Neuromyelitis Optica Spectrum Disorder
Conditions
Interventions
Inebilizumab treatment group:Inebilizumab treatment (intravenous infusion of 300 mg on day 1, repeated intravenous infusion of 300 mg on day 15
subsequent intravenous infusion of 300 mg every 6 months starting from the first administration).
Mycophenolate mofetil treatment group:Oral administration of mycophenolate mofetil 0.5 g in the morning and evening.
Sponsors
Affiliated Provincial Hospital of Shandong First Medical University (Shandong Provincial Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily sign the informed consent form. 2. Aged >=18 years, regardless of gender. 3. Patients diagnosed with NMOSD, based on the *Chinese Guidelines for the Diagnosis and Treatment of Neuromyelitis Optica Spectrum Disorders (2021 Edition)*, with the basic criteria of "medical history + core clinical symptoms + imaging features + biomarkers", stratified by AQP4-IgG, and diagnosed with reference to other subclinical and immunological evidence. Other diseases must also be excluded. The NMOSD diagnostic criteria (IPND, 2015) are adopted. 4. NMOSD in the acute phase, defined as new-onset neurological deficit symptoms or exacerbation of pre-existing symptoms within 30 days before screening, with symptoms lasting at least 24 hours and clinically determined as relapse, and no fever for at least 24 hours before screening. 5. NMOSD relapse (including acute episodes during screening): =1 relapse occurred within 12 months before screening. 6. EDSS score of 2.0 <= EDSS <= 8.0.
Exclusion criteria
Exclusion criteria: 1. Planning to become pregnant, breastfeeding, or in pregnancy/lactation period; 2. Patients with severe coagulation dysfunction or hypogammaglobulinemia; 3. Patients with acute or chronic infections requiring treatment, tuberculosis, or active hepatitis; 4. Patients with concomitant malignant tumors, severe complications, or severe hepatic/renal dysfunction; 5. Determined by clinicians as inappropriate for application.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Expanded Disability Status Scale, EDSS;modified Rankin Scale, mRS;B lymphocyte subsets; Imaging indices; Antibody titer; Biomarkers; | — |
Countries
China
Contacts
Public ContactShougang Guo
Provincial Hospital of Shandong First Medical University (Shandong Provincial Hospital)
Outcome results
None listed