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NCT00071487 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
A Phase 2 study, sponsored by Human Genome Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 449
- Enrollment target
NCT00071487: Completed Phase 2 study, sponsored by Human Genome Sciences.
NCT00071487 is a Phase 2 study that has completed, run by Human Genome Sciences. The registered enrollment target is 449 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (238% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00071487, a Phase 2 study, has completed, sponsored by Human Genome Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 449 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.
Primary Outcome
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare.
Interventions
- DRUG Placebo
- DRUG Belimumab 1 mg/kg
- DRUG Belimumab 10 mg/kg
- DRUG Belimumab 4 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 449 participants |
| Start Date | 2003-10 |
| Est. Completion | 2006-06 |
| Phase | Phase 2 |
What the finished NCT00071487 record still lists
NCT00071487 is an interventional study that assigns participants to a tested intervention. The registered 449 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (238% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00071487 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00071487 about?
NCT00071487 is a clinical study titled "Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)". The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.
What is the current status of trial NCT00071487?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 449 participants. The study started on 2003-10. Estimated completion is 2006-06.
What interventions are being tested in trial NCT00071487?
The interventions under investigation include: Placebo (DRUG), Belimumab 1 mg/kg (DRUG), Belimumab 10 mg/kg (DRUG), Belimumab 4 mg/kg (DRUG).
Who is sponsoring clinical trial NCT00071487?
This trial is sponsored by Human Genome Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00071487's enrollment target sits among peer trials
449 89th of 2000 higher than 1,912 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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