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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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

CP-690,550

Placebo/CP-690,550

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Xeljanz, tofacitinib, Jak-inhibitor, oral treatment, chronic, severe, moderate, Pruritus, Itch, DLQI, treatment, safety, efficacy, CP-690,550, Plaque Psoriasis, Psoriasis Vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Alabama at Birmingham
Burke Pharmaceutical Research
Bakersfield Dermatology and Skin Cancer Medical Group
University of California San Diego
Dermatology Research Associates
Expresscare Medical (X-Rays only)
MedDerm Associates
University of California San Diego
Healthcare Partners Medical Group
North Florida Dermatology Associates, PA
Dermatologic Surgery Specialists, PC
Sherman Immediate Care Center (Imaging Only)
Schaumburg Dermatology
NorthShore University HealthSystem - Division of Dermatology
Dundee Dermatology
Hudson Dermatology
Brigham & Women's Hospital
Hamzavi Dermatology
Somerset Skin Centre - Dermcenter
University of Minnesota - Department of Dermatology
Saint Louis University - Department of Dermatology
Central Dermatology, PC
Bettencourt Skin Center
Dartmouth Hitchcock Medical Center - Section of Dermatology
Comprehensive Clinical Research
The Rockefeller University
University of North Carolina at Chapel Hill Hospital
University of North Carolina at Chapel Hill
Wake Forest University Health Sciences
Radiant Research, Inc.
Oregon Dermatology and Research Center
Oregon Health & Science University
Penn State Milton S. Hershey Medical Center
Health Concepts
Arlington Research Center, Inc.
Austin Dermatology Associates
Dermatology Treatment & Research Center, PA
InSight Diagnostic Center
Center for Clinical Studies
Suzanne Bruce and Associates, PA
Office of Mark S. Lee, MD
Progressive Clinical Research, PA
Center for Clinical Studies
Virginia Clinical Research, Inc.
Kirk Barber Research
Northwest Dermatology & Laser Centre
Stratica Medical
Guildford Dermatology Specialists
Practice office of John D. Amiss MD
PerCuro Clinical Research Ltd
NewLab Clinical Research Inc.
Eastern Canada Cutaneous Research Associates Ltd.
Queen Elizabeth II Health Sciences Centre
CCA Medical Research Corporation
Co-Medica Research Network Inc.
The Guenther Dermatology Research Centre
Oshawa Clinic
SKiN Centre for Dermatology
K.Papp Clinical Research Inc.
XLR8 Medical Research Inc.
Siena Medical Research
Diex Research Sherbrooke Inc.
Hospital Pablo Tobon Uribe
Facharzt fuer Dermatologie und Allergologie
Klinische Forschung Berlin-Buch GmbH
Dres.Kirsten Prepeneit und Volker Streit
Klinikum der Johann Wolfgang Goethe Universitaet
Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie
Universitaetsklinikum Hamburg-Eppendorf
Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter
Universitaetsklinikum, Schleswig-Holstein, Klinik fuer Dermatologie
Hautarztpraxis Dres. Scholz, Sebastian, Schilling
Wilhelm Fresenius Klinik
Facharzt fuer Dermatologie, Venerologie, Allergologie, Naturheilverfahren, Lasermedizin
Tolna Megyei Onkormanyzat Balassa Janos Korhaza, Borgyogyaszati Osztaly
Vas Megyei Markusovszky Korhaz, Borgyogyaszati Osztaly
Veszprem Megyei Csolnoky Ferenc Korhaz, Borgyogyaszat
Instituto Mexicano de Investigacion Clinica, S.A. de C.V
Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio
Centro Medico San Lucas
Specjalistyczne Gabinety Lekarskie "Dermed�
MTZ Clinical Research Sp. z o.o.
Klinika Dermatologii Wojskowy Instytut Medyczny
The Office of Dr. Alma M. Cruz, MD.
Military Medical Academy
Chang Gung Memorial Hospital Kaohsiung branch
Chang Gung Medical Foundation, Linkou Branch
Taipei Medical University-Shuang Ho Hospital
Chung Shan Medical University Hospital
MIHC Kharkiv City Dermatovenerologic Dispensary #2
Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets
Lugansk Regional Dermatovenerologic Dispensary
Lviv regional municipal dermatovenerologic dispensary,
Department of dermatology and venereology of Odessa National Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Treatment 10 mg BID

Active Treatment 5 mg BID

Placebo Treatment

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16

Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.

