A Single Center, Randomized Controlled, Open Label Trial to Explore the Regulatory Effect of Belimumab on Antibody Titers in Primary Antiphospholipid Syndrome Patients Carrying Medium to High Titers of Antiphospholipid Antibodies
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
China
Ruijin Hospital
RECRUITING
Shanghai
Contact Information
Primary
Hui Shi, Dr
sh12053@rjh.com.cn
008613585515854
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 20
Treatments
Experimental: Experimental: SOC+Belimumab arm
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.
Active_comparator: Experimental: SOC arm
SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital