Actively Recruiting
Study of Systemic Lupus Erythematosus
Led by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Updated on 2026-05-01
2000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE. Patients 3 years of age and older with known or suspected SLE and their relatives may be eligible for this study. Patients will be evaluated with a medical history and physical examination, blood and urine tests. Other procedures may include: 1. Electrocardiogram 2. 24-hour urine collection 3. Imaging studies, such as chest and joint X-rays, magnetic resonance imaging (MRI) scans, bone scans, and bone densitometry. 4. Questionnaire about the degree of disease activity, and survey of risk factors for disease complications. 5. Apheresis-Collection of plasma (fluid portion of blood) or blood cells for analysis. Whole blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components. The required component (plasma or cells) is removed and the rest of the blood is returned to the body through the same needle or through a second needle in the other arm. 6. Skin biopsy-Removal of a small skin sample for microscopic analysis. An area of skin is numbed with an anesthetic and a small circular portion (about 1/4 inch in diameter) is removed, using a sharp cookie cutter-type instrument. 7. Kidney, bone marrow or other organ biopsy-Removal of a small sample of organ tissue. These biopsies are done only if they can provide information useful in better understanding the disease or making treatment decisions. 8. Genetic studies-Collection of a blood sample for gene testing. Patients will be followed at least once a year with a brief history and physical examination and routine blood and urine tests. Some patients may be seen more often. Treatment recommendations will be offered to patients' physicians, and patients who are eligible for other research treatment studies will be invited to enroll. Participating relatives of patients will fill out a brief medical history questionnaire and provide a DNA sample (either a blood sample or tissue swab from the inside of the cheek) for genetic testing....
CONDITIONS
Official Title
Study of Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with known or suspected SLE established by ACR/EULAR or ACR criteria
- Ability to give informed consent
- Adults and minor first- and second-degree relatives of patients (for genetic studies) able to give informed consent
- Affected individuals aged 3 years and older, no upper age limit
- Healthy volunteers aged 18 years and older, no upper age limit
- Healthy first- and second-degree relatives aged 3 years and older, no upper age limit
- Adults aged 18 years and older for vascular studies, no upper age limit
You will not qualify if you...
- Medical problems that would confuse study results, such as HIV infection, active malignancies, or other significant conditions
- Medical, surgical, or other conditions without adequate care facilities at NIH
- Inability or unwillingness to comply with follow-up requirements
- Any medical or psychological condition or treatment judged by the Principal Investigator to exclude participation
- Unwillingness to participate in research or provide samples or data
- Conditions or medications that would interfere with study interpretation
- Contraindications to MRI for vascular studies (e.g., certain implants, metal fragments)
- Renal dysfunction with eGFR below 60 mL/min/1.73m2 for some imaging procedures
- Pregnancy or breastfeeding excluded from vascular studies
- Clinical instability preventing MRI
- Healthy controls with known coronary artery disease or vascular disease
- Individuals under 18 excluded from vascular studies due to radiation exposure and lack of validation
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Sarfaraz A Hasni, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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