A Prospective Cohort Study of Myasthenia Gravis in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Steroid Drug, Withdraw all immunosuppresants.
- Who it may be relevant to
- Registry conditions: Myasthenia Gravis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Characteristics, Prognosis and Biomarkers of Myasthenia Gravis: a Prospective Cohort Study in China
Overview
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
- Drug Steroid Drug
Maintaining low-dose oral steroids - Other Withdraw all immunosuppresants
Withdraw all immunosuppresants
Primary outcome measures
- Relapse of myasthenia gravis [Time frame: Within two years after recruitment]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT06006832 · K2009