Secondary Outcome Measures

Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16

Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.

Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16

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

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

Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4

Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI 75) Response at 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.

Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16

Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).

Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52

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

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'

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

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

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'

Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score

Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response

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

Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52

Psoriasis Area and Severity Index (PASI) Component Scores

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

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

Total Body Surface Area (BSA) With 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

Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response

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

Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score

Nail Psoriasis Severity Index (NAPSI) Score

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

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

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

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

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

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

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

Dermatology Life Quality Index (DLQI) Score

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

36-Item Short-Form Health Survey Version 2, Acute (SF-36)

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

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

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

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

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

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

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)

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

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

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

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

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

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

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

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.

Full Information

NCT ID

NCT01309737

First Posted

March 4, 2011

Last Updated

September 18, 2014

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01309737

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

960 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Treatment 10 mg BID

Arm Type

Experimental

Arm Title

Active Treatment 5 mg BID

Arm Type

Experimental

Arm Title

Placebo Treatment

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

10 mg oral BID, Continuous treatment for 52 Weeks

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

5 mg oral BID, Continuous treatment for 52 Weeks

Intervention Type

Drug

Intervention Name(s)

Placebo/CP-690,550

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Placebo/CP-690,550

Intervention Description

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)

Primary Outcome Measure Information:

Title

Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16

Description

Time Frame

Week 16

Title

Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16

Description

Time Frame

Baseline, Week 16

Title

Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16

Description

Time Frame

Week 16

Title

Dermatology Life Quality Index (DLQI) Total Score

Description

Time Frame

Baseline

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16

Description

Time Frame

Baseline, Week 4,16

Title

Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4

Description

Time Frame

Week 4

Title

Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4

Description

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.

Time Frame

Week 4

Title

Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16

Description

Time Frame

Baseline, Week 16

Title

Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52

Description

Time Frame

Week 52

Title

Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52

Description

Time Frame

Week 52

Title

Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52

Description

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 Frame

Week 52

Title

Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'

Description

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 Frame

Baseline up to Week 16

Title

Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response

Description

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 Frame

Baseline up to Week 16

Title

Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response

Description

Time Frame

Baseline up to Week 16

Title

Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'

Description

Time Frame

Week 2, 4, 8, 12, 16, 20, 28, 40, 52

Title

Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score

Description

Time Frame

Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52

Title

Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response

Description

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.

Time Frame

Week 2, 4, 8, 12, 16, 20, 28, 40, 52

Title

Psoriasis Area and Severity Index (PASI) Score

Description

Time Frame

Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52

Title

Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52

Description

Time Frame

Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52

Title

Psoriasis Area and Severity Index (PASI) Component Scores

Description

Time Frame

Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52

Title

Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52

Description

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.

Time Frame

Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52

Title

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52

Description

Time Frame

Baseline, Week 2, 4, 8, 12,16, 20, 28, 40, 52

Title

Total Body Surface Area (BSA) With Psoriasis

Description

Time Frame

Baseline, Week 2, 4, 8,16, 20, 28, 40, 52

Title

Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52

Description

Time Frame

Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52

Title

Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response

Description

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.

Time Frame

Week 2, 4, 8,12,16, 20, 28, 40, 52

Title

Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response

Description

Time Frame

Week 2, 4, 8,12,16, 20, 28, 40, 52

Title

Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score

Description

Time Frame

Week 2, 4, 8,12,16, 20, 28, 40, 52

Title

Nail Psoriasis Severity Index (NAPSI) Score

Description

Time Frame

Baseline, Week 8, 16, 20, 28, 40, 52

Title

Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52

Description

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 Frame

Baseline,Week 8, 16, 20, 28, 40, 52

Title

Number of Affected Nails

Description

Time Frame

Baseline, Week 8, 16, 20, 28, 40, 52

Title

Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52

Description

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.

Time Frame

Baseline,Week 8,16, 20, 28, 40, 52

Title

Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response

Description

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.

Time Frame

Week 8, 16, 20, 28, 40, 52

Title

Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response

Description

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.

Time Frame

Week 8,16, 20, 28, 40, 52

Title

Itch Severity Item (ISI) Score

Description

Time Frame

Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52

Title

Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52

Description

Time Frame

Baseline, Week 2, 4, 8,12,16, 20, 28 , 40, 52

Title

Dermatology Life Quality Index (DLQI) Score

Description

Time Frame

Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52

Description

Time Frame

Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52

Title

36-Item Short-Form Health Survey Version 2, Acute (SF-36)

Description

Time Frame

Baseline, Week 16, 28, 52

Title

Hospital Anxiety and Depression Scale (HADS) Score

Description

Time Frame

Baseline, Week 8, 16, 28, 52

Title

Work Limitation Questionnaire (WLQ) Index Score

Description

Time Frame

Baseline, Week 8, 16, 28, 52

Title

Percentage of Participants With Patient Global Assessment (PtGA) Scale Response

Description

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).

Time Frame

Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52

Title

Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response

Description

Time Frame

Week 16, 28, 52

Title

Joint Pain Assessment (JPA) Score

Description

Time Frame

Baseline, Week 8,16, 28, 52

Title

Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score

Description

Time Frame

Baseline, Week 16, 28, 40, 52

Title

Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)

Description

Time Frame

Baseline,Week 16, 28, 40, 52

Title

Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional

Description

Time Frame

Baseline, Week 16

Title

Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work

Description

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.

Time Frame

Baseline, Week 16

Title

Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status

Description

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.

Time Frame

Week 16

Title

Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours

Description

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.

Time Frame

Baseline, Week 16

Title

Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours

Description

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.

Time Frame

Baseline, Week 16

Title

Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work

Description

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.

Time Frame

Baseline, Week 16

Title

Family Dermatology Life Quality Index (FDLQI) Score

Description

Time Frame

Baseline, Week 16, 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Burke Pharmaceutical Research

City

Hot Springs

State/Province

Arkansas

ZIP/Postal Code

71913

Country

United States

Facility Name

Bakersfield Dermatology and Skin Cancer Medical Group

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

University of California San Diego

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Dermatology Research Associates

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

Expresscare Medical (X-Rays only)

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

MedDerm Associates

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

University of California San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92122

Country

United States

Facility Name

Healthcare Partners Medical Group

City

Torrance

State/Province

California

ZIP/Postal Code

90503

Country

United States

Facility Name

North Florida Dermatology Associates, PA

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

Dermatologic Surgery Specialists, PC

City

Macon

State/Province

Georgia

ZIP/Postal Code

31217

Country

United States

Facility Name

Sherman Immediate Care Center (Imaging Only)

City

Algonquin

State/Province

Illinois

ZIP/Postal Code

60102

Country

United States

Facility Name

Schaumburg Dermatology

City

Schaumburg

State/Province

Illinois

ZIP/Postal Code

60194

Country

United States

Facility Name

NorthShore University HealthSystem - Division of Dermatology

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

Dundee Dermatology

City

West Dundee

State/Province

Illinois

ZIP/Postal Code

60118

Country

United States

Facility Name

Hudson Dermatology

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Brigham & Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Hamzavi Dermatology

City

Fort Gratiot

State/Province

Michigan

ZIP/Postal Code

48059

Country

United States

Facility Name

Somerset Skin Centre - Dermcenter

City

Troy

State/Province

Michigan

ZIP/Postal Code

48084

Country

United States

Facility Name

University of Minnesota - Department of Dermatology

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Saint Louis University - Department of Dermatology

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Central Dermatology, PC

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

Bettencourt Skin Center

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89074

Country

United States

Facility Name

Dartmouth Hitchcock Medical Center - Section of Dermatology

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Comprehensive Clinical Research

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

Facility Name

The Rockefeller University

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

University of North Carolina at Chapel Hill Hospital

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27516

Country

United States

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27104

Country

United States

Facility Name

Radiant Research, Inc.

