FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate the efficacy and safety for steroid non-resistant MG patients in a double blind, placebo controlled study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Clinically diagnosed as myasthenia gravis

• Those whose MG symptoms are well-controlled by the treatment with prednisone

• Steroid non-refractory Myasthenia Gravis: ≧20mg and ≦40mg / alternate day of steroid dose required to maintain

Exclusion Criteria:

• Those who have thymoma or the history of thymoma (Masaoka stage III or IV)

• Patients who received steroid pulse therapy, plasma exchange therapy, globulin therapy or radiation therapy within 12 weeks prior to the initiation of test drug

• Patients who started the immunosuppressant therapy or increased the dose of immunosuppressant within 12 weeks prior to the initiation of test drug.

• Patients who had undergone thymectomy within 24 weeks prior to the initiation of test drug.

• Pancreatitis or diabetes

• Serum creatinine≦1.5mg/dL