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

NCT07762872 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-08-13

No results posted yet for this study

Summary

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.

Conditions

  • Neuromyelitis Optica Spectrum Disorders (NMOSD)

Interventions

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.

Sponsors & Collaborators

  • The First Hospital of Hebei Medical University

    collaborator OTHER

  • The Second Hospital of Hebei Medical University

    collaborator OTHER

  • First Affiliated Hospital of Harbin Medical University

    collaborator OTHER

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Chifeng Municipal Hospital

    collaborator OTHER

  • Junwei Hao, MD

    lead OTHER

Principal Investigators

  • Junwei Hao, MD, PhD · Xuanwu Hospital Department of Neurology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2027-07-20
Completion
2028-01-20
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07762872 on ClinicalTrials.gov