Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

PHASE3CompletedINTERVENTIONAL
Enrollment

422

Participants

Timeline

Start Date

January 20, 2014

Primary Completion Date

December 18, 2015

Study Completion Date

December 18, 2015

Conditions
Psoriatic Arthritis
Interventions
DRUG

Tofacitinib 5 mg BID

Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months

DRUG

Tofacitinib 10 mg BID

Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months

DRUG

Adalimumab

Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months

DRUG

Placebo

Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months

DRUG

Placebo

Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months

Trial Locations (123)

1027

Revita Reumatologiai Rendelo, Budapest

1036

Qualiclinic Kft., Budapest

1062

Magyar Honvedseg Egeszsegugyi Kozpont,Reumatologiai osztaly, Budapest

1070

Hopital Erasme - Clinique Universitaire de Bruxelles, Brussels

1612

"UMHAT Sv. Ivan Rilski EAD", Sofia

3000

University Hospital Leuven, Department of Rheumatology, Leuven

3065

St. Vincent's Hospital (Melbourne), Fitzroy

3145

Emeritus Research Pty Ltd, Malvern East

3168

Monash Health, Monash Medical Centre, Clayton

Pharmacy Clinical Trials, Clayton

4000

"MHATPlovdiv AD", Plovdiv

4002

"MHAT Kaspela EOOD", Plovdiv

4215

Pacific Private Clinic, Southport

4558

Rheumatology Research Unit, Maroochydore

5800

"UMHAT Dr. G. Stranski EAD", Pleven

6003

"MC New rehabilitation center EOOD, Rheumatology Cabinet", Stara Zagora

8200

Csolnoky Ferenc Korhaz, Radiologiai Osztaly X-Ray Only, Veszprém

Csolnoky Ferenc Korhaz, Reumatologiai Osztaly, Veszprém

10117

Charite Universitaetsmedizin Berlin, Berlin

Klinische Forschung Berlin-Mitte GmbH, Berlin

11217

Taipei Veterans General Hospital, Taipei

12161

Rheumapraxis Steglitz, Berlin

15006

Complexo Hospitalario Universitario A Coruna, A Coruña

15706

Hospital Clinico de Santiago, Santiago de Compostela

16635

Altoona Center for Clinical Research, Duncansville

19055

Klinische Forschung Schwerin GmbH, Schwerin

21740

Klein & Associates, M.D., P.A., Hagerstown

29406

Low Country Rheumatology, PA, Charleston

31000

Investigacion y Biomedicina de Chihuahua SC, Chihuahua City

32174

Millennium Research, Ormond Beach

34684

Arthritis Center, Inc., Palm Harbor

35205

Rheumatology Associates, PC, Birmingham

35801

Rheumatology Associates of North Alabama, PC, Huntsville

39008

Hospital Universitario Marques de Valdecilla, Santander

40201

Chung Shan Medical University Hospital, Taichung

41010

Hospital Infanta Luisa, Seville

44130

Paramount Medical Research & Consulting, LLC, Middleburg Heights

44160

Centro Integral en Reumatologia SA de CV, Guadalajara

46026

Hospital Universitario y Politecnico La Fe, Valencia

50937

University Hospital of Cologne, Cologne

55121

St. Paul Rheumatology, PA, Eagan

61300

X-MEDICA s.r.o (radiology only), Brno

62247

Buddhist Dalin Tzu Chi General Hospital, Chiayi City

63800

Stavovska s.r.o. (pharmacy only), Brno

68516

Physician Research Collaboration, LLC, Lincoln

68601

Medical Plus s.r.o. Lekarna Hradebni s. r.o, Uherské Hradiště

70200

Vesalion s.r.o., Ostrava

77008

Pioneer Research Solutions, Inc., Houston

80000

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

Laboratorios de Analisis Clinicos CEMSI, Culiacán

80040

Sanatorio CEMSI Chapultepec (For Emergencies Only), Culiacán

80230

Hospital General de Culiacán Dr. Bernardo J. Gastélum, Culiacán

83301

Chang Gung Medical Foundation-Kaohsiung Branch, Kaohsiung City

84112

Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah, Salt Lake City

84132

University of Utah Hospital & Clinics, Salt Lake City

85306

Arizona Arthritis & Rheumatology Associates, P.C., Glendale

91106

Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie, Corbeil-Essonnes

91723

Medvin Clinical Research, Covina

92108

San Diego Arthritis Medical Clinic, San Diego

