Clinical trial NCT00663052: Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Psoriasis
Keywords: Enbrel
Psoriasis
Topical Psoriasis
Wyeth Psoriasis
Active Psoriasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
timeFrame: Baseline to Week 24
measure: Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
timeFrame: Baseline to Week 24
measure: Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
timeFrame: Baseline to week 24
measure: Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
timeFrame: Baseline to Week 24
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
timeFrame: Baseline to Week 24
measure: Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks
timeFrame: Baseline to Week 24
measure: Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24
timeFrame: Baseline to Week 24
measure: Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24
timeFrame: Baseline to Week 24
measure: 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
timeFrame: Baseline to Week 24
measure: 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
timeFrame: Baseline to Week 24
measure: Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24
timeFrame: Baseline to Week 24
measure: Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24
timeFrame: Baseline to Week 24
measure: Change From Baseline in the Photographed Image of Lesions in Selected Participants
timeFrame: Baseline to Week 24
measure: Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24
timeFrame: From Week 12 to Week 24
measure: Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12
timeFrame: Week 12
measure: Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24
timeFrame: Week 24
Other outcomes:
measure: Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24
timeFrame: Baseline to Week 24
measure: Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24
timeFrame: Baseline to Week 24
measure: Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24
timeFrame: Baseline to Week 24
measure: Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24
timeFrame: Baseline to Week 24
measure: Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24
timeFrame: Baseline to Week 24
measure: Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)
timeFrame: Baseline to Week 24
measure: Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)
timeFrame: Baseline to Week 24
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24
timeFrame: Baseline to Week 24
measure: Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index
timeFrame: Baseline, Week 12 and Week 24
measure: Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score
timeFrame: Baseline, Week 12 and Week 24
measure: Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score
timeFrame: Baseline, Week 12 and Week 24
measure: Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12
timeFrame: Week 12
measure: Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24
timeFrame: Week 24
measure: Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12
timeFrame: Week 12
measure: Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24
timeFrame: Week 24
measure: Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores
timeFrame: Week 12 and Week 24
measure: Percentage of Participants With Emergency Room Visits
timeFrame: Week 12 and Week 24
measure: Mean Number of Emergency Room Days
timeFrame: Week 12 and Week 24
measure: Percentage of Participants With Doctor Visits
timeFrame: Week 12 and Week 24
measure: Mean Number of Doctor Visits
timeFrame: Week 12 and Week 24
Locations:
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: San Miguel
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Feldkirch
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Jihlava
country: Czech Republic
facility: Pfizer Investigational Site
city: Ostrava- Poruba
country: Czech Republic
facility: Pfizer Investigational Site
city: Plzen-Bory
country: Czech Republic
facility: Pfizer Investigational Site
city: Bochum
country: Germany
facility: Pfizer Investigational Site
city: Erlangen
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt am Main
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Kiel
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Osnabrueck
country: Germany
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: Miskolc
country: Hungary
facility: Pfizer Investigational Site
city: Szeged
country: Hungary
facility: Pfizer Investigational Site
city: Catanzaro
country: Italy
facility: Pfizer Investigational Site
city: L'Aquila
country: Italy
facility: Pfizer Investigational Site
city: Gangnam-gu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Zapopan
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon / Mexico
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Santiago de Compostela
country: Spain
facility: Pfizer Investigational Site
state: La Coruña
city: Fuenlabrada
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Taipei TOC
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Kemeny L, Amaya M, Cetkovska P, Rajatanavin N, Lee WR, Szumski A, Marshall L, Mahgoub EY, Aldinc E. Effect of etanercept therapy on psoriasis symptoms in patients from Latin America, Central Europe, and Asia: a subset analysis of the PRISTINE trial. BMC Dermatol. 2015 May 21;15:9. doi: 10.1186/s12895-015-0028-8.
citation: Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. No abstract available.