Clinical trial
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
NCT00424476 · Human Genome Sciences Inc., Industry · Completed
Key facts
| NCT number | NCT00424476 |
|---|---|
| Title | A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) |
| Official title | 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) |
| Acronym | BLISS-52 |
| Lead sponsor | Human Genome Sciences Inc., Industry |
| Collaborators | GlaxoSmithKline Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Systemic Lupus Erythematosus |
| Intervention type | Drug |
| Interventions | Placebo, Belimumab 1 mg/kg, Belimumab 10 mg/kg |
| Enrollment | 865 |
| Start date | May 1, 2007 |
| Primary completion | May 1, 2009 |
| Completion | Mar 1, 2010 |
| First posted | Jan 19, 2007 |
| Last update posted | Dec 12, 2016 |
| Countries | Argentina, Australia, Brazil, Chile, Colombia, Hong Kong, India, Peru, Philippines, Romania, Russia, South Korea and 1 more |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: