Back to resultsFK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients
Primary Purpose
Myasthenia Gravis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
tacrolimus
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Myasthenia Gravis focused on measuring Tacrolimus, Myasthenia Gravis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
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.]
Secondary Outcome Measures
Total amount of steroid therapy (mg)
QMG score;MG-ADL
Success rate of achievement to the targeted steroid dose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00309088
Brief Title
FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients
Official Title
FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis
Keywords
Tacrolimus, Myasthenia Gravis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Other Intervention Name(s)
Prograf, FK506
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Total amount of steroid therapy (mg)
Time Frame
6 Months
Title
QMG score;MG-ADL
Time Frame
6 Months
Title
Success rate of achievement to the targeted steroid dose
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chubu region
Country
Japan
City
Chugoku region
Country
Japan
City
Hokkaido region
Country
Japan
City
Hokuriku region
Country
Japan
City
Kansai region
Country
Japan
City
Kanto region
Country
Japan
City
Kyushu region
Country
Japan
City
Shikoku region
Country
Japan
City
Tohoku region
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
21784757
Citation
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. Erratum In: J Neurol Neurosurg Psychiatry. 2011 Oct;82(10):1180.
Results Reference
derived
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140547 in the JapicCTI-RNo. field
Learn more about this trial
FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients
We'll reach out to this number within 24 hrs