Trial Title:
Myasthenia Gravis Registry in China
NCT ID:
NCT06241521
Condition:
Myasthenia Gravis
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Conditions: Keywords:
Myasthenia Gravis
Prospective study
Observational study
Patient registry
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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
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.).
Criteria for eligibility:
Study pop:
MG patients mostly of Chinese Han ethnicity (ocular MG type no more than 30%).
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Hospital
Address:
City:
Beijing
Zip:
100051
Country:
China
Status:
Recruiting
Contact:
Last name:
Hua Zhang
Investigator:
Last name:
Hua Zhang
Email:
Principal Investigator
Facility:
Name:
Xuanwu hospital, Capital medical university
Address:
City:
Beijing
Zip:
100053
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuwei Da
Investigator:
Last name:
Yuwei Da
Email:
Principal Investigator
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuzhou Guan
Investigator:
Last name:
Yuzhou Guan
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
401147
Country:
China
Status:
Recruiting
Contact:
Last name:
Fei Xiao
Investigator:
Last name:
Fei Xiao
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Huiyu Feng
Investigator:
Last name:
Huiyu Feng
Email:
Principal Investigator
Facility:
Name:
The Third Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Qiu
Investigator:
Last name:
Wei Qiu
Email:
Principal Investigator
Facility:
Name:
First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Recruiting
Contact:
Last name:
Bo Song
Investigator:
Last name:
Bo Song
Email:
Principal Investigator
Facility:
Name:
Xiangya hospital, Central south university
Address:
City:
Changsha
Zip:
410001
Country:
China
Status:
Recruiting
Contact:
Last name:
Huan Yang
Investigator:
Last name:
Huan Yang
Email:
Principal Investigator
Facility:
Name:
The First Hospital, Soochow University
Address:
City:
Suzhou
Zip:
215005
Country:
China
Status:
Recruiting
Contact:
Last name:
Qun Xue
Investigator:
Last name:
Qun Xue
Email:
Principal Investigator
Facility:
Name:
Affiliated Hospital of Xuzhou Medical University
Address:
City:
Xuzhou
Zip:
221004
Country:
China
Status:
Recruiting
Contact:
Last name:
Yong Zhang
Investigator:
Last name:
Yong Zhang
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330209
Country:
China
Status:
Recruiting
Contact:
Last name:
Daojun Hong
Investigator:
Last name:
Daojun Hong
Email:
Principal Investigator
Facility:
Name:
The First Hospital, Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Deng
Investigator:
Last name:
Hui Deng
Email:
Principal Investigator
Facility:
Name:
Huashan Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200040
Country:
China
Status:
Recruiting
Contact:
Last name:
Chongbo Zhao
Investigator:
Last name:
Chongbo Zhao
Email:
Principal Investigator
Facility:
Name:
Tangdu Hospital, The Air Force Medical University
Address:
City:
Xi'an
Zip:
710000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ting Chang
Investigator:
Last name:
Ting Chang
Email:
Principal Investigator
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongyu Zhou
Investigator:
Last name:
Hongyu Zhou
Email:
Principal Investigator
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjin
Zip:
300052
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunsheng Yang
Investigator:
Last name:
Chunsheng Yang
Email:
Principal Investigator
Start date:
February 1, 2024
Completion date:
January 30, 2035
Lead sponsor:
Agency:
Huashan Hospital
Agency class:
Other
Collaborator:
Agency:
China Alliance for Rare Diseases
Agency class:
Other
Collaborator:
Agency:
National Center for Neurological Disorders (China)
Agency class:
Other
Collaborator:
Agency:
China myasthenia gravis collaborating group (CMGCG)
Agency class:
Other
Source:
Huashan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06241521
