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
Funding:
NIAMS, NIH; Centocor
Comments:
Enrollment Completed
Contact:
- Mark Gourley, M.D.
-
Tel (301) 451-6807
gourleym@mail.nih.gov
- Paul Plotz, M.D.
-
Tel (301) 496-1474
plotzp@mail.nih.gov
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