A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
Longitudinal Study of Skin And Systemic Biomarkers In Subjects With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
2 other identifiers
observational
77
6 countries
21
Brief Summary
The purpose of this study is to obtain skin, blood, and urine samples from patients with active cutaneous lupus lesions and from healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2013
21 active sites
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 Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 10, 2013
CompletedFirst Posted
Study publicly available on registry
January 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedDecember 16, 2016
December 1, 2016
1.6 years
December 10, 2013
December 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The concentration of individual serum biomarkers
Investigation of pathways which may be dysregulated in cutaneous lupus lesions
Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)
Secondary Outcomes (2)
The concentration of individual urine biomarkers
Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)
The concentration of individual skin biomarkers
Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)
Study Arms (3)
Group 1: Healthy participants
20 healthy participants will be enrolled.
Group 2: DLE/SCLE without SLE
30 participants with Discoid Lupus Erythematosus/Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) without Systemic Lupus Erythematosus (SLE) will be enrolled.
Group 3: DLE/SCLE with SLE
30 participants with DLE/SCLE with SLE will be enrolled.
Interventions
Participants with LE will have 2 adjacent 4 mm punch biopsies collected from involved and uninvolved skin at one timepoint and again from the involved skin site approximately 12 weeks later. Healthy participants will have 2 adjacent 4 mm punch biopsies taken at one timepoint.
Blood for serum analyses will be taken from all participants. Blood for DNA analysis will only be taken from participants who consent to this separately.
Urine will be collected from all participants.
Eligibility Criteria
Healthy participants and participants with Discoid Lupus Erythematosus (DLE)/Subacute Cutaneous Lupus Erythematosus (SCLE) without Systemic Lupus Erythematosus (SLE) and DLE/SCLE with SLE will be observed.
You may qualify if:
- Have Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) with or without a diagnosis of Systemic Lupus Erythematosus (SLE)
- Active DLE or active SCLE confirmed by histological analysis (for participants with DLE or SCLE without SLE)
- Confirmed diagnosis of SLE using American College of Rheumatology criteria and has current or historical positive antinuclear antibodies (ANA) or anti double-stranded deoxyribonucleic acid (anti-dsDNA) (for participants with DLE or SCLE with SLE)
- An active skin lesion that can be biopsied (for participants with lupus erythematosus)
You may not qualify if:
- Known or thought to have a diagnosis of drug-induced lupus
- An active skin disease that is not a manifestation of lupus erythematosus
- Has an acute cutaneous lupus erythematosus rash only
- If taking anti-malarial therapy has not been on a stable dose for at least 8 weeks before Day 1
- Participants treated with greater than 10mg/day of prednisone therapy or equivalent in the last 4 weeks prior to Day 1
- Positive serology for human immunodeficiency virus antibody, hepatitis B virus, or hepatitis C virus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Unknown Facility
La Jolla, California, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Lansing, Michigan, United States
Unknown Facility
Neptune City, New Jersey, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Berlin, Germany
Unknown Facility
Kiel, Germany
Unknown Facility
Chihuahua City, Mexico
Unknown Facility
Jalisco, Mexico
Unknown Facility
Mexico City, Mexico
Unknown Facility
Gdansk, Poland
Unknown Facility
Krakow, Poland
Unknown Facility
Wroclaw, Poland
Unknown Facility
Taichung, Taiwan
Unknown Facility
Taipei, Taiwan
Unknown Facility
Leeds, United Kingdom
Unknown Facility
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2013
First Posted
January 13, 2014
Study Start
October 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
December 16, 2016
Record last verified: 2016-12