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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:

Adult dermatomyositis (n = 16)

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:

Enrollment Completed

Publications:

Muscle Study Group. A randomized, pilot trial of etanercept in dermatomyositis., Ann Neurol, 2011 Sep;70(3):427-36.[Abstract]

Contact:

Anthony A. Amato, M.D.
Professor of Neurology
Brigham and Women's Hospital
Neurology, ASB 1-2
75 Francis St
Boston, MA 02115
Tel (617) 732-5436
Fax (617) 730-2885
aamato@partners.org


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