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Study of Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00001372
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : October 10, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )

Brief 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.

Condition or disease
Systemic Lupus Erythematosus

Detailed 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 performed on healthy volunteers for research purposes and to support the identification and validation of new biomarker candidates.

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Study Type : Observational
Estimated Enrollment : 99999999 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Studies of the Pathogenesis and Natural History of Systemic Lupus Erythematosus (SLE)
Study Start Date : February 2, 1994

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
  • 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


  • 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


  • Inclusion Criteria:

    • Age 18 years with no upper age limit.
    • For vascular studies healthy control subjects will be age- and gender-matched.
    • For genetic studies only: Minor relatives (first and second degree) of SLE subjects Included in section IV-G.
    • Ability to give informed consent or minor relative s parents to give informed consent (for genetic studies only).
  • Exclusion Criteria:

    • Any concomitant medical problems or are taking medications which would confound the interpretation of studies they are considered for


  • Subjects with a contraindication to MRI scanning will not receive the optional PET/MRI. These contraindications include subjects with the following devices:

    • Central nervous system aneurysm clips
    • Implanted neural stimulator
    • Implanted cardiac pacemaker or defibrillator
    • Cochlear implant
    • Ocular foreign body (e.g. metal shavings)
    • Implanted Insulin pump
    • Metal shrapnel or bullet
  • Subjects with a BMI >40 will also not receive the PET MRI.
  • Subjects with renal excretory dysfunction, estimated glomerular filtration rate < 60 mL/min/1.73m(2) body surface area according to the Modification of Diet in Renal Disease criteria, will not receive the cardiac CT angiography, or gadolinium contrast agent during the PET/MRI.
  • Pregnant or lactating women will be excluded from vascular studies.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001372

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Contact: Yenealem Temesgen-Oyelakin, R.N. (301) 451-4990
Contact: Sarfaraz A Hasni, M.D. (301) 451-1599

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Principal Investigator: Sarfaraz A Hasni, M.D. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Identifier: NCT00001372     History of Changes
Other Study ID Numbers: 940066
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: July 3, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ):
Systemic Lupus Erythematosus
Natural History
Lupus Nephritis
Systemic Lupus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases