eligibility_summary
Eligible: Adults (≥18) with anti‑AQP4‑IgG+ NMOSD per 2015 IPND in acute relapse (new/worsening neuro symptoms within 30 days, ≥24 h, not due to fever), planning/receiving IV methylprednisolone, EDSS 2.5–8, consent, WOCBP use contraception. Exclude: pregnant/lactating, recent interventional study, severe mental illness, malignancy, PLEX/IA/IVIG in past month, HBV carriers or HBcAb+, active/untreated TB, other investigator concerns.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Prospective, multicenter real‑world observational study in acute AQP4-IgG+ NMOSD comparing IV methylprednisolone (IVMP) plus inebilizumab vs IVMP plus oral immunosuppressants (azathioprine or mycophenolate mofetil). Interventions and mechanisms: • Inebilizumab (monoclonal antibody, anti-CD19, IV): depletes CD19+ B-lineage cells (naive/memory B cells, plasmablasts, some plasma cells) via cytotoxic mechanisms, lowering AQP4-IgG and B-cell antigen presentation/cytokines. • IV methylprednisolone (glucocorticoid): broad anti-inflammatory effects via glucocorticoid receptor, NF-κB/AP-1 suppression, reduced cytokines/edema. • Azathioprine (antimetabolite): purine synthesis blockade, inhibits proliferating T/B cells. • Mycophenolate mofetil (antimetabolite): IMPDH inhibition, suppresses guanosine synthesis in activated T/B cells. Targets: CD19+ B cells/plasmablasts, autoantibody (AQP4-IgG) production, T/B-cell proliferation, inflammatory pathways.