NCT01923415

A Non-drug Study Profiling Cutaneous Lupus

Cross-Sectional Study in Subjects With Active Cutaneous Lupus Erythematosus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the clinical and molecular profiles of patients with cutaneous lupus.

Detailed description

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.

Conditions

• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Systemic
• Lupus Erythematosus, Discoid

Interventions

Type	Name	Description
PROCEDURE	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).
PROCEDURE	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.
PROCEDURE	No intervention, urine collection	Urine will be collected from all participants.

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-08-15
• Last updated: 2014-09-12

Locations

3 sites across 2 countries: United States, Poland