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 | EUCTR2011-005021-48-NL (EUCTR) | 07/06/2012 | 05/06/2012 | A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX) | A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO | adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) 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 Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Teva Pharmaceutical Industries | NULL | Not Recruiting | Female: yes Male: yes | 544 | Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland | |||
| 2 | EUCTR2011-005021-48-CZ (EUCTR) | 23/05/2012 | 15/02/2012 | A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX) | A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO | adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) 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 Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Teva Pharmaceutical Industries | NULL | Not Recruiting | Female: yes Male: yes | 544 | Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands | |||
| 3 | EUCTR2011-005021-48-ES (EUCTR) | 14/05/2012 | 21/02/2012 | A study to investigate and compare the efficacy, safety, tolerability andpharmacodynamic (biochemical and physiological effects of the drug) ofTL011 and MabThera® (rituximab) in patients with severe, activerheumatoid arthritis treated with methotrexate (MTX) | A multicenter, double-blind, randomized, active controlled, parallelgroupstudy to evaluate the efficacy, safety, tolerability andpharmacodynamic profiles of TL011 infusions compared with MabThera®(rituximab) in subjects with severe, active rheumatoid arthritis treatedwith methotrexate (MTX) - ALTO | Sujetos adultos con artritis reumatoide (AR) activa de grado severo tratados con MTX 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 Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg Concentrado para solución para perfusión INN or Proposed INN: RITUXIMAB | Teva Pharmaceutical Industries | NULL | Not Recruiting | Female: yes Male: yes | 544 | Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland | |||
| 4 | EUCTR2011-005021-48-BG (EUCTR) | 09/05/2012 | 20/04/2012 | A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX) | A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO | adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) 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 Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Teva Pharmaceutical Industries | NULL | Not Recruiting | Female: yes Male: yes | 544 | Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands | |||
| 5 | EUCTR2011-005021-48-HU (EUCTR) | 04/05/2012 | 15/02/2012 | A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX) | A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO | adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) 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 Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Teva Pharmaceutical Industries | NULL | Not Recruiting | Female: yes Male: yes | 544 | Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland | |||
| 6 | EUCTR2011-005021-48-PL (EUCTR) | 10/04/2012 | 14/03/2012 | A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX) | A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO | adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) 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 Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Teva Pharmaceutical Industries | NULL | Not Recruiting | Female: yes Male: yes | 544 | Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Poland;Macedonia, the former Yugoslav Republic of | |||
| 7 | NCT01123070 (ClinicalTrials.gov) | February 2010 | 11/5/2010 | TL011 in Severe, Active Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis;Biological: MabThera infusions | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 80 Years | Both | 48 | Phase 1/Phase 2 | Czech Republic;Hungary;Italy;Spain;United Kingdom;Germany |