Clinical Study Cohort of Idiopathic Inflammatory Myositis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- High Resolution Computed Tomography of Chest
研究概览
简要总结
Idiopathic inflammatory myositis (IIM), also known as myositis, are a heterogeneous group of diseases characterized by chronic inflammation of striated muscles and skin, with different clinical manifestations, treatment responses, and prognosis. This project will build a clinical follow-up cohort for idiopathic inflammatory myositis (IIM) centered on Renji Hospital, Shanghai Jiao Tong University School of Medicine, to promote the clinical and pathogenesis of this group of diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet the following criteria for inclusion in this study: meet the 2017 EULAR/ACR classification criteria for inflammatory myopathy (IIM) or the 2018 ENMC-DM classification criteria (see above), plus:
- •Age≥ 18 years old and ≤ 75 years old
- •Meet the 2017 EULAR/ACR classification criteria for inflammatory myopathy (IIM), the above score ≥ 5.5 points if there is no muscle biopsy, and 6.7 points ≥ if there is muscle biopsy
- •Cooperate with follow-up, examination and treatment and voluntarily sign the informed consent form.
排除标准
- •Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria:
- •a. IIM with other connective tissue diseases; b. Negative myositis antibody test; c. Those who are in the period of acute infection, or have a history of active tuberculosis in the past; d. People with allergies or allergies to multiple drugs; e. Those who have mental illness or other reasons and cannot cooperate with examination, follow-up or treatment; f. Women who are pregnant, or are trying to become pregnant; g. Those who are participating in or have participated in clinical trials within the specified time.
结局指标
主要结局
High Resolution Computed Tomography of Chest
时间窗: three months
High Resolution Computed Tomography of Chest will be used to assess the incidence of interstitial pneumonia.
Cutaneous Disease Area and Severity Index
时间窗: three months
Cutaneous Disease Area and Severity Index will be used to assess the the severity of the rash.
Forced vital capacity
时间窗: three months
t refers to the maximum amount of air that cr trying to inhale as quickly as possible.
Manual Muscle Testing
时间窗: three months
Manual Muscle Testing will be used to assess patients with muscle weakness.
Forced expiratory volume in one second
时间窗: three months
It refers to the volume of the maximum exhalation exhaled in the first second of the maximum deep inhalation.
次要结局
- Serum creatine kinase(three months)