BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115

Summary

This study provides subjects who complete the BEL113750 study and subjects who complete the open-label extension of HGS1006-C1115 (referred to as C1115) Study in Japan the option of continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those randomized to belimumab, or the option to begin treatment with belimumab for those randomized to placebo, as an add-on to their standard of care SLE therapy.

Timeline

Start

2012-06-11

Primary completion

2018-09-13

Completion

2018-09-13

Publications

• Tanaka Y, Bae SC, Bass D, Curtis P, Chu M, DeRose K, Ji B, Kurrasch R, Lowe J, Meizlik P, Roth DA. Long-term open-label continuation study of the safety and efficacy of belimumab for up to 7 years in patients with systemic lupus erythematosus from Japan and South Korea. RMD Open. 2021 Jul;7(2):e001629. doi: 10.1136/rmdopen-2021-001629.

Drugs

Indications