Status:
UNKNOWN
Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis
Lead Sponsor:
Qualitix Clinical Research Co., Ltd.
Conditions:
Myasthenia Gravis
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
This is an randomized, double-blind, double-dummy trial, and the objective is to compare the efficacy and safety of Mycophenolic acid (MA) and Azathioprine (AZA), immunosuppressive drugs, in myastheni...
Detailed Description
This will be a double-dummy study to keep the blinded quality. * MA group: 1 tablet AZA placebo and 4 tables MA (180 mg/tab,720 mg/day) twice daily. * AZA group: 1 tablet AZA (50mg/tab) and 4 tables ...
Eligibility Criteria
Inclusion
- Male or female age between 20-70 (including 20 and 70 years old).
- Osserman II and III Myasthenia Gravis.
- Positive serum anti-acetylcholine receptor antibodies.
- Poor control of disease with daily dose of prednisone ≥ 30 mg or 0.5 mg/kg at 3 months before enrollment.
- Without immunosuppressive therapy other than steroid.
Exclusion
- Ocular MG or minimal clinical syndrome that would not require the therapy of steroids.
- Negative serum anti-acetylcholine receptor antibodies.
- Use immunosuppressants other than steroids in the preceding year.
- Previous use other investigational medication within 3 months or current participate other clinical study.
- Poor renal function: serum creatinine \> 3.0 mg/dl or estimated creatinine clearance \< 30 ml/min
- Females who are pregnancy or breast-feeding.
- Recent history, within 5 years, of malignancy
- Unwilling or unable to participate the necessary continuous visits and examinations.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00997412
Start Date
May 1 2009
End Date
May 1 2011
Last Update
October 19 2009
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