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Protocol Details

Studies of the Pathogenesis and Natural History of Systemic Lupus Erythematosus (SLE)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

94-AR-0066

Sponsoring Institute

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 9
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Longitudinal Study

Recruitment Keyword(s)

Lupus Nephritis;
Lupus;
Systemic Lupus;
SLE

Condition(s)

Systemic Lupus Erythematosus

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Arthritis and Musculoskeletal and Skin Diseases

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.

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Eligibility

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 conditional for MRI

--Implanted cardiac pacemaker or defibrillator

--Cochlearor 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.

-Any clinical instability precluding subject from getting MRI as determined by the enrolling clinician.

-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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Sarfaraz A. Hasni, M.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
BG 10-CRC RM 3-2340
10 CENTER DR
BETHESDA MD 20814
(301) 451-1599
hasnisa@mail.nih.gov

Elaine B. Poncio
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health
Building 10
Room 3-2340
10 Center Drive
Bethesda, Maryland 20814
(301) 435-4489
elaine.poncio@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT00001372

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