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
29 participants
OBSERVATIONAL
2013-04-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Group 1: SLE
\>=10 participants with systemic lupus erythematosus (SLE)
No intervention, skin biopsy
All participants will have 2 adjacent 4 mm punch biopsies collected from uninvolved and involved skin (a total of 4 biopsies).
No intervention, blood collection
Blood for serum analyses will be taken from all participants, blood for DNA analysis only from subjects who consent to this separately.
No intervention, urine collection
Urine will be collected from all participants.
Group 2: DLE
\>=10 participants with discoid lupus erythematosus (DLE)
No intervention, skin biopsy
All participants will have 2 adjacent 4 mm punch biopsies collected from uninvolved and involved skin (a total of 4 biopsies).
No intervention, blood collection
Blood for serum analyses will be taken from all participants, blood for DNA analysis only from subjects who consent to this separately.
No intervention, urine collection
Urine will be collected from all participants.
Group 3: SCLE
\>=10 participants with subacute cutaneous lupus erythematosus (SCLE)
No intervention, skin biopsy
All participants will have 2 adjacent 4 mm punch biopsies collected from uninvolved and involved skin (a total of 4 biopsies).
No intervention, blood collection
Blood for serum analyses will be taken from all participants, blood for DNA analysis only from subjects who consent to this separately.
No intervention, urine collection
Urine will be collected from all participants.
Interventions
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No intervention, skin biopsy
All participants will have 2 adjacent 4 mm punch biopsies collected from uninvolved and involved skin (a total of 4 biopsies).
No intervention, blood collection
Blood for serum analyses will be taken from all participants, blood for DNA analysis only from subjects who consent to this separately.
No intervention, urine collection
Urine will be collected from all participants.
Eligibility Criteria
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Inclusion Criteria
* have a confirmed diagnosis of SLE with SLE Disease Activity Index (SLEDAI) of \>6 and current or historical positive ANA or anti-dsDNA
* have an active skin lesion that can be biopsied
* if using hydroxychloroquine or chloroquine, must be on stable doses for at least 2 months prior to screening.
Exclusion Criteria
* have any known malignancy within the previous 5 years (with the exception of a non-melanoma skin cancer that has been treated with no evidence of recurrence)
* have used a topical corticosteroid on active lesion
* have donated blood (volume \>=500 mL) within 56 days prior to screening
* has been treated with drugs that are associated with CLE induction within 2 months prior to the screening
* have been treated with \>10 mg/day prednisone therapy or equivalent in the last 4 weeks prior to screening.
18 Years
70 Years
ALL
No
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 Study
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Indianapolis, Indiana, United States
Dallas, Texas, United States
Lodz, , Poland
Countries
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Other Identifiers
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2013-001531-46
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NOCOMPOUNDLUN0001
Identifier Type: OTHER
Identifier Source: secondary_id
CR101971
Identifier Type: -
Identifier Source: org_study_id
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