Recruiting NCT04535843
Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biomarkers and omics data.
- Who it may be relevant to
- Registry conditions: Myasthenia Gravis. Basic parameters: 0 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The present study is a prospective cohort study aiming to improve the clinical capacity in the diagnosis and natural history of Chinese patients with myasthenia gravis (MG). 300 MG patients are planned to recruit, document and prospectively follow up. Management of screening test and cohort manifestation are studied.
Interventions
- Other Biomarkers and omics data
To detect disease-related biomarkers and omics data, in this prospective MG cohort.
Primary outcome measures
- Myasthenia gravis foundation of America post intervention status [Time frame: 3 years]
Secondary outcome measures (3)
- Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scores at the follow up [Time frame: Baseline, 1 year, 2 year, and 3 year]
- Change From Baseline in Activities of Daily Living (ADL) Scores at the follow up [Time frame: Baseline, 1 year, 2 year, and 3 year]
- Change From Baseline in Myasthenia Gravis-Quality of Life Questionnaire-15 item (MG-QOL15) Scores at the follow up [Time frame: Baseline, 1 year, 2 year, and 3 year]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 4 centers
- Shanghai Chest Hospital — Shanghai
- Obsterics and Gynecology Hospital of Fudan University — Shanghai
- Children's Hospital of Fudan University — Shanghai
- Huashan Hospital — Shanghai
Publications
- Jin L, Zou Z, Wang Q, Zeng W, Jiang Q, Chen J, Shi J, Yu Y, Hong D, Zeng Q, Tan S, Yue Y, Zhang Z, Zhang Y, Guo X, Du L, Zhao Z, Huang S, Chen Y, Wu Z, Yan C, Xi J, Song J, Luo S, Zhao C. Patterns and predictors of therapeutic response to efgartigimod in acetylcholine receptor-antibody generalized myasthenia gravis subtypes. Ther Adv Neurol Disord. 2025 Feb 18;18:17562864251319656. doi: 10.1177/17 PMID 39974170
- Jin L, He D, Zeng Q, Tan S, Shi J, Liu Y, Zou Z, Song J, Yan C, Huan X, Wang Y, Yang L, Xi J, Wu Z, Liu Z, Zheng J, Zhao C, Chu X, Luo S. Eculizumab in thymoma-associated myasthenia gravis: a real-world cohort study. Ther Adv Neurol Disord. 2024 Dec 25;17:17562864241309431. doi: 10.1177/17562864241309431. eCollection 2024. PMID 39735403
Identifiers
NCT: NCT04535843 · 2020-999