Skip to main content
OpenTrials
Completed

NCT Number: NCT00936065

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Daejeon, Korea, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

etanercept

Drug

Etanercept at a dose of 50mg twice weekly for 12 weeks followed by 25mg twice weekly for 12 weeks

Other names: Etanercept 50mg followed by 25mg

Etanercept + Acitretin

Drug

Combination of etanercept at a dose of 25mg twice weekly and acitretin 10mg BID for 24 weeks

Other names: Etancercept 25mg and Acitretin 10mg

acitretin

Drug

Acitretin at a dose of 10mg BID for 24 weeks

Other names: Acitretin 10mg

Primary outcomes

  1. Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24

    Time frame: 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 outcomes

  1. Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score

    Time frame: Weeks 2, 4, 8, 12, 18, and 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).

  2. Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear

    Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 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. Assessment of clear = PGA score of 0 (no evidence).

  3. Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear

    Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 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. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).

  4. Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild

    Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 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. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), 2 (mild).

  5. Time to Achieve a PASI 50 Score

    Time frame: Baseline up to Week 24

    PASI 50 defined as a 50% or greater improvement in PASI score from Baseline

  6. Time to Achieve a PASI 75 Score

    Time frame: Baseline up to Week 24

    PASI 75 defined as a 75% or greater improvement in PASI score from Baseline

  7. Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild

    Time frame: Baseline up to 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. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), or 2 (mild).

  8. Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear

    Time frame: Baseline up to 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. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).

  9. Change From Baseline in the PGA of Psoriasis

    Time frame: Baseline, Weeks 2, 4, 8, 12, 18, and 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. Assessment of clear = PGA score of 0 (no evidence). Change = Week x, minus Baseline, where smaller scores indicate improvement.

  10. Change From Baseline in the PASI Score

    Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24

    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.

  11. Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  12. Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24

    Time frame: Baseline, 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.

  13. Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24

    Time frame: Baseline, 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.

  14. Change From Baseline in SGA of Itching at Each Visit

    Time frame: Baseline, Weeks 2, 4, 8, 12 ,18 and 24

    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.

  15. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  16. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  17. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  18. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  19. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  20. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  21. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  22. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  23. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  24. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  25. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  26. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  27. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  28. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  29. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  30. Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24

    Time frame: Baseline, 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.

  31. 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

    Time frame: Baseline, 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.

  32. 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

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 9, 2009
Registry last updated
Apr 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.