A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea

F Zhang, SC Bae, D Bass, M Chu, S Egginton… - Annals of the rheumatic …, 2018 - Elsevier
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 …