A Non-drug Study Profiling Cutaneous Lupus

Completed

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

In brief

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

Key facts

Study ID

NCT01923415

Run by

Janssen Research & Development, LLC

People needed

29

Starts

2013-04-01

Expected to finish

2014-08-01

Last updated by the study team

2014-09-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Indianapolis, Indiana, United States
• Study site — Dallas, Texas, United States
• Study site — Lodz, Poland

Full record on ClinicalTrials.gov

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