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<?xml version="1.0" encoding="UTF-8"?>
<clinical_study>
  <required_header>
    <download_date>Information obtained from ClinicalTrials.gov on June 26, 2009</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>http://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>
    </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.  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.
    </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>
  <condition>Lupus Nephritis</condition>
  <condition>Systemic Lupus Erythematosus</condition>
  <eligibility>
    <criteria>
      <textblock>
        -  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 .
      </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_contact>
    <last_name>Patient Recruitment and Public Liaison Office</last_name>
    <phone>(800) 411-1222</phone>
    <email>prpl@mail.cc.nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>TTY</last_name>
    <phone>1-866-411-1010</phone>
  </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>
  </location>
  <link>
    <url>http://clinicalstudies.info.nih.gov/detail/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>October 2008</verification_date>
  <lastchanged_date>November 25, 2008</lastchanged_date>
  <firstreceived_date>November 3, 1999</firstreceived_date>
</clinical_study>