CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 503 enrolled
Drug / intervention
Placebo plus standard therapy +2 morebiological
Likely dose
Belimumab 10 mg/kg plus standard therapyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01632241
NCT01632241Phase 4Completed
CompareCT.gov

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)

Human Genome Sciences Inc., a GSK Company·interventional·Posted Jul 2, 2012·Updated Sep 8, 2021

In Brief

A Phase 4 clinical trial evaluating Placebo plus standard therapy, Belimumab 10 mg/kg plus standard therapy, and 1 other intervention for Systemic Lupus Erythematosus. Completed, enrolled 503 participants across 96 sites in 6 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesBrazil, Colombia, France, South Africa, United Kingdom, United States
CollaboratorsGlaxoSmithKline

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 2, 2012
Enrollment StartFeb 19, 2013
Primary CompletionJun 18, 2018
Study CompletionJan 28, 2019
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 14 years ago

Interventions

Placebo plus standard therapybiological

Placebo plus standard therapy

Belimumab 10 mg/kg plus standard therapybiological

Belimumab 10mg/kg plus standard therapy

Standard therapydrug

Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.