A Pilot Trial of Rituxan in Refractory Myasthenia Gravis

Inclusion Criteria

• •Criteria for patient selection will be based upon the recent recommendations for clinical research standards by the Task Force of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America (Jaretzki et al, 2000).
• •Patients will be included in the trial based upon fulfilling all the criteria given below, except that they will be required to fulfill criterion 3 OR 4:
• •1. Patients must have a diagnosis of "Definite" MG (Seybold, 1999) as based on clinical, electrophysiological and serological criteria (Appendix 1)
• •2. Patients must have disease predominantly affecting bulbar or respiratory muscles of moderate or severe degree (Osserman grades 2B, 3 without crisis, or 4 without crisis) (Osserman and Genkins, 1971 and Appendix 2) as listed in Appendix 3, and a Quantitative MG score of \<25 (Appendix 7)
• •3. Patients must have disease refractory to treatment for at least 12 months with prednisone at a dose of 15mg/day and/or immunosuppressive drugs (azathioprine or cyclophosphamide at a dose of 100mg/day or cyclosporine at a dose to produce trough levels of \>50), with or without thymectomy and plasmapheresis/IVIG alone or in combination with above drugs at intervals of no more than once every 3 weeks, OR
• •4. Patients must have experienced intolerance or unacceptable side-effects following treatment with corticosteroids, immunosuppressive drugs (azathioprine, cyclophosphamide or cyclosporine), plasmapheresis or IVIG
• •5. Patients must be between 18 years and 80 years old
• •6. Patients must have adequate organ function / laboratory parameters as measured by the following criteria (values should be obtained within 2 weeks prior to enrollment):
• •* Documented CD20 + cells
• •* Absolute neutrophil count: \>2000/mm3
• •* Platelets: \>100,000/mm3
• •* Hemoglobin: \>10 gm/dL
• •* Adequate renal function as indicated by normal BUN and creatinine levels
• •* Adequate liver function, as indicated by AST and ALT \<2x Upper Limit of normal.
• •* Normal serum electrolytes
• •7. Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for one year after completion of treatment
• •8. Written informed consent.