46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,325 / 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
| 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 | NCT02371096 (ClinicalTrials.gov) | January 2015 | 5/2/2015 | Comparative Pharmacokinetic Trial of RGB-03 and MabThera | Rheumatoid Arthritis | Drug: MabThera (rituximab);Drug: RGB-03 | Gedeon Richter Plc. | NULL | Not yet recruiting | 18 Years | 75 Years | Both | Phase 1 | NULL | ||
| 2 | NCT01592292 (ClinicalTrials.gov) | November 2011 | 11/4/2012 | 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 | NULL | Completed | 20 Years | N/A | All | 90 | N/A | Korea, Republic of |
| 3 | NCT01641952 (ClinicalTrials.gov) | October 2011 | 13/7/2012 | 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 | NULL | Completed | 18 Years | N/A | All | 505 | N/A | Romania |
| 4 | EUCTR2008-005450-20-BE (EUCTR) | 29/10/2009 | 01/10/2009 | 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) INN or Proposed INN: INFLIXIMAB Other descriptive name: remicade Trade Name: Humira (adalimumab) INN or Proposed INN: ADALIMUMAB Trade Name: Enbrel (etanercept) INN or Proposed INN: ETANERCEPT Other descriptive name: Enbrel Trade Name: Mabthera (rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: Mabthera Trade Name: Orencia (abatacept) INN or Proposed INN: ABATACEPT Other descriptive name: Orencia | Radboud University Nijmegen Medical Centre, department of Rheumatic Diseases | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 261 | Belgium | |||
| 5 | NCT01075477 (ClinicalTrials.gov) | September 2009 | 24/2/2010 | 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 | NULL | Completed | 18 Years | N/A | Both | 151 | N/A | Finland;United States |
| 6 | NCT00845832 (ClinicalTrials.gov) | March 2009 | 17/2/2009 | A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate | A Randomized, Active Controlled, Double-blind, Study to Compare the Safety and Reduction in Disease Activity With the Combination of Rituximab (MabThera®)and Tocilizumab (RoActemra®) Versus Tocilizumab in Patients With Active Rheumatoid Arthritis With an Incomplete Response to Methotrexate | Rheumatoid Arthritis | Drug: Placebo;Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Terminated | 18 Years | 65 Years | All | 24 | Phase 2 | France;Germany;Greece;Netherlands;Poland;Spain;Switzerland;United Kingdom;Belgium;Sweden |
| 7 | NCT01000610 (ClinicalTrials.gov) | March 17, 2008 | 21/10/2009 | 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 | NULL | Completed | 18 Years | N/A | All | 18 | Phase 4 | Tunisia |
| 8 | NCT00576433 (ClinicalTrials.gov) | December 2007 | 18/12/2007 | 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 | NULL | Completed | 18 Years | 80 Years | Both | 60 | Phase 4 | Russian Federation |
| 9 | NCT00502853 (ClinicalTrials.gov) | October 25, 2007 | 17/7/2007 | 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 | NULL | Completed | 18 Years | 75 Years | All | 10 | Phase 4 | Italy |
| 10 | NCT00934648 (ClinicalTrials.gov) | October 2007 | 6/7/2009 | 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 | NULL | Completed | 18 Years | N/A | All | 15 | Phase 4 | Morocco |
| 11 | NCT00502840 (ClinicalTrials.gov) | July 23, 2007 | 17/7/2007 | 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 | NULL | Completed | 18 Years | 75 Years | All | 193 | Phase 3 | Germany |
| 12 | NCT00504777 (ClinicalTrials.gov) | July 2007 | 19/7/2007 | 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 | NULL | Completed | 18 Years | N/A | All | 36 | Phase 4 | Taiwan |
| 13 | NCT00462345 (ClinicalTrials.gov) | June 2007 | 18/4/2007 | 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 | NULL | Completed | 18 Years | 80 Years | All | 40 | Phase 4 | Korea, Republic of |
| 14 | NCT00424502 (ClinicalTrials.gov) | January 2007 | 18/1/2007 | 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 | NULL | Completed | 18 Years | N/A | All | 20 | Phase 4 | Hungary |
| 15 | NCT02079532 (ClinicalTrials.gov) | November 2006 | 4/3/2014 | 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 | NULL | Completed | 18 Years | 75 Years | All | 302 | Phase 3 | Germany |
| 16 | NCT01126541 (ClinicalTrials.gov) | September 2006 | 18/5/2010 | 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 | NULL | Completed | 18 Years | N/A | All | 224 | Phase 3 | France |
| 17 | NCT01272908 (ClinicalTrials.gov) | July 18, 2006 | 7/1/2011 | 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 | NULL | Completed | 18 Years | 80 Years | All | 120 | Phase 3 | Canada;Sweden |
| 18 | NCT00422383 (ClinicalTrials.gov) | February 2006 | 15/1/2007 | 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 | NULL | Completed | 18 Years | N/A | All | 378 | Phase 3 | Australia;Belgium;Brazil;Italy;Netherlands;New Zealand;Slovakia;South Africa;Spain;Taiwan;Thailand;United Kingdom;Switzerland;United States;Hungary;Germany;France;Finland;China;Canada |
| 19 | NCT00502996 (ClinicalTrials.gov) | February 2006 | 17/7/2007 | 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 | NULL | Completed | 18 Years | N/A | All | 246 | Phase 3 | Argentina;Brazil;Chile;Colombia;Ecuador;El Salvador;Mexico;Peru;Uruguay;Venezuela |
| 20 | NCT00422942 (ClinicalTrials.gov) | January 2006 | 15/1/2007 | 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 | NULL | Terminated | 18 Years | 80 Years | All | 3 | Phase 2 | Netherlands;Spain |
| 21 | NCT00503425 (ClinicalTrials.gov) | June 30, 2005 | 17/7/2007 | 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 | NULL | Completed | 18 Years | N/A | All | 215 | Phase 3 | Israel |
| 22 | NCT00468546 (ClinicalTrials.gov) | May 2003 | 30/4/2007 | 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 | Completed | 18 Years | 80 Years | All | 520 | Phase 3 | United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom |
| 23 | NCT02693210 (ClinicalTrials.gov) | February 2001 | 23/2/2016 | 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: Cyclophosphamide;Drug: Methotrexate;Other: Placebo Cyclophosphamide;Other: Placebo Methotrexate;Other: Placebo Rituximab;Drug: Rituximab | Hoffmann-La Roche | NULL | Completed | 21 Years | N/A | Both | 161 | Phase 2 | Australia;Belgium;Canada;Czech Republic;Germany;Israel;Italy;Netherlands;Poland;Spain;United Kingdom |