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Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
NCT01649765 · View on ClinicalTrials.gov ↗
Study Summary
This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus
Conditions Studied
Interventions
- OTHER placebo
- DRUG belimumab 10mg/kg
Study Locations (20)
Other
- GSK Investigational Site — Rosario
- GSK Investigational Site — Santa Fe
- GSK Investigational Site — San Luis Potosí City
- GSK Investigational Site — Lima
- GSK Investigational Site — Lima
- GSK Investigational Site — Surco
- GSK Investigational Site — Saint Petersburg
- GSK Investigational Site — Espluges de Llobregat
- GSK Investigational Site — Madrid
- GSK Investigational Site — Valencia
- GSK Investigational Site — Bristol
- GSK Investigational Site — Liverpool
- GSK Investigational Site — London
New York
- GSK Investigational Site — New York
- GSK Investigational Site — The Bronx
Arizona
- GSK Investigational Site — Phoenix
District of Columbia
- GSK Investigational Site — Washington D.C.
Georgia
- GSK Investigational Site — Augusta
Missouri
- GSK Investigational Site — St Louis
Ohio
- GSK Investigational Site — Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2012-09-07 |
| Est. Completion | 2025-09-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01649765
The ClinicalTrials.gov registry entry for NCT01649765 describes a study currently listed as completed. It is categorized as Phase 2, 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 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 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 2 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: NCT01649765 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, New York, 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 NCT01649765 about?
NCT01649765 is a clinical study titled "Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy". This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus
What is the current status of trial NCT01649765?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2012-09-07. Estimated completion is 2025-09-30.
What conditions does trial NCT01649765 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 NCT01649765?
The interventions under investigation include: placebo (OTHER), belimumab 10mg/kg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01649765?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01649765 being conducted?
This trial has 20 study locations across Arizona, District of Columbia, Georgia, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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