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

NCT02034344 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 77

Last updated 2016-12-16

No results posted yet for this study

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.

Conditions

  • Lupus Erythematosus, Cutaneous
  • Lupus Erythematosus, Systemic
  • Lupus Erythematosus, Discoid
  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States
  • Germany
  • Mexico
  • Poland
  • Taiwan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02034344 on ClinicalTrials.gov