Myasthenia Gravis
Conditions
Keywords
Tacrolimus, Myasthenia Gravis
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.
Interventions
DRUGtacrolimus
oral
DRUGplacebo
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| QMG score;MG-ADL | 6 Months |
| Success rate of achievement to the targeted steroid dose | 6 Months |
| Total amount of steroid therapy (mg) | 6 Months |
Countries
Japan
Outcome results
None listed