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 | NCT03155347 (ClinicalTrials.gov) | August 2, 2017 | 15/5/2017 | An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy | A Randomized, Multi-Center, Double Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab (TCZ) in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current DMARD Therapy | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: MTX;Drug: Placebo Matched to MTX;Drug: Placebo Matched to Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | 70 Years | All | 340 | Phase 3 | China |
| 2 | EUCTR2013-000337-13-PT (EUCTR) | 13/11/2015 | 11/11/2015 | Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA) | Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in RA (PreCePRA) - PreCePRA | Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL | Universitätsklinikum Erlangen | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Serbia;Portugal;Germany | ||
| 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 | EUCTR2013-000054-22-GB (EUCTR) | 01/10/2013 | 07/08/2013 | OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENT | OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENT - ACT-MOVE | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanised anti-human monoclonal antibody directed against the IL-6R | Roche Products Limited | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | United Kingdom | |||
| 5 | EUCTR2013-000337-13-DE (EUCTR) | 13/05/2013 | 12/02/2013 | Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA) | Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in RA (PreCePRA) | Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL | Universitätsklinikum Erlangen | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | Serbia;Portugal;Germany | ||
| 6 | EUCTR2011-003538-16-PL (EUCTR) | 23/04/2013 | 08/03/2013 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand | |||
| 7 | EUCTR2011-002894-48-NO (EUCTR) | 11/04/2013 | 06/09/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 8 | EUCTR2011-003538-16-CZ (EUCTR) | 29/03/2013 | 08/11/2012 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand | |||
| 9 | EUCTR2011-003538-16-DE (EUCTR) | 26/03/2013 | 10/12/2012 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | Phase 3 | Czech Republic;Hungary;United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Australia;Peru;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand | ||
| 10 | EUCTR2011-003538-16-PT (EUCTR) | 14/03/2013 | 13/12/2012 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | United States;Portugal;Taiwan;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand | |||
| 11 | EUCTR2011-003538-16-IT (EUCTR) | 08/03/2013 | 14/01/2013 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SARILUMAB Product Code: SAR153191 INN or Proposed INN: sarilumab Product Name: SARILUMAB Product Code: SAR153191 INN or Proposed INN: sarilumab | SANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENT | NULL | Not Recruiting | Female: yes Male: yes | 522 | Portugal;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Colombia;Italy;Switzerland;India;Australia;Peru;Korea, Republic of;Korea, Democratic People's Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Germany;New Zealand | |||
| 12 | EUCTR2011-003538-16-AT (EUCTR) | 19/02/2013 | 14/01/2013 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 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: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand | |||
| 13 | EUCTR2011-003538-16-GR (EUCTR) | 18/02/2013 | 14/01/2013 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 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: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;Japan;New Zealand | |||
| 14 | EUCTR2011-003538-16-HU (EUCTR) | 14/02/2013 | 14/11/2012 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | Portugal;United States;Taiwan;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand | |||
| 15 | EUCTR2010-022242-24-BG (EUCTR) | 07/02/2013 | 11/12/2012 | A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite DMARD Therapy | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Phase 3 | Serbia;United States;Taiwan;Ukraine;Lithuania;Russian Federation;Chile;Colombia;India;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;Romania;Croatia;Peru;Bulgaria;South Africa;Japan;Korea, Republic of | ||
| 16 | EUCTR2011-002894-48-BG (EUCTR) | 06/02/2013 | 20/11/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 17 | EUCTR2011-003538-16-LT (EUCTR) | 04/02/2013 | 05/11/2012 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | United States;Portugal;Hong Kong;Taiwan;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand | |||
| 18 | EUCTR2011-003538-16-SK (EUCTR) | 29/01/2013 | 08/03/2013 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand | |||
| 19 | EUCTR2011-002894-48-DE (EUCTR) | 25/01/2013 | 24/07/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 459 | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 20 | EUCTR2011-002894-48-ES (EUCTR) | 18/01/2013 | 29/10/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 INN or Proposed INN: Not applicable Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 21 | EUCTR2011-003538-16-ES (EUCTR) | 16/01/2013 | 29/11/2012 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-? Antagonists - SARIL-RA-TARGET | 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: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | Phase 3 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Australia;Peru;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand | ||
