A Non-drug Study Profiling Cutaneous Lupus

Lupus Erythematosus, Systemic Clinical Trial

Official title:

Cross-Sectional Study in Subjects With Active Cutaneous Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923415
• Other study ID #: CR101971
• Secondary ID: 2013-001531-46NO
• Status: Completed
• Phase: Phase 0
• First received: August 12, 2013
• Last updated: September 11, 2014
• Start date: April 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• have active DLE or active SCLE confirmed by histological analysis

• 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 an active skin disease other than CLE

• 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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

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

Intervention

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).
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of biomarkers in skin biopsies	Investigation of pathways which may be dysregulated in cutaneous lupus lesions.	Day 1	No
Secondary	Urine Biomarkers analysis	The presence of potential biomarkers of disease activity will be explored in urine.	Day 1	No
Secondary	Blood Biomarkers analysis	The presence of potential biomarkers of disease activity will be explored in blood.	Day 1	No