FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients
FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients
1 other identifier
interventional
80
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2006
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2006
CompletedFirst Posted
Study publicly available on registry
March 31, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedAugust 25, 2014
August 1, 2014
2.2 years
March 29, 2006
August 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Total amount of steroid therapy (mg)
6 Months
QMG score;MG-ADL
6 Months
Success rate of achievement to the targeted steroid dose
6 Months
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Chubu Region, Japan
Unknown Facility
Chugoku Region, Japan
Unknown Facility
Hokkaido Region, Japan
Unknown Facility
Hokuriku Region, Japan
Unknown Facility
Kansai Region, Japan
Unknown Facility
Kanto Region, Japan
Unknown Facility
Kyushu Region, Japan
Unknown Facility
Shikoku Region, Japan
Unknown Facility
Tohoku Region, Japan
Related Publications (1)
Yoshikawa H, Kiuchi T, Saida T, Takamori M. Randomised, double-blind, placebo-controlled study of tacrolimus in myasthenia gravis. J Neurol Neurosurg Psychiatry. 2011 Sep;82(9):970-7. doi: 10.1136/jnnp-2011-300148. Epub 2011 Jul 22.
PMID: 21784757DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2006
First Posted
March 31, 2006
Study Start
April 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
August 25, 2014
Record last verified: 2014-08