Phase 4 N=273 Randomized Double-blind Treatment

Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis

Plaque Psoriasis · Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT00663052 ↗

Enrolled (actual)

273

Serious AEs

2.6%

Results posted

Apr 2012

Primary outcome: Primary: Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24 — 78.2; 59.9 Percentage of participants — p=0.0015

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Etanercept (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24	78.2; 59.9	0.0015 sig
SECONDARY Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24	9.0; 5.9; 38.3; 20.4; 71.4; 51.8	0.3605
SECONDARY Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24	1.5; 0.0; 6.0; 4.4; 35.3; 21.9	0.2435
SECONDARY Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24	0.0; 0.0; 0.8; 0.7; 9.8; 5.8	1.0000
SECONDARY Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24	0.0; 0.0; 0.0; 0.7; 0.0; 1.5	1.0000
SECONDARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24	-4.5; -3.2; -8.7; -6.8; -13.6; -10.6	0.0103 sig
SECONDARY Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks	57; 57; 85; 113; 141; 171	<0.0001 sig
SECONDARY Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24	0.0; 0.0; 0.0; 0.7; 1.5; 1.5	1.0000
SECONDARY Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24	0.8; 2.2; 12.8; 6.6; 33.8; 18.2	0.6223
SECONDARY 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	27.1; 22.1; 46.6; 38.0; 72.9; 59.1	0.3956
SECONDARY 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	85; 114; 53; 57	0.0003 sig
SECONDARY Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24	-0.4; -0.3; -0.9; -0.7; -1.4; -1.1	0.0193 sig
SECONDARY Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24	-1.8; -0.3; -5.3; -3.1; -13.4; -8.4	—
SECONDARY Change From Baseline in the Photographed Image of Lesions in Selected Participants	—	—
SECONDARY Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24	89.5; 89.1; 85.0; 81.0; 86.5; 82.5	1.0000
SECONDARY Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12	3.2; 2.6; 3.3; 2.7; 3.2; 2.5	—
SECONDARY Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24	3.2; 2.8; 3.4; 3.0; 3.3; 2.9	—

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.

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00663052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.