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Duke Lupus Registry

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT00512694
Collaborator
(none)
1,000
Enrollment
1
Location
215
Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Lupus is a systemic autoimmune disease that can present with many varied symptoms, including joint pain, fevers, kidney disease, and rashes. Lupus can affect anyone, but it is most common in younger women.

The Duke Lupus Registry will collect information and blood samples from patients with lupus (systemic lupus erythematosus or cutaneous lupus) seen in the Duke Rheumatology clinics. The goal of this Registry is to understand how lupus changes over time so that we can improve the treatment of patients with lupus.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The Duke Lupus Registry is a prospective cohort comprised of patients with lupus seen in the Duke Rheumatology clinic.

    The Duke Lupus Registry has two main purposes:

    1. Improved patient care. By following disease activity scores and medication usage, we expect to improve our care of the patients seen in clinic.

    2. Future research on lupus outcomes. This may encompass a broad array of areas, including but not limited to cardiovascular health, pregnancy and fertility, infections, medication use, quality of life, and depression.

    At each office visit, patients will complete a questionnaire, physicians will measure lupus activity, and patients may be asked to provide a small blood sample. Patients will not be required to make extra visits to Duke in order to participate -- all paperwork and blood draws will occur during a regularly scheduled office visit with the physician.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Duke Lupus Registry
    Study Start Date :
    Jul 1, 2007
    Anticipated Primary Completion Date :
    Jun 1, 2025
    Anticipated Study Completion Date :
    Jun 1, 2025

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Diagnosis of Systemic Lupus Erythematosus or Cutaneous Lupus

      • Patient of a rheumatologist at Duke University Medical Center

      Exclusion Criteria:

      • Inability to travel to Duke for follow-up visits

      • Inability to speak English

      • Not able to provide informed consent

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Duke University Medical Center Durham North Carolina United States 27710

      Sponsors and Collaborators

      • Duke University

      Investigators

      • Principal Investigator: Megan E. B. Clowse, MD, MPH, Duke University

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      None provided.
      Responsible Party:
      Duke University
      ClinicalTrials.gov Identifier:
      NCT00512694
      Other Study ID Numbers:
      • Pro00008875
      • 8652-07-6R1
      First Posted:
      Aug 8, 2007
      Last Update Posted:
      Nov 2, 2021
      Last Verified:
      Oct 1, 2021
      Keywords provided by Duke University
      Lupus
      Systemic Lupus Erythematosus
      Cutaneous Lupus
      Additional relevant MeSH terms:
      Lupus Erythematosus, Systemic

      Study Results

      No Results Posted as of Nov 2, 2021