A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
NCT ID: NCT02034344
Last Updated: 2016-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
77 participants
OBSERVATIONAL
2013-10-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1: Healthy participants
20 healthy participants will be enrolled.
Skin biopsy
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 collection
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 collection
Urine will be collected from all participants.
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.
Skin biopsy
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 collection
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 collection
Urine will be collected from all participants.
Group 3: DLE/SCLE with SLE
30 participants with DLE/SCLE with SLE will be enrolled.
Skin biopsy
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 collection
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 collection
Urine will be collected from all participants.
Interventions
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Skin biopsy
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 collection
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 collection
Urine will be collected from all participants.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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La Jolla, California, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Lansing, Michigan, United States
Neptune City, New Jersey, United States
Charlotte, North Carolina, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Salt Lake City, Utah, United States
Berlin, , Germany
Kiel, , Germany
Chihuahua City, , Mexico
Jalisco, , Mexico
Mexico City, , Mexico
Gdansk, , Poland
Krakow, , Poland
Wroclaw, , Poland
Taichung, , Taiwan
Taipei, , Taiwan
Leeds, , United Kingdom
London, , United Kingdom
Countries
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Other Identifiers
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NOCOMPOUNDLUP0001
Identifier Type: OTHER
Identifier Source: secondary_id
CR102355
Identifier Type: -
Identifier Source: org_study_id