Myasthenia Gravis Registry in China

NCT ID: NCT06241521

Last Updated: 2024-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2035-01-30

Brief Summary

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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

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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.).

Conditions

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Myasthenia Gravis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Myasthenia gravis patients

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Alliance for Rare Diseases

UNKNOWN

Sponsor Role collaborator

National Center for Neurological Disorders (China)

UNKNOWN

Sponsor Role collaborator

China myasthenia gravis collaborating group (CMGCG)

UNKNOWN

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chongbo Zhao

Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Xuanwu hospital, Capital medical university

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

The Third Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Xiangya hospital, Central south university

Changsha, Hunan, China

Site Status RECRUITING

The First Hospital, Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

The First Hospital, Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Tangdu Hospital, The Air Force Medical University

Xi’an, Shanxi, China

Site Status RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Sushan Luo, MD, PhD

Role: CONTACT

86 2152889999

Facility Contacts

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Hua Zhang

Role: primary

Yuwei Da

Role: primary

Yuzhou Guan

Role: primary

Fei Xiao

Role: primary

Huiyu Feng

Role: primary

Wei Qiu

Role: primary

Bo Song

Role: primary

Huan Yang

Role: primary

Qun Xue

Role: primary

Yong Zhang

Role: primary

Daojun Hong

Role: primary

Hui Deng

Role: primary

Chongbo Zhao

Role: primary

Ting Chang

Role: primary

Hongyu Zhou

Role: primary

Chunsheng Yang

Role: primary

Other Identifiers

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2022YFC3501303

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

82071410

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

82001335

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023M-022

Identifier Type: -

Identifier Source: org_study_id

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