Myasthenia GravisNCT04535843
Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China
An observational study of Myasthenia Gravis, run by Huashan Hospital at 4 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 90 years
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Biomarkers and omics data
- How many people
- 500 participants
- Where
- 4 sitesChina
- Study dates
- 1 Feb 2024to 1 May 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from the outpatient clinics and inpatient wards are planned to be enrolled, as long as meeting the inclusion criteria.
Who may be able to join
- 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.
Who cannot join
- excluding the possible diagnosis of Lambert-Eaton syndrome, congenital myasthenia syndrome,botulism injection, chronic progressive extraocular ophthalmoplegia, etc;
- poor compliance to the follow up.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200000
Changlu Wang, MD, 86-021-22200000
- Recruiting
Obsterics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011
Weirong Gu, MD, 86-021-33189900
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Wenhui Li, MD, 86-021-64931923
- Recruiting
Huashan Hospital
Shanghai, 200040
Chongbo Zhao, MD, +86 21 52889999, zhao_chongbo@fudan.edu.cn
About this study
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.
- Conditions
- Myasthenia Gravis
- Being tested
- Biomarkers and omics data
- Keywords
- myasthenia gravis, precision diagnosis, antibody detection
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers and omics dataOther
To detect disease-related biomarkers and omics data, in this prospective MG cohort.
| Study group | Role | What they receive |
|---|---|---|
| myasthenia gravis | 300 MG patients are anticipated for precision diagnosis and disease monitoring. Receives: Other: Biomarkers and omics data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myasthenia gravis foundation of America post intervention status
Myasthenia gravis foundation of America post intervention status (PIS) is assessed by the investigators during follow up. According to history inquiry and physical examination, participants are rated as clinical remission (no complain of myasthenia, no weakness at physical examination, and no therapies concerning MG for one year), pharmocological remission (no complain of myasthenia, no weakness at physical examination, but undertaking MG therapies at the last year), minimal manifestation (no complain of weakness, but showing weakness at physical examination), improvement (symptoms and signs), unchanged (symptoms and signs) , worsening(symptoms and signs), exacerbation(symptoms and signs), and death (medical record).
Measured: 3 years
Secondary outcomes (3)
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scores at the follow up
A quantitative MG scoring system (QMG Score) is essential in the objective evaluation of therapy for MG.This scoring system is based on quantitative testing of sentinel muscle groups. Total QMG score range from 0 (extreme disease severity) to 39 (none), higher score indicated less disease severity.
Measured: Baseline, 1 year, 2 year, and 3 year
Change From Baseline in Activities of Daily Living (ADL) Scores at the follow up
The MG-ADL scale assesses the impact of MG on patients' daily functions. Physicians use this tool to score a patient's MG symptoms based on the patient's recall of symptoms during the prior week. A person's score can range from zero (normal) to 24 (most severe).
Measured: 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
The MG-QOL15 is helpful in informing the clinician about the patient's perception of the extent of and dissatisfaction with MG-related dysfunction. Total MG-QOL15 score range from 0 (none) to 60 (extreme disease severity), higher score indicated more disease severity.
Measured: Baseline, 1 year, 2 year, and 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Feb 2024
- Primary completion1 Feb 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chongbo Zhao, Huashan Hospital
- Investigators
- Chongbo Zhao, MD, Study chair, Huashan Hospital, Shanghai,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535843
- Sponsor's protocol ID
- 2020-999
- Status last verified
- May 2025
- First submitted
- 23 Aug 2020
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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: 10.1177/17562864251319656. eCollection 2025.
PubMed 39974170Jin 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.
PubMed 39735403
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China
- ClinicalTrials.gov ID
- NCT04535843
- Acronym / sponsor ID
- 2020-999
- Conditions
- Myasthenia Gravis
- Keywords
- myasthenia gravis, precision diagnosis, antibody detection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myasthenia gravis | – | Other: Biomarkers and omics data300 MG patients are anticipated for precision diagnosis and disease monitoring. |
Who may qualify
- Ages
- 0 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from the outpatient clinics and inpatient wards are planned to be enrolled, as long as meeting the inclusion criteria.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- excluding the possible diagnosis of Lambert-Eaton syndrome, congenital myasthenia syndrome,botulism injection, chronic progressive extraocular ophthalmoplegia, etc;
- poor compliance to the follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarkers and omics dataTo detect disease-related biomarkers and omics data, in this prospective MG cohort. | Other | myasthenia gravis |
Primary outcome
Myasthenia gravis foundation of America post intervention status
Time frame: 3 years
Myasthenia gravis foundation of America post intervention status (PIS) is assessed by the investigators during follow up. According to history inquiry and physical examination, participants are rated as clinical remission (no complain of myasthenia, no weakness at physical examination, and no therapies concerning MG for one year), pharmocological remission (no complain of myasthenia, no weakness at physical examination, but undertaking MG therapies at the last year), minimal manifestation (no complain of weakness, but showing weakness at physical examination), improvement (symptoms and signs), unchanged (symptoms and signs) , worsening(symptoms and signs), exacerbation(symptoms and signs), and death (medical record).
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Derived from this study: PubMed 39974170Jin 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: 10.1177/17562864251319656. eCollection 2025.
- Derived from this study: PubMed 39735403Jin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chongbo Zhao, MD study chair
Huashan Hospital, Shanghai,China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by Huashan Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chongbo Zhao, MD (86-021-52889999, zhao_chongbo@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myasthenia gravis foundation of America post intervention status (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04535843, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.