A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
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| ClinicalTrials.gov Identifier: NCT02034344 |
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Recruitment Status :
Completed
First Posted : January 13, 2014
Last Update Posted : December 16, 2016
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Brief Summary:
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 or disease | Intervention/treatment |
|---|---|
| Lupus Erythematosus, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus, Discoid Healthy | Procedure: Skin biopsy Procedure: Blood collection Procedure: Urine collection |
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.
| Study Type : | Observational |
| Actual Enrollment : | 77 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Longitudinal Study of Skin And Systemic Biomarkers In Subjects With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers |
| Study Start Date : | October 2013 |
| Actual Primary Completion Date : | May 2015 |
| Actual Study Completion Date : | May 2015 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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Group 1: Healthy participants
20 healthy participants will be enrolled.
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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. |
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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.
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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. |
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Group 3: DLE/SCLE with SLE
30 participants with DLE/SCLE with SLE will be enrolled.
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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. |
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) ]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) ]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) ]The presence of potential biomarkers of disease activity will be explored in blood.
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Healthy participants and participants with Discoid Lupus Erythematosus (DLE)/Subacute Cutaneous Lupus Erythematosus (SCLE) without Systemic Lupus Erythematosus (SLE) and DLE/SCLE with SLE will be observed.
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034344
Locations
| United States, California | |
| La Jolla, California, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| Lansing, Michigan, United States | |
| United States, New Jersey | |
| Neptune, New Jersey, United States | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States | |
| United States, Pennsylvania | |
| Duncansville, Pennsylvania, United States | |
| Philadelphia, Pennsylvania, United States | |
| United States, Utah | |
| Salt Lake City, Utah, United States | |
| Germany | |
| Berlin, Germany | |
| Kiel, Germany | |
| Mexico | |
| Chihuahua, Mexico | |
| Jalisco, Mexico | |
| Mexico City, Mexico | |
| Poland | |
| Gdansk, Poland | |
| Krakow, Poland | |
| Wroclaw, Poland | |
| Taiwan | |
| Taichung, Taiwan | |
| Taipei, Taiwan | |
| United Kingdom | |
| Leeds, United Kingdom | |
| London, United Kingdom | |
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT02034344 |
| Other Study ID Numbers: |
CR102355 NOCOMPOUNDLUP0001 ( Other Identifier: Janssen Research & Development, LLC ) |
| First Posted: | January 13, 2014 Key Record Dates |
| Last Update Posted: | December 16, 2016 |
| Last Verified: | December 2016 |
Keywords provided by Janssen Research & Development, LLC:
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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:
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Lupus Erythematosus, Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Discoid Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Skin Diseases |