Clinical Study Data Request Registered Users, Please Login


Proposal 1481

Title of the 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

Gates Foundation to PATH with subcontract to Fred Hutchinson Cancer Research Center

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

Study GSK-HGS1006-C1056: 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)
Study GSK-HGS1006-C1057: 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)

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.