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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00001372 |
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:
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 |
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Lupus Nephritis Systemic Lupus Erythematosus |
Study Type: | Observational |
Official Title: | Studies of the Pathogenesis and Natural History of Systemic Lupus Erythematosus (SLE) |
Study Start Date: | February 1994 |
This research protocol will evaluate subjects with systemic lupus erythematosus (SLE) and their relatives to study the pathogenesis and natural history of the disease. 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 laboratory-based research investigations. DNA will be isolated from eligible subjects for genetic studies. 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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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 .
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 940066, 94-AR-0066 |
Study First Received: | November 3, 1999 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00001372 |
Health Authority: | United States: Federal Government |
Systemic Lupus Erythematosus Kidney Disease Autoimmunity Lupus Nephritis |
Lupus Systemic Lupus SLE |
Glomerulonephritis Autoimmune Diseases Urologic Diseases Lupus Erythematosus, Systemic |
Lupus Nephritis Nephritis Connective Tissue Diseases Kidney Diseases |
Immune System Diseases |