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

Huashan Hospital500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Myasthenia Gravis

Interventions

Biomarkers and omics dataOTHER

To detect disease-related biomarkers and omics data, in this prospective MG cohort.

Eligibility

Sex: ALLMin age: 0 YearsMax age: 90 Years

Medical Language ↔ Plain English

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; * poor compliance to the follow up.

Locations (4)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Obsterics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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).

Time frame: 3 years

Secondary Outcomes

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.

Time frame: Baseline, 1 year, 2 year, and 3 year

Change From Baseline in Activities of Daily Living (ADL) Scores at the follow up

The MG-ADL scale assesses the impact of MG on patients' daily functions. Physicians use this tool to score a patient's MG symptoms based on the patient's recall of symptoms during the prior week. A person's score can range from zero (normal) to 24 (most severe).

Time frame: 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.

Central Contacts

Chongbo Zhao, MD

CONTACT

86-021-52889999 zhao_chongbo@fudan.edu.cn

Data from ClinicalTrials.gov

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