Rituximab in the Treatment of Myositis (RIM)

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"Rituximab in the Treatment of Myositis (RIM)" is an NIH, NIAMS sponsored clinical trial being conducted at over 20 locations in the United States in addition to several Canadian and European sites. This study will be directed and coordinated by Chester V. Oddis, MD, Professor of Medicine, University of Pittsburgh Division of Rheumatology and Ann M. Reed, MD, Professor of Pediatrics and Medicine, Mayo Foundation and School of Medicine at the Mayo Clinic.

The goal of this study is to examine the effectiveness of rituximab, a biological agent that is being studied in adult and pediatric autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosis.  The result of the study will help determine the drug's potential benefit in the management of individuals diagnosed with myositis. Adults with definite or probable dermatomyositis or polymyositis, and children five years of age and older with definite or probable juvenile dermatomyositis for at least six months may be eligible to participate.

Eligible participants will be asked to participate for up to 45 weeks for a total of 14 study visits. The study doctor will be measuring muscle strength and evaluating the symptoms of the disease. Other study tests include electrocardiogram (ECG), physical examination, and blood testing for muscle enzymes, general chemistry and immunological tests.  Study subjects may be asked to voluntarily consent to participate in a muscle biopsy sub-study in which a muscle biopsy will be performed from a weakened muscle at study entry and again at four months. All study participants will receive the investigational study drug while participating in the study.

For further information or to locate a center nearest you, please visit the study website at www.rimstudy.org.

If you are unable to locate a clinical center near you, our centers at the National Institute of Health located in Bethesda, Maryland have funds available to assist with travel costs.

For further information and a listing of participating centers, see the NIH ClinicalTrials listing.

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Last revised 09-May-2007 by Steven Leber