placebo + standard therapy

Placebo + standard therapy refers to the control arm used in GlaxoSmithKline's Phase 4 BASE (Belimumab Assessment of Safety in SLE) study (NCT01705977). This trial was a large-scale, double-blind, randomized study involving 4,003 adults with active, autoantibody-positive systemic lupus erythematosus (SLE). In this arm, patients received a placebo (matching the intravenous administration of belimumab) in addition to their existing standard of care, which could include corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives. The study's primary objective was to evaluate the long-term safety profile of belimumab (Benlysta) by comparing it against this standard-of-care-only baseline, focusing on outcomes such as mortality, serious infections, and malignancies.

Other names

placebo plus standard therapyplacebo + SoCplacebo plus standard of care