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A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01309737
First received: March 4, 2011
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: CP-690,550
Drug: Placebo/CP-690,550
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [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 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.


Secondary Outcome Measures:
  • Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.

  • Dermatology Life Quality Index (DLQI) Total Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 4,16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [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 Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.

  • Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [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 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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' [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
    The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [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 [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. 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%.

  • Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
    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' [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [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 [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [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 [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. 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.

  • Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.

  • Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 [ Time Frame: Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.

  • Psoriasis Area and Severity Index (PASI) Component Scores [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. 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.

  • Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 [ Time Frame: Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. 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 [ Time Frame: Baseline, Week 2, 4, 8, 12,16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.

  • Total Body Surface Area (BSA) With Psoriasis [ Time Frame: Baseline, Week 2, 4, 8,16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 2, 4, 8,12,16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. 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 90 (PASI 90) Response [ Time Frame: Week 2, 4, 8,12,16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. 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 Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score [ Time Frame: Week 2, 4, 8,12,16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. 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).

  • Nail Psoriasis Severity Index (NAPSI) Score [ Time Frame: Baseline, Week 8, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 [ Time Frame: Baseline,Week 8, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    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.

  • Number of Affected Nails [ Time Frame: Baseline, Week 8, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    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.

  • Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 [ Time Frame: Baseline,Week 8,16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response [ Time Frame: Week 8, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    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 Nail Psoriasis Severity Index 100 (NAPSI 100) Response [ Time Frame: Week 8,16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    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.

  • Itch Severity Item (ISI) Score [ Time Frame: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends 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 [ Time Frame: Baseline, Week 2, 4, 8,12,16, 20, 28 , 40, 52 ] [ Designated as safety issue: No ]
    ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.

  • Dermatology Life Quality Index (DLQI) Score [ Time Frame: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI 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) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI 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.

  • 36-Item Short-Form Health Survey Version 2, Acute (SF-36) [ Time Frame: Baseline, Week 16, 28, 52 ] [ Designated as safety issue: No ]
    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).

  • Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: Baseline, Week 8, 16, 28, 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 8, 16, 28, 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).

  • Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response [ Time Frame: Week 16, 28, 52 ] [ Designated as safety issue: No ]
    The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from "very dissatisfied" to "very satisfied" with the study treatment.

  • Joint Pain Assessment (JPA) Score [ Time Frame: Baseline, Week 8,16, 28, 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 16, 28, 40, 52 ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  • Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) [ Time Frame: Baseline,Week 16, 28, 40, 52 ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 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 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners, 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.

  • Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The 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.

  • Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, 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 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, 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 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, 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 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.The first section assesses direct costs associated with healthcare resource use, 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 [ Time Frame: Baseline, Week 16, 52 ] [ Designated as safety issue: No ]
    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.


Enrollment: 960
Study Start Date: March 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Treatment 10 mg BID Drug: CP-690,550
10 mg oral BID, Continuous treatment for 52 Weeks
Experimental: Active Treatment 5 mg BID Drug: CP-690,550
5 mg oral BID, Continuous treatment for 52 Weeks
Placebo Comparator: Placebo Treatment Drug: Placebo/CP-690,550
0 mg oral BID, Continuous Treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
Drug: Placebo/CP-690,550
0 mg oral BID, Continuous Treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)

  Eligibility

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309737

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, California
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, United States, 93309
University of California San Diego
La Jolla, California, United States, 92037
Dermatology Research Associates
Los Angeles, California, United States, 90045
Expresscare Medical (X-Rays only)
Los Angeles, California, United States, 90045
MedDerm Associates
San Diego, California, United States, 92103
University of California San Diego
San Diego, California, United States, 92122
Healthcare Partners Medical Group
Torrance, California, United States, 90503
United States, Florida
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States, 32204
United States, Georgia
Dermatologic Surgery Specialists, PC
Macon, Georgia, United States, 31217
United States, Illinois
Sherman Immediate Care Center (Imaging Only)
Algonquin, Illinois, United States, 60102
Schaumburg Dermatology
Schaumburg, Illinois, United States, 60194
NorthShore University HealthSystem - Division of Dermatology
Skokie, Illinois, United States, 60077
Dundee Dermatology
West Dundee, Illinois, United States, 60118
United States, Indiana
Hudson Dermatology
Evansville, Indiana, United States, 47714
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
Somerset Skin Centre - Dermcenter
Troy, Michigan, United States, 48084
United States, Minnesota
University of Minnesota - Department of Dermatology
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Saint Louis University - Department of Dermatology
Saint Louis, Missouri, United States, 63104
Central Dermatology, PC
St. Louis, Missouri, United States, 63117
United States, Nevada
Bettencourt Skin Center
Henderson, Nevada, United States, 89074
United States, New Hampshire
Dartmouth Hitchcock Medical Center - Section of Dermatology
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
United States, New York
The Rockefeller University
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27516
University of North Carolina at Chapel Hill Hospital
Chapel Hill, North Carolina, United States, 27514
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Radiant Research, Inc.
Columbus, Ohio, United States, 43212
United States, Oregon
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, South Dakota
Health Concepts
Rapid City, South Dakota, United States, 57702
United States, Texas
Arlington Research Center, Inc.
Arlington, Texas, United States, 76011
Austin Dermatology Associates
Austin, Texas, United States, 78705
Dermatology Treatment & Research Center, PA
Dallas, Texas, United States, 75230
InSight Diagnostic Center
Dallas, Texas, United States, 75243
Center for Clinical Studies
Houston, Texas, United States, 77030
Suzanne Bruce and Associates, PA
Houston, Texas, United States, 77056
Office of Mark S. Lee, MD
San Antonio, Texas, United States, 78229
Progressive Clinical Research, PA
San Antonio, Texas, United States, 78229
Center for Clinical Studies
Webster, Texas, United States, 77598
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Canada, Alberta
Kirk Barber Research
Calgary, Alberta, Canada, T2S 3B3
Northwest Dermatology & Laser Centre
Calgary, Alberta, Canada, T3G 0B4
Stratica Medical
Edmonton, Alberta, Canada, T5K 1X3
Canada, British Columbia
Guildford Dermatology Specialists
Surrey, British Columbia, Canada, V3R 6A7
PerCuro Clinical Research Ltd
Victoria, British Columbia, Canada, V8V 3P9
Practice office of John D. Amiss MD
Victoria, British Columbia, Canada, V8V 3M9
Canada, Newfoundland and Labrador
NewLab Clinical Research Inc.
St. John's, Newfoundland and Labrador, Canada, A1C 2H5
Canada, Nova Scotia
Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, Canada, B3H 1Z4
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
CCA Medical Research Corporation
Ajax, Ontario, Canada, L1S 7K8
Co-Medica Research Network Inc.
Courtice, Ontario, Canada, L1E 3C3
The Guenther Dermatology Research Centre
London, Ontario, Canada, N6A 3H7
Oshawa Clinic
Oshawa, Ontario, Canada, L1H 1B9
SKiN Centre for Dermatology
Peterborough, Ontario, Canada, K9J 1Z2
K.Papp Clinical Research Inc.
Waterloo, Ontario, Canada, N2J 1C4
XLR8 Medical Research Inc.
Windsor, Ontario, Canada, N8W 1E6
Canada, Quebec
Siena Medical Research
Montreal, Quebec, Canada, H3Z 2S6
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada, J1H 1Z1
Colombia
Hospital Pablo Tobon Uribe
Medellin, Antioquia, Colombia, 0000
Germany
Facharzt fuer Dermatologie und Allergologie
Berlin, Germany, 10435
Klinische Forschung Berlin-Buch GmbH
Berlin, Germany, 13125
Dres.Kirsten Prepeneit und Volker Streit
Buchholz, Germany, 21244
Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt/Main, Germany, 60590
Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie
Halle, Germany, 06120
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter
Hanau, Germany, 63450
Universitaetsklinikum, Schleswig-Holstein, Klinik fuer Dermatologie
Luebeck, Germany, 23538
Hautarztpraxis Dres. Scholz, Sebastian, Schilling
Mahlow, Germany, 15831
Wilhelm Fresenius Klinik
Wiesbaden/ Bierstadt, Germany, 65191
Facharzt fuer Dermatologie, Venerologie, Allergologie, Naturheilverfahren, Lasermedizin
Witten, Germany, 58453
Hungary
Tolna Megyei Onkormanyzat Balassa Janos Korhaza, Borgyogyaszati Osztaly
Szekszard, Hungary, 7100
Vas Megyei Markusovszky Korhaz, Borgyogyaszati Osztaly
Szombathely, Hungary, 9700
Veszprem Megyei Csolnoky Ferenc Korhaz, Borgyogyaszat
Veszprem, Hungary, 8200
Mexico
Instituto Mexicano de Investigacion Clinica, S.A. de C.V
Mexico, D.f., Mexico, 06700
Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio
Zapopan, Jalisco, Mexico, 45190
Centro Medico San Lucas
Monterrey, Nuevo Leon, Mexico, 64710
Poland
Specjalistyczne Gabinety Lekarskie "Dermed�
Lodz, Poland, 90-265
Klinika Dermatologii Wojskowy Instytut Medyczny
Warszawa, Poland, 04-141
MTZ Clinical Research Sp. z o.o.
Warszawa, Poland, 02-106
Puerto Rico
The Office of Dr. Alma M. Cruz, MD.
Carolina, Puerto Rico, 00985
Serbia
Military Medical Academy
Belgrade, Serbia, 11000
Taiwan
Chang Gung Memorial Hospital Kaohsiung branch
Niao-Sung Hsiang, Kaohsiung County, Taiwan, 833
Chang Gung Medical Foundation, Linkou Branch
Kwei-Shan, Taoyuan, Taiwan, 333
Taipei Medical University-Shuang Ho Hospital
New Taipei City, Taiwan, 235
Chung Shan Medical University Hospital
Taichung, Taiwan, 402
Ukraine
MIHC Kharkiv City Dermatovenerologic Dispensary #2
Kharkiv, Ukraine, 61038
Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets
Kyiv, Ukraine, 01032
Lugansk Regional Dermatovenerologic Dispensary
Lugansk, Ukraine, 91047
Lviv regional municipal dermatovenerologic dispensary,
Lviv, Ukraine, 79013
Department of dermatology and venereology of Odessa National Medical University
Odessa, Ukraine, 65006
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01309737     History of Changes
Other Study ID Numbers: A3921079
Study First Received: March 4, 2011
Results First Received: July 24, 2014
Last Updated: September 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Xeljanz
tofacitinib
Jak-inhibitor
oral treatment
chronic
severe
moderate
Pruritus
Itch
DLQI
treatment
safety
efficacy
CP-690,550
Plaque Psoriasis
Psoriasis Vulgaris

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Tofacitinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014