A Multicenter, Prospective Cohort Study in Patients With Myasthenia Gravis in China
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 1,199
- 试验地点
- 21
- 主要终点
- Treatment method
研究概览
简要总结
This study is a multi-center, prospective cohort study designed to characterize current clinical practice, clinical and patient-reported outcomes (PROs), disease prognosis, treatment patterns and healthcare resource utilization for Chinese patients with myasthenia gravis (MG). This study will enroll patients with MG as diagnosed by physician. Approximately 1,200 MG patients are intended to be recruited from approximately 40 sites across majority of regions in China. The clinical and PROs included MGFA class, MGFA PIS, MG-ADL (Activities of Daily Living), QMG (Quantitative MG score), MG QOL-15R, EQ-5D etc. All MG patients enrolled will be followed up every 6 months until end of 2027.
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
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study will enroll patients of all ages who are diagnosed with MG of all MGFA classifications by physicians.
- •Patients must have the following data to be enrolled in this study:
- •MGFA classification
- •MG-ADL score
- •MG patients or their legal guardians/representatives are able to sign the Informed Consent Form (ICF).
排除标准
- •Patients aged ≥18 years with ocular myasthenia gravis (MGFA class I) lasting for more than 2 years;
- •Patients who are currently participating in an interventional clinical trial cannot be enrolled in this study.
结局指标
主要结局
Treatment method
时间窗: Every 6 months up to 3 years
Targeted treatment methods (list of methods, including medication, immunoglobulin, plasma exchange, surgery etc. )
Treatment duration
时间窗: Every 6 months up to 3 years
Therapies start and end date
Treatment dose
时间窗: Every 6 months up to 3 years
Dose (e.g. mg)
Treatment frequency
时间窗: Every 6 months up to 3 years
Frequency (e.g. times/day)
Clinical outcome
时间窗: Every 6 months up to 3 years
MGFA classification (e.g I, II, III, IV, V)
Patient-reported outcome
时间窗: Every 6 months up to 3 years
MG-Activities of Daily Living (MG-ADL, aggregated value in a scale, ranged 0- best to 24- worst)
次要结局
- Laboratory test - blood cell test(Every 6 months up to 3 years)
- Demographic factors(Baseline)
- Cormobidity(Every 6 months up to 3 years)
- MG diagnosis history(Every 6 months up to 3 years)
- Vital sign - blood pressure(Every 6 months up to 3 years)
- Laboratory tests etc.) - MG-related antibodies(Every 6 months up to 3 years)
- Vital sign - pulse(Every 6 months up to 3 years)
- Healthcare resource utilization(Every 6 months up to 3 years)