CLINICAL TRIAL: RITUXIMAB IN REFRACTORY ADULT AND JUVENILE MYOSITIS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Dermatomyositis and polymositis are two diseases in which there is inflammation in muscles that leads to weakness and disability. The cause of both of these diseases is unknown and treatments are limited in their efficacy. In this study Rituximab will be studied to determine its efficacy in the treatment of patients with these two diseases that have been refractory to standard treatments. Rituximab, an antibody, has been developed to remove a certain type of inflammatory cell from the body and is currently being used to treat several conditions successfully. The efficacy and safety of this drug in these two muscle diseases is unknown. Study participants will be given both the drug and placebo sequentially with neither the patient nor the investigator knowing the order of treatment. The drug and placebo will each be given as two separate infusions. Participants will undergo a series of evaluations both before and after the treatments, for several months (for a total of 14 visits), including measurement of strength, completing questionnaires and having blood obtained. Blood and urine will also be collected for future analysis. A total of 202 subjects are being recruited to participate in this study across 29 sites both within the United States and abroad.