A Prospective Cohort Study of Myasthenia Gravis in China
Study Details
Study Description
Brief 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:
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Whether low-dose oral steroids may lead to a reduction in the recurrence rate among patients with MG.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| maintenance steroid therapy group Maintaining low-dose oral steroids |
Drug: Steroid Drug
Maintaining low-dose oral steroids
|
| immunosuppresants withdrawal group Withdraw all immunosuppresants |
Other: Withdraw all immunosuppresants
Withdraw all immunosuppresants
|
Outcome Measures
Primary Outcome Measures
- Relapse of myasthenia gravis [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.
Secondary Outcome Measures
- Time of relapse [Within two years after recruitment]
The time between recruitment and relapse of MG.
- Change of MG assessment scales at relapse [Within two years after recruitment]
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).
- Adverse events of steroids [Within two years after recruitment]
Using CTCAE (Common Terminology Criteria for Adverse Events) to assess Adverse events.
Eligibility Criteria
Criteria
Inclusion Criteria:
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1: Attended the outpatient department of neurology of PUMCH from 9/30/2022 to 9/30/2024.
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2: Diagnosed as myasthenia gravis.
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3: Follow-up time at PUMCH>6 months.
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4: The patient understood and signed the informed consent form.
Exclusion Criteria:
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1: Comorbidities with other conditions that cause skeletal muscle weakness make the clinical symptoms difficult to assess
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2: Records related to comorbidities and medications were not available at baseline and during follow-up.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Yuzhou Guan, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K2009