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 | EUCTR2010-021184-32-BG (EUCTR) | 27/05/2015 | 14/04/2015 | GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy | A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies | Refractory 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: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 124 | Phase 1;Phase 2 | United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | ||
| 2 | EUCTR2010-021184-32-PL (EUCTR) | 21/04/2015 | 06/02/2015 | GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy | A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies | Refractory 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: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 124 | Phase 1;Phase 2 | United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | ||
| 3 | EUCTR2010-021184-32-GB (EUCTR) | 25/03/2015 | 12/06/2015 | GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy | A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies | Refractory 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: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 124 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | ||
| 4 | EUCTR2010-021184-32-HU (EUCTR) | 09/01/2015 | 27/10/2014 | GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy | A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies | Refractory 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: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 124 | Phase 1;Phase 2 | United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | ||
| 5 | EUCTR2010-021184-32-EE (EUCTR) | 23/03/2012 | 08/03/2012 | GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy | A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies | Refractory 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: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 2 | Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | ||
| 6 | EUCTR2010-021184-32-IT (EUCTR) | 03/08/2011 | 02/02/2011 | GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy | A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies | Refractory 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: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 2 | Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany | ||
| 7 | EUCTR2010-021184-32-DE (EUCTR) | 30/11/2010 | 30/08/2010 | GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy | A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies | Refractory rheumatoid arthritis MedDRA version: 19.0;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: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 2 | Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany |