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 | NCT02011334 (ClinicalTrials.gov) | July 2014 | 4/12/2013 | 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 | NULL | Completed | 18 Years | N/A | Both | 285 | Phase 3 | Argentina;Brazil;Colombia;Dominican Republic;Mexico;Venezuela;Ecuador;Uruguay |
| 2 | NCT02046616 (ClinicalTrials.gov) | May 28, 2014 | 24/1/2014 | A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs) | 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 Subgroup of Patients Inflammation Will Be Measured by Ultrasound. | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Methotrexate;Drug: Non-Biologic DMARDs | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 133 | Phase 3 | Denmark;Finland;Norway;Sweden |
| 3 | NCT02046603 (ClinicalTrials.gov) | March 4, 2014 | 24/1/2014 | A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and 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 (SC) Tocilizumab Monotherapy or Combination Therapy With Methotrexate (MTX) or Other Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Patients With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-Tumour Necrosis Factor (Anti-TNF) Biologic Agent | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: DMARDs;Drug: Oral Corticosteroids;Drug: Methotrexate | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 162 | Phase 3 | United Kingdom |
| 4 | NCT01987479 (ClinicalTrials.gov) | January 30, 2014 | 8/11/2013 | A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis | Multi-Center, Open Label, Single Arm Phase IIIB Study on Safety and Efficacy of Subcutaneous Tocilizumab in Monotherapy or in Combination With Methotrexate or Other Non-Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis Patients With an Inadequate Response to Non-Biologic DMARDs - OSCAR | Rheumatoid Arthritis | Drug: Non-Biologic DMARDs;Drug: Tocilizumab;Drug: Methotrexate | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 150 | Phase 3 | Netherlands |
| 5 | EUCTR2013-000342-19-NL (EUCTR) | 24/10/2013 | 08/10/2013 | 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 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | Roche Nederland B.V. | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Netherlands | |||
| 6 | NCT01995201 (ClinicalTrials.gov) | September 2013 | 1/11/2013 | A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active 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 | Drug: DMARD;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | N/A | Both | 401 | Phase 3 | Ireland;Portugal;Spain |
| 7 | NCT01245439 (ClinicalTrials.gov) | September 2011 | 17/11/2010 | 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 | NULL | Completed | 18 Years | N/A | All | 65 | Phase 3 | Turkey |
| 8 | NCT01353859 (ClinicalTrials.gov) | March 2011 | 13/5/2011 | 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 | NULL | Completed | 18 Years | N/A | All | 39 | Phase 3 | Indonesia;Greece |
| 9 | EUCTR2008-006924-68-AT (EUCTR) | 28/10/2010 | 12/01/2009 | 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 INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | France;Portugal;Hungary;Czech Republic;Spain;Austria;Netherlands;United Kingdom;Italy | ||
| 10 | NCT01149057 (ClinicalTrials.gov) | October 2010 | 22/6/2010 | 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 | Completed | 18 Years | N/A | All | 145 | Phase 4 | Israel |
| 11 | NCT01195272 (ClinicalTrials.gov) | August 2010 | 2/9/2010 | A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs. | 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 | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 21 | Phase 4 | United Kingdom |
| 12 | EUCTR2010-018331-18-GB (EUCTR) | 12/05/2010 | 18/03/2010 | 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 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 13 | NCT01063062 (ClinicalTrials.gov) | February 28, 2010 | 3/2/2010 | 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 | NULL | Completed | 18 Years | N/A | All | 107 | Phase 3 | Egypt |
| 14 | NCT01089023 (ClinicalTrials.gov) | January 2010 | 8/3/2010 | 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 | NULL | Completed | 18 Years | N/A | All | 95 | Phase 4 | Bahrain;Iran, Islamic Republic of;Kuwait;Qatar;United Arab Emirates |
| 15 | EUCTR2008-006924-68-HU (EUCTR) | 11/11/2009 | 02/09/2009 | 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 | Trade Name: RoActemra INN or Proposed INN: Tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Portugal;Hungary;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy | |||
| 16 | EUCTR2009-012218-30-PT (EUCTR) | 06/10/2009 | 12/08/2009 | 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 | Roche Farmacêutica Química, Lda. | NULL | Not Recruiting | Female: yes Male: yes | Portugal | ||||
| 17 | EUCTR2008-006924-68-GR (EUCTR) | 03/06/2009 | 19/11/2009 | 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 | Trade Name: RoActemra INN or Proposed INN: Tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | France;Portugal;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;United Kingdom;Italy | ||
| 18 | EUCTR2008-006924-68-PT (EUCTR) | 18/05/2009 | 17/03/2009 | 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 | Trade Name: RoActemra INN or Proposed INN: Tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | France;Portugal;Hungary;Czech Republic;Spain;Netherlands;United Kingdom;Italy | |||
