drugset / Trial / NCT07410039

Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study

NCT07410039

Phase 4 Recruiting 200 enrolled Chinese PLA General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This project is a multi-center, prospective, real-world cohort study that collects clinical data of Chinese patients with AQP4-positive NMOSD in the acute stage. It comprehensively assesses the clinical outcomes of the patients and aims to compare the clinical efficacy and safety of icoxib as a combined add-on treatment versus simple hormone shock therapy during the acute phase of NMOSD.Using simple hormone shock therapy (IVMP) as the control group, the efficacy and safety of etanercept treatment in the acute attack phase of Chinese patients with AQP4-positive neuromyelitis optica spectrum disorder (NMOSD) were evaluated.

Timeline

Start
2026-02-01
Primary completion
2027-06-30
Completion
2029-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Eculizumab Monoclonal antibody 900 mg Intravenous
Comparator Human immunoglobulin Protein / enzyme biologic 0.4 g/kg Intravenous
Comparator Methylprednisolone Other / unclassified 120 mg Intravenous