Recruiting

Study of Systemic Lupus Erythematosus

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Systemic Lupus Erythematosus

From 3 to 120 Years
+21 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 1994

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Summary

Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study ContactSarfaraz A Hasni, M.D.
Last updated: October 3, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: February 10, 1994Actual date on which the first participant was enrolled.

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. This research protocol will evaluate subjects with systemic lupus erythematosus (SLE) and their relatives to study the pathogenesis and natural history of the disease and the mechanisms leading to enhanced organ damage. Patients will be evaluated by a history and physical examination and routine laboratory studies will be obtained as needed to assess disease activity or complications of the disease and to monitor for drug-related toxicities. Blood, skin or urine specimens may be requested for research purposes, including genetic studies. In addition, a subset of these patients will undergo several tests to understand the pathogenic changes affecting their blood vessels. Patients who are eligible for other research protocols will be offered the opportunity to participate in these studies by signed informed consent. Any medical care recommended or provided to the patient will be consistent with routine standards of practice and provided in consultation with the patient s referring physician. Blood and urine samples and cardiovascular testing will also be collected or applied to from healthy volunteers for research purposes and to support the identification and validation of new biomarker candidates.

Official TitleStudies of the Pathogenesis and Natural History of Systemic Lupus Erythematosus (SLE) 
Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study ContactSarfaraz A Hasni, M.D.
Last updated: October 3, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
2250 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective: These studies use existing medical records or past data.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 3 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Systemic Lupus Erythematosus
Criteria
9 inclusion criteria required to participate
Healthy Volunteers (first- and second-degree relatives) age \>=3 with no upper age limit
Ability of the patient or minor relative s parents to give informed consent
Healthy Volunteers (non-related) age \>=18 with no upper age limit
Vascular studies adults only age \>=18 with no upper age limit

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12 exclusion criteria prevent from participating
Subjects with a contraindication to MRI scanning will not receive the optional Cardiovascular MRI. These contraindications include subjects with the following devices: * Central nervous system aneurysm clips unless it is labeled safe or conditional for MRI * Implanted neural stimulator (e.g.TENS-Unit) unless it is labeled safe or conditional for MRI * Implanted cardiac pacemaker or defibrillator unless it is labeled safe or conditional for MRI * Cochlear or any type of ear implant unless it is labeled safe or conditional for MRI * Ocular foreign body (e.g. metal shavings) * Implanted Insulin pump or drug infusion device unless it is labeled safe or conditional for MRI * Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI
Subjects with renal excretory dysfunction, estimated glomerular filtration rate \< 60 mL/min/1.73m\^2 using the CKD-EPI equation or equivalent (using the CRIS-calculated eGFR to define the threshold) and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but will not be exposed to the cardiac CT angiography, or gadolinium-based contrast agents.
Pregnant or lactating women will be excluded from vascular studies.
Any clinical instability precluding subject from getting MRI as determined by the enrolling clinician.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Longitudinal cohort study with affected SLE patients
Group II
Patient relatives
Group III
Unrelated healthy volunteers
Study Objectives
Primary Objectives

Natural History of SLE

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
National Institutes of Health Clinical CenterBethesda, United StatesSee the location
Recruiting
One Study Center