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The purpose of this study is to evaluate the regulatory effect of Belimumab on the antiphospholipid antibody (aPL) as well as to observe related past and new clinical events in primary antiphospholipid syndrome patients.
This is a single center, randomized controlled trial in Ruijin Hospital. The enrolled patients will be randomized in a 1: 1 ratio to receive either SOC+Belimumab or SOC treatment. Belimumab is administered intravenously at a dose of 10mg/kg once a month for 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: SOC+Belimumab arm | Experimental | Belimumab 10mg/kg once a month as an add-on treatment regimen. SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin. |
|
| Experimental: SOC arm | Active Comparator | SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belimumab+SOC | Drug | 10mg/kg once a month for 18 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The level of antiphospholipid antibody titers | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| New thrombotic event | Any new thrombotic event during Belimumab treatment | 18 months |
| Effects of Belimumab on the genotype, phenotype, and functional heterogeneity of T and B cells | Application of single-cell RNA sequencing technology (scRNAseq) |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events | Number and intensity of adverse events | 18 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Shi, Dr | Contact | 008613585515854 | sh12053@rjh.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D016736 | Antiphospholipid Syndrome |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| SOC |
| Drug |
SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin. |
|
| 18 months |