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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






Enrollment Completed



Diane Koontz
Tel (412) 647-3105


Web Site: 


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