CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 709 enrolled
Drug / intervention
Belimumab +1 moredrug
Likely dose
Belimumab 10mg/kgfrom 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/NCT01345253
NCT01345253Phase 3Completed
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GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

GlaxoSmithKline·interventional·Posted May 2, 2011·Updated Oct 4, 2019

In Brief

A Phase 3 clinical trial evaluating Belimumab and Placebo for Systemic Lupus Erythematosus. Completed, enrolled 709 participants across 47 sites in 3 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus (SLE) over a 52 week period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesChina, Japan, South Korea
CollaboratorsHuman Genome Sciences Inc.

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2, 2011
Enrollment StartMay 23, 2011
Primary CompletionSep 15, 2015
Study CompletionSep 21, 2018
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 15.2 years ago

Interventions

Belimumabdrug

10mg/kg administered intravenously. Dosing at Weeks 0, 2, and 4, then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.

Placebodrug

Administered intravenously. Dosing at Weeks 0, 2, and 4, and then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.