NCT00663052
Completed
Phase 4
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
Overview
- Phase
- Phase 4
- Intervention
- Etanercept
- Conditions
- Plaque Psoriasis
- Sponsor
- Pfizer
- Enrollment
- 273
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
- •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.
Arms & Interventions
Group A
A
Intervention: Etanercept
Group B
B
Intervention: Etanercept
Outcomes
Primary Outcomes
Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24
Time Frame: 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).
Secondary Outcomes
- Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24(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(Baseline to Week 24)
- Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24(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(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(Baseline to Week 24)
- Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24(Baseline to Week 24)
- Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24(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(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(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(Baseline to Week 24)
- Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks(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(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)
- Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24(From Week 12 to Week 24)
- Change From Baseline in the Photographed Image of Lesions in Selected Participants(Baseline to Week 24)
- Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12(Week 12)
Study Sites (1)
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