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Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) — EMBRACE  

Systemic Lupus Erythematosus Clinical Trial

Official title:
A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE)

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).

Clinical Trial Description

Study participants receive stable standard therapy for lupus in addition to receiving either placebo (no active medicine) or belimumab. The controlled period of the study is 52 weeks. The random assignment in this study is "2 to 1" which means that for every 3 participants, 2 will receive belimumab and 1 will receive placebo. Participants who successfully complete the 52-week study may enter into a 6-month open-label extension. All participants in the open-label extension receive belimumab plus standard therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01632241
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 4
Start date February 19, 2013
Completion date January 28, 2019
View Details
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