| Criteria | Contact
Information | Information
Sheet |
An MG patient speaks about MGTX:
CRITERIA
Eligibility
Ages Eligible for Study: greater than 18 and less than 65 years , Genders Eligible for Study: Both
Inclusion Criteria:
- Male and female MG patients age greater than 18 and less than 65 years
- Onset of generalized MG within the last 5 years
- Positive serum anti-acetylcholine receptor binding antibodies (AchR Ab =/> 0.5 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.
Top
of Page