Clinical Trial: Etanercept for Treatment of Hidradenitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Open Label Clinical Trial of Etanercept for the Treatment of Hidradenitis Suppurativa

Brief Summary:

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

Detailed Summary:

Purpose: The primary objective of this study is to determine the safety and estimate the efficacy of etanercept for the treatment of hidradenitis suppurativa. The secondary objective of this study is to determine the impact of etanercept treatment of hidradenitis suppurativa on skin related quality of life.

Duration:

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.

Subject Recruitment and Selection:

It is planned that enrollment will be 12-21 patients.

Background:

Hidradenitis suppurativa is a physically, psychologically, and socially disabling disease characterized by inflammatory, cystic papules and nodules affecting the underarms, groin, perineum, and breasts. Lesions can become erosive and often develop deep abscesses and sinus tracts and drain foul smelling pus. Left untreated, hidradenitis can result in permanent scarring. In the most severe cases, characterized by chronic ulceration and granulation, there may be an increased risk of aggressive squamous cell carcinoma.

Current treatment of hidradenitis consists of intra-lesional injections of steroids, topical and/or systemic antibiotics, hormonal therapy, and isotretinoin. For many patients with severe hidradenitis (stage II and III), these therapies are often ineffective. Patients with stage II and III hidradenitis often require surgical excision of the affected area (a highl
Sponsor: University of Pennsylvania

Current Primary Outcome: Physician's Global Assessment Score - Response Rate (Percentage) [ Time Frame: 12 weeks ]

Original Primary Outcome: The primary objective of this study is to determine the safety and estimate the efficacy of etanercept for the treatment of hidradenitis suppurativa

Current Secondary Outcome:

• Number of Lesions (Response Rate - Percentage) [ Time Frame: 12 weeks ]
  A physician assessed number of lesions as baseline and week 12. Responders were defined as those achieving at least a 50% reduction in number of lesions. A response rate was calculated as percentage of patients classified as responders.
• Patient Global Assessment [ Time Frame: 12 weeks ]

  The Patient Global Assessment asked patients to rate the extent of hidradenitis activity compared to when the patient started treatment with etanercept (day 0 of study). The scale included a selection of:

  Much worse than before treatment Moderately worse (about 50% more disease activity) A little worse Same A little improved Moderately improved (about 50% reduction in disease activity) Much better than before treatment (no active disease or almost no active disease)

• Patient's Pain Score [ Time Frame: 12 weeks ]
  Patient's were asked to self-report their pain on a 100-mm visual analog scale (with 0 corresponding to no pain and 100 mm corresponding to severe pain). Responders were defined as those achieving at least a 50% reduction in pain score from baseline to week 12. Reponse rate was calculated as the percentage of patients classified as responders.
• Dermatology Life Quality Index Score (DLQI) [ Time Frame: 12 weeks ]

  The DLQI is a dermatology-specific health-related quality of life measure. The effect on a patient's life is as follows: 0-1=none; 2-5=small; 6-10=moderate; 11-20=very large; and 21-30=extremely large. Responders were defined as those who achieved a 50% improvement in the DLQI score.

  Response rates were calculated as the percentage of participants achieving a response.

Original Secondary Outcome: The secondary objective of this study is to determine the impact of etanercept treatment of hidradenitis suppurativa on skin related quality of life

Information By: University of Pennsylvania

Dates:
Date Received: April 11, 2005
Date Started: April 2005
Date Completion:
Last Updated: January 4, 2011
Last Verified: January 2011