An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate

PHASE4CompletedINTERVENTIONAL
Enrollment

1,152

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Rhematoid Arthritis
Interventions
DRUG

Tofacitinib with methotrexate

Tofacitinib 5 mg twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months

DRUG

Tofacitinib without methotrexate

Tofacitinib 5 mg twice daily, oral for 12 months Placebo for methotrexate (previous stable dose) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months

BIOLOGICAL

Adalimumab with methotrexate

Placebo for tofacitinib twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Adalimumab 40 mg every other week, subcutaneous for 12 months

Trial Locations (215)

21

ABK REUMAR S.R.L. de Medicentro Biociencias_ BIO CIENCIAS PERU S.R.L., Lima

27

Instituto Peruano del Hueso y la Articulacion, Lima

33

Investigaciones Clinicas S.A.C., Lima

402

Chung Shan Medical University Hospital, Taichung

807

Kaohsiung Medical University Chung-Ho Memorial Hospital - New, Kaohsiung City

1000

University of the Philippines Manila-Philippine General Hospital, Manila

1003

Jose R. Reyes Memorial Medical Center-Rayuma Klinik, Manila

1015

Organizacion Medica de Investigacion S.A - OMI, Buenos Aires

1102

St. Luke's Medical Center, Quezon City

1118

Far Eastern University - NRMF Medical Center, Quezon City

1233

NMTH Tsar Boris Clinic of Internal Diseases, Sofia

1336

MHAT Lyulin EAD, Sofia

2021

LCS Clinical Research Unit, Johannesburg

2050

Royal Prince Alfred Hospital, Camperdown

2193

WCR: Wits Clinical Research Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg

WCR: Wits Clinical Research, Johannesburg

Charlotte Maxeke Johannesburg Academic Hospital, Parktown, Johannesburg

3145

Emeritus Research, Malvern East

4000

Centro Medico Privado de Reumatologia, San Miguel de Tucumán

Centro Radiologico Luis Mendez Collado SRL, San Miguel de Tucumán

4001

Netcare St Augustine's Hospital, Durban

4002

"MHAT Kaspela EOOD", Plovdiv

4004

MHAT EUROHOSPITAL Plovdiv, Plovdiv

4215

Pacific Private Clinic, Southport

QML Pathology, Southport

4217

Mary Mediatrix Medical Center, Lipa City

5000

Iloilo Doctors' Hospital, Inc, Iloilo City

St. Paul's Hospital of Iloilo, Inc., Iloilo City

5011

The Queen Elizabeth Hospital, Woodville South

5400

CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica, San Juan

MHAT Akta Medika OOD, Rousse

5800

"UMHAT Dr. Georgi Stranski EAD", Pleven

6000

Perpetual Succour Hospital, Cebu City

6100

RK Will Pty Ltd, Victoria Park

7002

MHAT Ruse AD, Rousse

7405

Arthritis Clinical Research Trials, Cape Town

7500

Panorama Medical Centre, Cape Town

7600

Wineland Medical Research Centre, Stellenbosch

7700

"MHAT Targovishte AD", Targovisthe

8000

Brokenshire Integrated Health Ministries, Inc., Davao City

Davao Doctors Hospital, Davao City

9301

Iatros International, Bloemfontein

9700

MHAT Shumen AD, Shumen

10400

Phramongkutklao Hospital, Bangkok

Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,Mahidol University, Bangkok

Div. of Allergy Immunology and Rheumatology, Dept. of Medicine,, Bangkok

10700

Siriraj Hospital Mahidol University, Bangkok

11217

Taipei Veterans General Hospital, Taipei

11312

East-Tallinn Central Hospital Ltd, Tallinn

11803

Dr. Prem C. Chatpar M.D.,LLC, Plainview

11850

CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C. Consultorio Medico de Reumatologia, Mexico City

13419

North Estonia Medical Centre Foundation, Tallinn

15006

Complexo Hospitalario Universitario A Coruna, A Coruña

15706

Complejo Hospitalario Universitario de Santiago de Compostela, Hospital Clinico Universitario, Santiago de Compostela

16635

Altoona Center For Clinical Research, Duncansville

21702

Arthritis Treatment Center, Frederick

22332

Inha University Hospital, Jung-Gu

27000

Unidad de Enfermedades Reumaticas y Cronico Degenerativas S. C., Torreón

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28144

PMG Research of Salisbury, LLC, Salisbury

Rowan Diagnostic Clinic, Salisbury

28401

PMG Research of Wilmington, Wilmington

29009

Hospital Regional Universitario de Malaga, Málaga

29406

Low Country Rheumatology, PA, Charleston

31000

Investigacion y Biomedica de Chihuahua, SC, Chihuahua City

31048

Bnai Zion Medical Center, Haifa

32132

Riverside Clinical Research, Edgewater

32216

Jacksonville Center for Clinical Research, Jacksonville

32514

Gulf Region Clinical Research Institute Llc, Pensacola

32804

Omega Research Consultants, LLC, Orlando

32960

The Center for Arthritis and Rheumatism, Vero Beach

The Office of Alastair C. Kennedy, MD, Vero Beach

33180

AARDS Research, Inc., Aventura

Arthritis and Rheumatic Disease Specialties, Aventura

33305

Chang Gung Medical Foundation - Linkou Branch, Taoyuan

33309

Centre for Rheumatology, Immunology and Arthritis, Fort Lauderdale

33321

West Broward Rheumatology Associates, Inc., Tamarac

33614

BayCare Medical Group Inc, Tampa

34684

Arthritis Center, Inc., Palm Harbor

34787

Advanced Clinical Research of Orlando, Inc., Winter Garden

35801

Rheumatology Associates of North Alabama, PC, Huntsville

38305

West Tennessee Research Institute, Jackson

39232

Arthritis and Osteoporosis Treatment and Research Center, Flowood

41010

Hospital Infanta Luisa, Seville

41944

Kyungpook National University Hospital, Daegu

42472

Daegu Catholic University Medical Center, Daegu

44160

Centro Integral en Reumatologia, SA de CV, Guadalajara

Centro de Integral en Reumatologia SA de CV, Jalisco

46227

Diagnostic Rheumatology and Research PC, Indianapolis

49007

Jasper Clinic, Kalamazoo

55139

Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Eg., Samsun

Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uygulama ve Egitim Merkezi, Samsun

58140

Cumhuriyet Universitesi Tip Fakultesi Hastanesi, Sivas

58701

Trinity Health Center - Medical Arts, Minot

60061

Deerbrook Medical Associates, Vernon Hills

61469

Chonnam National University Hospital, Gwangju

63128

St. Louis Center For Clinical Research Barbara Caciolo, MD, St Louis

63800

Revmatologie s.r.o., Brno

65807

Clinvest/ A Division of Banyan Group, Inc., Springfield

70809

Ochsner Clinic Baton Rouge, Baton Rouge

71203

Arthritis and Diabetes Clinic, Inc, Monroe

73112

Lynn Health Science Institute, Oklahoma City

75000

University Clinical Center Tuzla, Tuzla

75150

Southwest Rheumatology Research, LLC., Mesquite

75231

Arthritis Care And Diagnostic Center, P.A., Dallas

Metroplex Clinical Research Center, Dallas

77004

Accurate Clinical Management, LLC, Houston

77065

Rheumatology Clinic of Houston, PA, Houston

77074

Houston Institute For Clinical Research, Houston

77521

Accurate Clinical Management, LLC, Baytown

78000

University Hospital Clinical Center Banja Luka, Banja Luka

78213

Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C., San Luis Potosí City

78229

Accurate Clinical Research, Inc., San Antonio

78232

Arthritis & Osteoporosis Center of South Texas, San Antonio

78290

Unidad de Investigaciones Reumatologicas A.C., San Luis Potosí City

79424

Arthritis & Osteoporosis Associates, LLP, Lubbock

80000

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

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

80010

Foundation Parnu Hospital, Pärnu

81362

Kaohsiung Veterans General Hospital, Kaohsiung City

83404

Institute of Arthritis Research, Idaho Falls

83814

Coeur D'Alene Arthritis Clinic, Coeur d'Alene

85234

Arthrocare, Arthritis Care & Research, PC, Gilbert

90033

Keck Medicine of USC - Division of Rheumatology, Los Angeles

University of Southern California (USC) Norris Comprehensive Cancer Center, Los Angeles

90095

Ronald Reagan UCLA Medical Center - Drug Information Center, Los Angeles

UCLA David Geffen School of Medicine, Division of Rheumatology, Los Angeles

90110

Songklanagarind Hospital - Prince of Songkhla University, Songkhla

90602

Medvin Clinical Research, Whittier

91120

Hadassah Medical Center, Jerusalem

91405

Medvin Clinical Research, Van Nuys

91722

Medvin Clinical Research, Covina

91786

Inland Rheumatology Clinical Trials, Inc., Upland

92108

San Diego Arthritis Medical Clinic, San Diego

92646

HealthCare Partners Medical Group, Huntington Beach

92835

St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare, Fullerton

92870

Medvin Clinical Research, Placentia

97002

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien City

97133

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

Departamento de Imagen de Hospital Star Medica Merida, Mérida

Laboratorio clínico del Hospital Star Medica Merida, Mérida

Storage for lab kits and study materials, Mérida

99204

Arthritis Northwest, PLLC, Spokane

119991

SBEI HPE First Moscow State Medical University n.a.I.M.Sechenov of MoH of RF based on UCH#1, Moscow

