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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: CP 690,550 5 mg; Drug: CP 690,550 10 mg; Biological: Etanercept 50 mg; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1101
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma de Buenos Aires, Argentina, C1114AAP
    • Centro De Investigaciones Dermatologicas
  • Ciudad Autonoma de Buenos Aires, Argentina, C1425AWC
    • IMAI (Instituto Medico de Asistencia e Investigaciones)
  • C1114aap
    • Ciudad Autonoma de Buenos Aires, C1114aap, Argentina
      • Centro De Investigaciones Dermatologicas
• Austria
  • Feldkirch, Austria, A-6807
    • LKH Feldkirch Abteilung fuer Dermatologie und Venerologie
  • Innsbruck, Austria, A-6020
    • LKH Innsbruck Universitaetsklinik fuer Dermatologie und Venerologie
  • Salzburg, Austria, 5020
    • LKH Salzburg, Landesklinik fuer Dermatologie
  • Wien, Austria, 1130
    • Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhuegel
• Belgium
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires Saint-luc
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
• Bosnia and Herzegovina
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Department for skin and venerial diseases, Clinical Center University of Sarajevo
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Dr Georgi Stranski- Pleven
  • Sofia, Bulgaria, 1404
    • Tsentar za kozhno-venericheski zaboliavania" EOOD
  • Sofia, Bulgaria, 1407
    • Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia
  • Sofia, Bulgaria, 1431
    • Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia
  • Sofia, Bulgaria, 1606
    • MBAL na Voennomeditsinska akademia- Sofia
• Chile
  • Santiago, Chile, 7640881
    • Clinica Dermovein S.A.
  • Santiago, Chile, 8380456
    • Hospital Clinico Universidad de Chile, Departamento Dermatologia
  • RM
    • Santiago, Rm 8431657, RM, Chile, 8420383
      • Clínica Dávila
  • V Region
    • Vina del Mar, V Region, Chile, 00000
      • Centro de Especialidades Dermatologicas
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Reumalab S.A.S.
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 0000
      • Centro Integral de Reumatología del Caribe Circaribe S.A
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 0000
      • Centro de Investigacion Clinica de la Universidad del Rosario
    • Bogota, Cundinamarca, Colombia, 0000
      • Riesgo de Fractura S.A.
  • Santander
    • Bucaramanga, Santander, Colombia, 0000
      • Medicity S.A.S
• Croatia
  • Osijek, Croatia, 31000
    • Department of Dermatovenerology, University Hospital Center Osijek
  • Zagreb, Croatia, 10 000
    • Dermatovenerological Clinic, University hospital center "Sestre milosrdnice"
  • Zagreb, Croatia, 10000
    • Department of dermatovenerology, University Hospital Center Zagreb
• Czechia
  • Ceske Budejovice, Czechia, 37001
    • Nemocnice Ceske Budejovice, a.s.
  • Hradec Kralove, Czechia, 50005
    • FN Kradec Kralove
  • Plzen - Bory, Czechia, 30599
    • Fakultni Nemocnice Plzen
  • Praha 1, Czechia, 11000
    • Kozni ordinace
  • Usti nad Labem, Czechia, 40113
    • Kralska zdravotni a.s., Masarykovy nemocnice o.z.
  • Usti nad Labem, Czechia, 40113
    • Kralska zdravotni
• Denmark
  • Aarhus C, Denmark, 8000
    • Department of Dermatology, Aarhus University Hospital
  • Copenhagen NV, Denmark, 2400
    • Bispebjerg Hospital, University of Copenhagen
  • Herning, Denmark, 7400
    • Hudklinikken Herning
• France
  • BREST Cédex, France, 29609
    • CHU Morvan
  • Besancon, France, 25030
    • CHU de Besancon - Hopital Saint Jacques
  • Boulogne, France, 92104
    • Hopital Ambroise Pare, Service de Dermatologie
  • Limoges, France, 87042
    • Hôpital Dupuytren
  • NANCY Cédex, France, 54035
    • Hôpital Fournier
  • Nantes Cedex 1, France, 44035
    • CHU de Nantes - Hotel Dieu
  • Nice, France, 06200
    • CHU de Nice - Hôpital de l'Archet II
  • Paris, France, 75010
    • Hopital Saint-Louis
  • Paris, France, 75018
    • Hôpital Bichat
  • Pierre-Benite, France, 69310
    • Centre Hospitalier Lyon Sud
  • Poitiers, France, 86000
    • C.H.U. de Poitiers
  • Reims, France, 51100
    • Hôpital Robert Debré
  • Saint Priest En Jarez, France, 42270
    • Hopital Nord
  • Toulouse cedex 9, France, 31059
    • Hôpital Larrey
  • Vandoeuvre-les-Nancy, France, 54511
    • Hopital de Brabois / Batiment Philippe Canton
  • Cedex 09
    • Le Mans, Cedex 09, France, 72037
      • CHG Le Mans
• Germany
  • Berlin, Germany, 10117
    • Charite - Universitaetsmedizin Berlin
  • Berlin, Germany, 13507
    • Hautarztpraxis
  • Buchholz, Germany, 21244
    • Dres.Kirsten Prepeneit und Volker Streit
  • Dresden, Germany, 01307
    • Universitaetsklinik Carl Gustav Carus
  • Duelmen, Germany, 48249
    • Hautzentrum Duelmen
  • Erlangen, Germany, 91054
    • Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
  • Frankfurt/Main, Germany, 60590
    • Klinikum der Johann Wolfgang Goethe Universitaet
