Psoriasis Clinical Trial

Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator 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.

View Eligibility Criteria

Eligibility Criteria

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 disease modifying anti-rheumatic drug (DMARD).
Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
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 Criteria:

Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
Pregnant or breast feeding, females of child-bearing potential not using highly effective 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 is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

422

Study ID:

NCT01877668

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 107 Locations for this study

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Rheumatology Associates, PC
Birmingham Alabama, 35205, United States
Rheumatology Associates of North Alabama, PC
Huntsville Alabama, 35801, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale Arizona, 85306, United States
Medvin Clinical Research
Covina California, 91723, United States
Desert Medical Advances
Palm Desert California, 92260, United States
Advances In Medicine (X-Rays)
Rancho Mirage California, 92270, United States
San Diego Arthritis Medical Clinic
San Diego California, 92108, United States
Millennium Research
Ormond Beach Florida, 32174, United States
Arthritis Center, Inc.
Palm Harbor Florida, 34684, United States
Klein & Associates, M.D., P.A.
Hagerstown Maryland, 21740, United States
Clinical Pharmacology Study Group
Worcester Massachusetts, 01605, United States
St. Paul Rheumatology, PA
Eagan Minnesota, 55121, United States
Physician Research Collaboration, LLC
Lincoln Nebraska, 68516, United States
Dartmouth-Hitchcock Medical Center (DHMC)
Lebanon New Hampshire, 03756, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights Ohio, 44130, United States
Altoona Center for Clinical Research
Duncansville Pennsylvania, 16635, United States
Low Country Rheumatology, PA
Charleston South Carolina, 29406, United States
Pioneer Research Solutions, Inc.
Houston Texas, 77008, United States
Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah
Salt Lake City Utah, 84112, United States
University of Utah Hospital & Clinics
Salt Lake City Utah, 84132, United States
Dynacare Laboratories (Specimen processing for shipment)
Seattle Washington, 98122, United States
Investigational Drug Service Pharmacy, Swedish Medical Center.
Seattle Washington, 98122, United States
Seattle Rheumatology Associates
Seattle Washington, 98122, United States
Swedish Medical Center
Seattle Washington, 98122, United States
Rheumatology Research Unit
Maroochydore Queensland, 4558, Australia
Pacific Private Clinic
Southport Queensland, 4215, Australia
Monash Health, Monash Medical Centre
Clayton Victoria, 3168, Australia
Pharmacy Clinical Trials
Clayton Victoria, 3168, Australia
St. Vincent's Hospital (Melbourne)
Fitzroy Victoria, 3065, Australia
Emeritus Research Pty Ltd
Malvern East Victoria, 3145, Australia
Hopital Erasme - Clinique Universitaire de Bruxelles
Brussels , 1070, Belgium
University Hospital Leuven, Department of Rheumatology
Leuven , 3000, Belgium
UMHAT "Dr. G. Stranski" EAD
Pleven , 5800, Bulgaria
MHAT"Plovdiv" AD
Plovdiv , 4000, Bulgaria
MHAT "Kaspela" EOOD
Plovdiv , 4002, Bulgaria
UMHAT "Sv. Ivan Rilski" EAD
Sofia , 1612, Bulgaria
MC "New rehabilitation center" EOOD, Rheumatology Cabinet
Stara Zagora , 6003, Bulgaria
Rheumatology Research Associates
Edmonton Alberta, T5M 0, Canada
K. Papp Clinical Research
Waterloo Ontario, N2J 1, Canada
West Island Rheumatology Research Associates
Pointe-Claire Quebec, H9R 3, Canada
Revmacentrum MUDr. Mostera, s.r.o.
Brno Czech Republic, 615 0, Czechia
MEDIGAP, s.r.o. (radiology only)
Praha 1 - Nove Mesto Czech Republic, 110 0, Czechia
Revmatologicky Ustav - Lekarna (pharmacy only)
Praha 2 Czech Republic, 128 5, Czechia
Revmatologicka ambulance
Praha 4 Czech Republic, 140 0, Czechia
Lekarna Na Lidicke (Pharmacy only)
Brno , 602 0, Czechia
X-MEDICA s.r.o (radiology only)
Brno , 61300, Czechia
Revmatologie s.r.o.
Brno , 638 0, Czechia
Stavovska s.r.o. (pharmacy only)
Brno , 63800, Czechia
Vesalion s.r.o.
Ostrava , 70200, Czechia
MEDIGAP, s.r.o
Praha 1- Nove Mesto , 110 0, Czechia
Revmatologicky ustav - Lekarna
Praha 2 , 128 5, Czechia
Revmatologicky ustav
Praha 2 , 128 5, Czechia
Medical Plus s.r.o. Lekarna Hradebni s. r.o
Uherske Hradiste , 68601, Czechia
Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie
Corbeil Essonnes cedex , 91106, France
Charite Universitaetsmedizin Berlin
Berlin , 10117, Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin , 10117, Germany
Rheumapraxis Steglitz
Berlin , 12161, Germany
University Hospital of Cologne
Koeln , 50937, Germany
Klinische Forschung Schwerin GmbH
Schwerin , 19055, Germany
Revita Reumatologiai Rendelo
Budapest , 1027, Hungary
Qualiclinic Kft.
