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This study is a single-center, retrospective-prospective, non-interventional cohort study to assess the clinical outcomes of Chinese NMOSD patients treated with satralizumab in a real-world patient management model by collecting follow-up data in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Satralizumab treatment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Satralizumab | Drug | Satralizumab is the first monoclonal antibody approved for the treatment of NMOSD in China. Currently, there is still a lack of standard patient management pattern for NMOSD. While satralizumab offers the advantage of home administration, there remains a pressing need for optimized patient management. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients relapse-free at 12 months of treatment with satralizumab | 12 months | |
| Change from baseline in EDSS score at 12 months of treatment with satralizumab | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients relapse-free at 6 months of treatment with satralizumab | 6 months | |
| Change from baseline in EDSS score at 6 months of treatment with satralizumab | 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
-
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This study is a real-world study and will enroll patients diagnosed with NMOSD who are AQP4-IgG positive and receiving satralizumab in routine clinical practice in China
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Quan, Doctor | Contact | +8613651957283 | chao_quan@fudan.edu.cn | |
| Wenjuan Huang, Doctor | Contact | +8619921296182 | drhuangwenjuan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chao Quan, Doctor | Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China | Principal Investigator |
| Qiang Dong, Doctor | Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Shanghai | Shanghai Municipality | 200040 | 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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| ID | Term |
|---|---|
| C000655944 | satralizumab |
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|
| Change patterns from baseline in clinical outcome assessments (COAs) at Months 1, 3, 6, and 12 during satralizumab treatment |
| 1, 3, 6, 12 months |
| Incidence of AEs and SAEs during satralizumab treatment | Adverse 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. | 1, 2, 3, 6, 9, 12 months |
| Study Chair |
| Lei Zhou | Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China | Study Director |
| Wenjuan Huang, Doctor | Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China | Study Director |
| Jingzi Zhangbao, Doctor | Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China | Study Director |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |