A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate

PHASE3CompletedINTERVENTIONAL
Enrollment

1,002

Participants

Timeline

Start Date

February 23, 2016

Primary Completion Date

March 15, 2018

Study Completion Date

November 10, 2022

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Placebo to Upadacitinib

Tablet; Oral

DRUG

Methotrexate

Capsule or Tablet; Oral

DRUG

Placebo to Methotrexate

Capsule or Tablet; Oral

DRUG

Upadacitinib

Tablet; Oral

Trial Locations (290)

622

Dalin Tzu Chi General Hospital /ID# 153535, Dalin

1000

Univ Medical Ctr Ljubljana /ID# 143667, Ljubljana

1006

Charles Nicolle Univ Hosp /ID# 152866, Tunis

1007

Hospital La Rabta /ID# 152867, Tunis

1011

Clin Especializada Med Interna /ID# 153716, Guatemala City

1021

Clinica Medica Reumatologia /ID# 153714, Guatemala City

Clinica Medica Reumatologia /ID# 153931, Guatemala City

1036

Qualiclinic Kft. /ID# 143259, Budapest

1046

Aprillus Asistencia e Investig /ID# 149179, Capital Federal

1612

Diagnostic Consultative Center /ID# 143174, Sofia

UMHAT Sv. Ivan Rilski /ID# 143175, Sofia

1646

Iari /Id# 148595, San Isidro

1708

HFR Fribourg - Hopital Canton /ID# 143700, Fribourg

2000

Instituto CAICI /ID# 143141, Rosario

2010

Institut Mohamed Kassab /ID# 152869, Manouba

2025

Middlemore Clinical Trials /ID# 143600, Auckland

2046

Hopital Mongi Slim /ID# 152870, La Marsa

2050

Royal Prince Alfred Hospital /ID# 143149, Camperdown

2143

Pest Megyei Flor Ferenc Korhaz /ID# 143260, Kistarcsa

2164

LTD M+M Centers /ID# 143279, Ādaži

3124

Emeritus Research /ID# 143146, Camberwell

3204

Waikato Hospital /ID# 143602, Hamilton

3529

CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 143258, Miskolc

3600

ReumaClinic Genk /ID# 143159, Genk

4000

Centro Integral de Reumatologi /ID# 143143, San Miguel de Tucumán

Centro Medico Privado/Reuma /ID# 143140, San Miguel de Tucumán

MHAT Trimontsium /ID# 143173, Plovdiv

UMHAT Pulmed OOD /ID# 143176, Plovdiv

Hopital Farhat Hached /ID# 152868, Sousse

4001

MHAT Kaspela /ID# 143172, Plovdiv

4558

Rheumatology Research Unit /ID# 143147, Maroochydore

5011

The Queen Elizabeth Hospital /ID# 143148, Woodville

5900

Consultora Integral de Salud S /ID# 143144, Córdoba

6000

Rhumaconsult SPRL /ID# 143158, Charleroi

7000

Southern Clinical Research Pty /ID# 143150, Hobart

CHU Ambroise Pare /ID# 152955, Mons

7010

Porter Rheumatology Ltd /ID# 143601, Nelson

7405

Arthritis Clinical Research Tr /ID# 143670, Cape Town

7600

Winelands Medical Research Ctr /ID# 143669, Stellenbosch

7910

Timaru Medical Specialists Ltd /ID# 143599, Timaru

8000

Fejer Megyei Szent Gyorgy Korh /ID# 144724, Székesfehérvár

8380

Hevizgyogyfurdo es Szent Andra /ID# 143257, Hévíz

9000

UZ Gent /ID# 143157, Ghent

9300

Algemeen Stedelijk Ziekenhuis /ID# 153504, Aalst

9700

Markusovszky Egyetemi Oktatókórház /ID# 143261, Szombathely

10000

Clinical Hospital Dubrava /ID# 143217, Zagreb

Medical Center Kuna-Peric /ID# 143218, Zagreb

Poliklinika Bonifarm /ID# 143215, Zagreb

10002

National Taiwan Univ Hosp /ID# 143702, Taipei City

10010

Creer /Id# 153713, Guatemala City

10128

Center of Clinical and Basic Research /ID# 143239, Tallinn

10138

East Tallinn Central Hospital /ID# 143240, Tallinn

11000

Clinical Center Serbia /ID# 143649, Belgrade

Clinical Center Serbia /ID# 143650, Belgrade

11650

Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiova /ID# 143589, Mexico City

