Clinical Characteristics, Prognosis and Biomarkers of Myasthenia Gravis: a Prospective Cohort Study in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Relapse of myasthenia gravis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1: Attended the outpatient department of neurology of PUMCH from 9/30/2022 to 9/30/
- •2: Diagnosed as myasthenia gravis.
- •3: Follow-up time at PUMCH>6 months.
- •4: The patient understood and signed the informed consent form.
排除标准
- •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.
研究组 & 干预措施
maintenance steroid therapy group
Maintaining low-dose oral steroids
干预措施: Steroid Drug (Drug)
immunosuppresants withdrawal group
Withdraw all immunosuppresants
干预措施: Withdraw all immunosuppresants (Other)
结局指标
主要结局
Relapse of myasthenia gravis
时间窗: 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.
次要结局
- Adverse events of steroids(Within two years after recruitment)
- Time of relapse(Within two years after recruitment)
- Change of MG assessment scales at relapse(Within two years after recruitment)