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Infliximab in Polymyositis and Dermatomyositis

Principal Investigator:

Mark Gourley, NIAMS, NIH


Study Design:

Phase 1-2, randomized, placebo controlled, cross-over trial. Infliximab dose 5-7.5 mg/kg, NIH only


Types & Number of IIM Studied:

Active Polymyositis and Dermatomyositis (N = 12)


Entry Criteria:

Probable or definite Bohan and Peter criteria for polymyositis or dermatomyositis, Refractory to methotrexate, azathioprine, or another immunosuppressive agent, as well as steroids


IMACS Core Set Measures Included:

All: Physician and Patient Global Activity Assessments, Manual Muscle Testing, enzymes, Health Assessment Questionnaire, Myositis Disease Activity Assessment Tool; Myositis Damage Index, Health-Related Quality of Life by SF-36


Other Measures Included:

Magnetic resonance imaging, flow cytometry, microarrays, cytokine levels/genes, MHC typing


Primary Outcome:

IMACS Definitions of Improvement and 15% increase of Manual Muscle Testing alone


Study Duration:

16 weeks treatment, placebo crossover to treatment for 16 weeks more with total duration 70 weeks



NIAMS, NIH; Centocor



Enrollment Completed



Mark Gourley, M.D.
Tel (301) 451-6807
Paul Plotz, M.D.
Tel (301) 496-1474


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