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf
  • Heidelberg, Germany, 69115
    • Hautklinik der Ruprecht-Karls-Universitaet Heidelberg
  • Koeln, Germany, 50924
    • Universitaets- Hautklinik Koeln
  • Mahlow, Germany, 15831
    • Hautarztpraxis Dres. Scholz, Sebastian, Schilling
  • Mainz, Germany, 55131
    • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR
  • Muenchen, Germany, 80802
    • Technische Universitaet Muenchen
  • Osnabrueck, Germany, 49078
    • Dres. med. Bredlich/PD Rosenbach/Thiele
  • Tuebingen, Germany, 72076
    • Eberhard-Karls-Universitaet Tuebingen
  • Witten, Germany, 58453
    • Hautarztpraxis
• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)
• Hungary
  • Budapest, Hungary, 1036
    • Synexus Magyarorszag Kft.
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum/Bor- es Nemikortani Klinika
  • Miskolc, Hungary, 3529
    • Miskolci Semmelweis Ignac Korhaz-Rendelointezet/Borgyogyaszat
  • Szeged, Hungary, 6720
    • SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika
  • Szolnok, Hungary, 5000
    • Allergo-Derm Bakos Kft.
• Israel
  • Afula, Israel, 18101
    • Dermatology department
• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital, Yonsei University College of Medicine/Department of Dermatology
  • Seoul
    • Gangnam-Gu, Seoul, Korea, Republic of, 135-710
      • Samsung Medical Center / Department of Dermatology
• Netherlands
  • Beek, Netherlands, 6191 JW
    • PT & R
  • Breda, Netherlands, 4800 RK
    • Amphia Hospital Location Molengracht / Department Dermatology
  • Rotterdam, Netherlands, 3015 CA
    • Erasmus MC
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1105 AZ
      • Academic Medical Centre (AMC)
• Poland
  • Bialystok, Poland, 05-354
    • NZOZ OSTEO-MEDIC S.C. Artur Racewicz, Jerzy Supronik
  • Gdansk, Poland, 80-952
    • Klinika Dermatologii, Wenerologii i Alergologii, Uniwersyteckie Centrum Kliniczne
  • Krakow, Poland, 31-501
    • Krakowskie Centrum Medyczne NZOZ
  • Opole, Poland, 45-080
    • Novum Instytut Dermatologii Leczniczej i Estetycznej
  • Poznan, Poland, 60-539
    • Solumed S.C.
• Russian Federation
  • Moscow, Russian Federation, 107076
    • State Research Center of Dermatovenerology, Department of clinical dermatology
  • Moscow, Russian Federation, 107076
    • State Research Center of Dermatovenerology, Department of dermatology
  • Moscow, Russian Federation, 121614
    • Dermatovenerologic dispensary #7
  • Rostov-on-Don, Russian Federation, 344007
    • Rostov-on-Don regional dermatovenerologic dispensary
  • Ryazan, Russian Federation, 390046
    • Ryazan regional clinical dermatovenerologic dispensary
  • Saint-Petersburg, Russian Federation, 194021
    • Dermatovenerologic dispensary #10 of Vyborg region
  • Saint-Petersburg, Russian Federation, 194044
    • Military Medical Academy S.M. Kirov
  • Saint-Petersburg, Russian Federation, 195067
    • North-Western State Medical University I.I. Mechnikov, Dermatovenerology Department
  • Saratov, Russian Federation, 410028
    • Clinic of dermatovenerologic diseases
  • Smolensk, Russian Federation, 214019
    • Smolensk State Medical Academy
  • Yaroslavl, Russian Federation, 150003
    • Clinical Hospital of Emergency Care N.V. Soloviev
  • Moscow Region
    • Korolev, Moscow Region, Russian Federation, 141070
      • Korolev Dermatovenerologic Dispensary
• Singapore
  • Singapore, Singapore, 529889
    • Changi General Hospital
  • Singapore, Singapore, 308205
    • National Skin Centre
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
    • Dermatologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta
  • Piestany, Slovakia, 921 12
    • Narodny ustav reumatickych chorob
  • Svidnik, Slovakia, 089 01
    • DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre
  • Valencia, Spain, 46014
    • Consorcio Hospital General Universitario de Valencia
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Hospital Universitario Fundacion Alcorcon
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Puerta de Hierro Majadahonda
• Sweden
  • Falun, Sweden, 791 82
    • Falu lasarett, Hudkliniken
  • Lulea, Sweden, 972 33
    • Hermelinen Forskning AB
  • Malmo, Sweden, 205 02
    • Skanes Universitetssjukhus i Malmo, Hudkliniken
  • Stockholm, Sweden, 118 83
    • Sodersjukhuset, Hudkliniken
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset Solna
• Switzerland
  • St. Gallen, Switzerland, 9007
    • Kantonsspital St. Gallen
• Turkey
  • Izmir, Turkey, 35340
    • Dokuz Eylul Universitesi Tip Fakultesi Dermatoloji Anabilim Dali
  • Ankara
    • Besevler, Ankara, Turkey, 06500
      • Gazi University Medical Faculty
  • Istanbul
    • Capa, Istanbul, Turkey, 34390
      • Istanbul University Istanbul Medical Faculty
    • Pendik, Istanbul, Turkey, 34890
      • T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali
  • Mersin
    • Akdeniz, Mersin, Turkey, 33070
      • Mersin University Medical Faculty
