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Efficacy and safety of belimumab in childhood-onset lupus
Proposal
1481
Title of Proposed Research
Efficacy and safety of belimumab in childhood-onset lupus
Lead Researcher
Dr Anca Askanase MD, MPH
Affiliation
Columbia University Medical Center
630 168th St, Room PH 10-08
New York NY 10032
Funding Source
None
Potential Conflicts of Interest
Dr Askanase has been a consultant in the past for GSK. She was also an investigator in the phase III trials of belimumab.
Data Sharing Agreement Date
23 January 2017
Lay Summary
Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease that predominantly affects young women of child-bearing age. When it occurs in childhood, it can be more severe than in adults and involve multiple organ systems. The course of SLE is often unpredictable, with periods of remission and flare that often require changes in medications and re-evaluation of treatment and outcome. A major challenge in improving the care of SLE patients is the current lack of uniformity in how patients respond to different treatments.
Belimumab is a drug that targets specific immune cells thought to cause SLE, that has been approved for use in patients with lupus. Its use in childhood-onset SLE (patients diagnosed prior to their 19th birthdays) has not been well-documented. We propose to investigate the safety and efficacy of belimumab in patients with childhood-onset SLE compared to those with adult-onset SLE. A better understanding of how it may help control disease in childhood-onset SLE may allow us to better tailor therapy and improve patient outcomes.
Study Data Provided
[{ "PostingID": 1416, "Title": "GSK-HGS1006-C1056", "Description": "A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)
Medicine: belimumab, Condition: Systemic Lupus Erythematosus, Phase: 3, Clinical Study ID: HGS1006-C1056, Sponsor: GSK" },{ "PostingID": 1417, "Title": "GSK-HGS1006-C1057", "Description": "A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)
Medicine: belimumab, Condition: Systemic Lupus Erythematosus, Phase: 3, Clinical Study ID: HGS1006-C1057, Sponsor: GSK" }]
Statistical Analysis Plan
The statistical analysis plan will be added after the research is published.
Publication Citation
The publication citation will be added after the research is published.
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