Myasthenia Gravis Registry in China

Last updated: January 27, 2024
Sponsor: Huashan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polymyositis (Inflammatory Muscle Disease)

Sarcopenia

Neuropathy

Treatment

N/A

Clinical Study ID

NCT06241521
2023M-022
2022YFC3501303
82071410
82001335
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Fluctuating weakness in skeletal muscles, such as extraocular, bulbar, limb muscles,etc.. Demonstrating fluctuation and fatigability: Weakness is usually worse in themorning and improves with rest; worsens with sustained activity.
  • Patients themselves or their guardians can understand and sign the informed consentform. To meet the eligibility criteria, at least one of the following additional criteria must bemet:
  • a. Positive Tensilon test;
  • b. Decrease in compound muscle action potential by more than 10% with low-frequencyrepetitive nerve stimulation or widening of the "jitter" (the variability in time ofthe 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

Exclusion Criteria:

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

Study Design

Total Participants: 1500
Study Start date:
February 01, 2024
Estimated Completion Date:
January 30, 2035

Study 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.).

Connect with a study center

  • Beijing Hospital

    Beijing, Beijing 100051
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Xuanwu hospital, Capital medical university

    Beijing, Beijing 100053
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 401147
    China

    Active - Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • The Third Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • Xiangya hospital, Central south university

    Changsha, Hunan 410001
    China

    Active - Recruiting

  • The First Hospital, Soochow University

    Suzhou, Jiangsu 215005
    China

    Active - Recruiting

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221004
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330209
    China

    Active - Recruiting

  • The First Hospital, Jilin University

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

  • Tangdu Hospital, The Air Force Medical University

    Xi'an, Shanxi 710000
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Active - Recruiting

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