Myasthenia Gravis (MG) Trial Print E-mail
  • Inclusion Criteria:
    1. Male and female MG patients aged > 18.0 and < 65.0 years.
    2. Onset of generalized MG within the last 5 years.
    3. positive serum anti-acetylecholine receptor binding antibodies ( AchR Ab =/> 1.00 nmol/L. AchrAb levels of 0.50-0.99 nmol/L will be acceptable if there is another confirmatory test for MG, including single-fiber EMG, repetitive nerve stimulation or unequivocal edrophonium testing.)
    4. MGFA class 2-4 at entry, using the MG Foundation of America( MGFA) classification, while receiving optimal anti-cholinesterase treatment with or without oral prednisone.
    5. Subject has given written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject’s routine care.
  • Exclusion criteria:
    1. Ocular MG without generalized weakness (MGFA Class 1) or insignificant weakness that would not require the use of corticosteroids.
    2. Myasthenic weakness requiring intubation (MGFA Class 5) in the prior month.
    3. Previous thymectomy, sternotomy or thoracotomy.
    4. Immunosuppressive therapy with Rituximab at any time; other immunosuppressive therapies (except corticosteroids, plasma exchange and IVIg) in the preceding year.
    5. Chest CT evidence of thymoma.
    6. Pregnancy or lactation.
    7. Unwillingness to avoid pregnancy.
    8. Contraindications to the use of corticosteroids.
    9. Other disorders that require treatment with systemic corticosteroids (excludes topical or inhaled corticosteroids).
    10. Concurrent or history of significant neurologic, cardiac, hepatic, pulmonary or renal disease that would be a contraindication to ETTX, or interfere with the trial treatments or subsequent clinical assessments.
    11. Unwillingness or incapacity to participate, to agree to necessary follow-up visits, or to give written and informed consent.
    12. Current dose of prednisone > than 1.5mg/kg or 100mg on alternate days or the equivalent daily doses (>0.75mg/kg or 50mg).
    13. Participation in another experimental clinical trial.
    14. History of alcohol or drug abuse within the 2 years prior to randomization.
    15. Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s returning for follow-up visits on schedule.
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