Etanercept for Treatment of Hidradenitis
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Open Label Clinical Trial of Etanercept for the Treatment of Hidradenitis Suppurativa|
- Physician's Global Assessment Score - Response Rate (Percentage) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Efficacy was measured using the Physician Global Assessment (PGA). Responders were classified as those achieving at least a 50% reduction on the Physician Global Assessment score at week 12 compared with baseline. A response rate was calculated as the percentage of patients that were classified as responders at 12-weeks.
PGA was scored at baseline and at 12 weeks on a 100-mm visual analog scale, with 0 indicating no disease and 100-mm indicating severe disease.
- Number of Lesions (Response Rate - Percentage) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
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.
|Study Start Date:||April 2005|
|Study Completion Date:||November 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Experimental: Treatment arm
Open-label treatment with etanercept 50 mg/week subcutaneous injection
etanercept 50 mg/week subcutaneous injection
Other Name: Enbrel
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00107991
|Principal Investigator:||Joel Gelfand, MD||University of Pennsylvania|