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 Completed
Contact:
- Diane Koontz
-
Tel (412) 647-3105
koontzdc@dom.pitt.edu
Web Site:
http://www.edc.gsph.pitt.edu/rimstudy/
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