Back to resultsStudy Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis (PRISTINE)
Primary Purpose
Plaque Psoriasis, Psoriasis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Etanercept
Etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring Enbrel, Psoriasis, Topical Psoriasis, Wyeth Psoriasis, Active 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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
A
B
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
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).
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).
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.
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.
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.
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.
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).
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.
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through 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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00663052
Brief Title
Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis
Acronym
PRISTINE
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
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis, Psoriasis
Keywords
Enbrel, Psoriasis, Topical Psoriasis, Wyeth Psoriasis, Active Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
273 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
A
Arm Title
Group B
Arm Type
Experimental
Arm Description
B
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Description
ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Description
ETN 50 mg BIW for 12 weeks folowed ETN 50 mg QW for 12 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24
Description
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).
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
Description
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).
Time Frame
Baseline to Week 24
Title
Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
Description
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).
Time Frame
Baseline to Week 24
Title
Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
Description
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).
Time Frame
Baseline to week 24
Title
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
Description
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).
Time Frame
Baseline to Week 24
Title
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
Description
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).
Time Frame
Baseline to Week 24
Title
Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks
Description
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.
Time Frame
Baseline to Week 24
Title
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24
Description
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.
Time Frame
Baseline to Week 24
Title
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24
Description
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.
Time Frame
Baseline to Week 24
Title
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
Description
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.
Time Frame
Baseline to Week 24
Title
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
Description
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).
Time Frame
Baseline to Week 24
Title
Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24
Description
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.
Time Frame
Baseline to Week 24
Title
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24
Time Frame
Baseline to Week 24
Title
Change From Baseline in the Photographed Image of Lesions in Selected Participants
Description
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.
Time Frame
Baseline to Week 24
Title
Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24
Description
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.
Time Frame
From Week 12 to Week 24
Title
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12
Description
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.
Time Frame
Week 12
Title
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24
Description
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.
Time Frame
Week 24
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24
Description
SGA of Psoriasis: score based on participant's assessment of itching at a scale of 0 to 5; where 0 = no itching and 5 = severe itching.
Time Frame
Baseline to Week 24
Title
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24
Description
SGA of Joint Pain: score based on participant's assessment of joint pain at a scale of 0 to 5; where 0 = no pain and 5 = severe pain.
Time Frame
Baseline to Week 24
Title
Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24
Description
SGA of Psoriasis: score based on participant's assessment of psoriasis disease activity at a scale of 0 to 5; where 0 = good and 5 = severe.
Time Frame
Baseline to Week 24
Title
Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at Week 12
Description
PASE a participant-administered questionnaire and a simple scoring system to assist physicians in screening participants with psoriasis for evidence of psoriatic arthritis with two sub-scales: system sub-scale and function sub-scale. Total of 15 questions in both sub-scales (7 questions in system and 8 in function sub-scale) to score from 1 to 5; where 1 = strongly disagree and 5 = strongly agree. The total of system and function scores provides the total PASE score ranging from 15 to 75 where higher scores indicate greater severity.
Time Frame
Baseline, Week 12
Title
Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24
Description
Physician Psoriasis Satisfaction Questionnaire (PPSQ) included two global satisfaction questions to which physicians respond either 'satisfactory' or 'not satisfactory.' These are: 1) whether the participant's current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant's current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.
Time Frame
Baseline to Week 24
Title
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
Description
Physician Psoriasis Satisfaction Questionnaire (PPSQ) includes two global satisfaction questions to which physicians respond either 'satisfactory' or 'not satisfactory.' These are: 1) whether the participant's current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant's current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.
Time Frame
Baseline to Week 24
Title
Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)
Description
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) with Yes/No answers are summarized here.
Time Frame
Baseline to Week 24
Title
Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)
Description
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) with Yes/No answers are summarized here.
Time Frame
Baseline to Week 24
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24
Description
DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Time Frame
Baseline to Week 24
Title
Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index
Description
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (example "confined to bed"). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.
