Myasthenia Gravis Registry in China

January 27, 2024 updated by: Chongbo Zhao, Huashan Hospital
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

Study Overview

Status

Recruiting

Conditions

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.).

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Yuzhou Guan
        • Principal Investigator:
          • Yuzhou Guan
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:
          • Yuwei Da
        • Principal Investigator:
          • Yuwei Da
      • Beijing, Beijing, China, 100051
        • Recruiting
        • Beijing Hospital
        • Principal Investigator:
          • Hua Zhang
        • Contact:
          • Hua Zhang
    • Chongqing
      • Chongqing, Chongqing, China, 401147
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Fei Xiao
        • Principal Investigator:
          • Fei Xiao
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
          • Huiyu Feng
        • Principal Investigator:
          • Huiyu Feng
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • The Third Hospital, Sun Yat-sen University
        • Contact:
          • Wei Qiu
        • Principal Investigator:
          • Wei Qiu
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Bo Song
        • Principal Investigator:
          • Bo Song
    • Hunan
      • Changsha, Hunan, China, 410001
        • Recruiting
        • Xiangya Hospital, Central South University
        • Contact:
          • Huan yang
        • Principal Investigator:
          • Huan Yang
    • Jiangsu
      • Suzhou, Jiangsu, China, 215005
        • Recruiting
        • The First Hospital, Soochow University
        • Contact:
          • Qun Xue
        • Principal Investigator:
          • Qun Xue
      • Xuzhou, Jiangsu, China, 221004
        • Recruiting
        • Affiliated Hospital of Xuzhou Medical University
        • Principal Investigator:
          • Yong Zhang
        • Contact:
          • Yong Zhang
    • Jiangxi
      • Nanchang, Jiangxi, China, 330209
        • Recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
          • Daojun Hong
        • Principal Investigator:
          • Daojun Hong
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital, Jilin University
        • Contact:
          • Hui Deng
        • Principal Investigator:
          • Hui Deng
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital, Fudan University
        • Contact:
          • Chongbo Zhao
        • Principal Investigator:
          • Chongbo Zhao
    • Shanxi
      • Xi'an, Shanxi, China, 710000
        • Recruiting
        • Tangdu Hospital, The Air Force Medical University
        • Contact:
          • Ting Chang
        • Principal Investigator:
          • Ting Chang
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
          • Hongyu Zhou
        • Principal Investigator:
          • Hongyu Zhou
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
          • Chunsheng Yang
        • Principal Investigator:
          • Chunsheng Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

MG patients mostly of Chinese Han ethnicity (ocular MG type no more than 30%).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Myasthenia gravis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MSE proportion
Time Frame: Ten years
The proportion of patients achieving minimal symptom expression (MSE, defined as reaching an ADL score of 0 or 1) after treatment.
Ten years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety events
Time Frame: Ten years
Safety events including upper respiratory tract infection, lower respiratory tract infection, urinary tract infection, and other infections;
Ten years
Relapse of MG symptoms
Time Frame: Ten years
Having reached MSE for over a year but experiencing a symptom relapse, manifested as an increase in ADL score greater than or equal to 2 points.
Ten years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Collaborators

China Alliance for Rare Diseases
National Center for Neurological Disorders (China)
China myasthenia gravis collaborating group (CMGCG)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2034

Study Completion (Estimated)

January 30, 2035

Study Registration Dates

First Submitted

January 27, 2024

First Submitted That Met QC Criteria

January 27, 2024

First Posted (Estimated)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 27, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023M-022
  • 2022YFC3501303 (Other Grant/Funding Number: China's National Key R&D Program)
  • 82071410 (Other Grant/Funding Number: National Natural Science Foundation of China)
  • 82001335 (Other Grant/Funding Number: National Natural Science Foundation of China)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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