Clinical trial NCT01325571: A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis
Official title: A Randomized, Double-blinded, Placebo-controlled, and Multi-centered Clinical Trial Evaluating the Efficacy and Safety of Tacrolimus Capsule in Myasthenia Gravis That Was Insufficiently Treated by Glucocorticoid Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myasthenia Gravis
Keywords: prograf
immunosuppressant
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma China, Inc.
First posted: 2011-03-30
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in quantitative myasthenia gravis (QMG) score for disease severity
timeFrame: Baseline and at 24 weeks
measure: Change from baseline in QMG score for disease severity
timeFrame: Baseline and at 4 weeks
measure: Change from baseline in QMG score for disease severity
timeFrame: Baseline and at 8 weeks
measure: Change from baseline in QMG score for disease severity
timeFrame: Baseline and at 12 weeks
measure: Change from baseline in QMG score for disease severity
timeFrame: Baseline and at 16 weeks
measure: Change from baseline in QMG score for disease severity
timeFrame: Baseline and at 20 weeks
Secondary outcomes:
measure: Changes in Osserman classification
timeFrame: Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
measure: Changes in myasthenia gravis activity of daily living scale
timeFrame: Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
city: Guangdong
country: China
city: Jiangsu
country: China
city: Jilin
country: China
city: Shandong
country: China
city: Shanghai
country: China
city: Sichuan
country: China
city: Wuhan
country: China
city: Zhejiang
country: China
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Zhou L, Liu W, Li W, Li H, Zhang X, Shang H, Zhang X, Bu B, Deng H, Fang Q, Li J, Zhang H, Song Z, Ou C, Yan C, Liu T, Zhou H, Bao J, Lu J, Shi H, Zhao C. Tacrolimus in the treatment of myasthenia gravis in patients with an inadequate response to glucocorticoid therapy: randomized, double-blind, placebo-controlled study conducted in China. Ther Adv Neurol Disord. 2017 Sep;10(9):315-325. doi: 10.1177/1756285617721092. Epub 2017 Jul 26.