Budapest , 1036, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont,Reumatologiai osztaly
Budapest , 1062, Hungary
Csolnoky Ferenc Korhaz, Radiologiai Osztaly X-Ray Only
Veszprem , 8200, Hungary
Csolnoky Ferenc Korhaz, Reumatologiai Osztaly
Veszprem , 8200, Hungary
Centro Integral en Reumatologia SA de CV
Guadalajara Jalisco, 44160, Mexico
Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.
Culiacan Sinaloa, 80000, Mexico
Laboratorios de Analisis Clinicos CEMSI
Culiacan Sinaloa, 80000, Mexico
Sanatorio CEMSI Chapultepec (For Emergencies Only)
Culiacan Sinaloa, 80040, Mexico
Hospital General de Culiacán Dr. Bernardo J. Gastélum
Culiacan Sinaloa, 80230, Mexico
Instituto Medico Panamericano, S.A. de C.V. (For Emergencies Only)
Merida Yucatan, 97000, Mexico
Unidad Reumatologica Las Americas, S.C.P.
Merida Yucatan, 97000, Mexico
Centro de Investigacion Clinica Pensiones
Merida Yucatan, 97070, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
Merida Yucatan, 97130, Mexico
Hospital Star Medica Merida (For Emergencies Only)
Merida Yucatan, 97133, Mexico
HOSPITAL STAR MEDICA S.A DE C.V- (emergencies only)
Merida Yucatan, 97133, Mexico
Investigacion y Biomedicina de Chihuahua SC
Chihuahua , 31000, Mexico
Cliditer, S. A. de C. V
Mexico City , 06700, Mexico
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.,"
Bialystok , 15-00, Poland
ZDROWIE OSTEO-MEDIC s.c. L. i A. Racewicz, A. i J. Supronik
Bialystok , 15-35, Poland
ClinicMed Badurski i wspolnicy Spolka Jawna
Bialystok , 15-87, Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy,
Bydgoszcz , 85-16, Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Elblag , 82-30, Poland
Centrum Radiologii for X-Ray only
Elblag , 82-30, Poland
NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
Elblag , 82-30, Poland
Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"
Grodzisk Mazowiecki , 05-82, Poland
Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
Lublin , 20-58, Poland
NZOZ Lecznica MAK-MED S.C.
Nadarzyn , 05-83, Poland
Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj
Poznan , 61-39, Poland
NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu
Torun , 87-10, Poland
Medica Pro Familia Sp. z o.o. S.K.A.
Warsaw , 01-86, Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warszawa , 02-11, Poland
Reumatika Centrum Reumatologii
Warszawa , 02-69, Poland
Klinika Ambroziak Estederm Sp. z o.o. ,S.K.A
Warszawa , 02-75, Poland
Synexus Polska Sp. z o.o. Oddz. we Wroclawiu
Wroclaw , 50-08, Poland
Regional State Budgetary Healthcare Institution of Karelia Republic
Petrozavodsk Karelia Republic, 18501, Russian Federation
State Budgetary Institution of Healthcare of Moscow City Clinical Hospital
Moscow , 11904, Russian Federation
OOO City Neurological Centre "Sibneiromed"
Novosibirsk , 63009, Russian Federation
Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"
Novosibirsk , 63009, Russian Federation
State Institution of Healthcare "Regional Clinical Hospital"
Saratov , 41005, Russian Federation
State Budget Educational Institution of Highest Professional Education
Tomsk , 63405, Russian Federation
State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl , 15000, Russian Federation
State Institution of Healthcare of Yaroslavl Region
Yaroslavl , 15000, Russian Federation
ROMJAN s.r.o., Reumatologicka ambulancia
Bratislava Slovak Republic, 832 6, Slovakia
MEDMAN s.r.o. - reumatologicka ambulancia
Martin Slovak Republic, 036 0, Slovakia
Nestatna reumatologicka ambulancia
Bratislava , 841 0, Slovakia
Reumex s.r.o
Rimavska Sobota , 979 0, Slovakia
Hospital Clinico de Santiago
Santiago De Compostela A Coruna, 15706, Spain
Corporació Sanitaria Parc Tauli
Sabadell Barcelona, 08208, Spain
Hospital Universitario Marques de Valdecilla
Santander Cantabria, 39008, Spain
Complexo Hospitalario Universitario A Coruna
A Coruna , 15006, Spain
Hospital Infanta Luisa
Sevilla , 41010, Spain
Hospital Universitario y Politecnico La Fe
Valencia , 46026, Spain
Taipei Veterans General Hospital
Taipei Taiwan Roc, 11217, Taiwan
Buddhist Dalin Tzu Chi General Hospital
Chia-Yi , 62247, Taiwan
Chang Gung Medical Foundation-Kaohsiung Branch
Kaohsiung , 83301, Taiwan
Chung Shan Medical University Hospital
Taichung , 40201, Taiwan
Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital
Goodmayes Essex, IG3 8, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford Essex, RM7 0, United Kingdom
The Dudley Group NHS Foundation Trust
Dudley West Midlands, DY1 2, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford West Yorkshire, BD5 0, United Kingdom
Bradford Royal Infirmary, BTHFT
Bradford West Yorkshire, BD9 6, United Kingdom
Wirral University Teaching Hospital NHS Foundation Trust
Upton Wirral, CH49 , United Kingdom
York Teaching Hospital NHS Foundation Trust
York , YO31 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

422

Study ID:

NCT01877668

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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