129090

"CJSC European Medical Center", Moscow

150003

State Autonomous Healthcare lnstitution of Yarostavl Region, Yaroslavl

150007

"State Budgetary Healthcare Institution of Yaroslavl Region Clinical Hospital #3", Yaroslavl

185019

Republic Hospital n.a. V.A. Baranov, Petrozavodsk

"State Budgetary Healthcare Institution of Karelia Republic Republic Hospital n.a. V.A. Baranov", Petrozavodsk

191014

Limited Liability Company AVA-PETER, Saint Petersburg

214025

"Non-state Healthcare Institution Regional Hospital at Smolensk Station of OJSC Russian Railways", Smolensk

390026

"State Budgetary Institution of Ryazan Region Regional Clinical Cardiology Dispensary", Ryazan

400006

Spitalul Clinic Judetean de Urgenta Cluj Napoca Reumatologie, Cluj-Napoca

410053

"State Institution of Healthcare Regional Clinical Hospital", Saratov

430031

"Spitalul Judetean de Urgenta Dr. Constantin Opris", Baia Mare

430352

S.C. Clinica Somesan S.R.L., Baia Mare

443095

"State Budgetary Institution of Healthcare Samara Regional Clinical Hospital n.a. V.D. Seredavin", Samara

460018

"State Budgetary Healthcare Institution Orenburg Regional Clinical Hospital", Orenburg

520052

Covamed Serv SRL, Sfântu Gheorghe

630102

SBEI HPE Novosibirsk State Medical University of MoH of RF, Novosibirsk

650066

"SAHI of KR Kemerovo Regional Clinical Hospital", Kemerovo

700661

Spitalul Clinic de Recuperare Iasi, Iași

800578

"Spitalul Clinic Judetean de Urgenta - Sf.Apostol Andrei Galati", Galati

2520997

Estudios Clinicos Quinta Region Ltda., Viña del Mar

3109601

Rambam Health Care Campus, Haifa

5262000

The Chaim Sheba Medical Center, Tel Litwinsky

5550170

Quantum Research Ltda, Puerto Varas

Quantum Research, Puerto Varas

7510047

Prosalud, Santiago

06606

Joao M. A. Nascimento, Bridgeport

19152-3303

Arthritis Group, Philadelphia

C1426AAL

Atencion Integral en Reumatologia (AIR), CABA

N2M 5N6

Kw Musculoskeletal Research Inc, Kitchener

G8Z 1Y2

Centre de Recherche Musculo-Squelettique, Trois-Rivières

615 00

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

470 01

Revmatologicka ambulance, Česká Lípa

702 00

Vesalion, s.r.o., Ostrava- Moravska Ostrava

140 00

Revmatologie, Prague

LV-1012

Health Center 4, Riga

LV1005

ORTO clinic Ltd, Riga

LT-62114

Alytaus District S. Kudirkos Hospital, Alytus

LT-50128

"VAKK Clinic of Dr. Kilda", Kaunas

LT-76231

PI Republican Siauliai Hospital, Šiauliai

04020

Unidad de Investigacion en Medicina Interna y Enfermedades criticas-Hogar Clinica San Juan de Dios, Arequipa

30-002

Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Krakow, Krakow

01-518

Centrum Medyczne Amed, Warsaw

85-168

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

41-902

Centrum Medyczne SILESIANA Sp. z o.o., Bytom

Nzoz Bif-Med, Bytom

82-300

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

81-384

Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia

40-040

Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice

90-242

Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna, Lodz

05-830

Lecznica MAK-MED, NZOZ, Nadarzyn

61-397

Prywatna Praktyka Lekarska, Poznan

01192

Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warsaw

02-106

MTZ Clinical Research Sp. z o.o., Warsaw

50-088

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

010976

Ianuli Med Consult SRL, Reumatologie, Bucharest

011172

Spitalul Clinic Sf. Maria, Medicina interna - Reumatologie, Bucharest

Spitalul Clinic Sf. Maria, Bucharest

020475

"Spitalul Clinic Dr. I. Cantacuzino", Bucharest

020983

"Centrul Clinic de Boli Reumatismale Dr. Ion Stoia", Bucharest

0002

Clinical Research Unit, University of Pretoria, Pretoria

Netcare Jakaranda Hospital, Pretoria

University of Pretoria, Pretoria

04763

Hanyang University Seoul Hospital, Seoul

05030

Konkuk University Medical Center, Seoul

08036

Hospital Clinic de Barcelona, Barcelona

06100

Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi, Ankara

DY1 2HQ

The Dudley Group NHS Foundation Trust, Dudley

WS11 5XY

The Royal Wolverhamptons NHS Trust, Cannock

LS7 4SA

The Leeds Teaching Hospitals NHS Trust, Leeds

L9 7AL

Aintree University Hospital NHS Foundation Trust, Liverpool

NW3 2QG

Royal Free London NHS Foundation Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02187055 - An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate | Biotech Hunter | Biotech Hunter