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Proposal 1154

Title of the Proposed Research

Developing New Outcome Measures for SLE by Deconvoluting Available Datasets

Lead Researcher

Peter E. Lipsky, MD

Affiliation

Lupus Research Institute
New York, NY
USA

Funding Source

Lupus Research Institute (LRI); members of the LRI

Potential Conflicts of Interest

None

Data Sharing Agreement Date

30 Apr 2015

Lay Summary

Outcome measures for SLE are complex, not relevant to the practicing clinician and poorly responsive to trial interventions. One way to develop more effective and appropriate outcome measures is to analyze the available clinical trial data based and attempt to deconstruct the data captured in the current measures and reconstruct them in a manner that more effectively separates responders from non responders. The approach will involve an analysis of data from the BLISS trials. The data that had been collected in these trials will be dissected to determine whether novel combinations of the data can be employed as novel outcome measures to be assessed in future clinical trials. The statistical analysis will be informed by an iterative process with a composite of experienced clinicians and trialists.

Study Data Provided

Study 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 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

This will be added after the research is published.

Publication Citation