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ClinicalTrials.gov-NCT00001372.xml
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ClinicalTrials.gov-NCT00001372.xml
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<?xml version="1.0" encoding="UTF-8"?>
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd
and an XML DTD at:
https://clinicaltrials.gov/ct2/html/images/info/public.dtd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on May 26, 2016</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/show/NCT00001372</url>
</required_header>
<id_info>
<org_study_id>940066</org_study_id>
<secondary_id>94-AR-0066</secondary_id>
<nct_id>NCT00001372</nct_id>
</id_info>
<brief_title>Study of Systemic Lupus Erythematosus</brief_title>
<official_title>Studies of the Pathogenesis and Natural History of Systemic Lupus Erythematosus (SLE)</official_title>
<sponsors>
<lead_sponsor>
<agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Institutes of Health Clinical Center (CC)</source>
<oversight_info>
<authority>United States: Federal Government</authority>
</oversight_info>
<brief_summary>
<textblock>
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.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
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
performed on healthy volunteers for research purposes and to support the identification and
validation of new biomarker candidates.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date>February 1994</start_date>
<phase>N/A</phase>
<study_type>Observational</study_type>
<study_design>N/A</study_design>
<enrollment type="Anticipated">100000</enrollment>
<condition>Systemic Lupus Erythematosus</condition>
<eligibility>
<criteria>
<textblock>
- 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.
</textblock>
</criteria>
<gender>Both</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Sarfaraz A Hasni, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</affiliation>
</overall_official>
<overall_contact>
<last_name>Yenealem Temesgen-Oyelakin, R.N.</last_name>
<phone>(301) 451-4990</phone>
<email>yenealem.temesgen-oyelakin@nih.gov</email>
</overall_contact>
<overall_contact_backup>
<last_name>Sarfaraz A Hasni, M.D.</last_name>
<phone>(301) 451-1599</phone>
<email>hasnisa@mail.nih.gov</email>
</overall_contact_backup>
<location>
<facility>
<name>National Institutes of Health Clinical Center, 9000 Rockville Pike</name>
<address>
<city>Bethesda</city>
<state>Maryland</state>
<zip>20892</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)</last_name>
<phone>800-411-1222</phone>
<phone_ext>TTY8664111010</phone_ext>
<email>prpl@mail.cc.nih.gov</email>
</contact>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1994-AR-0066.html</url>
<description>NIH Clinical Center Detailed Web Page</description>
</link>
<reference>
<citation>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.</citation>
<PMID>7762914</PMID>
</reference>
<reference>
<citation>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.</citation>
<PMID>8144943</PMID>
</reference>
<reference>
<citation>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.</citation>
<PMID>7511686</PMID>
</reference>
<verification_date>May 2016</verification_date>
<lastchanged_date>May 19, 2016</lastchanged_date>
<firstreceived_date>November 3, 1999</firstreceived_date>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Systemic Lupus Erythematosus</keyword>
<keyword>Natural History</keyword>
<keyword>Lupus Nephritis</keyword>
<keyword>Lupus</keyword>
<keyword>Systemic Lupus</keyword>
<keyword>SLE</keyword>
<is_fda_regulated>No</is_fda_regulated>
<has_expanded_access>No</has_expanded_access>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Lupus Erythematosus, Systemic</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>