11850

CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 153562, Mexico City

12462

University General Hospital Attikon /ID# 143252, Athens

13419

North Estonian Medical Centre /ID# 145456, Tallinn

15006

Comple Hosp Univ de A Coruna /ID# 143672, A Coruña

15090

Advanced Rheumatology & Arthri /ID# 147947, Wexford

15702

Clinica Gaias /ID# 143673, Santiago de Compostela

15705

Hosp Nuestra Senora Esperanza /ID# 143677, Santiago de Compostela

16080

Uludag Universitesi Ataturk Rehabilitasyon ve Uygulama Merkezi /ID# 143705, Osmangazi

20089

Istituto Clinico Humanitas /ID# 147531, Rozzano

20095

Rheumaforschungszentrum II /ID# 143247, Hamburg

20157

Azienda Ospedaliera Luigi Sacc /ID# 143270, Milan

21000

Klinicki bolnicki centar Split /ID# 143216, Split

Special Hospital for Rheuma /ID# 143648, Novi Sad

21018

Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 143714, Vinnytsia

22081

Schoen Klinikum Hamburg Eilbek /ID# 143251, Hamburg

22205

Arthritis Clinic of N. VA, P.C /ID# 143734, Arlington

24768

Praxis Walter, Rendsburg /ID# 143250, Rendsburg

27100

Fondazione IRCCS Policlinico /ID# 143265, Pavia

28040

Hospital Clin Univ San Carlos /ID# 143674, Madrid

31000

Invest y Biomed de Chihuahua /ID# 143595, Chihuahua City

32117

International Medical Research - Daytona /ID# 143748, Daytona Beach

32174

Millennium Research /ID# 143736, Ormond Beach

33142

FL Med Ctr and Research, Inc. /ID# 143724, Miami

33542

FL Med Clinic, PA /ID# 143744, Zephyrhills

34239

Sarasota Arthritis Center /ID# 145978, Sarasota

35180

Izmir Tepecik Training and Research Hospital /ID# 157863, Konak

35360

Izmir Katip Celebi Ataturk Training & Research Hospital /ID# 143704, Izmir

37134

A.O.U.I. di Verona Policlinico /ID# 143266, Verona

38119

Dr. Ramesh Gupta /ID# 143732, Memphis

38305

West Tennessee Research Inst /ID# 143723, Jackson

39008

H. Un. Marques de Valdecilla /ID# 143671, Santander

40447

China Medical University Hosp /ID# 143703, Taichung

42003

Four Rivers Clinical Research /ID# 143741, Paducah

44649

Rheumazentrum Ruhrgebiet /ID# 145652, Herne

50009

Hosp Lithuanian Univ Health Sc /ID# 143582, Kaunas

50937

Uniklinik Koln /ID# 143248, Cologne

58701

Trinity Health Med Arts Clinic /ID# 143727, Minot

60061

Deerbrook Medical Associates /ID# 143728, Vernon Hills

65026

Odessa National Medical Univ /ID# 143715, Odesa

69600

Zaporizhzhia Regional Clinical /ID# 143712, Zaporizhia

71000

Clinical Center University of Sarajevo /ID# 143164, Sarajevo

74135

Healthcare Research Consultant /ID# 143747, Tulsa

75150

SW Rheumatology Res. LLC /ID# 143745, Mesquite

76018

Regional Clinical Hospital /ID# 152029, Ivano-Frankivsk

76178

Centro Reumatologico de Queret /ID# 149493, Querétaro

76710

Arthritis & Osteoporosis Clinic /ID# 159542, Waco

77004

Rheumatic Disease Clin Res Ctr /ID# 151103, Houston

77089

Accurate Clinical Research /ID# 143749, Houston

77701

Diagnostic Group Integrated He /ID# 152921, Beaumont

78000

University Clinical Centre of the Republic of Srpska /ID# 143161, Banja Luka

University Clinical Centre of the Republic of Srpska /ID# 143162, Banja Luka

78215

Sun Research Institute /ID# 159546, San Antonio

78229

Accurate Clinical Management /ID# 159543, San Antonio

NextGen Clinical Trials LLP /ID# 150930, San Antonio

78278

Barzilai Medical Center /ID# 144725, Ashkelon

78404

Adriana Pop-Moody MD Clinic PA /ID# 147626, Corpus Christi

78539

Doctor's Hosp at Renaissance /ID# 156407, Edinburg

78666

Arthritis Clinic of Central TX /ID# 159541, San Marcos

79007

"MNCE Lviv City Clinical Hospital #4 /ID# 143711", Lviv

79013

Lviv Regional Clinical Hospita /ID# 154449, Lviv

79201

Revmatologie Bruntal, s.r.o /ID# 143220, Bruntál

79935

MedResearch Inc. /ID# 156409, El Paso

80002

Ctr Int de Reum del Caribe SAS /ID# 143211, Barranquilla

80010

Paernu Hospital /ID# 143238, Pärnu

80337

LMU Klinikum der Universität München /ID# 143249, Munich

91101

MEDEOS s.r.o. /ID# 143656, Trenčín

91701

REUMA-GLOBAL, s.r.o. /ID# 143655, Trnava

91942

TriWest Research Associates- La Mesa /ID# 143738, La Mesa

92260

Desert Medical Advances /ID# 143730, Palm Desert

92288

Klaipeda University Hospital /ID# 143583, Klaipėda

100008

Karaganda State Medical Univ /ID# 153431, Karaganda

110221

Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 143214, Bogota

Riesgo de Fractura S.A - CAYRE /ID# 143212, Bogotá

Simedics IPS SAS /ID# 152572, Bogotá

117997

Russian National Research Medi /ID# 143642, Moscow

119049

Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 143641, Moscow

141060

Family Outpatient clinic#4,LLC /ID# 151010, Korolev

160000

Regional Clinical Hospital /ID# 147173, Shymkent

170036

Tver Regional Clinical Hosp. /ID# 143639, Tver'

185019

Republican Clin Hos n.a. Baran /ID# 143634, Petrozavodsk

220013

First City Clinical Hospital /ID# 159020, Minsk

220116

City Clinical Hospital #9 /ID# 145650, Minsk

233099

1st Aff Hosp of Bengbu Med Col /ID# 162974, Bengbu

357500

LLC Novaya Klinika /ID# 143631, Pyatigorsk

361003

The 1st Aff Hosp Xiamen Univ /ID# 162076, Xiamen

390026

Ryazan State Medical Universit /ID# 143646, Ryazan

394036

Voronezh State Medical Univers /ID# 150926, Voronezh

410028

Ecomed SRL /ID# 143629, Oradea

420012

Kazan State Medical University /ID# 143645, Kazan'

