Belimumab 1 mg/kg (DrugBank: Belimumab)
2 diseases| 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 | 1 |
| 49 | 全身性エリテマトーデス | 6 |
| 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 | NCT00071812 (ClinicalTrials.gov) | December 2003 | 31/10/2003 | A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) | Arthritis, Rheumatoid | Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 4 mg/kg;Drug: Belimumab 10 mg/kg | Human Genome Sciences Inc. | NULL | Completed | 18 Years | 65 Years | All | 283 | Phase 2 | United States |
| 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 | NCT01858792 (ClinicalTrials.gov) | May 2011 | 19/12/2012 | A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies | Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients With Higher Disease Activity (Anti-dsDNA Positive and Low Complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies | Lupus Erythematosus, Discoid | Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Other: Placebo | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Completed | 18 Years | N/A | Both | 1 | N/A | NULL |
| 2 | NCT01914770 (ClinicalTrials.gov) | July 2009 | 3/4/2012 | Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76 | Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76 | Systemic Lupus Erythematosus | Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Drug: Placebo | GlaxoSmithKline | Human Genome Sciences Inc. | Completed | 18 Years | N/A | Both | 1016 | N/A | NULL |
| 3 | NCT00724867 (ClinicalTrials.gov) | August 2008 | 28/7/2008 | A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States | A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United States | Systemic Lupus Erythematosus | Biological: Belimumab 1 mg/kg;Biological: Belimumab 10 mg/kg | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Completed | 18 Years | N/A | All | 268 | Phase 3 | United States;Canada |
| 4 | NCT00424476 (ClinicalTrials.gov) | May 2007 | 17/1/2007 | A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk 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) | Systemic Lupus Erythematosus | Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg | Human Genome Sciences Inc. | GlaxoSmithKline | Completed | 18 Years | N/A | All | 865 | Phase 3 | Argentina;Australia;Brazil;Chile;Colombia;Hong Kong;India;Korea, Republic of;Peru;Philippines;Romania;Russian Federation;Taiwan;Bulgaria;China |
| 5 | NCT00410384 (ClinicalTrials.gov) | December 2006 | 8/12/2006 | A Study of Belimumab in Subjects With Systemic Lupus Erythematosus | 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) | Systemic Lupus Erythematosus | Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg | Human Genome Sciences Inc. | GlaxoSmithKline | Completed | 18 Years | N/A | All | 819 | Phase 3 | United States;Austria;Belgium;Canada;Costa Rica;Czech Republic;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Sweden;United Kingdom |
| 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 |
| 6 | NCT00071487 (ClinicalTrials.gov) | October 2003 | 24/10/2003 | Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus, Systemic | Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 4 mg/kg;Drug: Belimumab 10 mg/kg | Human Genome Sciences Inc. | NULL | Completed | 18 Years | 65 Years | All | 449 | Phase 2 | United States;Canada |