| 22 | EUCTR2011-002894-48-GR (EUCTR) | 16/11/2012 | 19/10/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 23 | EUCTR2011-002894-48-PT (EUCTR) | 09/11/2012 | 09/12/2011 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 15.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 INN or Proposed INN: No Active Name Specified Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 24 | EUCTR2011-002894-48-HU (EUCTR) | 16/10/2012 | 16/08/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 459 | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 25 | EUCTR2011-002894-48-EE (EUCTR) | 08/10/2012 | 08/12/2011 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 26 | NCT01709578 (ClinicalTrials.gov) | October 2012 | 15/10/2012 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-a Antagonists | Rheumatoid Arthritis | Drug: Sarilumab;Drug: placebo;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide | Sanofi | Regeneron Pharmaceuticals | Completed | 18 Years | N/A | All | 546 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Ecuador;Germany;Greece;Guatemala;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic;Hong Kong |
| 27 | EUCTR2011-002894-48-GB (EUCTR) | 14/09/2012 | 06/12/2011 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 28 | EUCTR2011-002894-48-NL (EUCTR) | 10/09/2012 | 14/12/2011 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 459 | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 29 | EUCTR2011-002894-48-BE (EUCTR) | 02/08/2012 | 18/07/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 459 | Phase 1;Phase 3 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 30 | NCT01604343 (ClinicalTrials.gov) | August 2012 | 21/5/2012 | A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D) | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite DMARD Therapy | Arthritis, Rheumatoid | Drug: Placebo;Drug: Sirukumab | Janssen Research & Development, LLC | GlaxoSmithKline | Completed | 18 Years | N/A | Both | 1670 | Phase 3 | United States;Bulgaria;Canada;Chile;Colombia;Croatia;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;South Africa;Taiwan;Ukraine;Argentina;Brazil;India;Peru |
| 31 | EUCTR2010-022242-24-LT (EUCTR) | 11/07/2012 | 29/05/2012 | A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite DMARD Therapy | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Phase 3 | Serbia;United States;Taiwan;Ukraine;Lithuania;Russian Federation;Chile;Colombia;India;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;Romania;Croatia;Peru;South Africa;Bulgaria;Japan;Korea, Republic of | ||
| 32 | NCT01251120 (ClinicalTrials.gov) | November 2011 | 30/11/2010 | A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis | A Pragmatic, Randomized, Parallel Group Study of the Effect on Disease Remission, Work Productivity and Tolerability of Tocilizumab in Combination With DMARDs and Individually Designed Best Practice DMARD Therapy in Patients With Early, Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: DMARD | Hoffmann-La Roche | NULL | Terminated | 18 Years | N/A | All | 2 | Phase 4 | Finland |
| 33 | NCT01313208 (ClinicalTrials.gov) | March 2011 | 10/3/2011 | Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD Therapy | Rheumatoid Arthritis | Drug: etanercept;Drug: Placebo;Drug: DMARD Therapy | Amgen | NULL | Completed | 18 Years | 80 Years | All | 210 | Phase 4 | United States;Canada |
| 34 | EUCTR2010-019935-37-FI (EUCTR) | 15/09/2010 | 02/07/2010 | A pragmatic, randomized, parallel group study of the effect on disease remission, work productivity, and tolerability of tocilizumab in combination with DMARDs and individually designed best practice DMARD therapy in patients with early, moderate to severe Rheumatoid Arthritis | A pragmatic, randomized, parallel group study of the effect on disease remission, work productivity, and tolerability of tocilizumab in combination with DMARDs and individually designed best practice DMARD therapy in patients with early, moderate to severe Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 Other descriptive name: TOCILIZUMAB | Roche Oy | NULL | Not Recruiting | Female: yes Male: yes | 160 | Finland | |||
| 35 | EUCTR2009-009696-34-DE (EUCTR) | 23/11/2009 | 14/05/2009 | A Study in Patients with Rheumatoid Arthritis | A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients with Active Rheumatoid Arthritis on Concomitant DMARD Therapy | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY2439821 Product Code: LY2439821 INN or Proposed INN: N.A. | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 648 | Phase 2 | India;Russian Federation;Germany;Peru;Taiwan;Argentina;Romania;Korea, Republic of;Chile;Poland | ||
| 36 | NCT01211834 (ClinicalTrials.gov) | October 2009 | 29/9/2010 | Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD Therapy | Rheumatoid Arthritis | Drug: tocilizumab;Drug: DMARDs;Drug: Placebo | JW Pharmaceutical | NULL | Completed | 18 Years | N/A | Both | 90 | Phase 3 | Korea, Republic of |
