NCT00134394

Etanercept With Tacrolimus for Psoriasis

Double-Blind, Placebo-Controlled, Bilateral Comparison of Topical Tacrolimus 0.1% vs. Placebo Ointment as Adjunctive Therapy for Patients With Moderate to Severe Psoriasis Who Are Candidates for or Poor Responders to Etanercept Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: University of Medicine and Dentistry of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to evaluate the efficacy of etanercept 50 mg subcutaneously (SQ) weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus placebo ointment twice daily.

Detailed description

The study is designed to evaluate the efficacy of etanercept 50 mg SQ weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus placebo ointment twice daily. Subjects will be either beginning etanercept therapy or already using a stable dose of etanercept when they begin to apply tacrolimus to half of their body and placebo ointment to the other half. The study is double blinded. Total duration of the study is 12 weeks.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Etanercept plus tacrolimus

Timeline

• Start date: 2005-02-01
• Completion: 2007-12-01
• First posted: 2005-08-24
• Last updated: 2008-08-07

Locations

1 site across 1 country: United States