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A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In 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, chronic, Pruritus, Itch, DLQI, severe, moderate, treatment, safety, efficacy, CP-690,550, Plaque Psoriasis, Psoriasis Vulgaris, Jax-inhibitor, Oral Treatment

Eligibility Criteria

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

Inclusion Criteria:

Are 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering as least 10%of body surface area
a Psoriasis Area and Severity Index (PASI) score of 12 and are considered to be candidates for systemic or light therapy
No evidence of active or latent tuberculosis

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

Radiant Research, Inc.
University of California, Irvine - Dermatology Research
Skin Surgery Medical Group, Inc.
Clinical Science Institute
Cherry Creek Research, Inc.
The Savin Center, P.C.
Renstar Medical Research
Academic Alliance in Dermatology
Atlanta Dermatology, Vein & Research Center, P.C.
Peachtree Dermatology Associates Research Center
MedaPhase Inc.
Southern Illinois University School of Medicine
Dawes Fretzin Clinical Research Group, LLC
Tufts Medical Center
Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin
Skin Specialists, P.C.
New York University School of Medicine
Skin Search of Rochester, Inc.
Raleigh Radiology Blue Ridge
Wake Research Associates
Central Sooner Research
Baker Allergy, Asthma and Dermatology Research Center, LLC
University of Pittsburgh Medical Center - Department of Dermatology
Clinical Partners, LLC
Dermatology Associates of Knoxville, PC
Modern Research Associates, PLLC
Menter Dermatology Research Institute
Center for Clinical Studies
Rockwood Dermatology Center
Rockwood Research Center
Wenatchee Valley Medical Center - Clinical Research Department
Madison Skin and Research, Inc.
Dermadvances Research
Dr. Zohair Tomi PMC Inc.
Eastern Canada Cutaneous Research Associates Ltd.
Ultranova Skincare
Lynderm Research Inc.
North Bay Dermatology Centre
Oakville Dermatology Laser Centre
Office of Dr. Michael Robern
K.Papp Clinical Research Inc.
CRCMRGilbert Inc., Centre de Dermatologie Maizerets
Centro de Reumatologia y Ortopedia
Riesgo de Fractura S.A
Charite - Universitaetsmedizin Berlin
Aerztehaus "Rudolf Virchow"
Klinik und Poliklinik fuer Dermatologie und Allergologie der Universitaet Bonn
Universitaetsklinik Carl Gustav Carus
Klinische Forschung Hamburg GmbH
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Universitaetsklinikum Muenster
Klinische Forschung Schwerin GmbH
Praxisklinik fuer Dermatologie, Allergologie und Venenheilkunde
Facharzt fuer Dermatologie und Venerologie, Allergologie
Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza
Josa Andras Oktatokorhaz, Borgyogyaszat
Pecsi Tudomanyegyetem/Bor-, Nemikortani es Onkodermatologiai Klinika
Gunma University Hospital
JR Sapporo hospital
Kobe University Hospital
Kumamoto University Hospital
Social Insurance Chuo General Hospital
Centro de Dermatologia de Monterrey
Poznanski Osrodek Medyczny
Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny
Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
Oddzial Dermatologiczny
Clinical Hospital Center Zvezdara
National Cheng-Kung University Hospital
National Taiwan University Hospital
Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I. Georgiyevskyj"
Dept of Dermatology, Infectious and Parasitic Skin Diseases
Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets
Ternopil Regional Clinical Dermatovenerologic Dispensary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Treatment 10 mg BID

ActiveTreatment 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 a 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 75% reduction in PASI relative to Baseline.

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

The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.

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

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 "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.

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

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

Psoriasis Area and Severity Index (PASI) Score

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, 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 body surface area (BSA)" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.

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

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 "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported.

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

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response up to Week 52 is reported.

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

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported.

Nail Psoriasis Severity Index (NAPSI) Score

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

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 psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.

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

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

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

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

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 option ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety or depression symptoms.

Work Limitation Questionnaire (WLQ) Index Score

WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).

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, Rheumatologist). Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.

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

The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants employed at the time of assessment answered (Yes/No [Y/N]): "Were you absent or on sick leave from work due to psoriasis today?", and participants unemployed (UEmp) at the time of assessment answered (Yes/No): "Are you unemployed due to your psoriasis?" Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.

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

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.

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.

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.

