49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
| 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 | EUCTR2005-001391-12-GB (EUCTR) | 12/10/2005 | 15/06/2005 | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | Systemic lupus erythematosus (SLE) MedDRA version: 7.1;Level: PT;Classification code 10042945 | Product Name: edratide Product Code: TV-4710 INN or Proposed INN: edratide | TEVA Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Spain;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2005-001391-12-DE (EUCTR) | 23/09/2005 | 15/07/2005 | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | Systemic lupus erythematosus (SLE) MedDRA version: 7.1;Level: PT;Classification code 10042945 | Product Name: edratide Product Code: TV-4710 INN or Proposed INN: edratide | TEVA Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Hungary;United Kingdom;Germany;Spain;Italy | |||
| 3 | EUCTR2005-001391-12-ES (EUCTR) | 01/09/2005 | 07/07/2005 | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | Systemic lupus erythematosus (SLE) MedDRA version: 7.1;Level: PT;Classification code 10042945 | Product Name: edratide Product Code: TV-4710 INN or Proposed INN: edratide Product Name: edratide Product Code: TV-4710 INN or Proposed INN: edratide Product Name: edratide Product Code: TV-4710 INN or Proposed INN: edratide | TEVA Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Hungary;Spain;Germany;Italy;United Kingdom | ||
| 4 | EUCTR2005-001391-12-IT (EUCTR) | 28/07/2005 | 23/03/2006 | A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Three Doses of Edratide TV-4710 for Injection Administered Subcutaneously to Systemic Lupus Erythematosus SLE patients | A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Three Doses of Edratide TV-4710 for Injection Administered Subcutaneously to Systemic Lupus Erythematosus SLE patients | Treatment of active SLE patients who are concurrently undergoing a regimented program of decreased steroid use. MedDRA version: 6.1;Level: PT;Classification code 10042945 | Product Name: Edratide Acetate Product Code: TV-4710 Product Name: Edratide Acetate Product Code: TV-4710 Product Name: Edratide Acetate Product Code: TV-4710 | TEVA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Germany;United Kingdom;Spain;Italy | |||
| 5 | EUCTR2005-001391-12-HU (EUCTR) | 27/07/2005 | 15/06/2005 | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | Systemic lupus erythematosus (SLE) MedDRA version: 7.1;Level: PT;Classification code 10042945 | Product Name: edratide Product Code: TV-4710 INN or Proposed INN: edratide | TEVA Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Germany;United Kingdom;Spain;Italy | |||
| 6 | NCT00203151 (ClinicalTrials.gov) | July 2005 | 13/9/2005 | A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus | A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Edratide for Subcutaneous Injection in Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: edratide | Teva Pharmaceutical Industries | NULL | Terminated | 18 Years | 65 Years | Both | 340 | Phase 2 | United States |