FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.] [ Time Frame: 6 Months ]
Secondary Outcome Measures :
Total amount of steroid therapy (mg) [ Time Frame: 6 Months ]
QMG score;MG-ADL [ Time Frame: 6 Months ]
Success rate of achievement to the targeted steroid dose [ Time Frame: 6 Months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
16 Years to 64 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.