A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01241591
First received: November 12, 2010
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.


Condition Intervention Phase
Psoriasis
Drug: CP 690,550 5 mg
Drug: CP 690,550 10 mg
Biological: Etanercept 50 mg
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP- 690,550 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).

  • Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline/Day 1.


Secondary Outcome Measures:
  • Percentage of Participants With a PGA Response of "Clear" or "Almost Clear" During the 12-Week Double-Blind Treatment [ Time Frame: Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
    The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response is defined as 0 (clear) or 1 (almost clear).

  • Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment [ Time Frame: Baseline and Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).

  • Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment [ Time Frame: Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75% reduction in PASI relative to baseline/Day 1.

  • Mean PASI Score During the 12-Week Double-Blind Treatment [ Time Frame: Baseline and Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.

  • Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment [ Time Frame: Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.

  • Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment [ Time Frame: Baseline and Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.

  • Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment [ Time Frame: Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.

  • Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment [ Time Frame: Baseline and Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The % surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.

  • Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment [ Time Frame: Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant(fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.

  • Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment [ Time Frame: Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0; higher scores represent greater severity of psoriasis.

  • Median Time to PASI50 Response During the 12-Week Double-Blind Treatment [ Time Frame: Baseline up to Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment [ Time Frame: Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0; higher scores represent greater severity of psoriasis.

  • Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment [ Time Frame: Baseline up to Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment [ Time Frame: Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment [ Time Frame: Baseline, Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.

  • Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment [ Time Frame: Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.

  • Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment [ Time Frame: Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.

  • Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment [ Time Frame: Baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]
    The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

  • Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: No ]
    The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.

  • Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment [ Time Frame: Baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]
    The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).

  • Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: No ]
    The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.

  • Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: No ]
    The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

  • Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: No ]
    The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

  • Median Time to DLQI Response [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: No ]
    The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. DLQI Response was defined as a 5-point reduction in the total DLQI score.

  • Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.

  • Mean SF-36 Domain Scores at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.

  • Mean Change From Baseline in SF-36 MCS and PCS Scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.

  • Mean Change From Baseline in SF-36 Domain Scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.

  • Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment [ Time Frame: Baseline and Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
    The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).

  • Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment [ Time Frame: Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe). Response defined as score of 0 or 1.

  • Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from "very dissatisfied" to "very satisfied" with the study medication.

  • Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from "very dissatisfied" to "very satisfied" with the study medication.

  • Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a 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 ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  • Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a 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 ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  • Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  • Mean Change From Baseline in EQ-5D VAS at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  • Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").

  • Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").

  • Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment [ Time Frame: Baseline (BL) and Week 12 ] [ Designated as safety issue: No ]
    The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners [GPs], primary care physicians [PCPs], or family medicine physicians [FMP], emergency room visits, and hospitalizations), and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work.

  • Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The questionnaire assesses employment status of participant (employed: yes or no) and if currently employed it asks the participant if they were absent or on sick leave from work due to psoriasis; if unemployed it asks the participant if the unemployment is due to psoriasis.

  • Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.

  • Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The PQOL-12 is a 12-item questionnaire; 8 of the items on the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.

  • Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The PQOL-12 is a 12-item questionnaire; 8 of the items on the PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.


Enrollment: 1101
Study Start Date: November 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CP 690,550 5 mg BID+Placebo BIW Drug: CP 690,550 5 mg
CP-690,550 5 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
Experimental: CP 690,550 10 mg BID+Placebo BIW Drug: CP 690,550 10 mg
CP-690,550 10 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
Active Comparator: Placebo BID+Etanercept 50 mg BIW Biological: Etanercept 50 mg
Placebo orally dosed twice daily and etanercept 50 mg subcutaneously dosed twice weekly for 12 weeks
Placebo Comparator: Placebo BID+Placebo BIW Other: Placebo
Placebo orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris);
  • Have plaque-type psoriasis covering at least 10% of total body surface area
  • Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis

Exclusion Criteria:

  • Non-plaque or drug induced forms of psoriasis
  • Cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis
  • Cannot discontinue phototherapy
  • Any uncontrolled significant medical condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241591

  Show 122 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01241591     History of Changes
Other Study ID Numbers: A3921080
Study First Received: November 12, 2010
Results First Received: January 27, 2014
Last Updated: May 8, 2014
Health Authority: European Union: European Medicines Agency

Keywords provided by Pfizer:
CP-690,550
Etanercept
Moderate
Severe
Chronic
Plaque
Psoriasis
Efficacy
Safety
Tofacitinib
Xeljanz
OPT Compare
OPT
head-to-head
non-inferiority
Psoriasis vulgaris
short-term
Itch
Pruritus
Plaque psoriasis
DLQI

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Tofacitinib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014