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

August 12, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zheng Liu, MD, PhD
  • Phone Number: +86 13754093891
  • Email: lzwcy@xwhosp.org

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100053
        • Recruiting
        • Xuanwu Hospital Capital Medical University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Xixi Yang, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Satralizumab Treatment Group
NMOSD patients receiving Satralizumab at early phase of an NMOSD attack
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EDSS
Time Frame: 24 weeks
Change in EDSS score between at baseline and at 6 months of treatment
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EDSS
Time Frame: 12 weeks
Change in EDSS score between at baseline and at 3 months of treatment
12 weeks
mRS
Time Frame: 12 weeks
Changes in mRS between at baseline and at 3 months of treatment
12 weeks
EQ-5D
Time Frame: 12 weeks
Changes in EQ-5D between at baseline and at 3 months of treatment
12 weeks
ADL score
Time Frame: 12 weeks
Changes in ADL score between at baseline and at 3 months of treatment
12 weeks
mRS
Time Frame: 24 weeks
Changes in mRS between at baseline and at 6 months of treatment
24 weeks
EQ-5D
Time Frame: 24 weeks
Changes in EQ-5D between at baseline and at 6 months of treatment
24 weeks
ADL score
Time Frame: 24 weeks
Changes in ADL score between at baseline and at 6 months of treatment
24 weeks
relapse
Time Frame: 24 weeks
Relapse events occurring within 6 months of treatment
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Junwei Hao, MD

Collaborators

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

Investigators

  • Principal Investigator: Junwei Hao, MD, PhD, Xuanwu Hospital Department of Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2026

Primary Completion (Estimated)

July 20, 2027

Study Completion (Estimated)

January 20, 2028

Study Registration Dates

First Submitted

August 7, 2026

First Submitted That Met QC Criteria

August 12, 2026

First Posted (Actual)

August 13, 2026

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 12, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xw-[2025]291-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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