Effect of Belimumab on Antibody Titers in Primary APS Patients
ConditionAntiphospholipid Syndrome (APS)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Belimumab+SOC
- SOC
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov