Study of Systemic Lupus Erythematosus - Full Text View

Sponsor:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001372

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:

Electrocardiogram
24-hour urine collection
Imaging studies, such as chest and joint X-rays, magnetic resonance imaging (MRI) scans, bone scans, and bone densitometry.
Questionnaire about the degree of disease activity, and survey of risk factors for disease complications.
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.
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.
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.
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:

MedlinePlus related topics: Lupus

U.S. FDA Resources

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. 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. 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 will also be collected 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. 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
Subjects considered as healthy volunteers will be disqualified if they have any concomitant medical problems or are taking medications which would confound the interpretation of studies they are considered for

Criteria for Healthy Control Subjects

INCLUSION CRITERIA:

Age 18 - 70 years
Ability to give informed consent

EXCLUSION CRITERIA:

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

Contacts and Locations

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

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Sub-Investigator: Patient Recruitment and Public Liaison Office (PRPL) For more information at the NIH Clinical Center contact

Sponsors and Collaborators

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

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Boumpas DT, Fessler BJ, Austin HA 3rd, Balow JE, Klippel JH, Lockshin MD. Systemic lupus erythematosus: emerging concepts. Part 2: Dermatologic and joint disease, the antiphospholipid antibody syndrome, pregnancy and hormonal therapy, morbidity and mortality, and pathogenesis. Ann Intern Med. 1995 Jul 1;123(1):42-53. Review.

Emlen W, Niebur J, Kadera R. Accelerated in vitro apoptosis of lymphocytes from patients with systemic lupus erythematosus. J Immunol. 1994 Apr 1;152(7):3685-92.

Casciola-Rosen LA, Anhalt G, Rosen A. Autoantigens targeted in systemic lupus erythematosus are clustered in two populations of surface structures on apoptotic keratinocytes. J Exp Med. 1994 Apr 1;179(4):1317-30.

ClinicalTrials.gov Identifier:	NCT00001372 History of Changes
Other Study ID Numbers:	940066, 94-AR-0066
Study First Received:	November 3, 1999
Last Updated:	December 21, 2011
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 February 09, 2012