92260

Desert Medical Advances, Palm Desert

92270

Advances In Medicine (X-Rays), Rancho Mirage

97000

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

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

97070

Centro de Investigacion Clinica Pensiones, Mérida

97130

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

97133

Hospital Star Medica Merida (For Emergencies Only), Mérida

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

98122

Dynacare Laboratories (Specimen processing for shipment), Seattle

Investigational Drug Service Pharmacy, Swedish Medical Center., Seattle

Seattle Rheumatology Associates, Seattle

Swedish Medical Center, Seattle

119049

State Budgetary Institution of Healthcare of Moscow City Clinical Hospital, Moscow

150003

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

State Institution of Healthcare of Yaroslavl Region, Yaroslavl

185019

Regional State Budgetary Healthcare Institution of Karelia Republic, Petrozavodsk

410053

"State Institution of Healthcare Regional Clinical Hospital", Saratov

630091

"OOO City Neurological Centre Sibneiromed", Novosibirsk

630099

"Limited Liability Company Consultative Diagnostic Rheumatology Center Healthy Joints", Novosibirsk

634050

State Budget Educational Institution of Highest Professional Education, Tomsk

01605

Clinical Pharmacology Study Group, Worcester

03756

Dartmouth-Hitchcock Medical Center (DHMC), Lebanon

T5M 0H4

Rheumatology Research Associates, Edmonton

N2J 1C4

K. Papp Clinical Research, Waterloo

H9R 3J1

West Island Rheumatology Research Associates, Pointe-Claire

615 00

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

128 50

Revmatologicky Ustav - Lekarna (pharmacy only), Prague

Revmatologicky ustav - Lekarna, Prague

Revmatologicky ustav, Prague

140 00

Revmatologicka ambulance, Prague

110 00

MEDIGAP, s.r.o. (radiology only), Praha 1 - Nove Mesto

MEDIGAP, s.r.o, Praha 1- Nove Mesto

602 00

Lekarna Na Lidicke (Pharmacy only), Brno

638 00

Revmatologie s.r.o., Brno

06700

Cliditer, S. A. de C. V, Mexico City

15-002

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

15-351

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

15-879

ClinicMed Badurski i wspolnicy Spolka Jawna, Bialystok

85-168

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

82-300

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

Centrum Radiologii for X-Ray only, Elblag

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

05-825

"Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy Medica", Grodzisk Mazowiecki

20-582

Zespol Poradni Specjalistycznych Reumed Filia Onyksowa, Lublin

05-830

NZOZ Lecznica MAK-MED S.C., Nadarzyn

61-397

Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj, Poznan

87-100

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

01-868

Medica Pro Familia Sp. z o.o. S.K.A., Warsaw

02-118

Rheuma Medicus Zaklad Opieki Zdrowotnej, Warsaw

02-691

Reumatika Centrum Reumatologii, Warsaw

02-758

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

50-088

Synexus Polska Sp. z o.o. Oddz. we Wroclawiu, Wroclaw

832 63

ROMJAN s.r.o., Reumatologicka ambulancia, Bratislava

036 01

MEDMAN s.r.o. - reumatologicka ambulancia, Martin

841 04

Nestatna reumatologicka ambulancia, Bratislava

979 01

Reumex s.r.o, Rimavská Sobota

08208

Corporació Sanitaria Parc Tauli, Sabadell

IG3 8YB

Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital, Goodmayes

RM7 0AG

Barking, Havering and Redbridge University Hospitals NHS Trust, Romford

DY1 2HQ

The Dudley Group NHS Foundation Trust, Dudley

BD5 0NA

Bradford Teaching Hospitals NHS Foundation Trust, Bradford

BD9 6RJ

Bradford Royal Infirmary, BTHFT, Bradford

CH49 5PE

Wirral University Teaching Hospital NHS Foundation Trust, Upton

YO31 8HE

York Teaching Hospital NHS Foundation Trust, York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY