||
1703 | EUCTR2005-002396-33-ES | 27/12/2005 | 28 August 2014 | Estudio internacional, randomizado, doble ciego, para evaluar la eficacia y seguridad de diversos regímenes de retratamiento con rituximab en combinación con metotrexato, en pacientes con AR que manifiestan una respuesta inadecuada a metotrexato. A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate. | Estudio internacional, randomizado, doble ciego, para evaluar la eficacia y seguridad de diversos regímenes de retratamiento con rituximab en combinación con metotrexato, en pacientes con AR que manifiestan una respuesta inadecuada a metotrexato. A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate. | Artritis Reumatoide (Rheumatoid arthritis) | Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab CAS Number: 174722-31 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann-La Roche Ltd. | Not Recruiting | Female: yes Male: yes | 375 | Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy | ||||
1704 | EUCTR2005-000902-30-GB | 09/12/2005 | 24 April 2012 | A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients | A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients | Rheumatoid arthritis | Trade Name: Prednisolone Tablets USP 5 mg Product Name: Prednisolone Tablets USP 5 mg Pharmaceutical Form: Tablet INN or Proposed INN: Prednisolone CAS Number: 50-24-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | GlaxoSmithKline Research & Development Limited | Authorised | Female: yes Male: yes | 45 | United Kingdom | ||||
1705 | EUCTR2004-002482-20-GB | 02/12/2005 | 15 July 2013 | A Pilot Study to Test the Effect of Treating Depression Associated with Rueumatoid Arthritis (RA) using Venlaflaxine - Venlaflaxine & Numact Study | A Pilot Study to Test the Effect of Treating Depression Associated with Rueumatoid Arthritis (RA) using Venlaflaxine - Venlaflaxine & Numact Study | Symptoms of Depression as defined by the Hospital Anxiety and Depression Questionnaire associated with Rheumatoid Arthritis | Trade Name: Efexor XL 75 mg Product Name: Efexor XL 75 mg (venlafaxine) Product Code: NA Pharmaceutical Form: Modified-release capsule, hard INN or Proposed INN: Venlafaxine Hydrochloride Concentration unit: mg milligram(s) Concentration number: 75- | Newcastle upon Tyne Hospitals NHS Trust | Not Recruiting | Female: yes Male: yes | 20 | 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 |
1706 | NCT00264537 | December 2005 | 19 October 2017 | A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive | A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Methotrexate-naive Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Placebo injections;Drug: Placebo capsules;Drug: Methotrexate capsules;Biological: Golimumab 50 mg injections;Biological: Golimumab 100 mg injections | Centocor, Inc. | Schering-Plough | Not recruiting | 18 Years | N/A | All | 637 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Chile;Hungary;India;Korea, Republic of;Malaysia;New Zealand;Philippines;Poland;Russian Federation;Singapore;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Brazil;Mexico;Turkey |
1707 | NCT00281294 | December 2005 | 19 February 2015 | A Phase 2 Study to Evaluate the Safety, Tolerability, and Activity of Fontolizumab in Subjects With Active Rheumatoid Arthritis | A Phase 2 Study to Evaluate the Safety, Tolerability, and Activity of Fontolizumab in Subjects With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Fontolizumab | PDL BioPharma, Inc. | Not recruiting | 18 Years | N/A | Both | 40 | Phase 2 | United States | |
1708 | NCT00642629 | December 2005 | 19 February 2015 | A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, Administered to Patients With Rheumatoid Arthritis to Determine Safety, Tolerability, Pharmacokinetic and Synovial Tissue Outcomes | Active, Moderate to Severe Rheumatoid Arthritis | Drug: STA 5326 mesylate;Drug: Placebo | Synta Pharmaceuticals Corp. | Not recruiting | 18 Years | N/A | Both | 35 | Phase 2 | Netherlands | ||
1709 | NCT00669942 | December 2005 | 19 October 2017 | Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients | A Randomized, Double Blind, Placebo-controlled, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients With Pharmacodynamics Assessed in an Expanded Cohort at the Maximum Tolerated Dose | Rheumatoid Arthritis | Biological: AIN457;Drug: Placebo | Novartis Pharmaceuticals | Not recruiting | 18 Years | 75 Years | All | 104 | Phase 1/Phase 2 | United States;Belgium;Germany;Netherlands;Singapore;Spain | |
1710 | NCT00705289 | December 2005 | 19 October 2017 | A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250) | Epidemiology, Correlation and Predictive Value of Disease Activity and Biomarkers in RA Patients Initiated on Infliximab in Clinical Practice | Rheumatoid Arthritis | Biological: Infliximab | Merck Sharp & Dohme Corp. | Not recruiting | N/A | N/A | All | 728 | 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 |
1711 | EUCTR2005-000784-26-GB | 25/11/2005 | 24 April 2012 | A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with Methotrexate Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005. | A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with Methotrexate Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005. | Rheumatoid Arthritis, Nos | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Abatacept CAS Number: 332348-12-6 Current Sponsor code: BMS-188667 Other descriptive name: CTLA4Ig Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Bristol Myers Squibb International Corporation | Authorised | Female: yes Male: yes | 750 | Phase 3B | Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy;Austria | |||
1712 | EUCTR2005-001889-13-SE | 24/11/2005 | 19 March 2012 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3 | Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Trade Name: Remicade Product Name: Remicade Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: infliximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Schering-Plough Research Institute, a division of Schering Corporation | Not Recruiting | Female: yes Male: yes | 315 | Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden | ||||
1713 | EUCTR2005-002392-32-IE | 23/11/2005 | 26 June 2012 | A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis. | A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis. | Active rheumatoid arthritis | Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab CAS Number: 174722-31 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann-La Roche Ltd. | Authorised | Female: yes Male: yes | 500 | Germany;United Kingdom;Slovenia;Ireland;Sweden | ||||
1714 | EUCTR2005-003495-38-IE | 17/11/2005 | 18 April 2012 | A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy. | A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy. | Rheumatoid Arthritis | Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Pharmaceutical Form: Film-coated tablet Current Sponsor code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Pharmaceutical Form: Film-coated tablet Current Sponsor code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Pharmaceutical Form: Film-coated tablet Current Sponsor code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | F. Hoffmann-La Roche Ltd | Authorised | Female: yes Male: yes | 330 | United Kingdom;Germany;Estonia;Spain;Ireland;Greece | ||||
1715 | EUCTR2004-001825-69-IT | 04/11/2005 | 19 March 2012 | A Multi Center, Open label, Extension study of RA 1 using Extracoproreal photoimmune therapy with Uvadex | A Multi Center, Open label, Extension study of RA 1 using Extracoproreal photoimmune therapy with Uvadex | Rheumatoid arthritis MedDRA version: 6.1 Level: PT Classification code 10039073 | Trade Name: UVADEX Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Methoxsalen Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- | THERAKOS | Authorised | Female: yes Male: yes | 68 | 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 |
1716 | NCT00160641 | November 2005 | 19 October 2017 | A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis | A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Participated in Study CDP870-050 | Rheumatoid Arthritis | Biological: Certolizumab Pegol | UCB Pharma | Not recruiting | 18 Years | N/A | All | 567 | Phase 3 | United States;Bulgaria;Croatia;Czech Republic;Estonia;Israel;Latvia;Lithuania;Poland;Russian Federation;Serbia;Slovakia;Ukraine;Former Serbia and Montenegro | |
1717 | NCT00162292 | November 2005 | 19 February 2015 | Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background | Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background | Rheumatoid Arthritis | Drug: BMS-582949 and Methotrexate | Bristol-Myers Squibb | Not recruiting | 18 Years | 70 Years | Both | 33 | Phase 1 | United States;Mexico | |
1718 | NCT00256919 | November 2005 | 19 February 2015 | Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA) | A Randomised, Placebo-controlled, Parallel Group Single Dose Study of GW856553 in Patients With Active RA to Investigate the C-Reactive Protein (CRP) Dose Response Relationship | Arthritis, Rheumatoid | Drug: GW856553 | GlaxoSmithKline | Not recruiting | 18 Years | N/A | Both | 51 | Phase 2 | Bulgaria;Germany;Spain;Sweden;Ukraine | |
1719 | NCT00292422 | November 2005 | 19 February 2015 | Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid Arthritis | A Randomized, Blinded, Placebo-Controlled, Multicenter, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to DMARD Therapy | Rheumatoid Arthritis | Drug: BG9924 | Biogen Idec | Not recruiting | 18 Years | 75 Years | Both | 50 | Phase 2 | United States;Poland | |
1720 | NCT00316771 | November 2005 | 14 November 2016 | A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy | A Randomized, Double-blind, Placebo-controlled, Study to Determine the Efficacy and Safety of 5 Dose Regimens of RO4402257 in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy. | Rheumatoid Arthritis | Drug: P38 Inhibitor (4) 150mg;Drug: P38 Inhibitor (4) 25mg;Drug: P38 Inhibitor (4) 300mg;Drug: P38 Inhibitor (4) 50mg;Drug: P38 Inhibitor (4) 75mg;Drug: Placebo | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 374 | Phase 2 | South Africa;Spain;United Kingdom;United States;Australia;Brazil;Canada;Estonia;Germany;Greece;Ireland;Mexico;New Zealand;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 |
1721 | NCT00320450 | November 2005 | 19 February 2015 | SB-681323 In Subjects With Rheumatoid Arthritis | A Randomised, Parallel Group, Placebo-controlled, Double Blind Study to Assess the Safety and Tolerability of SB-681323 at 7.5mg Daily Dose for 28 Days and Its Effect on the Levels of Serum C-reactive Protein (CRP) in Subjects With Rheumatoid Arthritis (RA) | Arthritis, Rheumatoid | Drug: SB-681323 | GlaxoSmithKline | Not recruiting | 18 Years | N/A | Both | 78 | Phase 2 | Denmark;Germany;Hong Kong;Italy;Norway;Poland;Spain;Sweden;United Kingdom;Hungary | |
1722 | NCT00380744 | November 2005 | 19 February 2015 | A Safety and Pharmacokinetics Study in Patients With Rheumatoid Arthritis | A Phase 1b/2 Multiple-Dose Safety Study and Pharmacokinetic/ Pharmacodynamic Study of LY2189102 in Patients With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: LY2189102;Drug: placebo | Eli Lilly and Company | Not recruiting | 18 Years | 75 Years | Both | 104 | Phase 1/Phase 2 | United States;Poland;Argentina;Hungary;Spain | |
1723 | EUCTR2005-003436-21-GB | 26/10/2005 | 18 April 2012 | A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 | A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 | Rheumatoid Arthritis MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: SMP-114 Product Code: SMP-114 Pharmaceutical Form: Tablet INN or Proposed INN: rimacalib CAS Number: 215174-50-8 Current Sponsor code: SMP-114 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Dainippon Sumitomo Pharma Europe Ltd | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Hungary;Czech Republic;Germany;United Kingdom | |||
1724 | EUCTR2005-002969-37-SE | 14/10/2005 | 1 May 2012 | A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship. - GM2005/00244/02 | A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship. - GM2005/00244/02 | Rheumatoid Arthritis | Product Code: GW856553 Pharmaceutical Form: Tablet Current Sponsor code: GW856553 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Code: GW856553 Pharmaceutical Form: Tablet Current Sponsor code: GW856553 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Code: GW856553 Pharmaceutical Form: Tablet Current Sponsor code: GW856553 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | GlaxoSmithKline Research & Development Ltd | Not Recruiting | Female: yes Male: yes | 48 | Germany;Spain;Sweden | ||||
1725 | NCT00141102 | October 2005 | 19 October 2017 | Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis | Double-Blind, Triple Dummy, Parallel-Group, Randomized, Six-Month Study To Compare Celecoxib (200 Mg BID) With Diclofenac Sr (75 Mg BID) Plus Omeprazole (20 Mg QD) For Gastrointestinal Events In Subjects With Osteoarthritis And Rheumatoid Arthritis At High-Risk Of Gastrointestinal Adverse Events | Osteoarthritis;Arthritis, Rheumatoid | Drug: Celecoxib;Drug: Diclofenac + Omeprazole | Pfizer | Not recruiting | 18 Years | N/A | All | 4484 | Phase 4 | Belgium;Brazil;Canada;China;Colombia;Costa Rica;Croatia;Czech Republic;Ecuador;Estonia;France;Germany;Greece;Guatemala;Hong Kong;India;Korea, Republic of;Latvia;Lithuania;Netherlands;Panama;Peru;Portugal;Russian Federation;Serbia;Singapore;South Africa;Spain;Sweden;Taiwan;Ukraine;United Kingdom;Former Serbia and Montenegro;Ireland | |
No. | 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 |
1726 | NCT00241982 | October 2005 | 19 February 2015 | Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis | Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: long-circulating liposomal prednisolone | Radboud University | Utrecht University | Not recruiting | 18 Years | N/A | Both | 22 | Phase 2 | Netherlands |
1727 | NCT00249041 | October 2005 | 19 February 2015 | Enbrel Liquid Immunogenicity Protocol | Open-label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: 50 mg Etanercept;Drug: Enbrel liquid | Amgen | Immunex Corporation | Not recruiting | 18 Years | N/A | Both | 447 | Phase 3 | United States;Canada |
1728 | NCT00299130 | October 2005 | 16 December 2017 | A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis | A Randomized, Placebo Controlled, Double-blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate, Compared to Methotrexate Monotherapy, in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Folate;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Placebo;Drug: Rituximab | Genentech, Inc. | Hoffmann-La Roche | Not recruiting | 18 Years | 80 Years | All | 511 | Phase 3 | United States |
1729 | EUCTR2005-002326-63-LT | 21/09/2005 | 19 March 2012 | A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. | A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. | Rheumatoid Arthritis Classification code 10039073 | Product Name: Certolizumab pegol Product Code: CDP870 Pharmaceutical Form: Solution for injection INN or Proposed INN: Certolizumab pegol Current Sponsor code: CDP870 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 200- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | UCB Celltech | Not Recruiting | Female: yes Male: yes | 590 | Phase 3 | Czech Republic;Estonia;Latvia;Lithuania | |||
1730 | EUCTR2005-002909-23-ES | 21/09/2005 | 26 June 2012 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. Estudio de extensión, a largo plazo, de la seguridad durante el tratamiento con tocilizumab (MRA) en pacientes con artritis reumatoide que hayan terminado el tratamiento en estudios trocales con MRA | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. Estudio de extensión, a largo plazo, de la seguridad durante el tratamiento con tocilizumab (MRA) en pacientes con artritis reumatoide que hayan terminado el tratamiento en estudios trocales con MRA | Rheumatoid arthritis | Product Name: MRA Product Code: RO4877533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- | F Hoffmann La-Roche AG | Not Recruiting | Female: yes Male: yes | 2420 | Portugal;Finland;United Kingdom;Czech Republic;Germany;Iceland;Slovenia;Denmark;Spain;Italy;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 |
1731 | EUCTR2005-002421-31-GB | 16/09/2005 | 24 April 2012 | A phase II randomized, double-blind, multicentre, placebo-controlled, dose-ranging, parallel group study to compare the efficacy, safety and tolerability of 3 strengths of AD 452 in adult subjects with active rheumatoid arthritis who are currently taking methotrexate | A phase II randomized, double-blind, multicentre, placebo-controlled, dose-ranging, parallel group study to compare the efficacy, safety and tolerability of 3 strengths of AD 452 in adult subjects with active rheumatoid arthritis who are currently taking methotrexate | Rheumatoid arthritis Level: PT Classification code 10039073 | Product Name: AD 452 4.5 mg Tablet Pharmaceutical Form: Tablet CAS Number: 51742-86-0 Current Sponsor code: AD 452 Other descriptive name: (+) erythromefloquine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: AD 452 9 mg tablet Pharmaceutical Form: Tablet CAS Number: 51742-86-0 Current Sponsor code: AD 452 Other descriptive name: (+)erythromefloquine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 9- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: AD 452 18 mg tablet Pharmaceutical Form: Tablet CAS Number: 51742-86-0 Current Sponsor code: AD 452 Other descriptive name: (+)erythromefloquine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 18- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Arakis Ltd | Authorised | Female: yes Male: yes | 292 | Phase 2 | Germany;United Kingdom | |||
1732 | EUCTR2005-001977-82-GB | 09/09/2005 | 24 April 2012 | A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety, tolerability, pharmacokinetics and effect on synovial thickness and vascularity of 28 days repeat dosing of GW274150 or 7.5mg prednisolone in RA subjects | A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety, tolerability, pharmacokinetics and effect on synovial thickness and vascularity of 28 days repeat dosing of GW274150 or 7.5mg prednisolone in RA subjects | Rheumatoid arthritis | Product Name: GW274150 Tablets Product Code: GW274150 Pharmaceutical Form: Tablet Current Sponsor code: GW274150 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Deltacortril Enteric Product Name: Prednisolone Pharmaceutical Form: Tablet INN or Proposed INN: Prednisolone Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | GlaxoSmithKline Research & Development Limited | Authorised | Female: yes Male: yes | 45 | United Kingdom | ||||
1733 | EUCTR2005-002219-26-SE | 08/09/2005 | 19 March 2012 | A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA) | A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA) | Rheumatoid arthritis (RA) | Product Name: SB-681323 Tablets Product Code: SB-681323 Pharmaceutical Form: Tablet Current Sponsor code: SB-681323 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2,5 and 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | GlaxoSmithKline R&D Ltd | Not Recruiting | Female: yes Male: yes | 82 | Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden | ||||
1734 | EUCTR2005-002423-13-DE | 06/09/2005 | 7 August 2012 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 | Rheumatoid arthritis | Trade Name: RoActemra Product Name: MRA Product Code: RO4877533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: R04877533 Other descriptive name: MRA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- | F. Hoffmann-La Roche Ltd | Not Recruiting | Female: yes Male: yes | 630 | Hungary;Slovakia;Germany;Bulgaria;Italy | ||||
1735 | EUCTR2005-000551-15-GB | 05/09/2005 | 3 April 2017 | Effect of folic acid supplementation and allopurinol on endothelial function in patients with rheumatoid arthritis treated with methotrexate - Endothelial function in rheumatoid arthritis patients on methotrexate | Effect of folic acid supplementation and allopurinol on endothelial function in patients with rheumatoid arthritis treated with methotrexate - Endothelial function in rheumatoid arthritis patients on methotrexate | Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory polyarthritis associated with excess cardiovascular (CV) mortality. Hyperhomocysteinaemia is recognized as an independent CV risk factor and homocysteine levels are frequently elevated in RA patients. Endothelial dysfunction is considered a marker of early atherosclerotic disease and seems to correlate well with future increase CV risk. RA patients are known to have endothelial dysfunction. | Product Name: Allopurinol Product Code: Allopurinol Pharmaceutical Form: Capsule* INN or Proposed INN: Allopurinol CAS Number: 315-30-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: Folic acid Product Code: Folic acid Pharmaceutical Form: Capsule* INN or Proposed INN: Folic acid CAS Number: 59-30-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | University of Dundee | Not Recruiting | Female: yes Male: yes | 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 |
1736 | EUCTR2004-005102-68-GB | 01/09/2005 | 1 May 2012 | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options. Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options. Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. | RHEUMATOID ARTHRITIS,NOS | Product Name: Abatacept Product Code: BMS-188667 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Abatacept CAS Number: 332348-12-6 Current Sponsor code: BMS-188667 Other descriptive name: CTLA4Ig Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- | Bristol-Myers Squibb International Corporation | Authorised | Female: yes Male: yes | 750 | Phase 3 | Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy | |||
1737 | NCT00466037 | September 2005 | 19 February 2015 | The Effect of Rituximab on the Humoral Response to Influenza Vaccine | Vaccination Against Influenza in Rheumatoid Arthritis Patients: The Effect of Rituximab on the Humoral Response | Rheumatoid Arthritis | Biological: Influenza vaccine | Tel-Aviv Sourasky Medical Center | Not recruiting | 18 Years | 85 Years | Both | 64 | N/A | ||
1738 | NCT00691028 | September 2005 | 19 October 2017 | Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis | Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: TA-650 3 mg/kg;Drug: TA-650 6 mg/kg;Drug: TA-650 10 mg/kg | Mitsubishi Tanabe Pharma Corporation | Not recruiting | 20 Years | 75 Years | All | 327 | Phase 3 | ||
1739 | EUCTR2005-001633-14-DK | 17/08/2005 | 19 March 2012 | Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira?) 40 mg s.c. eow versus infliximab (Remicade?) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study | Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira?) 40 mg s.c. eow versus infliximab (Remicade?) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study | Rheumatoid arthritis | Trade Name: Humira Product Name: Humira Pharmaceutical Form: Injection* Trade Name: Remicade Product Name: Remicade Pharmaceutical Form: Injection* | Hvidovre Hospital, Dept. Rheumatology | Authorised | Female: yes Male: yes | 112 | Denmark;Sweden | ||||
1740 | NCT00111410 | August 2005 | 22 August 2016 | Evaluating the Effect of Anakinra (r-metHuIL-1ra) on Vaccine AntibodyResponse in Subjects With Rheumatoid Arthritis (RA) | A Multicenter, Double-Blind, Randomized, Placebo Controlled Study to Estimate the Effect of Anakinra (r-metHuIL-1ra) on Vaccine Antibody Response in Subjects With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Anakinra (r-metHuIL-1ra) | Amgen | Not recruiting | 18 Years | 74 Years | Both | 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 |
1741 | NCT00141830 | August 2005 | 19 February 2015 | Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis | A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy | Rheumatoid Arthritis | Drug: Methotrexate plus ERB-041 for 12 weeks;Drug: Placebo for 12 weeks | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | 80 Years | Both | 159 | Phase 2 | United States;Canada;Hungary;Italy;Mexico;Spain | |
1742 | NCT00141934 | August 2005 | 19 February 2015 | A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects. | Phase II Randomised, Double-Blind, Multicentre, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of 3 Strengths of AD 452 in Adults With Active RA Who Are Currently Taking Methotrexate. | Rheumatoid Arthritis | Drug: AD 452 | Sosei | Not recruiting | 18 Years | 75 Years | Both | 232 | Phase 2 | United States | |
1743 | NCT00243412 | August 2005 | 19 October 2017 | A Study of the Safety and Efficacy of Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Methotrexate | A Double-Blind, Randomized, Multicenter, Phase II Study of the Safety and Efficacy of Two Rituximab Regimens in Subjects With Moderate to Severe Active Rheumatoid Arthritis Receiving Stable Doses of Methotrexate | Rheumatoid Arthritis | Drug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: Placebo;Drug: Rituximab | Genentech, Inc. | Not recruiting | 18 Years | 65 Years | All | 42 | Phase 2 | United States | |
1744 | NCT00370435 | August 2005 | 16 December 2017 | Study Of 90mg Of GW274150 In Subjects Over 50 Years, Who Have Rheumatoid Arthritis (RA) | An Open-label, Single Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of 90mg of GW274150 in Adult and Elderly RA Subjects. | Arthritis, Rheumatoid | Drug: GW274150 | GlaxoSmithKline | Not recruiting | 50 Years | N/A | All | 6 | Phase 2 | United Kingdom | |
1745 | NCT00508768 | August 2005 | 19 February 2015 | A Study of Oral SCIO-469 Pharmacokinetics (Study of a Drug in the Body to Watch How the Drug is Absorbed, Distributed, Metabolized and Eliminated Over a Period of Time) in the Body of Female Patients With Active Rheumatoid Arthritis | A Randomized, Double-Blind, Parallel-Group, Pharmacokinetic Study of Oral SCIO-469 (90 mg qd and 30 mg Tid) in Female Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Oral SCIO-469 capsule | Scios, Inc. | Not recruiting | 18 Years | N/A | Female | 16 | 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 |
1746 | EUCTR2005-001319-23-HU | 22/07/2005 | 19 March 2012 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy | A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy | Rheumatoid arthritis | Product Name: ERB-041 Product Code: ERB-041 Pharmaceutical Form: Capsule* INN or Proposed INN: Not available CAS Number: 524684-52-4 Current Sponsor code: ERB-041 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: ERB-041 Product Code: ERB-041 Pharmaceutical Form: Capsule* INN or Proposed INN: Not available CAS Number: 524684-52-4 Current Sponsor code: ERB-041 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: ERB-041 Product Code: ERB-041 Pharmaceutical Form: Capsule* INN or Proposed INN: Not available CAS Number: 524684-52-4 Current Sponsor code: ERB-041 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical resaearch and Development | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Spain;Italy | ||||
1747 | EUCTR2004-002215-80-HU | 20/07/2005 | 19 March 2012 | A Double-Blind, Parallel, Randomized Extension Trial to Evaluate Safety and Efficacy of TMI-005 (Apratastat) in Subjects with Rheumatoid Arthritis on Methotrexate Who Have Completed Protocol 3140A1-200-WW | A Double-Blind, Parallel, Randomized Extension Trial to Evaluate Safety and Efficacy of TMI-005 (Apratastat) in Subjects with Rheumatoid Arthritis on Methotrexate Who Have Completed Protocol 3140A1-200-WW | Rheumatoid Arthritis | Product Name: TMI-005 (WAY-177005) Product Code: TMI-005 (WAY-177005) Pharmaceutical Form: Capsule* INN or Proposed INN: Not yet established CAS Number: 287405-51-0 Current Sponsor code: TMI-005 Other descriptive name: WAY-177005 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Product Name: TMI-005 (WAY-177005) Product Code: TMI-005 (WAY-177005) Pharmaceutical Form: Capsule* INN or Proposed INN: Not yet established CAS Number: 287405-51-0 Current Sponsor code: TMI-005 Other descriptive name: WAY-177005 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Product Name: TMI-005 (WAY-177005) Product Code: TMI-005 (WAY-177005) Pharmaceutical Form: Capsule* INN or Proposed INN: Not yet established CAS Number: 287405-51-0 Current Sponsor code: TMI-005 Other descriptive name: WAY-177005 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development | Authorised | Female: yes Male: yes | 360 | Hungary | ||||
1748 | EUCTR2005-000158-61-GB | 18/07/2005 | 9 October 2012 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1 Level: LLT Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Pharmaceutical Form: Capsule, hard CAS Number: 221148-46-5 Current Sponsor code: GW406381 Other descriptive name: GW406381X Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: GW406381 Product Code: GW406381X Pharmaceutical Form: Capsule, hard CAS Number: 221148-46-5 Current Sponsor code: GW406381 Other descriptive name: GW406381X Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: GW406381 Product Code: GW406381X Pharmaceutical Form: Capsule, hard CAS Number: 221148-46-5 Current Sponsor code: GW406381 Other descriptive name: GW406381X Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: GW406381 Product Code: GW406381X Pharmaceutical Form: Capsule, hard CAS Number: 221148-46-5 Current Sponsor code: GW406381 Other descriptive name: GW406381X Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Celebrex 200 mg capsule, hard Product Name: Celecoxib Pharmaceutical Form: Capsule, hard INN or Proposed INN: Celecoxib CAS Number: 169590-42-5 Current Sponsor code: Celecoxib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | GlaxoSmithKline Research & Development Limited | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania | ||||
1749 | EUCTR2005-001138-33-LT | 14/07/2005 | 11 February 2013 | A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis. | A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis. | Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis | Product Name: MRA Product Code: RO4877533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: R04877533 Other descriptive name: MRA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use Product Name: Methotrexate sodium Pharmaceutical Form: Tablet INN or Proposed INN: Methotrexate sodium CAS Number: 15475-56-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | F. Hoffmann La-Roche AG | Not Recruiting | Female: yes Male: yes | 650 | Portugal;Slovenia;Spain;Lithuania;Denmark;Norway;Italy | ||||
1750 | NCT00109408 | July 2005 | 14 November 2016 | A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis | A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 673 | Phase 3 | United States;Argentina;Australia;Canada;China;Denmark;France;Israel;Italy;Lithuania;Mexico;Norway;Peru;Portugal;Serbia;Slovenia;South Africa;Spain;Croatia;Former Serbia and Montenegro | |
No. | 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 |
1751 | NCT00122382 | July 2005 | 19 October 2017 | Remission and Joint Damage Progression in Early Rheumatoid Arthritis | A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate | Rheumatoid Arthritis | Drug: Abatacept;Drug: placebo;Drug: methotrexate | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 1052 | Phase 3 | United States;Australia;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Puerto Rico;Russian Federation;South Africa;Spain;United Kingdom;Austria;Ireland | |
1752 | NCT00503425 | June 30, 2005 | 16 December 2017 | A Study of MabThera (Rituximab) in Participants With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARD) and/or Anti-Tumor Necrosis Factor (Anti-TNF) Therapy. | An Open Label Study to Assess the Safety and Effect on Disease Activity of MabThera in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With DMARDs and/or One Anti-TNF Alpha Agent | Rheumatoid Arthritis | Drug: Rituximab [MabThera/Rituxan] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 215 | Phase 3 | Israel | |
1753 | EUCTR2004-005115-29-GB | 24/06/2005 | 19 March 2012 | A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship | A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship | Rheumatoid arthritis | Product Name: SB-681323 Tablets Product Code: SB-681323 Pharmaceutical Form: Tablet Current Sponsor code: SB-681323 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: SB-681323 Tablets Product Code: SB-681323 Pharmaceutical Form: Tablet Current Sponsor code: SB-681323 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Prednisolone Tablets BP Product Name: Overencapsulated Prednisolone Tablets Pharmaceutical Form: Capsule, hard INN or Proposed INN: Prednisolone CAS Number: 50-24-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10 (2x5)- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | GlaxoSmithKline Research & Development Ltd | Authorised | Female: yes Male: yes | 77 | Germany;United Kingdom | ||||
1754 | NCT00134693 | June 21, 2005 | 16 December 2017 | A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein That Is an Indicator For Rheumatoid Arthritis | A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship | Arthritis, Rheumatoid | Drug: Prednisolone;Drug: SB-681323 | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 77 | Phase 2 | Australia;France;Germany;Russian Federation;United Kingdom | |
1755 | EUCTR2005-000549-13-CZ | 15/06/2005 | 19 March 2012 | A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study of Two Doses of VX-702 in Subjects with Moderate to Severe Rheumatoid Arthritis - VeRA | A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study of Two Doses of VX-702 in Subjects with Moderate to Severe Rheumatoid Arthritis - VeRA | rheumatoid arthritis | Product Code: VX-702 Pharmaceutical Form: Tablet Current Sponsor code: VX-702 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Current Sponsor code: VX-702 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 300 | 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 |
1756 | EUCTR2004-002846-36-DE | 14/06/2005 | 19 March 2012 | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/A | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/A | Rheumatoid Arthritis MedDRA version: 7.1 Level: LLT Classification code 10039073 | Product Name: CP690,550 Product Code: CP690,550 Pharmaceutical Form: Tablet INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: CP690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: CP690,550 Product Code: CP690,550 Pharmaceutical Form: Tablet INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: CP690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Pfizer Pharma GmbH | Not Recruiting | Female: yes Male: yes | 312 | Phase 2A | Germany;Spain;Italy | |||
1757 | EUCTR2005-000884-25-DE | 14/06/2005 | 24 April 2012 | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy. | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy. | Rheumatoid Arthritis | Product Name: MRA Product Code: RO4877533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: R04877533 Other descriptive name: MRA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann-La Roche AG | Not Recruiting | Female: yes Male: yes | 450 | United Kingdom;Germany;Iceland;Italy;Sweden | ||||
1758 | NCT00202852 | June 1, 2005 | 16 December 2017 | A Placebo-Controlled, Double-Blinded, Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate (Study P04280)(COMPLETED) | A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate | Arthritis, Rheumatoid | Other: Placebo;Drug: MTX;Biological: Infliximab | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 75 Years | All | 143 | Phase 3 | Korea, Republic of | |
1759 | NCT00113308 | June 2005 | 16 December 2017 | COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg Administered Orally Once Daily, in Adults With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: GW406381 | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 2208 | Phase 3 | United States;Argentina;Austria;Belgium;Bulgaria;Canada;Chile;Costa Rica;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Korea, Republic of;Latvia;Mexico;Netherlands;New Zealand;Norway;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic;Estonia;Lithuania;Pakistan;Slovakia;Taiwan | |
1760 | NCT00205478 | June 2005 | 19 February 2015 | Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702 | A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo Controlled Study of Two Doses of VX-702 in Subjects With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: VX-702 | Vertex Pharmaceuticals Incorporated | Not recruiting | 18 Years | 75 Years | Both | 300 | Phase 2 | Bulgaria;Croatia;Czech Republic;Former Serbia and Montenegro;Poland;Russian Federation;Slovakia;Slovenia;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 |
1761 | NCT00233558 | June 2005 | 19 February 2015 | Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid Arthritis | Multicentre, Randomised, Open Label Study Comparing a “Scheduled Steroid Reduction Strategy” Versus a Free Steroid Reduction Strategy (Physician’s Usual Practice for Reducing Steroids) in Patients With Active RA Treated With Humira 40 mg Eow + MTX During 9 Months | Rheumatoid Arthritis | Drug: adalimumab (up to 9 months exposure);Drug: methotrexate | Abbott | Not recruiting | 18 Years | N/A | Both | 160 | Phase 4 | United States | |
1762 | NCT00688103 | June 2005 | 19 October 2017 | Efficacy and Safety of Etanercept in Active RA Despite Methotrexate Therapy in Japan | Efficacy and Safety of Etanercept in Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan | Rheumatoid Arthritis | Drug: ETN Alone;Drug: ETN+MTX | Japan Biological Agent Study Integrated Consortium | Not recruiting | 18 Years | N/A | All | 151 | Phase 4 | Japan | |
1763 | EUCTR2005-001350-24-SK | 31/05/2005 | 27 February 2017 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, dosed subcutaneously at 400 mg every two weeks as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, dosed subcutaneously at 400 mg every two weeks as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | Rheumatoid arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Certolizumab pegol CAS Number: 428863-50-7 Current Sponsor code: CDP870 Other descriptive name: CDP870 Fab'-PEG Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 150 + or --15 | UCB Celltech | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Latvia | |||
1764 | EUCTR2004-002620-18-DE | 13/05/2005 | 1 May 2012 | A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versus Placebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects with Undifferentiated Inflammatory Arthritis at High Risk for the Development of Rheumatoid Arthritis. Revised protocol 2, dated 02-Feb-06, incorporating Amendments 02 and 03; and Pharmacogenetics Blood Sample Amendment Number 01 | A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versus Placebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects with Undifferentiated Inflammatory Arthritis at High Risk for the Development of Rheumatoid Arthritis. Revised protocol 2, dated 02-Feb-06, incorporating Amendments 02 and 03; and Pharmacogenetics Blood Sample Amendment Number 01 | Rheumatoid Arthritis, NOS | Product Name: Abatacept Product Code: BMS-188667 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Abatacept CAS Number: 332348-12-6 Current Sponsor code: BMS-188667 Other descriptive name: CTLA4Ig Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use | Bristol-Myers Squibb International Corporation | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Germany;Belgium;Spain;Italy | ||||
1765 | EUCTR2005-000549-13-SK | 03/05/2005 | 27 February 2017 | A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study of Two Doses of VX-702 in Subjects with Moderate to Severe Rheumatoid Arthritis - VeRA | A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study of Two Doses of VX-702 in Subjects with Moderate to Severe Rheumatoid Arthritis - VeRA | rheumatoid arthritis | Product Code: VX-702 Pharmaceutical Form: Tablet Current Sponsor code: VX-702 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Current Sponsor code: VX-702 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Czech Republic;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 |
1766 | NCT00106522 | May 2005 | 14 November 2016 | A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy | A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 499 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Iceland;Italy;Mexico;Netherlands;Puerto Rico;Sweden;Switzerland;United Kingdom | |
1767 | NCT00115219 | May 2005 | 19 February 2015 | Evaluating Efficacy and Safety of Etanercept 50 mg Twice Weekly (BIW) in Rheumatoid Arthritis (RA) Subjects Who Are Sub-Optimal Responders to Etanercept 50 mg Once Weekly (QW) | A Multi-center, Randomized, Double-Blind, Active-Controlled Study Evaluating Efficacy and Safety of Etanercept 50 mg Twice Weekly (BIW) in Rheumatoid Arthritis Subjects Who Are Sub-optimal Responders to Etanercept 50 mg Once Weekly (QW) | Rheumatoid Arthritis | Drug: Etanercept | Amgen | Not recruiting | 18 Years | N/A | Both | 200 | Phase 4 | United States | |
1768 | NCT00419809 | May 2005 | 19 February 2015 | SB-681323-Methotrexate Interaction Study | A Placebo Controlled Study to Evaluate the Safety and Tolerability of Repeat Doses of SB-681323 in Patients Receiving Methotrexate for Rheumatoid Arthritis. | Arthritis, Rheumatoid | Drug: SB-681323 oral tablets | GlaxoSmithKline | Not recruiting | 18 Years | 75 Years | Both | 18 | Phase 1 | Australia | |
1769 | NCT00432484 | May 2005 | 19 February 2015 | Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis | Lingzhi (Ganoderma Lucidum) and Sen Miao San Supplementation in Rheumatoid Arthritis(RA): An Animal Model and A Phase I Study | Rheumatoid Arthritis | Drug: Lingzhi and Sen Miao San | Chinese University of Hong Kong | Not recruiting | 18 Years | N/A | Both | 70 | Phase 2 | China | |
1770 | EUCTR2004-005210-37-SE | 26/04/2005 | 19 March 2012 | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. | Rheumatoid Arthritis | Product Name: MRA Product Code: RO4877533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: R04877533 Other descriptive name: MRA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann La-Roche AG | Not Recruiting | Female: yes Male: yes | 1200 | Finland;Czech Republic;Germany;Spain;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 |
1771 | EUCTR2005-000674-43-GB | 06/04/2005 | 3 April 2012 | AN OPEN LABEL STUDY OF THE EFFECT OF TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: Clinical, radiological, synovial and immunological outcomes - Rituximab in Rheumatoid Arthritis | AN OPEN LABEL STUDY OF THE EFFECT OF TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: Clinical, radiological, synovial and immunological outcomes - Rituximab in Rheumatoid Arthritis | Rheumatoid Arthritis | Trade Name: Mabthera Product Name: Mabthera Product Code: N/A Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: n/a CAS Number: n/a Current Sponsor code: n/a Other descriptive name: none Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | University of Leeds | Authorised | Female: yes Male: yes | 15 | United Kingdom | ||||
1772 | NCT00106574 | April 2005 | 14 November 2016 | A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis | A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy | Rheumatoid Arthritis | Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 1220 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;China;Costa Rica;Czech Republic;Finland;France;Germany;Hong Kong;Mexico;Panama;Russian Federation;South Africa;Spain;Sweden;Thailand | |
1773 | NCT00124982 | April 2005 | 19 October 2017 | Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options | Rheumatoid Arthritis | Drug: Abatacept;Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD);Drug: Anti-Tumor Necrosing Factor (TNF) Therapy | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 1286 | Phase 3 | United States;Belgium;Czech Republic;France;Germany;Ireland;Italy;Mexico;Spain;United Kingdom;Canada | |
1774 | NCT01745055 | April 2005 | 19 October 2017 | Co-Administration Of Methotrexate And CP-690,550 | A Phase 1, Open Label Study Of The Pharmacokinetics Of Multiple Doses Of Oral CP-690,550 And Single Doses Of Oral Methotrexate In Rheumatoid Arthritis Subjects | Rheumatoid Arthritis | Drug: CP-690,550 (tofacitinib);Drug: Methotrexate (MTX) | Pfizer | Not recruiting | 18 Years | 70 Years | All | 12 | Phase 1 | United States | |
1775 | EUCTR2004-004022-27-ES | 24/03/2005 | 19 March 2012 | Phase IIa, multicenter, randomised, double-blind, placebo controlled study of the efficacy and safety of RO0506997, an a4 integrin antagonist, in combination with methotrexate, versus methotrexate alone, in patients with mild/moderate active rheumatoid arthritis (RA) who have had a partial response to a stable dose of methotrexate. | Phase IIa, multicenter, randomised, double-blind, placebo controlled study of the efficacy and safety of RO0506997, an a4 integrin antagonist, in combination with methotrexate, versus methotrexate alone, in patients with mild/moderate active rheumatoid arthritis (RA) who have had a partial response to a stable dose of methotrexate. | Rhematoid Arthritis Classification code 10039073 | Product Code: RO0506997 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: RO0506997 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Code: RO0506997 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: RO0506997 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Code: RO0506997 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: RO0506997 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Code: RO0506997 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: RO0506997 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | F.Hoffmann - La Roche Ltd | Authorised | Female: yes Male: yes | 160 | Phase 2a | 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 |
1776 | EUCTR2004-003733-14-FI | 23/03/2005 | 1 May 2012 | A study investigating whether tocilizumab (study drug) prevents joint damage, and how safe it is, in patients with moderate to severe rheumatoid arthritis randomly divided to groups receiving treatment with tocilizumab and methotrexate or methotrexate and placebo. | A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. - LITHE | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: Tocilizumab Product Code: RO4877533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Tocilizumab CAS Number: 375823-41-9 Current Sponsor code: R04877533 Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann La-Roche Ltd. | Authorised | Female: yes Male: yes | 1170 | France;Norway;Italy;Australia;Brazil;South Africa;Finland;Denmark;Mexico;China;Spain;United States;Greece;Poland | ||||
1777 | EUCTR2005-000129-47-SE | 21/03/2005 | 19 March 2012 | The effect of Adalimumab (Humira) on vascular abnormalities in rheumatoid arthritis. A pilot study. | The effect of Adalimumab (Humira) on vascular abnormalities in rheumatoid arthritis. A pilot study. | Rheumatoid Arthritis. | Trade Name: Humira Product Name: Humira Pharmaceutical Form: Solution for injection INN or Proposed INN: Adalimumab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | Dept. of Rhematology UMAS | Not Recruiting | Female: yes Male: yes | 15 | Sweden | ||||
1778 | NCT00144586 | March 2005 | 19 February 2015 | Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP | An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA220JP or MRA221JP | Rheumatoid Arthritis | Drug: MRA(Tocilizumab) | Chugai Pharmaceutical | Not recruiting | 20 Years | 75 Years | Both | 42 | Phase 3 | ||
1779 | NCT00503503 | March 2005 | 19 February 2015 | Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan | Safety and Efficacy From Large Scale All Cases Surveillance for Etanercept in Japan | Rheumatoid Arthritis | Drug: Enbrel (etanercept) | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 11 Years | 90 Years | Both | Phase 4 | |||
1780 | EUCTR2004-002993-49-HU | 11/02/2005 | 9 October 2012 | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study | Rheumatoid Arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: certolizumab pegol CAS Number: 428863-50-7 Current Sponsor code: CDP870 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 150-+ or - 15 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Celltech R&D Ltd | Not Recruiting | Female: yes Male: yes | 950 | Phase 3 | Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania | ||||
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 |
1781 | EUCTR2004-004893-96-GB | 04/02/2005 | 1 May 2012 | Randomised double-blind trial of combination antibiotic therapy in rheumatoid arthritis | Randomised double-blind trial of combination antibiotic therapy in rheumatoid arthritis | Patients with medical diagnosis of Rheumatoid Arthritis | Trade Name: Dalacin C phosphate Product Name: Clindamycin Pharmaceutical Form: Intravenous infusion Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use Trade Name: Tetraccycline Product Name: Tetraccycline-hydrochloride Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Hammersmith Hospitals NHS trust | Authorised | Female: yes Male: yes | United Kingdom | |||||
1782 | EUCTR2004-001909-10-GB | 02/02/2005 | 15 July 2013 | Effect of Rosuvastatin on surrogate markers for cardiovascular events and joint disease progression in patients with rheumatoid arthritis - RORA trial | Effect of Rosuvastatin on surrogate markers for cardiovascular events and joint disease progression in patients with rheumatoid arthritis - RORA trial | Rheumatoid Arthritis | Trade Name: rosuvastatin Product Name: rosuvastatin Product Code: ZD 4522 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | University of Dundee | Not Recruiting | Female: yes Male: yes | United Kingdom | |||||
1783 | NCT00095147 | February 2005 | 19 October 2017 | Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis | A Phase IIIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination With Methotrexate in Controlling Disease Activity in Subjects With Rheumatoid Arthritis Having an Inadequate Clinical Response to Methotrexate | Rheumatoid Arthritis | Drug: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB);Drug: Infliximab (INF) + MTX, DB;Drug: Placebo (PLA) + MTX, DB;Drug: PLA + MTX switched to ABA+ MTX, DB;Drug: ABA, open-label (OL) | Bristol-Myers Squibb | Not recruiting | 18 Years | 75 Years | All | 431 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;Czech Republic;Denmark;Korea, Republic of;Mexico;Peru;Poland;Puerto Rico;Russian Federation;South Africa;Spain;Sweden;Switzerland | |
1784 | NCT00105976 | February 2005 | 19 February 2015 | Efficacy Study of MM-093 in Rheumatoid Arthritis Patients on Methotrexate (MTX) | A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Dose Levels (2.5, 7.5 and 20 mg) of MM-093 in Patients With Active Rheumatoid Arthritis on Stable Doses of Methotrexate | Rheumatoid Arthritis | Drug: MM-093 | Merrimack Pharmaceuticals | Not recruiting | 18 Years | 80 Years | Both | 260 | Phase 2 | United States | |
1785 | NCT00124449 | February 2005 | 19 October 2017 | Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients | A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA | Arthritis, Rheumatoid | Drug: Abatacept;Drug: placebo | Bristol-Myers Squibb | Not recruiting | 18 Years | 75 Years | All | 56 | Phase 2 | United States;Australia;Belgium;France;Germany;Italy;Mexico;Puerto Rico;Spain;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 |
1786 | NCT00144560 | February 2005 | 19 February 2015 | Drug-Drug Interaction Study of MRA in Patient With Rheumatoid Arthritis (RA) | An Open-Label, Clinical Pharmacology Study to Investigate Drug-Drug Interaction in Patients With RA | Rheumatoid Arthritis | Drug: MRA(Tocilizumab) | Chugai Pharmaceutical | Not recruiting | 20 Years | 75 Years | Both | 31 | N/A | ||
1787 | NCT00291928 | February 2005 | 19 February 2015 | HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II | A Double-blind, Randomized, Placebo Controlled, Dose Escalation, Multi-centerphase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20antibody, in Patients With Active Rheumatoid Arthritis Who Have Previously Failedone or More Disease Modifying Anti-rheumatic Drugs | Arthritis, Rheumatoid | Drug: Part A;Drug: Part B | GlaxoSmithKline | Not recruiting | 18 Years | N/A | Both | 201 | Phase 2 | United States;Denmark;Finland;France;Hungary;Poland;United Kingdom | |
1788 | NCT00423358 | February 2005 | 19 October 2017 | Treatment of Hypovitaminosis D in Rheumatoid Arthritis | Treatment of Hypovitaminosis D in Rheumatoid Arthritis | Rheumatoid Arthritis;Hypovitaminosis D | Dietary Supplement: Vitamin D;Dietary Supplement: placebo | University of Wisconsin, Madison | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | 90 Years | All | 22 | N/A | United States |
1789 | NCT00522184 | February 2005 | 19 February 2015 | Intra-Articular Injection of Etanercept in Patient Suffering From Rheumatoid Arthritis : a Double-Blind Randomized Study | Intra-Articular Injection of Etanercept in Patient Suffering From Rheumatoid Arthritis : a Double-Blind Randomized Study for Evaluation of Efficacy and Safety of Etanercept Versus Intra-Articular Steroid Injection in Acute Synovitis | Rheumatoid Arthritis | Procedure: intra-articular injection of etanercept;Procedure: intra-articular injection of steroid | Centre Hospitalier Universitaire de Nice | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Both | 34 | Phase 3 | France |
1790 | EUCTR2004-004302-24-FI | 18/01/2005 | 19 March 2012 | A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis | A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 7.0 Level: LLT Classification code 10039073 | Product Name: L-000883191 Product Code: L-000883191 Pharmaceutical Form: Tablet INN or Proposed INN: NA CAS Number: NA Current Sponsor code: NA Other descriptive name: NA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.25- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Paracetamol Product Name: Paracetamol Product Code: NA Pharmaceutical Form: Tablet INN or Proposed INN: NA CAS Number: 103-90-2 Current Sponsor code: NA Other descriptive name: NA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 325- | Suomen MSD Oy | Not Recruiting | Female: yes Male: yes | 136 | Finland;Czech Republic;Germany;Spain;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 |
1791 | NCT00106548 | January 2005 | 19 February 2015 | A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis | A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: Methotrexate | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | Both | 623 | Phase 3 | Argentina;Australia;Austria;Brazil;Bulgaria;Canada;China;France;Germany;Hungary;Israel;Italy;Mexico;Singapore;Slovakia;Switzerland;Thailand;Spain | |
1792 | NCT00123149 | January 2005 | 3 October 2016 | Open-Label Extension Safety Study of PROCRIT in Patients With Anemia of Chronic Disease Due to Rheumatoid Arthritis | An Open-Label (OL) Extension Study to Assess Safety of PROCRIT (Epoetin Alfa) in Patients With Anemia of Chronic Disease (ACD) Due to Rheumatoid Arthritis (RA) | Anemia;Rheumatoid Arthritis | Drug: Epoetin alfa | Ortho Biotech Products, L.P. | Not recruiting | 18 Years | 99 Years | Both | 0 | Phase 2 | ||
1793 | NCT00132769 | January 2005 | 19 October 2017 | A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED) | A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK-0873 in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MK-0873;Drug: Comparator: Placebo | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 65 Years | All | 106 | Phase 2 | Belgium;Canada;Czech Republic;Finland;Germany;Italy;Norway;Spain;Switzerland | |
1794 | NCT00144573 | January 2005 | 19 February 2015 | Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment | An Open-Label, Clinical Pharmacology Study to Evaluate the Safety and PK of MRA in Patients With RA With Renal Impairment | Rheumatoid Arthritis | Drug: MRA(Tocilizumab) | Chugai Pharmaceutical | Not recruiting | 20 Years | 75 Years | Both | 14 | N/A | ||
1795 | NCT00147498 | January 2005 | 19 October 2017 | Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CP-690,550;Other: Placebo | Pfizer | Not recruiting | 18 Years | 70 Years | All | 264 | Phase 2 | United States;Belgium;Brazil;Canada;Germany;Italy;Mexico;Slovakia;Spain;Austria | |
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 |
1796 | NCT00246168 | January 2005 | 19 February 2015 | ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain. | ULTRACET (Tramadol Hydrochloride and Acetaminophen) add-on Therapy for the Treatment of the Pain of Rheumatoid Arthritis: A Randomized, Double-blind, Placebo-controlled Study | Arthritis, Rheumatoid | Drug: tramadol hydrochloride + acetaminophen | Janssen Korea, Ltd., Korea | Not recruiting | 18 Years | 79 Years | Both | 277 | Phase 4 | ||
1797 | NCT00365001 | January 2005 | 19 February 2015 | A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis. | A Randomized, Open-label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: Methotrexate;Drug: Simvastatin | Hoffmann-La Roche | Not recruiting | 18 Years | 75 Years | Both | 23 | Phase 1 | United States;New Zealand | |
1798 | NCT00583557 | January 2005 | 19 October 2017 | A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01 | A Multi-Center, Open-Label, Continuation Trial of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) Who Completed the Phase 2 Protocol LBRA01 | Rheumatoid Arthritis | Drug: belimumab | Human Genome Sciences Inc. | Not recruiting | 18 Years | N/A | All | 155 | Phase 2 | United States;Poland | |
1799 | EUCTR2005-000492-18-IT | 16/12/2004 | 19 March 2012 | Insulin resistance and endothelial dysfunction TNF-Alpha dependent in patients with rheumatoid arthritis or metabolic syndrome | Insulin resistance and endothelial dysfunction TNF-Alpha dependent in patients with rheumatoid arthritis or metabolic syndrome | Metabolic Syndrome and Rheumatoid Arthritis MedDRA version: 6.1 Level: SOC Classification code 10021428 | Trade Name: REMICADE*EV F 100MG+F 2ML Pharmaceutical Form: Solution for injection INN or Proposed INN: Infliximab CAS Number: 170277-31-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI | Not Recruiting | Female: yes Male: yes | Italy | |||||
1800 | EUCTR2004-000922-59-SE | 01/12/2004 | 19 March 2012 | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination with Methotrexate in Controlling Disease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate Clinical Response to Methotrexate. Revised Protocol 1 , incorporating Amendment 02 (v5.0). Pharmacogenomic Amendment 01. Protocol Amendment 03 - Long-Term Extension. Protocol Amendment 05 - Long Term Extension Site Specific (V2.0, Date 23-Dec-2006). | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination with Methotrexate in Controlling Disease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate Clinical Response to Methotrexate. Revised Protocol 1 , incorporating Amendment 02 (v5.0). Pharmacogenomic Amendment 01. Protocol Amendment 03 - Long-Term Extension. Protocol Amendment 05 - Long Term Extension Site Specific (V2.0, Date 23-Dec-2006). | Rheumatoid Arthrithis, Nos | Product Name: Abatacept Product Code: BMS-188667 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Abatacept CAS Number: 332348-12-6 Current Sponsor code: BMS-188667 Other descriptive name: CTLA4Ig Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use Trade Name: Remicade Product Name: Remicade Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Infliximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use | Bristol Myers Squibb International Corporation | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | Czech Republic;Denmark;Spain;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 |
1801 | EUCTR2004-002157-30-FI | 01/12/2004 | 19 March 2012 | A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis | Rheumatoid Arthritis | Product Code: TAK-715 Pharmaceutical Form: Tablet Current Sponsor code: TAK-715 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Code: TAK-715 Pharmaceutical Form: Tablet Current Sponsor code: TAK-715 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Takeda Europe R&D Centre Ltd. (TEuR&D) | Not Recruiting | Female: yes Male: yes | 400 | Finland;Denmark | ||||
1802 | EUCTR2004-003741-40-AT | 26/11/2004 | 22 April 2013 | A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. | A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. | Rheumatoid Arthritis | Product Name: MRA Product Code: RO4877533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Tocilizumab CAS Number: 375823-41-9 Current Sponsor code: R04877533 Other descriptive name: MRA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann La-Roche AG | Not Recruiting | Female: yes Male: yes | 630 | Hungary;Austria;Germany;Italy | ||||
1803 | EUCTR2004-002006-30-GB | 17/11/2004 | 15 July 2013 | Triple therapy in early active rheumatoid arthritis - TEAR | Triple therapy in early active rheumatoid arthritis - TEAR | Rheumatoid arthritis | Product Name: Methotrexate Pharmaceutical Form: Tablet INN or Proposed INN: Methotrexate Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 25- Trade Name: Salazopyrin En-Tabs Product Name: sulfasalazine Pharmaceutical Form: Tablet INN or Proposed INN: Sulfasalazine Concentration unit: g gram(s) Concentration type: up to Concentration number: 4- Trade Name: Plaquenil Product Name: Hydroxychloroquine Pharmaceutical Form: Tablet INN or Proposed INN: Hydroxychloroquine Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 400- | North Glasgow NHS Trust | Not Recruiting | Female: yes Male: yes | 96 | United Kingdom | ||||
1804 | EUCTR2004-000563-96-HU | 12/11/2004 | 29 May 2012 | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | Rheumatoid Arthritis | Trade Name: Enbrel (etanercept) Product Code: 0881 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: etanercept CAS Number: N/Applicable Current Sponsor code: 0881 Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Powder and solvent for solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: Methotrexate-Lachema Product Name: methotrexate sodium tablets 2.5 mg Pharmaceutical Form: Capsule* INN or Proposed INN: methotrexate CAS Number: 7413-34-5 Other descriptive name: methotrexate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Methotrexate-Lachema Product Name: methotrexate sodium tablets 2.5 mg Pharmaceutical Form: Capsule* INN or Proposed INN: methotrexate CAS Number: 7413-34-5 Other descriptive name: methotrexate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Wyeth Pharmaceuticals | Not Recruiting | Female: yes Male: yes | 580 | Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden | ||||
1805 | NCT00170872 | November 2004 | 19 February 2015 | 6 Week Open-label Trial With Lumiracoxib 200mg o.d. in Primary Knee Osteoarthritis or Rheumatoid Arthritis | A 6 Week, Multicenter, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of Lumiracoxib 200mg o.d. in Patients With Primary Knee Osteoarthritis or Rheumatoid Arthritis | Osteoarthritis;Rheumatoid Arthritis | Drug: Lumiracoxib | Novartis | Not recruiting | 18 Years | N/A | Both | 135 | Phase 3 | ||
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 |
1806 | NCT00195494 | November 2004 | 19 October 2017 | Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis | A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Etanercept;Drug: Methotrexate;Drug: Placebo | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | All | 542 | Phase 4 | United States | |
1807 | NCT00236028 | November 2004 | 19 February 2015 | A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis | A Randomized, Double-blind, Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared With Methotrexate Alone for the Treatment of Patients With Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Infliximab | Centocor, Inc. | Not recruiting | 18 Years | 75 Years | Both | 607 | Phase 3 | ||
1808 | NCT00379600 | November 2004 | 7 November 2016 | The Anti-Inflammatory And Metabolic Effects Of Rosiglitazone In Subjects With Rheumatoid Arthritis | A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Anti-inflammatory and Metabolic Effects of Rosiglitazone XR, 8mg Once Daily, in Subjects With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: rosiglitazone XR | GlaxoSmithKline | Not recruiting | 18 Years | N/A | Both | 96 | Phase 2 | Lithuania;United Kingdom | |
1809 | NCT00747214 | November 2004 | 19 October 2017 | A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA | A Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to That of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects With RA | Rheumatoid Arthritis | Drug: CRx-102;Drug: Placebo;Drug: DMARD Therapy | Zalicus | Not recruiting | 18 Years | N/A | All | 59 | Phase 2 | ||
1810 | NCT00854321 | November 2004 | 19 February 2015 | Patients With Rheumatoid Arthritis (RA) Treated With Rituximab in Kuopio University Hospital | One Centre Follow-up Study on Safety and Efficacy | Rheumatoid Arthritis | Drug: rituximab;Drug: rituximab, observational study amon patients with active RA | Kuopio University Hospital | Not recruiting | 18 Years | N/A | Both | 49 | 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 |
1811 | NCT01600521 | November 2004 | 20 April 2015 | A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications | A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications | Rheumatoid Arthritis | Drug: A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs | University of Minnesota - Clinical and Translational Science Institute | Not recruiting | 18 Years | N/A | Both | 1748 | N/A | China | |
1812 | EUCTR2004-000012-13-CZ | 26/10/2004 | 9 October 2012 | A Double-Blind, Placebo-Controlled, Parallel, Randomized Study To Evaluate The Efficacy And Safety Of 3 Oral Dose Levels Of TMI-005 In Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate - | Rheumatoid Arthritis | Product Name: TMI-005 (WAY-177005) Product Code: TMI-005 (WAY-177005) Pharmaceutical Form: Capsule* INN or Proposed INN: Not yet established CAS Number: 287405-51-0 Current Sponsor code: TMI-005 Other descriptive name: WAY-177005 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: TMI-005 (WAY-177005) Product Code: TMI-005 (WAY-177005) Pharmaceutical Form: Capsule* INN or Proposed INN: Not yet established CAS Number: 287405-51-0 Current Sponsor code: TMI-005 Other descriptive name: WAY-177005 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: TMI-005 (WAY-177005) Product Code: TMI-005 (WAY-177005) Pharmaceutical Form: Capsule* INN or Proposed INN: Not yet established CAS Number: 287405-51-0 Current Sponsor code: TMI-005 Other descriptive name: WAY-177005 Concentration unit: mg milligram(s) Concentration number: 150- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development | Authorised | Female: yes Male: yes | 360 | Czech Republic;Estonia;Italy | |||||
1813 | EUCTR2004-000482-35-GB | 11/10/2004 | 19 March 2012 | A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arthritis. - HM2004/00255/00 | A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arthritis. - HM2004/00255/00 | Rheumatoid Arthritis | Product Name: Rosiglitazone Extended Release Tablets Product Code: BRL-049653 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Rosiglitazone CAS Number: 0155141-29-0 Other descriptive name: Rosiglitazone maleate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 8- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | GlaxoSmithKline Research & Development Ltd. | Authorised | Female: yes Male: yes | 96 | United Kingdom;Lithuania | ||||
1814 | NCT00094341 | October 2004 | 19 February 2015 | Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes | An Open-Label, Randomized, Crossover Study to Assess Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes | Rheumatoid Arthritis | Drug: Etanercept | Amgen | Not recruiting | 18 Years | N/A | Both | 215 | Phase 4 | United States | |
1815 | NCT00242853 | October 2004 | 19 February 2015 | A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis | An Enabling Study to Investigate the Correlation of Biomarkers of the Activity of Inducible Nitric Oxide Synthase (iNOS) With Disease Activity and Treatment Response in Patients With Rheumatoid Arthritis(RA) | Rheumatoid Arthritis;Osteoarthritis | Procedure: Power doppler ultrasonography;Procedure: High frequency ultrasonography;Procedure: Exhaled nitric oxide assessment | GlaxoSmithKline | Not recruiting | 18 Years | 75 Years | Both | 48 | N/A | 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 |
1816 | NCT00650390 | October 2004 | 19 February 2015 | Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab | Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab | Rheumatoid Arthritis | Biological: adalimumab | Abbott | Not recruiting | 18 Years | N/A | Both | N/A | |||
1817 | EUCTR2004-001490-26-GB | 15/09/2004 | 15 July 2013 | A SINGLE-CENTER, RANDOMIZED, SINGLE-BLIND STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA | A SINGLE-CENTER, RANDOMIZED, SINGLE-BLIND STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA | RHEUMATOID ARTHRITIS | Trade Name: Asendis 50 mg Product Code: CRx-150 Pharmaceutical Form: Tablet INN or Proposed INN: Amoxapine & dipyridamole Current Sponsor code: CRx-150 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50 or 100 and-100 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | CombinatoRx, Inc | Not Recruiting | Female: yes Male: yes | Estonia;United Kingdom | |||||
1818 | EUCTR2004-000612-54-SE | 11/09/2004 | 19 March 2012 | A Multicenter, Randomized, Parallel-Group, Active-Controlled Double-Blind Study Conducted Under In-House Blinding Conditions to Determine the Incidence of Gastroduodenal Ulcers in Patients With Osteoarthritis or Rheumatoid Arthritis After 12 Weeks of Treatment With L-001069957 21 mg Plus Low-Dose Aspirin, L- 01069957 42 mg Plus Low-Dose Aspirin, Celecoxib 400 mg Plus Low-Dose Aspirin, or Low-Dose Aspirin Alone - 12-Week NO-Rofecoxib Plus Aspirin Endoscopy Study | A Multicenter, Randomized, Parallel-Group, Active-Controlled Double-Blind Study Conducted Under In-House Blinding Conditions to Determine the Incidence of Gastroduodenal Ulcers in Patients With Osteoarthritis or Rheumatoid Arthritis After 12 Weeks of Treatment With L-001069957 21 mg Plus Low-Dose Aspirin, L- 01069957 42 mg Plus Low-Dose Aspirin, Celecoxib 400 mg Plus Low-Dose Aspirin, or Low-Dose Aspirin Alone - 12-Week NO-Rofecoxib Plus Aspirin Endoscopy Study | Osteoarthritis (OA) ICD: M19.9 MedDRA: 10031161 Rheumatoid Arthritis (RA) ICD: M06.9 MedDRA: 10039037 | Product Name: L-001069957 Product Code: L-001069957 Pharmaceutical Form: Tablet INN or Proposed INN: 6-(nitrooxy)hexyl(2Z)-4-(acetyloxy)-3-[4-(methylsulfonyl)phenyl]-2-phenylbut-2-enoate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 21- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: L-001069957 Product Code: L-001069957 Pharmaceutical Form: Tablet INN or Proposed INN: 6-(nitrooxy)hexyl(2Z)-4-(acetyloxy)-3-[4-(methylsulfonyl)phenyl]-2-phenylbut-2-enoate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 42- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Aspirin Tablets Pharmaceutical Form: Tablet INN or Proposed INN: Acetylsalicylic acid CAS Number: 530-75-6 Other descriptive name: Acetylsalicylic Acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Celebrex Product Name: Celecoxib Pharmaceutical Form: Capsule* INN or Proposed INN: Celecoxib CAS Number: 169590-42-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Merck Sharp & Dohme (Sweden) AB | Not Recruiting | Female: yes Male: yes | 1360 | Sweden | ||||
1819 | EUCTR2004-000106-41-SE | 07/09/2004 | 19 March 2012 | A study to investigate the effect of GW406381 on methotrexate pharmacokinetics in patients treated with methotrexate for rheumatoid arthritis - GW406381 and methotrexate | A study to investigate the effect of GW406381 on methotrexate pharmacokinetics in patients treated with methotrexate for rheumatoid arthritis - GW406381 and methotrexate | The patients entering the trial have rheumatoid arthritis although treatment of the disease itself is not under investigation in this study. | Product Name: GW406381 Product Code: GW406381 Pharmaceutical Form: Capsule* | GlaxoSmithKline Research & Development Ltd | Not Recruiting | Female: yes Male: yes | Sweden | |||||
1820 | NCT00117091 | September 2004 | 19 February 2015 | Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA) | An Open-Label Multicentre Study of Anakinra (Kineret®) in Combination With DMARDS in Subjects With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Anakinra (Kineret®) | Amgen | Not recruiting | 18 Years | N/A | Both | Phase 3 | |||
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 |
1821 | NCT00412256 | September 2004 | 19 February 2015 | Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial) | Clinical Trial to Evaluate the Effect of Parenteral Supplementation With Omega-3-Fatty Acids in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Omegaven (10% fish-oil emulsion; Fresenius-Kabi) | Humanis Klinikum Niederosterreich | Not recruiting | 18 Years | N/A | Both | 60 | Phase 3 | Austria | |
1822 | NCT00638950 | September 2004 | 19 February 2015 | A Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products in Patients With Rheumatoid Arthritis | Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products: Effects on Pathophysiological Biomarkers in Rheumatoid Arthritis | Rheumatoid Arthritis | Dietary Supplement: n-3 LC-PUFA;Dietary Supplement: Placebo | University of Jena | Not recruiting | 35 Years | 74 Years | Both | 45 | N/A | Germany | |
1823 | NCT00831649 | September 2004 | 27 June 2016 | A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201 | A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201 | Rheumatoid Arthritis | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Not recruiting | 18 Years | 75 Years | Both | Phase 2 | ||
1824 | NCT00831922 | September 2004 | 18 December 2018 | Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis | A Multicenter, Open Label, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis With Inadequate Response to at Least One Disease Modifying Anti Rheumatic Drugs (DMARD) | Rheumatoid Arthritis | Drug: masitinib (AB1010) | AB Science | Not recruiting | 18 Years | N/A | All | 43 | Phase 2 | ||
1825 | NCT00095498 | August 2004 | 16 December 2017 | Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis | A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: placebo;Drug: denosumab | Amgen | Not recruiting | 18 Years | N/A | All | 227 | 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 |
1826 | NCT00146640 | August 2004 | 19 February 2015 | Prednisone Timed-Release Tablet (TRT) Study: TRT Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis | A New Timed-release Tablet Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis- A Randomized, Multi-centre, Double-blind, Active Controlled Study With Open Extension on the New Drug Only | Rheumatoid Arthritis | Drug: Prednisone | Merck KGaA | Not recruiting | 18 Years | 80 Years | Both | 288 | Phase 3 | Germany;Poland | |
1827 | NCT00234897 | August 2004 | 19 February 2015 | Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis | Humira Efficacy Response Optimization Study in Subjects With Active Rheumatoid Arthritis (HERO) | Rheumatoid Arthritis | Drug: adalimumab | Abbott | Not recruiting | 18 Years | N/A | Both | 1938 | Phase 4 | United States | |
1828 | NCT00235872 | August 2004 | 19 October 2017 | Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis | Open-Label Continuous Administration Study With Adalimumab (D2E7) in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: adalimumab | Abbott | Abbott Japan Co.,Ltd;Eisai Co., Ltd. | Not recruiting | 20 Years | N/A | All | 309 | Phase 3 | Japan |
