A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Subjects With Systemic Lupus Erythematosus or Myositis
The objective of this study is to assess the safety and tolerability of sifalimumab in adult subjects 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 MICP179.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Open-label Study to Evaluate the Long-term Safety of Sifalimumab in Adult Subjects With Systemic Lupus Erythematosus or Myositis|
- Summarizing treatment-emergent AEs and SAEs. The occurrence of treatment-emergent AEs and SAEs will be summarized from the period immediately following the first administration of investigational product. [ Time Frame: Through Day 1177. ] [ Designated as safety issue: Yes ]
- To evaluate the PK and IM of sifalimumab at the proposed dose regimen. [ Time Frame: Day 1177 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
The primary objective of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) doses of sifalimumab in adult subjects with active systemic Lupus Erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who were previously treated with investigational product(sifalimumab or placebo) in one of the following sifalimumab clinical studies: MI-CP151, MI-CP152, or MICP179.
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|Study Director:||Warren Greth, MD||MedImmune LLC|