A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis

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

Official Title
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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

Conditions
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Myasthenia Gravis

Intervention / Treatment
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* Drug: Tacrolimus capsule
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tacrolimus group<br> | Drug: Tacrolimus capsule<br>* oral<br>* Other names: FK506;|
| Placebo Comparator: placebo group<br> | Drug: Placebo<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| Change from baseline in QMG score for disease severity |  | Baseline and at 8 weeks | 
| Change from baseline in QMG score for disease severity |  | Baseline and at 12 weeks | 
| Change from baseline in QMG score for disease severity |  | Baseline and at 16 weeks | 
| Change from baseline in QMG score for disease severity |  | Baseline and at 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prograf, immunosuppressant