Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis

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

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

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Etanercept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Etanercept|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis