Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Ha… (NCT00585650) | Clinical Trial Compass
CompletedPhase 1/2
Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet
United States20 participantsStarted 2007-05
Plain-language summary
The purpose of this research study is to see how well (compared to placebo) Enbrel® (etanercept) 50 mg twice a week for 12 weeks affects plaque psoriasis of the hands and/or feet (palmoplantar psoriasis).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Moderate to severe palmar plantar psoriasis based on physician's global assessment (PGA).
* 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
Exclusion Criteria:
* Previous treatment with Enbrel® (etanercept) or similar drugs
* Receipt of investigational drugs or "biologics" within 4 weeks of the screening visit.
* 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 initiation.
* 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) (≤25 mg/week) or Soriatane…
What they're measuring
1
The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks.