Myasthenia Gravis Registry in China

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Description

Myasthenia gravis (MG) is an autoimmune disease caused by dysfunction at the neuromuscular junction, characterized by partial or generalized skeletal muscle weakness and fatigability. The estimated annual incidence rate of MG in China is 0.68/100,000, with a high rate of relapse and poor treatment compliance. This study is a prospective, observational, multi-center patient registry across China. To support standardized management and follow-up of MG patients in China, a Cloud-based MG Patient Management Platform (CN MG Base) was established in September 2023 with the support of the Chinese Rare Diseases Alliance. The platform aims to collect longitudinal clinical data including demographic information, age of onset, medical history, comorbidities, medication usage, treatment responses, and others. It is intended to collect newly registered MG cases each year and follow up with these patients at one-year intervals for ten years

Targeted Conditions

Study Overview

Start Date
February 1, 2024
Completion Date
January 30, 2035
Enrollment
1500
Date Posted
February 5, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Beijing Hospital
Beijing, Beijing 100051, China

Xuanwu hospital, Capital medical university
Beijing, Beijing 100053, China

Peking Union Medical College Hospital
Beijing, Beijing 100730, China

The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing 401147, China

The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510060, China

The Third Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510060, China

First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450052, China

Xiangya hospital, Central south university
Changsha, Hunan 410001, China

The First Hospital, Soochow University
Suzhou, Jiangsu 215005, China

Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu 221004, China

The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330209, China

The First Hospital, Jilin University
Changchun, Jilin 130021, China

Huashan Hospital, Fudan University
Shanghai, Shanghai 200040, China

Tangdu Hospital, The Air Force Medical University
Xi'an, Shanxi 710000, China

West China Hospital, Sichuan University
Chengdu, Sichuan 610041, China

Tianjin Medical University General Hospital
Tianjin, Tianjin 300052, China

Eligibility

Study Population
MG patients mostly of Chinese Han ethnicity (ocular MG type no more than 30%).
Eligibility Criteria
Inclusion Criteria:

Fluctuating weakness in skeletal muscles, such as extraocular, bulbar, limb muscles, etc.. Demonstrating fluctuation and fatigability: Weakness is usually worse in the morning and improves with rest; worsens with sustained activity.
Patients themselves or their guardians can understand and sign the informed consent form.

To meet the eligibility criteria, at least one of the following additional criteria must be met:

a. Positive Tensilon test;
b. Decrease in compound muscle action potential by more than 10% with low-frequency repetitive nerve stimulation or widening of the "jitter" (the variability in time of the second action potential relative to the first) on single-fiber electromyography, with or without blocking;
c. Positive antibodies: Serum testing positive for AChR antibodies, MuSK antibodies, or LRP4 antibodies.

Exclusion Criteria:

Patients with mental illness who cannot cooperate.
Patients with multiple organ dysfunction or in extremely critical condition, unable to complete relevant medical history collection or evaluation.

Study Contact Info

Study Contact Name
Sushan Luo, MD, PhD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
This study is a observational nationwide multicenter MG registry research. Starting from the baseline, annual follow-ups will be conducted to prospectively collect information on treatment medications, prognosis, and safety events. The following classification definitions can be applied: ① MG clinical subtypes (ocular, early-onset generalized, thymoma-related, late-onset generalized, MuSK-related, and seronegative); ② Different treatment methods (classic immunotherapy group, B-cell-targeted therapy, complement inhibition therapy, rapid-acting therapy, and IL-6 pathway inhibitors, etc.).
NCTid (if applicable)
NCT06241521