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| Name | Class |
|---|---|
| Tang-Du Hospital | OTHER |
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Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Belimumab (Benlysta ®) is a human immunoglobulin G1λ monoclonal antibody that inhibits B-cell survival and differentiation by neutralizing soluble B lymphocyte stimulator. Belimumab may benefit some patients with NMOSD due to the important role of B cells in the pathogenesis of NMOSD. Clinical trials may be needed to observe its efficacy and safety.
The investigators primarily aim to observe the number of attacks from initiation of belimumab treatment.
The secondary outcomes are to determine: The safety profile of belimumab in participants with NMO and whether belimumab improves Expanded Disability Status Scale (EDSS), et al.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belimumab | Experimental | Belimumab will be intravenously administered with a dose of 10mg/kg on Days 0,14 and28, then every 28 days until week 48, with a final evaluation at week 52. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belimumab | Drug | Belimumab will be intravenously administered with a dose of 10mg/kg on Days 0,14 and28, then every 28 days until week 48, with a final evaluation at week 52. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of attacks | An acute attack was defined as a new neurological worsening lasting for at least 24 hours and occurring more than 30 days after the previous attack. | From baseline to one year after |
| Measure | Description | Time Frame |
|---|---|---|
| Worsening in EDSS | The Expanded Disability Status Scale (EDSS) is a rating system that is frequently used for classifying and standardizing the severity and progression. EDSS ranges from 0 to 10. | Worsening from baseline in EDSS to 52 weeks |
| Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Optic nerve,brain and spinal cord Magnetic Resonance Imaging (MRI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | 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 |
|---|---|
| C511911 | belimumab |
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The total number of new and/or enlarging T2 lesions for all participants was calculated as the sum of the individual number of lesions at Weeks 12, 24, and 52 |
| From baseline to 52 weeks |
| Counts of peripheral blood B cell subsets | Compare peripheral blood plasma cells before and one year after initial intervention | From baseline to 52 weeks |
| Determination of serum AQP4 antibodies | Compare serum AQP4-ab titers before and one year after initial intervention | From baseline to 52 weeks |
| Incidence of treatment-emergent adverse events [safety and tolerability] | Adverse events related to belimumab are recorded | From baseline to 52 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 |