Satralizumab in the early treatment of NMOSD attacks: a multicenter real-world study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter prospective cohort will enroll about 50 adults with AQP4-IgG–positive NMOSD who are experiencing an acute attack and are receiving Satralizumab as part of their care. Participants will be followed at baseline, 3 months, and 6 months to capture measures such as EDSS, mRS, EQ-5D, activities of daily living, relapse events, and safety data, with exploratory assessments like inflammatory markers and visual function. The study aims to assess the real-world effectiveness and safety of initiating Satralizumab in the early phase of attacks to inform clinical management and options for NMOSD treatment. Treatment, timing, and concurrent acute-phase therapies will be documented to understand practical outcomes in routine care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Xuanwu Hospital Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Junwei Hao, MD, PhD — Xuanwu Hospital Department of Neurology
• Study coordinator: Xixi Yang, MD, PhD
• Email: xyang891@outlook.com
• Phone: +86 15601179281

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Modified Zipper Therapy for AQP4‑antibody–positive NMOSD acute attacks

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• Rituximab vs multiple approved NMOSD therapies to prevent relapses

  This study tests whether rituximab or one of four other approved medicines is better at preventing NMOSD relapses in adults who have AQP4-IgG.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.