A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis
- Registration Number
- NCT01276639
- Lead Sponsor
- Pfizer
- Brief Summary
The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 901
- Are 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering as least 10%of body surface area
- a Psoriasis Area and Severity Index (PASI) score of 12 and are considered to be candidates for systemic or light therapy
- No evidence of active or latent tuberculosis
- Non-plaque or drug induced forms of psoriasis
- cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
- any uncontrolled significant medical condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ActiveTreatment 5 mg BID CP-690,550 - Active Treatment 10 mg BID CP-690,550 - Placebo Treatment Placebo/CP-690,550 -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 Week 16 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 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and 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 (PASI 75) Response at Week 16 Week 16 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. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.
- Secondary Outcome Measures
Name Time Method Hospital Anxiety and Depression Scale (HADS) Score Baseline, Week 4, 16, 28, 52 HADS: 14-item questionnaire that screens for the presence of anxiety and depression symptoms. There are 7 items comprising the anxiety subscale, and 7 items comprising the depression subscale. Each item has response option ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety or depression symptoms.
Work Limitation Questionnaire (WLQ) Index Score Baseline, Week 4, 16, 28, 52 WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 \[no loss\] to 100 \[complete loss of work\]).
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 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.
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Baseline, Week 16, 28, 52 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).
Joint Pain Assessment (JPA) Score Baseline, Week 4, 16, 28, 52 The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to "select the number that best describes any joint pain that participant may have experienced over the past 24 hours" with response options ranging from "0-no joint pain" to "10-worst possible joint pain."
Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score Baseline, Week 16, 28, 40, 52 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.
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Baseline, Week 16, 28, 40, 52 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 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline, Week 16 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, Dermatologist, Rheumatologist). Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Baseline, Week 16 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 second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants employed at the time of assessment answered (Yes/No \[Y/N\]): "Were you absent or on sick leave from work due to psoriasis today?", and participants unemployed (UEmp) at the time of assessment answered (Yes/No): "Are you unemployed due to your psoriasis?" Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status Week 16 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, 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 and employment status, work impacted events due to psoriasis, and absence or sick leave for work due to psoriasis at Week 16 are reported. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours Baseline, Week 16 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, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours Baseline, Week 16 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, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Percent absent hours = (hours absent from work/hours scheduled to work) multiplied by 100. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work Baseline, Week 16 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, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants rate how much psoriasis affected their ability to work by reporting a number from 0 to 10, where 0 means "ability to work was not affected by psoriasis", and 10 means "ability to work was completely affected by psoriasis". Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
Family Dermatology Life Quality Index (FDLQI) Score Baseline, Week 16, 52 The FDLQI is a 10-item questionnaire that examine the impact of health-related quality of life issues associated with living with a person with a skin condition (example, emotional distress, personal relationships, reactions of other people, social life, caregiving) over the last month. The FDLQI need to be completed by a family member (for example, spouse or partner, parent) who currently lives with the participant. Each question is scored on a scale from 0 (Not at all/ Not relevant) to 3 (Very much). Total score is calculated by summing the score of each item resulting in a maximum score of '30' and a minimum score of '0'. Higher scores indicate greater impairment to quality of life.
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16 Baseline, Week 16 Assessment of BSA 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. Body regions are assigned specific number of handprints with percentage \[Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)\]. 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. The total BSA affected was the summation of individual regions affected.
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16 Week 16 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. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.
Dermatology Life Quality Index (DLQI) Total Score Baseline The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 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.
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16 Week 4, 16 The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 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 With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4 Week 4 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 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and 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 (PASI 75) Response at Week 4 Week 4 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. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline.
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 Baseline, Week 16 The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.
Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52 Week 52 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 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and 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). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).
Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52 Week 52 The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by 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 percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response = at least 75% reduction in PASI relative to Baseline. Maintenance of PASI 75 response at Week 52 among participants achieving PASI 75 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).
Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52 Week 52 The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by 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 percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response = at least 90% reduction in PASI relative to Baseline. Maintenance of PASI 90 response at Week 52 among participants achieving PASI 90 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).
Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Baseline up to Week 16 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 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and 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). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response Baseline up to Week 16 The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response Baseline up to Week 16 The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 2, 4, 8, 12, 16, 20, 28, 40, 52 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 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and 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 Physician Global Assessment (PGA) of Psoriasis Score Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 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 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and 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 each PGA score is reported.
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response Week 2, 4, 8, 12, 16, 20, 28, 40, 52 The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported.
Psoriasis Area and Severity Index (PASI) Score Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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.
Psoriasis Area and Severity Index (PASI) Component Scores Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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.
Total Body Surface Area (BSA) With Psoriasis Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 Assessment of BSA 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. Body regions are assigned specific number of handprints with percentage \[Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)\]. 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. The total BSA affected was the summation of individual regions affected.
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 Assessment of BSA 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. Body regions are assigned specific number of handprints with percentage \[Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)\]. 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. The total BSA affected was the summation of individual regions affected.
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 2, 4, 8, 12, 16, 20, 28, 40, 52 The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported.
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response Week 2, 4, 8, 12, 16, 20, 28, 40, 52 The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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. PASI 90 response was defined as at least 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response up to Week 52 is reported.
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 2, 4, 8, 12, 16, 20, 28, 40, 52 The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported.
Nail Psoriasis Severity Index (NAPSI) Score Baseline, Week 8, 16, 20, 28, 40, 52 The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Baseline, Week 8, 16, 20, 28, 40, 52 The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.
Number of Affected Nails Baseline, Week 8, 16, 20, 28, 40, 52 Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Baseline, Week 8, 16, 20, 28, 40, 52 The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.
Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response Week 8, 16, 20, 28, 40, 52 The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported.
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 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 \[no psoriasis\]; 1=almost clear; 2=mild; 3=moderate; 4=severe).
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 16, 28, 52 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 treatment.
Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response Week 8, 16, 20, 28, 40, 52 The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported.
Itch Severity Item (ISI) Score Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 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 for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment.
Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 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.
Dermatology Life Quality Index (DLQI) Score Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 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.
Trial Locations
- Locations (74)
Menter Dermatology Research Institute
🇺🇸Dallas, Texas, United States
Centro de Dermatologia de Monterrey
🇲🇽Monterrey, Nuevo Leon, Mexico
Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
🇵🇱Wroclaw, Poland
Ternopil Regional Clinical Dermatovenerologic Dispensary
🇺🇦Ternopil, Ukraine
National Cheng-Kung University Hospital
🇨🇳Tainan, Taiwan
Dept of Dermatology, Infectious and Parasitic Skin Diseases
🇺🇦Kharkiv, Ukraine
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I. Georgiyevskyj"
🇺🇦Simferopol, Crimea, Ukraine
Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets
🇺🇦Kyiv, Ukraine
University of California, Irvine - Dermatology Research
🇺🇸Irvine, California, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Atlanta Dermatology, Vein & Research Center, P.C.
🇺🇸Alpharetta, Georgia, United States
Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin
🇺🇸Boston, Massachusetts, United States
Peachtree Dermatology Associates Research Center
🇺🇸Atlanta, Georgia, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
MedaPhase Inc.
🇺🇸Newnan, Georgia, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Raleigh Radiology Blue Ridge
🇺🇸Raleigh, North Carolina, United States
New York University School of Medicine
🇺🇸New York, New York, United States
Skin Search of Rochester, Inc.
🇺🇸Rochester, New York, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Dermatology Associates of Knoxville, PC
🇺🇸Knoxville, Tennessee, United States
Baker Allergy, Asthma and Dermatology Research Center, LLC
🇺🇸Lake Oswego, Oregon, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
University of Pittsburgh Medical Center - Department of Dermatology
🇺🇸Pittsburgh, Pennsylvania, United States
Ultranova Skincare
🇨🇦Barrie, Ontario, Canada
Lynderm Research Inc.
🇨🇦Markham, Ontario, Canada
Office of Dr. Michael Robern
🇨🇦Ottawa, Ontario, Canada
Kobe University Hospital
🇯🇵Chuo-ku, Kobe, Japan
Modern Research Associates, PLLC
🇺🇸Dallas, Texas, United States
Gunma University Hospital
🇯🇵Maebashi-shi, Gunma, Japan
Madison Skin and Research, Inc.
🇺🇸Madison, Wisconsin, United States
Dr. Zohair Tomi PMC Inc.
🇨🇦St. John's, Newfoundland and Labrador, Canada
Social Insurance Chuo General Hospital
🇯🇵Shinjyuku-ku, Tokyo, Japan
Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Dermadvances Research
🇨🇦Winnipeg, Manitoba, Canada
CRCMRGilbert Inc., Centre de Dermatologie Maizerets
🇨🇦Quebec, Canada
K.Papp Clinical Research Inc.
🇨🇦Waterloo, Ontario, Canada
Aerztehaus "Rudolf Virchow"
🇩🇪Berlin, Germany
Eastern Canada Cutaneous Research Associates Ltd.
🇨🇦Halifax, Nova Scotia, Canada
Centro de Reumatologia y Ortopedia
🇨🇴Barranquilla, Atlantico, Colombia
Riesgo de Fractura S.A
🇨🇴Bogot, Cundinamarca, Colombia
Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny
🇵🇱Szczecin, Poland
North Bay Dermatology Centre
🇨🇦North Bay, Ontario, Canada
Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza
🇭🇺Kecskemet, Hungary
Josa Andras Oktatokorhaz, Borgyogyaszat
🇭🇺Nyiregyhaza, Hungary
Pecsi Tudomanyegyetem/Bor-, Nemikortani es Onkodermatologiai Klinika
🇭🇺Pecs, Hungary
JR Sapporo hospital
🇯🇵Sapporo, Hokkaido, Japan
Kumamoto University Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan
Klinische Forschung Schwerin GmbH
🇩🇪Schwerin, Germany
Praxisklinik fuer Dermatologie, Allergologie und Venenheilkunde
🇩🇪Vechta, Germany
Facharzt fuer Dermatologie und Venerologie, Allergologie
🇩🇪Wuppertal, Germany
Poznanski Osrodek Medyczny
🇵🇱Poznan, Poland
Oddzial Dermatologiczny
🇵🇱Wroclaw, Poland
Clinical Hospital Center Zvezdara
🇷🇸Belgrade, Serbia
Charite - Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
Rockwood Research Center
🇺🇸Spokane, Washington, United States
Klinik und Poliklinik fuer Dermatologie und Allergologie der Universitaet Bonn
🇩🇪Bonn, Germany
Rockwood Dermatology Center
🇺🇸Spokane, Washington, United States
Wenatchee Valley Medical Center - Clinical Research Department
🇺🇸Wenatchee, Washington, United States
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Oakville Dermatology Laser Centre
🇨🇦Oakville, Ontario, Canada
Universitaetsklinik Carl Gustav Carus
🇩🇪Dresden, Germany
Klinische Forschung Hamburg GmbH
🇩🇪Hamburg, Germany
Radiant Research, Inc.
🇺🇸Birmingham, Alabama, United States
Center for Clinical Studies
🇺🇸Houston, Texas, United States
Cherry Creek Research, Inc.
🇺🇸Denver, Colorado, United States
The Savin Center, P.C.
🇺🇸New Haven, Connecticut, United States
Skin Specialists, P.C.
🇺🇸Omaha, Nebraska, United States
Skin Surgery Medical Group, Inc.
🇺🇸San Diego, California, United States
Academic Alliance in Dermatology
🇺🇸Tampa, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States