GP2013
( DrugBank: - / KEGG DRUG: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 15 |
46. 悪性関節リウマチ
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
Showing 1 to 10 of 15 trials
| 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 | EUCTR2012-003876-38-PL (EUCTR) | 10/11/201520151110 | 16/11/201520151116 | Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past Clinical study to find out if the biologically similar medicine GP2013is safe in patients with rheum ... | A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and ... | Rheumatoid Arthritis MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Rheumatoid Arthritis MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid a ... | Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product N ... | Hexal AG (a Sandoz company) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Hungary;Poland;Germany | ||
| 2 | EUCTR2012-003876-38-HU (EUCTR) | 28/07/201520150728 | 22/05/201520150522 | Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past Clinical study to find out if the biologically similar medicine GP2013is safe in patients with rheum ... | A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and ... | Rheumatoid Arthritis MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Rheumatoid Arthritis MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid a ... | Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product N ... | Hexal AG (a Sandoz company) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Hungary;Poland;Germany | ||
| 3 | EUCTR2012-003876-38-DE (EUCTR) | 21/07/201520150721 | 29/04/201520150429 | Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past Clinical study to find out if the biologically similar medicine GP2013is safe in patients with rheum ... | A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and ... | Rheumatoid Arthritis MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Rheumatoid Arthritis MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid a ... | Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product N ... | Hexal AG (a Sandoz company) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Hungary;Poland;Germany | ||
| 4 | NCT02514772 (ClinicalTrials.gov) | July 201520150700 | 30/7/201520150730 | GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera® GP2013Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or Ma ... | A Randomized, Double- Blind, Controlled, Parallel-group, Multicenter Study to Assess the Safety and Immunogenicity of Transitioning to GP2013 or Re-treatment With Rituxan® or MabThera® in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera® A Randomized, Double- Blind, Controlled, Parallel-group, Multicenter Study to Assess the Safety and ... | Rheumatoid Arthritis | Biological: GP2013 - A Proposed biosimilar rituximab;Biological: Originator rituximab - Rituxan ® or MabThera ® Biological: GP2013- A Proposed biosimilar rituximab;Biological: Originator rituximab - Rituxan ® or ... | Sandoz | Hexal AG | Completed | 18 Years | N/A | All | 107 | Phase 3 | United States;Germany;Hungary;Poland |
| 5 | EUCTR2010-021184-32-BG (EUCTR) | 27/05/201520150527 | 14/04/201520150414 | 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 A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety ... | 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] Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rh ... | 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 Product Name: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Na ... | 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 United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hung ... | ||
| 6 | EUCTR2010-021184-32-PL (EUCTR) | 21/04/201520150421 | 06/02/201520150206 | 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 A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety ... | 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] Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rh ... | 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 Product Name: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Na ... | 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 United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hung ... | ||
| 7 | EUCTR2010-021184-32-GB (EUCTR) | 25/03/201520150325 | 12/06/201520150612 | 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 A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety ... | 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] Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rh ... | 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 Product Name: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Na ... | 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 United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hung ... | ||
| 8 | EUCTR2010-021184-32-HU (EUCTR) | 09/01/201520150109 | 27/10/201420141027 | 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 A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety ... | 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] Refractory rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rh ... | 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 Product Name: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Na ... | 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 United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hung ... | ||
| 9 | EUCTR2010-021184-32-EE (EUCTR) | 23/03/201220120323 | 08/03/201220120308 | 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 A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety ... | 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] Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rh ... | 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 Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: R ... | 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 Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Braz ... | ||
| 10 | EUCTR2010-021184-32-IT (EUCTR) | 03/08/201120110803 | 02/02/201120110202 | 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 A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety ... | 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] Refractory rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rh ... | 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 Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: R ... | 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 Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Brazil;Belgi ... |