The purpose of the study is to obtain preliminary data regarding the safety and tolerability
of etanercept in DM. In addition, we will use the study to assess the variability,
reliability, and responsiveness of the core set of outcome measures recommended by IMACS. The
study will be performed under the aegis of the Muscle Study Group (MSG), consisting of
experienced investigators with an avid interest in myopathies. The ultimate goal of this
pilot study will be to obtain necessary, prerequisite information important in designing
future therapeutic trials of etanercept and other agents in patients with DM. The specific
aims of the study are:
Aim 1: To preliminarily assess the safety and tolerability of etanercept in patients with DM.
Aim 2: To assess the safety and tolerability of prednisone in the dosing schedule we propose
to use.
Aim 3: To evaluate outcome measures recommended by IMACS and assess their variability,
reliability, and responsiveness in order to facilitate the design of future therapeutic
trials in the inflammatory myopathies.