Clinical Trial: FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients
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 Summary:
Sponsor: Astellas Pharma Inc
Current Primary Outcome: 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 ]
Original Primary Outcome:
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
Information By: Astellas Pharma Inc
Dates:
Date Received: March 29, 2006
Date Started: April 2006
Date Completion:
Last Updated: August 22, 2014
Last Verified: August 2014
