Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MR-31-22-008563; ChiCTR2000030 | Other Identifier | Chinese Clinical Trial Registry |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eculizumab treatment group | Eculizumab was administered intravenously at a dosage of 900 mg weekly for four consecutive weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eculizumab administration | Drug | Eculizumab was administered intravenously at a dosage of 900 mg weekly for four consecutive weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in disability status measured by the MRC scale score | Measured by the MRC scale score for patients with LETM | 0, 1, 2, 3, 4, 8 weeks |
| The change in disability status | Measured by the best corrected visual acuity (BCVA) | 0, 1, 2, 3, 4, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of serological biomarkers (sGFAP and sNfL) | Serum GFAP and NfL concentrations were analyzed in duplicates using SIMOA. | 0, 2, 4, 8 weeks |
| The changes of OCT measurements (pRNFL and mGCIPL). |
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:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chao Quan, Doctor | Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Shanghai | Shanghai Municipality | 200040 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | 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
| 0, 1, 2, 3, 4, 8 weeks |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |