Double-blind, Randomized, Placebo-controlled Study of Recombinant Human Tumor Necrosis Factor Receptor (p75) Fusion Protein Etanercept (Enbrel) in Patients With Moderate to Severe Plaque Psoriasis of the Hands and/or Feet
This 24-week multicenter study consists of two phases. The first phase is a 12 week,
double-blind, randomized trial of etanercept, 50 mg twice weekly versus placebo in subjects
with PPP. Subjects who meet the eligibility criteria will be randomized to either 50 mg
etanercept twice weekly or placebo. Subcutaneous injections will occur twice weekly at
approximately the same time of day over the first 12-week treatment period. The primary
efficacy endpoint will be assessed after 12 weeks of treatment. At the end of the first 12
weeks, all patient (both treatment and placebo arms) will be treated with etanercept 50 mg
twice a week (BIW) for an additional 12 weeks.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks
Psoriasis area and severity index (PASI) is the most widely used tool for the measurement of severity of psoriasis. This tool is used to assess the skin lesions of the entire body however, the palmoplantar psoriasis severity index is a modified form of the the PASI that is assessed for skin lesions of the hands and feet only. The severity is estimated by three clinical signs: erythema induration and desquamation. Severity parameters are measured on a scale of 0 to 4.. The sum of all three severity parameters is then calculated based on surface area affected.
Gerald D Weinstein, M.D.
University of California, Irvine
United States: Food and Drug Administration
|Wake Forest University School of Medicine||Winston-Salem, North Carolina 27157-1023|
|Dermatology Associates, PLLC||Seattle, Washington 98101|
|UC Irvine Dermatology Clinical Research Center||Irvine, California 92697|