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Completed

NCT Number: NCT06888622

BLAZE-Limiting Approach in NMOSD

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.

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Key information

Conditions

Neuromyelitis Optica Spectrum Disorders (NMOSD) Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Eculizumab administration

Drug

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

Primary outcomes

  1. The change in disability status measured by the MRC scale score

    Time frame: 0, 1, 2, 3, 4, 8 weeks

    Measured by the MRC scale score for patients with LETM

  2. The change in disability status

    Time frame: 0, 1, 2, 3, 4, 8 weeks

    Measured by the best corrected visual acuity (BCVA)

Secondary outcomes

  1. Incidence of AEs and SAEs during eculizumab treatment

    Time frame: 1, 2, 3, 4, 8 weeks

    dverse events were coded using MedDRA version 27.1. Adverse events were analyzed in the safety analysis population (all patients who received at least one dose of study treatment) in terms of percentage incidence and as rates by exposure time (number of events per 100 patient-years of exposure and the associated 95% CI) to adjust for any differences in duration of exposure. The severity of adverse events was measured by NCI CTCAE version 5.0.

  2. The Change in Expanded Disability Status Scale (EDSS) scores

    Time frame: 0, 1, 2, 3, 4, 8 weeks

    Measured by Expanded Disability Status Scale (EDSS) scores for the entire cohort.

  3. The Change in Opticospinal Impairment Scale (OSIS) scores

    Time frame: 0, 1, 2, 3, 4, 8 weeks

    Measured by Opticospinal Impairment Scale (OSIS) for the entire cohort.

  4. The change in Visual Functional System Score (VFSS)

    Time frame: 0, 1, 2, 3, 4, 8 weeks

    Measured by Visual Functional System Score (VFSS) for patients with ON.

Other outcomes

  1. The changes of serological biomarkers (sGFAP and sNfL)

    Time frame: 0, 2, 4, 8 weeks

    Serum GFAP and NfL concentrations were analyzed in duplicates using SIMOA.

  2. The changes of OCT measurements (pRNFL and mGCIPL).

    Time frame: 0, 1, 2, 3, 4, 8 weeks

    The peripapillary retinal nerve fiber layer (pRNFL) and macular ganglion cell-inner plexiform layer (mGCIPL) was analyzed by optical coherence tomography (OCT) measurements

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

Eculizumab for Blaze-limiting Approach in NMOSD: A Prospective Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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