432018

Ulyanovsk Regional Clin Hosp /ID# 143644, Ulyanovsk

443095

Samara Regional Clinical Hosp /ID# 150928, Samara

450005

Reg Clin Hosp n.a. Kuvatova G. /ID# 143632, Ufa

460018

Orenburg Regional Clinical Hos /ID# 143630, Orenburg

515041

1st Aff Hosp of Shantou Univ /ID# 162968, Shantou

630099

LLC Medical Center /ID# 143647, Novosibirsk

680003

Medicity S.A.S. /ID# 143213, Bucaramanga

700656

Spitalul Clinic de Recuperare /ID# 143620, Iași

999077

Queen Mary Hospital /ID# 143255, Hong Kong

Tuen Mun Hospital /ID# 143256, Tuenmen

1538515

Toho University Ohashi Medical Center /ID# 148027, Meguro-ku

3109601

Rambam Health Care Campus /ID# 143263, Haifa

4781156

Ctr de Inv Clinica del Sur /ID# 143208, Temuco

5262100

Sheba Medical Center /ID# 145975, Ramat Gan

5550170

Quantum Research LTDA. /ID# 143210, Puerto Varas

7008607

Japanese Red Cross Okayama Hospital /ID# 159619, Okayama

7500588

Quantum Research Stgo. /ID# 145651, Santiago

7510047

Soc. de Prestaciones medicas y Paramedicas Goecke /ID# 143209, Santiago

7510186

Someal /Id# 143207, Providencia

8207257

Investigaciones Medicas SSMSO /ID# 151685, Santiago

8628655

Kumamoto Shinto General Hospital /ID# 148266, Kumamoto

34684-2672

Arthritis Research of Florida /ID# 143743, Palm Harbor

08755

Ocean Rheumatology, PA /ID# 143737, Toms River

08043

Arthritis Rheumatic Back Disorder /ID# 143733, Voorhees Township

45377-9464

STAT Research, Inc. /ID# 143750, Vandalia

29486-7887

Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 145653, Summerville

C1015ABO

Org Medica de Investigacion /ID# 143142, Buenos Aires

74110-120

CIP - Centro Internacional de Pesquisa /ID# 143171, Goiânia

80030-110

Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 143169, Curitiba

90035-903

Hospital de Clinicas de Porto Alegre /ID# 143168, Porto Alegre

90480-000

LMK Sevicos Medicos S/S /ID# 143167, Porto Alegre

04266-010

CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 143166, São Paulo

22271-100

CCBR Brasil /ID# 150925, Rio de Janeiro

T5M 0H4

Rheumatology Research Assoc /ID# 143206, Edmonton

R3A IM3

Manitoba Clinic /ID# 143203, Winnipeg

R3N 0K6

Ciads /Id# 143205, Winnipeg

L4J 1W3

CA Ctr for Clin Trials CCCT /ID# 159080, Thornhill

G5L 8W1

Ctr. de Rheum de l'est du QC /ID# 151317, Rimouski

Unknown

Centro de Estudios Clinicos Qu /ID# 152913, Viña del Mar

Fund Inst de Reum F. Chalem /ID# 159544, Bogotá

748 01

L.K.N. Arthrocentrum, s.r.o /ID# 143224, Hlučín

779 00

CTCenter MaVe, s.r.o. /ID# 143226, Olomouc

140 00

Nuselská poliklinika, Revmatologie /ID# 143232, Prague

Nuselská poliklinika, Revmatologie /ID# 143233, Prague

140 59

Thomayerova nemocnice /ID# 143228, Prague

760 01

PV MEDICAL Services s.r.o. /ID# 143234, Zlín

638 00

Revmatologie, s.r.o. /ID# 143223, Brno

690 02

RHEUMA s.r.o. /ID# 143230, Břeclav

274 01

Nemocnice Slany /ID# 143221, Slaný

686 01

Medical Plus, s.r.o. /ID# 143219, Uherské Hradište

01010

Clinicas Hospital Herrera Ller /ID# 153715, Guatemala City

D04 T6F4

St Vincent's University Hosp /ID# 143262, Dublin

466-8560

Nagoya University Hospital /ID# 148031, Nagoya

440-8510

NHO Toyohashi Medical Center /ID# 161033, Toyohashi

299-0111

Teikyo University Chiba Medical Center /ID# 159618, Ichihara

810-8563

NHO Kyushu Medical Center /ID# 148263, Fukuoka

NHO Kyushu Medical Center /ID# 148264, Fukuoka

070-8644

National Hospital Organization Asahikawa Medical Center /ID# 148021, Asahikawa

078-8243

Katayama Orthopedic Rheumatology Clinic /ID# 148029, Asahikawa

650-0017

Kobe University Hospital /ID# 153461, Kobe

252-0315

National Hospital Organization Sagamihara National Hospital /ID# 148019, Sagamihara-shi

586-8521

NHO Osaka Minami Med Ctr /ID# 148042, Osaka

781-0112

Bay Side Misato Medical Center /ID# 148256, Kochi

862-0920

Center for Arthritis and Clinical Rheumatology Matsubara Clinic /ID# 148254, Kumamoto

