Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

Last updated: June 6, 2017
Sponsor: Pfizer
Overall Status: Completed

Phase

3

Condition

Psoriasis And Psoriatic Disorders

Arthritis And Arthritic Pain

Psoriatic Arthritis

Treatment

N/A

Clinical Study ID

NCT01877668
A3921091
2011-003668-55
  • Ages > 18
  • All Genders

Study Summary

This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males or females, aged >= 18 years at time of consent.

  • Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months

  • Meet the Classification Criteria of PsA (CASPAR) at time of screening

  • Must not have been adequately treated with a a traditional non-biologic diseasemodifying anti-rheumatic drug (DMARD).

  • Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed andrequired

  • Must not have taken a biologic Tumour Necrosis Factor Inhibitor

  • Must have 3 or more swollen joints AND 3 or more tender joints

  • Must have active psoriasis skin lesions

Exclusion

Exclusion Criteria:

  • Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with theexception of nail psoriasis which is allowed

  • Pregnant or breast feeding, females of child-bearing potential not using highlyeffective contraception

  • New York Heart Association Class III and IV congestive heart failure

  • History of hypersensitivity or infusion reaction to biologic agents

  • Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection

Study Design

Total Participants: 422
Study Start date:
January 20, 2014
Estimated Completion Date:
December 18, 2015

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Rheumatology Research Unit

    Maroochydore, Queensland 4558
    Australia

    Site Not Available

  • Pacific Private Clinic

    Southport, Queensland 4215
    Australia

    Site Not Available

  • Monash Health, Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Pharmacy Clinical Trials

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • St. Vincent's Hospital (Melbourne)

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • Emeritus Research Pty Ltd

    Malvern East, Victoria 3145
    Australia

    Site Not Available

  • Emeritus Research Pty Ltd

    Melbourne, Victoria 3145
    Australia

    Site Not Available

  • Hopital Erasme - Clinique Universitaire de Bruxelles

    Brussels, 1070
    Belgium

    Site Not Available

  • UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • University Hospital Leuven, Department of Rheumatology

    Leuven, 3000
    Belgium

    Site Not Available

  • ZNA Jan Palfijn

    Merksem, 2170
    Belgium

    Site Not Available

  • UMHAT "Dr. G. Stranski" EAD

    Pleven, 5800
    Bulgaria

    Site Not Available

  • MHAT "Kaspela" EOOD

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • MHAT"Plovdiv" AD

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • UMHAT "Sv. Ivan Rilski" EAD

    Sofia, 1612
    Bulgaria

    Site Not Available

  • MC "New rehabilitation center" EOOD, Rheumatology Cabinet

    Stara Zagora, 6003
    Bulgaria

    Site Not Available

  • Rheumatology Research Associates

    Edmonton, Alberta T5M 0H4
    Canada

    Site Not Available

  • Credit Valley Rheumatology

    Mississauga, Ontario L5M 2V8
    Canada

    Site Not Available

  • Toronto Western Hospital

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • K. Papp Clinical Research

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • West Island Rheumatology Research Associates

    Pointe Claire, Quebec H9R 3J1
    Canada

    Site Not Available

  • West Island Rheumatology Research Associates

    Pointe-Claire, Quebec H9R 3J1
    Canada

    Site Not Available

  • Rheumatology

    Prague, 140 00
    Czech Republic

    Site Not Available

  • Revmacentrum MUDr. Mostera, s.r.o.

    Brno, Czech Republic 615 00
    Czechia

    Site Not Available

  • MEDIGAP, s.r.o. (radiology only)

    Praha 1 - Nove Mesto, Czech Republic 110 00
    Czechia

    Site Not Available

  • Revmatologicky Ustav - Lekarna (pharmacy only)

    Praha 2, Czech Republic 128 50
    Czechia

    Site Not Available

  • Revmatologicka ambulance

    Praha 4, Czech Republic 140 00
    Czechia

    Site Not Available

  • Lekarna Na Lidicke (Pharmacy only)

    Brno, 602 00
    Czechia

    Site Not Available

  • Revmatologie s.r.o.

    Brno, 638 00
    Czechia

    Site Not Available

  • Stavovska s.r.o. (pharmacy only)

    Brno, 63800
    Czechia

    Site Not Available

  • X-MEDICA s.r.o (radiology only)

    Brno, 61300
    Czechia

    Site Not Available

  • Vesalion s.r.o.

