A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea
Background Intravenous belimumab plus standard of care (SoC) is approved in the USA
and Europe for treatment of active, autoantibody-positive systemic lupus erythematosus
(SLE). Methods This phase III, multicentre, randomised, double-blind, placebo-controlled
study (BEL113750; NCT01345253) was conducted in 49 centres across China, Japan and
South Korea (May 2011–September 2015). Patients with SLE were randomised 2: 1 to
intravenous belimumab 10 mg/kg or placebo, plus SoC, every 4 weeks until Week 48. The …
and Europe for treatment of active, autoantibody-positive systemic lupus erythematosus
(SLE). Methods This phase III, multicentre, randomised, double-blind, placebo-controlled
study (BEL113750; NCT01345253) was conducted in 49 centres across China, Japan and
South Korea (May 2011–September 2015). Patients with SLE were randomised 2: 1 to
intravenous belimumab 10 mg/kg or placebo, plus SoC, every 4 weeks until Week 48. The …