NCT06829524尚未招募不适用
A Real-World Practical Model of Integrated Management for Chinese Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) on Satralizumab
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of patients relapse-free at 12 months of treatment with satralizumab
研究概览
简要总结
This study is a single-center, retrospective-prospective, non-interventional cohort study to assess the clinical outcomes of Chinese NMOSD patients treated with satralizumab in a real-world patient management model by collecting follow-up data in clinical practice.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have been diagnosed with NMOSD and tested seropositive for AQP4 antibody, ≥ 12 years old;
- •EDSS score ≤ 8.5 at baseline;
- •Patients have experienced ≥ 1 relapse of NMOSD in the last 12 months or ≥ 2 relapses in the last 24 months;
- •Patients should have received or be anticipated to receive satralizumab treatment for at least 12 months;
- •Patients understand the study procedures and sign the informed consent form indicating willingness to participate in the study (for those < 18 years of age, the guardian should sign the informed consent form on behalf of the patient).
排除标准
- 未提供
研究组 & 干预措施
Satralizumab treatment group
干预措施: Satralizumab (Drug)
结局指标
主要结局
Proportion of patients relapse-free at 12 months of treatment with satralizumab
时间窗: 12 months
Change from baseline in EDSS score at 12 months of treatment with satralizumab
时间窗: 12 months
次要结局
- Proportion of patients relapse-free at 6 months of treatment with satralizumab(6 months)
- Change from baseline in EDSS score at 6 months of treatment with satralizumab(6 months)
- Change patterns from baseline in clinical outcome assessments (COAs) at Months 1, 3, 6, and 12 during satralizumab treatment(1, 3, 6, 12 months)
- Incidence of AEs and SAEs during satralizumab treatment(1, 2, 3, 6, 9, 12 months)
研究者
Chao Quan
Professor, Chief Physician
Huashan Hospital
研究点 (1)
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