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Longitudinal Concurrent and Predictive Biomarkers of Clinical Disease Severity in Systemic Lupus Erythematosus in BLISS-52/BLISS-76
Proposal
1691
Title of Proposed Research
Longitudinal Concurrent and Predictive Biomarkers of Clinical Disease Severity in Systemic Lupus Erythematosus in BLISS-52/BLISS-76
Lead Researcher
Austin Huang
Affiliation
Pfizer
Funding Source
No external funding other than FTE effort.
Potential Conflicts of Interest
Has company shares as part of Pfizer's standard compensation package.
Data Sharing Agreement Date
22 May 2017
Lay Summary
The proposed study looks at the relationship between laboratory observations (e.g. blood measurements) and clinical symptoms of disease severity (e.g. joint pain) in Lupus patients.
Previously, studies have focused on comparing these relationships at the beginning and the end of the study. By comparison, we will examine how these measurements change over time in the study as the disease gets better or worse. The goal of this research is to use these findings to help with designing future clinical trials in Lupus.
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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