46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,325 / 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-003955-14-DE (EUCTR) | 21/12/2020 | 04/11/2020 | A Placebo controlled trial in adult patients with active rheumatoid arthritis with inadequate (partial) response to anti-TNF therapy | A Randomized, Double-blind, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Adults with Active Rheumatoid Arthritis who have demonstrated an inadequate Response to anti-TNF therapy. | Active Rheumatoid Arthritis MedDRA version: 23.1;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: AMT-101 Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Germany | ||
| 2 | EUCTR2012-003536-23-PL (EUCTR) | 05/06/2013 | 22/04/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | 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 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden | |||
| 3 | EUCTR2012-003536-23-GB (EUCTR) | 21/05/2013 | 15/03/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | 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 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden | ||
| 4 | EUCTR2012-003536-23-NL (EUCTR) | 01/05/2013 | 22/02/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | 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 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | Mexico;Argentina;Poland;Belgium;Brazil;Romania;Norway;Netherlands;Sweden;United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary | |||
| 5 | 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 | Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand;Austria;Turkey;Lithuania;Guatemala;Korea, Republic of;Australia;Peru;India;Switzerland;Italy;Colombia;Israel;Chile;Russian Federation;Ukraine;Spain;Greece;Ecuador;Slovakia;Hong Kong;Estonia;Taiwan;United States;Portugal | |||
| 6 | EUCTR2012-003536-23-NO (EUCTR) | 09/04/2013 | 12/02/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | Rheumatoid Arthritis MedDRA version: 16.0;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 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Germany;Sweden | ||
| 7 | EUCTR2012-003536-23-SE (EUCTR) | 08/04/2013 | 07/02/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | 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 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden | |||
| 8 | EUCTR2012-003536-23-BE (EUCTR) | 04/04/2013 | 07/01/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | 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 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Netherlands;Germany;Norway;Sweden | |||
| 9 | EUCTR2012-003536-23-ES (EUCTR) | 01/04/2013 | 04/02/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | 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 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden | |||
| 10 | 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 | |||
| 11 | EUCTR2012-003536-23-IT (EUCTR) | 29/03/2013 | 05/02/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | 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 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden | ||
| 12 | 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 | ||
| 13 | 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 | |||
| 14 | EUCTR2012-003536-23-FI (EUCTR) | 13/03/2013 | 19/02/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | 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 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden | |||
| 15 | EUCTR2012-003536-23-EE (EUCTR) | 13/03/2013 | 12/02/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | 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 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Netherlands;Norway;Sweden | |||
| 16 | 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 | |||
| 17 | EUCTR2012-003536-23-HU (EUCTR) | 07/03/2013 | 16/01/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | 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 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Sweden;Norway;Germany;Netherlands;Romania;Brazil;Belgium;Poland;Argentina | |||
| 18 | NCT01768572 (ClinicalTrials.gov) | March 2013 | 11/1/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists | Rheumatoid Arthritis | Drug: sarilumab SAR153191 (REGN88);Drug: tocilizumab;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide;Drug: subcutaneous placebo;Drug: intravenous placebo | Sanofi | Regeneron Pharmaceuticals | Completed | 18 Years | N/A | All | 202 | Phase 3 | United States;Argentina;Belgium;Brazil;Czechia;Estonia;Finland;Hungary;Israel;Italy;Mexico;Netherlands;Norway;Poland;Romania;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic |
| 19 | EUCTR2012-003536-23-CZ (EUCTR) | 20/02/2013 | 03/01/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | 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 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden | |||
| 20 | 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 | |||
| 21 | 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 | |||
| 22 | 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 | |||
| 23 | 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 | |||
| 24 | 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 | |||
| 25 | 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 | ||
| 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 | EUCTR2010-020839-39-BE (EUCTR) | 10/05/2011 | 25/11/2010 | Efficacy and safety of CDP6038 in patients with rheumatoid arthritis withan unsuccessful response to anti-TNF therapy | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056 | 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] - Musculoskeletal Diseases [C05] | Product Name: CDP6038 Product Code: CDP6038 Other descriptive name: Recombinant human Mab of IgG4 subtype Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: Tocilizumab INN or Proposed INN: RoActemra® Other descriptive name: TOCILIZUMAB | UCB Biosciences, Inc. A Member of the UCB Group of Companies | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;Belgium;United Kingdom | ||
| 28 | EUCTR2010-020839-39-GB (EUCTR) | 25/02/2011 | 12/10/2010 | Efficacy and safety of CDP6038 in patients with rheumatoid arthritis with an unsuccessful response to anti-TNF therapy | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056 | 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: Olikizumab Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: Recombinant human Mab of IgG4 subtype Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: Tocilizumab INN or Proposed INN: RoActemra® Other descriptive name: TOCILIZUMAB | UCB Biosciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 220 | United Kingdom;United States | |||
| 29 | 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 | ||
| 30 | NCT02528292 (ClinicalTrials.gov) | October 2010 | 5/8/2011 | Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Rheumatoid Arthritis | Phase 4 Study of Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Patients With Rheumatoid Arthritis Undergoing Treatment With Anti-TNF Therapy | Rheumatoid Arthritis | Procedure: Synovial biopsy;Drug: Anti-TNF therapy | Barts & The London NHS Trust | NULL | Active, not recruiting | 18 Years | N/A | Both | 24 | Phase 4 | United Kingdom |
| 31 | 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 |
| 32 | 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 | ||||
| 33 | NCT01060098 (ClinicalTrials.gov) | April 2010 | 29/1/2010 | T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF Blockade | T Cells and TNF: The Impact of TNF Blockade on Effector T Cell Populations in Rheumatoid Arthritis and Other Conditions Treated With Anti-TNFalpha Agents | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: anti-TNF therapy (etanercept or adalimumab) | Imperial College London | NULL | Completed | 18 Years | 80 Years | All | 48 | United Kingdom | |
| 34 | 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 | |||
| 35 | 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 | ||
| 36 | 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 | |||
| 37 | 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 | |||
| 38 | 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 | ||
| 39 | 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 | |||
| 40 | 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 | |||
| 41 | 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 | |||
| 42 | EUCTR2008-000587-17-IT (EUCTR) | 12/03/2009 | 20/03/2009 | Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background No-Biologic DMARDs who have an Inadequate Response to Current Non-Biologic DMARD and/or Anti-TNF Therapy - ND | Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background No-Biologic DMARDs who have an Inadequate Response to Current Non-Biologic DMARD and/or Anti-TNF Therapy - ND | 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 INN or Proposed INN: tocilizumab | ROCHE | 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 | |||
| 43 | 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 | ||
| 44 | 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 |
| 45 | 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 | |||
| 46 | 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 | |||
| 47 | 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 | |||
| 48 | EUCTR2008-006256-22-FR (EUCTR) | 21/11/2008 | 31/10/2008 | Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy. | Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy. | rheumatoid arthritis requiring anti-TNF alpha treatment MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions | Trade Name: remicade INN or Proposed INN: infliximab Trade Name: humira INN or Proposed INN: adalimumab Trade Name: enbrel INN or Proposed INN: etanercept | CHU Saint-Etienne | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 49 | 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 | |||
| 50 | 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 | |||
| 51 | 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 | |||
| 52 | 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 | |||
| 53 | 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 |
| 54 | 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 | |||
| 55 | 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 | ||
| 56 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece | |||
| 57 | 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 | |||
| 58 | 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 | ||
| 59 | 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 | |||
| 60 | 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 | |||
| 61 | 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;Greece;Spain;Belgium;Denmark;Czech Republic;United Kingdom | |||
| 62 | EUCTR2007-000593-24-GB (EUCTR) | 28/03/2008 | 01/08/2007 | An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis. | An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis. | Rheumatoid Arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Enbrel INN or Proposed INN: Etanercept Other descriptive name: Enbrel Trade Name: Humira INN or Proposed INN: adalimumab Other descriptive name: Humira | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 52 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom;Sweden | ||
