Myasthenia Gravis
Conditions
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: 1. Whether low-dose oral steroids may lead to a reduction in the recurrence rate among patients with MG. 2. 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.
Interventions
DRUGSteroid Drug
Maintaining low-dose oral steroids
OTHERWithdraw all immunosuppresants
Withdraw all immunosuppresants
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactYuzhou Guan
Outcome results
None listed