Study of Systemic Lupus Erythematosus

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001372
First received: November 3, 1999
Last updated: June 3, 2014
Last verified: November 2013
  Purpose

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
Lupus Nephritis
Systemic Lupus Erythematosus

Study Type: Observational
Official Title: Studies of the Pathogenesis and Natural History of Systemic Lupus Erythematosus (SLE)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 99999999
Study Start Date: February 1994
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 applied to from healthy volunteers for research purposes and to support the identification and validation of new biomarker candidates.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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, as described in details in Section IV.H.

  • 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

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 if it 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

Criteria for Healthy Control Subjects:

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

Exclusion Criteria for vascular studies only, for SLE and healthy controls:

  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001372

Contacts
Contact: Elizabeth Joyal, R.N. (301) 435-4489 ejoyal@mail.cc.nih.gov
Contact: Sarfaraz A Hasni, M.D. (301) 451-1599 hasnisa@mail.nih.gov

Locations
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Sarfaraz A Hasni, M.D. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00001372     History of Changes
Other Study ID Numbers: 940066, 94-AR-0066
Study First Received: November 3, 1999
Last Updated: June 3, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Systemic Lupus Erythematosus
Kidney Disease
Autoimmunity
Lupus Nephritis
Lupus
Systemic Lupus
SLE

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Nephritis
Nephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Glomerulonephritis
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014