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

NCT07410039 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-12

No results posted yet for this study

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.

Conditions

  • Neuromyelitis Optica Spectrum Disorder Attack

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.

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07410039 on ClinicalTrials.gov