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NCT00410384 · ClinicalTrials.gov registry record · Phase 3
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
A Phase 3 study of Systemic Lupus Erythematosus, sponsored by Human Genome Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 819
- Enrollment target
- 20
- Study locations
NCT00410384: Completed Phase 3 study of Systemic Lupus Erythematosus, sponsored by Human Genome Sciences.
NCT00410384 is a Phase 3 study of Systemic Lupus Erythematosus that has completed, run by Human Genome Sciences. The registered enrollment target is 819 participants, above the 372-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (120% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00410384, a Phase 3 study of Systemic Lupus Erythematosus, has completed, sponsored by Human Genome Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 819 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.
Primary Outcome
Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Belimumab 1 mg/kg
- DRUG Belimumab 10 mg/kg
Study Locations (20)
California
- Talbert Medical Group - Huntington Beach
- Valerius Medical Group & Research Ctr of Greater Long Beach, Inc. - Long Beach
- University of Southern California - Los Angeles
- Wallace Rheumatic Study Center - Los Angeles
- UCLA Rheumatology - Los Angeles
- Arthritis Care Center, Inc. - San Jose
- Inland Rheumatic Disease Specialties - Upland
Florida
- Arthritis and Rheumatic Disease Specialties - Aventura
- University of Miami-Division of Rheumatology and Immunology - Miami
- Rheumatology Associates of Central Florida - Orlando
- Southwest Florida Clinical Research Center - Tampa
- Tampa Medical Group, P.A. - Tampa
Arizona
- Arizona Arthritis and Rheumatology Research, PPLC - Paradise Valley
- The University of Arizona Arthritis Center - Tucson
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- Arthritis Associates of Colorado Springs - Colorado Springs
District of Columbia
- Washington Hospital Center - Washington D.C.
Georgia
- Emory University - Atlanta
Idaho
- Selah Medical Clinical Research Unit - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 819 participants |
| Start Date | 2006-12 |
| Est. Completion | 2010-03 |
| Phase | Phase 3 |
What the finished NCT00410384 record still lists
NCT00410384 is an interventional study that assigns participants to a tested intervention. The registered 819 participants enrollment target is mid-sized for trials with a published cap, above the 372-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (120% higher).
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00410384 names 20 study sites across 9 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT00410384 about?
NCT00410384 is a clinical study titled "A Study of Belimumab in Subjects With Systemic Lupus Erythematosus". The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.
What is the current status of trial NCT00410384?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 819 participants. The study started on 2006-12. Estimated completion is 2010-03.
What conditions does trial NCT00410384 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT00410384?
The interventions under investigation include: Placebo (DRUG), Belimumab 1 mg/kg (DRUG), Belimumab 10 mg/kg (DRUG).
Who is sponsoring clinical trial NCT00410384?
This trial is sponsored by Human Genome Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00410384 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00410384's enrollment target sits among peer trials
819 10th of 99 higher than 90 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus 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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