Clinical trial NCT01241591: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 1101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12
timeFrame: Week 12
measure: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With a PGA Response of "Clear" or "Almost Clear" During the 12-Week Double-Blind Treatment
timeFrame: Weeks 2, 4, and 8
measure: Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment
timeFrame: Baseline and Weeks 2, 4, 8, and 12
measure: Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment
timeFrame: Weeks 2, 4, and 8
measure: Mean PASI Score During the 12-Week Double-Blind Treatment
timeFrame: Baseline and Weeks 2, 4, 8, and 12
measure: Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment
timeFrame: Weeks 2, 4, 8, and 12
measure: Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment
timeFrame: Baseline and Weeks 2, 4, 8, and 12
measure: Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment
timeFrame: Weeks 2, 4, 8, and 12
measure: Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment
timeFrame: Baseline and Weeks 2, 4, 8, and 12
measure: Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment
timeFrame: Weeks 2, 4, 8, and 12
measure: Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment
timeFrame: Weeks 2, 4, 8, and 12
measure: Median Time to PASI50 Response During the 12-Week Double-Blind Treatment
timeFrame: Baseline up to Week 12
measure: Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment
timeFrame: Weeks 2, 4, 8, and 12
measure: Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment
timeFrame: Baseline up to Week 12
measure: 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
timeFrame: Weeks 2, 4, 8, and 12
measure: Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment
timeFrame: Baseline, Weeks 2, 4, 8, and 12
measure: Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment
timeFrame: Weeks 2, 4, 8, and 12
measure: Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment
timeFrame: Weeks 2, 4, 8, and 12
measure: Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment
timeFrame: Baseline and Weeks 4 and 12
measure: Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment
timeFrame: Weeks 4 and 12
measure: Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment
timeFrame: Baseline and Weeks 4 and 12
measure: Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment
timeFrame: Weeks 4 and 12
measure: Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment
timeFrame: Weeks 4 and 12
measure: Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment
timeFrame: Weeks 4 and 12
measure: Median Time to DLQI Response
timeFrame: Weeks 4 and 12
measure: Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12
timeFrame: Baseline and Week 12
measure: Mean SF-36 Domain Scores at Baseline and Week 12
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline in SF-36 MCS and PCS Scores
timeFrame: Week 12
measure: Mean Change From Baseline in SF-36 Domain Scores
timeFrame: Week 12
measure: Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment
timeFrame: Baseline and Weeks 2, 4, and 8
measure: Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment
timeFrame: Weeks 2, 4, 8, and 12
measure: Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment
timeFrame: Week 12
measure: Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12
timeFrame: Week 12
measure: Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment
timeFrame: Baseline and Week 12
measure: Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment
timeFrame: Week 12
measure: Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline in EQ-5D VAS at Week 12
timeFrame: Week 12
measure: Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12
timeFrame: Week 12
measure: Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment
timeFrame: Baseline (BL) and Week 12
measure: Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment
timeFrame: Week 12
measure: Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work
timeFrame: Baseline and Week 12
measure: Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment
timeFrame: Week 12
measure: Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment
timeFrame: Week 12
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Dermatologicas
state: C1114aap
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Dermatologicas
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: IMAI (Instituto Medico de Asistencia e Investigaciones)
city: Feldkirch
country: Austria
facility: LKH Feldkirch Abteilung fuer Dermatologie und Venerologie
city: Innsbruck
country: Austria
facility: LKH Innsbruck Universitaetsklinik fuer Dermatologie und Venerologie
city: Salzburg
country: Austria
facility: LKH Salzburg, Landesklinik fuer Dermatologie
city: Wien
country: Austria
facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhuegel
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Sarajevo
country: Bosnia and Herzegovina
facility: Department for skin and venerial diseases, Clinical Center University of Sarajevo
city: Pleven
country: Bulgaria
facility: Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Dr Georgi Stranski- Pleven
city: Sofia
country: Bulgaria
facility: Tsentar za kozhno-venericheski zaboliavania" EOOD
city: Sofia
country: Bulgaria
facility: Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia
city: Sofia
country: Bulgaria
facility: Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia
city: Sofia
country: Bulgaria
facility: MBAL na Voennomeditsinska akademia- Sofia
city: Santiago, Rm 8431657
country: Chile
facility: Clinica Davila
state: RM
city: Vina del Mar
country: Chile
facility: Centro de Especialidades Dermatologicas
state: V Region
city: Santiago
country: Chile
facility: Clinica Dermovein S.A.
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile, Departamento Dermatologia
city: Medellin
country: Colombia
facility: Reumalab S.A.S.
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro Integral de Reumatología del Caribe Circaribe S.A
state: Atlantico
city: Bogota
country: Colombia
facility: Centro de Investigacion Clinica de la Universidad del Rosario
state: Cundinamarca
city: Bogota
country: Colombia
facility: Riesgo de Fractura S.A.
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Medicity S.A.S
state: Santander
city: Osijek
country: Croatia
facility: Department of Dermatovenerology, University Hospital Center Osijek
city: Zagreb
country: Croatia
facility: Dermatovenerological Clinic, University hospital center "Sestre milosrdnice"
city: Zagreb
country: Croatia
facility: Department of dermatovenerology, University Hospital Center Zagreb
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice, a.s.
city: Hradec Kralove
country: Czechia
facility: FN Kradec Kralove
city: Plzen - Bory
country: Czechia
facility: Fakultni nemocnice Plzen
city: Praha 1
country: Czechia
facility: Kozni ordinace
city: Usti nad Labem
country: Czechia
facility: Kralska zdravotni a.s., Masarykovy nemocnice o.z.
