eligibility_summary
Eligible: adults (≥18) with AQP4-IgG+ NMOSD (2015 IPND), EDSS 2.5–8 in acute phase, consent. Exclude: pregnant/lactating, recent interventional study, recent B-cell depleter or low B cells, severe allergy to study drugs, active serious infection (incl. hepatitis/TB/positive TB screen) or recent hospitalization, substance abuse <1 yr, malignancy, severe mental illness or inability to follow-up.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Observational, multicenter real-world study comparing inebilizumab vs rituximab in anti–AQP4-IgG NMOSD. Interventions: IV methylprednisolone followed by either inebilizumab 300 mg IV Day 1 & 15 or rituximab 500 mg IV Day 1 & 15. Drug types and mechanisms: Inebilizumab is a humanized anti-CD19 monoclonal antibody that depletes B-lineage cells, notably late memory B cells, plasmablasts, and some plasma cells, reducing pathogenic antibody production. Rituximab is a chimeric anti-CD20 monoclonal antibody that depletes CD20+ B cells via ADCC/CDC and promotes an immunoregulatory T-cell phenotype with neutrophil/macrophage phagocytosis. Targets/pathways: B-cell depletion (CD19 vs CD20), reduction of plasmablast/plasma cell pools, and attenuation of humoral autoimmunity driving AQP4-IgG–mediated NMOSD.