| 37 | NCT00966875 (ClinicalTrials.gov) | August 2009 | 25/8/2009 | A Study in Patients With Rheumatoid Arthritis | A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients With Active Rheumatoid Arthritis on Concomitant DMARD Therapy | Rheumatoid Arthritis | Biological: LY2439821;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | 75 Years | All | 448 | Phase 2 | United States;Argentina;Chile;Germany;India;Korea, Republic of;Peru;Poland;Romania;Russian Federation;Taiwan;Hungary |
| 38 | NCT00848354 (ClinicalTrials.gov) | June 2009 | 18/2/2009 | Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy | A Randomized, Open-label Study In The Latin America Region Comparing The Safety And Efficacy Of Etanercept With Conventional Dmard Therapy In Subjects With Rheumatoid Arthritis. | Rheumatoid Arthritis | Biological: Phase 1: Etanercept;Drug: Phase 1: Methotrexate;Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX;Drug: Phase 1: Conventiaonal DMARD | Pfizer | Amgen | Completed | 18 Years | 69 Years | All | 429 | Phase 4 | Argentina;Chile;Colombia;Mexico;Panama;Brazil;Ecuador;Spain;Venezuela |
| 39 | NCT00783536 (ClinicalTrials.gov) | November 2008 | 29/10/2008 | A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid Arthritis | An Randomized, Open Label, Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate With DMARD Therapy in Subjects With Active Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Etanercept + Methotrexate;Drug: DMARDS | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 4 | NULL |
| 40 | NCT00773461 (ClinicalTrials.gov) | October 31, 2008 | 15/10/2008 | A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis. | A Randomized, Double Blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With DMARD Therapy, in Patients With Active Rheumatoid Arthritis and Inadequate Response to Current DMARD Therapy | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo | Hoffmann-La Roche | NULL | Completed | 18 Years | 70 Years | All | 209 | Phase 3 | China |
| 41 | NCT00664716 (ClinicalTrials.gov) | July 2007 | 21/4/2008 | Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Patients | Assessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy. | Rheumatoid Arthritis | Biological: Placebo;Biological: baminercept alfa;Biological: Baminercept alfa | Biogen Idec | NULL | Completed | 18 Years | 75 Years | Both | 391 | Phase 2 | Argentina;Brazil;Hungary;Mexico;Poland;Romania;Russian Federation;United Kingdom |
| 42 | EUCTR2006-005466-39-HU (EUCTR) | 25/06/2007 | 22/03/2007 | A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy | A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy | Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: BG9924 | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Hungary;United Kingdom | ||
| 43 | NCT00422227 (ClinicalTrials.gov) | June 2007 | 11/1/2007 | Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region | A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Etanercept , Methotrexate;Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Completed | 18 Years | 70 Years | All | 300 | Phase 4 | Hong Kong;India;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand |
| 44 | EUCTR2006-005466-39-GB (EUCTR) | 12/04/2007 | 07/01/2007 | A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy | A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy | Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: BG9924 | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 380 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;United Kingdom | ||
| 45 | EUCTR2004-001490-26-EE (EUCTR) | 01/09/2006 | 08/03/2006 | A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA | A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA | RHEUMATOID ARTHRITIS | Trade Name: Persantin 100 mg Product Name: N/A Product Code: CRx-150 INN or Proposed INN: Dipyridamole and Amoxapine Trade Name: Defanyl 50 and 100 mg Product Name: N/A Product Code: CRx-150 | CombinatoRx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 72 | United Kingdom;Estonia | |||
| 46 | NCT02006706 (ClinicalTrials.gov) | August 10, 2006 | 5/12/2013 | A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy | An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure | Rheumatoid Arthritis | Drug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisolone | Hoffmann-La Roche | NULL | Completed | 18 Years | 80 Years | All | 15 | Phase 3 | Serbia |
| 47 | EUCTR2004-001930-18-EE (EUCTR) | 17/04/2006 | 19/01/2006 | A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RA | A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RA | RHEUMATOID ARTHRITIS | Trade Name: Persantin 100 mg and Product Name: N/A Product Code: CRx-102 INN or Proposed INN: prednisolone & dipyridamole | CombinatoRx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Estonia | |||
| 48 | EUCTR2004-004995-35-DK (EUCTR) | 10/04/2006 | 20/09/2005 | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | ACTIVE RHEUMATOID ARTHRITIS | Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone | CombinatoRx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | Czech Republic;Germany;United Kingdom;Denmark;Italy | ||
| 49 | EUCTR2004-004995-35-GB (EUCTR) | 24/02/2006 | 16/03/2005 | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | ACTIVE RHEUMATOID ARTHRITIS | Trade Name: Paroxetine hydrochloride 10 & 20 mg and Prednisolone 1 mg BP Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone | CombinatoRx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | Czech Republic;Austria;Denmark;Germany;Italy;United Kingdom | ||
