Effect of Belimumab on Antibody Titers in Primary APS Patients
NCT06747312 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-12-24
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.
Conditions
- Antiphospholipid Syndrome (APS)
Interventions
- DRUG
-
Belimumab+SOC
10mg/kg once a month for 18 months
- DRUG
-
SOC
SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.
Sponsors & Collaborators
-
Ruijin Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-04-01
- Primary Completion
- 2026-05-31
- Completion
- 2027-05-31
Countries
- China
Study Locations
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