Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis

Psoriasis Clinical Trial

Official title:

A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects With Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195507
• Other study ID #: 0881A6-101764
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 20, 2013
• Start date: December 2004
• Est. completion date: February 2007

Study information

• Verified date: April 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Etanercept

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Netherlands,  Norway,  Poland,  Portugal,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 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).	54 weeks	No
Secondary	Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline	Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe.	54 weeks	No
Secondary	Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear"	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.	54 weeks	No
Secondary	Number of Patients With Survey Response of "Somewhat Satisfied" or Better	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.	54 weeks	Yes