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National Institute of Environmental Health SciencesNational Institutes of Health

Infliximab in Polymyositis/Dermatomyositis/Inclusion Body Myositis

  • Principal Investigator:

    Ingrid Lundberg, Karolinska Institute
  • Study Design:

    Phase 2 Open trial, Infliximab dose 5 mg/kg
  • Types & Number of IIM Studied:

    Active Polymyositis/Dermatomyositis/Inclusion Body Myositis with reduced muscle function (N = 15)
  • Entry Criteria:

    Refractory to prednisolone and methotrexate
  • IMACS Core Set Measures Included:

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

    Myositis Functional Index, aerobic capacity, biopsies
  • Primary Outcome:

    Improved functional index and decreased inflammation in muscle biopsies
  • Study Duration:

    16 weeks
  • Funding:

    Schering Plough
  • Comments:

    Started in 2003. Enrollment completed.

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Last Reviewed: August 03, 2009