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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
10mg/kg once a month for 18 months
SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.
Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe level of antiphospholipid antibody titers
Time frame: 18 months
New thrombotic event
Any new thrombotic event during Belimumab treatment
Time frame: 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)
Time frame: 18 months
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