1829 | NCT00279734 | August 2004 | 19 February 2015 | Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers | An Exploratory Study to Evaluate the Effect of Abatacept (BMS-188667) on the Antibody Response Following Tetanus Toxoid and 23-Valent Pneumococcal Vaccinations in Healthy Subjects | Rheumatoid Arthritis | Drug: Tetanus + pnemococcal vaccines alone;Drug: Abatacept + vaccines;Drug: Abatacept + Vaccines | Bristol-Myers Squibb | Not recruiting | 18 Years | 65 Years | Both | 80 | Phase 1 | United States | |
1830 | NCT00696059 | August 2004 | 19 February 2015 | Humira in Rheumatoid Arthritis - Do Bone Erosions Heal? | Can Bone Erosions Heal in Adalimumab (Humira) Treated Rheumatoid Arthritis Patients. An Imaging Study Using Computed Tomography and Magnetic Resonance Imaging. | Rheumatoid Arthritis;Arthritis;Joint Diseases | Drug: Adalimumab (Humira) | Hvidovre University Hospital | Abbott | Not recruiting | 18 Years | 90 Years | Both | 52 | 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 |
1831 | EUCTR2004-000362-12-CZ | 23/07/2004 | 19 March 2012 | A Double-Blind, Randomised, Dose-Ranging Study to Compare K-832 with Placebo in the treatment of Patients with Active Rheumatoid Arthritis - N/A | A Double-Blind, Randomised, Dose-Ranging Study to Compare K-832 with Placebo in the treatment of Patients with Active Rheumatoid Arthritis - N/A | Rheumatoid Arthritis MedDRA version: 6.0 Level: LLT Classification code 10028395 | Product Name: K-832 Product Code: K-832 Pharmaceutical Form: Tablet INN or Proposed INN: To be confirmed CAS Number: 225666-85-3 Current Sponsor code: K-832 Other descriptive name: N/A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: K-832 Product Code: K-832 Pharmaceutical Form: Tablet INN or Proposed INN: To be confirmed CAS Number: 225666-85-3 Current Sponsor code: K-832 Other descriptive name: N/A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Kowa Research Europe Ltd | Not Recruiting | Female: yes Male: yes | 260 | Czech Republic | ||||
1832 | EUCTR2004-000074-31-SE | 06/07/2004 | 19 March 2012 | A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis | A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis | rheumatoid arthritis MedDRA version: 7.0 Level: LLT Classification code 10039073 | Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c Product Code: L-000124467 (freebase); L-000124467-009J (succinat Pharmaceutical Form: Tablet INN or Proposed INN: not available Other descriptive name: L-000124467 Concentration unit: mg milligram(s) Concentration number: 0.2- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c Product Code: L-000124467 (freebase); L-000124467-009J (succinat Pharmaceutical Form: Tablet INN or Proposed INN: not available Other descriptive name: L-000124467 Concentration unit: mg milligram(s) Concentration number: 1.0- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c Product Code: L-000124467 (freebase); L-000124467-009J (succinat Pharmaceutical Form: Tablet INN or Proposed INN: not available Other descriptive name: L-000124467 Concentration unit: mg milligram(s) Concentration number: 5.0- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: paracetamol (acetaminophen) Product Name: paracetamol (acetaminophen) Pharmaceutical Form: Tablet CAS Number: 103-90-2 Concentration unit: mg milligram(s) Concentration number: 325- | Merck Sharp & Dohme (Sweden) AB | Not Recruiting | Female: yes Male: yes | 150 | Sweden | ||||
1833 | NCT00239382 | July 1, 2004 | 20 August 2018 | A Study to Compare Meloxicam IM Once Daily Versus Meloxicam Orally Once Daily in Patients With Rheumatoid Arthritis | A Randomized, Open-labelled Study to Compare the Efficacy and Safety of Meloxicam 15 mg IM Ampoules Once Daily and Meloxicam 15 mg Tablets Administered Orally Once Daily Over a Period of 7 Days in Patients With RA. | Arthritis, Rheumatoid | Drug: Meloxicam ampoule;Drug: Meloxicam tablet | Boehringer Ingelheim | Not recruiting | 18 Years | N/A | All | 150 | Phase 3 | China | |
1834 | NCT00089921 | July 2004 | 19 February 2015 | SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate | A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than Hydroxychloroquine | Arthritis, Rheumatoid | Drug: SCIO-469;Drug: Placebo | Scios, Inc. | Not recruiting | 18 Years | N/A | Both | 302 | Phase 2 | United States | |
1835 | NCT00154336 | July 2004 | 16 December 2017 | A Study of Imatinib 400 mg Once Daily in Combination With Methotrexate in the Treatment of Rheumatoid Arthritis. | 3-Month, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety & Tolerability of Imatinib 400 mg Daily in Combination With Methotrexate (MTX)Compared to MTX Alone in the Treatment of Rheumatoid Arthritis (RA). | Rheumatoid Arthritis | Drug: Imatinib;Drug: Methotrexate;Drug: Imatinib Placebo | Novartis Pharmaceuticals | Not recruiting | 18 Years | 75 Years | All | 50 | Phase 2 | Austria;Canada;Finland;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 |
1836 | NCT00236678 | July 2004 | 19 February 2015 | Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients With ACD Due to RA Receiving PROCRIT | A Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients With Anemia of Chronic Disease (ACD) Due to Rheumatoid Arthritis Receiving PROCRIT? (Epoetin Alfa) | Anemia;Rheumatoid Arthritis | Drug: Epoetin alfa | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Ortho Biotech Products, L.P. | Not recruiting | 18 Years | N/A | Both | 29 | Phase 2 | |
1837 | NCT00506896 | July 2004 | 19 February 2015 | Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients | Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients: A Randomized Double-Blind Controlled Study | Rheumatoid Arthritis | Drug: intraarticular injection | Federal University of São Paulo | Not recruiting | 18 Years | 65 Years | Both | 60 | Phase 2 | Brazil | |
1838 | NCT00094562 | June 2004 | 28 January 2019 | A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss | AAFA™ Fish Oil Nutritional Supplementation to Maintain Body Weight in Patients With Disease-Related Weight Loss | Cancer;Cancer Cachexia;Chronic Obstructive Pulmonary Disease;Chronic Heart Failure;Rheumatoid Arthritis | Drug: Fish oil supplement | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | National Center for Complementary and Integrative Health (NCCIH) | Not recruiting | 18 Years | 90 Years | All | 25 | Phase 2 | United States |
1839 | NCT00144534 | June 2004 | 19 February 2015 | Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP | An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA213JP | Rheumatoid Arthritis | Drug: MRA (Tocilizumab) | Chugai Pharmaceutical | Not recruiting | 20 Years | 75 Years | Both | 115 | Phase 3 | ||
1840 | NCT00244153 | June 2004 | 19 February 2015 | Intraarticular Opioids Vs Glucocorticosteroids in Gonarthritis | Intraarticular Application of Opioids Versus Glucocorticosteroids Versus Placebo in Rheumatoid Arthritis | Rheumatic Disease | Drug: intraarticular morphine;Drug: intraarticular dexamethasone | Charite University, Berlin, Germany | Recruiting | 19 Years | N/A | Both | 120 | Phase 1/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 |
1841 | NCT00252668 | June 2004 | 19 February 2015 | Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects | An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects | Rheumatoid Arthritis | Drug: Etanercept;Drug: Methotrexate | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Both | 300 | Phase 4 | ||
1842 | NCT00273533 | June 2004 | 19 February 2015 | Ramipril in Rheumatoid Arthritis | Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Ramipril | University of Zurich | Sanofi | Not recruiting | 18 Years | 60 Years | Both | 13 | Phase 2/Phase 3 | Switzerland |
1843 | NCT00542022 | June 2004 | 2 November 2015 | Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis (0812-008) | A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK0812 in Rheumatoid Arthritis Patients | Arthritis, Rheumatoid | Drug: MK0812 / Duration of Treatment: 12 Weeks;Drug: Comparator: placebo (unspecified) / Duration of Treatment: 12 Weeks | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 65 Years | Both | 149 | Phase 2 | ||
1844 | NCT02097745 | June 2004 | 19 October 2017 | A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies | An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies | Rheumatoid Arthritis | Drug: methotrexate;Drug: rituximab [MabThera/Rituxan] | Hoffmann-La Roche | Biogen | Not recruiting | 18 Years | 80 Years | All | 341 | Phase 3 | United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom |
1845 | NCT00083759 | May 2004 | 19 October 2017 | Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate | A Phase II, Multicenter, Double-blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Natalizumab (300 mg) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Receiving Concomitant Treatment With Methotrexate (MTX) | Rheumatoid Arthritis | Drug: natalizumab;Drug: placebo | Biogen | Elan Pharmaceuticals | Not recruiting | 18 Years | 75 Years | All | 299 | Phase 2 | United States;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 |
1846 | NCT00099554 | May 2004 | 19 February 2015 | Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab) | A Phase 4, Open-Label, Single Arm, Observational Study Evaluating the Effectiveness and Safety of Enbrel® (Etanercept) 50 mg Once Weekly in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab) | Rheumatoid Arthritis | Drug: Etanercept | Amgen | Not recruiting | 18 Years | N/A | Both | 200 | Phase 4 | United States;Canada | |
1847 | NCT00110903 | May 2004 | 19 February 2015 | Treatment for Subjects With Active Rheumatoid Arthritis (RA) | Open-Label Study to Assess the Safety of Etanercept Liquid Administered Once Weekly in Subjects With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Etanercept Liquid | Amgen | Not recruiting | 18 Years | N/A | Both | Phase 3 | |||
1848 | NCT00195338 | May 2004 | 19 October 2017 | Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg | A Post-Marketing Surveillance Looking At Safety And Adherence To Treatment Of Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg | Rheumatoid Arthritis | Drug: etanercept | Pfizer | Innovex, Inc | Not recruiting | 17 Years | N/A | All | 25 | N/A | Luxembourg |
1849 | NCT00195403 | May 2004 | 19 October 2017 | A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA | A Drug Use Investigation of Enbrel for Post-Marketing Surveillance | Rheumatoid Arthritis | Drug: Etanercept | Pfizer | Not recruiting | 4 Years | N/A | All | 1014 | N/A | Korea, Republic of | |
1850 | NCT00259610 | May 2004 | 19 October 2017 | Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) | Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) | Rheumatoid Arthritis | Drug: methotrexate;Drug: sulfasalazine;Drug: hydroxychloroquine;Drug: etanercept | University of Alabama at Birmingham | Amgen;Barr Laboratories;Pfizer | Not recruiting | 18 Years | N/A | All | 755 | 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 |
1851 | NCT00291915 | May 2004 | 19 February 2015 | Multicenter Randomized Prospective Trial Comparing Methotrexate Alone or in Combination With Adalimumab in Early Arthritis | Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis | Rheumatoid Arthritis;Arthritis | Drug: Adalimumab;Drug: Methotrexate | Goupe d'Etudes et de Recherche Clinique En Rhumatologie | Recruiting | 18 Years | N/A | Both | 80 | Phase 4 | France | |
1852 | NCT00144547 | April 2004 | 19 February 2015 | Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP | An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA012JP | Rheumatoid Arthritis | Drug: MRA(Tocilizumab) | Chugai Pharmaceutical | Not recruiting | 20 Years | N/A | Both | 241 | Phase 3 | ||
1853 | NCT00280644 | April 2004 | 19 February 2015 | Leflunomide in Rheumatoid Arthritis | Efficacy of Leflunomide on Joint Inflammation and Destruction of Joint Integrity in Active Rheumatoid Arthritis (RA) Patients | Arthritis, Rheumatoid | Drug: Leflunomide | Sanofi | Not recruiting | 18 Years | 75 Years | Both | 60 | Phase 4 | Turkey | |
1854 | NCT00468377 | March 2004 | 19 February 2015 | Safety and Efficacy Study of Re-treatment With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Respond Poorly to Anti-TNFa Therapies | An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies | Arthritis, Rheumatoid | Drug: Rituximab | Hoffmann-La Roche | Genentech, Inc. | Not recruiting | 18 Years | 80 Years | Both | 341 | Phase 3 | United States |
1855 | NCT00484809 | March 2004 | 19 February 2015 | Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children | A Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA). | Rheumatoid Arthritis | Drug: Enbrel (Etanercept) | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 4 Years | N/A | Both | 100 | 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 |
1856 | NCT00725621 | March 2004 | 19 October 2017 | Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED) | Real Life Dosing Regimen of Remicade in Austria, Monitored Over 9 Consecutive Infusions in Rheumatoid Arthritis Therapy | Rheumatoid Arthritis | Biological: Infliximab | Merck Sharp & Dohme Corp. | Centocor, Inc. | Not recruiting | N/A | N/A | All | 516 | N/A | Austria |
1857 | NCT00077870 | February 2004 | 19 February 2015 | A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Multicenter, Blinded Phase I/II Study of the Safety of Escalating Doses of Ocrelizumab (PRO70769) in Subjects With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate | Rheumatoid Arthritis | Drug: ocrelizumab | Genentech, Inc. | Not recruiting | 18 Years | 80 Years | Both | 237 | Phase 1/Phase 2 | United States | |
1858 | NCT00144521 | February 2004 | 19 February 2015 | Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA) | A Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA | Rheumatoid Arthritis | Drug: MRA(Tocilizumab);Drug: MRA placebo;Drug: MTX;Drug: MTX placebo | Chugai Pharmaceutical | Not recruiting | 20 Years | 75 Years | Both | 127 | Phase 3 | ||
1859 | NCT00224562 | February 2004 | 19 February 2015 | The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a Antagonists | The RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a Antagonists | Rheumatoid Arthritis;Crohn's Disease;Ankylosing Spondylitis;Psoriasis | Drug: TNF-alpha antagonists | Assistance Publique - Hôpitaux de Paris | Recruiting | N/A | N/A | Both | N/A | France | ||
1860 | NCT00367965 | February 2004 | 19 February 2015 | Study of Eszopiclone Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis | The Effect of Eszopiclone 3 mg Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis | Insomnia;Arthritis, Rheumatoid | Drug: Eszopiclone;Drug: placebo | Sunovion | Not recruiting | 25 Years | 64 Years | Both | 153 | Phase 3 | 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 |
1861 | NCT00647491 | February 2004 | 19 February 2015 | A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: adalimumab;Biological: placebo | Abbott | Eisai Limited | Not recruiting | 20 Years | N/A | Both | 352 | Phase 2/Phase 3 | Japan | |
1862 | NCT00679510 | February 2004 | 11 November 2019 | Rosuvastatin in Rheumatoid Arthritis (RORA) | Phase 2: Effects of Rosuvastatin on Surrogate Markers for Cardiovascular Events in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: rosuvastatin;Drug: placebo | University of Dundee | Not recruiting | 40 Years | N/A | All | 50 | Phase 2/Phase 3 | United Kingdom | |
1863 | NCT00157872 | January 7, 2004 | 16 December 2017 | A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231) | A Multicenter, Randomized, Parallel-Group, 8-Week, Double-Blind, and Active Comparator-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Rofecoxib Tablet 25 mg Once Daily Versus Naproxen Table 500 mg Twice Daily in the Treatment of Chinese Patient With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MK0966; rofecoxib;Drug: Comparator: naproxen tablet 500 mg | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 150 | Phase 4 | China | |
1864 | NCT00378261 | January 2004 | 19 February 2015 | APART Advanced Profiling of Anti-Rheumatic Therapies | A Multicenter, Randomized, Open Study to Evaluate the Impact of an Electronic Data Capture System on the Care of Patients With Rheumatoid Arthritis | Arthritis, Rheumatoid | Procedure: Use of an Electronic Data Capture System by patients and physicians to assess patient-physician interactions & therapeutic decisions & outcomes in RA subjects. | Centocor Ortho Biotech Services, L.L.C. | Not recruiting | 18 Years | N/A | Both | 1079 | Phase 4 | ||
1865 | NCT00071812 | December 2003 | 19 October 2017 | A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) | Arthritis, Rheumatoid | Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 4 mg/kg;Drug: Belimumab 10 mg/kg | Human Genome Sciences Inc. | Not recruiting | 18 Years | 65 Years | All | 283 | 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 |
1866 | NCT00076206 | December 2003 | 21 December 2015 | Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy | A Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Oral Dose Levels (1, 2, And 4 Mg) of CCI-779 in Subjects With Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy | Rheumatoid Arthritis | Drug: CCI-779;Drug: Placebo | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | 75 Years | Both | Phase 2 | United States | ||
1867 | NCT00095173 | December 2003 | 19 October 2017 | BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis | A Phase III, Multi-Center, Multi-National, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents With Active Polyarticular Juvenile Rheumatoid Arthritis (JRA) | Juvenile Rheumatoid Arthritis | Drug: Abatacept;Drug: Placebo | Bristol-Myers Squibb | Not recruiting | 6 Years | 17 Years | All | 214 | Phase 3 | United States;Austria;Brazil;France;Germany;Italy;Mexico;Peru;Portugal;Spain;Switzerland | |
1868 | NCT00234936 | December 2003 | 19 February 2015 | Quality of Life Study With Adalimumab in Rheumatoid Arthritis | Quality of Life Study With Adalimumab in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Adalimumab;Drug: Methotrexate | Abbott | Not recruiting | 18 Years | N/A | Both | 200 | Phase 3 | ||
1869 | NCT00619905 | December 2003 | 19 February 2015 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Rheumatoid Arthritis With Ongoing Treatment With Methotrexate | A Randomized, Double-Blind, Placebo-Controlled, Cohort Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 (Anti-Interleukin-1Beta Monoclonal Antibody) in Patients With Active Rheumatoid Arthritis (RA) Despite Ongoing Treatment With Methotrexate (MTX) 15 mg or More Weekly for at Least 3 Months. | Rheumatoid Arthritis | Drug: ACZ885 | Novartis | Not recruiting | 18 Years | 75 Years | Both | 53 | Phase 1/Phase 2 | Germany;Netherlands;Switzerland | |
1870 | NCT00207714 | November 2003 | 19 October 2017 | An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis | A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate | Rheumatoid Arthritis | Drug: Golimumab;Drug: MTX;Drug: Placebo;Drug: Infliximab | Centocor, Inc. | Centocor BV | Not recruiting | 18 Years | N/A | All | 172 | Phase 2 | |
