At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 738 enrolled
Drug / intervention
belimumabdrug
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.
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 or HGS1006-C1057
In Brief
A Phase 3 clinical trial evaluating belimumab for Systemic Lupus Erythematosus. Completed, enrolled 738 participants across 110 sites in 28 countries.
Detailed Summary
This is a long-term continuation study to provide continuing treatment to subjects with SLE.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesArgentina, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czechia, France, Germany, Hong Kong, India, Israel, Italy, Mexico, Netherlands, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom
CollaboratorsGlaxoSmithKline
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2008
First PostedJul 2008
Primary CompletionDec 2016
TodayJul 2026
First PostedJul 10, 2008
Enrollment StartMay 30, 2008
Primary CompletionDec 9, 2016
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 18.0 years ago
Interventions
belimumabdrug
Recombinant, fully human, monoclonal antibody Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.