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RecruitingPhase 2NCT06747312

Effect of Belimumab on Antibody Titers in Primary APS Patients

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Trial Parameters

ConditionAntiphospholipid Syndrome (APS)
SponsorRuijin Hospital
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment20
SexALL
Min Age18 Years
Max AgeN/A
Start Date2024-04-01
Completion2026-05-31
Interventions
Belimumab+SOCSOC

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Age ≥ 18 years old. * Positive for high-titer antiphospholipid antibodies according to the criteria of the "EULAR Guidelines for the Treatment of Antiphospholipid Syndrome in Adults" published in 2019. * Stable APS regimen according to EULAR recommendations for antiphospholipid syndrome. * Female patients who are not pregnant, breastfeeding, of childbearing potential, or not using contraception. Exclusion Criteria: * Patients with a history of malignant tumor in the past 5 years, except for basal cell carcinoma or squamous cell carcinoma of skin or cervical carcinoma in situ treated locally, and there is no evidence of metastasis within 3 years; * Patients with a history of primary immunodeficiency; * Serious lack of IgG (IgG level \< 400 mg/dL); * IgA deficiency (IgA level \< 10 mg/dL); * Patients with a current history of infection; * Patients with a current history of drug or alcohol abuse or dependence, or have a history of drug or alcohol abuse or depen

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