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National Institute of Environmental Health SciencesNational Institutes of Health

Rituximab in Adult Polymyositis and Dermatomyositis and Juvenile Dermatomyositis

  • Principal Investigator:

    Chester Oddis, University Pittsburgh; Ann Reed, Mayo Clinic

  • Study Design:

    Double-blind, randomized placebo phase design; multi-center phase 2 trial

  • Types & Number of IIM Studied:

    Active, refractory adult Polymyositis (N = 76), Dermatomyositis (N = 76), and Juvenile Dermatomyositis (N = 50)

  • Entry Criteria:

    Probable or definite criteria for polymyositis or dermatomyositis; failed steroids and 1 other immunosuppressive agent

  • IMACS Core Set Measures Included:

    All: Physician and Patient/Parent Global Activity and Damage Assessments, Manual Muscle Testing, 2 enzymes, [Childhood] Health Assessment Questionnaire; Myositis Disease Activity Assessment Tool; Myositis Damage Index

  • Other Measures Included:

    Pre and post needle biopsies in subset; antibodies; flow cytometry

  • Primary Outcome:

    IMACS Definition of Improvement for both adult and pediatric subset

  • Study Duration:

    6 months

  • Funding:

    NIAMS, NIH

  • Comments:

    Enrollment to begin October 2005

  • Contact:

    Sherrie Pryber Phone 412 647-3241 / e-mail: pryber@dom.pitt.edu Diane

    Diane Koontz Phone 412-647-3105 / e-mail: koontzdc@dom.pitt.edu

  • Web Site:

    http://www.edc.gsph.pitt.edu/rimstudy/ (http://www.edc.gsph.pitt.edu/rimstudy/) Exit NIEHS

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Last Reviewed: August 03, 2009