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A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
NCT00410384 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00410384
The ClinicalTrials.gov registry entry for NCT00410384 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 819 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Human Genome Sciences, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00410384 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00410384?
This trial is sponsored by Human Genome Sciences, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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