Study of Systemic Lupus Erythematosus
Studies of the Pathogenesis and Natural History of Systemic Lupus Erythematosus (SLE)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 3 Years to 120 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Urine samples, Physical exams, Heart tracing (ECG), MRI scans, X-rays, Questionnaires, Biopsies, Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients will be evaluated with a medical history and physical examination, blood and urine tests."
- "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."
- "Skin biopsy-Removal of a small skin sample for microscopic analysis."
- "Kidney, bone marrow or other organ biopsy-Removal of a small sample of organ tissue."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how systemic lupus erythematosus (SLE), also called lupus, starts and changes over time. It also studies genes that may raise a person's chance of getting lupus. People age 3 and older with known or suspected lupus, their close relatives, and healthy volunteers may join.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- People age 3 or older with known or suspected lupus based on standard medical guidelines. There is no upper age limit.
- Close relatives, such as parents, siblings, children, grandparents, aunts, or uncles, may join for gene studies.
- Healthy relatives must be age 3 or older. Healthy volunteers who are not related must be age 18 or older.
- You must be able to give informed consent, meaning you understand the study and agree to join. Parents must give permission for children.
- Only adults age 18 or older may join the blood vessel studies.
Who can't join
- Health problems or medicines that could make study results hard to understand, including HIV in the blood or active cancer.
- Medical or mental health conditions that the study doctor says make participation unsuitable, including needing urgent care or care NIH cannot support.
- Being unable or unwilling to return for follow-up visits, take part in research, or provide study samples or information.
- For blood vessel studies only: being under age 18, pregnant, or breastfeeding.
- For healthy volunteers in blood vessel studies: a history of heart artery disease, poor blood flow in other arteries, or fatty buildup in arteries.
- The optional heart MRI is not offered if certain implants or metal in the body make it unsafe, unless cleared as MRI-safe.
- Medical instability that makes an MRI unsafe, as judged by the study doctor.
- People with a kidney filtering test result below 60 may still join, but cannot have the heart artery CT scan or receive gadolinium, a dye used for MRI scans.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
* 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.
Study sites (1)
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Study contact · 800-411-1222 ext. TTY dial 711 · ccopr@nih.govMore trials in Bethesda