Improving diagnosis and understanding of myasthenia gravis in Chinese patients
Official title: Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China
Run by Huashan Hospital · NCT04535843 · Data updated 2026-11-12
This study is trying to improve how doctors diagnose and understand myasthenia gravis in Chinese patients by tracking the health of 300 people with the condition over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years to 90 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 4 sites (Shanghai, Shanghai Municipality and 3 other locations) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | February 1, 2028 |
| Study ends | May 1, 2028 |
| Registry record updated | May 28, 2025 |
| Trial ID | NCT04535843 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with myasthenia gravis who exhibit fluctuating muscle weakness and meet specific diagnostic criteria.
✕Probably not a fit
Patients with conditions that mimic or overlap with myasthenia gravis, such as Lambert-Eaton syndrome or congenital myasthenia syndrome, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to enhance the clinical capacity for diagnosing and understanding the natural history of myasthenia gravis (MG) among Chinese patients. It plans to recruit 300 patients with MG, documenting their conditions and following them over time. The study will focus on the management of screening tests and the manifestations of the cohort, utilizing biomarkers and omics data for analysis.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and better management strategies for patients with myasthenia gravis.
How similar studies have gone: While this approach is focused on a specific population, similar studies have shown promise in improving diagnostic accuracy and patient outcomes in other regions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * fluctuating muscle weakness and fatigability, along with one of the below: * more than 10% amplitude decrement in low frequency repetitive nerve stimulation,less than 10% amplitude increment in high frequency repetitive nerve stimulation; * anti-AChR or MuSK antibody positivity; * positive to the neostigmine test; * understanding and assigning the informed consent form, and having a good compliance with the follow up. Exclusion Criteria: * excluding the possible diagnosis of Lambert-Eaton syndrome, congenital myasthenia syndrome,botulism injection, chronic progressive extraocular ophthalmoplegia, etc; * poor compliance to the follow up.
Where it's running
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China Recruiting -
Obsterics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting -
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting -
Huashan Hospital
Shanghai, China Recruiting
Study contacts
- Study coordinator: Chongbo Zhao, MD
- Email: zhao_chongbo@fudan.edu.cn
- Phone: 86-021-52889999
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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MG patient registry to track long-term experiences and treatment patterns
This registry collects information from adults with myasthenia gravis to see how symptoms and quality of life change over time and how treatments relate to those changes.
-
Ublituximab maintenance after efgartigimod response in myasthenia gravis
This study tests whether giving ublituximab as maintenance after a positive response to efgartigimod helps adults with myasthenia gravis.
-
Pregnant Women with Neuroimmune Diseases: A long-term follow-up study
This study follows women with neuroimmune diseases and healthy controls through pregnancy and up to ten years to see how pregnancy affects disease activity and outcomes for both mother and baby.
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Early ravulizumab for adults with myasthenic crisis in the ICU
This project will test whether giving ravulizumab early to adults with AChR-positive generalized myasthenia gravis who are in the ICU for a myasthenic crisis helps speed recovery.
-
KITE-363 treatment for relapsed or refractory autoimmune neurologic diseases
This study will test whether KITE-363 is safe and can help people with relapsed or treatment-resistant autoimmune neurologic diseases such as MS, CIDP, and myasthenia gravis.
-
ADAPT Forward master protocol testing multiple regimens for generalized myasthenia gravis
This platform tests several drug regimens, including efgartigimod IV and empasiprubart IV, in adults with generalized myasthenia gravis to find safer and more effective treatment combinations.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.