• United Kingdom
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary, Balmoral building, Clinic 3, Dermatology
  • Leytonstone
    • London, Leytonstone, United Kingdom, E11 1NR
      • Whipps Cross University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CP 690,550 5 mg BID+Placebo BIW	Drug: CP 690,550 5 mg; CP-690,550 5 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
Experimental: CP 690,550 10 mg BID+Placebo BIW	Drug: CP 690,550 10 mg; CP-690,550 10 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
Active Comparator: Placebo BID+Etanercept 50 mg BIW	Biological: Etanercept 50 mg; Placebo orally dosed twice daily and etanercept 50 mg subcutaneously dosed twice weekly for 12 weeks
Placebo Comparator: Placebo BID+Placebo BIW	Other: Placebo; Placebo orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 12
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.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Weeks 2, 4, and 8
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).	Baseline and Weeks 2, 4, 8, and 12
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.	Weeks 2, 4, and 8
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.	Baseline and Weeks 2, 4, 8, and 12
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.	Weeks 2, 4, 8, and 12
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.	Baseline and Weeks 2, 4, 8, and 12
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.	Weeks 2, 4, 8, and 12
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.	Baseline and Weeks 2, 4, 8, and 12
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.	Weeks 2, 4, 8, and 12
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.	Weeks 2, 4, 8, and 12
Median Time to PASI50 Response During the 12-Week Double-Blind Treatment		Baseline up to Week 12
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.	Weeks 2, 4, 8, and 12
Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment		Baseline up to Week 12
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		Weeks 2, 4, 8, and 12
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.	Baseline, Weeks 2, 4, 8, and 12
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.	Weeks 2, 4, 8, and 12
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.	Weeks 2, 4, 8, and 12
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.	Baseline and Weeks 4 and 12
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.	Weeks 4 and 12
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).	Baseline and Weeks 4 and 12
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.	Weeks 4 and 12
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.	Weeks 4 and 12
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.	Weeks 4 and 12
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.	Weeks 4 and 12
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.	Baseline and Week 12
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.	Baseline and Week 12
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.	Week 12
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.	Week 12
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).	Baseline and Weeks 2, 4, and 8
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.	Weeks 2, 4, 8, and 12
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.	Week 12
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.	Week 12
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.	Baseline and Week 12
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.	Week 12
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.	Baseline and Week 12
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.	Week 12
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").	Baseline and Week 12
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").	Week 12
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.	Baseline (BL) and Week 12
Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment		Week 12
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.	Baseline and Week 12
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.	Week 12
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.	Baseline and Week 12
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.	Week 12

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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;:
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: November 12, 2010
• First Submitted That Met QC Criteria: November 12, 2010
• First Posted (Estimate): November 16, 2010

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Safety; Psoriasis; Efficacy; Itch; Chronic; Xeljanz; Pruritus; DLQI; CP-690,550; Tofacitinib; Plaque psoriasis; Plaque; Severe; Psoriasis vulgaris; Etanercept; Moderate; OPT Compare; OPT; head-to-head; non-inferiority; short-term
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Protein Kinase Inhibitors; Etanercept; Tofacitinib
• Other Study ID Numbers: A3921080

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No