NCT01510067

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Dec 2006

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Dec 2006Jan 2030

Study Start

First participant enrolled

December 1, 2006

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
18 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2030

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

23.1 years

First QC Date

January 10, 2012

Last Update Submit

March 24, 2026

Conditions

Cutaneous Lupus Erythematosus (CLE)

Keywords

CLELupusLupus Erythematosus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Texas Southwestern

Dallas, Texas, 75390, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Skin Tissue Biopsies

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Victoria Werth, M.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria P Werth, MD

CONTACT

215-615-2940werth@pennmedicine.upenn.edu

Joyce Okawa, R.N

CONTACT

215-615-2940Joyce.Okawa@pennmedicine.upenn.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2012

First Posted

January 13, 2012

Study Start

December 1, 2006

Primary Completion (Estimated)

January 2, 2030

Study Completion (Estimated)

January 2, 2030

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)