A Phase II Trial of Rituximab in Myasthenia Gravis
|Michael Benatar, MD, PhD
|The University of Miami is currently looking for people with Myasthenia Gravis (MG) for a research study conducted by the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). We are working with Dr. Richard J. Nowak at Yale University School of Medicine who is the Protocol Principal Investigator and leading this national study.
The National Institute of Neurological Disorders and Stroke (NINDS), a division of the National Institutes of Health (NIH), is supporting this trial.
The purpose of the research study is to learn whether rituximab vs. placebo is a safe therapy and helpful for people with MG.
Fifty people will be enrolled and will take part in the study for 52 weeks. 25 participants will receive rituximab and 25 participants will receive placebo (an inactive salt-water substance). Neither participants nor the study team will know if who is receiving the study drug or the placebo.
Participants must have a diagnosis of generalized MG, be at least 21 years old, and be taking prednisone in order to be in the study.
- Male or female 21 to 90 years old
- Diagnosis of generalized myasthenia gravis
- Elevated AChR antibody titer
- Prednisone dose of at least 15 mg/day
- No recent treatment with IVIg or PLEX within the last 4 weeks
- No recent treatment with azathioprine, cyclosporine, cyclophosphamide, mycophenolate mofetil, methotrexate, or other immunosuppressive drugs within the last 8 weeks
- No previous treatment with rituximab (MabThera® / Rituxan®) or natalizumab (Tysabri®)
- No history of thymectomy in the last 6 months
- No history of thymoma, tumor, infection, or interstitial lung disease on chest CT, MRI, or chest x-ray
|NINDS and Genentech Pharmaceuticals
Phone: (305) 243-6481
|Presentations / Publications