Richard J. Nowak, MD, MS, Yale University School of Medicine, is the Protocol Principal Investigator for the study “A Phase II Trial of Rituximab in Myasthenia Gravis” (NN103). Other primary investigators include Drs. Jonathan M. Goldstein, Richard J. Barohn, Mazen M. Dimachkie, Kevin C. O’Connor and David A. Hafler.
Myasthenia gravis (MG) is an autoimmune disorder of neuromuscular transmission with an estimated annual incidence of about 1-2 per 100,000 and prevalence as high as 20-50 per 100,000. Treatment consists of symptomatic therapy with acetylcholinesterase inhibitors and immunotherapy such as corticosteroids, azathioprine, cyclosporine, plasma exchange (PLEX) and intravenous immunoglobulin (IVIg). Despite current therapies a subset of patients remain medically refractory or have intolerable medication adverse effects. There is need for another agent in the management of MG as there are few effective drugs.
This research study is being conducted to determine the safety, tolerability and activity of rituximab administered in two four-week infusion cycles separated by six months in subjects with myasthenia gravis. The study will be conducted by the NINDS-funded Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) at NeuroNEXT sites around the United States. Fifty participants age 21 and older will be enrolled. The Clinical Coordination Center is at Massachusetts General Hospital and the Data Coordination Center is at the University of Iowa.
The following fifteen institutions have been selected to participate in the study:
Albert Einstein College of Medicine Yeshiva University
Weill Cornell Medical Center
Ohio State University
University of Alabama at Birmingham
University of California - Davis
University of California - Los Angeles
University of Cincinnati
University of Colorado Denver
University of Kansas Medical Center
University of Miami School of Medicine
University of Pittsburgh
University of Rochester
University of Texas Southwestern Medical Center
University of Virginia - Charlottesville
The study intervention is provided by Genentech Pharmaceuticals.
For more information related to the University of Alabama at Birmingham site please contact Shirley Gibbs at 205-975-0447.