Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72 weeks.

Official Title
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An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects

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: - Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of this protocol) Exclusion Criteria: Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit Pregnant or breast-feeding females Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 mg<br>50 mg once weekly | Drug: Etanercept<br>* Enbrel 50 mg once weekly or 50 mg twice weekly<br>|
| Experimental: 100 mg<br>50 mg twice weekly | Drug: Etanercept<br>* Enbrel 50 mg once weekly or 50 mg twice weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject incidence of adverse events, including infectious episodes |  | 72 weeks | 
| Changes from baseline in laboratory values |  | 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original study |  | 72 weeks | 
| Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis |  | 72 weeks | 
| Patient Global Assessment of psoriasis |  | 72 weeks | 
| Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores |  | 72 weeks | 
| Changes from baseline in SF-36 Health Survey scores |  | 72 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, adults, skin, Phase 3, clinical trial, Amgen, etanercept, Enbrel®, moderate, severe, extension