NCT00585650

Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This multicenter investigation is a 12 week, double-blind, randomized trial of etanercept, 50 mg twice weekly versus placebo in subjects with palmoplantar psoriasis (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 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 patients (both treatment and placebo arms) will be treated with etanercept 50 mg twice a week (BIW) for an additional 12 weeks.

Conditions

• Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	Etanercept	Subcutaneous injections 50 mg Etanercept will occur twice weekly over a 12-week treatment period.
OTHER	Placebo injections	Placebo injections twice weekly for 12 weeks.

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2008-01-03
• Last updated: 2023-08-18
• Results posted: 2011-11-08

Locations

3 sites across 1 country: United States