Actively Recruiting
Effect of Belimumab on Antibody Titers in Primary APS Patients
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
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
H
Hui Shi, Dr
CONTACT
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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