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CRITERIA


Eligibility

Ages Eligible for Study: at least 18 but less than 60 years, Genders Eligible for Study: Both


Inclusion Criteria:

  • Male and female MG patients at least 18 but less than 60 years of age

  • Onset of generalized MG within the last 3 years

  • Positive serum anti-acetylcholine receptor binding antibodies (AchR Ab =/> 1.0 nmol/L)

  • MGFA class II-IV at entry, using the MG Foundation of America (MGFA) classification, while receiving optimal anti-cholinesterase treatment with or without oral prednisone

Exclusion Criteria:

  • 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.

  • Immunosuppressive therapy with Rituximab at any time; other immunosuppressive therapies (except corticosteroids, plasma exchange and IVIg) in the preceding year

  • Ocular MG without generalized weakness (MGFA Class I) or minimal weakness that would not require the use of corticosteroids

  • Myasthenic weakness requiring intubation (MGFA Class V) in the prior month

  • Immunosuppressive therapy other than corticosteroids in the preceding year

  • Medically unfit for thymectomy

  • Chest CT evidence of thymoma

  • Pregnancy or lactation; contraindications to the use of corticosteroids, unless postmenopausal or surgically sterile. Women considering becoming pregnant during the period of the study are to be excluded.

  • A serious concurrent medical, neurological or psychiatric condition that would interfere with thymectomy or subsequent clinical assessments

  • Current alternate day dose of prednisone > than 1.5 mg/kg or 100 mg or the equivalent daily doses (> 0.75 mg/kg or 50 mg).

  • Participation in another experimental clinical trial

  • History of alcohol or drug abuse within the 2 years prior to randomization.

 

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