Aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder
Conditions
Interventions
Satralizumab treatment group:None
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients have been diagnosed with NMOSD and tested seropositive for AQP4 antibody, >= 12 years old. 2.EDSS score = 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
Exclusion criteria: 1.Patients with contraindications for the use of satrelizumab include: known allergy to satrelizumab or any non-active ingredient, active hepatitis B infection, and active or untreated latent tuberculosis. 2.Patients assessed by the investigator/researcher as being in a critical illness state or having any mental or cognitive disorder that may interfere with the study and are unable to complete the required key assessments of this protocol. 3.Patients assessed by the investigator/researcher as unlikely to participate in regular follow-up assessments during routine clinical care. 4.Patients who refuse to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients relapse-free at 12 months of treatment with satralizumab;Change from baseline in EDSS score at 12 months of treatment with satralizumab; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients relapse-free at 6 months of treatment with satralizumab;Change from baseline in EDSS score at 6 months of treatment with satralizumab;Change patterns from baseline in clinical outcome assessments (COAs) at Months 1, 3, 6, and 12 during satralizumab treatment;Incidence of AEs and SAEs during satralizumab treatment; | — |
Countries
China
Contacts
Public ContactChao Quan
Huashan Hospital, Fudan University
Outcome results
None listed