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Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
Sponsor: GlaxoSmithKline
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
Official title: A Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus
Key Details
Gender
All
Age Range
5 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
93
Start Date
2012-09-07
Completion Date
2025-09-30
Last Updated
2026-04-20
Healthy Volunteers
No
Conditions
Interventions
Belimumab 10 mg/kg
Belimumab was administered.
Placebo
Placebo was administered
Locations (32)
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Augusta, Georgia, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
The Bronx, New York, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Buenos Aires, Argentina
GSK Investigational Site
Rosario, Argentina
GSK Investigational Site
Santa Fe, Argentina
GSK Investigational Site
Calgary, Alberta, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Aichi, Japan
GSK Investigational Site
Kagoshima, Japan
GSK Investigational Site
Miyagi, Japan
GSK Investigational Site
Tokyo, Japan
GSK Investigational Site
San Luis Potosí City, Mexico
GSK Investigational Site
Lima, Peru
GSK Investigational Site
Lima, Peru
GSK Investigational Site
Surco, Peru
GSK Investigational Site
Lodz, Poland
GSK Investigational Site
Warsaw, Poland
GSK Investigational Site
Moscow, Russia
GSK Investigational Site
Saint Petersburg, Russia
GSK Investigational Site
Tolyatti, Russia
GSK Investigational Site
Espluges de Llobregat, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Valencia, Spain
GSK Investigational Site
Bristol, United Kingdom
GSK Investigational Site
Liverpool, United Kingdom
GSK Investigational Site
London, United Kingdom
GSK Investigational Site
London, United Kingdom