    Ostrava, 70200
    Czechia

    Site Not Available

  • MEDIGAP, s.r.o

    Praha 1- Nove Mesto, 110 00
    Czechia

    Site Not Available

  • Revmatologicky ustav

    Praha 2, 128 50
    Czechia

    Site Not Available

  • Revmatologicky ustav - Lekarna

    Praha 2, 128 50
    Czechia

    Site Not Available

  • Medical Plus s.r.o. Lekarna Hradebni s. r.o

    Uherske Hradiste, 68601
    Czechia

    Site Not Available

  • Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie

    Corbeil Essonnes cedex, 91106
    France

    Site Not Available

  • Rheumazentrum Prof. Dr. med Gunther Neeck

    Bad Doberan, 18209
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117
    Germany

    Site Not Available

  • Rheumapraxis Steglitz

    Berlin, 12161
    Germany

    Site Not Available

  • Universitaetsklinikum Erlangen, Medizinische Klinik 3

    Erlangen, 91054
    Germany

    Site Not Available

  • CIRI

    Frankfurt am Main, 60528
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • University Hospital of Cologne

    Koeln, 50937
    Germany

    Site Not Available

  • Elisabeth Klinik Bigge

    Olsberg, 59939
    Germany

    Site Not Available

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055
    Germany

    Site Not Available

  • Magyar Honvedseg Egeszsegugyi Kozpont,Reumatologiai osztaly

    Budapest, 1062
    Hungary

    Site Not Available

  • Qualiclinic Kft.

    Budapest, 1036
    Hungary

    Site Not Available

  • Revita Reumatologiai Rendelo

    Budapest, 1027
    Hungary

    Site Not Available

  • Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum

    Debrecen, 4032
    Hungary

    Site Not Available

  • MAV Korhaz es Rendelointezet Szolnok, Reumatologiai Osztaly

    Szolnok, 5000
    Hungary

    Site Not Available

  • Csolnoky Ferenc Korhaz, Radiologiai Osztaly X-Ray Only

    Veszprem, 8200
    Hungary

    Site Not Available

  • Csolnoky Ferenc Korhaz, Reumatologiai Osztaly

    Veszprem, 8200
    Hungary

    Site Not Available

  • Universidad La Salle A.C.

    Mexico, Distrito Federal 14000
    Mexico

    Site Not Available

  • Centro Integral en Reumatologia SA de CV

    Guadalajara, Jalisco 44160
    Mexico

    Site Not Available

  • Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.

    Culiacan, Sinaloa 80000
    Mexico

    Site Not Available

  • Hospital General de Culiacán Dr. Bernardo J. Gastélum

    Culiacan, Sinaloa 80230
    Mexico

    Site Not Available

  • Laboratorios de Analisis Clinicos CEMSI

    Culiacan, Sinaloa 80000
    Mexico

    Site Not Available

  • Sanatorio CEMSI Chapultepec (For Emergencies Only)

    Culiacan, Sinaloa 80040
    Mexico

    Site Not Available

  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

    Merida, Yucatan 97130
    Mexico

    Site Not Available

  • Centro de Investigacion Clinica Pensiones

    Merida, Yucatan 97070
    Mexico

    Site Not Available

  • HOSPITAL STAR MEDICA S.A DE C.V- (emergencies only)

    Merida, Yucatan 97133
    Mexico

    Site Not Available

  • Hospital Star Medica Merida (For Emergencies Only)

    Merida, Yucatan 97133
    Mexico

    Site Not Available

  • Instituto Medico Panamericano, S.A. de C.V. (For Emergencies Only)

    Merida, Yucatan 97000
    Mexico

    Site Not Available

  • Unidad Reumatologica Las Americas, S.C.P.

    Merida, Yucatan 97000
    Mexico

    Site Not Available

  • Investigacion y Biomedicina de Chihuahua SC

    Chihuahua, 31000
    Mexico

    Site Not Available

  • Centro de Estudios Clinicos Especializados

    Merida - Yucatan, 97133
    Mexico

    Site Not Available

  • Cliditer, S. A. de C. V

    Mexico City, 06700
    Mexico

    Site Not Available

  • ClinicMed Badurski i wspolnicy Spolka Jawna

    Bialystok, 15-879
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.,"

    Bialystok, 15-002
    Poland

    Site Not Available

  • ZDROWIE OSTEO-MEDIC s.c. L. i A. Racewicz, A. i J. Supronik

    Bialystok, 15-351
    Poland

    Site Not Available

  • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy,

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

    Elblag, 82-300
    Poland

    Site Not Available

  • Centrum Radiologii for X-Ray only

    Elblag, 82-300
    Poland

    Site Not Available

  • NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela

    Elblag, 82-300
    Poland

    Site Not Available

  • Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"

    Grodzisk Mazowiecki, 05-825
    Poland

    Site Not Available

  • Zespol Poradni Specjalistycznych Reumed Filia Onyksowa

    Lublin, 20-582
    Poland

    Site Not Available

  • NZOZ Lecznica MAK-MED S.C.

