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The primary objective of this registry study is to evaluate the therapeutic efficacy and safety profiles of distinct monoclonal antibody-based therapies for aquaporin-4 immunoglobulin G-seropositive neuromyelitis optica spectrum disorders within the Chinese population under real-world clinical conditions. Secondary objectives include quantitative assessment of longitudinal neuroimaging biomarker variations and immunological profile alterations in longitudinal biological specimens pre- and post-therapeutic intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inebilizumab treatment | AQP4-IgG positive NMOSD Patient who received Inebilizumab |
| |
| Satralizumab treatment | AQP4-IgG positive NMOSD Patient who received Satralizumab |
| |
| Eculizumab treatment | AQP4-IgG positive NMOSD Patient who received Eculizumab |
| |
| Ofatumumab treatment | AQP4-IgG positive NMOSD Patient who received Ofatumumab |
| |
| Rituximab treatment | AQP4-IgG positive NMOSD Patient who received Rituximab |
| |
| Conventional immunosuppressive agents treatment | AQP4-IgG positive NMOSD Patient who received Conventional immunosuppressive agents |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mab Therapy | Drug | Whether receive mab therapy or not. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first relapse | Up to 96 weeks | |
| Median time to relapse | Up to 96 weeks | |
| Annualized relapse rate | Up to 96 weeks | |
| EDSS score | Up to 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of radiologically identified new gadolinium-enhancing lesions and/or new or enlarging T2-weighted lesions | Up to 96 weeks | |
| AQP4-IgG titer in serum and cerebral spinal fluid | Up to 96 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Medical History and Current Health Status
Infection Risk
Additional Exclusion Criteria
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Confirmed diagnosis of aquaporin-4 immunoglobulin G (AQP4-IgG)-seropositive neuromyelitis optica spectrum disorders (NMOSD) per the 2015 International Consensus Diagnostic Criteria, with serological or cerebrospinal fluid verification of AQP4-IgG positivity for inclusion in the AQP4-NMOSD cohort.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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| 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 |
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| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |