Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis

Phase 4

Completed

• Conditions: Psoriasis

• Registration Number: NCT00195507
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Study Completion: 2007-02
• Results First Submitted: 2009-03-31
• Status Verified: 2010-04
• Results First Submitted QC: 2010-04-07
• Results First Posted: 2010-05-04
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

• Stable, active plaque psoriasis
• Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine, PUVA or Fumarate

Exclusion Criteria

• Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of the study
• Systemic psoriasis therapy within 28 days prior

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks	54 weeks	Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).

Secondary Outcome Measures

Name	Time	Method
Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline	54 weeks	Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe.
Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear"	54 weeks	Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=sever psoriasis, 7=clear). This assessment measured the time (in days) from baseline to the visit where a patient achieved a PGA status of 0 or 1. Patients who did not achieve this status by their last visit were not included.
Number of Patients With Survey Response of "Somewhat Satisfied" or Better	54 weeks	Patients completed a patient satisfaction survey at baseline and throughout the study. Patients were asked to rate, based on their experienced during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 7-point scale: Very satisfied, Satisfied, Somewhat Satisfied, Neutral, Somewhat Dissatisfied, Dissatisfied and Very Dissatisfied.