Registry for patients with Myasthenia Gravis in China

Myasthenia Gravis Registry in China

This study is creating a national registry for people with Myasthenia Gravis in China to track their health and treatment over ten years.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 16 sites (Beijing, Beijing Municipality and 15 other locations)
• Trial ID: NCT06241521 on ClinicalTrials.gov

What this trial studies

This observational study aims to create a nationwide patient registry for Myasthenia Gravis (MG) in China, focusing on the collection of longitudinal clinical data. It will gather information on patient demographics, medical history, treatment responses, and safety events through a Cloud-based MG Patient Management Platform. Patients will be followed annually for ten years to monitor their condition and treatment outcomes. The registry will also classify patients based on MG subtypes and treatment methods to support standardized management.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with Myasthenia Gravis who exhibit fluctuating muscle weakness and can provide informed consent.

Not a fit: Patients with severe mental illness or multiple organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could improve the management and treatment outcomes for patients with Myasthenia Gravis in China.

How similar studies have performed: Other patient registries for autoimmune diseases have shown success in improving patient management and treatment outcomes, indicating potential for this approach.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 15 other locations

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

Study contacts

• Study coordinator: Sushan Luo, MD, PhD

Conditions Myasthenia Gravis; Prospective study; Observational study; Patient registry