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Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis

Primary Purpose

Moderate to Severe Psoriasis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Etanercept
Etanercept + Acitretin
Acitretin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Psoriasis focused on measuring Etanercept, Acitretin, Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI 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.
  • Negative urine pregnancy test before the first dose of study drug in all female patients

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.
  • Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
  • Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab (Raptiva®) and alefacept (Amevive®) is also prohibited.

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24
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 combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). 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 in Psoriasis Area and Severity Index (PASI 50) Score
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 combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). 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 Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
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. Assessment of clear = PGA score of 0 (no evidence).
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
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. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
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. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), 2 (mild).
Time to Achieve a PASI 50 Score
PASI 50 defined as a 50% or greater improvement in PASI score from Baseline
Time to Achieve a PASI 75 Score
PASI 75 defined as a 75% or greater improvement in PASI score from Baseline
Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
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. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), or 2 (mild).
Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear
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. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).
Change From Baseline in the PGA of Psoriasis
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. Assessment of clear = PGA score of 0 (no evidence). Change = Week x, minus Baseline, where smaller scores indicate improvement.
Change From Baseline in the PASI Score
Combined assessment of lesion severity, area affected into single score; range:0(no disease) to 72(maximal disease).Body divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated:0(0%) to 6(90-100%), severity estimated by clinical signs: erythema, induration, desquamation; scale: 0(none) to 4(maximum). Final PASI = sum of severity parameters for each section * area score * weight of section(head:0.1,arm:0.2,body: 0.3, leg:0.4). Change=Week X-Baseline, smaller scores show improvement.
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Change from Baseline in the percentage of the surface area of the body affected by psoriasis. Change = Week x minus Baseline, where smaller scores indicate improvement.
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Participants were asked to rate the severity of their joint pain on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Participants were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Change From Baseline in SGA of Itching at Each Visit
Participants were asked to rate the severity of their psoriasis itching on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the overall appearance of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the flaking of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the redness of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on tightness in the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on bleeding of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on burning sensation of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on skin pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on joint pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their comfort level with their personal appearance. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their anxiety. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their depression. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their fatigue. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how others responded to their personal appearance at work/school. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how their skin affected social and leisure activities. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to respond to the statement "I would like to continue with my current psoriasis treatment". Responses were based on a 5-point scale: strongly disagree (0), disagree(1), neither agree nor disagree (2), agree (3), strongly agree (4). Change = Week X minus Baseline, where larger scores indicate improvement.
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a "yes" or "no", "Taking into account your psoriasis symptoms, the appearance of your skin and all other problems which psoriasis causes, do you consider that your current health state is satisfactory?" Percentage of participants who responded "yes" reported.
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a "yes" or "no", "Taking into account your psoriasis symptoms, the appearance of your skin, medicine side effects and medicine ease/difficulty of use, do you consider that your current psoriasis treatment is satisfactory?" Percentage of participants who responded "yes" reported.

