A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis
- Registration Number
- NCT01309737
- 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
- 960
- 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering at least 10% of body surface area
- A Psoriasis Area and Severity Index (PASI) score of 12 or greater
- Are considered to be candidates for systemic or light therapy
- Have 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 Active Treatment 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 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.
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).
- Secondary Outcome Measures
Name Time Method 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.
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 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 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).
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.
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.
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16 Baseline, 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.
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 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 a 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%.
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.
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 and where higher scores indicate greater severity of psoriatic lesions.
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 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 50 response was defined as at least a 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 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 a 75% reduction in PASI relative to Baseline.
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 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.
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 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 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.
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.
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).
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).
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.'n' signifies participants evaluable at specified time point for each arm.
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. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.
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).
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 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.
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.
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. 'n' signifies participants evaluable at specified time point for each arm.
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 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 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 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 a 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported.
Total Body Surface Area (BSA) With Psoriasis Baseline, Week 2, 4, 8,16, 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 (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 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).
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. 'N' (number of participants analyzed) signifies participants with baseline nail psoriasis and who were unique in longitudinal model.
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 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 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. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model.
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 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. Percentage of participants with PASI 90 response is reported.
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. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.
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).
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 and 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. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
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 of psoriasis affected nails (presence of psoriatic manifestations on the nail matrix / nail bed) were assessed and reported. 'N' (number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.
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 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 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.
Hospital Anxiety and Depression Scale (HADS) Score Baseline, Week 8, 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 options ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total HADS score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Work Limitation Questionnaire (WLQ) Index Score Baseline, Week 8, 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-item); 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 \[complete loss of work\]).
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).
Joint Pain Assessment (JPA) Score Baseline, Week 8,16, 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".
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.
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.
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 (currently employed \[Emp\]) answered (Yes/No \[Y/N\]): "Were you absent or on sick leave from work due to psoriasis today?", and participants (unemployed \[UEmp\]) 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.
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) - 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. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
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. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
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. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Trial Locations
- Locations (92)
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
InSight Diagnostic Center
🇺🇸Dallas, Texas, United States
PerCuro Clinical Research Ltd
🇨🇦Victoria, British Columbia, Canada
Diex Research Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
Dermatologic Surgery Specialists, PC
🇺🇸Macon, Georgia, United States
The Rockefeller University
🇺🇸New York, New York, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
XLR8 Medical Research Inc.
🇨🇦Windsor, Ontario, Canada
Oshawa Clinic
🇨🇦Oshawa, Ontario, Canada
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
Specjalistyczne Gabinety Lekarskie "Dermed�
🇵🇱Lodz, Poland
Chang Gung Medical Foundation, Linkou Branch
🇨🇳Kwei-Shan, Taoyuan, Taiwan
Expresscare Medical (X-Rays only)
🇺🇸Los Angeles, California, United States
Healthcare Partners Medical Group
🇺🇸Torrance, California, United States
MedDerm Associates
🇺🇸San Diego, California, United States
University of California San Diego
🇺🇸San Diego, California, United States
Bakersfield Dermatology and Skin Cancer Medical Group
🇺🇸Bakersfield, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
NorthShore University HealthSystem - Division of Dermatology
🇺🇸Skokie, Illinois, United States
Schaumburg Dermatology
🇺🇸Schaumburg, Illinois, United States
Sherman Immediate Care Center (Imaging Only)
🇺🇸Algonquin, Illinois, United States
Dundee Dermatology
🇺🇸West Dundee, Illinois, United States
Saint Louis University - Department of Dermatology
🇺🇸Saint Louis, Missouri, United States
Central Dermatology, PC
🇺🇸St. Louis, Missouri, United States
Radiant Research, Inc.
🇺🇸Columbus, Ohio, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Arlington Research Center, Inc.
🇺🇸Arlington, Texas, United States
Dermatology Treatment & Research Center, PA
🇺🇸Dallas, Texas, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
Suzanne Bruce and Associates, PA
🇺🇸Houston, Texas, United States
Instituto Mexicano de Investigacion Clinica, S.A. de C.V
🇲🇽Mexico, D.f., Mexico
Centro Medico San Lucas
🇲🇽Monterrey, Nuevo Leon, Mexico
MIHC Kharkiv City Dermatovenerologic Dispensary #2
🇺🇦Kharkiv, Ukraine
Department of dermatology and venereology of Odessa National Medical University
🇺🇦Odessa, Ukraine
Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter
🇩🇪Hanau, Germany
Facharzt fuer Dermatologie, Venerologie, Allergologie, Naturheilverfahren, Lasermedizin
🇩🇪Witten, Germany
Guildford Dermatology Specialists
🇨🇦Surrey, British Columbia, Canada
SKiN Centre for Dermatology
🇨🇦Peterborough, Ontario, Canada
Eastern Canada Cutaneous Research Associates Ltd.
🇨🇦Halifax, Nova Scotia, Canada
Siena Medical Research
🇨🇦Montreal, Quebec, Canada
Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie
🇩🇪Halle, Germany
Universitaetsklinikum, Schleswig-Holstein, Klinik fuer Dermatologie
🇩🇪Luebeck, Germany
Military Medical Academy
🇷🇸Belgrade, Serbia
North Florida Dermatology Associates, PA
🇺🇸Jacksonville, Florida, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
CCA Medical Research Corporation
🇨🇦Ajax, Ontario, Canada
K.Papp Clinical Research Inc.
🇨🇦Waterloo, Ontario, Canada
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Hamzavi Dermatology
🇺🇸Fort Gratiot, Michigan, United States
Stratica Medical
🇨🇦Edmonton, Alberta, Canada
Klinika Dermatologii Wojskowy Instytut Medyczny
🇵🇱Warszawa, Poland
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Hospital Pablo Tobon Uribe
🇨🇴Medellin, Antioquia, Colombia
Tolna Megyei Onkormanyzat Balassa Janos Korhaza, Borgyogyaszati Osztaly
ðŸ‡ðŸ‡ºSzekszard, Hungary
Vas Megyei Markusovszky Korhaz, Borgyogyaszati Osztaly
ðŸ‡ðŸ‡ºSzombathely, Hungary
Lviv regional municipal dermatovenerologic dispensary,
🇺🇦Lviv, Ukraine
Northwest Dermatology & Laser Centre
🇨🇦Calgary, Alberta, Canada
Bettencourt Skin Center
🇺🇸Henderson, Nevada, United States
Somerset Skin Centre - Dermcenter
🇺🇸Troy, Michigan, United States
Facharzt fuer Dermatologie und Allergologie
🇩🇪Berlin, Germany
Klinische Forschung Berlin-Buch GmbH
🇩🇪Berlin, Germany
Dres.Kirsten Prepeneit und Volker Streit
🇩🇪Buchholz, Germany
Klinikum der Johann Wolfgang Goethe Universitaet
🇩🇪Frankfurt/Main, Germany
Hautarztpraxis Dres. Scholz, Sebastian, Schilling
🇩🇪Mahlow, Germany
Wilhelm Fresenius Klinik
🇩🇪Wiesbaden/ Bierstadt, Germany
Veszprem Megyei Csolnoky Ferenc Korhaz, Borgyogyaszat
ðŸ‡ðŸ‡ºVeszprem, Hungary
MTZ Clinical Research Sp. z o.o.
🇵🇱Warszawa, Poland
Chang Gung Memorial Hospital Kaohsiung branch
🇨🇳Niao-Sung Hsiang, Kaohsiung County, Taiwan
Taipei Medical University-Shuang Ho Hospital
🇨🇳New Taipei City, Taiwan
Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets
🇺🇦Kyiv, Ukraine
Dartmouth Hitchcock Medical Center - Section of Dermatology
🇺🇸Lebanon, New Hampshire, United States
Kirk Barber Research
🇨🇦Calgary, Alberta, Canada
Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio
🇲🇽Zapopan, Jalisco, Mexico
Co-Medica Research Network Inc.
🇨🇦Courtice, Ontario, Canada
The Office of Dr. Alma M. Cruz, MD.
🇵🇷Carolina, Puerto Rico
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
Lugansk Regional Dermatovenerologic Dispensary
🇺🇦Lugansk, Ukraine
Practice office of John D. Amiss MD
🇨🇦Victoria, British Columbia, Canada
The Guenther Dermatology Research Centre
🇨🇦London, Ontario, Canada
NewLab Clinical Research Inc.
🇨🇦St. John's, Newfoundland and Labrador, Canada
University of Minnesota - Department of Dermatology
🇺🇸Minneapolis, Minnesota, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of North Carolina at Chapel Hill Hospital
🇺🇸Chapel Hill, North Carolina, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Austin Dermatology Associates
🇺🇸Austin, Texas, United States
Office of Mark S. Lee, MD
🇺🇸San Antonio, Texas, United States
Progressive Clinical Research, PA
🇺🇸San Antonio, Texas, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
Hudson Dermatology
🇺🇸Evansville, Indiana, United States
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada