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
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
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.
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.
Primary Inclusion Criteria
1. Have completed the LBSL02 trial and achieved a satisfactory response.
Primary Exclusion Criteria
Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02.
Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99.
Used any of the following prohibited medications during their participation in LBSL02: