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Effectivity of Belimumab in arthritic and hematologic SLE manifestations
Proposal
5847
Title of Proposed Research
Effectivity of Belimumab in arthritic and hematologic SLE manifestations
Lead Researcher
Nicolai Leuchten
Affiliation
Dep. of Internal Medicine III Carl Gustav Carus Medical Center University of Dresden Germany
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
08 November 2019
Lay Summary
Belimumab is a drug, that the European Medicines Agency and the U.S. Food and Drug Administration approved for the treatment of Systemic Lupus Erythematosus (SLE). SLE is a severe chronic autoimmune disease that can affect virtually every part of the human body, including the joints and the blood cells. So far belimumab has been shown to reduce overall SLE disease activity and prevent SLE flares. At present it is not sufficiently clear which specific SLE manifestations responds to belimumab treatment and in which timeframe. In daily clinical practice therapy is changed to treat specific SLE manifestations, like arthritis. Therefore knowing the effect of belimumab on a certain manifestation is important to the clinical decision. We therefore propose to analyze the belimumab trial data for the effect on SLE arthritis and on reduced blood cells.
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)" },{ "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)" },{ "PostingID": 14488, "Title": "GSK-HGS1006-C1115", "Description": "A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE)" },{ "PostingID": 19766, "Title": "GSK-BEL113750", "Description": "GSK1550188 A 52 week study of belimumab versus placebo in the treatment of subjects with systemic lupus erythematosus (SLE) located in Northeast Asia" },{ "PostingID": 19767, "Title": "GSK-BEL112233", "Description": "A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 in the United States" }]
Statistical Analysis Plan
Publication Citation
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