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Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Etanercept

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT00195507

First Posted

September 13, 2005

Last Updated

February 20, 2013

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00195507

Brief Title

Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

December 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

720 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Etanercept

Primary Outcome Measure Information:

Title

Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks

Description

Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).

Time Frame

54 weeks

Secondary Outcome Measure Information:

Title

Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline

Description

Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe.

Time Frame

54 weeks

Title

Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear"

Description

Time Frame

54 weeks

Title

Number of Patients With Survey Response of "Somewhat Satisfied" or Better

Description

Time Frame

54 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: