Myasthenia Gravis
Conditions
Keywords
prograf, immunosuppressant
Brief summary
To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.
Interventions
oral
DRUGPlacebo
oral
Sponsors
Astellas Pharma China, Inc.
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed as myasthenia gravis (MG) by clinical diagnosis * QMG scores ≥7 at the time of enrollment * basic treatment drugs are mainly glucocorticoids, and the efficacy of glucocorticoid therapy was not sufficient
Exclusion criteria
* receiving blood purification therapy or immunoglobulin therapy within 8 weeks before the study * QMG swallowing function score ≥ 2 points or QMG vital capacity = 3 * abnormal hepatic functions * uncontrolled diabetes patients * hyperkalemia patients * immuno-inhibitors are forbidden due to malignancy, history of malignancy or history of HIV infection * patients who are allergic to Tacrolimus or macrolide antibiotics * receiving other immuno-inhibitors within 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in quantitative myasthenia gravis (QMG) score for disease severity | Baseline and at 24 weeks |
| Change from baseline in QMG score for disease severity | Baseline and at 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Osserman classification | Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks |
| Changes in myasthenia gravis activity of daily living scale | Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks |
Countries
China
Outcome results
None listed