49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
| 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 | EUCTR2006-005177-21-AT (EUCTR) | 06/12/2007 | 26/02/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||
| 2 | EUCTR2006-005177-21-FR (EUCTR) | 11/09/2007 | 23/07/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 3 | EUCTR2006-005177-21-NL (EUCTR) | 03/08/2007 | 04/06/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||
| 4 | EUCTR2006-005177-21-SE (EUCTR) | 08/06/2007 | 07/05/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||
| 5 | EUCTR2006-005177-21-GB (EUCTR) | 29/05/2007 | 02/01/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 6 | EUCTR2006-005177-21-SK (EUCTR) | 17/05/2007 | 20/03/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 7 | EUCTR2006-005177-21-ES (EUCTR) | 09/05/2007 | 09/03/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)Un estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 76 semanas para evaluar la eficacia y la seguridad de belimumab (HGS1006, LymphoStat-BTM), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)Un estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 76 semanas para evaluar la eficacia y la seguridad de belimumab (HGS1006, LymphoStat-BTM), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) - BLISS-76 | Systemic Lupus Erythematosus (SLE)Lupus Eritematoso Sistémico MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | France;Czech Republic;Slovakia;Belgium;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 8 | EUCTR2006-005177-21-BE (EUCTR) | 07/05/2007 | 29/01/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||
| 9 | EUCTR2006-005177-21-DE (EUCTR) | 03/05/2007 | 20/02/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||
| 10 | EUCTR2006-005177-21-CZ (EUCTR) | 23/04/2007 | 28/02/2007 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 810 | Phase 3 | Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden |