Lupus secrets revealed: major study tracks disease over time
NCT ID NCT00001372
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 20 times
Summary
This study aims to learn more about how lupus (SLE) develops and changes over time by observing patients and their relatives. Up to 2000 people aged 3 and older with known or suspected lupus, along with their family members, will provide medical history, blood and urine samples, and possibly imaging or biopsies. The goal is to understand genetic factors and disease patterns, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 2,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 1994
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
subjects with systemic lupus erythematosus (SLE) and their relatives
- Ages
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3 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Patients with known or suspected SLE will be evaluated in either the outpatient or inpatient research ward of the Clinical Center as indicated. Patients will not be selected based on age, race or gender. However, due to the nature of the disease, the patient population will not be expected to be evenly distributed, since SLE is predominantly a disease of young females, with increased prevalence in select racial groups, particularly African Americans and Hispanics. First and second-degree relatives of the patient may be recruited in the study for genetic analysis. We will ask for the patient s permission to contact his/her relatives. * SLE or suspected SLE established by ACR/EULAR or ACR criteria * Ability to give informed consent * Adult and minor relatives (first and second degree) of individuals Included in IV-G (only for genetic studies) * Ability of the patient or minor relative s parents to give informed consent * Affected individuals age \>= 3 years with no upper age limit * Healthy Volunteers (non-related) age \>=18 with no upper age limit * Healthy Volunteers (first- and second-degree relatives) age \>=3 with no upper age limit * Vascular studies adults only age \>=18 with no upper age limit EXCLUSION CRITERIA: * Concomitant medical problems which would confound the interpretation of studies gathered by this protocol. Included in this is the presence of HIV in the blood, active malignancies, or other significant medical conditions that may interferes with interpretation of some lupus studies. * Concomitant medical, surgical or other conditions for which inadequate facilities are available to support their care at NIH * Inability or unwillingness to comply with follow up requirements (e.g. distance, social, physical limitations) * Any comorbidity of medical or psychological/psychiatric condition or treatment after reviewing of patients previous or outside medical records, that in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g. Patient requiring urgent and/or acute medical care, surgical or other procedures) * Unwilling to participate in research studies or to provide research samples or data * Any concomitant medical problems or are taking medications which would confound the interpretation of studies they are considered for EXCLUSION CRITERIA FOR VASCULAR STUDIES ONLY, FOR SLE AND HEALTHY CONTROLS: * 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. * Healthy controls with known history of coronary artery disease, peripheral vascular disease or atherosclerosis. * Individuals younger than 18 years old will be excluded given the radiation exposure as well as the lack of proper validation for the proposed vascular function studies.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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