At a glance
ClinicalIndex Comparison Record- ✓Diagnostic criteria for DM met by: symmetric proximal greater than distal weakness AND (characteristic DM rash OR laboratory evidence of myopathy OR muscle biopsy findings)
- ✓Symmetric proximal muscle weakness required for entry
- ✓Age greater than 18 years
- ✓Able to self-inject or have caregiver administer subcutaneous injections at home
- ✕Active infection, uncontrolled diabetes, MI/CVA/TIA within 3 months, symptomatic cardiomyopathy, symptomatic coronary artery disease, or uncontrolled hypertension
- ✕SLE, HIV, immunosuppressing disease, positive PPD or mycobacterial disease history, chronic hepatitis B or C
- ✕Cancer (except basal cell) within 5 years prior to screening
- ✕History of multiple sclerosis, transverse myelitis, optic neuritis, CIDP, epilepsy, or other chronic serious illness
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study of Etanercept in Dermatomyositis
In Brief
A Phase 1 clinical trial evaluating Etanercept and Placebo for Dermatomyositis. Completed, enrolled 16 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Etanercept 50 mg will be injected subcutaneously once per week for 52 weeks
Placebo, contained in 50mg syringes, will be injected subcutaneously once per week for 52 weeks.