This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The primary aim of this study is to improve strength in patients with inclusion body myositis (IBM) using etanercept. Patients with IBM are unresponsive to presently available immunomodulating therapies. We have used etanercept off-label fir atleast one year in 2 patients with IBM, with promising results and apparent stablization of their weakness. To date, there is no published data on the use of etanercept in patients with IBM. We propose to treat 15 IBM patients in a double-blind randomized, placebo-controlled phase I/II study with etanercept for 12 months. The primary outcome measure will be change in quantitative muscle testing (QMT) by hand held dynamometry. A secondary aim of this study is to evaluate the safety of etanercept in patients with IBM. While etanercept has a reasonable safety profile in patients with rheumatoid arthritis (RA, Juvenile RA, psoriatic arthritis and ankylosing spondylitis), data is not available for patients with IBM. We will collect safety data for all patients enrolled in this study.
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