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 |
1871 | NCT00162201 | October 2003 | 16 December 2017 | An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy | An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 16 | Phase 1 | United Kingdom | |
1872 | NCT00649922 | October 2003 | 19 February 2015 | Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis | Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: adalimumab;Biological: placebo | Abbott | Not recruiting | 20 Years | N/A | Both | 226 | Phase 4 | ||
1873 | NCT00069017 | September 2003 | 19 February 2015 | Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients With Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate | A Phase II, Randomized, Double-Blind Study to Evaluate the Effects of MEDI-522, a Humanized MAb to Integrin Alpha V Beta 3, On Disease Activity and Progression of Joint Damage in Pts With Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate | Rheumatoid Arthritis | Biological: MEDI-522;Other: Placebo | MedImmune LLC | Not recruiting | 18 Years | N/A | Both | 300 | Phase 2 | United States;Canada | |
1874 | NCT00234884 | September 2003 | 19 October 2017 | Post-marketing Observational Study in Subjects With Rheumatoid Arthritis | A Five-year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed Humira | Rheumatoid Arthritis | Biological: adalimumab | Abbott | Not recruiting | 18 Years | N/A | All | 3435 | Phase 4 | Australia;Austria;Belgium;France;Germany;Greece;Italy;Netherlands;Portugal;Spain;United Kingdom | |
1875 | NCT00221000 | August 2003 | 31 October 2016 | Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis | A Phase II, Multicenter, Randomized, Double-blind, Sham Pheresis-controlled, Study of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis in Patients Who Have an Inadequate Response to Disease Modifying Antirheumatic Drugs and Biological Agents | Rheumatoid Arthritis | Drug: Methoxsalen;Procedure: Extracorporeal Photopheresis | Mallinckrodt | Not recruiting | 18 Years | N/A | Both | 86 | Phase 2 | United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Mexico;Slovakia;South Africa | |
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 |
1876 | NCT00794898 | July 1, 2003 | 16 December 2017 | Efficacy of Remicade in the Treatment of Active Rheumatoid Arthritis Despite Methotrexate (Study P03027) | Onset of Efficacy of Anti-TNF Chimeric Monoclonal Antibody (Remicade) in the Treatment of Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment | Arthritis, Rheumatoid | Biological: Infliximab (Remicade) | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 75 Years | All | 19 | Phase 4 | ||
1877 | NCT00195364 | July 2003 | 19 February 2015 | Study Evaluating Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain | Long-Term Safety Study of Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain | Rheumatoid Arthritis;Inflammation | Drug: Etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Both | 93 | Phase 4 | Spain | |
1878 | NCT00235859 | July 2003 | 19 February 2015 | Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate | A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Injections in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate | Rheumatoid Arthritis | Drug: adalimumab;Drug: methotrexate | Abbott | Eisai Limited | Not recruiting | 18 Years | N/A | Both | 128 | Phase 3 | |
1879 | NCT00647920 | July 2003 | 19 February 2015 | Study of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate | Study of the Human Anti-TNF-Antibody Adalimumab | Rheumatoid Arthritis | Biological: adalimumab;Biological: placebo | Abbott | Not recruiting | 18 Years | N/A | Both | 47 | Phase 3 | Taiwan | |
1880 | NCT00649545 | July 2003 | 19 February 2015 | Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis | A Multi-Center Study of the Safety and Efficacy of Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: adalimumab | Abbott | Not recruiting | 18 Years | N/A | Both | 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 |
1881 | NCT02184052 | July 2003 | 19 February 2015 | Safety and Efficacy of Mobic® Ampoules in the Initiation of Treatment of Painful Exacerbations of Osteoarthritis, Rheumatoid Arthritis and Other Similar Painful Inflammatory Conditions | Meloxicam (MOBIC®) Ampoule Post Marketing Surveillance Study | Arthritis, Rheumatoid | Drug: Meloxicam | Boehringer Ingelheim | Not recruiting | N/A | N/A | Both | 121 | N/A | ||
1882 | NCT00062465 | June 2003 | 19 February 2015 | Treating Rheumatoid Arthritis With Tripterygium Wilfordi Hook F or Sulfasalazine | A 24-Week, Double Blind, Randomized Study to Determine the Effects of 24 Weeks of Dosing With Tripterygium Wilfordii Hook F (TwHF) or Sulfasalazine, in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: TwHF | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | N/A | N/A | Both | 157 | Phase 2 | United States | |
1883 | NCT00074438 | June 2003 | 19 February 2015 | Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis | Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: methotrexate;Drug: rituximab;Drug: corticosteroids;Drug: placebo | Genentech, Inc. | Roche Pharma AG | Not recruiting | 18 Years | 80 Years | Both | 465 | Phase 2 | United States |
1884 | NCT00213538 | June 2003 | 16 December 2017 | Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis | Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Response to anakinra associated with methotrexate | University Hospital, Rouen | Not recruiting | 18 Years | N/A | All | 341 | N/A | France | |
1885 | NCT00235833 | June 2003 | 19 October 2017 | Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis | Long-term Continuously Repeated Dose Study of Adalimumab (D2E7) in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: adalimumab | Abbott | Abbott Japan Co.,Ltd;Eisai Co., Ltd. | Not recruiting | 20 Years | N/A | All | 25 | 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 |
1886 | NCT00245934 | June 2003 | 19 February 2015 | Study Evaluating Enbrel in Patients With Rheumatoid Arthritis | Observational Study With Enbrel in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Enbrel | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Both | 1500 | N/A | ||
1887 | NCT00317538 | June 2003 | 19 February 2015 | Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to Etanercept | Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to Etanercept | Rheumatoid Arthritis | Drug: infliximab, etanercept | Centocor Ortho Biotech Services, L.L.C. | Not recruiting | 18 Years | N/A | Both | 28 | Phase 3 | ||
1888 | NCT00396747 | June 2003 | 19 February 2015 | A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study | Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone | Rheumatoid Arthritis | Drug: Infliximab, methylprednisolone, methotrexate;Drug: Methotrexate;Drug: Methotrexate + Methylprednisolone;Drug: Methotrexate + Infliximab | Université Catholique de Louvain | Not recruiting | 18 Years | N/A | Both | 45 | Phase 4 | Belgium | |
1889 | NCT00548834 | June 2003 | 19 February 2015 | Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis | Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD | Rheumatoid Arthritis | Drug: CDP870 | UCB Pharma | Not recruiting | 18 Years | 75 Years | Both | 220 | Phase 3 | ||
1890 | NCT00095342 | May 2003 | 19 February 2015 | Study Evaluating TMI-005 in Active Rheumatoid Arthritis | A Double-Blind, Placebo-Controlled, Parallel, Randomized Study to Evaluate the Efficacy and Safety of 3 Oral Dose Levels of TMI-005 in Subjects With Active Rheumatoid Arthritis on a Background of Methotrexate | Rheumatoid Arthritis | Drug: TMI-005 | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | 75 Years | Both | 390 | Phase 2 | United States;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 |
1891 | NCT00468546 | May 2003 | 19 October 2017 | A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies | Rheumatoid Arthritis | Drug: MabThera/Rituxan;Drug: Methotrexate;Other: Placebo | Hoffmann-La Roche | Biogen | Not recruiting | 18 Years | 80 Years | All | 520 | Phase 3 | United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom |
1892 | NCT00563849 | May 2003 | 19 February 2015 | Leflunomide + Methotrexate in Rheumatoid Arthritis | An Open-Label, Multi-Center Study to Evaluation of Leflunomide Plus Methotexate for the Treatment of Rheumatoid Arthritis in DMARDs:(Disease-Modifying Antirheumatic Drug) na¿ve or Restart (Skip DMARDs More Than 4 Weeks) Subjects. | Rheumatoid Arthritis | Drug: Leflunomide | Sanofi | Not recruiting | 18 Years | 75 Years | Both | 74 | Phase 4 | Korea, Republic of | |
1893 | NCT02214888 | May 2003 | 19 February 2015 | Efficacy, Safety and Pharmacokinetics of BIRB 796 BS Tablets in Patients With Active Rheumatoid Arthritis | A 12 Week Double-blind, Randomized, Placebo-controlled Trial to Investigate Efficacy, Safety and Pharmacokinetics of BIRB 796 BS Tablets at Doses of 50 and 70 mg Administered Twice a Day in Patients With Active Rheumatoid Arthritis Who Have Failed at Least One DMARD | Arthritis, Rheumatoid | Drug: BIRB 796 BS, low dose;Drug: BIRB 796 BS, high dose;Drug: Placebo | Boehringer Ingelheim | Not recruiting | 18 Years | 75 Years | Both | 170 | Phase 2 | ||
1894 | NCT00195377 | April 2003 | 19 February 2015 | Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain | Evaluating Safety and QoL in Patients Treated With Etanercept: an Open Multicenter Study | Arthritis, Psoriatic;Arthritis, Rheumatoid | Drug: Etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 4 Years | N/A | Both | 1000 | Phase 4 | Spain | |
1895 | NCT00213564 | April 2003 | 19 February 2015 | Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis | Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: response to infliximab associated with methotrexate | University Hospital, Rouen | Not recruiting | 18 Years | N/A | Both | 40 | 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 |
1896 | NCT00144508 | March 2003 | 19 February 2015 | Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA) | An Open-Label, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA | Rheumatoid Arthritis | Drug: MRA (Tocilizumab);Other: current treatment | Chugai Pharmaceutical | Not recruiting | 20 Years | N/A | Both | 306 | Phase 3 | ||
1897 | NCT00160693 | March 2003 | 11 June 2018 | Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis | A Phase III, Multicenter, Open-Label Long-Term Study to Assess the Safety and Tolerability of CDP870 400 mg Subcutaneously Every 4 Weeks, in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Certolizumab Pegol | UCB Pharma | Not recruiting | 18 Years | N/A | All | 402 | Phase 3 | United States;Austria;Belgium;Czechia;Germany;Ireland;United Kingdom;Czech Republic | |
1898 | NCT00234845 | March 2003 | 19 February 2015 | Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis | A Multi-Centre Randomized, Double-Blind Study Comparing Adalimumab (D2E7) Plus Methotrexate With Placebo Plus Methotrexate on Work Disability in Subjects With Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: adalimumab;Drug: methotrexate | Abbott | Not recruiting | 18 Years | N/A | Both | 148 | Phase 3 | United States | |
1899 | NCT00244556 | March 2003 | 19 February 2015 | Study Comparing Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Active Rheumatoid Arthritis Despite Current Methotrexate Therapy | A Randomized Comparison of the Safety and Efficacy of Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Patients With Active Rheumatoid Arthritis Despite Current Methotrexate Therapy | Rheumatoid Arthritis | Drug: Methotrexate plus ENBREL or ENBREL alone | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Both | 300 | Phase 4 | ||
1900 | NCT00356473 | March 2003 | 19 February 2015 | Effects of Atorvastatin on Disease Activity and HDL Cholesterol Function in Patients With Rheumatoid Arthritis | Effects of Atorvastatin on Disease Activity and HDL Cholesterol Anti-inflammatory Properties in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Atorvastatin | University of California, Los Angeles | Not recruiting | 18 Years | N/A | Both | 20 | 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 |
1901 | NCT00908089 | March 2003 | 13 April 2015 | TNF-blocking Therapy in Combination With Disease-modifying Antirheumatic Drugs in Early Rheumatoid Arthritis | Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab;Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + placebo | Helsinki University | Seinajoki Central Hospital;Oulu University Hospital;Jyväskylä Central Hospital;Kuopio University Hospital;Satakunta Central Hospital;University of Turku;Rheumatism Foundation Hospital;Orton Invalid Foundation;South Karelia central hospital;Lappi Central Hospital;Central Hospital of Kanta-Hame | Not recruiting | 18 Years | 60 Years | Both | 100 | Phase 4 | Finland |
1902 | NCT00092742 | February 2003 | 3 August 2015 | Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072) | A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of Etoricoxib 90 mg q.d. vs. Diclofenac Sodium 75 mg b.i.d. in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MK0663, etoricoxib;Drug: Comparator: Diclofenac sodium | Merck Sharp & Dohme Corp. | Not recruiting | 50 Years | N/A | Both | 4086 | Phase 3 | United States | |
1903 | NCT00650455 | February 2003 | 19 February 2015 | Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients | Clinical Protocol for a Multicenter, Double-Blind, Randomized, Placebo Controlled, Comparison of the Efficacy and Safety of Bextra® (Valdecoxib) 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe RA Population | Arthritis, Rheumatoid | Drug: valdecoxib;Drug: naproxen;Drug: placebo | Pfizer | Not recruiting | 18 Years | N/A | Both | 489 | Phase 4 | United States;Canada | |
1904 | NCT00250445 | January 2003 | 10 August 2015 | A Study to Evaluate the Safety of an Investigational Drug (Etoricoxib) in Patients With Osteoarthritis (OA) or Rheumatoid Arthritis (RA)(0663-066) | A Randomized, Double-Blind, Active-Comparator-Controlled, Parallel-Group Study to Evaluate the Safety of Etoricoxib in Patients With Osteoarthritis or Rheumatoid Arthritis | Rheumatoid Arthritis,Osteoarthritis | Drug: MK0663, etoricoxib;Drug: Comparator: Diclofenac sodium | Merck Sharp & Dohme Corp. | Not recruiting | 50 Years | N/A | Both | 23498 | Phase 3 | ||
1905 | NCT00546533 | January 2003 | 19 February 2015 | Study Evaluating the Efficacy and Safety of Etanercept | Open-Label Evaluation Of The Efficacy And Safety Of Etanercept In Patients With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | N/A | N/A | Both | 40 | 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 |
1906 | NCT00048568 | December 2002 | 19 October 2017 | A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: Abatacept;Drug: Methotrexate;Drug: Placebo | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 1250 | Phase 3 | United States | |
1907 | NCT00048581 | December 2002 | 19 October 2017 | Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past. | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 in Subjects With Active Rheumatoid Arthritis on Background Disease Modifying Anti-Rheumatic Drugs (DMARDS) Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy | Rheumatoid Arthritis | Drug: Abatacept;Drug: Placebo | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 738 | Phase 3 | United States | |
1908 | NCT00048932 | December 2002 | 19 October 2017 | A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Double-blind Abatacept;Drug: Double-blind Placebo;Drug: Open-label Abatacept | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 1795 | Phase 3 | United States | ||
1909 | NCT00433875 | December 2002 | 19 February 2015 | Phase 2 AMG 714 in Rheumatoid Arthritis | A Double-Blind, Placebo Controlled, Randomized, Parallel-Group Clinical Trial With Multiple Dose Treatment of Anti-IL 15 Human Monoclonal Antibody (AMG 714) in Patients With Active Rheumatoid Arthritis Who Have Previously Failed One or More Disease Modifying Anti-Rheumatic Drugs | Rheumatoid Arthritis | Drug: AMG 714 | Amgen | Not recruiting | 18 Years | N/A | Both | 180 | Phase 2 | ||
1910 | NCT00482417 | December 2002 | 7 December 2015 | Efficacy and Safety Study of MK0359 in Patients With Arthritis (0359-017) | Rheumatoid Arthritis | Drug: MK0359 | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 65 Years | Both | 11 | Phase 2 | |||
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 |
1911 | NCT00764725 | December 2002 | 19 February 2015 | Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT) | A Prospective Randomized, Open, Multi-Center Trial Comparing TNF-Blockade + MTX to MTX+SSZ+HCQ in Patients With Early RA With an Inadequate Response to MTX | Rheumatoid Arthritis | Drug: conventional DMARD combination;Biological: MTX plus anti-TNF | Karolinska Institutet | Not recruiting | 18 Years | N/A | Both | 487 | Phase 4 | ||
1912 | NCT00116727 | October 2002 | 19 February 2015 | Rheumatoid Arthritis DMARD Intervention and UtilizationStudy | Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 2) | Rheumatoid Arthritis | Drug: ENBREL® | Amgen | Immunex Corporation;Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Both | 5103 | N/A | United States |
1913 | NCT00121043 | October 2002 | 19 February 2015 | Evaluating Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using aSelf-Reported Questionnaire | An Open Label, Randomized, Crossover Study to Assess Acceptability and Functionality of SimpleJectTM Vs Pre-Filled Syringe(s) Using Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using A Self-Reported Questionnaire | Rheumatoid Arthritis | Device: SimpleJectTM;Drug: Kineret® (Anakinra) | Amgen | Not recruiting | 18 Years | N/A | Both | Phase 4 | |||
1914 | NCT00544154 | October 2002 | 19 February 2015 | Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis | Efficacy and Safety of CDP870 400 mg in Combination With Methotrexate Compared to Methotrexate Alone in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Are Partial Responders to Methotrexate | Arthritis, Rheumatoid | Drug: CDP870 | UCB Pharma | Not recruiting | 18 Years | 75 Years | Both | 247 | Phase 3 | ||
1915 | NCT00042406 | September 2002 | 19 February 2015 | Trial With HuMax-CD4 in Patients With Rheumatoid Arthritis Failing Treatment With Methotrexate and a TNF-alpha Blocker | A Double-Blind, Placebo-Controlled, Randomized, Parallel Group Clinical Trial of Anti-CD4 Receptor Human Monoclonal Antibody (HuMax-CD4) in Patients With Active RA Failing Treatment With Methotrexate and TNF-alpha Blocking Agents | Rheumatoid Arthritis | Drug: HuMax-CD4 | Emergent Product Development Seattle LLC | Not recruiting | 18 Years | N/A | Both | 75 | Phase 2/Phase 3 | United States;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 |
1916 | NCT00049751 | September 2002 | 19 February 2015 | Study of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis | A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Adalimumab | Abbott | Not recruiting | 18 Years | N/A | Both | 3000 | Phase 3 | United States | |
