Myasthenia Gravis Registry in China

NCT06241521 · tracked via the Priya Life Science China tracker

Sponsor

Huashan Hospital

Phase

Observational

Started

2024-02-01

Last updated

2024-02-05

Condition(s) studied

Myasthenia Gravis

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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

MSE proportion — Ten years
The proportion of patients achieving minimal symptom expression (MSE, defined as reaching an ADL score of 0 or 1) after treatment.

Trial sites (16)

Facility	City	Region	Status
Beijing Hospital	Beijing	Beijing Municipality	Recruiting
Xuanwu hospital, Capital medical university	Beijing	Beijing Municipality	Recruiting
Peking Union Medical College Hospital	Beijing	Beijing Municipality	Recruiting
The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing Municipality	Recruiting
The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	Recruiting
The Third Hospital, Sun Yat-sen University	Guangzhou	Guangdong	Recruiting
First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	Recruiting
Xiangya hospital, Central south university	Changsha	Hunan	Recruiting
The First Hospital, Soochow University	Suzhou	Jiangsu	Recruiting
Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu	Recruiting
The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	Recruiting
The First Hospital, Jilin University	Changchun	Jilin	Recruiting
Huashan Hospital, Fudan University	Shanghai	Shanghai Municipality	Recruiting
Tangdu Hospital, The Air Force Medical University	Xi’an	Shanxi	Recruiting
West China Hospital, Sichuan University	Chengdu	Sichuan	Recruiting
Tianjin Medical University General Hospital	Tianjin	Tianjin Municipality	Recruiting

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Other trials for the same condition

UCAR T-cell Therapy Targeting CD19/BCMA in Patients With r/r Myasthenia Gravis Starting soon

Construction of A Multimodal Digital Assessment Model for Myasthenia Gravis Recruiting

Safety and Efficacy of BAFF-R CART for Refractory Neuroimmune Diseases Recruiting

Cohort Study on Neuroimmune Diseases in the Reproductive Age Recruiting

A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06241521 on ClinicalTrials.gov ↗ ← All trials in China