This study is a single-center, retrospective-prospective, non-interventional cohort study to assess the clinical outcomes of Chinese NMOSD patients treated with satralizumab in a real-world patient management model by collecting follow-up data in clinical practice.
Study Type
OBSERVATIONAL
Enrollment
100
Satralizumab is the first monoclonal antibody approved for the treatment of NMOSD in China. Currently, there is still a lack of standard patient management pattern for NMOSD. While satralizumab offers the advantage of home administration, there remains a pressing need for optimized patient management.
Huashan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGProportion of patients relapse-free at 12 months of treatment with satralizumab
Time frame: 12 months
Change from baseline in EDSS score at 12 months of treatment with satralizumab
Time frame: 12 months
Proportion of patients relapse-free at 6 months of treatment with satralizumab
Time frame: 6 months
Change from baseline in EDSS score at 6 months of treatment with satralizumab
Time frame: 6 months
Change patterns from baseline in clinical outcome assessments (COAs) at Months 1, 3, 6, and 12 during satralizumab treatment
Time frame: 1, 3, 6, 12 months
Incidence of AEs and SAEs during satralizumab treatment
Adverse events were coded using MedDRA version 27.1. Adverse events were analyzed in the safety analysis population (all patients who received at least one dose of study treatment) in terms of percentage incidence and as rates by exposure time (number of events per 100 patient-years of exposure and the associated 95% CI) to adjust for any differences in duration of exposure. The severity of adverse events was measured by NCI CTCAE version 5.0.
Time frame: 1, 2, 3, 6, 9, 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.