Full Information

First Posted
July 7, 2009
Last Updated
March 12, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00936065
Brief Title
Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis
Official Title
A Multicenter, Randomized, Open Pilot Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly Followed Etanercept 25mg Twice Weekly, the Combination of Etanercept 25 mg Twice Weekly and Acitretin and Acitretin Alone in Patients With Moderate to Severe Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (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
To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Psoriasis
Keywords
Etanercept, Acitretin, Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Title
Group B
Arm Type
Experimental
Arm Title
Group C
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Etanercept
Other Intervention Name(s)
Etanercept 50mg followed by 25mg
Intervention Description
Etanercept at a dose of 50mg twice weekly for 12 weeks followed by 25mg twice weekly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Etanercept + Acitretin
Other Intervention Name(s)
Etancercept 25mg and Acitretin 10mg
Intervention Description
Combination of etanercept at a dose of 25mg twice weekly and acitretin 10mg BID for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Acitretin
Other Intervention Name(s)
Acitretin 10mg
Intervention Description
Acitretin at a dose of 10mg BID for 24 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24
Description
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 combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). 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 in Psoriasis Area and Severity Index (PASI 50) Score
Description
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 combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). 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
Weeks 2, 4, 8, 12, 18, and 24
Title
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
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. Assessment of clear = PGA score of 0 (no evidence).
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
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. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
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. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), 2 (mild).
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Time to Achieve a PASI 50 Score
Description
PASI 50 defined as a 50% or greater improvement in PASI score from Baseline
Time Frame
Baseline up to Week 24
Title
Time to Achieve a PASI 75 Score
Description
PASI 75 defined as a 75% or greater improvement in PASI score from Baseline
Time Frame
Baseline up to Week 24
Title
Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
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. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), or 2 (mild).
Time Frame
Baseline up to Week 24
Title
Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear
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. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).
Time Frame
Baseline up to Week 24
Title
Change From Baseline in the PGA of Psoriasis
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. Assessment of clear = PGA score of 0 (no evidence). Change = Week x, minus Baseline, where smaller scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18, and 24
Title
Change From Baseline in the PASI Score
Description
Combined assessment of lesion severity, area affected into single score; range:0(no disease) to 72(maximal disease).Body divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated:0(0%) to 6(90-100%), severity estimated by clinical signs: erythema, induration, desquamation; scale: 0(none) to 4(maximum). Final PASI = sum of severity parameters for each section * area score * weight of section(head:0.1,arm:0.2,body: 0.3, leg:0.4). Change=Week X-Baseline, smaller scores show improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Description
Change from Baseline in the percentage of the surface area of the body affected by psoriasis. Change = Week x minus Baseline, where smaller scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Description
Participants were asked to rate the severity of their joint pain on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Description
Participants were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12 ,18 and 24
Title
Change From Baseline in SGA of Itching at Each Visit
Description
Participants were asked to rate the severity of their psoriasis itching on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12 ,18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the overall appearance of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the flaking of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the redness of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on tightness in the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on bleeding of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on burning sensation of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on skin pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on joint pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their comfort level with their personal appearance. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their anxiety. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their depression. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their fatigue. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how others responded to their personal appearance at work/school. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how their skin affected social and leisure activities. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to respond to the statement "I would like to continue with my current psoriasis treatment". Responses were based on a 5-point scale: strongly disagree (0), disagree(1), neither agree nor disagree (2), agree (3), strongly agree (4). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a "yes" or "no", "Taking into account your psoriasis symptoms, the appearance of your skin and all other problems which psoriasis causes, do you consider that your current health state is satisfactory?" Percentage of participants who responded "yes" reported.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24
Title
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Description
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a "yes" or "no", "Taking into account your psoriasis symptoms, the appearance of your skin, medicine side effects and medicine ease/difficulty of use, do you consider that your current psoriasis treatment is satisfactory?" Percentage of participants who responded "yes" reported.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 18 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI 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. Negative urine pregnancy test before the first dose of study drug in all female patients 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. Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes. Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab (Raptiva®) and alefacept (Amevive®) is also prohibited.
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
Daejeon
State/Province
Korea
ZIP/Postal Code
301 721
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Gyeonggido
State/Province
Korea
ZIP/Postal Code
420 717
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
110 744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
130 702
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
137 701
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
152 703
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
S0
State/Province
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
135 710
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
138 736
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
431-070
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27455955
Citation
Lee JH, Youn JI, Kim TY, Choi JH, Park CJ, Choe YB, Song HJ, Kim NI, Kim KJ, Lee JH, Yoo HJ. A multicenter, randomized, open-label pilot trial assessing the efficacy and safety of etanercept 50 mg twice weekly followed by etanercept 25 mg twice weekly, the combination of etanercept 25 mg twice weekly and acitretin, and acitretin alone in patients with moderate to severe psoriasis. BMC Dermatol. 2016 Jul 25;16(1):11. doi: 10.1186/s12895-016-0048-z.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881A6-4625&StudyName=Study%20Evaluating%20the%20Efficacy%20and%20Safety%20of%20Etanercept%20and%20Acitretin%20in%20Korean%20Patient%20With%20Moderate%20to%20Severe%20Psoriasis%20%20
Description
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Learn more about this trial

Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis

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