Back to resultsA Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CP 690,550 5 mg
CP 690,550 10 mg
Etanercept 50 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring CP-690,550, Etanercept, Moderate, Severe, Chronic, Plaque, Psoriasis, Efficacy, Safety, Tofacitinib, Xeljanz, OPT Compare, OPT, head-to-head, non-inferiority, Psoriasis vulgaris, short-term, Itch, Pruritus, Plaque psoriasis, DLQI
Eligibility Criteria
Inclusion Criteria:
- Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris);
- Have plaque-type psoriasis covering at least 10% of total body surface area
- Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis
Exclusion Criteria:
- Non-plaque or drug induced forms of psoriasis
- Cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis
- Cannot discontinue phototherapy
- Any uncontrolled significant medical condition
Sites / Locations
- Centro de Investigaciones Dermatologicas
- Centro de Investigaciones Dermatologicas
- IMAI (Instituto Medico de Asistencia e Investigaciones)
- LKH Feldkirch Abteilung fuer Dermatologie und Venerologie
- LKH Innsbruck Universitaetsklinik fuer Dermatologie und Venerologie
- LKH Salzburg, Landesklinik fuer Dermatologie
- Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhuegel
- Cliniques universitaires Saint-Luc
- Universitair Ziekenhuis Gent
- Department for skin and venerial diseases, Clinical Center University of Sarajevo
- Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Dr Georgi Stranski- Pleven
- Tsentar za kozhno-venericheski zaboliavania" EOOD
- Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia
- Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia
- MBAL na Voennomeditsinska akademia- Sofia
- Clinica Davila
- Centro de Especialidades Dermatologicas
- Clinica Dermovein S.A.
- Hospital Clinico Universidad de Chile, Departamento Dermatologia
- Reumalab S.A.S.
- Centro Integral de Reumatología del Caribe Circaribe S.A
- Centro de Investigacion Clinica de la Universidad del Rosario
- Riesgo de Fractura S.A.
- Medicity S.A.S
- Department of Dermatovenerology, University Hospital Center Osijek
- Dermatovenerological Clinic, University hospital center "Sestre milosrdnice"
- Department of dermatovenerology, University Hospital Center Zagreb
- Nemocnice Ceske Budejovice, a.s.
- FN Kradec Kralove
- Fakultni nemocnice Plzen
- Kozni ordinace
- Kralska zdravotni a.s., Masarykovy nemocnice o.z.
- Kralska zdravotni
- Department of Dermatology, Aarhus University Hospital
- Bispebjerg Hospital, University of Copenhagen
- Hudklinikken Herning
- CHG Le Mans
- CHU de Besancon - Hopital Saint Jacques
- Hopital Ambroise Pare, Service de Dermatologie
- Chu Morvan
- Hopital Dupuytren
- Hopital Fournier
- CHU de Nantes - Hotel Dieu
- CHU de NICE - Hôpital de l'Archet II
- Hopital Saint-Louis
- Hôpital Bichat
- Centre Hospitalier Lyon Sud
- C.H.U. de Poitiers
- Hopital Robert Debre
- Hopital Nord
- Hôpital Larrey
- Hôpital de Brabois / Bâtiment Philippe Canton
- Charite - Universitaetsmedizin Berlin
- Hautarztpraxis
- Dres.Kirsten Prepeneit und Volker Streit
- Universitaetsklinik Carl Gustav Carus
- Hautzentrum Duelmen
- Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
- Klinikum der Johann Wolfgang Goethe Universitaet
- Universitaetsklinikum Hamburg-Eppendorf
- Hautklinik der Ruprecht-Karls-Universitaet Heidelberg
- Universitaets- Hautklinik Koeln
- Hautarztpraxis Dres. Scholz, Sebastian, Schilling
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR
- Technische Universitaet Muenchen
- Dres. med. Bredlich/PD Rosenbach/Thiele
- Eberhard-Karls-Universitaet Tuebingen
- Hautarztpraxis
- The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)
- Synexus Magyarorszag Kft.
- Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum/Bor- es Nemikortani Klinika
- Miskolci Semmelweis Ignac Korhaz-Rendelointezet/Borgyogyaszat
- SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika
- ALLERGO-DERM BAKOS Kft.
