Etanercept for Treatment of Hidradenitis
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: etanercept
Intervention description: etanercept 50 mg/week subcutaneous injection
Intervention MeSH terms: Etanercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: clinical trial; efficacy; etanercept; hidradenitis suppurativa; quality of life; safety; tnf

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 one month follow-up visit (Week 18 visit). The total duration of the study will be
      approximately 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be able to give informed consent.

          -  Severe hidradenitis suppurativa clinically confirmed by the investigator and defined
             as recurrent abscesses, with 4 or more lesions (e.g. nodules or abscesses) with sinus
             track and scar formation (e.g. Stage II or III disease) that has not responded to
             previous standard therapies such as topical or oral antibiotics, or intralesional
             injections of steroids.

          -  Age 18 or older.

          -  Willingness to use at least one form of effective contraception during the study
             period and for one month after discontinuation of etanercept if female and of child
             bearing capacity or if male. If the patient elects to use a hormonal form of
             contraception then the patient must be on the same form of hormonal contraception for
             90 days prior to the start of Etanercept and must plan to continue using the same form
             of hormonal contraception for the duration of the study (e.g. until week 18).

        Exclusion Criteria:

          -  Use of oral or topical antibiotics, isotretinoin, or intralesional steroids within 30
             days prior to day 0 or at any time during the study treatment period.

          -  Use of systemic immunosuppressants within 90 days prior to day 0 of this study.

          -  Use of an investigational medication 90 days prior to day 0 of this study.

          -  Use of a live vaccine 90 days prior to day 0 of this study.

          -  Any previous use of TNF- α inhibitors.

          -  If using a hormonal form of contraception, the patient will be excluded if they have
             not used the same form of hormonal contraception for 90 days prior to the start of the
             etanercept (e.g. day 0) or are not willing to continue the use of the same form of
             hormonal contraception for the duration of the study.

          -  Active infection within 30 days of day 0 of the study that is moderate (discomfort
             sufficient to reduce or affect normal daily activity) or severe (incapacitating with
             inability to work or perform normal daily activities) or requires treatment with
             antibiotics.

          -  History of tuberculosis or other mycobacterial disease or positive screening visit
             purified protein derivative (PPD) (≥ 5 mm).

          -  Known history of an immuno-suppressing disease (e.g. HIV)

          -  Clinically significant abnormality in liver function, renal function, chemistry panel
             or complete blood count (CBC) (aspartate aminotransferase (AST) or alanine
             aminotransferase (ALT) ≥ 2 times the laboratory's upper limit of normal, hemoglobin <
             10.0 g/dL, platelet count <125,000/cm3, white blood count <3,500 cells/cm3 or > 15,000
             cells/cm3, or serum creatinine ≥ 2.0 mg/dL) or severe co-morbidities defined as
             diabetes mellitus requiring insulin, congestive heart failure, history of myocardial
             infarction, unstable angina, uncontrolled hypertension (systolic blood pressure > 180
             mmHg or diastolic blood pressure >110 mmHg), severe pulmonary disease (requiring
             oxygen therapy), history of cancer within 5 years (other than resected basal cell or
             squamous cell carcinoma and in situ cervical cancer), known history of active
             hepatitis B or C or HIV infection, history of demyelinating diseases or lupus.

          -  Pregnancy or lactation

          -  History of alcohol or drug abuse within 12 months of screening visit