Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China

Study Overview
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Brief Summary
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The present study is a prospective cohort study aiming to improve the clinical capacity in the diagnosis and natural history of Chinese patients with myasthenia gravis (MG). 300 MG patients are planned to recruit, document and prospectively follow up. Management of screening test and cohort manifestation are studied.

Official Title
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Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China

Conditions
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Myasthenia Gravis

Intervention / Treatment
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* Device: pheripheral biomarkers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fluctuating muscle weakness and fatigability, along with one of the below: more than 10% amplitude decrement in low frequency repetitive nerve stimulation,less than 10% amplitude increment in high frequency repetitive nerve stimulation; anti-AChR or MuSK antibody positivity; positive to the neostigmine test; understanding and assigning the informed consent form, and having a good compliance with the follow up. Exclusion Criteria: excluding the possible diagnosis of Lambert-Eaton syndrome, congenital myasthenia syndrome,botulism injection, chronic progressive extraocular ophthalmoplegia, etc; participating other clinical trials; poor compliance to the follow up.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 90 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| myasthenia gravis<br>300 MG patients are anticipated for precision diagnosis and disease monitoring. | Device: pheripheral biomarkers<br>* Detect the pheripheral biomarkers,including lymphocytes and cytokines, in this prospective MG cohort.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myasthenia gravis foundation of America post intervention status | Myasthenia gravis foundation of America post intervention status (PIS) is assessed by the investigators during follow up. According to history inquiry and physical examination, participants are rated as clinical remission (no complain of myasthenia, no weakness at physical examination, and no therapies concerning MG for one year), pharmocological remission (no complain of myasthenia, no weakness at physical examination, but undertaking MG therapies at the last year), minimal manifestation (no complain of weakness, but showing weakness at physical examination), improvement (symptoms and signs), unchanged (symptoms and signs) , worsening(symptoms and signs), exacerbation(symptoms and signs), and death (medical record). | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scores at the follow up | A quantitative MG scoring system (QMG Score) is essential in the objective evaluation of therapy for MG.This scoring system is based on quantitative testing of sentinel muscle groups. Total QMG score range from 0 (extreme disease severity) to 39 (none), higher score indicated less disease severity. | Baseline, 1 year, 2 year, and 3 year | 
| Change From Baseline in Manual Muscle Testing (MMT) Scores at the follow up | The MMT score is the sum of strength or function values assigned by the examining physician to 30 muscle groups usually affected by MG. Total MMT score range from 0 (none) to 124 (extreme muscle weakness), higher score indicated more disease severity. | Baseline, 1 year, 2 year, and 3 year | 
| Change From Baseline in Myasthenia Gravis-Quality of Life Questionnaire-15 item (MG-QOL15) Scores at the follow up | The MG-QOL15 is helpful in informing the clinician about the patient's perception of the extent of and dissatisfaction with MG-related dysfunction. Total MG-QOL15 score range from 0 (none) to 60 (extreme disease severity), higher score indicated more disease severity. | Baseline, 1 year, 2 year, and 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myasthenia gravis, precision diagnosis, antibody detection