Actively Recruiting
Study of Belimumab's Effect on Antiphospholipid Antibody Levels in Primary Antiphospholipid Syndrome Patients Randomized Trial Comparing Belimumab Plus Standard Care to Standard Care Alone
Led by Ruijin Hospital · Updated on 2024-12-24
20
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of Belimumab on antiphospholipid antibody levels and clinical events in patients with primary antiphospholipid syndrome (APS) who have medium to high antibody titers. This Phase 2 trial is conducted at a single center and aims to understand how Belimumab regulates these antibodies compared to standard care. The study focuses on patients with confirmed APS receiving stable treatment according to established guidelines. Participants are randomly assigned to one of two groups. One group receives standard of care (SOC) treatment, which may include aspirin, vitamin K antagonists, or low molecular weight heparin. The other group receives SOC plus Belimumab, administered as a 10 mg/kg intravenous infusion once a month for 18 months. The study is open-label, meaning both patients and researchers know which treatment is given. During the 18-month treatment period, participants will have their antiphospholipid antibody levels measured to assess changes over time. Researchers will monitor for any related past or new clinical events. Safety and efficacy are tracked throughout, with regular evaluations to observe the regulatory effect of Belimumab. The total participation time aligns with the treatment duration, with ongoing observation to assess outcomes.
CONDITIONS
Official Title
Effect of Belimumab on Antibody Titers in Primary APS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age ≥ 18 years old
- Positive for high-titer antiphospholipid antibodies according to 2019 EULAR Guidelines
- Stable antiphospholipid syndrome treatment regimen as recommended by EULAR
- Female patients must not be pregnant, breastfeeding, or of childbearing potential without contraception
You will not qualify if you...
- History of malignant tumor in past 5 years except certain treated skin or cervical cancers without metastasis
- History of primary immunodeficiency
- Severe IgG deficiency (IgG level < 400 mg/dL)
- IgA deficiency (IgA level < 10 mg/dL)
- Current infection
- History or current drug or alcohol abuse within past year
- Positive HIV test or screening
- Hepatitis infection status
- History of allergic reaction to contrast agents, human or mouse proteins, or monoclonal antibodies
- Abnormal lab values with clinical significance
- Major medical or mental illnesses
- Diseases affecting liver, kidney, heart, blood, or endocrine systems
- Live vaccine within last month
- Participation in another clinical trial within 28 days or within 5 half-lives of study drug
- Use of B-cell targeted therapies within one year
- Use of TNF inhibitors or interleukin blockers within one year
- Use of high-dose prednisone (≥100mg/day) or intravenous gamma globulin or plasma exchange within one year
- Active infections such as herpes zoster, tuberculosis
- Depression or suicidal thoughts
- Other conditions deemed unsuitable by investigator
AI-Screening
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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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