CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 268 enrolled
Drug / intervention
Belimumab 1 mg/kg +1 morebiological
Likely dose
Belimumab 1 mg/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/NCT00724867
NCT00724867Phase 3Completed
CompareCT.gov

A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United States

Human Genome Sciences Inc., a GSK Company·interventional·Posted Jul 30, 2008·Updated Mar 28, 2016

In Brief

A Phase 3 clinical trial evaluating Belimumab 1 mg/kg and Belimumab 10 mg/kg for Systemic Lupus Erythematosus. Completed, enrolled 268 participants across 51 sites.

Detailed Summary

This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 30, 2008
Enrollment StartAug 1, 2008
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 17.9 years ago

Interventions

Belimumab 1 mg/kgbiological

Belimumab 1 mg/kg IV over one hour every 28 days

Belimumab 10 mg/kgbiological

Belimumab 10 mg/kg IV over one hour every 28 days