    Nadarzyn, 05-830
    Poland

    Site Not Available

  • Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj

    Poznan, 61-397
    Poland

    Site Not Available

  • NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu

    Torun, 87-100
    Poland

    Site Not Available

  • Medica Pro Familia Sp. z o.o. S.K.A.

    Warsaw, 01-868
    Poland

    Site Not Available

  • Klinika Ambroziak Estederm Sp. z o.o. ,S.K.A

    Warszawa, 02-758
    Poland

    Site Not Available

  • Reumatika Centrum Reumatologii

    Warszawa, 02-691
    Poland

    Site Not Available

  • Rheuma Medicus Zaklad Opieki Zdrowotnej

    Warszawa, 02-118
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddz. we Wroclawiu

    Wroclaw, 50-088
    Poland

    Site Not Available

  • Regional State Budgetary Healthcare Institution of Karelia Republic

    Petrozavodsk, Karelia Republic 185019
    Russian Federation

    Site Not Available

  • Municipal Budgetary Institution "Central City Clinical Hospital #6"

    Ekaterinburg, 620149
    Russian Federation

    Site Not Available

  • City Clinical Hospital #7

    Kazan, 420103
    Russian Federation

    Site Not Available

  • State Budgetary Institution of Healthcare of Moscow City Clinical Hospital

    Moscow, 119049
    Russian Federation

    Site Not Available

  • Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"

    Novosibirsk, 630099
    Russian Federation

    Site Not Available

  • OOO City Neurological Centre "Sibneiromed"

    Novosibirsk, 630091
    Russian Federation

    Site Not Available

  • OOO AVA-PETER "Scandinavia clinic"

    Saint Petersburg, 191014
    Russian Federation

    Site Not Available

  • State Institution of Healthcare "Regional Clinical Hospital"

    Saratov, 410053
    Russian Federation

    Site Not Available

  • AVA-PETER Ltd.

    St Petersburg, 191014
    Russian Federation

    Site Not Available

  • State Budget Educational Institution of Highest Professional Education

    Tomsk, 634050
    Russian Federation

    Site Not Available

  • State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a. N.V. Solovyev

    Yaroslavl, 150003
    Russian Federation

    Site Not Available

  • State Institution of Healthcare of Yaroslavl Region

    Yaroslavl, 150003
    Russian Federation

    Site Not Available

  • ROMJAN s.r.o., Reumatologicka ambulancia

    Bratislava, Slovak Republic 832 63
    Slovakia

    Site Not Available

  • MEDMAN s.r.o. - reumatologicka ambulancia

    Martin, Slovak Republic 036 01
    Slovakia

    Site Not Available

  • Nestatna reumatologicka ambulancia

    Bratislava, 841 04
    Slovakia

    Site Not Available

  • Reumex s.r.o

    Rimavska Sobota, 979 01
    Slovakia

    Site Not Available

  • Hospital Clinico de Santiago

    Santiago De Compostela, A Coruna 15706
    Spain

    Site Not Available

  • Corporació Sanitaria Parc Tauli

    Sabadell, Barcelona 08208
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitario Sierrallana

    Torrelavega, Cantabria 39300
    Spain

    Site Not Available

  • Complexo Hospitalario Universitario A Coruna

    A Coruna, 15006
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Infanta Luisa

    Sevilla, 41010
    Spain

    Site Not Available

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Buddhist Dalin Tzu Chi General Hospital

    Dalin Township, Chiayi County 62247
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, Taiwan Roc 11217
    Taiwan

    Site Not Available

  • Buddhist Dalin Tzu Chi General Hospital

    Chia-Yi, 62247
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-Kaohsiung Branch

    Kaohsiung, 83301
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung, 40201
    Taiwan

