A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02
This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 2 Protocol LBSL02|
- To evaluate the long-term safety of LymphoStat-B™ in subjects with SLE. [ Time Frame: Until study completion ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2004|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Belimumab 10 mg/kg
Belimumab 10 mg/kg IV over one hour every 28 days.
Belimumab 10mg/kg IV over one hour every 28 days
The purpose of this continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with Systemic Lupus Erythematosus (SLE), that completed study LBSL02 and benefitted from treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583362
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|