Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
VICTORIA WERTH, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01510067
First received: January 10, 2012
Last updated: April 20, 2016
Last verified: April 2016
  Purpose
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
Cutaneous Lupus Erythematosus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Biospecimen Retention:   Samples With DNA
Blood, Skin Tissue Biopsies

Estimated Enrollment: 400
Study Start Date: December 2006
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects will be recruited from among the patients seen at the Autoimmune Skin Disease Clinic at the Hospital of the University of Pennsylvania and other collaborating centers.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510067

Contacts
Contact: Victoria P Werth, MD 215-615-2940 werth@mail.med.upenn.edu;
Contact: Joyce Okawa, R.N 215-615-2940 Joyce.Okawa@uphs.upenn.edu

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Victoria P Werth, MD    215-898-0168      
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Benjamin Chong         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Victoria Werth, M.D. University of Pennsylvania
  More Information

Responsible Party: VICTORIA WERTH, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01510067     History of Changes
Other Study ID Numbers: 805758 
Study First Received: January 10, 2012
Last Updated: April 20, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Pennsylvania:
CLE
Lupus
Lupus Erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2016