Trial record 4 of 434 for:    "Lupus"

A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02034344
First received: December 10, 2013
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to obtain skin, blood, and urine samples from patients with active cutaneous lupus lesions and from healthy participants.


Condition Intervention Phase
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Healthy
Procedure: Skin biopsy
Procedure: Blood collection
Procedure: Urine collection
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Longitudinal Study of Skin And Systemic Biomarkers In Subjects With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The concentration of individual serum biomarkers [ Time Frame: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus) ] [ Designated as safety issue: No ]
    Investigation of pathways which may be dysregulated in cutaneous lupus lesions


Secondary Outcome Measures:
  • The concentration of individual urine biomarkers [ Time Frame: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus) ] [ Designated as safety issue: No ]
    The presence of potential biomarkers of disease activity will be explored in urine.

  • The concentration of individual skin biomarkers [ Time Frame: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus) ] [ Designated as safety issue: No ]
    The presence of potential biomarkers of disease activity will be explored in blood.


Estimated Enrollment: 80
Study Start Date: October 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1: Healthy participants
20 healthy participants will be enrolled.
Procedure: Skin biopsy
Participants with LE will have 2 adjacent 4 mm punch biopsies collected from involved and uninvolved skin at one timepoint and again from the involved skin site approximately 12 weeks later. Healthy participants will have 2 adjacent 4 mm punch biopsies taken at one timepoint.
Procedure: Blood collection
Blood for serum analyses will be taken from all participants. Blood for DNA analysis will only be taken from participants who consent to this separately.
Procedure: Urine collection
Urine will be collected from all participants.
Group 2: DLE/SCLE without SLE
30 participants with Discoid Lupus Erythematosus/Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) without Systemic Lupus Erythematosus (SLE) will be enrolled.
Procedure: Skin biopsy
Participants with LE will have 2 adjacent 4 mm punch biopsies collected from involved and uninvolved skin at one timepoint and again from the involved skin site approximately 12 weeks later. Healthy participants will have 2 adjacent 4 mm punch biopsies taken at one timepoint.
Procedure: Blood collection
Blood for serum analyses will be taken from all participants. Blood for DNA analysis will only be taken from participants who consent to this separately.
Procedure: Urine collection
Urine will be collected from all participants.
Group 3: DLE/SCLE with SLE
30 participants with DLE/SCLE with SLE will be enrolled.
Procedure: Skin biopsy
Participants with LE will have 2 adjacent 4 mm punch biopsies collected from involved and uninvolved skin at one timepoint and again from the involved skin site approximately 12 weeks later. Healthy participants will have 2 adjacent 4 mm punch biopsies taken at one timepoint.
Procedure: Blood collection
Blood for serum analyses will be taken from all participants. Blood for DNA analysis will only be taken from participants who consent to this separately.
Procedure: Urine collection
Urine will be collected from all participants.

Detailed Description:

This is a Phase 0 multi-center and longitudinal study of biomarkers and clinical parameters in patients with lupus erythematosus (LE). Approximately 80 participants (20 healthy participants and 60 patients with LE) will be enrolled. This will include 30 with Discoid Lupus Erythematosus/Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) without Systemic Lupus Erythematosus (SLE), and 30 with DLE/SCLE with SLE. All patients with LE will continue to be managed by their personal physicians per their standard-of-care. Study participants will undergo interventional procedures that include collection of urine, blood samples and skin biopsy. There will be a single sample collection timepoint for healthy participants and two sample collection timepoints for LE patients, separated by approximately 12 weeks. A blood sample for genomic analysis will be collected for research purposes from patients who provide consent and where local regulations permit. The data obtained in this study will be used in the evaluation of new therapies for lupus and may help in developing new treatments. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examinations. The total duration of study participation will be approximately 11 days for healthy participants and 95 days for patients with LE.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) with or without a diagnosis of Systemic Lupus Erythematosus (SLE)
  • Active DLE or active SCLE confirmed by histological analysis (for participants with DLE or SCLE without SLE)
  • Confirmed diagnosis of SLE using American College of Rheumatology criteria and has current or historical positive antinuclear antibodies (ANA) or anti double-stranded deoxyribonucleic acid (anti-dsDNA) (for participants with DLE or SCLE with SLE)
  • An active skin lesion that can be biopsied (for participants with lupus erythematosus)

Exclusion Criteria:

  • Known or thought to have a diagnosis of drug-induced lupus
  • An active skin disease that is not a manifestation of lupus erythematosus
  • Has an acute cutaneous lupus erythematosus rash only
  • If taking anti-malarial therapy has not been on a stable dose for at least 8 weeks before Day 1
  • Participants treated with greater than 10mg/day of prednisone therapy or equivalent in the last 4 weeks prior to Day 1
  • Positive serology for human immunodeficiency virus antibody, hepatitis B virus, or hepatitis C virus
  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: NCT02034344

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

  Show 27 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02034344     History of Changes
Other Study ID Numbers: CR102355, NOCOMPOUNDLUP0001
Study First Received: December 10, 2013
Last Updated: September 24, 2014
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission

Keywords provided by Janssen Research & Development, LLC:
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Healthy
Active Cutaneous Lupus Erythematosus
Longitudinal Study
Biomarkers
Subacute Cutaneous Lupus Erythematosus
Skin Biopsy

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

ClinicalTrials.gov processed this record on October 01, 2014