    Site Not Available

  • Clinical Trial Pharmacy of Taipei Veterans General Hospital

    Taipei City, 11217
    Taiwan

    Site Not Available

  • Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital

    Goodmayes, Essex IG3 8YB
    United Kingdom

    Site Not Available

  • Barking, Havering and Redbridge University Hospitals NHS Trust

    Romford, Essex RM7 0AG
    United Kingdom

    Site Not Available

  • West Suffolk Hospitals NHS Foundation Trust

    Bury St.Edmunds, Suffolk IP33 2QZ
    United Kingdom

    Site Not Available

  • Cardiff & Vale University Health Board

    Cardiff, Wales CF14 4XW
    United Kingdom

    Site Not Available

  • The Dudley Group NHS Foundation Trust

    Dudley, West Midlands DY1 2HQ
    United Kingdom

    Site Not Available

  • Bradford Royal Infirmary, BTHFT

    Bradford, West Yorkshire BD9 6RJ
    United Kingdom

    Site Not Available

  • Bradford Teaching Hospitals NHS Foundation Trust

    Bradford, West Yorkshire BD5 0NA
    United Kingdom

    Site Not Available

  • Wirral University Teaching Hospital NHS Foundation Trust

    Upton, Wirral CH49 5PE
    United Kingdom

    Site Not Available

  • Royal National Hospital for Rheumatic Diseases NHS Foundation Trust

    Bath, BA1 1RL
    United Kingdom

    Site Not Available

  • West Suffolk Hospital - West Suffolk Hospitals NHS Trust

    Bury St Edmunds, IP33 2QZ
    United Kingdom

    Site Not Available

  • Guy's & St Thomas' NHS Foundation Trust

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Mount Vernon Hospital - Hillingdon Hospital Nhs Trust

    Northwood, HA6 2DN
    United Kingdom

    Site Not Available

  • York Teaching Hospital NHS Foundation Trust

    York, YO31 8HE
    United Kingdom

    Site Not Available

  • Rheumatology Associates, PC

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Rheumatology Associates of North Alabama, PC

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Medvin Clinical Research

    Covina, California 91723
    United States

    Site Not Available

  • St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

    Fullerton, California 92835
    United States

    Site Not Available

  • Desert Medical Advances

    Palm Desert, California 92260
    United States

    Site Not Available

  • Advances In Medicine (X-Rays)

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • San Diego Arthritis Medical Clinic

    San Diego, California 92108
    United States

    Site Not Available

  • Rheumatology Associates of Central Florida, PA

    Orlando, Florida 32806
    United States

    Site Not Available

  • Millennium Research

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Arthritis Center, Inc.

    Palm Harbor, Florida 34684
    United States

    Site Not Available

  • Integral Rheumatology & Immunology Specialists (IRIS)

    Plantation, Florida 33324
    United States

    Site Not Available

  • Arthritis and Rheumatology of GA, P.C.

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Office of Jefrey D. Lieberman, MD, P.C.

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Marietta Rheumatology Associates

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Professional Research Network Of Kansas, LLC

    Wichita, Kansas 67203
    United States

    Site Not Available

  • Bluegrass Community Research, Inc

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Klein & Associates, M.D., P.A.

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Bronson Internal Medicine and Rheumatology

    Battle Creek, Michigan 49015
    United States

    Site Not Available

  • St. Paul Rheumatology, PA

    Eagan, Minnesota 55121
    United States

    Site Not Available

  • Physician Research Collaboration, LLC

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center (DHMC)

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • University of Rochester, Allergy/lmmunology & Rheumatology

    Rochester, New York 14623
    United States

    Site Not Available

  • Cincinnati Rheumatic Disease Study Group, Inc.

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Low Country Rheumatology, PA

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Pioneer Research Solutions, Inc.

    Houston, Texas 77008
    United States

    Site Not Available

  • Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • University of Utah Hospital & Clinics

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Western Institutional Review Board

    Puyallup, Washington 98374
    United States

    Site Not Available

  • Dynacare Laboratories (Specimen processing for shipment)

    Seattle, Washington 98122
    United States

    Site Not Available

  • Investigational Drug Service Pharmacy, Swedish Medical Center.

    Seattle, Washington 98122
    United States

    Site Not Available

  • Seattle Rheumatology Associates

    Seattle, Washington 98122
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Site Not Available

  • PharmaSeek, LLC

    Middleton, Wisconsin 53562
    United States

    Site Not Available

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