neuromyelitis optica spectrum disorders
Conditions
Interventions
Steroid rapid tapering group:After acute steroid pulse therapy, switch to oral prednisone 60mg once daily for tapering, reducing by 10mg per week. Discontinue prednisone two weeks after the second dos
Steroid slow tapering group:After the acute phase hormone shock, switch to oral prednisone 60mg once daily for tapering, decrease by 10mg every week until reaching 10mg once daily for maintenance for
Sponsors
West China Hospital,Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Diagnosed with NMOSD positive for AQP4 antibodies (meeting the 2015 International Neuromyelitis Optica Diagnostic Criteria): a. Presenting with at least one core clinical feature; b. Positive for serum AQP4 antibodies confirmed prior to screening (CBA method); c. Other diagnoses excluded. (2) Core clinical features: a. Optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome; b. Symptomatic drowsiness in the context of typical NMOSD involving hypothalamic lesions or acute hypothalamic syndrome; c. Encephalopathy in the context of typical NMOSD with cerebral lesions. (3) Experienced at least one clinical attack (including the initial attack) in the two months prior to screening. (5) Aged between 18 and 75 years. (6) Signed informed consent and agree to comply with the study protocol requirements.
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating women, or those planning to become pregnant during the study period. (2) Presence of severe infections, other severe systemic diseases, or malignancies. (3) Coinfection with active hepatitis B, hepatitis C, HIV, syphilis, active tuberculosis, or other infectious diseases. (4) Previous use of medications: Prior use of IL-6 inhibitors (such as tocilizumab, sarilumab, etc.); receipt of B-cell depleting agents within the preceding 6 months (excluding cases where B-cell levels have returned to normal); receipt of investigational drug therapy within the preceding 3 months at baseline. (5) Laboratory exclusion criteria: White blood cell count 1.5 times the upper limit of normal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients without recurrence.;ARR;Timed-25-foot walk test;12-Item Multiple Sclerosis Walking Scale;Nine-Hole Peg Test;Expanded Disability Status Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| serum AQP4-IgG;serum NfL and GFAP;B cell subsets and immunoglobulin levels; | — |
Countries
China
Contacts
Public ContactHongyu Zhou
West China Hospital,Sichuan University
Outcome results
None listed