BLAZE-Limiting Approach in NMOSD

Fudan University

Status: Completed

Conditions: Neuromyelitis Optica Spectrum Disorders (NMOSD)

Treatments: Drug: Eculizumab administration

Study type: Observational

Funder types: Other

Identifiers

NCT06888622

KY2025-062

MR-31-22-008563 ( ChiCTR2000030;Other Identifier)

Details and patient eligibility

About

This is an observational cohort study based on data from the hospital-based NMOSD registry (Chinese Medical Research Registration Number MR-31-22-008563; ChiCTR2000030651). Between October 2023 (when eculizumab was approved for NMOSD in China) and February 2025, 26 consecutive patients with AQP4-IgG-positive NMOSD received eculizumab, and 9 of them were included in this study.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

(1)Patients have been diagnosed with NMOSD and tested seropositive for AQP4 antibody; (2) Age ≥ 18 years; (3) Received eculizumab during an acute phase of NMOSD, defined as within 30 days of attack onset； (4) Adherence to an 8-week follow-up from eculizumab initiation.

Exclusion criteria

1. Patients with unresolved Neisseria meningitidis infection or severe infections that preclude the use of immunotherapy;
2. Patients with severe comorbidities (such as heart failure, respiratory failure, severe hepatic or renal dysfunction, etc.);
3. Patients with incomplete records of clinical symptoms and signs, as well as insufficient data on serum marker tests in their medical records.

Trial design

9 participants in 1 patient group

Eculizumab treatment group

Description:

Eculizumab was administered intravenously at a dosage of 900 mg weekly for four consecutive weeks

Treatment:

Drug: Eculizumab administration