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Proposal 1691

Title of the 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

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)
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.

Summary Results

Results summary or link will be posted when available.