The purpose of this study is to evaluate the regulatory effect of Telitacicept on antibody titers in primary antiphospholipid syndrome patients carrying high-risk antiphospholipid antibody profiles.
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+Telitacicept or SOC treatment.Telitacicept is administered subcutaneously at a dose of 160mg once a week for 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
160mg once a week for 48 weeks
SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.
Ruijin Hospital
Shanghai, Shanghai Municipality, China
The proportion of patients with decreased aPL titer at week 48 of treatment
Time frame: week 48
new thrombotic event
any new thrombotic event during Telitacicept treatment
Time frame: 48 weeks
Effects of Telitacicept on the genotype, phenotype, and functional heterogeneity of T and B cells
Application of single-cell RNA sequencing technology (scRNAseq)
Time frame: baseline, week 12, 24, 36, 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.