| 19 | NCT00891020 (ClinicalTrials.gov) | May 2009 | 29/4/2009 | 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 | NULL | Completed | 18 Years | N/A | All | 886 | Phase 3 | United States;Puerto Rico;United Kingdom |
| 20 | EUCTR2008-006924-68-CZ (EUCTR) | 28/04/2009 | 12/02/2009 | 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 | Trade Name: RoActemra INN or Proposed INN: Tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy | |||
| 21 | EUCTR2008-006924-68-FR (EUCTR) | 06/04/2009 | 19/03/2009 | 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. | 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. | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: RoActemra Product Code: RO4877533/F04-F05 INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Portugal;France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;United Kingdom;Italy | ||
| 22 | EUCTR2008-006924-68-IT (EUCTR) | 03/04/2009 | 23/03/2009 | 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 - extension to study 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 - extension to study MA21573 | Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF therapies. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: TOCILIZUMAB | F. Hoffmann-La Roche | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy | |||
| 23 | EUCTR2008-006924-68-NL (EUCTR) | 02/04/2009 | 09/02/2009 | 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: Tocilizumab Product Code: RO4877533 INN or Proposed INN: Tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy | |||
| 24 | EUCTR2008-000587-17-DE (EUCTR) | 26/03/2009 | 17/12/2008 | 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 | Trade Name: RoActemra Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece | |||
| 25 | EUCTR2008-006924-68-GB (EUCTR) | 06/03/2009 | 29/04/2009 | 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 | Trade Name: RoActemra Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Portugal;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Italy;United Kingdom | ||
| 26 | NCT00883753 (ClinicalTrials.gov) | March 2009 | 17/4/2009 | An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy | An Extension Phase of the Multi-National Open-Label Study (MA21573) 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 | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 934 | Phase 3 | Australia;Canada;Czech Republic;France;Greece;Hungary;Italy;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;United Kingdom;Austria;Turkey |
| 27 | EUCTR2008-000587-17-HU (EUCTR) | 27/02/2009 | 28/11/2008 | 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) INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece | |||
| 28 | EUCTR2008-006924-68-ES (EUCTR) | 13/02/2009 | 19/01/2009 | Fase de extensión del estudio abierto multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.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. - extension MA21573 | Fase de extensión del estudio abierto multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.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. - extension MA21573 | Artritis reumatoide/Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy | |||
| 29 | EUCTR2008-000587-17-GR (EUCTR) | 13/01/2009 | 30/01/2009 | 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 | Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to DMARDs or anti- TNF therapies MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: Tocilizumab | F. Hoffmann- La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece | |||
| 30 | NCT00810277 (ClinicalTrials.gov) | November 30, 2008 | 16/12/2008 | A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs | An Open Label Study to Evaluate the Safety and 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 DMARDs. | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 14 | Phase 3 | Finland |
| 31 | EUCTR2008-000587-17-BE (EUCTR) | 13/10/2008 | 19/08/2008 | 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 - ACT-Sure | 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 - ACT-Sure | Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece | |||
| 32 | EUCTR2008-000587-17-DK (EUCTR) | 22/09/2008 | 04/07/2008 | 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) INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | 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 | |||
| 33 | EUCTR2008-000587-17-CZ (EUCTR) | 15/09/2008 | 20/06/2008 | 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) INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Belgium;Spain;Greece | |||
| 34 | EUCTR2008-000587-17-IE (EUCTR) | 11/09/2008 | 05/06/2008 | 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: Tocilizumab (Actemra) Product Code: RO4877533 (TCZ) INN or Proposed INN: Tocilizumab | F. Hoffmann-La Roche Ltd | NULL | 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 | |||
| 35 | EUCTR2008-004126-16-FI (EUCTR) | 05/09/2008 | 15/07/2008 | 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) INN or Proposed INN: tocilizumab | Roche Oy | NULL | Not Recruiting | Female: yes Male: yes | Finland | ||||
| 36 | NCT00750880 (ClinicalTrials.gov) | September 2008 | 10/9/2008 | An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy. | International Multi-Center 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 or Anti-TNF Therapy. | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 1681 | Phase 3 | Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Luxembourg;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;Sweden;Switzerland;Turkey;United Kingdom;United States |
| 37 | EUCTR2008-000587-17-FI (EUCTR) | 20/08/2008 | 05/06/2008 | 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) INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | 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 | |||
| 38 | EUCTR2008-000587-17-NL (EUCTR) | 12/08/2008 | 10/09/2008 | 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: RoActemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 39 | EUCTR2008-000587-17-FR (EUCTR) | 12/08/2008 | 16/07/2008 | 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: Tolicizumab Roche Product Code: RO4877533/F04-F05 INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 40 | EUCTR2008-000587-17-PT (EUCTR) | 08/08/2008 | 06/06/2008 | 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 - ACT-SURE | 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 - ACT-SURE | Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | 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 | |||
| 41 | EUCTR2008-000587-17-ES (EUCTR) | 22/07/2008 | 26/05/2008 | Estudio abierto, multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.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 | Estudio abierto, multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.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 | Artritis reumatoideRheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 42 | EUCTR2008-000587-17-SE (EUCTR) | 03/07/2008 | 21/05/2008 | 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) INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | 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 | |||
| 43 | EUCTR2008-000587-17-AT (EUCTR) | 19/06/2008 | 09/05/2008 | 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 - ACT-SURE | 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 - ACT-SURE | Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | 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 | |||
| 44 | EUCTR2008-000587-17-GB (EUCTR) | 18/06/2008 | 18/04/2008 | 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) INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | 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 | |||
| 45 | EUCTR2004-005102-68-CZ (EUCTR) | 14/04/2006 | 14/04/2006 | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, Version 1.0 dated 7-Feb-2006. | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, Version 1.0 dated 7-Feb-2006. | RHEUMATOID ARTHRITIS,NOS | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Germany;United Kingdom;Czech Republic;Belgium;Spain;Ireland;Italy | ||
| 46 | EUCTR2004-005102-68-BE (EUCTR) | 15/11/2005 | 25/07/2005 | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating Amendments 2, 3 and 8. + Protocol Amendments 1 & 5.+ Protocol Amendment 11 - Site specific: All sites in Belgium (v1.0, dated 23-Sep-2008) | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating Amendments 2, 3 and 8. + Protocol Amendments 1 & 5.+ Protocol Amendment 11 - Site specific: All sites in Belgium (v1.0, dated 23-Sep-2008) | RHEUMATOID ARTHRITIS,NOS | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy | ||
| 47 | EUCTR2004-005102-68-IT (EUCTR) | 03/11/2005 | 04/11/2005 | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options | Rheumatiod arthritis MedDRA version: 6.1;Level: HLT;Classification code 10039075 | Product Name: abatacept Product Code: BMS-188667 | BRISTOL-M.SQUIBB | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy | ||
| 48 | EUCTR2004-005102-68-DE (EUCTR) | 15/09/2005 | 15/07/2005 | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, version 1.0 dated 7-Feb-2006. | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, version 1.0 dated 7-Feb-2006. | RHEUMATOID ARTHRITIS,NOS | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Czech Republic;United Kingdom;Germany;Belgium;Spain;Ireland;Italy | ||
| 49 | EUCTR2004-005102-68-GB (EUCTR) | 01/09/2005 | 27/05/2005 | 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 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Belgium;Spain;Ireland;Germany;Italy;United Kingdom | ||
| 50 | EUCTR2004-005102-68-ES (EUCTR) | 16/08/2005 | 17/06/2005 | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including Protocol amendment 2 + Pharmacogenetic Amendment 1. | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including Protocol amendment 2 + Pharmacogenetic Amendment 1. | RHEUMATOID ARTHRITIS,NOS | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Czech Republic;Belgium;Spain;Ireland;Germany;Italy;United Kingdom | ||
| 51 | EUCTR2004-005102-68-IE (EUCTR) | 05/08/2005 | 02/06/2005 | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including protocol amendment 2 + Pharmacogenetic Amendment 1. | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including protocol amendment 2 + Pharmacogenetic Amendment 1. | RHEUMATOID ARTHRITIS,NOS | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy | ||
| 52 | NCT00124982 (ClinicalTrials.gov) | April 2005 | 30/6/2005 | 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 | NULL | Completed | 18 Years | N/A | All | 1286 | Phase 3 | United States;Belgium;Czech Republic;France;Germany;Ireland;Italy;Mexico;Spain;United Kingdom;Canada |