Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy
United States126 participantsStarted 2006-06
Plain-language summary
The purpose of this trial is to determine if thymectomy combined with prednisone therapy is more beneficial in treating non-thymomatous myasthenia gravis than prednisone therapy alone.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (muscle acetylcholine receptors, AchRAb =/\> 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 electromyography (EMG), repetitive nerve stimulation, or unequivocal edrophonium testing.)
* 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:
* 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 IV) 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).
* Pa…
What they're measuring
1
Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months
2
Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years
Timeframe: baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months