Actively Recruiting
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
Led by Ruijin Hospital · Updated on 2024-12-24
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the regulatory effect of Belimumab on antiphospholipid antibodies in patients with primary antiphospholipid syndrome (APS), a condition characterized by high levels of these antibodies. This randomized controlled trial aims to observe changes in antibody levels as well as related past and new clinical events in these patients. The trial is conducted at a single center and sponsored by Ruijin Hospital. Participants are randomly assigned to one of two groups: one group receives standard of care (SOC) treatment plus Belimumab, while the other group receives SOC treatment alone. SOC treatment includes medications such as aspirin, vitamin K antagonists, or low molecular weight heparin. Belimumab is given as an intravenous infusion at a dose of 10 mg/kg once a month for 18 months. During the study, participants will be monitored closely with regular assessments to measure the levels of antiphospholipid antibody titers over 18 months. Researchers will also track any new thrombotic events and study the effects of Belimumab on the immune system's T and B cells. The study includes detailed evaluations of genotype, phenotype, and immune function. Safety and clinical events will be observed throughout the trial period, which lasts 18 months.
CONDITIONS
Brief Title
Effect of Belimumab on Antibody Titers in Primary APS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Positive for high-titer antiphospholipid antibodies as defined by 2019 EULAR Guidelines
- Stable APS treatment regimen according to EULAR recommendations
- Female participants must not be pregnant, breastfeeding, and must meet contraception requirements if of childbearing potential
You will not qualify if you...
- History of malignant tumor in the past 5 years except certain skin cancers or cervical carcinoma in situ without metastasis within 3 years
- History of primary immunodeficiency
- Serious IgG deficiency (IgG level < 400 mg/dL)
- IgA deficiency (IgA level < 10 mg/dL)
- Current infection or active infection during screening
- History or current drug or alcohol abuse within past year
- Positive HIV test or hepatitis infection
- History of allergic reaction to contrast agents, human or mouse proteins, or monoclonal antibodies
- Abnormal laboratory values of clinical significance
- Concurrent major medical or mental illnesses
- Diseases affecting liver, kidney, heart, blood, or endocrine system
- Vaccination with live vaccine within last month
- Participation in another clinical trial within 28 days or within 5 times the half-life of study drug
- Use of B-cell targeted therapy within one year
- Use of tumor necrosis factor inhibitors or interleukin receptor blockers within one year
- Use of intravenous gamma globulin or high-dose prednisone for more than 14 days within one year or plasma exchange
- Depression or suicidal thoughts
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 months
Participants receive either Belimumab plus standard of care (SOC) or SOC alone. Belimumab is given intravenously at 10mg/kg once a month as an add-on treatment for 18 months.
Monthly visits for 18 months
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
H
Hui Shi, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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