city: Usti nad Labem
country: Czechia
facility: Kralska zdravotni
city: Aarhus C
country: Denmark
facility: Department of Dermatology, Aarhus University Hospital
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital, University of Copenhagen
city: Herning
country: Denmark
facility: Hudklinikken Herning
city: Le Mans
country: France
facility: CHG Le Mans
state: Cedex 09
city: Besancon
country: France
facility: CHU de Besancon - Hopital Saint Jacques
city: Boulogne
country: France
facility: Hopital Ambroise Pare, Service de Dermatologie
city: BREST Cédex
country: France
facility: Chu Morvan
city: Limoges
country: France
facility: Hopital Dupuytren
city: NANCY Cédex
country: France
facility: Hopital Fournier
city: Nantes Cedex 1
country: France
facility: CHU de Nantes - Hotel Dieu
city: Nice
country: France
facility: CHU de NICE - Hôpital de l'Archet II
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: Hôpital Bichat
city: Pierre-Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: C.H.U. de Poitiers
city: Reims
country: France
facility: Hopital Robert Debre
city: Saint Priest En Jarez
country: France
facility: Hopital Nord
city: Toulouse cedex 9
country: France
facility: Hôpital Larrey
city: Vandoeuvre-les-Nancy
country: France
facility: Hôpital de Brabois / Bâtiment Philippe Canton
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin
city: Berlin
country: Germany
facility: Hautarztpraxis
city: Buchholz
country: Germany
facility: Dres.Kirsten Prepeneit und Volker Streit
city: Dresden
country: Germany
facility: Universitaetsklinik Carl Gustav Carus
city: Duelmen
country: Germany
facility: Hautzentrum Duelmen
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
city: Frankfurt/Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe Universitaet
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Hautklinik der Ruprecht-Karls-Universitaet Heidelberg
city: Koeln
country: Germany
facility: Universitaets- Hautklinik Koeln
city: Mahlow
country: Germany
facility: Hautarztpraxis Dres. Scholz, Sebastian, Schilling
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR
city: Muenchen
country: Germany
facility: Technische Universitaet Muenchen
city: Osnabrueck
country: Germany
facility: Dres. med. Bredlich/PD Rosenbach/Thiele
city: Tuebingen
country: Germany
facility: Eberhard-Karls-Universitaet Tuebingen
city: Witten
country: Germany
facility: Hautarztpraxis
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum/Bor- es Nemikortani Klinika
city: Miskolc
country: Hungary
facility: Miskolci Semmelweis Ignac Korhaz-Rendelointezet/Borgyogyaszat
city: Szeged
country: Hungary
facility: SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika
city: Szolnok
country: Hungary
facility: ALLERGO-DERM BAKOS Kft.
city: Afula
country: Israel
facility: Dermatology Department
city: Gangnam-Gu
country: Korea, Republic of
facility: Samsung Medical Center / Department of Dermatology
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine/Department of Dermatology
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre (AMC)
state: Noord Holland
city: Beek
country: Netherlands
facility: PT & R
city: Breda
country: Netherlands
facility: Amphia Hospital Location Molengracht / Department Dermatology
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Bialystok
country: Poland
facility: NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
city: Gdansk
country: Poland
facility: Klinika Dermatologii, Wenerologii i Alergologii, Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne NZOZ
city: Opole
country: Poland
facility: Novum Instytut Dermatologii Leczniczej i Estetycznej
city: Poznan
country: Poland
facility: Solumed S.C.
city: Korolev
country: Russian Federation
facility: Korolev Dermatovenerologic Dispensary
state: Moscow Region
city: Moscow
country: Russian Federation
facility: State Research Center of Dermatovenerology, Department of clinical dermatology
city: Moscow
country: Russian Federation
facility: State Research Center of Dermatovenerology, Department of dermatology
city: Moscow
country: Russian Federation
facility: Dermatovenerologic dispensary #7
city: Rostov-on-Don
country: Russian Federation
facility: Rostov-on-Don regional dermatovenerologic dispensary
city: Ryazan
country: Russian Federation
facility: Ryazan regional clinical dermatovenerologic dispensary
city: Saint-Petersburg
country: Russian Federation
facility: Dermatovenerologic dispensary #10 of Vyborg region
city: Saint-Petersburg
country: Russian Federation
facility: Military medical academy S.M. Kirov
city: Saint-Petersburg
country: Russian Federation
facility: North-Western State Medical University I.I. Mechnikov, Dermatovenerology Department
city: Saratov
country: Russian Federation
facility: Clinic of dermatovenerologic diseases
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical Academy
city: Yaroslavl
country: Russian Federation
facility: Clinical hospital of emergency care N.V. Soloviev
city: Singapore
country: Singapore
facility: National Skin Centre
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Banska Bystrica
country: Slovakia
facility: Dermatologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta
city: Piestany
country: Slovakia
facility: Narodny ustav reumatickych chorob
city: Svidnik
country: Slovakia
facility: DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
state: Madrid
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Falun
country: Sweden
facility: Falu lasarett, Hudkliniken
city: Lulea
country: Sweden
facility: Hermelinen Forskning AB
city: Malmo
country: Sweden
facility: Skanes Universitetssjukhus i Malmo, Hudkliniken
city: Stockholm
country: Sweden
facility: Sodersjukhuset, Hudkliniken
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Besevler
country: Turkey
facility: Gazi University Medical Faculty
state: Ankara
city: Capa
country: Turkey
facility: Istanbul university Istanbul Medical Faculty
state: Istanbul
city: Pendik
country: Turkey
facility: T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali
state: Istanbul
city: Akdeniz
country: Turkey
facility: Mersin University Medical Faculty
state: Mersin
city: Izmir
country: Turkey
facility: Dokuz Eylul Universitesi Tip Fakultesi Dermatoloji Anabilim Dali
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
state: Leytonstone
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary, Balmoral building, Clinic 3, Dermatology
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.
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.
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.