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Lupus Erythematosus, CutaneousNCT01923415

A Non-drug Study Profiling Cutaneous Lupus

An observational study of Lupus Erythematosus, Cutaneous and Lupus Erythematosus, Systemic, run by Janssen Research & Development, LLC at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Type of treatment
Surgery or procedure
How many people
29 participants
Where
3 sitesin 2 countries
Study dates
Apr 2013to Aug 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Study site

    Dallas, Texas

  • Study site

    Indianapolis, Indiana

Other trials in United States

Poland1 site

  • Study site

    Lodz

Other trials in Poland

About this study

Official title: Cross-Sectional Study in Subjects With Active Cutaneous Lupus Erythematosus

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

Read the 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.

Being tested
No intervention, skin biopsy, No intervention, blood collection, No intervention, urine collection
Keywords
Lupus Erythematosus, Subacute, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid, Active Cutaneous Lupus Erythematosus, Systemic Cutaneous Lupus Erythematosus, Skin Biopsy, Lesions
Medical subject headings
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention, skin biopsyProcedure or surgery

    All participants will have 2 adjacent 4 mm punch biopsies collected from uninvolved and involved skin (a total of 4 biopsies).

  • No intervention, blood collectionProcedure or surgery

    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 collectionProcedure or surgery

    Urine will be collected from all participants.

Study groups in NCT01923415
Study groupRoleWhat they receive
Group 1: SLE>=10 participants with systemic lupus erythematosus (SLE)
Receives: Procedure: No intervention, skin biopsy; Procedure: No intervention, blood collection; Procedure: No intervention, urine collection
Group 2: DLE>=10 participants with discoid lupus erythematosus (DLE)
Receives: Procedure: No intervention, skin biopsy; Procedure: No intervention, blood collection; Procedure: No intervention, urine collection
Group 3: SCLE>=10 participants with subacute cutaneous lupus erythematosus (SCLE)
Receives: Procedure: No intervention, skin biopsy; Procedure: No intervention, blood collection; Procedure: No intervention, urine collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of biomarkers in skin biopsies

    Investigation of pathways which may be dysregulated in cutaneous lupus lesions.

    Measured: Day 1

Secondary outcomes (2)

  1. Urine Biomarkers analysis

    The presence of potential biomarkers of disease activity will be explored in urine.

    Measured: Day 1

  2. Blood Biomarkers analysis

    The presence of potential biomarkers of disease activity will be explored in blood.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01923415
Sponsor's protocol ID
CR101971
Other IDs
2013-001531-46, NOCOMPOUNDLUN0001
Status last verified
Sep 2014
First submitted
12 Aug 2013
Last updated
12 Sep 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lupus Erythematosus, Cutaneous and Lupus Erythematosus, Systemic, run by Janssen Research & Development, LLC at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of biomarkers in skin biopsies (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01923415.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2014.

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