Myasthenia GravisNCT06006832
A Prospective Cohort Study of Myasthenia Gravis in China
An observational study of Myasthenia Gravis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this prospective cohort study is to investigate long-term therapeutic strategies for myasthenia gravis (MG) and identify potential biomarkers. The main questions it aims to answer are: 1. Whether low-dose oral steroids may lead to a reduction in the recurrence rate among patients with MG. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Steroid Drug and Withdraw all immunosuppresants
- Type of treatment
- Pill or oral medicine
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2023to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with myasthenia gravis who can completed long-term follow-up at PUMCH.
Who may be able to join
- 1: Attended the outpatient department of neurology of PUMCH from 9/30/2022 to 9/30/2024.
- 2: Diagnosed as myasthenia gravis.
- 3: Follow-up time at PUMCH>6 months.
- 4: The patient understood and signed the informed consent form.
Who cannot join
- 1: Comorbidities with other conditions that cause skeletal muscle weakness make the clinical symptoms difficult to assess
- 2: Records related to comorbidities and medications were not available at baseline and during follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Bin Peng, 8610-69155817, pumchkyc@163.com
About this study
Official title: Clinical Characteristics, Prognosis and Biomarkers of Myasthenia Gravis: a Prospective Cohort Study in China
The goal of this prospective cohort study is to investigate long-term therapeutic strategies for myasthenia gravis (MG) and identify potential biomarkers. The main questions it aims to answer are:
- Whether low-dose oral steroids may lead to a reduction in the recurrence rate among patients with MG.
- To identify potential biomarkers that can predict disease progression and prognosis.
This study recruits well-controlled patients with MG. Based on patient preferences and considerations such as coexisting conditions (e.g., uncontrolled hypertension, diabetes, severe osteoporosis, obesity), the participants will be non-randomly divided into two groups: a maintenance steroid therapy group and a withdrawal group (withdraw all immunosuppresants). Subsequently, these groups of patients will undergo long-term follow-up assessments.
- Conditions
- Myasthenia Gravis
- Being tested
- Steroid Drug, Withdraw all immunosuppresants
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid DrugDrug
Maintaining low-dose oral steroids
Withdraw all immunosuppresantsOther
Withdraw all immunosuppresants
| Study group | Role | What they receive |
|---|---|---|
| maintenance steroid therapy group | Maintaining low-dose oral steroids Receives: Drug: Steroid Drug | |
| immunosuppresants withdrawal group | Withdraw all immunosuppresants Receives: Other: Withdraw all immunosuppresants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse of myasthenia gravis
One of the following three is met: (1) MGFA Postintervention Status: failure to maintain MMS (minimal manifestations status) or better. (2) Myasthenia gravis activities of daily living (MG-ADL) score ≥ 3; (3) Re-administration of cholinesterase inhibitors was required after achieving Complete Stable Remission (CSR) on the MGFA Postintervention Status.
Measured: Within two years after recruitment
Secondary outcomes (3)
Time of relapse
The time between recruitment and relapse of MG.
Measured: Within two years after recruitment
Change of MG assessment scales at relapse
Change of MG assessment scales at relapse, including MGFA PIS (Postintervention Status), MG-ADL (myasthenia gravis activities of daily living), QMG (Quantitative Myasthenia gravis) and MGC (Myasthenia gravis composite).
Measured: Within two years after recruitment
Adverse events of steroids
Using CTCAE (Common Terminology Criteria for Adverse Events) to assess Adverse events.
Measured: Within two years after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start20 Aug 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (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 Peking Union Medical College 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
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuzhou Guan, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006832
- Sponsor's protocol ID
- K2009
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics, Prognosis and Biomarkers of Myasthenia Gravis: a Prospective Cohort Study in China
- ClinicalTrials.gov ID
- NCT06006832
- Acronym / sponsor ID
- K2009
- Conditions
- Myasthenia Gravis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 23 Aug 2023 (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 goal of this prospective cohort study is to investigate long-term therapeutic strategies for myasthenia gravis (MG) and identify potential biomarkers. The main questions it aims to answer are:
- Whether low-dose oral steroids may lead to a reduction in the recurrence rate among patients with MG.
- To identify potential biomarkers that can predict disease progression and prognosis.
This study recruits well-controlled patients with MG. Based on patient preferences and considerations such as coexisting conditions (e.g., uncontrolled hypertension, diabetes, severe osteoporosis, obesity), the participants will be non-randomly divided into two groups: a maintenance steroid therapy group and a withdrawal group (withdraw all immunosuppresants). Subsequently, these groups of patients will undergo long-term follow-up assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| maintenance steroid therapy group | – | Drug: Steroid DrugMaintaining low-dose oral steroids |
| immunosuppresants withdrawal group | – | Other: Withdraw all immunosuppresantsWithdraw all immunosuppresants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with myasthenia gravis who can completed long-term follow-up at PUMCH.
Key inclusion criteria (4 listed)
- 1: Attended the outpatient department of neurology of PUMCH from 9/30/2022 to 9/30/2024.
- 2: Diagnosed as myasthenia gravis.
- 3: Follow-up time at PUMCH>6 months.
- 4: The patient understood and signed the informed consent form.
Key exclusion criteria (2 listed)
- 1: Comorbidities with other conditions that cause skeletal muscle weakness make the clinical symptoms difficult to assess
- 2: Records related to comorbidities and medications were not available at baseline and during 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 |
|---|---|---|
| Steroid DrugMaintaining low-dose oral steroids | Drug | maintenance steroid therapy group |
| Withdraw all immunosuppresantsWithdraw all immunosuppresants | Other | immunosuppresants withdrawal group |
Primary outcome
Relapse of myasthenia gravis
Time frame: Within two years after recruitment
One of the following three is met: (1) MGFA Postintervention Status: failure to maintain MMS (minimal manifestations status) or better. (2) Myasthenia gravis activities of daily living (MG-ADL) score ≥ 3; (3) Re-administration of cholinesterase inhibitors was required after achieving Complete Stable Remission (CSR) on the MGFA Postintervention Status.
3 secondary outcomes
Time of relapse
Time frame: Within two years after recruitment
Change of MG assessment scales at relapse
Time frame: Within two years after recruitment
Adverse events of steroids
Time frame: Within two years after recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yuzhou Guan principal investigator
Peking Union Medical College Hospital
1 site 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 Peking Union Medical College Hospital at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuzhou Guan (8610-69155817, guanyz001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse of myasthenia gravis (time frame: Within two years after recruitment). 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 12 Jan 2024.