Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis

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.