NCT01923415

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2013

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

1.3 years

First QC Date

August 12, 2013

Last Update Submit

September 11, 2014

Conditions

Lupus Erythematosus, CutaneousLupus Erythematosus, SystemicLupus Erythematosus, Discoid

Keywords

Lupus Erythematosus, Subacute, CutaneousLupus Erythematosus, SystemicLupus Erythematosus, DiscoidActive Cutaneous Lupus ErythematosusSystemic Cutaneous Lupus ErythematosusSkin BiopsyLesions

Outcome Measures

Primary Outcomes (1)

  • Assessment of biomarkers in skin biopsies

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

    Day 1

Secondary Outcomes (2)

  • Urine Biomarkers analysis

    Day 1

  • Blood Biomarkers analysis

    Day 1

Study Arms (3)

Group 1: SLE

\>=10 participants with systemic lupus erythematosus (SLE)

Procedure: No intervention, skin biopsyProcedure: No intervention, blood collectionProcedure: No intervention, urine collection

Group 2: DLE

\>=10 participants with discoid lupus erythematosus (DLE)

Procedure: No intervention, skin biopsyProcedure: No intervention, blood collectionProcedure: No intervention, urine collection

Group 3: SCLE

\>=10 participants with subacute cutaneous lupus erythematosus (SCLE)

Procedure: No intervention, skin biopsyProcedure: No intervention, blood collectionProcedure: No intervention, urine collection

Interventions

No intervention, skin biopsyPROCEDURE

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

Group 1: SLEGroup 2: DLEGroup 3: SCLE
No intervention, blood collectionPROCEDURE

Blood for serum analyses will be taken from all participants, blood for DNA analysis only from subjects who consent to this separately.

Group 1: SLEGroup 2: DLEGroup 3: SCLE
No intervention, urine collectionPROCEDURE

Urine will be collected from all participants.

Group 1: SLEGroup 2: DLEGroup 3: SCLE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Lodz, Poland

Location

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.

MeSH Terms

Conditions

Lupus Erythematosus, CutaneousLupus Erythematosus, SystemicLupus Erythematosus, Discoid

Interventions

Urine Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Janssen Research & Development, LLC Clinical Study

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2013

First Posted

August 15, 2013

Study Start

April 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

US(2)PL(1)