| 63 | EUCTR2007-000593-24-SE (EUCTR) | 16/01/2008 | 21/11/2007 | An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis. | An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis. | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Enbrel INN or Proposed INN: Etanercept Other descriptive name: Enbrel Trade Name: Humira INN or Proposed INN: adalimumab Other descriptive name: Humira | F.Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 52 | United Kingdom;Sweden | |||
| 64 | EUCTR2006-005467-26-BE (EUCTR) | 08/05/2007 | 14/02/2007 | A phase 2b, randomised, double-blind, placebo-controlled, multi-centre, 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 anti-TNF therapy | A phase 2b, randomised, double-blind, placebo-controlled, multi-centre, 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 anti-TNF 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 | 120 | Phase 2 | Belgium;United Kingdom | ||
| 65 | EUCTR2006-005467-26-GB (EUCTR) | 12/04/2007 | 16/01/2007 | A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter 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 Anti-TNF Therapy | A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter 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 Anti-TNF Therapy | Rheumatoid Arthritis 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 | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;United Kingdom | ||
| 66 | EUCTR2006-005386-19-BE (EUCTR) | 19/12/2006 | 03/11/2006 | Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini | Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini | Rheumatoid arthritis refractory to TNF blockers patients MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: MabThera | Cliniques Universitaires Saint-Luc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Belgium | ||||
| 67 | NCT01272908 (ClinicalTrials.gov) | July 18, 2006 | 7/1/2011 | A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET) | Rituximab Phase IIIb Open-label, Multi-centre Assessment of Safety and Effectiveness in Patients With RA Following an Inadequate Response to One Prior Anti-TNF Inhibitor (RESET) | Rheumatoid Arthritis | Drug: rituximab | Hoffmann-La Roche | NULL | Completed | 18 Years | 80 Years | All | 120 | Phase 3 | Canada;Sweden |
| 68 | EUCTR2005-000884-25-SE (EUCTR) | 11/08/2005 | 07/06/2005 | 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 methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF 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 methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF 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 | 450 | United Kingdom;Germany;Iceland;Italy;Sweden | |||
| 69 | EUCTR2005-000884-25-GB (EUCTR) | 11/07/2005 | 19/04/2005 | 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 methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF 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 methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF 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 | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Iceland;Germany;Italy;United Kingdom;Sweden | ||
| 70 | EUCTR2005-000884-25-IS (EUCTR) | 27/06/2005 | 27/04/2005 | 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 methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF 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 methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF 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 | 450 | Phase 3 | Germany;Iceland;Italy;United Kingdom;Sweden | ||
| 71 | EUCTR2005-000884-25-DE (EUCTR) | 14/06/2005 | 13/04/2005 | 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 methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF 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 methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF 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 | 450 | United Kingdom;Germany;Iceland;Italy;Sweden | |||
| 72 | EUCTR2005-000884-25-IT (EUCTR) | 02/05/2005 | 22/06/2005 | 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 combionation with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF 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 combionation with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy. | rheumatoid arthritis MedDRA version: 6.1;Level: PT;Classification code 10039073 | Product Name: Tocilizumab Product Code: Ro 48-77533 Trade Name: METHOTREXATE*2,5MG 25CPR INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*7,5MG/ML 4SIR. INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*10MG/1,33ML 4S INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*20MG/2,66ML 4S INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*15MG/2ML 4SIR INN or Proposed INN: Methotrexate | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 570 | United Kingdom;Germany;Iceland;Italy;Sweden | |||
| 73 | NCT00106522 (ClinicalTrials.gov) | May 2005 | 25/3/2005 | A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy | A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | Both | 499 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Iceland;Italy;Mexico;Netherlands;Puerto Rico;Sweden;Switzerland;United Kingdom |
| 74 | 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 |
| 75 | NCT00162201 (ClinicalTrials.gov) | October 2003 | 9/9/2005 | An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy | An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 16 | Phase 1 | United Kingdom |
| 76 | NCT00048581 (ClinicalTrials.gov) | December 2002 | 2/11/2002 | Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past. | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 in Subjects With Active Rheumatoid Arthritis on Background Disease Modifying Anti-Rheumatic Drugs (DMARDS) Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy | Rheumatoid Arthritis | Drug: Abatacept;Drug: Placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 738 | Phase 3 | United States |