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Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT01510067
Collaborator
(none)
700
Enrollment
2
Locations
217.1
Duration (Months)
350
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Cutaneous Lupus Erythematosus (CLE) database, established in 2006, is a multi-site database between the University of Pennsylvania and the University of Texas Southwestern (UTSW).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The database has yielded valuable information and clinical insights into the pathophysiology, disease processes, treatments and quality of life associated with CLE. The CLE database incorporates the CLASI (Cutaneous Lupus Activity and Severity Index), a validated outcome measure of disease responsiveness in patients and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with CLE (cutaneous lupus erythematosus).

    The CLE database has led to publication of significant studies on lupus and its clinical course, the effect of lupus on Quality of Life (QoL), including the effect of photosensitivity on QoL, and the effect of first line medications.

    The CLE database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    700 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus
    Study Start Date :
    Dec 1, 2006
    Anticipated Primary Completion Date :
    Jan 2, 2025
    Anticipated Study Completion Date :
    Jan 2, 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:
      • Subjects who meet the criteria for having CLE, using the Gilliam classifications, and/or a diagnosis of systemic lupus erythematosus (SLE), using the American Rheumatism Association/American College of Rheumatology criteria. Subjects must be 18 years or older.
      Exclusion Criteria:
      • All subjects who do not meet the criteria for having CLE. Subjects who meet the criteria for CLE but who are not yet 18 years old

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
      2 University of Texas Southwestern Dallas Texas United States 75390

      Sponsors and Collaborators

      • University of Pennsylvania

      Investigators

      • Principal Investigator: Victoria Werth, M.D., University of Pennsylvania

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Victoria Werth, Principal Investigator, University of Pennsylvania
      ClinicalTrials.gov Identifier:
      NCT01510067
      Other Study ID Numbers:
      • 805758
      First Posted:
      Jan 13, 2012
      Last Update Posted:
      Feb 14, 2022
      Last Verified:
      Jan 1, 2022
      Individual Participant Data (IPD) Sharing Statement:
      No
      Plan to Share IPD:
      No
      Keywords provided by Victoria Werth, Principal Investigator, University of Pennsylvania
      CLE
      Lupus
      Lupus Erythematosus
      Additional relevant MeSH terms:
      Lupus Erythematosus, Systemic
      Lupus Erythematosus, Cutaneous

      Study Results

      No Results Posted as of Feb 14, 2022