A Pilot Study of Etanercept in Dermatomyositis
A Pilot Study of Etanercept in Dermatomyositis
NCT ID: NCT00112385 Phase: PHASE1 Status: COMPLETED Enrollment: 16 Completion: 2010-06
Conditions
Dermatomyositis
Interventions
Etanercept, Placebo
Summary
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.
Primary Outcome
Occurrence of at Least One Adverse Event