Conditions: Systemic Lupus Erythematosus
Keywords: Sifalimumab MEDI-545
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 118
Healthy volunteers: no

Brief summary:
The objective of this study is to assess the safety and tolerability of sifalimumab in adult participants with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who participated in the following clinical studies: MI-CP151, MI-CP152, or MI-CP179.

Detailed description:
The primary objective of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) doses of sifalimumab in adult participants with active SLE or DM or PM who were previously treated with investigational product (sifalimumab or placebo) in one of the following sifalimumab clinical studies: MI-CP151, MI-CP152, or MI-CP179.

Arms:
arm 1: All participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment.

Interventions: intervention 1: Sifalimumab
Intervention descriptions: intervention 1: All participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment.

Protocol document: