Myasthenia Gravis Registry in China

Status: Recruiting
Location: See all (16) locations...
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Hospital
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Xuanwu hospital, Capital medical university
RECRUITING
Beijing
The First Hospital, Jilin University
RECRUITING
Changchun
Xiangya hospital, Central south university
RECRUITING
Changsha
West China Hospital, Sichuan University
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
The First Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
The Third Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Huashan Hospital, Fudan University
RECRUITING
Shanghai
The First Hospital, Soochow University
RECRUITING
Suzhou
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Tangdu Hospital, The Air Force Medical University
RECRUITING
Xi’an
Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Sushan Luo, MD, PhD
luosushan@fudan.edu.cn
86 2152889999
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2035-01-30
Participants
Target number of participants: 1500
Treatments
Myasthenia gravis patients
Related Therapeutic Areas
Sponsors
Collaborators: China myasthenia gravis collaborating group (CMGCG), China Alliance for Rare Diseases, National Center for Neurological Disorders (China)
Leads: Huashan Hospital

This content was sourced from clinicaltrials.gov