neuromyelitis optica spectrum disorders
Conditions
Interventions
trial group:protein a immunoadsorption add on IVMP
Control group:intravenous methylprednisolone, IVMP
Sponsors
The Third Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years (inclusive), irrespective of gender; 2. Fulfill the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorders (NMOSD) with acute exacerbation, presenting with worsening neurological/visual impairment persisting >24 hours, and >=1 month interval from the last clinical relapse; 3. =1.0-point increase (if baseline EDSS =0.5-point increase (if baseline EDSS >=5.5) compared to pre-relapse scores, and requiring hospitalization per clinical evaluation; 4. Serum aquaporin-4 immunoglobulin G (AQP4-IgG) seropositivity confirmed via cell-based assay (CBA); 5. =1g methylprednisolone equivalent/day for >=3 days) administered within 30 days preceding enrollment; 6. Willingness of participant/legal representative to permit adjunctive B-cell depleting monoclonal antibody therapy for relapse prophylaxis, initiated >=1 month post-treatment commencement per clinical indication; 7. Demonstrated comprehension of study objectives, protocol adherence capacity, and provision of written informed consent by participant/legal representative.
Exclusion criteria
Exclusion criteria: 1. Radiological (absence of new or enhancing lesions on MRI) and clinical assessments do not support a relapse diagnosis. 2. Body weight <40 kg. 3. Lactating women or pregnant individuals. 4. Inability to establish peripheral/central vascular access or history of hypersensitivity to plasma separators. 5. Contraindications to intravenous methylprednisolone therapy. 6. Total IgG level <=6 g/L at screening. 7. Use of monoclonal antibody therapies (including B-cell-depleting agents, complement inhibitors, or IL-6 inhibitors) within 6 months prior to screening, or FcRn antagonist therapy within 3 months. 8. High-dose intravenous immunoglobulin (IVIG) therapy, immunoadsorption, or plasmapheresis within 1 month before screening. 9. Requirement for ongoing ACE inhibitor therapy that cannot be discontinued during the treatment period or within 1 week prior to treatment initiation. 10. Severe bleeding tendency (platelet count <75×10^9/L). 11. Severe cardiac dysfunction (New York Heart Association [NYHA] class IV), unstable myocardial infarction, ischemic stroke, intracranial hemorrhage, or severe cerebral edema with herniation. 12. Active severe infections; seropositivity for hepatitis C, HIV, or syphilis; active hepatitis B infection; systemic fever with confirmed bacterial infection and leukocytosis. 13. Participation in other drug/medical device clinical trials within 1 month prior to screening (excluding observational studies). 14. Any condition deemed inappropriate for study participation by the investigator, including critical illness requiring or anticipated to require assisted ventilation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EDSS scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood routine examination indicators;The difference of visual field results ( VFI, MD ) between the optic neuritis involved patients from the baseline to 3 months follow up was compared;The difference in the significant improvement rate of FS score of pyramidal function of the myelitis involved patients from baseline between the end of IAtherapy , 1 month and 3 months was compared.;Coagulation function test indicators;The difference in the significant improvement rate of FS score of pyramidal function of the optic neuritis involved patients from baseline between the end of IAtherapy , 1 month and 3 months was compa;The difference of AQP4-IgG titer between the end of IA trerapy and baseline was compared;EDSS score difference between end of IA therapy (or 3m ) and baseline;vital sign;The difference of IgG or IgA or IgM between the end of IA trerapy and baseline was compared;Limb sensory function score or intestinal bladder function score difference ( if there are related symptoms ) between baseline, at the end of IA trerapy, 1 month and 3 months follow up;HAI or ADL score difference changed from baseline between the end of IA trerapy, 1 month and 3 months was compared; | — |
Countries
China
Contacts
Public ContactQiu Wei
The Third Affiliated Hospital Sun Yat-sen University
Outcome results
None listed