The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients with myasthenia gravis receiving prednisone, or other corticosteroids. During the study, patients will undergo gradual corticosteroid dose reduction, if they respond to treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
136
1g bid for 36 weeks
po bid for 36 weeks
Proportion of subjects reaching responder status
Time frame: Week 36
Time to start of response
Time frame: Event driven
Mean and median prednisone dose and cholinesterase inhibitor dose
Time frame: Week 36
Adverse events, lab parameters, vital signs
Time frame: Throughout study
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Sun City, Arizona, United States
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Sacramento, California, United States
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Miami, Florida, United States
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Kansas City, Kansas, United States
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Rochester, New York, United States
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Chapel Hill, North Carolina, United States
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Columbus, Ohio, United States
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Upland, Pennsylvania, United States
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Dallas, Texas, United States
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Galveston, Texas, United States
...and 33 more locations