The purpose of this research study is to see how well (compared to placebo) Enbrel«
(etanercept) 50 mg twice a week affects plaque psoriasis of the hands and/or feet
Minimum age: 18 Years.
Maximum age: 70 Years.
- Moderate to severe palmar plantar psoriasis based on physician's global assessment
- Between 18 and 70 years of age
- Negative urine pregnancy test at screening and at baseline
- Sexually active men and women of child-bearing potential must agree to use a
medically accepted form of contraception (birth control) during the exclusionary
medicine wash-out period and throughout the study.
- Ability to self inject study drug or have a designee who can do so
- Capable of understanding and giving written voluntary informed consent
- Previous treatment with Enbrel┬« (etanercept) or similar drugs
- Receipt of investigational drugs or "biologics" within 4 weeks of the screening
- Evidence of skin conditions (e. g. eczema) other than psoriasis that would interfere
with evaluations of the study medication.
- Receipt of any biologic medication within the previous 6 months that resulted in a
decreased white blood cell count (cells to help fight infections)
- Ultraviolet light treatment (e. g. UVB, PUVA) within one month prior to study drug
- Receipt of immune-suppressing drugs other than Rheumatrex┬« (methotrexate) or
Soriatane┬« (acetretin) within 4 weeks prior to the first dose of study drug.
Medications you would not be allowed to take during this study include for example,
Cytoxan┬« (cyclosporine), Imuran┬« (azathioprine), or Sulfazine┬« (sulfasalazine). If
you remain on Rheumatrex┬« (methotrexate) (ÔëĄ25 mg/week) or Soriatane┬« (acitretin) (ÔëĄ50
mg/day), you must be considered to have inadequate disease control in the opinion of
the investigator based on physician's global assessment. You must have been on a
stable dose of systemic treatment for at least 1 month prior to the start of the
study medication. You will be required to maintain a stable dose of the systemic
treatment throughout the study.
- Use of topical steroids in the past 14 days unless they have been used for longer
than 14 days and the severity of disease allows entry into study.
- Systemic steroid use (prednisone, etc).
- Prior or concurrent use of Cytoxan┬« (cyclophosphamide).
- Elevated liver tests; red blood cell count less than normal; decreased platelet count
(cells to help with blood clotting); decreased white blood cell count (cells to fight
infection); kidney insufficiency
- Any severe adverse event, infection or abnormal laboratory value at the time of the
screening visit that would preclude participation in the study
- Presence of a severe infection, less than 30 days prior to the screening visit or
between the screening visit and the first dose of study drug
- Pregnant or breast-feeding females.
- Significant concurrent medical diseases including: Uncompensated congestive heart
failure (heart is unable to pump as normal): Myocardial infarction (heart attack)
within 12 months of screening period; Unstable or stable angina pectoris (chest pains
related to your heart); Uncontrolled high blood pressure
- Severe lung disease requiring medical or oxygen therapy
- History of cancer (other than surgically removed skin cancer and in situ cervical
cancer) within 5 years of the screening visit
- History of tuberculosis
- Known to be HIV positive
- Rheumatoid arthritis
- Any neurologic demyelinating disease (such as multiple sclerosis or any neurologic
disease causing loss of sensation or loss of normal movement) or seizure disorder
- Current or history of psychiatric disease that would interfere with ability to comply
with the study protocol or give informed consent.
- History of alcohol or drug abuse.
- Not up-to-date with all immunizations in agreement with the current immunization
- Significant exposure to the varicella virus (chicken pox)
- Guttate or generalized pustular psoriasis
- Surgery or trauma within a month of baseline considered by the investigator to
represent a significant risk or interfere with patient evaluation.