FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients
- Registration Number
- NCT00309088
- Lead Sponsor
- Astellas Pharma Inc
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 placebo - 1 tacrolimus -
- Primary Outcome Measures
Name Time Method Mean dose of steroid to maintain minimal manifestation(MM)[The dose of steroid should be decreased by the rate of 5mg/alternate day/ 4 weeks after the initiation of tacrolimus or placebo treatment as far as the MM state should be maintained.] 6 Months
- Secondary Outcome Measures
Name Time Method Success rate of achievement to the targeted steroid dose 6 Months Total amount of steroid therapy (mg) 6 Months QMG score;MG-ADL 6 Months