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A Multicenter Prospective Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in NMOSD (SATURN)

2026年8月12日 更新者：Junwei Hao, MD

Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in Neuromyelitis Optica Spectrum Disorder: A Multicenter Prospective Cohort Study

This study is a multicenter, prospective cohort study designed to enroll 50 NMOSD patients who receive Satralizumab treatment during the early phase of an NMOSD attack. Follow-up visits will be conducted at baseline, 3 months, and 6 months to record and assess EDSS scores, modified Rankin Scale (mRS) scores, EQ-5D scores, Activities of Daily Living (ADL) scores, relapse events, safety data, and exploratory endpoints (e.g., blood inflammatory markers and visual function), with the aim of evaluating the efficacy and safety of Satralizumab in the early treatment of NMOSD-thereby providing patients with more effective therapeutic options and further optimizing the clinical management of NMOSD.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

50

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Zheng Liu, MD, PhD
  • 电话号码：+86 13754093891
  • 邮箱：lzwcy@xwhosp.org

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100053
        • 招聘中
        • Xuanwu Hospital Capital Medical University
        • 接触：
        • 接触：
        • 副研究员：
          • Xixi Yang, MD, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients with NMOSD (AQP4-IgG-positive) at early phase of an NMOSD attack, and age ≥ 18 years. The EDSS score ≤ 8.5 during an acute relapse in NMOSD.

描述

Inclusion Criteria:

  • Diagnosis of AQP4-IgG-positive NMOSD* and age ≥ 18 years; EDSS score ≤ 8.5 during an acute relapse in NMOSD patients; NMOSD patients experiencing an acute relapse who are scheduled to receive or are currently receiving recommended acute-phase treatments-including intravenous methylprednisolone, IVIG, PE, or PA; Receiving Satralizumab treatment; Patient understands the study procedures and has signed the informed consent form indicating willingness to participate in the study.

Exclusion Criteria:

  • Patients with NMOSD who received other biologics (e.g., rituximab, inebilizumab, tocilizumab, eculizumab) either within the past 6 months prior to this acute exacerbation or during the current acute phase; Patients with contraindications to Satralizumab, including: known allergy to Satralizumab or any inactive ingredient, active Hepatitis B infection, active or therapy-naive latent tuberculosis; Pregnant or lactating women; Patients with concomitant Neoplasm malignant or other severe diseases; Patients currently enrolled in other interventional clinical studies; Patients assessed by the investigator/research staff as having a Critical illness or any Mental disorder or Cognitive disorder that may interfere with the study and who are unable to complete the key assessments required by this protocol; patients assessed by the investigator/research staff as unlikely to attend scheduled follow-up assessments under routine clinical care.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Satralizumab Treatment Group
NMOSD patients receiving Satralizumab at early phase of an NMOSD attack
药品：Satralizumab
As recommended in the prescribing information, patients will receive subcutaneous satralizumab Injection as part of their routine treatment. The loading dose is 120 mg administered at Weeks 0, 2, and 4, followed by a maintenance dose of 120 mg every 4 weeks. Maintenance treatment is recommended for a minimum duration of 24 weeks.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
EDSS
大体时间：24 weeks
Change in EDSS score between at baseline and at 6 months of treatment
24 weeks

次要结果测量

结果测量
措施说明
大体时间
EDSS
大体时间：12 weeks
Change in EDSS score between at baseline and at 3 months of treatment
12 weeks
mRS
大体时间：12 weeks
Changes in mRS between at baseline and at 3 months of treatment
12 weeks
EQ-5D
大体时间：12 weeks
Changes in EQ-5D between at baseline and at 3 months of treatment
12 weeks
ADL score
大体时间：12 weeks
Changes in ADL score between at baseline and at 3 months of treatment
12 weeks
mRS
大体时间：24 weeks
Changes in mRS between at baseline and at 6 months of treatment
24 weeks
EQ-5D
大体时间：24 weeks
Changes in EQ-5D between at baseline and at 6 months of treatment
24 weeks
ADL score
大体时间：24 weeks
Changes in ADL score between at baseline and at 6 months of treatment
24 weeks
relapse
大体时间：24 weeks
Relapse events occurring within 6 months of treatment
24 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Junwei Hao, MD

合作者

The Second Hospital of Hebei Medical University
Shandong Provincial Hospital
The First Hospital of Hebei Medical University
First Affiliated Hospital of Harbin Medical University
Chifeng Municipal Hospital

调查人员

  • 首席研究员：Junwei Hao, MD, PhD、Xuanwu Hospital Department of Neurology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月20日

初级完成 (估计的)

2027年7月20日

研究完成 (估计的)

2028年1月20日

研究注册日期

首次提交

2026年8月7日

首先提交符合 QC 标准的

2026年8月12日

首次发布 (实际的)

2026年8月13日

研究记录更新

最后更新发布 (实际的)

2026年8月13日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • xw-[2025]291-001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Individual's age, gender, EDSS, mRS, ADL, EQ-5D, laboratory parameters and adverse event records, etc.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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