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NCT01632241 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)
A Phase 4 study, sponsored by Human Genome Sciences Inc., a GSK Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 503
- Enrollment target
NCT01632241: Completed Phase 4 study, sponsored by Human Genome Sciences Inc., a GSK Company.
NCT01632241 is a Phase 4 study that has completed, run by Human Genome Sciences Inc., a GSK Company. The registered enrollment target is 503 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01632241, a Phase 4 study, has completed, sponsored by Human Genome Sciences Inc., a GSK Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 503 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).
Primary Outcome
SRI response is defined as \>=4 point reduction, from Baseline in safety of estrogen in Lupus National Assessment(SELENA)SLEDAI\[SS\] score (with modified SLEDAI-2K scoring for proteinuria \[PU\]), no worsening (increase of \<0.30 points from Baseline) in Physician's Global Assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics(BILAG)A organ domain score \[ODS\] or 2 new BILAG B ODS compared with Baseline. Drop-outs and treatment failures were set to non-responders. Anal
Interventions
- BIOLOGICAL Placebo plus standard therapy
- BIOLOGICAL Belimumab 10 mg/kg plus standard therapy
- DRUG Standard therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 503 participants |
| Start Date | 2013-02-19 |
| Est. Completion | 2019-01-28 |
| Phase | Phase 4 |
What the finished NCT01632241 record still lists
NCT01632241 is an interventional study that assigns participants to a tested intervention. The registered 503 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo plus standard therapy is the first listed.
NCT01632241 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01632241 about?
NCT01632241 is a clinical study titled "Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)". The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).
What is the current status of trial NCT01632241?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 503 participants. The study started on 2013-02-19. Estimated completion is 2019-01-28.
What interventions are being tested in trial NCT01632241?
The interventions under investigation include: Placebo plus standard therapy (BIOLOGICAL), Belimumab 10 mg/kg plus standard therapy (BIOLOGICAL), Standard therapy (DRUG).
Who is sponsoring clinical trial NCT01632241?
This trial is sponsored by Human Genome Sciences Inc., a GSK Company, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01632241's enrollment target sits among peer trials
503 163rd of 2000 higher than 1,837 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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