Myasthenia GravisNCT06241521
Myasthenia Gravis Registry in China
An observational study of Myasthenia Gravis, run by Huashan Hospital at 16 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myasthenia Gravis
- How many people
- 1,500 participants
- Where
- 16 sitesChina
- Study dates
- 1 Feb 2024to 30 Jan 2035
- How long will I take part?
- 10 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: MG patients mostly of Chinese Han ethnicity (ocular MG type no more than 30%).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100051
Hua Zhang
Hua Zhang
- Recruiting
Xuanwu hospital, Capital medical university
Beijing, Beijing Municipality, 100053
Yuwei Da
Yuwei Da
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yuzhou Guan
Yuzhou Guan
- Recruiting
The First Hospital, Jilin University
Changchun, Jilin, 130021
Hui Deng
Hui Deng
- Recruiting
Xiangya hospital, Central south university
Changsha, Hunan, 410001
Huan Yang
Huan Yang
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Hongyu Zhou
Hongyu Zhou
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 401147
Fei Xiao
Fei Xiao
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Huiyu Feng
Huiyu Feng
- Recruiting
The Third Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Wei Qiu
Wei Qiu
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330209
Daojun Hong
Daojun Hong
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Chongbo Zhao
Chongbo Zhao
- Recruiting
The First Hospital, Soochow University
Suzhou, Jiangsu, 215005
Qun Xue
Qun Xue
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Chunsheng Yang
Chunsheng Yang
- Recruiting
Tangdu Hospital, The Air Force Medical University
Xi’an, Shanxi, 710000
Ting Chang
Ting Chang
- Recruiting
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221004
Yong Zhang
Yong Zhang
- Recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Bo Song
Bo Song
About this study
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
Read the detailed description
This study is a observational nationwide multicenter MG registry research. Starting from the baseline, annual follow-ups will be conducted to prospectively collect information on treatment medications, prognosis, and safety events. The following classification definitions can be applied: ① MG clinical subtypes (ocular, early-onset generalized, thymoma-related, late-onset generalized, MuSK-related, and seronegative); ② Different treatment methods (classic immunotherapy group, B-cell-targeted therapy, complement inhibition therapy, rapid-acting therapy, and IL-6 pathway inhibitors, etc.).
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, Prospective study, Observational study, Patient registry
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Myasthenia gravis patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSE proportion
The proportion of patients achieving minimal symptom expression (MSE, defined as reaching an ADL score of 0 or 1) after treatment.
Measured: Ten years
Secondary outcomes (2)
Safety events
Safety events including upper respiratory tract infection, lower respiratory tract infection, urinary tract infection, and other infections;
Measured: Ten years
Relapse of MG symptoms
Having reached MSE for over a year but experiencing a symptom relapse, manifested as an increase in ADL score greater than or equal to 2 points.
Measured: Ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2034 (estimated)
- Study completion30 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Alliance for Rare Diseases, National Center for Neurological Disorders (China), China myasthenia gravis collaborating group (CMGCG)
- Responsible party
- Principal investigator, Chongbo Zhao, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241521
- Sponsor's protocol ID
- 2023M-022
- Other IDs
- 2022YFC3501303, 82071410, 82001335
- Status last verified
- Jan 2024
- First submitted
- 27 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myasthenia Gravis Registry in China
- ClinicalTrials.gov ID
- NCT06241521
- Acronym / sponsor ID
- 2023M-022
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, Prospective study, Observational study, Patient registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- China Alliance for Rare Diseases, National Center for Neurological Disorders (China), China myasthenia gravis collaborating group (CMGCG)
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2034 (estimated)
- Study completion
- 30 Jan 2035 (estimated)
- First posted
- 5 Feb 2024 (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.
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
Detailed description
This study is a observational nationwide multicenter MG registry research. Starting from the baseline, annual follow-ups will be conducted to prospectively collect information on treatment medications, prognosis, and safety events. The following classification definitions can be applied: ① MG clinical subtypes (ocular, early-onset generalized, thymoma-related, late-onset generalized, MuSK-related, and seronegative); ② Different treatment methods (classic immunotherapy group, B-cell-targeted therapy, complement inhibition therapy, rapid-acting therapy, and IL-6 pathway inhibitors, etc.).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myasthenia gravis patients | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- MG patients mostly of Chinese Han ethnicity (ocular MG type no more than 30%).
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MSE proportion
Time frame: Ten years
The proportion of patients achieving minimal symptom expression (MSE, defined as reaching an ADL score of 0 or 1) after treatment.
2 secondary outcomes
Safety events
Time frame: Ten years
Relapse of MG symptoms
Time frame: Ten years
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 5 Feb 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.
16 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 16 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 6 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 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 Sushan Luo, MD, PhD (86 2152889999, luosushan@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSE proportion (time frame: Ten years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.