Clinical Trial: A Study to Evaluate Safety of Multi-Dose MEDI-545 in Adult Patients With Dermatomyositis or Polymyositis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 1B, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Safety of Multiple-Dose, Intravenously Administered MEDI-545, A Fully Human Anti Interferon-Alpha Monoclonal Ant
Brief Summary: The primary objective of the study is to evaluate the safety and tolerability of multiple IV doses of MEDI-545 in adult patients with myositis.
Detailed Summary: The primary objective of the study is to evaluate the safety and tolerability of multiple intravenous (IV) doses of MEDI-545 in adult patients with dermatomyositis (DM) or polymyositis (PM).
Sponsor: MedImmune LLC
Current Primary Outcome: The primary endpoints of the study are safety and tolerability of multiple intravenous (IV) doses of MEDI-545 in adult patients with Dermatomyositis or Polymyositis, assessed primarily by summarizing AEs assessing changes in viral cultures and titers. [ Time Frame: 12 months ]
Original Primary Outcome: The primary endpoints of the study are the safety and tolerability of MEDI-545, which will be assessed primarily by summarizing AEs and by assessing changes in viral cultures and titers. [ Time Frame: 12 months ]
Current Secondary Outcome:
- The secondary endpoints of the study are the PK and IM of multiple IV doses of MEDI-545. [ Time Frame: 12 months ]
- The third endpoint of the study are the evaluations of disease activities. [ Time Frame: 12 months ]
Original Secondary Outcome:
- The secondary endpoints of the study are the PK and IM of multiple IV doses of MEDI-545 and evaluations of disease activity. [ Time Frame: 12 months ]
- The third endpoint of the study are the evaluations of disease activities. [ Time Frame: 12 months ]
Information By: MedImmune LLC
Dates:
Date Received: September 20, 2007
Date Started: April 2008
Date Completion:
Last Updated: May 25, 2012
Last Verified: May 2012
