NCT00410384

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 819 (actual)
• Sponsor: Human Genome Sciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
DRUG	Belimumab 1 mg/kg	Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
DRUG	Belimumab 10 mg/kg	Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-09-01
• Completion: 2010-03-01
• First posted: 2006-12-12
• Last updated: 2017-02-01
• Results posted: 2011-05-05

Locations

146 sites across 19 countries: United States, Austria, Belgium, Canada, Costa Rica, Czechia, France, Germany, Israel, Italy, Mexico, Netherlands, Poland, Puerto Rico, Romania, Slovakia, Spain, Sweden, United Kingdom