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Center for Global Research Data

Study of entry variables to optimize lupus trial design

Lead Investigator: Ewa Olech, IQVIA
Title of Proposal Research: Study of entry variables to optimize lupus trial design
Vivli Data Request: 3321
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Systemic Lupus Erythematosus (SLE) or Lupus is a systemic autoimmune disease that occurs when a patient body’s immune system attacks his or her own tissues and organs. Inflammation caused by lupus can affect many different body organs and systems, including joints, skin, kidneys, blood cells, brain, heart and lungs. Lupus is a chronic, waxing and waning disease that can range from mild/moderate bouts of inflammation in joints and/or skin to unpredictable, organ threatening flares indicating a serious and potentially life-threatening dysregulation of the immune system.
Most clinical trials of new medications for lupus have failed. This may be partially due to the fact that lupus is a complicated disease making lupus clinical trials difficult to design. Belimumab is the only treatment with successful development program. Since efficacy of belimumab has been confirmed in multiple clinical trials, we will use the data from these studies to examine the impact of seasonal variations and lupus blood markers on study results. The information obtained from this project will be helpful in designing successful SLE clinical trials in the future.

Requested Studies:

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)
Sponsor: GlaxoSmithKline
Study ID: NCT01484496
Sponsor ID: 112341

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)
Sponsor: GlaxoSmithKline
Study ID: NCT00424476
Sponsor ID: HGS1006-C1057

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)
Sponsor: GlaxoSmithKline
Study ID: NCT00410384
Sponsor ID: HGS1006-C1056