Clinical Trial: Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis
Brief Summary: Inclusion body myositis (IBM) is the most common late onset acquired muscle disease. Patients develop progressive weakness that may result in the need for assistive devices including a wheelchair. IBM may be due to abnormal immune activation, due in part to overproduction of tumor necrosis factor (TNF)-alpha. Etanercept blocks the activity of TNF-alpha, thereby blunting immune overactivation. Previous unblinded studies and case reports suggest that etanercept may improve strength or slow the progressive weakness in IBM. We are conducting a double-blind, randomized, placebo-controlled study to test if Etanercept is beneficial in slowing the progressive weakness in patients with IBM.
Detailed Summary: Travel expenses not covered by the study.
Sponsor: Washington University School of Medicine
Current Primary Outcome: Change in Quantitative Muscle Testing on 12 proximal and 12 distal muscles [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Washington University School of Medicine
Dates:
Date Received: December 4, 2008
Date Started: April 2005
Date Completion:
Last Updated: May 28, 2014
Last Verified: May 2014