An observational study in Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic and Lupus Erythematosus, Discoid, sponsored by Janssen Research & Development, LLC. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-09-12.
Sponsored by Janssen Research & Development, LLC · Observational
The purpose of this study is to characterize the clinical and molecular profiles of patients with cutaneous lupus.
This is a Phase 0, multiple-center observational study of biomarkers and clinical parameters in patients with lupus, including discoid lupus erythematosus (DLE), subacute cutaneous LE (SCLE) and active systemic lupus erythematosus (SLE). There is no study-related therapeutic intervention and this protocol will not restrict or introduce any medical interventions including medications. Study participants will undergo procedures that include collection of urine, blood samples, and skin biopsy. At least 30 participants (≥10 DLE, ≥10 SCLE, and ≥10 SLE) will be enrolled in this study. All participants will continue to be managed by their personal physicians per their standard of care. The data obtained in this study will help in the evaluation of new therapeutics for lupus and may facilitate lupus drug discovery. A blood sample for genomic analysis will be collected for research purposes from patients who provide consent and where local regulations permit. There will be a single sample collection time point for each patient. The safety assessments will include laboratory measurements (serum chemistry and hematology), monitoring of adverse events (AEs) related to study procedures, and physical examination.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 29 is below the median of 140 across 283 observational studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
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Participants have CLE (either DLE or SCLE) or SLE with cutaneous manifestations
Exclusion Criteria:
have an active skin disease other than CLE
\>=10 participants with systemic lupus erythematosus (SLE)
Procedure: No intervention, skin biopsy · Procedure: No intervention, blood collection · Procedure: No intervention, urine collection
\>=10 participants with discoid lupus erythematosus (DLE)
Procedure: No intervention, skin biopsy · Procedure: No intervention, blood collection · Procedure: No intervention, urine collection
\>=10 participants with subacute cutaneous lupus erythematosus (SCLE)
Procedure: No intervention, skin biopsy · Procedure: No intervention, blood collection · Procedure: No intervention, urine collection
All participants will have 2 adjacent 4 mm punch biopsies collected from uninvolved and involved skin (a total of 4 biopsies).
Blood for serum analyses will be taken from all participants, blood for DNA analysis only from subjects who consent to this separately.
Urine will be collected from all participants.
Assessment of biomarkers in skin biopsies
Investigation of pathways which may be dysregulated in cutaneous lupus lesions.
Time frame: Day 1
Urine Biomarkers analysis
The presence of potential biomarkers of disease activity will be explored in urine.
Time frame: Day 1
Blood Biomarkers analysis
The presence of potential biomarkers of disease activity will be explored in blood.
Time frame: Day 1
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC