Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and efficacy of different doses of etanercept for the treatment of moderate to severe psoriasis.

Official Title
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A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly and Etanercept 50 mg Once Weekly for the Treatment of Moderate to Severe Psoriasis

Conditions
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Plaque Psoriasis, Psoriasis

Intervention / Treatment
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* Drug: Etanercept
* Drug: Etanercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older at time of consent. Active, moderate to severe chronic plaque psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving greater than or equal to 10% body surface area (BSA) or PASI greater than or equal to 10. In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine and psoralen plus ultraviolet A radiation (PUVA) therapy. Exclusion Criteria: Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. Rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes. Active or recent (within 2 years) tuberculosis (TB) infection.

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>A | Drug: Etanercept<br>* ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks.<br>|
| Experimental: Group B<br>B | Drug: Etanercept<br>* ETN 50 mg BIW for 12 weeks folowed ETN 50 mg QW for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24 | PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). | Baseline to Week 24 | 
| Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). | Baseline to Week 24 | 
| Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). | Baseline to week 24 | 
| Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). | Baseline to Week 24 | 
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores were combined for final PASI. For each section, percent area of skin involved estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). | Baseline to Week 24 | 
| Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks | Time taken to achieve first PASI was calculated using Kaplan-Meier estimate and presented as median. PASI 50=50% improvement from baseline in PASI; PASI 75=75% improvement from baseline in PASI; PASI 90=90% improvement from baseline in PASI; PASI 100=100% improvement from baseline in PASI. PASI score percent improvement =100*(baseline score - visit score)/baseline score. | Baseline to Week 24 | 
| Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear. | Baseline to Week 24 | 
| Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear; 1 = Almost Clear. | Baseline to Week 24 | 
| Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear; 1 = Almost Clear and 2 = Mild. | Baseline to Week 24 | 
| Time to First Physician Global Assessment (PGA) of Psoriasis of Clear/Almost Clear (0, 1), or Clear/Almost Clear/Mild (0, 1, 2) Over 24 Weeks | Time taken to achieve PGA was calculated using Kaplan-Meier estimate and presented as median. Assessment of clear or almost clear or Mild = PGA score of 0 (no evidence) or 1 (minimal/faint) or 2 (mild plaque elevation, mild fine scales predominates or light red coloration). | Baseline to Week 24 | 
| Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. | Baseline to Week 24 | 
| Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 |  | Baseline to Week 24 | 
| Change From Baseline in the Photographed Image of Lesions in Selected Participants | Compare the before and after photographs with the clinical assessments (Psoriasis Area and Severity Index, Physician's Global Assessment) taken at the same time for illustration purposes. Measured as yes or no for change. | Baseline to Week 24 | 
| Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 | Moderate topical steroids to very potent topical steroids, topical vitamin D analogs, topical steroids in combination with vitamin D analogs, and anthralin compounds were prohibited for 14 days before the baseline visit until week 12. | From Week 12 to Week 24 | 
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 ( never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here. | Week 12 | 
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here. | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enbrel, Psoriasis, Topical Psoriasis, Wyeth Psoriasis, Active Psoriasis