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RECRUITING
NCT07410039
PHASE4

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

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

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.

Official title: Eculizumab Add-On Therapy in the Acute Phase of Neuromyelitis Optica Spectrum Disorder: A Multicenter Prospective Real-World Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-02-01

Completion Date

2029-06-30

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DRUG

Eculizumab+IVMP

(PETA-NMOSD Study): After the completion of intravenous methylprednisolone (IVMP), according to domestic treatment guidelines, it is necessary to continue immunosuppressive therapy and maintain it to prevent and reduce relapses. The specific treatment regimen is divided into four groups based on the patient's treatment preference.Eculizumab continuation treatment group,B-cell depletion treatment group,Mycophenolate mofetil group,Satellitezhuibao Treatment Group。

DRUG

IVIG+IVMP

Patients who met the inclusion and exclusion criteria were divided into three groups for their acute-phase treatment based on their treatment preferences: 1. Eculizumab plus treatment group: Eculizumab + IVMP (intravenous methylprednisolone pulse therapy) 2. Human immunoglobulin addition treatment group: IVIG + IVMP 3. Single IVMP treatment group: IVMP After completing the acute-phase treatment, patients who met the inclusion and exclusion criteria entered the conversion treatment study (PETA-NMOSD) according to their treatment preferences, and were also divided into three groups: 1. B-cell depletion treatment group: Rituximab/Inalezumab + oral hormone sequential tapering 2. Methylprednisolone group: MMF + oral hormone sequential reduction and maintenance at a low dose 3. Eculizumab continuation treatment group: Eculizumab + oral hormone sequential tapering

DRUG

IVMP

Single hormone shock therapy group: 1) Initiate hormone shock therapy during the acute phase of the attack (≤ 21 days); 2) Intravenous injection of methylprednisolone (IVMP) for 14 days: 1000 mg/day (5 days), 500 mg (3 days), 240 mg (3 days), 120 mg (3 days), then switch to oral administration.

Locations (1)

the First Medical Center of Chinese PLA General Hospital

Beijing, China