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A Multicenter Prospective Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in NMOSD
Sponsor: Junwei Hao, MD
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.
Official title: Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in Neuromyelitis Optica Spectrum Disorder: A Multicenter Prospective Cohort Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2026-07-20
Completion Date
2028-01-20
Last Updated
2026-08-13
Healthy Volunteers
No
Interventions
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.
Locations (1)
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China