Eculizumab for Blaze-limiting Approach in NMOSD: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- The change in disability status measured by the MRC scale score
研究概览
简要总结
This is an observational cohort study based on data from the hospital-based NMOSD registry (Chinese Medical Research Registration Number MR-31-22-008563; ChiCTR2000030651). Between October 2023 (when eculizumab was approved for NMOSD in China) and February 2025, 26 consecutive patients with AQP4-IgG-positive NMOSD received eculizumab, and 9 of them were included in this study.
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)Patients have been diagnosed with NMOSD and tested seropositive for AQP4 antibody; (2) Age ≥ 18 years; (3) Received eculizumab during an acute phase of NMOSD, defined as within 30 days of attack onset； (4) Adherence to an 8-week follow-up from eculizumab initiation.
排除标准
- •Patients with unresolved Neisseria meningitidis infection or severe infections that preclude the use of immunotherapy;
- •Patients with severe comorbidities (such as heart failure, respiratory failure, severe hepatic or renal dysfunction, etc.);
- •Patients with incomplete records of clinical symptoms and signs, as well as insufficient data on serum marker tests in their medical records.
研究组 & 干预措施
Eculizumab treatment group
Eculizumab was administered intravenously at a dosage of 900 mg weekly for four consecutive weeks
干预措施: Eculizumab administration (Drug)
结局指标
主要结局
The change in disability status measured by the MRC scale score
时间窗: 0, 1, 2, 3, 4, 8 weeks
Measured by the MRC scale score for patients with LETM
The change in disability status
时间窗: 0, 1, 2, 3, 4, 8 weeks
Measured by the best corrected visual acuity (BCVA)
次要结局
- The Change in Opticospinal Impairment Scale (OSIS) scores(0, 1, 2, 3, 4, 8 weeks)
- Incidence of AEs and SAEs during eculizumab treatment(1, 2, 3, 4, 8 weeks)
- The Change in Expanded Disability Status Scale (EDSS) scores(0, 1, 2, 3, 4, 8 weeks)
- The change in Visual Functional System Score (VFSS)(0, 1, 2, 3, 4, 8 weeks)
研究者
Chao Quan
Professor, Chief Physician
Huashan Hospital