Clinical Trial: A Non-drug Study Profiling Cutaneous Lupus

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Cross-Sectional Study in Subjects With Active Cutaneous Lupus Erythematosus

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

Detailed Summary: 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.
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome: Assessment of biomarkers in skin biopsies [ Time Frame: Day 1 ]

Investigation of pathways which may be dysregulated in cutaneous lupus lesions.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Urine Biomarkers analysis [ Time Frame: Day 1 ]
    The presence of potential biomarkers of disease activity will be explored in urine.
  • Blood Biomarkers analysis [ Time Frame: Day 1 ]
    The presence of potential biomarkers of disease activity will be explored in blood.


Original Secondary Outcome: Same as current

Information By: Janssen Research & Development, LLC

Dates:
Date Received: August 12, 2013
Date Started: April 2013
Date Completion:
Last Updated: September 11, 2014
Last Verified: September 2014