An observational study in Neuromyelitis Optica Spectrum Disorders (NMOSD), sponsored by Huashan Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Huashan Hospital · Observational
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.
162 studies on the registry are indexed under Neuromyelitis Optica; 72 are open to participants now.
This study's enrollment of 9 is below the median of 200 across 57 observational studies indexed under Neuromyelitis Optica.
Browse Neuromyelitis Optica studies →Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.
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This is an observational cohort study based on data from the prospectively followed NMOSD cohort of the hospital-based registry (The Chinese Medical Research Registration Number MR-31-22-008563; ChiCTR2000030651). Between October 2023 (when eculizumab was approved for NMOSD in China) and February 2025 consecutive patients with AQP4-IgG-positive NMOSD received eculizumab were enrolled.
(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:
Eculizumab was administered intravenously at a dosage of 900 mg weekly for four consecutive weeks
Drug: Eculizumab administration
Eculizumab was administered intravenously at a dosage of 900 mg weekly for four consecutive weeks
The change in disability status measured by the MRC scale score
Measured by the MRC scale score for patients with LETM
Time frame: 0, 1, 2, 3, 4, 8 weeks
The change in disability status
Measured by the best corrected visual acuity (BCVA)
Time frame: 0, 1, 2, 3, 4, 8 weeks
Incidence of AEs and SAEs during eculizumab treatment
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.
Time frame: 1, 2, 3, 4, 8 weeks
The Change in Expanded Disability Status Scale (EDSS) scores
Measured by Expanded Disability Status Scale (EDSS) scores for the entire cohort.
Time frame: 0, 1, 2, 3, 4, 8 weeks
The Change in Opticospinal Impairment Scale (OSIS) scores
Measured by Opticospinal Impairment Scale (OSIS) for the entire cohort.
Time frame: 0, 1, 2, 3, 4, 8 weeks
The change in Visual Functional System Score (VFSS)
Measured by Visual Functional System Score (VFSS) for patients with ON.
Time frame: 0, 1, 2, 3, 4, 8 weeks
The changes of serological biomarkers (sGFAP and sNfL)
Serum GFAP and NfL concentrations were analyzed in duplicates using SIMOA.
Time frame: 0, 2, 4, 8 weeks
The changes of OCT measurements (pRNFL and mGCIPL).
The peripapillary retinal nerve fiber layer (pRNFL) and macular ganglion cell-inner plexiform layer (mGCIPL) was analyzed by optical coherence tomography (OCT) measurements
Time frame: 0, 1, 2, 3, 4, 8 weeks
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Huashan Hospital