NIH Clinical Research Studies

Protocol Number: 94-AR-0066

Active Accrual, Protocols Recruiting New Patients

Title:
Studies of the Pathogenesis and Natural History of Systemic Lupus Erythematosus (SLE)
Number:
94-AR-0066
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.

Sponsoring Institute:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: Yes
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA

SLE or suspected SLE established by ARA criteria.

Ability to give informed consent .

Adult and minor relatives (first and second degree) of individuals included in III-A-1 (only for genetic studies) .

Willingness of the patient's or minor relative's parents to give informed consent (only for genetic studies).

Adult healthy volunteers (for punch biopsy of the skin and bone marrow biopsy).

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 the NIH .

Special Instructions:
Currently Not Provided
Keywords:
Systemic Lupus Erythematosus
Kidney Disease
Autoimmunity
Recruitment Keyword(s):
Lupus Nephritis
Lupus
Systemic Lupus
SLE
Condition(s):
Lupus Nephritis
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

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Systemic lupus erythematosus: ermerging concepts Part 2: dermatologic and joint disease, the antiphospholipid antibody syndrome, pregnancy and hormonal therapy, mobidity and mortality, and pathogenesis

Accelerated in vitro apoptosis of lymphocytes from patients with systemic lupus erythematosus

Autoantigens targeted in systemic lupus erythematosus are clustered in two populations of surface structures on apoptotic keratinocytes

Active Accrual, Protocols Recruiting New Patients

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