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43212

Country

United States

Facility Name

Oregon Dermatology and Research Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Penn State Milton S. Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Health Concepts

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57702

Country

United States

Facility Name

Arlington Research Center, Inc.

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

Austin Dermatology Associates

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Dermatology Treatment & Research Center, PA

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

InSight Diagnostic Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75243

Country

United States

Facility Name

Center for Clinical Studies

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Suzanne Bruce and Associates, PA

City

Houston

State/Province

Texas

ZIP/Postal Code

77056

Country

United States

Facility Name

Office of Mark S. Lee, MD

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Progressive Clinical Research, PA

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Center for Clinical Studies

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Virginia Clinical Research, Inc.

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Kirk Barber Research

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2S 3B3

Country

Canada

Facility Name

Northwest Dermatology & Laser Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3G 0B4

Country

Canada

Facility Name

Stratica Medical

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5K 1X3

Country

Canada

Facility Name

Guildford Dermatology Specialists

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 6A7

Country

Canada

Facility Name

Practice office of John D. Amiss MD

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 3M9

Country

Canada

Facility Name

PerCuro Clinical Research Ltd

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 3P9

Country

Canada

Facility Name

NewLab Clinical Research Inc.

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1C 2H5

Country

Canada

Facility Name

Eastern Canada Cutaneous Research Associates Ltd.

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1Z4

Country

Canada

Facility Name

Queen Elizabeth II Health Sciences Centre

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 3A7

Country

Canada

Facility Name

CCA Medical Research Corporation

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1S 7K8

Country

Canada

Facility Name

Co-Medica Research Network Inc.

City

Courtice

State/Province

Ontario

ZIP/Postal Code

L1E 3C3

Country

Canada

Facility Name

The Guenther Dermatology Research Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 3H7

Country

Canada

Facility Name

Oshawa Clinic

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1H 1B9

Country

Canada

Facility Name

SKiN Centre for Dermatology

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J 1Z2

Country

Canada

Facility Name

K.Papp Clinical Research Inc.

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

XLR8 Medical Research Inc.

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8W 1E6

Country

Canada

Facility Name

Siena Medical Research

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3Z 2S6

Country

Canada

Facility Name

Diex Research Sherbrooke Inc.

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 1Z1

Country

Canada

Facility Name

Hospital Pablo Tobon Uribe

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

0000

Country

Colombia

Facility Name

Facharzt fuer Dermatologie und Allergologie

City

Berlin

ZIP/Postal Code

10435

Country

Germany

Facility Name

Klinische Forschung Berlin-Buch GmbH

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Dres.Kirsten Prepeneit und Volker Streit

City

Buchholz

ZIP/Postal Code

21244

Country

Germany

Facility Name

Klinikum der Johann Wolfgang Goethe Universitaet

City

Frankfurt/Main

ZIP/Postal Code

60590

Country

Germany

Facility Name

Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie

City

Halle

ZIP/Postal Code

06120

Country

Germany

Facility Name

Universitaetsklinikum Hamburg-Eppendorf

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter

City

Hanau

ZIP/Postal Code

63450

Country

Germany

Facility Name

Universitaetsklinikum, Schleswig-Holstein, Klinik fuer Dermatologie

City

Luebeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Hautarztpraxis Dres. Scholz, Sebastian, Schilling

City

Mahlow

ZIP/Postal Code

15831

Country

Germany

Facility Name

Wilhelm Fresenius Klinik

City

Wiesbaden/ Bierstadt

ZIP/Postal Code

65191

Country

Germany

Facility Name

Facharzt fuer Dermatologie, Venerologie, Allergologie, Naturheilverfahren, Lasermedizin

City

Witten

ZIP/Postal Code

58453

Country

Germany

Facility Name

Tolna Megyei Onkormanyzat Balassa Janos Korhaza, Borgyogyaszati Osztaly

City

Szekszard

ZIP/Postal Code

7100

Country

Hungary

Facility Name

Vas Megyei Markusovszky Korhaz, Borgyogyaszati Osztaly

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

Veszprem Megyei Csolnoky Ferenc Korhaz, Borgyogyaszat

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Instituto Mexicano de Investigacion Clinica, S.A. de C.V

City

Mexico

State/Province

D.f.

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45190

Country

Mexico

Facility Name

Centro Medico San Lucas

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64710

Country

Mexico

Facility Name

Specjalistyczne Gabinety Lekarskie "Dermed�

City

Lodz

ZIP/Postal Code

90-265

Country

Poland

Facility Name

MTZ Clinical Research Sp. z o.o.

City

Warszawa

ZIP/Postal Code

02-106

Country

Poland

Facility Name

Klinika Dermatologii Wojskowy Instytut Medyczny

City

Warszawa

ZIP/Postal Code

04-141

Country

Poland

Facility Name

The Office of Dr. Alma M. Cruz, MD.

City

Carolina

ZIP/Postal Code

00985

Country

Puerto Rico

Facility Name

Military Medical Academy

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Chang Gung Memorial Hospital Kaohsiung branch

City

Niao-Sung Hsiang

State/Province

Kaohsiung County

ZIP/Postal Code

833

Country

Taiwan

Facility Name

Chang Gung Medical Foundation, Linkou Branch

City

Kwei-Shan

State/Province

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Taipei Medical University-Shuang Ho Hospital

City

New Taipei City

ZIP/Postal Code

235

Country

Taiwan

Facility Name

Chung Shan Medical University Hospital

City

Taichung

ZIP/Postal Code

402

Country

Taiwan

Facility Name

MIHC Kharkiv City Dermatovenerologic Dispensary #2

City

Kharkiv

ZIP/Postal Code

61038

Country

Ukraine

Facility Name

Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets

City

Kyiv

ZIP/Postal Code

01032

Country

Ukraine

Facility Name

Lugansk Regional Dermatovenerologic Dispensary

City

Lugansk

ZIP/Postal Code

91047

Country

Ukraine

Facility Name

Lviv regional municipal dermatovenerologic dispensary,

City

Lviv

ZIP/Postal Code

79013

Country

Ukraine

Facility Name

Department of dermatology and venereology of Odessa National Medical University

City

Odessa

ZIP/Postal Code

65006

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

32816215

Citation

Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

Results Reference

derived

PubMed Identifier

28396102

Citation

Merola JF, Elewski B, Tatulych S, Lan S, Tallman A, Kaur M. Efficacy of tofacitinib for the treatment of nail psoriasis: Two 52-week, randomized, controlled phase 3 studies in patients with moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2017 Jul;77(1):79-87.e1. doi: 10.1016/j.jaad.2017.01.053. Epub 2017 Apr 7.

Results Reference

derived

PubMed Identifier

26149717

Citation

Papp KA, Menter MA, Abe M, Elewski B, Feldman SR, Gottlieb AB, Langley R, Luger T, Thaci D, Buonanno M, Gupta P, Proulx J, Lan S, Wolk R; OPT Pivotal 1 and OPT Pivotal 2 investigators. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo-controlled, phase III trials. Br J Dermatol. 2015 Oct;173(4):949-61. doi: 10.1111/bjd.14018.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921079&StudyName=A%20One-Year%20Study%20To%20Evaluate%20The%20Efficacy%20And%20Safety%20Of%20CP-690%2C550%20For%20Patients%20With%20Moderate%20To%20Severe%20Chronic%20Plaque%20Psoriasis

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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