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National Institute of Environmental Health SciencesNational Institutes of Health

Etanercept in Adult Dermatomyositis

  • Principal Investigator:

    A. Amato & Muscle Study Group (9 sites)
  • Study Design:

    Randomized, double-blind, placebo-controlled trial of Etanercept (all patients will initially be started on prednisone)
  • Types & Number of IIM Studied:

    Active, new adult dermatomyositis (N = 30)
  • Entry Criteria:

    Definite Dermatomyositis
  • IMACS Core Set Measures Included:

    Physician and Patient Global Activity Assessments, Manual Muscle Testing, Health Assessment Questionnaire
  • Other Measures Included:

    Cutaneous Assessment Disease Activity Severity Index (CDASI), pulmonary function testing, electrocardiogram, MVICT, magnetic resonance imaging, skin biopsy; DNA microarrays on muscle, skin, and peripheral white blood cells
  • Primary Outcome:

    Cumulative dose of prednisone; Number of treatment failures; Responsiveness of IMACS outcome variables
  • Study Duration:

    12 months
  • Comments:

    Pending NIH and FDA grant approval

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Last Reviewed: August 03, 2009