This study is being done to test a drug called etanercept (Enbrel®). Etanercept has been
approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic moderate
to severe plaque psoriasis (PsO), for use in reducing the signs and symptoms of moderately to
severely active rheumatoid arthritis (RA) in adults and children, and psoriatic arthritis
(PsA) and ankylosing spondylitis (AS) in adults. It is available by prescription for the
treatment of PsO, RA, PsA, and AS. Etanercept is approved for injection under the skin at a
dose of 50 mg per week in patients with psoriasis.
The purpose of this study is to determine whether etanercept is safe and effective for the
treatment of hidradenitis. Another purpose of this study is to determine the impact of
etanercept treatment of hidradenitis on skin related to quality of life.
The skin lesions typically associated with hidradenitis are thought to be partly due to a
blockage that occurs in sweat glands, called apocrine ducts, which become inflamed and
eventually destroyed. A protein found in the body called tumor necrosis factor alpha, or TNF-
α, is a hormone that causes this inflammation or swelling. The study drug, etanercept, blocks
the action of TNF- α. By blocking the action of TNF-α, etanercept may provide a reduction in
the signs and symptoms of hidradenitis.
This study will take place at the University of Pennsylvania and will involve up to 21
participants ages 18 and up. Approximately 21 subjects will participate at the University of
Pennsylvania.
Each patient will participate in this study for a maximum of 6 months. The study consists of
a screening visit, baseline assessment visit (Day 1), a treatment period (Week 2 - Week 14),
and a one month follow-up visit (Week 18 visit). The total duration of the study will be
approximately 2 years.