Clinical trial NCT01923415: A Non-drug Study Profiling Cutaneous Lupus
Official title: Cross-Sectional Study in Subjects With Active Cutaneous Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Keywords: Lupus Erythematosus, Subacute, Cutaneous
Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Active Cutaneous Lupus Erythematosus
Systemic Cutaneous Lupus Erythematosus
Skin Biopsy
Lesions
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2013-08-15
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants have CLE (either DLE or SCLE) or SLE with cutaneous manifestations

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of biomarkers in skin biopsies
timeFrame: Day 1
Secondary outcomes:
measure: Urine Biomarkers analysis
timeFrame: Day 1
measure: Blood Biomarkers analysis
timeFrame: Day 1
Other outcomes:
Locations:
city: Indianapolis
country: United States
state: Indiana
city: Dallas
country: United States
state: Texas
city: Lodz
country: Poland
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Study
role: STUDY_DIRECTOR
References: