FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients

Astellas Pharma Inc0 sites80 target enrollmentApril 2006

ConditionsMyasthenia Gravis

Interventionstacrolimus placebo

Drugstacrolimus placebo

Overview

Phase: Phase 3
Intervention: tacrolimus
Conditions: Myasthenia Gravis
Sponsor: Astellas Pharma Inc
Enrollment: 80
Primary Endpoint: 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.]
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

June 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Astellas Pharma Inc

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

1

Intervention: tacrolimus

2

Intervention: placebo

Outcomes

Primary Outcomes

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