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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

 

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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