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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:

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:

Enrollment Completed

 

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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