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NCT01649765 · ClinicalTrials.gov registry record · Phase 2
Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
A Phase 2 study of Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
- 20
- Study locations
NCT01649765: Completed Phase 2 study of Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline.
NCT01649765 is a Phase 2 study of Systemic Lupus Erythematosus that has completed, run by GlaxoSmithKline. The registered enrollment target is 93 participants, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01649765, a Phase 2 study of Systemic Lupus Erythematosus, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
- 20
- Study locations
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
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
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 |
What the finished NCT01649765 record still lists
NCT01649765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (75% lower).
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.
NCT01649765 names 20 study sites across 7 states, led by Other, New York, Arizona.
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.
What interventions are being tested in trial NCT01649765?
The interventions under investigation include: placebo (OTHER), belimumab 10mg/kg (DRUG).
Who is sponsoring clinical trial NCT01649765?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT01649765's enrollment target sits among peer trials
93 57th of 99 higher than 43 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.
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