Neuromyelitis Optica Spectrum Disorders (NMOSD)
Conditions
Brief summary
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.
Interventions
DRUGSatralizumab
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.
Sponsors
Huashan Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients have been diagnosed with NMOSD and tested seropositive for AQP4 antibody, ≥ 12 years old; 2. EDSS score ≤ 8.5 at baseline; 3. Patients have experienced ≥ 1 relapse of NMOSD in the last 12 months or ≥ 2 relapses in the last 24 months; 4. Patients should have received or be anticipated to receive satralizumab treatment for at least 12 months; 5. Patients understand the study procedures and sign the informed consent form indicating willingness to participate in the study (for those \< 18 years of age, the guardian should sign the informed consent form on behalf of the patient).
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients relapse-free at 12 months of treatment with satralizumab | 12 months |
| Change from baseline in EDSS score at 12 months of treatment with satralizumab | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients relapse-free at 6 months of treatment with satralizumab | 6 months | — |
| Change from baseline in EDSS score at 6 months of treatment with satralizumab | 6 months | — |
| Change patterns from baseline in clinical outcome assessments (COAs) at Months 1, 3, 6, and 12 during satralizumab treatment | 1, 3, 6, 12 months | — |
| Incidence of AEs and SAEs during satralizumab treatment | 1, 2, 3, 6, 9, 12 months | 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. |
Countries
China
Contacts
Primary ContactChao Quan, Doctor
Backup ContactWenjuan Huang, Doctor
Outcome results
None listed