The Immunological Basis for Treatment Resistance to Anti-TNF Treatments
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: etanercept
Intervention description: 100 mg Etanercept injections per week (2 separate single-use pre-filled 50 mg subcutaneous injections taken on two separate days) for 3 months
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Psoriasis; ENBREL; etanercept; anti-TNF

Summary:

      The purpose of this study is to determine the relationship between two types of cell signals,
      type I interferon (IFN) and tumor necrosis factor (TNF), in psoriatic skin prior to and
      during treatment with etanercept and correlate that information with the degree of the
      improvement in the psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age at screening.

          -  Clinically stable moderate to severe plaque psoriasis at screening and baseline.

          -  Subject must be:

               -  A man or

               -  A woman who is surgically sterile or at least 3 years postmenopausal or

               -  A woman of childbearing potential who has had a negative pregnancy test within 7
                  days before the first dose of study drug.

          -  If the subject is sexually active, (s)he must agree to use a medically acceptable form
             of contraception during screening and throughout the study.

        Exclusion Criteria:

          -  Grade 3 or 4 adverse events or infections within 28 days before screening, or between
             the screening visit and drug initiation.

          -  Active or chronic infection within 4 weeks before screening visit, or between the
             screening and baseline visits.

          -  Evidence of skin conditions other than psoriasis that would interfere with the
             evaluations of the effect of study medication on psoriasis.

          -  Use of oral psoralen with ultraviolet A (PUVA), oral retinoids, cyclosporine,
             alefacept, or any other systemic anti-psoriasis therapy within 28 days study drug
             initiation.

          -  Use of ulltraviolet B (UVB) therapy, topical steroids at no higher than moderate
             strength, topical vitamin A or D analog preparations, or anthralin with 14 days of
             study initiation.

          -  Prior or concurrent use of cyclophosphamide therapy

          -  Concurrent sulfasalazine therapy.

          -  Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to
             have antibodies to etanercept.

          -  Current enrollment in any other investigational device or investigational drug
             trial(s), or receipt of any other investigational agent(s) within 28 days before
             baseline visit.

          -  Use of any biologic drugs within 28 days of study drug initiation.

          -  Concurrent use of Anakinra.

          -  Severe comorbidities (diabetes mellitus requiring insulin; congestive heart failure
             (CHF) of any severity or myocardial infarction or cerebrovascular accident or
             transient ischemic attack within 3 months of screening visit; unstable angina
             pectoris, uncontrolled hypertension (sitting systolic blood pressure (BP) <80 mm Hg or
             > 160 or diastolic BP > 100 mm Hg), oxygen-dependent severe pulmonary disease, history
             of cancer within 5 years (other than resected cutaneous basal or squamous cell
             carcinoma of the skin or in situ cervical cancer)

          -  Known history of tuberculosis (TB), or previous positive purified protein derivative
             (PPD) test. Any mycobacterial disease or high risk factors for tuberculosis (TB), such
             as family member with TB, positive purified protein derivative (PPD) or taking
             anti-tuberculosis medication.

          -  Known HIV-positive status or known history of any other immuno-suppressing disease.

          -  Concurrent or history of psychiatric disease that would interfere with ability to
             comply with study protocol or give informed consent.

          -  History of alcohol or drug abuse within 12 months of screening visit.

          -  Latex sensitivity [Nota Bene: only applicable if they are using prefilled syringe or
             prefilled SureClick™ autoinjector presentations]

          -  Exposure to hepatitis B or hepatitis C or to high risk factors for hepatitis B or C,
             such as intravenous drug use in patient.

          -  Systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis,
             optic neuritis or seizure disorder.

          -  Use of a live vaccine 90 days prior to screening visit, or concurrent use of a live
             vaccine.

          -  Any condition or circumstances judged by the patient's physician[or the investigator
             or medically qualified study staff] to render this clinical trial detrimental or
             otherwise unsuitable for the patient's participation.

          -  History of non-compliance with other therapies.

          -  Pregnant or nursing females.

          -  Diagnosis of multiple sclerosis in first degree family relationship (parent, sibling
             or child)