Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
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.