Study of Systemic Lupus Erythematosus

  • STATUS
    Recruiting
  • participants needed
    2000
  • sponsor
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Updated on 16 June 2022
apheresis
lupus
Accepts healthy volunteers

Summary

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 10 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....

Description

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.

Details
Condition Systemic Lupus Erythematosus
Clinical Study IdentifierNCT00001372
SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last Modified on16 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

SLE or suspected SLE established by 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 greater than or equal to 9 years with no upper age limit
Healthy Volunteers (non-related) age greater than or equal to 18 with no upper age limit
Healthy Volunteers (first- and second-degree relatives) age greater than or equal to 9 with no upper age limit
Vascular studies adults only age greater than or equal to 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
Criteria for Exclusion
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
Implanted cardiac pacemaker or defibrillator
conditional for MRI
Ocular foreign body (e.g. metal shavings)
Cochlearor any type of ear implant unless it is labeled safe or conditional for
Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI
MRI
Implanted Insulin pump or drug infusion device unless it is labeled safe or
Pregnant or lactating women will be excluded from vascular studies
conditional 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
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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