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NCT Number: NCT07762872

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Satralizumab

Drug

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.

Primary outcomes

  1. EDSS

    Time frame: 24 weeks

    Change in EDSS score between at baseline and at 6 months of treatment

Secondary outcomes

  1. EDSS

    Time frame: 12 weeks

    Change in EDSS score between at baseline and at 3 months of treatment

  2. mRS

    Time frame: 12 weeks

    Changes in mRS between at baseline and at 3 months of treatment

  3. EQ-5D

    Time frame: 12 weeks

    Changes in EQ-5D between at baseline and at 3 months of treatment

  4. ADL score

    Time frame: 12 weeks

    Changes in ADL score between at baseline and at 3 months of treatment

  5. mRS

    Time frame: 24 weeks

    Changes in mRS between at baseline and at 6 months of treatment

  6. EQ-5D

    Time frame: 24 weeks

    Changes in EQ-5D between at baseline and at 6 months of treatment

  7. ADL score

    Time frame: 24 weeks

    Changes in ADL score between at baseline and at 6 months of treatment

  8. relapse

    Time frame: 24 weeks

    Relapse events occurring within 6 months of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Xixi Yang, MD, PhD

CONTACT

[email protected]

+86 15601179281

Zheng Liu, MD, PhD

CONTACT

[email protected]

+86 13754093891

Sponsors and collaborators

Lead sponsor

Junwei Hao, MD

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SATURN

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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