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NCT01484496 · ClinicalTrials.gov registry record · Phase 3
A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
A Phase 3 study, sponsored by Human Genome Sciences Inc., a GSK Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 839
- Enrollment target
NCT01484496: Completed Phase 3 study, sponsored by Human Genome Sciences Inc., a GSK Company.
NCT01484496 is a Phase 3 study that has completed, run by Human Genome Sciences Inc., a GSK Company. The registered enrollment target is 839 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01484496, a Phase 3 study, has completed, sponsored by Human Genome Sciences Inc., a GSK Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 839 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).
Primary Outcome
SRI response is defined as \>=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, 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 or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for t
Interventions
- BIOLOGICAL Placebo
- DRUG Standard therapy
- BIOLOGICAL Belimumab 200 mg SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 839 participants |
| Start Date | 2011-11-16 |
| Est. Completion | 2015-10-01 |
| Phase | Phase 3 |
What the finished NCT01484496 record still lists
NCT01484496 is an interventional study that assigns participants to a tested intervention. The registered 839 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01484496 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01484496 about?
NCT01484496 is a clinical study titled "A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)". The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).
What is the current status of trial NCT01484496?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 839 participants. The study started on 2011-11-16. Estimated completion is 2015-10-01.
What interventions are being tested in trial NCT01484496?
The interventions under investigation include: Placebo (BIOLOGICAL), Standard therapy (DRUG), Belimumab 200 mg SC (BIOLOGICAL).
Who is sponsoring clinical trial NCT01484496?
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 NCT01484496's enrollment target sits among peer trials
839 394th of 2000 higher than 1,607 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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