Time Frame
Baseline, Week 12 and Week 24
Title
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score
Description
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame
Baseline, Week 12 and Week 24
Title
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score
Description
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame
Baseline, Week 12 and Week 24
Title
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12
Description
WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).
Time Frame
Week 12
Title
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24
Description
WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).
Time Frame
Week 24
Title
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12
Description
MOS scale has 12 questions to assess sleep quality & quantity: 1)time to fall asleep, 2)hours of sleep/night in past 4 weeks,3)sleep not peaceful, 4)got enough sleep to feel rested in morning,5)awaken short of breath/headache 6)feel drowsy in day,7)trouble going to sleep, 8)wake up during sleep; trouble going back to sleep,9)trouble staying awake in day, 10)Snoring,11)take naps in day,12)get amount of sleep needed. Sleep problem index(SPI) I:mean of 4,5,7,8,9,12; SPI II:mean of 1,3,4,5,6,7,8,9,12. All reported responses are on scale:0-100, higher scores indicate greater intensity of attribute.
Time Frame
Week 12
Title
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24
Description
MOS: participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time Frame
Week 24
Title
Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores
Description
FACIT Fatigue questionnaire: Participant rated 13 items questionnaire to assess fatigue. For each question, participant rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue. The total FACIT-Fatigue score ranges from 0 to 52 and is the sum of non-missing item scores; divided by the number of non-missing items, then multiplied by 13. If more than 6 items were missing, the total score was missing.
Time Frame
Week 12 and Week 24
Title
Percentage of Participants With Emergency Room Visits
Description
As a part of pharmacoeconomic questionnaire, the visits to emergency room were evaluated and presented as Yes or No.
Time Frame
Week 12 and Week 24
Title
Mean Number of Emergency Room Days
Description
As a part of pharmacoeconomic questionnaire, mean number of emergency room days were summarized.
Time Frame
Week 12 and Week 24
Title
Percentage of Participants With Doctor Visits
Description
As a part of pharmacoeconomic questionnaire, the percentage of participants who had doctor visits were presented as Yes or No.
Time Frame
Week 12 and Week 24
Title
Mean Number of Doctor Visits
Description
As a part of pharmacoeconomic questionnaire, the mean number of doctor visits were summarized.
Time Frame
Week 12 and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
01114
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
01199
Country
Argentina
Facility Name
Pfizer Investigational Site
City
San Miguel
State/Province
Buenos Aires
ZIP/Postal Code
1684
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Feldkirch
Country
Austria
Facility Name
Pfizer Investigational Site
City
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
B-1200
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Liege
ZIP/Postal Code
4020
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Jihlava
ZIP/Postal Code
586 33
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Ostrava- Poruba
ZIP/Postal Code
708 00
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Plzen-Bory
ZIP/Postal Code
305 99
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Pfizer Investigational Site
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Facility Name
Pfizer Investigational Site
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Pfizer Investigational Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
80802
Country
Germany
Facility Name
Pfizer Investigational Site
City
Osnabrueck
ZIP/Postal Code
49078
Country
Germany
Facility Name
Pfizer Investigational Site
City
Athens
ZIP/Postal Code
124 62
Country
Greece
Facility Name
Pfizer Investigational Site
City
Athens
ZIP/Postal Code
16121
Country
Greece
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Catanzaro
ZIP/Postal Code
88110
Country
Italy
Facility Name
Pfizer Investigational Site
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Gangnam-gu
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45190
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon / Mexico
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Santiago de Compostela
State/Province
La Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Pfizer Investigational Site
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Taipei TOC
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Bangkok
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
25994179
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.
Results Reference
derived
PubMed Identifier
25913550
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881A6-4425&StudyName=Study%20Evaluating%20Etanercept%20for%20the%20Treatment%20of%20Moderate%20to%20Severe%20Psoriasis
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis
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