- Dermatology Department
- Samsung Medical Center / Department of Dermatology
- Severance Hospital, Yonsei University College of Medicine/Department of Dermatology
- Academic Medical Centre (AMC)
- PT & R
- Amphia Hospital Location Molengracht / Department Dermatology
- Erasmus MC
- NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
- Klinika Dermatologii, Wenerologii i Alergologii, Uniwersyteckie Centrum Kliniczne
- Krakowskie Centrum Medyczne NZOZ
- Novum Instytut Dermatologii Leczniczej i Estetycznej
- Solumed S.C.
- Korolev Dermatovenerologic Dispensary
- State Research Center of Dermatovenerology, Department of clinical dermatology
- State Research Center of Dermatovenerology, Department of dermatology
- Dermatovenerologic dispensary #7
- Rostov-on-Don regional dermatovenerologic dispensary
- Ryazan regional clinical dermatovenerologic dispensary
- Dermatovenerologic dispensary #10 of Vyborg region
- Military medical academy S.M. Kirov
- North-Western State Medical University I.I. Mechnikov, Dermatovenerology Department
- Clinic of dermatovenerologic diseases
- Smolensk State Medical Academy
- Clinical hospital of emergency care N.V. Soloviev
- National Skin Centre
- Changi General Hospital
- Dermatologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta
- Narodny ustav reumatickych chorob
- DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.
- Hospital Universitario Fundacion Alcorcon
- Hospital Puerta de Hierro Majadahonda
- Hospital General Universitario de Alicante
- Hospital Universitario de La Princesa
- Hospital 12 de Octubre
- Consorcio Hospital General Universitario de Valencia
- Falu lasarett, Hudkliniken
- Hermelinen Forskning AB
- Skanes Universitetssjukhus i Malmo, Hudkliniken
- Sodersjukhuset, Hudkliniken
- Karolinska Universitetssjukhuset Solna
- Kantonsspital St. Gallen
- Gazi University Medical Faculty
- Istanbul university Istanbul Medical Faculty
- T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali
- Mersin University Medical Faculty
- Dokuz Eylul Universitesi Tip Fakultesi Dermatoloji Anabilim Dali
- Whipps Cross University Hospital
- Leicester Royal Infirmary, Balmoral building, Clinic 3, Dermatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
CP 690,550 5 mg BID+Placebo BIW
CP 690,550 10 mg BID+Placebo BIW
Placebo BID+Etanercept 50 mg BIW
Placebo BID+Placebo BIW
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12
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 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12
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. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline/Day 1.
Secondary Outcome Measures
Percentage of Participants With a PGA Response of "Clear" or "Almost Clear" During the 12-Week Double-Blind Treatment
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 to 4). The severity scores are summed and averaged after which the total average is 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 is defined as 0 (clear) or 1 (almost clear).
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment
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 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).
Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment
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. PASI75 response was defined as at least a 75% reduction in PASI relative to baseline/Day 1.
Mean PASI Score During the 12-Week Double-Blind Treatment
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.
Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.
Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment
Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The % surface area 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. 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.
Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment
Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area 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. 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.
Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment
PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (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; higher scores represent greater severity of psoriasis.
Median Time to PASI50 Response During the 12-Week Double-Blind Treatment
Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment
PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (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; higher scores represent greater severity of psoriasis.
Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment
Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment
Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment
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.
Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment
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.
Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment
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.
Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment
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 questions are rated by the participant as 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.
Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment
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 questions are rated by the participant as 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. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment
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 questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).
Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment
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 questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment
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 questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment
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 questions are rated by the participant as 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.
Median Time to DLQI Response
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 questions are rated by the participant as 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. DLQI Response was defined as a 5-point reduction in the total DLQI score.
Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.
Mean SF-36 Domain Scores at Baseline and Week 12
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.
Mean Change From Baseline in SF-36 MCS and PCS Scores
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.
Mean Change From Baseline in SF-36 Domain Scores
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment
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; 1=almost clear; 2=mild; 3=moderate; 4=severe).
Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment
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; 1=almost clear; 2=mild; 3=moderate; 4=severe). Response defined as score of 0 or 1.
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment
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 medication.
Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12
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 medication.
Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment
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.
Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment
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.
Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment
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 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Mean Change From Baseline in EQ-5D VAS at Week 12
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 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment
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 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").
Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12
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 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment
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 [GPs], primary care physicians [PCPs], or family medicine physicians [FMP], emergency room visits, and hospitalizations), 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 During the 12-Week Double-Blind Treatment
Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work
Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The questionnaire assesses employment status of participant (employed: yes or no) and if currently employed it asks the participant if they were absent or on sick leave from work due to psoriasis; if unemployed it asks the participant if the unemployment is due to psoriasis.
Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment
Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.
Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment
The PQOL-12 is a 12-item questionnaire; 8 of the items on the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.
Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment
The PQOL-12 is a 12-item questionnaire; 8 of the items on the PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01241591
Brief Title
A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects 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 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 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
To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
CP-690,550, Etanercept, Moderate, Severe, Chronic, Plaque, Psoriasis, Efficacy, Safety, Tofacitinib, Xeljanz, OPT Compare, OPT, head-to-head, non-inferiority, Psoriasis vulgaris, short-term, Itch, Pruritus, Plaque psoriasis, DLQI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CP 690,550 5 mg BID+Placebo BIW
Arm Type
Experimental
Arm Title
CP 690,550 10 mg BID+Placebo BIW
Arm Type
Experimental
Arm Title
Placebo BID+Etanercept 50 mg BIW
Arm Type
Active Comparator
Arm Title
Placebo BID+Placebo BIW
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CP 690,550 5 mg
Intervention Description
CP-690,550 5 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CP 690,550 10 mg
Intervention Description
CP-690,550 10 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
Intervention Type
Biological
Intervention Name(s)
Etanercept 50 mg
Intervention Description
Placebo orally dosed twice daily and etanercept 50 mg subcutaneously dosed twice weekly for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12
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 to 4). The severity scores are summed and averaged after which the total average is 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).
Time Frame
Week 12
Title
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12
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. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline/Day 1.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With a PGA Response of "Clear" or "Almost Clear" During the 12-Week Double-Blind Treatment
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 to 4). The severity scores are summed and averaged after which the total average is 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 is defined as 0 (clear) or 1 (almost clear).
Time Frame
Weeks 2, 4, and 8
Title
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment
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 to 4). The severity scores are summed and averaged after which the total average is 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).
Time Frame
Baseline and Weeks 2, 4, 8, and 12
Title
Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment
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. PASI75 response was defined as at least a 75% reduction in PASI relative to baseline/Day 1.
Time Frame
Weeks 2, 4, and 8
Title
Mean PASI Score During the 12-Week Double-Blind Treatment
Description
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.
Time Frame
Baseline and Weeks 2, 4, 8, and 12
Title
Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment
Description
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.
Time Frame
Weeks 2, 4, 8, and 12
Title
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment
Description
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.
Time Frame
Baseline and Weeks 2, 4, 8, and 12
Title
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment
Description
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.
Time Frame
Weeks 2, 4, 8, and 12
Title
Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment
Description
Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The % surface area 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. 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.
Time Frame
Baseline and Weeks 2, 4, 8, and 12
Title
Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment
Description
Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area 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. 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.
Time Frame
Weeks 2, 4, 8, and 12
Title
Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment
Description
PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (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; higher scores represent greater severity of psoriasis.
Time Frame
Weeks 2, 4, 8, and 12
Title
Median Time to PASI50 Response During the 12-Week Double-Blind Treatment
Time Frame
Baseline up to Week 12
Title
Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment
Description
PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (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; higher scores represent greater severity of psoriasis.
Time Frame
Weeks 2, 4, 8, and 12
Title
Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment
Time Frame
Baseline up to Week 12
Title
Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment
Time Frame
Weeks 2, 4, 8, and 12
Title
Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, and 12
Title
Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment
Description
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.
Time Frame
Weeks 2, 4, 8, and 12
Title
Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment
Description
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.
Time Frame
Weeks 2, 4, 8, and 12
Title
Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment
Description
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 questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Time Frame
Baseline and Weeks 4 and 12
Title
Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment
Description
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 questions are rated by the participant as 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. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Time Frame
Weeks 4 and 12
Title
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment
Description
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 questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).
Time Frame
Baseline and Weeks 4 and 12
Title
Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment
Description
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 questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Time Frame
Weeks 4 and 12
Title
Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment
Description
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 questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Time Frame
Weeks 4 and 12
Title
Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment
Description
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 questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Time Frame
Weeks 4 and 12
Title
Median Time to DLQI Response
Description
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 questions are rated by the participant as 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. DLQI Response was defined as a 5-point reduction in the total DLQI score.
Time Frame
Weeks 4 and 12
Title
Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12
Description
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.
Time Frame
Baseline and Week 12
Title
Mean SF-36 Domain Scores at Baseline and Week 12
Description
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in SF-36 MCS and PCS Scores
Description
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.
Time Frame
Week 12
Title
Mean Change From Baseline in SF-36 Domain Scores
Description
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.
Time Frame
Week 12
Title
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment
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; 1=almost clear; 2=mild; 3=moderate; 4=severe).
Time Frame
Baseline and Weeks 2, 4, and 8
Title
Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment
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; 1=almost clear; 2=mild; 3=moderate; 4=severe). Response defined as score of 0 or 1.
Time Frame
Weeks 2, 4, 8, and 12
Title
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment
Description
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 medication.
Time Frame
Week 12
Title
Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12
Description
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 medication.
Time Frame
Week 12
Title
Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment
Description
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.
Time Frame
Baseline and Week 12
Title
Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment
Description
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.
Time Frame
Week 12
Title
Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment
Description
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 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in EQ-5D VAS at Week 12
Description
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 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time Frame
Week 12
Title
Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment
Description
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 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12
Description
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 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").
Time Frame
Week 12
Title
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment
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 (interactions with healthcare providers such as general practitioners [GPs], primary care physicians [PCPs], or family medicine physicians [FMP], emergency room visits, and hospitalizations), and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work.
Time Frame
Baseline (BL) and Week 12
Title
Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment
Time Frame
Week 12
Title
Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work
Description
Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The questionnaire assesses employment status of participant (employed: yes or no) and if currently employed it asks the participant if they were absent or on sick leave from work due to psoriasis; if unemployed it asks the participant if the unemployment is due to psoriasis.
Time Frame
Baseline and Week 12
Title
Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment
Description
Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.
Time Frame
Week 12
Title
Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment
Description
The PQOL-12 is a 12-item questionnaire; 8 of the items on the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment
Description
The PQOL-12 is a 12-item questionnaire; 8 of the items on the PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris);
Have plaque-type psoriasis covering at least 10% of total body surface area
Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis
Exclusion Criteria:
Non-plaque or drug induced forms of psoriasis
Cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis
Cannot discontinue phototherapy
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
Centro de Investigaciones Dermatologicas
City
Ciudad Autonoma de Buenos Aires
State/Province
C1114aap
Country
Argentina
Facility Name
Centro de Investigaciones Dermatologicas
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1114AAP
Country
Argentina
Facility Name
IMAI (Instituto Medico de Asistencia e Investigaciones)
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1425AWC
Country
Argentina
Facility Name
LKH Feldkirch Abteilung fuer Dermatologie und Venerologie
City
Feldkirch
ZIP/Postal Code
A-6807
Country
Austria
Facility Name
LKH Innsbruck Universitaetsklinik fuer Dermatologie und Venerologie
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
LKH Salzburg, Landesklinik fuer Dermatologie
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhuegel
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Cliniques universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Department for skin and venerial diseases, Clinical Center University of Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Dr Georgi Stranski- Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Tsentar za kozhno-venericheski zaboliavania" EOOD
City
Sofia
ZIP/Postal Code
1404
Country
Bulgaria
Facility Name
Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
MBAL na Voennomeditsinska akademia- Sofia
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Clinica Davila
City
Santiago, Rm 8431657
State/Province
RM
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Centro de Especialidades Dermatologicas
City
Vina del Mar
State/Province
V Region
ZIP/Postal Code
00000
Country
Chile
Facility Name
Clinica Dermovein S.A.
City
Santiago
ZIP/Postal Code
7640881
Country
Chile
Facility Name
Hospital Clinico Universidad de Chile, Departamento Dermatologia
City
Santiago
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Reumalab S.A.S.
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
0
Country
Colombia
Facility Name
Centro Integral de Reumatología del Caribe Circaribe S.A
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Centro de Investigacion Clinica de la Universidad del Rosario
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Riesgo de Fractura S.A.
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Medicity S.A.S
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Department of Dermatovenerology, University Hospital Center Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Dermatovenerological Clinic, University hospital center "Sestre milosrdnice"
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Department of dermatovenerology, University Hospital Center Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Nemocnice Ceske Budejovice, a.s.
City
Ceske Budejovice
ZIP/Postal Code
37001
Country
Czechia
Facility Name
FN Kradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Fakultni nemocnice Plzen
City
Plzen - Bory
ZIP/Postal Code
30599
Country
Czechia
Facility Name
Kozni ordinace
City
Praha 1
ZIP/Postal Code
11000
Country
Czechia
Facility Name
Kralska zdravotni a.s., Masarykovy nemocnice o.z.
City
Usti nad Labem
ZIP/Postal Code
40113
Country
Czechia
Facility Name
Kralska zdravotni
City
Usti nad Labem
ZIP/Postal Code
40113
Country
Czechia
Facility Name
Department of Dermatology, Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Bispebjerg Hospital, University of Copenhagen
City
Copenhagen NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Hudklinikken Herning
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
CHG Le Mans
City
Le Mans
State/Province
Cedex 09
ZIP/Postal Code
72037
Country
France
Facility Name
CHU de Besancon - Hopital Saint Jacques
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hopital Ambroise Pare, Service de Dermatologie
City
Boulogne
ZIP/Postal Code
92104
Country
France
Facility Name
Chu Morvan
City
BREST Cédex
ZIP/Postal Code
29609
Country
France
Facility Name
Hopital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Fournier
City
NANCY Cédex
ZIP/Postal Code
54035
Country
France
Facility Name
CHU de Nantes - Hotel Dieu
City
Nantes Cedex 1
ZIP/Postal Code
44035
Country
France
Facility Name
CHU de NICE - Hôpital de l'Archet II
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Benite
ZIP/Postal Code
69310
Country
France
Facility Name
C.H.U. de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Hopital Robert Debre
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Hopital Nord
City
Saint Priest En Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Hôpital Larrey
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Hôpital de Brabois / Bâtiment Philippe Canton
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Charite - Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Hautarztpraxis
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
Dres.Kirsten Prepeneit und Volker Streit
City
Buchholz
ZIP/Postal Code
21244
Country
Germany
Facility Name
Universitaetsklinik Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Hautzentrum Duelmen
City
Duelmen
ZIP/Postal Code
48249
Country
Germany
Facility Name
Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe Universitaet
City
Frankfurt/Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Hautklinik der Ruprecht-Karls-Universitaet Heidelberg
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Universitaets- Hautklinik Koeln
City
Koeln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Hautarztpraxis Dres. Scholz, Sebastian, Schilling
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Technische Universitaet Muenchen
City
Muenchen
ZIP/Postal Code
80802
Country
Germany
Facility Name
Dres. med. Bredlich/PD Rosenbach/Thiele
City
Osnabrueck
ZIP/Postal Code
49078
Country
Germany
Facility Name
Eberhard-Karls-Universitaet Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Hautarztpraxis
City
Witten
ZIP/Postal Code
58453
Country
Germany
Facility Name
The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)
City
Hong Kong
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Synexus Magyarorszag Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum/Bor- es Nemikortani Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Miskolci Semmelweis Ignac Korhaz-Rendelointezet/Borgyogyaszat
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
ALLERGO-DERM BAKOS Kft.
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Dermatology Department
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Samsung Medical Center / Department of Dermatology
City
Gangnam-Gu
State/Province
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University College of Medicine/Department of Dermatology
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Academic Medical Centre (AMC)
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
PT & R
City
Beek
ZIP/Postal Code
6191 JW
Country
Netherlands
Facility Name
Amphia Hospital Location Molengracht / Department Dermatology
City
Breda
ZIP/Postal Code
4800 RK
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 CA
Country
Netherlands
Facility Name
NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
City
Bialystok
ZIP/Postal Code
05-354
Country
Poland
Facility Name
Klinika Dermatologii, Wenerologii i Alergologii, Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Krakowskie Centrum Medyczne NZOZ
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Novum Instytut Dermatologii Leczniczej i Estetycznej
City
Opole
ZIP/Postal Code
45-080
Country
Poland
Facility Name
Solumed S.C.
City
Poznan
ZIP/Postal Code
60-539
Country
Poland
Facility Name
Korolev Dermatovenerologic Dispensary
City
Korolev
State/Province
Moscow Region
ZIP/Postal Code
141070
Country
Russian Federation
Facility Name
State Research Center of Dermatovenerology, Department of clinical dermatology
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
State Research Center of Dermatovenerology, Department of dermatology
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Dermatovenerologic dispensary #7
City
Moscow
ZIP/Postal Code
121614
Country
Russian Federation
Facility Name
Rostov-on-Don regional dermatovenerologic dispensary
City
Rostov-on-Don
ZIP/Postal Code
344007
Country
Russian Federation
Facility Name
Ryazan regional clinical dermatovenerologic dispensary
City
Ryazan
ZIP/Postal Code
390046
Country
Russian Federation
Facility Name
Dermatovenerologic dispensary #10 of Vyborg region
City
Saint-Petersburg
ZIP/Postal Code
194021
Country
Russian Federation
Facility Name
Military medical academy S.M. Kirov
City
Saint-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
North-Western State Medical University I.I. Mechnikov, Dermatovenerology Department
City
Saint-Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Clinic of dermatovenerologic diseases
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Smolensk State Medical Academy
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Clinical hospital of emergency care N.V. Soloviev
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
National Skin Centre
City
Singapore
ZIP/Postal Code
308205
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Dermatologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Narodny ustav reumatickych chorob
City
Piestany
ZIP/Postal Code
921 12
Country
Slovakia
Facility Name
DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.
City
Svidnik
ZIP/Postal Code
089 01
Country
Slovakia
Facility Name
Hospital Universitario Fundacion Alcorcon
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Consorcio Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Falu lasarett, Hudkliniken
City
Falun
ZIP/Postal Code
791 82
Country
Sweden
Facility Name
Hermelinen Forskning AB
City
Lulea
ZIP/Postal Code
972 33
Country
Sweden
Facility Name
Skanes Universitetssjukhus i Malmo, Hudkliniken
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Sodersjukhuset, Hudkliniken
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Gazi University Medical Faculty
City
Besevler
State/Province
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Istanbul university Istanbul Medical Faculty
City
Capa
State/Province
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali
City
Pendik
State/Province
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Mersin University Medical Faculty
City
Akdeniz
State/Province
Mersin
ZIP/Postal Code
33070
Country
Turkey
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi Dermatoloji Anabilim Dali
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Whipps Cross University Hospital
City
London
State/Province
Leytonstone
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Leicester Royal Infirmary, Balmoral building, Clinic 3, Dermatology
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
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
27271195
Citation
Valenzuela F, Paul C, Mallbris L, Tan H, Papacharalambous J, Valdez H, Mamolo C. Tofacitinib versus etanercept or placebo in patients with moderate to severe chronic plaque psoriasis: patient-reported outcomes from a Phase 3 study. J Eur Acad Dermatol Venereol. 2016 Oct;30(10):1753-1759. doi: 10.1111/jdv.13702. Epub 2016 Jun 7.
Results Reference
derived
PubMed Identifier
26051365
Citation
Bachelez H, van de Kerkhof PC, Strohal R, Kubanov A, Valenzuela F, Lee JH, Yakusevich V, Chimenti S, Papacharalambous J, Proulx J, Gupta P, Tan H, Tawadrous M, Valdez H, Wolk R; OPT Compare Investigators. Tofacitinib versus etanercept or placebo in moderate-to-severe chronic plaque psoriasis: a phase 3 randomised non-inferiority trial. Lancet. 2015 Aug 8;386(9993):552-61. doi: 10.1016/S0140-6736(14)62113-9. Epub 2015 Jun 4.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921080&StudyName=A%20Phase%203%2C%20Multi%20Site%2C%20Randomized%2C%20Double%20Blind%2C%20Placebo%20Controlled%20Study%20Of%20The%20Efficacy%20And%20Safety%20Comparing%20CP-%20690%2C550%20And
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis
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