Full Information

NCT ID

NCT01276639

First Posted

January 12, 2011

Last Updated

September 18, 2014

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01276639

Brief Title

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

Official Title

Phase 3 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, chronic, Pruritus, Itch, DLQI, severe, moderate, treatment, safety, efficacy, CP-690,550, Plaque Psoriasis, Psoriasis Vulgaris, Jax-inhibitor, Oral Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

901 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Treatment 10 mg BID

Arm Type

Experimental

Arm Title

ActiveTreatment 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

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 a 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 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

Time Frame

Baseline up to Week 16

Title

Time to Achieve 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 "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%.

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

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

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, 12, 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 "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported.

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

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response up to Week 52 is reported.

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

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported.

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

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

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

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 4, 16, 28, 52

Title

Work Limitation Questionnaire (WLQ) Index Score

Description

Time Frame

Baseline, Week 4, 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 4, 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 employed at the time of assessment answered (Yes/No [Y/N]): "Were you absent or on sick leave from work due to psoriasis today?", and participants unemployed (UEmp) at the time of assessment answered (Yes/No): "Are you unemployed due to your psoriasis?" Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.

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.

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.

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: Are 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering as least 10%of body surface area a Psoriasis Area and Severity Index (PASI) score of 12 and are considered to be candidates for systemic or light therapy No evidence of active or latent tuberculosis 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

Radiant Research, Inc.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

University of California, Irvine - Dermatology Research

City

Irvine

State/Province

California

ZIP/Postal Code

92697

Country

United States

Facility Name

Skin Surgery Medical Group, Inc.

City

San Diego

State/Province

California

ZIP/Postal Code

92117

Country

United States

Facility Name

Clinical Science Institute

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Cherry Creek Research, Inc.

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

Facility Name

The Savin Center, P.C.

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

Facility Name

Renstar Medical Research

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Academic Alliance in Dermatology

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

Atlanta Dermatology, Vein & Research Center, P.C.

City

Alpharetta

State/Province

Georgia

ZIP/Postal Code

30022

Country

United States

Facility Name

Peachtree Dermatology Associates Research Center

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30327

Country

United States

Facility Name

MedaPhase Inc.

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30263

Country

United States

Facility Name

Southern Illinois University School of Medicine

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62702

Country

United States

Facility Name

Dawes Fretzin Clinical Research Group, LLC

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Skin Specialists, P.C.

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68144

Country

United States

Facility Name

New York University School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Skin Search of Rochester, Inc.

City

Rochester

State/Province

New York

ZIP/Postal Code

14623

Country

United States

Facility Name

Raleigh Radiology Blue Ridge

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Wake Research Associates

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Central Sooner Research

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73071

Country

United States

Facility Name

Baker Allergy, Asthma and Dermatology Research Center, LLC

City

Lake Oswego

State/Province

Oregon

ZIP/Postal Code

97035

Country

United States

Facility Name

University of Pittsburgh Medical Center - Department of Dermatology

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Clinical Partners, LLC

City

Johnston

State/Province

Rhode Island

ZIP/Postal Code

02919

Country

United States

Facility Name

Dermatology Associates of Knoxville, PC

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37917

Country

United States

Facility Name

Modern Research Associates, PLLC

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Menter Dermatology Research Institute

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Center for Clinical Studies

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Rockwood Dermatology Center

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Rockwood Research Center

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Wenatchee Valley Medical Center - Clinical Research Department

City

Wenatchee

State/Province

Washington

ZIP/Postal Code

98801

Country

United States

Facility Name

Madison Skin and Research, Inc.

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53719

Country

United States

Facility Name

Dermadvances Research

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3C 1R4

Country

Canada

Facility Name

Dr. Zohair Tomi PMC Inc.

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 4S8

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

Ultranova Skincare

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6L2

Country

Canada

Facility Name

Lynderm Research Inc.

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P 1A8

Country

Canada

Facility Name

North Bay Dermatology Centre

City

North Bay

State/Province

Ontario

ZIP/Postal Code

P1B 3Z7

Country

Canada

Facility Name

Oakville Dermatology Laser Centre

City

Oakville

State/Province

Ontario

ZIP/Postal Code

L6J 7W5

Country

Canada

Facility Name

Office of Dr. Michael Robern

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K2G 6E2

Country

Canada

Facility Name

K.Papp Clinical Research Inc.

