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A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind 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 (SLE)
A study for pediatric patients with Systemic Lupus Erythematosus (SLE) using study drug Belimumab
| Sponsor: | GSK |
| Enrolling: | Male and Female Patients |
| IRB Number: | AAAP7001 |
| U.S. Govt. ID: | NCT01649765 |
| Contact: | Lourdes Franco: 212-342-3560 / lf2014@cumc.columbia.edu |
Additional Study Information:
The purpose of the study is to find out if study drug belimumab is safe and effective in treating children with active lupus who are also taking other lupus medicine. Belimumab (also known as BENLYSTA hasbeen approved in the United States, Canada, and Europe for the treatment of adults with active SLEwho are receiving other lupus medicines but not yet approved in children. However, we hope to learnmore about how safe is this drug in children or teenagers and about how well it works.
This study is closed
