Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis

• Status: Unknown status
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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 myasthenia gravis patients. This prospective study will enroll 40 myasthenia gravis (MG) patients who are poor controlled under prior steroid therapy. All subjects should be randomly assigned to MA group and AZA group that will receive routine pyridostigmine and prednisolone in combination with MA or AZA.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qualitix Clinical Research Co., Ltd.
• Treatments: Azathioprine; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.