RecruitingNCT06241521

Myasthenia Gravis Registry in China


Sponsor

Huashan Hospital

Enrollment

1,500 participants

Start Date

Feb 1, 2024

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria6

  • 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 Criteria2

  • 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.

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Locations(16)

Beijing Hospital

Beijing, Beijing Municipality, China

Xuanwu hospital, Capital medical university

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The Third Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Xiangya hospital, Central south university

Changsha, Hunan, China

The First Hospital, Soochow University

Suzhou, Jiangsu, China

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital, Jilin University

Changchun, Jilin, China

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Tangdu Hospital, The Air Force Medical University

Xi’an, Shanxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06241521


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