A Non-drug Study Profiling Cutaneous Lupus

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01923415
First received: August 12, 2013
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Procedure: No intervention, skin biopsy
Procedure: No intervention, blood collection
Procedure: No intervention, urine collection
Phase 0

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Cross-Sectional Study in Subjects With Active Cutaneous Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Assessment of biomarkers in skin biopsies [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Investigation of pathways which may be dysregulated in cutaneous lupus lesions.


Secondary Outcome Measures:
  • Urine Biomarkers analysis [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The presence of potential biomarkers of disease activity will be explored in urine.

  • Blood Biomarkers analysis [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The presence of potential biomarkers of disease activity will be explored in blood.


Biospecimen Retention:   Samples With DNA

Blood from participants with discoid lupus erythematosus (DLE), subacute cutaneous lupus erythematosus (SCLE), and active systemic lupus erythematosus (SLE) with cutaneous involvement.


Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1: SLE
>=10 participants with systemic lupus erythematosus (SLE)
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.
Group 2: DLE
>=10 participants with discoid lupus erythematosus (DLE)
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.
Group 3: SCLE
>=10 participants with subacute cutaneous lupus erythematosus (SCLE)
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.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants have CLE (either DLE or SCLE) or SLE with cutaneous manifestations

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01923415

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
United States, Indiana
Recruiting
Indianapolis, Indiana, United States
United States, Texas
Active, not recruiting
Dallas, Texas, United States
Poland
Not yet recruiting
Lodz, Poland
Recruiting
Lodz, Poland
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Study Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01923415     History of Changes
Other Study ID Numbers: CR101971, 2013-001531-46, NOCOMPOUNDLUN0001
Study First Received: August 12, 2013
Last Updated: August 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen Research & Development, LLC:
Lupus Erythematosus, Subacute, Cutaneous
Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Active Cutaneous Lupus Erythematosus
Systemic Cutaneous Lupus Erythematosus
Skin Biopsy
Lesions

Additional relevant MeSH terms:
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Discoid
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Skin Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014