1917 | NCT00055133 | September 2002 | 19 February 2015 | A Study Using Intravenous Paxceed™ to Treat Patients With Rheumatoid Arthritis | A Phase 2 Open-Label Clinical Study Using Intravenous Paxceed™ to Treat Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Micellar Paclitaxel for Injection | Angiotech Pharmaceuticals | Not recruiting | 21 Years | 70 Years | Both | 50 | Phase 2 | United States | |
1918 | NCT00121056 | September 2002 | 19 February 2015 | REKinDLE: Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations | Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations (REKinDLE) | Rheumatoid Arthritis | Drug: Enbrel®;Drug: Kineret® | Amgen | Not recruiting | 18 Years | N/A | Both | N/A | |||
1919 | NCT00282412 | September 2002 | 8 August 2016 | Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism | Rheumatoid Arthritis: Tolerance Induction by Mixed Chimerism | Rheumatoid Arthritis | Biological: Hematopoietic Stem Cell Transplantation | Northwestern University | Not recruiting | 18 Years | 60 Years | Both | 4 | Phase 1 | United States | |
1920 | NCT00448383 | September 2002 | 19 February 2015 | A Study to Assess the Safety and Efficacy of Adalimumab When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis | An Open-Label, Multi-Center Study to Assess the Safety and Efficacy of the Fully Human Anti-TNF-a Monoclonal Antibody Adalimumab (D2E7) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: adalimumab | Abbott | Not recruiting | 18 Years | N/A | Both | 6610 | Phase 3 | ||
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 |
1921 | NCT00946686 | September 2002 | 16 December 2017 | To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions | A Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions | Rheumatoid Arthritis;Psoriatic Arthritis | Drug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical);Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.) | Sandoz | Not recruiting | 18 Years | N/A | All | 52 | Phase 1 | ||
1922 | NCT00111423 | August 2002 | 19 February 2015 | Evaluating the Safety of Extended Treatment With Pegsunercept (PEG sTNF-RI)in Subjects With Rheumatoid Arthritis (RA) | Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of Extended Treatment With Pegsunercept (PEG sTNF-RI) in Subjects With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Pegsunercept (PEG sTNF-RI) | Amgen | Not recruiting | 18 Years | N/A | Both | 216 | Phase 2 | ||
1923 | NCT02093026 | August 2002 | 16 December 2017 | Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA) | An Open-label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera®/Rituxan®) in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Rituximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Folic Acid | Hoffmann-La Roche | Genentech, Inc. | Not recruiting | 21 Years | N/A | All | 465 | Phase 2 | United States;Australia;Belgium;Brazil;Canada;Czech Republic;Finland;Germany;Israel;Italy;Mexico;New Zealand;Poland;Spain;Sweden;United Kingdom |
1924 | NCT00043732 | July 2002 | 19 February 2015 | Safety Study of SCIO-469 to Treat Patients With Active Rheumatoid Arthritis Receiving Methotrexate | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study of SCIO-469 in Patients in Active Rheumatoid Arthritis Receiving Methotrexate | Rheumatoid Arthritis | Drug: SCIO-469 | Scios, Inc. | Not recruiting | 18 Years | N/A | Both | 120 | Phase 2 | United States | |
1925 | NCT00650026 | July 2002 | 19 February 2015 | Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis | Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: adalimumab | Abbott | Not recruiting | 18 Years | N/A | Both | 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 |
1926 | NCT00042068 | June 2002 | 19 February 2015 | A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis | A Multi-center, Double-Blind, Randomized, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of Meloxicam (7.5, 15, and 22.5 mg) and Placebo in Patients With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Meloxicam | Boehringer Ingelheim | Not recruiting | 18 Years | 80 Years | Both | 1000 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;France;Germany;Hungary;Italy;Korea, Republic of;Russian Federation;Taiwan;Ukraine | |
1927 | NCT00034060 | April 2002 | 19 February 2015 | The Role of Cytokines on Growth Hormone Suppression in Premenopausal Women With Rheumatoid Arthritis and the Effect of Treatment With Etanercept | Suppression of the Growth Hormone/ Insulin-Like Growth Factor-1 (GH/IGF-1) Axis in Women With Rheumatoid Arthritis | Rheumatoid Arthritis;Healthy | Drug: Etanercept | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | N/A | N/A | Female | 36 | Phase 2 | United States | |
1928 | NCT00034203 | April 2002 | 19 February 2015 | Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: efalizumab | XOMA (US) LLC | Not recruiting | 18 Years | 80 Years | Both | Phase 2 | United States | |||
1929 | NCT00038298 | April 2002 | 19 February 2015 | A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Safety and Tolerability of AMG 719 in Subjects With Rheumatoid Arthritis Receiving Methothrexate | Rheumatoid Arthritis | Drug: Placebo;Drug: AMG 719;Drug: AGM 719;Drug: placebo to AMG 719 | Amgen | Not recruiting | 18 Years | N/A | Both | 53 | Phase 2 | United States | |
1930 | NCT00036153 | March 2002 | 19 February 2015 | Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis | A Randomized, Double-Blind Study to Assess the Efficacy of Tacrolimus (Prograf®)+ Methotrexate Vs. Placebo + Methotrexate in the Treatment of Rheumatoid Arthritis in Patients With Partial Response to Methotrexate | Rheumatoid Arthritis | Drug: Tacrolimus (Prograf®);Drug: Methotrexate | Astellas Pharma Inc | Astellas Pharma US, Inc. | Not recruiting | 18 Years | N/A | Both | 210 | Phase 3 | United States;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 |
1931 | NCT00451971 | March 2002 | 19 February 2015 | Objective Study in Rheumatoid Arthritis | Objective Study in Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: LEFLUNOMIDE | Sanofi | Not recruiting | 18 Years | 75 Years | Both | 249 | Phase 4 | Australia | |
1932 | NCT00959439 | March 2002 | 16 December 2017 | Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg) | A Comparative Bioavailability Study of Naproxen Delayed-Release Tablets, 375mg. | Rheumatoid Arthritis;Osteoarthritis | Drug: Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.);Drug: Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.) | Sandoz | Not recruiting | 21 Years | 50 Years | All | 34 | Phase 1 | ||
1933 | NCT00029042 | January 2002 | 19 February 2015 | Infliximab to Treat Children With Juvenile Rheumatoid Arthritis | A Randomized Double Blind Controlled Intra-Patient Dose Escalation Phase II Trial of Infliximab in Pediatric Patients With Refractory Juvenile Rheumatoid Arthritis | Juvenile Rheumatoid Arthritis | Drug: Infliximab | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | N/A | N/A | Both | 48 | Phase 2 | United States | |
1934 | NCT00048321 | January 2002 | 19 February 2015 | ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis | ISIS 104838-CS7, A Double-Blind, Placebo-Controlled, Randomized Trial of the Safety, Efficacy and Pharmacokinetic Profile of ISIS 104838 (TNF-Alpha Antisense Oligonucleotide) Subcutaneous Injections in Active Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: ISIS 104838 | Isis Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 160 | Phase 2 | United States;Canada | |
1935 | NCT00246064 | December 2001 | 19 February 2015 | The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol | The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol. Tapering Methotrexate in Patients With Rheumatoid Arthritis Beginning Therapy With Infliximab | Arthritis, Rheumatoid | Drug: infliximab | Centocor Ortho Biotech Services, L.L.C. | Not recruiting | 18 Years | 80 Years | Both | 210 | 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 |
1936 | NCT00035334 | October 2001 | 19 February 2015 | Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis | A Phase II/III Study of the Safety and Efficacy of NC-503 in Patients Suffering From Secondary (AA) Amyloidosis | Secondary (AA) Amyloidosis;Rheumatoid Arthritis;Nephrotic Syndrome;Familial Mediterranean Syndrome;Kidney Diseases;Gastrointestinal Diseases | Drug: NC-503 (Anti-amyloidotic (AA) Agent) | Bellus Health Inc | FDA Office of Orphan Products Development | Not recruiting | 18 Years | N/A | Both | 150 | Phase 2/Phase 3 | United States;Finland;France;Israel;Italy;Lithuania;Netherlands;Poland;Russian Federation;Spain;Turkey;United Kingdom |
1937 | NCT00036374 | October 2001 | 19 February 2015 | A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis | A Randomized, Double-Blind Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate for the Treatment of Patients With Polyarticular Juvenile Rheumatoid Arthritis | Rheumatoid Arthritis, Juvenile | Drug: Infliximab | Centocor, Inc. | Not recruiting | 4 Years | 18 Years | Both | 123 | Phase 3 | United States | |
1938 | NCT00036387 | October 2001 | 19 February 2015 | A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Rheumatoid Arthritis. | A Randomized, Double-blind Trial of the Safety of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis on Standard Disease-modifying Anti-Rheumatic Drug Background Therapy. | Arthritis, Rheumatoid | Drug: Infliximab | Centocor, Inc. | Not recruiting | 18 Years | N/A | Both | 347 | Phase 3 | United States | |
1939 | NCT00116714 | October 2001 | 19 February 2015 | Rheumatoid Arthritis (DMARD) Intervention and UtilizationStudy | Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 1) | Rheumatoid Arthritis | Drug: DMARD | Amgen | Immunex Corporation;Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Both | 4968 | N/A | United States |
1940 | NCT02180516 | October 2001 | 19 February 2015 | Safety and Efficacy of Meloxicam Compared to Other Nonsteroidal Antiinflammatory Drugs (NSAIDs) in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome | Safety and Efficacy of Meloxicam (MOBIC) Compared to Other NSAIDs in Approved Therapeutic Dosages and Routes of Administration in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome | Arthritis, Rheumatoid | Drug: Meloxicam;Drug: Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac | Boehringer Ingelheim | Not recruiting | N/A | N/A | Both | 9984 | 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 |
1941 | NCT00144651 | August 2001 | 19 February 2015 | Study of MRA in Patients With Rheumatoid Arthritis (RA) | An Open-label, Extension, Phase II Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Were Participated in Study MRA009JP | Rheumatoid Arthritis | Drug: MRA(Tocilizumab) | Chugai Pharmaceutical | Not recruiting | 20 Years | N/A | Both | 135 | Phase 2 | ||
1942 | NCT00537667 | August 2001 | 19 February 2015 | The SPECTRA Study | A Single Centre, Open-Label, Randomised, Study to Evaluate the Effect of Anakinra (r-metHuIL-1ra) Alone and in Combination With PEGylated Recombinant Methionyl Human Soluble Tumour Necrosis Factor Receptor Type I (PEG sTNF-RI) on Synovial Inflammation in Subjects With Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: anakinra;Drug: anakinra and PEG sTNF-R1 | Amgen | Not recruiting | 18 Years | N/A | Both | 22 | Phase 2 | ||
1943 | NCT00524160 | July 2001 | 19 February 2015 | A Study of the Effect on Pain Control of Treatment With Fentanyl, Administered Through the Skin, in Patients With Rheumatoid Arthritis or Osteoarthritis | Open-Label Study To Assess The Effect On Pain Control Of Durogesic (Fentanyl Transdermic Therapeutic System) Treatment In Subjects With Rheumatoid Arthritis Or Osteoarthritis Of The Knee Or Hip. | Arthritis;Osteoarthritis;Rheumatoid Arthritis | Drug: Fentanyl transdermal patch | Janssen Pharmaceutica N.V., Belgium | Not recruiting | 18 Years | N/A | Both | 264 | Phase 4 | ||
1944 | NCT00078806 | June 2001 | 19 February 2015 | Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis | Phase 3 Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis | Juvenile Rheumatoid Arthritis | Drug: Enbrel;Drug: Placebo | Amgen | Immunex Corporation | Not recruiting | 2 Years | 18 Years | Both | 75 | Phase 3 | United States;Canada |
1945 | NCT00037700 | May 2001 | 19 February 2015 | Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: anakinra;Drug: pegsunercept | Amgen | Not recruiting | 18 Years | N/A | Both | 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 |
1946 | NCT02209779 | May 2001 | 19 February 2015 | Efficacy and Safety of Different Doses of BIRB 796 BS in Patients With Active Rheumatoid Arthritis | A Randomised, Parallel, Double-blind, Placebo-controlled Study to Investigate Efficacy and Safety of Different Doses (5, 10, 20 and 30 mg) of BIRB 796 BS Administered Twice a Day Orally Over 4 Weeks in Patients With Active Rheumatoid Arthritis Who Have Failed at Least One DMARD | Arthritis, Rheumatoid | Drug: BIBR 796 BS;Drug: Placebo | Boehringer Ingelheim | Not recruiting | 18 Years | 75 Years | Both | 167 | Phase 2 | ||
1947 | NCT02251210 | May 2001 | 19 February 2015 | Efficacy and Safety of BIIL 284 BS in Adult Patients With Active Rheumatoid Arthritis | Three Month, Randomised, Double-blind, Double-dummy, Placebo-controlled, Multiple Dose-range Study of the Efficacy and Safety of BIIL 284 BS (5, 25 and 75 mg p.o. Once Daily) in Adult Patients With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: BIIL 284 BS low dose;Drug: BIIL 284 BS medium dose;Drug: BIIL 284 BS high dose;Drug: Placebo | Boehringer Ingelheim | Not recruiting | 18 Years | 70 Years | Both | 404 | Phase 2 | ||
1948 | NCT00014794 | April 2001 | 19 February 2015 | Positron Emission Tomography and Magnetic Resonance Imaging to Evaluate Synovial Blood Flow in Rheumatoid Arthritis Patients | H215O Positron Emission Tomography (PET) in the Assessment of Synovial Blood Flow in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: 15-O labeled water | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | N/A | N/A | Both | 10 | Phase 1 | United States | |
1949 | NCT02693210 | February 2001 | 7 November 2016 | A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis | A Randomised, Double Dummy Controlled, Parallel Group Study of the Efficacy and Safety of MabThera (Rituximab) Alone or in Combination With Either Cyclophosphamide or Methotrexate, in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Rituximab;Other: Placebo Rituximab;Other: Placebo Methotrexate;Other: Placebo Cyclophosphamide;Drug: Methotrexate;Drug: Cyclophosphamide | Hoffmann-La Roche | Not recruiting | 21 Years | N/A | Both | 161 | Phase 2 | Australia;Belgium;Canada;Czech Republic;Germany;Israel;Italy;Netherlands;Poland;Spain;United Kingdom | |
1950 | NCT00579644 | January 2001 | 22 January 2018 | Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone | Treatment of Early Rheumatoid Arthritis: Minocycline in Combination With Methotrexate Versus Methotrexate Alone | Rheumatoid Arthritis | Drug: Combination of Minocycline and MTX or MTX alone;Drug: methotrexate | University of Nebraska | Not recruiting | 19 Years | 75 Years | All | 91 | Phase 3 | ||
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 |
1951 | NCT00034853 | December 2000 | 19 February 2015 | Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA) | A 12 Week Double-blind Randomized Trial, With a 12 Week Open-label Extension, to Investigate the Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis | Arthritis, Juvenile Rheumatoid | Drug: meloxicam oral suspension;Drug: naproxen oral suspension | Boehringer Ingelheim | Not recruiting | 2 Years | 17 Years | Both | 180 | Phase 3 | United States;Brazil;Mexico;Ukraine;Argentina | |
1952 | NCT00195663 | December 2000 | 19 October 2017 | Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis | A Prospective Multi-Centre Randomised, Double-Blind, Active Comparator-Controlled, Parallel-Groups Study Comparing the Fully Human Monoclonal Anti-TNFa Antibody Adalimumab Given Every Second Week With Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate Administered Over 2 Years in Patients With Early Rheumatoid Arthritis (PREMIER). | Early Rheumatoid Arthritis | Biological: Adalimumab;Drug: Methotrexate;Biological: Adalimumab placebo;Drug: Methotrexate placebo | AbbVie (prior sponsor, Abbott) | Not recruiting | 18 Years | N/A | All | 799 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Slovakia;Spain;Sweden;Switzerland;United Kingdom | |
1953 | NCT00162266 | October 2000 | 19 October 2017 | Abatacept With Methotrexate- Phase IIB | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Two Different Doses of BMS-188667 Administered Intravenously to Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate | Rheumatoid Arthritis | Drug: Abatacept (BMS-188667);Drug: Placebo | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 524 | Phase 2 | United States;Argentina;Australia;Belgium;Canada;France;Germany;Ireland;Netherlands;South Africa;United Kingdom | |
1954 | NCT00162279 | October 2000 | 19 February 2015 | The Study of Abatacept in Combination With Etanercept | A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Intravenous Infusions of BMS-188667 (10 mg/kg) Given Monthly in Combination With Subcutaneous Injections of Etanercept (25mg)Given Twice Weekly to Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | Both | 141 | Phase 2 | United States | |
1955 | NCT00393471 | October 2000 | 19 February 2015 | Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis. | A Double-Blind Study Evaluating the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Comparison to Etanercept Alone or Methotrexate Alone in Rheumatoid Arthritis Patients. | Active Rheumatoid Arthritis | Drug: Etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Male | 615 | Phase 3 | Australia;Austria;Belgium;Czech Republic;Denmark;Finland;France;Germany;Greece;Israel;Italy;Netherlands;Norway;Poland;Portugal;Romania;Spain;Sweden;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 |
1956 | NCT00006292 | September 2000 | 19 February 2015 | Infliximab for the Treatment of Early Rheumatoid Arthritis | Randomized Double Blind Active Treatment Controlled Trial of the Anti-TNF-Alpha Antibody Infliximab in Patients With Erosive Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Infliximab | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | N/A | N/A | Both | 60 | Phase 2 | United States | |
1957 | NCT00279747 | September 2000 | 19 February 2015 | A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA) | A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension 0.25mg/kg and 0.125 mg/kg Administered Once Daily in Comparison to Naproxen Oral Suspension 5mg/kg Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis. | Arthritis, Juvenile Rheumatoid | Drug: meloxicam 0.25 mg/kg;Drug: meloxicam 0.125 mg/kg;Drug: naproxen 10 mg/kg | Boehringer Ingelheim | Not recruiting | 2 Years | 16 Years | Both | 226 | Phase 3 | Austria;Belgium;France;Germany;Italy;Russian Federation;United Kingdom | |
1958 | NCT00037648 | July 2000 | 19 February 2015 | Juvenile Rheumatoid Arthritis | A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Open-label Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuIL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis | Juvenile Chronic Arthritis | Drug: Anakinra;Drug: Placebo | Amgen | Not recruiting | 2 Years | 17 Years | Both | 86 | Phase 2 | United States | |
1959 | NCT00195650 | July 2000 | 19 October 2017 | Long Term Open Label Continuation Study | A Multi-Center Continuation Study of the Human Anti-TNF Antibody D2E7 Administered as a Subcutaneous Injection in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Adalimumab | Abbott | Not recruiting | 18 Years | N/A | All | 846 | Phase 3 | United States;Canada | |
1960 | NCT00078793 | June 2000 | 19 February 2015 | Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis | Phase IV Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis | Juvenile Rheumatoid Arthritis | Drug: Enbrel® | Amgen | Immunex Corporation | Not recruiting | 2 Years | 18 Years | Both | 600 | N/A | United States;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 |
1961 | NCT00233571 | June 2000 | 19 February 2015 | A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis | A Multi-Centre Open Label Continuation Study With Subcutaneous D2E7 (Adalimumab) for Patients With Rheumatoid Arthritis Who Completed a Preceding Clinical Study With D2E7 (Adalimumab) | Rheumatoid Arthritis | Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW) | Abbott | Not recruiting | 18 Years | N/A | Both | 796 | Phase 3 | ||
1962 | NCT00138983 | May 2000 | 19 February 2015 | Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol. | Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol. | Rheumatoid Arthritis;Polymyalgia Rheumatica;Giant Cell Arteritis;Polymyositis;Wegener’s Granulomatosis | Drug: Alendronate versus alfacalcidol (1-alpha OH vitamin D) | UMC Utrecht | Dutch Health Care Insurance Board | Not recruiting | 18 Years | 90 Years | Both | 200 | Phase 3 | Netherlands |
1963 | NCT00132418 | April 2000 | 19 February 2015 | Study of Enbrel in Rheumatoid Arthritis (RA) Subjects With Comorbid Disorders | Double-blind, Randomized, Placebo-controlled Study of Enbrel (Etanercept) in the Treatment of Rheumatoid Arthritis Subjects With Comorbid Disorders | Rheumatoid Arthritis | Drug: Enbrel;Drug: Placebo | Amgen | Immunex Corporation | Not recruiting | 18 Years | N/A | Both | 564 | Phase 4 | United States |
1964 | NCT00006055 | March 2000 | 19 February 2015 | Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases | Purpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu Arteritis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell Transplantation | Fairview University Medical Center | Not recruiting | 1 Year | 55 Years | Both | 10 | N/A | United States | ||
1965 | NCT00195702 | February 2000 | 19 October 2017 | Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Rheumatoid Arthritis Patients Currently Receiving Treatment With Methotrexate | Rheumatoid Arthritis | Biological: Adalimumab;Drug: Placebo | Abbott | Not recruiting | 18 Years | N/A | All | 619 | Phase 3 | United States;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 |
1966 | NCT00279760 | January 2000 | 26 September 2016 | Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis | A Pilot, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of LEA29Y and CTLA4Ig Administered Intravenously to Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Belatacept;Drug: Abatacept | Bristol-Myers Squibb | Not recruiting | 18 Years | 65 Years | Both | 210 | Phase 1/Phase 2 | United States;Belgium;Canada;France;Germany;Ireland;Netherlands;Switzerland;United Kingdom | |
1967 | NCT02247375 | January 2000 | 19 February 2015 | Pharmacokinetics, Safety and Efficacy of BIIL 284 BS in Patients With Rheumatoid Arthritis (RA) | A Double-blind, Randomized, Three Parallel Group Placebo-controlled Study to Investigate Pharmacokinetics, Effect on Expression of CD11b/CD18 (Mac-1), as Well as Safety and Efficacy of Two Oral Doses of BIIL 284 BS (Dosage: 25 mg Daily, 150 mg Daily) in Patients With Rheumatoid Arthritis Over Two Weeks | Arthritis, Rheumatoid | Drug: Low dose of BIIL 284 BS tablets;Drug: High dose of BIIL 284 BS tablets;Drug: Placebo | Boehringer Ingelheim | Not recruiting | 18 Years | 65 Years | Both | 26 | Phase 1 | ||
1968 | NCT00579878 | December 1999 | 19 February 2015 | Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis | Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations (Leflunomide-Hydroxychloroquine-Sulfasalazine or Methotrexate-Hydroxychloroquine-Sulfasalazine) in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Leflunomide;Drug: Methotrexate-Sulfasalazine-Hydroxychloroquine;Drug: Leflunomide-Sulfasalazine-Hydroxychloroquine | University of Nebraska | Not recruiting | 19 Years | 80 Years | Both | 70 | Phase 3 | United States | |
1969 | NCT00012506 | October 1999 | 19 February 2015 | The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis | Uveitis;Arthritis, Juvenile Rheumatoid | Drug: TNFR:Fc | National Eye Institute (NEI) | Recruiting | 2 Years | 18 Years | Both | Phase 3 | United States | |||
1970 | NCT02932644 | October 1999 | 24 October 2016 | Vitamin D and Cardiovascular Events in Rheumatoid Arthritis | Association Between Baseline Vitamin D Metabolite Levels and Risk of Cardiovascular Events in Rheumatoid Arthritis Patients. A Cohort Study With Patient-record Evaluated Outcomes. | Rheumatoid Arthritis;Cardiovascular Disease | Other: Baseline serum vitamin D level at or above 50 nmol/l;Other: Baseline serum vitamin D level below 50 nmol/l | Odense University Hospital | The Danish Rheumatism Association;University of Southern Denmark;Region of Southern Denmark;Pfizer;Odense Patient Explorative data Network (OPEN);The Danish Rheumatism Association;University of Southern Denmark;Region of Southern Denmark;Pfizer;Odense Patient Explorative data Network (OPEN) | Not recruiting | 18 Years | 75 Years | Both | 160 | 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 |
1971 | NCT00000435 | September 1999 | 19 February 2015 | dnaJ Peptide for Relieving Rheumatoid Arthritis | A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: dnaJ peptide;Drug: None-placebo | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | 85 Years | Both | 160 | Phase 2 | United States | |
1972 | NCT00000401 | July 1999 | 19 February 2015 | Oral Collagen for Rheumatoid Arthritis | Open Label Multicenter Induction of CII Tolerance in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Oral bovine type II collagen | University of Tennessee | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | 80 Years | Both | 110 | Phase 2 | United States |
1973 | NCT00001862 | February 1999 | 19 February 2015 | TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis | The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis | Juvenile Rheumatoid Arthritis;Uveitis | Drug: Enbrel | National Eye Institute (NEI) | Not recruiting | N/A | N/A | Both | 15 | Phase 2 | United States | |
1974 | NCT00356590 | December 1998 | 19 October 2017 | Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012 | Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012 | Rheumatoid Arthritis | Biological: Etanercept | Amgen | Immunex Corporation | Not recruiting | 18 Years | N/A | All | 468 | Phase 3 | Canada;United States |
1975 | NCT00209859 | October 1998 | 19 February 2015 | Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis | Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Intraarticular betamethasone;Drug: Cyclosporine/placebo-cyclosporine | Hvidovre University Hospital | Not recruiting | 18 Years | 75 Years | Both | 160 | 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 |
1976 | NCT00001677 | June 1998 | 19 February 2015 | Methotrexate Alone Versus Combination of Methotrexate and Subcutaneous Fludarabine for Severe Rheumatoid Arthritis: Safety, Tolerance and Efficacy | Methotrexate Alone Versus Combination of Methotrexate and Subcutaneous Fludarabine for Severe Rheumatoid Arthritis: Safety, Tolerance and Efficacy | Arthritis, Rheumatoid;Synovitis | Drug: Methotrexate;Drug: Fludarabine | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | N/A | N/A | Both | 40 | Phase 2 | United States | |
1977 | NCT00001614 | July 1997 | 19 February 2015 | The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis | The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis | Arthritis, Juvenile Rheumatoid;Uveitis | Drug: Chicken type II collagen | National Eye Institute (NEI) | Not recruiting | N/A | N/A | Both | 13 | Phase 1 | United States | |
1978 | NCT00278551 | June 1997 | 19 February 2015 | Stem Cell Support in Patients With Rheumatoid Arthritis | Immune Ablation and Hematopoietic Stem Cell Support in Patients With Rheumatoid Arthritis and High Risk Factors | RHEUMATOID ARTHRITIS | Biological: Immune ablation and hematopoietic stem cell transplant | Richard Burt, MD | Not recruiting | 18 Years | 60 Years | Both | 10 | Phase 1 | United States | |
1979 | NCT00357903 | April 1997 | 16 December 2017 | Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials | Open-Label Extension Treatment With Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) for Participating Patients in Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) Clinical Trials | Rheumatoid Arthritis | Biological: Etanercept | Amgen | Immunex Corporation | Not recruiting | 4 Years | N/A | All | 639 | Phase 3 | Canada;United States |
1980 | NCT00269867 | March 1997 | 19 February 2015 | Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis | A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment | Rheumatoid Arthritis | Drug: Placebo;Drug: Infliximab 3 mg/kg;Drug: Infliximab 10 mg/kg | Centocor, Inc. | Not recruiting | 18 Years | 75 Years | Both | 428 | Phase 3 | ||
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 |
1981 | NCT00000395 | September 1996 | 9 January 2017 | Antifolate Effectiveness in Arthritis | Mechanisms of Antifolate Efficacy in Arthritis | Rheumatoid Arthritis;Adjuvant Arthritis | Drug: Methotrexate;Dietary Supplement: Folinic acid;Dietary Supplement: Folic acid | University of Alabama at Birmingham | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Dietary Supplements (ODS) | Not recruiting | 18 Years | 85 Years | Both | 40 | Phase 2 | United States |
1982 | NCT00000429 | June 1996 | 19 February 2015 | Calcium Supplements for Bone Health in Juvenile Rheumatoid Arthritis | Calcium Supplementation for Bone Mineralization in Juvenile Rheumatoid Arthritis (JRA) | Juvenile Rheumatoid Arthritis | Drug: Calcium carbonate | Children's Hospital Medical Center, Cincinnati | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 6 Years | 18 Years | Both | 192 | Phase 2 | United States |
1983 | NCT00570934 | March 1995 | 17 October 2016 | Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRA | Effect of Supplementation With 2000 International Units (IU) Vitamin D, 1gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis | Juvenile Rheumatoid Arthritis | Dietary Supplement: Cholecalciferol;Dietary Supplement: Calcium;Dietary Supplement: Calcium and cholecalciferol;Drug: Placebo | University of Missouri-Columbia | Not recruiting | 3 Years | 15 Years | Both | 24 | Phase 3 | United States | |
1984 | NCT00004420 | September 1994 | 7 April 2015 | Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis | Juvenile Rheumatoid Arthritis | Drug: gamma-Linolenic acid | FDA Office of Orphan Products Development | University of Massachusetts, Worcester | Not recruiting | 1 Year | 15 Years | Both | 50 | N/A | ||
1985 | JPRN-JapicCTI-050016 | 23 April 2019 | A controlled, randomized trial of MRA monotherapy in patients with rheumatoid arthritis(RA) | A controlled, randomized trial of MRA monotherapy in patients with rheumatoid arthritis(RA) | RA | Intervention name : MRA (tocilizumab) Dosage And administration of the intervention : Intravenous infusion | Chugai Pharmaceutical Co., Ltd. | 20 | Phase 3 | |||||||
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 |
1986 | JPRN-JapicCTI-050018 | 23 April 2019 | Double-blind, parallel-group, controlled Phase 3 study of MRA in rheumatoid arthritis(RA) | Double-blind, parallel-group, controlled Phase 3 study of MRA in rheumatoid arthritis(RA) | RA | Intervention name : MRA (tocilizumab) Dosage And administration of the intervention : Intravenous infusion | Chugai Pharmaceutical Co., Ltd. | 20 | 74 | Phase 3 | ||||||
1987 | JPRN-JapicCTI-050146 | 23 April 2019 | Clinical Study to assess the efficacy and safety of increased dose of TA-650 in patients with Rheumatoid Arthritis | Clinical Study to assess the efficacy and safety of increased dose of TA-650 in patients with Rheumatoid Arthritis | Rheumatoid Arthritis | Intervention name : TA-650 (Infliximab) Dosage And administration of the intervention : Intravenous drip infusion | Mitsubishi Tanabe Pharma Corporation | 20 | 75 | BOTH | Phase 3 | |||||
1988 | JPRN-JapicCTI-070479 | 23 April 2019 | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. | Rheumatoid arthritis | Intervention name : Ocrelizumab Dosage And administration of the intervention : Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. | Chugai Pharmaceutical Co., Ltd. | 20 | BOTH | Phase 3 | ||||||
1989 | JPRN-JapicCTI-080531 | 23 April 2019 | A Phase III, Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use | A Phase III, Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use | Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago | Intervention name : esomeprazole Dosage And administration of the intervention : Oral | AstraZeneca | 20 | BOTH | Phase 3 | ||||||
1990 | JPRN-JapicCTI-080565 | 23 April 2019 | A Long Term Study to Investigate the Efficacy and Safety Study of D961H (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use | A Long Term Study to Investigate the Efficacy and Safety Study of D961H (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use | Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago | Intervention name : esomeprazole Dosage And administration of the intervention : Oral | AstraZeneca | 20 | BOTH | Phase 3 | ||||||
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 |
1991 | JPRN-JapicCTI-080650 | 23 April 2019 | Dose-Response Study of Ocrelizumab for Rheumatoid Arthritis. | Dose-Response Study of Ocrelizumab for Rheumatoid Arthritis. | Rheumatoid Arthritis | Intervention name : Ocrelizumab Dosage And administration of the intervention : 50mg,200mg,500mg twice as an IV infusion on Days1 and 15 Control intervention name : Placebo Dosage And administration of the control intervention : administered twice as an IV infusion on Days1 and 15 | Chugai Pharmaceutical Co., Ltd. | 20 | BOTH | Phase 2 | ||||||
1992 | JPRN-JapicCTI-111601 | 23 April 2019 | A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNF-alpha agents | A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNF-alpha agents | Rheumatoid Arthritis | Intervention name : Secukinumab INN of the intervention : Secukinumab Dosage And administration of the intervention : s.c. i.v. | Novartis Pharma K.K. | 18 | BOTH | Phase 3 | ||||||
1993 | JPRN-JapicCTI-121843 | 23 April 2019 | OSKIRA-Asia-1 | A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate Therapy | Rheumatoid Arthritis | Intervention name : Fostamatinib Dosage And administration of the intervention : 100mg twice daily for 12 weeks Intervention name : Fostamatinib Dosage And administration of the intervention : 75mg twice daily for 12 weeks Intervention name : Fostamatinib Dosage And administration of the intervention : 50mg twice daily for 12 weeks Intervention name : Fostamatinib Dosage And administration of the intervention : 100mg twice daily for 4 weeks, followed by150mg once daily up to Week 12 Control intervention name : Placebo Dosage And administration of the control intervention : twice daily for 12 weeks | AstraZeneca | 18 | BOTH | Phase 2 | ||||||
1994 | JPRN-JapicCTI-121990 | 23 April 2019 | OSKIRA-Asia-1X | A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia | Rheumatoid Arthritis | Intervention name : Fostamatinib Dosage And administration of the intervention : 100mg once daily | AstraZeneca | 18 | BOTH | Phase 2 | ||||||
1995 | JPRN-JapicCTI-132125 | 23 April 2019 | A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy | A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy | Rheumatoid Arthritis | Intervention name : Baricitinib Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 52 Control intervention name : Placebo Dosage And administration of the control intervention : Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous injection every 2 weeks through Week 50 Control intervention name : Adalimumab Dosage And administration of the control intervention : Adalimumab administered by SC injection every 2 weeks through Week 50 | Eli Lilly Japan K.K. | 18 | BOTH | Phase 3 | ||||||
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 |
1996 | JPRN-JapicCTI-132134 | 16 July 2019 | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis | Intervention name : Baricitinib Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 52. Control intervention name : Placebo Dosage And administration of the control intervention : Baricitinib placebo administered orally once daily through Week 52 and MTX placebo administered orally once weekly through Week 52. Control intervention name : Methotrexate Dosage And administration of the control intervention : Methotrexate (MTX) administered orally once weekly with dose ranging from 7.5 to 12.5 mg per week through Week 52. | Eli Lilly Japan K.K. | Not Recruiting | 18 | BOTH | Phase 3 | |||||
1997 | JPRN-JapicCTI-132138 | 23 April 2019 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis | Rheumatoid Arthritis | Intervention name : Baricitinib Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study. Control intervention name : Placebo Dosage And administration of the control intervention : Placebo administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study. | Eli Lilly Japan K.K. | 18 | BOTH | Phase 3 | ||||||
1998 | JPRN-JapicCTI-132156 | 16 July 2019 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors | Rheumatoid Arthritis | Intervention name : Baricitinib Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study. Control intervention name : Placebo Dosage And administration of the control intervention : Placebo administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study. | Eli Lilly Japan K.K. | Recruiting | 18 | BOTH | Phase 3 | |||||
1999 | JPRN-JapicCTI-142405 | 16 July 2019 | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis | Intervention name : Baricitinib Dosage And administration of the intervention : Baricitinib administered orally once daily Intervention name : placebo Dosage And administration of the intervention : Placebo administered orally once daily | Eli Lilly Japan K.K. | Not Recruiting | 18 | BOTH | Phase 3 |