A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

The purpose of this study is to further enhance the existing knowledge regarding the side
effects of belimumab when given with other lupus medicines to adults with active systemic
lupus erythematosus (SLE). This study mainly focuses on collecting information on serious
events that are not that common or may only be seen with long-term treatment. These events
include death, serious infections and other infections of interest, cancers, serious mental
health problems, including depression and suicide, and serious infusion and hypersensitivity
reactions. This study is being done to help understand if treatment with belimumab increases
the risk for these types of events. This study will also see if patients receiving belimumab
with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.