46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03589833 (ClinicalTrials.gov) | May 14, 2019 | 5/7/2018 | 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 | NULL | Completed | 18 Years | 65 Years | All | 504 | Phase 4 | China |
| 2 | NCT03636984 (ClinicalTrials.gov) | August 24, 2018 | 13/8/2018 | 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. | NULL | Not yet recruiting | 18 Years | N/A | All | 1000 | NULL | |
| 3 | EUCTR2017-001944-36-ES (EUCTR) | 21/05/2018 | 10/10/2017 | 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 INN or Proposed INN: AMG 592 Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 137 | Phase 1;Phase 2 | United States;Czech Republic;Mexico;Poland;Spain;Romania;Australia;Bulgaria;Germany;United Kingdom;New Zealand | ||
| 4 | EUCTR2017-001944-36-BG (EUCTR) | 13/03/2018 | 24/10/2017 | 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 INN or Proposed INN: N/A Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 153 | Phase 1;Phase 2 | United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;United Kingdom;New Zealand | ||
| 5 | NCT03016013 (ClinicalTrials.gov) | September 2016 | 8/1/2017 | 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 | NULL | Recruiting | 18 Years | 65 Years | All | 480 | Phase 3 | China |
| 6 | NCT02882087 (ClinicalTrials.gov) | October 2015 | 24/8/2016 | 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: Placebo plus MTX;Drug: RC18 160 mg plus MTX | RemeGen | NULL | Terminated | 18 Years | 65 Years | All | 60 | Phase 2 | China |
| 7 | NCT02076659 (ClinicalTrials.gov) | September 2011 | 24/2/2014 | 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. | NULL | Completed | 18 Years | 75 Years | All | 36 | Phase 1 | Italy |
| 8 | ChiCTR1900024107 | 2010-09-29 | 2019-06-26 | 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 | NULL | Completed | 18 | 60 | Both | A:30;B:30;C:30; | Phase 4 | China |
| 9 | NCT00617032 (ClinicalTrials.gov) | February 2004 | 5/2/2008 | Phase 1 Dose Escalation Study of Intra-Articular Administration of tgAAC94 | A Phase 1 Dose Escalation Study of Intra-Articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:Fc Fusion Gene, in Inflammatory Arthritis | Rheumatoid Arthritis | Genetic: tgAAC94 gene therapy vector;Genetic: tgAAC94 placebo | Targeted Genetics Corporation | NULL | Completed | 18 Years | N/A | Both | 15 | Phase 1 | United States;Canada |
| 10 | NCT00012506 (ClinicalTrials.gov) | October 1999 | 10/3/2001 | 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) | NULL | Recruiting | 2 Years | 18 Years | Both | Phase 3 | United States | ||
| 11 | NCT00001862 (ClinicalTrials.gov) | February 1999 | 3/11/1999 | 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) | NULL | Completed | N/A | N/A | Both | 15 | Phase 2 | United States |
| 12 | NCT03780959 (ClinicalTrials.gov) | May 1, 1997 | 18/12/2018 | Safety and Efficacy of Etanercept (Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein [TNFR:Fc]) in Children With Juvenile Rheumatoid Arthritis (JRA) | Safety, Population Pharmacokinetics, and Efficacy of Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) in Children With Juvenile Rheumatoid Arthritis | Juvenile Rheumatoid Arthritis | Drug: Etanercept;Drug: Placebo | Amgen | NULL | Completed | 4 Years | 18 Years | All | 69 | Phase 2/Phase 3 | NULL |
| 13 | NCT00357903 (ClinicalTrials.gov) | April 1997 | 26/7/2006 | 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 | Completed | 4 Years | N/A | All | 639 | Phase 3 | Canada;United States |