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 | EUCTR2006-005330-20-CZ (EUCTR) | 19/02/2010 | 19/04/2007 | anti TNF-IR phase III | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | Rheumatoid arthritis 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 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | France;Hungary;Czech Republic;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | ||
| 2 | JPRN-JapicCTI-090764 | 01/6/2009 | 26/05/2009 | 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. | NULL | 20 | BOTH | 200 | Phase 3 | NULL | ||
| 3 | NCT00808210 (ClinicalTrials.gov) | March 5, 2009 | 11/12/2008 | 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: Placebo | Genentech, Inc. | NULL | Terminated | 18 Years | N/A | All | 28 | Phase 2 | United States |
| 4 | EUCTR2006-005353-30-GB (EUCTR) | 04/11/2008 | 01/04/2008 | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis. | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis. | Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Lithuania;Austria;Italy;United Kingdom | ||
| 5 | NCT00779220 (ClinicalTrials.gov) | October 2008 | 23/10/2008 | 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 | NULL | Terminated | 20 Years | N/A | Both | 152 | Phase 2 | Japan |
| 6 | EUCTR2007-005759-41-DE (EUCTR) | 21/05/2008 | 21/02/2008 | A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy - FEATURE: Ocrelizumab in MTX-IR RA-patients; mono- vs. dual infusion | A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy - FEATURE: Ocrelizumab in MTX-IR RA-patients; mono- vs. dual infusion | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 300 | United Kingdom;Germany;France;Spain;Italy | |||
| 7 | EUCTR2007-005759-41-IT (EUCTR) | 06/05/2008 | 10/10/2008 | 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. - ND | 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. - ND | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ocrelizumab Product Code: RO-496-4913 | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Spain;Germany;United Kingdom;Italy | |||
| 8 | EUCTR2007-005759-41-GB (EUCTR) | 29/04/2008 | 29/02/2008 | 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 - FEATURE | 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 - FEATURE | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Germany;Italy;United Kingdom | ||
| 9 | NCT00673920 (ClinicalTrials.gov) | April 24, 2008 | 5/5/2008 | 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 | Terminated | 18 Years | N/A | All | 314 | Phase 3 | United States |
| 10 | EUCTR2007-005759-41-ES (EUCTR) | 23/04/2008 | 19/02/2008 | Estudio internacional randomizado, doble ciego, con grupos de tratamiento paralelos para evaluar la seguridad y eficacia de ocrelizumab administrado en un régimen de una o dos infusiones, comparado con placebo, en pacientes con artritis reumatoide activa que manifiestan una respuesta inadecuada a tratamiento con metotrexato.A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy | Estudio internacional randomizado, doble ciego, con grupos de tratamiento paralelos para evaluar la seguridad y eficacia de ocrelizumab administrado en un régimen de una o dos infusiones, comparado con placebo, en pacientes con artritis reumatoide activa que manifiestan una respuesta inadecuada a tratamiento con metotrexato.A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy | Artritis reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;Spain;Germany;Italy;United Kingdom | ||
| 11 | EUCTR2007-005759-41-FR (EUCTR) | 19/03/2008 | 12/02/2008 | 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 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;Spain;Germany;Italy;United Kingdom | ||
| 12 | EUCTR2004-002132-26-GB (EUCTR) | 19/02/2008 | 11/03/2005 | 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 INN or Proposed INN: Ocrelizumab Other descriptive name: rhuMAb 2H7 | F. Hoffmann-La Roche Limited | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;United Kingdom | ||
| 13 | EUCTR2006-005353-30-AT (EUCTR) | 19/12/2007 | 23/05/2007 | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis. | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis. | Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | Spain;Lithuania;Austria;United Kingdom;Italy | |||
| 14 | EUCTR2006-005330-20-SE (EUCTR) | 22/10/2007 | 27/08/2007 | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | |||
| 15 | EUCTR2006-005330-20-IT (EUCTR) | 10/10/2007 | 15/10/2007 | 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-α therapy. - ND | 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-α therapy. - ND | Rheumatoid Arthritis MedDRA version: 6.1;Level: PT;Classification code 10039073 | Product Name: Ocrelizumab Product Code: RO 496-4913 | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 1000 | France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | |||
| 16 | EUCTR2006-005353-30-LT (EUCTR) | 10/10/2007 | 28/06/2007 | A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM) FILM. | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis. - FILM | 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: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Panama;Philippines;Taiwan;Thailand;Spain;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;Mexico;Argentina;Brazil;Poland;Australia;Peru;South Africa;New Zealand;Korea, Republic of | |||
| 17 | EUCTR2006-005353-30-IT (EUCTR) | 01/10/2007 | 19/07/2007 | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab in combinationwith methotrexate (MTX) compared to MTX alone inmethotrexate- naïve patients with active rheumatoid arthritis. - ND | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab in combinationwith methotrexate (MTX) compared to MTX alone inmethotrexate- naïve patients with active rheumatoid arthritis. - ND | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO496-4913 | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 600 | Spain;Lithuania;Austria;United Kingdom;Italy | |||
| 18 | EUCTR2006-005147-28-GB (EUCTR) | 25/09/2007 | 18/12/2008 | 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 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Greece;Spain;Belgium;Austria;Germany;United Kingdom | ||
| 19 | EUCTR2006-005147-28-GR (EUCTR) | 11/09/2007 | 04/05/2007 | 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. | 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) Lower Lever Term (LLT) code number 10039073 | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | United Kingdom;Germany;France;Spain;Greece;Austria | |||
| 20 | EUCTR2006-005330-20-SK (EUCTR) | 07/09/2007 | 10/04/2008 | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | France;Czech Republic;Hungary;Slovenia;Slovakia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | ||
| 21 | EUCTR2006-005330-20-SI (EUCTR) | 30/08/2007 | 22/06/2007 | anti-TNF-IR phase III | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate 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 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | ||
| 22 | EUCTR2006-005330-20-NL (EUCTR) | 15/08/2007 | 13/06/2007 | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. - SCRIPT | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. - SCRIPT | Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | France;Hungary;Slovenia;Spain;Belgium;Germany;Netherlands;Italy;Sweden | |||
| 23 | EUCTR2006-005147-28-DE (EUCTR) | 25/07/2007 | 05/02/2007 | 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 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | France;Greece;Spain;Belgium;Austria;Germany;United Kingdom | ||
| 24 | EUCTR2006-005330-20-DE (EUCTR) | 18/07/2007 | 09/03/2007 | anti TNF-IR phase III | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | Rheumatoid arthritis 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 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | ||
| 25 | EUCTR2006-005330-20-FR (EUCTR) | 16/07/2007 | 26/03/2007 | 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. | 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: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | France;Czech Republic;Hungary;Slovakia;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | ||
| 26 | NCT00485589 (ClinicalTrials.gov) | June 11, 2007 | 11/6/2007 | A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM) | A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab in Combination With Methotrexate (MTX) Compared to MTX Alone in Methotrexate- Naive Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Ocrelizumab;Drug: Placebo | Genentech, Inc. | Roche Pharma AG | Terminated | 18 Years | N/A | All | 613 | Phase 3 | United States |
| 27 | EUCTR2006-005330-20-BE (EUCTR) | 07/06/2007 | 28/02/2007 | anti TNF-IR phase III | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate 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 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | France;Czech Republic;Hungary;Slovakia;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | ||
| 28 | EUCTR2006-005330-20-HU (EUCTR) | 01/06/2007 | 10/04/2007 | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | |||
| 29 | EUCTR2006-005147-28-BE (EUCTR) | 24/05/2007 | 21/02/2007 | 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. | 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) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | France;Greece;Spain;Belgium;Austria;Germany;United Kingdom | ||
| 30 | NCT00476996 (ClinicalTrials.gov) | May 15, 2007 | 18/5/2007 | 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 | Terminated | 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 |
| 31 | EUCTR2006-005147-28-FR (EUCTR) | 07/05/2007 | 06/03/2007 | 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. | 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: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913/F03 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | France;Greece;Spain;Belgium;Austria;Germany;United Kingdom | ||
| 32 | EUCTR2006-005147-28-AT (EUCTR) | 16/04/2007 | 23/03/2007 | 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. - 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. - STAGE | Rheumatoid Arthritis (RA) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | France;Greece;Spain;Belgium;Austria;Germany;United Kingdom | ||
| 33 | NCT00406419 (ClinicalTrials.gov) | December 27, 2006 | 30/11/2006 | 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 | Terminated | 18 Years | N/A | All | 1015 | Phase 3 | United States |
| 34 | NCT02720120 (ClinicalTrials.gov) | October 2005 | 22/3/2016 | A Study of Ocrelizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA) | A Randomized Placebo-Controlled, Multi-Center, Phase I/II Study of the Safety of Escalating Single Intravenous Doses of Ocrelizumab (rhuMAb 2H7, RO4964913, PRO70769) in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate But With Unsatisfactory Clinical Response | Rheumatoid Arthritis | Drug: Ocrelizumab;Drug: Placebo | Hoffmann-La Roche | NULL | Terminated | 18 Years | 80 Years | Both | 175 | Phase 1/Phase 2 | Australia;Belgium;Canada;Netherlands;New Zealand;Russian Federation;Spain;United Kingdom |
| 35 | NCT00077870 (ClinicalTrials.gov) | February 2004 | 12/2/2004 | 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. | NULL | Completed | 18 Years | 80 Years | Both | 237 | Phase 1/Phase 2 | United States |
| 36 | JPRN-JapicCTI-070479 | 26/11/2007 | 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. | NULL | 20 | BOTH | Phase 3 | NULL | ||||
| 37 | JPRN-JapicCTI-080650 | 23/10/2008 | 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. | NULL | 20 | BOTH | Phase 2 | NULL |