Infliximab in Polymyositis and Dermatomyositis

• Principal Investigator:

  Paul Plotz, 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 = 28)

• 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:

  Started 5/2003 - may add children to study after first 10 patients.

• Contact:

  
  Paul Plotz, MD or Anjelina Pokrovnichka- Tel: 301-496-1474; Email: plotzp@nih.mail.gov or pokrovna@mail.nih.gov

  Or Beverly Barham: Tel: 301-594-2494, Email: BBarham@cc.nih.gov

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