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

CRCMRGilbert Inc., Centre de Dermatologie Maizerets

City

Quebec

ZIP/Postal Code

G1J 1X7

Country

Canada

Facility Name

Centro de Reumatologia y Ortopedia

City

Barranquilla

State/Province

Atlantico

ZIP/Postal Code

0000

Country

Colombia

Facility Name

Riesgo de Fractura S.A

City

Bogot

State/Province

Cundinamarca

ZIP/Postal Code

0000

Country

Colombia

Facility Name

Charite - Universitaetsmedizin Berlin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Aerztehaus "Rudolf Virchow"

City

Berlin

ZIP/Postal Code

13055

Country

Germany

Facility Name

Klinik und Poliklinik fuer Dermatologie und Allergologie der Universitaet Bonn

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Universitaetsklinik Carl Gustav Carus

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Klinische Forschung Hamburg GmbH

City

Hamburg

ZIP/Postal Code

20253

Country

Germany

Facility Name

Universitaetsklinikum Schleswig-Holstein, Campus Kiel

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Universitaetsklinikum Muenster

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Klinische Forschung Schwerin GmbH

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Facility Name

Praxisklinik fuer Dermatologie, Allergologie und Venenheilkunde

City

Vechta

ZIP/Postal Code

49377

Country

Germany

Facility Name

Facharzt fuer Dermatologie und Venerologie, Allergologie

City

Wuppertal

ZIP/Postal Code

42275

Country

Germany

Facility Name

Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Josa Andras Oktatokorhaz, Borgyogyaszat

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Pecsi Tudomanyegyetem/Bor-, Nemikortani es Onkodermatologiai Klinika

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

Gunma University Hospital

City

Maebashi-shi

State/Province

Gunma

Country

Japan

Facility Name

JR Sapporo hospital

City

Sapporo

State/Province

Hokkaido

Country

Japan

Facility Name

Kobe University Hospital

City

Chuo-ku

State/Province

Kobe

Country

Japan

Facility Name

Kumamoto University Hospital

City

Kumamoto-shi

State/Province

Kumamoto

Country

Japan

Facility Name

Social Insurance Chuo General Hospital

City

Shinjyuku-ku

State/Province

Tokyo

Country

Japan

Facility Name

Centro de Dermatologia de Monterrey

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Poznanski Osrodek Medyczny

City

Poznan

ZIP/Postal Code

60-773

Country

Poland

Facility Name

Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu

City

Wroclaw

ZIP/Postal Code

50-368

Country

Poland

Facility Name

Oddzial Dermatologiczny

City

Wroclaw

ZIP/Postal Code

51-124

Country

Poland

Facility Name

Clinical Hospital Center Zvezdara

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

National Cheng-Kung University Hospital

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

110

Country

Taiwan

Facility Name

Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I. Georgiyevskyj"

City

Simferopol

State/Province

Crimea

ZIP/Postal Code

95006

Country

Ukraine

Facility Name

Dept of Dermatology, Infectious and Parasitic Skin Diseases

City

Kharkiv

ZIP/Postal Code

61057

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

Ternopil Regional Clinical Dermatovenerologic Dispensary

City

Ternopil

ZIP/Postal Code

46006

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

28751001

Citation

Wolk R, Armstrong EJ, Hansen PR, Thiers B, Lan S, Tallman AM, Kaur M, Tatulych S. Effect of tofacitinib on lipid levels and lipid-related parameters in patients with moderate to severe psoriasis. J Clin Lipidol. 2017 Sep-Oct;11(5):1243-1256. doi: 10.1016/j.jacl.2017.06.012. Epub 2017 Jun 24.

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

27538247

Citation

Tan H, Valdez H, Griffins CE, Mrowietz U, Tallman A, Wolk R, Gordon K. Early clinical response to tofacitinib treatment as a predictor of subsequent efficacy: Results from two phase 3 studies of patients with moderate-to-severe plaque psoriasis. J Dermatolog Treat. 2017 Feb;28(1):3-7. doi: 10.1080/09546634.2016.1214671. Epub 2016 Aug 18. Erratum In: J Dermatolog Treat. 2017 Feb;28(1):x.

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=A3921078&StudyName=A%20One-Year%20Study%20To%20Evaluate%20The%20Effects%20And%20Safety%20Of%20CP-690%2C550%20In%20Patients%20With%20Moderate%20To%20Severe%20Chronic%20Plaque%20Psoriasis

Description

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Learn more about this trial

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

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