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

Completed

Conditions studied: Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid, Healthy

In brief

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

Key facts

Study ID

NCT02034344

Run by

Janssen Research & Development, LLC

People needed

77

Starts

2013-10-01

Expected to finish

2015-05-01

Last updated by the study team

2016-12-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — La Jolla, California, United States
• Study site — Chicago, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — Lansing, Michigan, United States
• Study site — Neptune City, New Jersey, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Berlin, Germany
• Study site — Kiel, Germany
• Study site — Chihuahua City, Mexico
• Study site — Jalisco, Mexico
• Study site — Mexico City, Mexico
• Study site — Gdansk, Poland
• Study site — Krakow, Poland
• Study site — Wroclaw, Poland
• Study site — Taichung, Taiwan
• Study site — Taipei, Taiwan
• Study site — Leeds, United Kingdom
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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