| 50 | EUCTR2004-005210-37-FI (EUCTR) | 17/11/2005 | 14/03/2005 | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. | Rheumatoid Arthritis | Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA | F. Hoffmann La-Roche AG | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Finland;Czech Republic;Germany;Spain;Sweden | |||
| 51 | EUCTR2004-004995-35-IT (EUCTR) | 08/11/2005 | 02/02/2007 | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD | Evaluate the difference in ACR-20 response between rheumatoid arthritis subjects treated with each of two doses of CRx-139 plus DMARD therapy and subjects treated with steroid plus DMARD therapy after 8 weeks of treatment. MedDRA version: 6.1;Level: PT;Classification code 10039073 | INN or Proposed INN: Paroxetine INN or Proposed INN: Paroxetine Trade Name: Prednisolene tablets BP 1 mg INN or Proposed INN: Prednisolone | COMBINATORX, INC | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | Czech Republic;Austria;Denmark;Germany;United Kingdom;Italy | ||
| 52 | NCT00292422 (ClinicalTrials.gov) | November 2005 | 15/2/2006 | Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid Arthritis | A Randomized, Blinded, Placebo-Controlled, Multicenter, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to DMARD Therapy | Rheumatoid Arthritis | Drug: BG9924 | Biogen Idec | NULL | Completed | 18 Years | 75 Years | Both | 50 | Phase 2 | United States;Poland |
| 53 | EUCTR2004-004995-35-AT (EUCTR) | 16/10/2005 | 09/11/2005 | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | ACTIVE RHEUMATOID ARTHRITIS | Trade Name: Paroxetine Hydrochloride tablets 10 & 20 mg and Prednisolone 1 mg BP Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone | CombinatoRx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | Czech Republic;Denmark;Austria;Germany;Italy;United Kingdom | ||
| 54 | EUCTR2004-004995-35-CZ (EUCTR) | 30/08/2005 | 30/08/2005 | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | ACTIVE RHEUMATOID ARTHRITIS | Trade Name: Prednisolone Tablets BP 1 mg Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone | CombinatoRx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | Germany;United Kingdom;Czech Republic;Denmark;Italy | ||
| 55 | EUCTR2004-004995-35-DE (EUCTR) | 14/07/2005 | 17/03/2005 | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | ACTIVE RHEUMATOID ARTHRITIS | Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine Product Name: N/A Product Code: CRX-139 INN or Proposed INN: Prednisolone Product Name: N/A Product Code: CRX-139 INN or Proposed INN: paroxetine | CombinatoRx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | Czech Republic;United Kingdom;Germany;Denmark;Italy | ||
| 56 | EUCTR2004-005210-37-CZ (EUCTR) | 01/07/2005 | 30/06/2005 | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. | Rheumatoid Arthritis | Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA | F. Hoffmann La-Roche AG | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Finland;Germany;Czech Republic;Spain;Sweden | |||
| 57 | EUCTR2004-005210-37-DE (EUCTR) | 04/05/2005 | 10/03/2005 | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. | Rheumatoid Arthritis | Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA | F. Hoffmann La-Roche AG | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Finland;Czech Republic;Germany;Spain;Sweden | |||
| 58 | EUCTR2004-005210-37-SE (EUCTR) | 26/04/2005 | 10/03/2005 | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. | Rheumatoid Arthritis | Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA | F. Hoffmann La-Roche AG | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Finland;Czech Republic;Germany;Spain;Sweden | |||
| 59 | NCT00106574 (ClinicalTrials.gov) | April 2005 | 25/3/2005 | A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis | A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy | Rheumatoid Arthritis | Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | Both | 1220 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;China;Costa Rica;Czech Republic;Finland;France;Germany;Hong Kong;Mexico;Panama;Russian Federation;South Africa;Spain;Sweden;Thailand |
| 60 | EUCTR2004-005210-37-ES (EUCTR) | 29/03/2005 | 04/11/2005 | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy. | Rheumatoid Arthritis | Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA | F. Hoffmann La-Roche AG | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Czech Republic;Finland;Spain;Germany;Sweden | ||
| 61 | NCT00747214 (ClinicalTrials.gov) | November 2004 | 3/9/2008 | A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA | A Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to That of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects With RA | Rheumatoid Arthritis | Drug: CRx-102;Drug: Placebo;Drug: DMARD Therapy | Zalicus | NULL | Completed | 18 Years | N/A | All | 59 | Phase 2 | NULL |
| 62 | EUCTR2004-001490-26-GB (EUCTR) | 15/09/2004 | 01/06/2005 | A SINGLE-CENTER, RANDOMIZED, SINGLE-BLIND STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA | A SINGLE-CENTER, RANDOMIZED, SINGLE-BLIND STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA | RHEUMATOID ARTHRITIS | Trade Name: Asendis 50 mg Product Name: N/A Product Code: CRx-150 INN or Proposed INN: Amoxapine & dipyridamole | CombinatoRx, Inc | NULL | Not Recruiting | Female: yes Male: yes | Estonia;United Kingdom |