Myasthenia Gravis Registry in China
4 other identifiers
observational
1,500
1 country
16
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2024
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2024
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedFirst Posted
Study publicly available on registry
February 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2035
February 5, 2024
January 1, 2024
10 years
January 27, 2024
January 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MSE proportion
The proportion of patients achieving minimal symptom expression (MSE, defined as reaching an ADL score of 0 or 1) after treatment.
Ten years
Secondary Outcomes (2)
Safety events
Ten years
Relapse of MG symptoms
Ten years
Study Arms (1)
Myasthenia gravis patients
Eligibility Criteria
MG patients mostly of Chinese Han ethnicity (ocular MG type no more than 30%).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
- China Alliance for Rare Diseasescollaborator
- National Center for Neurological Disorders (China)collaborator
- China myasthenia gravis collaborating group (CMGCG)collaborator
Study Sites (16)
Beijing Hospital
Beijing, Beijing Municipality, 100051, China
Xuanwu hospital, Capital medical university
Beijing, Beijing Municipality, 100053, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 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 Municipality, 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 Municipality, 300052, China
Biospecimen
Whole blood, Plasma, Serum, Blood RNA extraction
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice President
Study Record Dates
First Submitted
January 27, 2024
First Posted
February 5, 2024
Study Start
February 1, 2024
Primary Completion (Estimated)
February 1, 2034
Study Completion (Estimated)
January 30, 2035
Last Updated
February 5, 2024
Record last verified: 2024-01