862-0976

Kumamoto Orthopaedic Hospital /ID# 148054, Kumamoto

857-1195

Sasebo Chuo Hospital /ID# 148261, Sasebo

940-2108

Nagaoka Red Cross Hospital /ID# 148018, Nagaoka-shi

573-1191

Kansai Medical University Hospital /ID# 159622, Hirakata-shi

569-8686

Osaka Medical College Hospital /ID# 159624, Takatsuki -shi

350-8550

Saitama Medical Center, Saitama Medical University /ID# 148015, Kawagoe-shi

329-0498

Jichi Medical University Hospital /ID# 159620, Shimotsuke-shi

113-8431

Juntendo University Hospital /ID# 148050, Bunkyo-ku

104-8560

St.Luke's International Hospital /ID# 148041, Chuo-ku

160-8582

Keio University Hospital /ID# 148057, Shinjuku-ku

752-0976

Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 148052, Shimonoseki-shi

874 - 001

National Hospital Organization Beppu Medical Center /ID# 161058, Beppu

260-8712

NHO Chiba-East-Hospital /ID# 148035, Chiba

910-0068

Sugimoto Rheumatology and Internal Medicine Clinic /ID# 148047, Fukui

814-0002

Shono Rheumatism Clinic /ID# 148046, Fukuoka

673-1462

Matsubara Mayflower Hospital /ID# 148033, Katō

830-8543

St. Mary's Hospital /ID# 148038, Kurume

615-8256

Kagawa University Hospital /ID# 148016, Kyoto

981-0112

Yu Family Clinic /ID# 148048, Miyagi

457-8511

Daido Hospital /ID# 160868, Nagoya

464-0071

Kondo Clinic for Ortho & Rheum /ID# 148032, Nagoya

649-2211

Shirahama Hamayu Hospital /ID# 148253, Nishimura

534-0021

Osaka City General Hospital /ID# 159617, Osaka

870-0823

Oribe Clinic of Rheumatology and Internal Medicine /ID# 156035, Ōita

769-2321

Sanuki Municipal Hospital /ID# 158842, Sanuki

060-0001

Sagawa Akira Rheumatology Clin /ID# 148043, Sapporo

060-8604

Sapporo City General Hospital /ID# 148037, Sapporo

060-8648

Hokkaido University Hospital /ID# 148262, Sapporo

063-0811

Hokkaido Medical Center for Rheumatic Diseases /ID# 148259, Sapporo

350-1305

Azuma Rheumatology Clinic /ID# 161050, Sayama

983-0833

Hikarigaoka Spellman Hospital /ID# 148020, Sendai

933-0874

Takaoka Rheumatic Orthopedic Clinic /ID# 148022, Takaoka

152-8902

National Hospital Organization Tokyo Medical Center /ID# 148040, Tokyo

284-0003

National Hospital Organization Shimoshizu National Hospital /ID# 148258, Yotsukaidō

010009

JSC Nat Scientific Med Res Ctr /ID# 143272, Astana

071403

Semey State Medical University /ID# 152661, Semey

LT-08661

Vilnius University Hospital /ID# 143584, Vilnius

06700

Clinstile, S.A. de C.V. /ID# 143591, Cuauhtémoc

03100

RM Pharma Specialists, S.A de C.V /ID# 143593, Mexico City

06090

Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 143592, Mexico City

60-218

Medyczne Centrum Hetmanska /ID# 144726, Poznan

51-685

WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 143606, Wroclaw

01-518

Centrum Medyczne AMED /ID# 143604, Warsaw

01-869

Centrum Medyczne Pratia Warszawa /ID# 143608, Warsaw

81-338

Centrum Medyczne Pratia Gdynia /ID# 143607, Gdynia

40-282

Silmedic Sp z o.o /ID# 143605, Katowice

82-300

NZOZ Centrum Reumatologiczne /ID# 143603, Elblag

1050-034

Instituto Portugues De Reumatologia /ID# 148313, Lisbon

1349-019

Centro Hospitalar Lisboa Ocidental, EPE /ID# 151009, Lisbon

4434-502

Centro Hospitalar De Vila Nova /ID# 143615, Vila Nova de Gaia

1649-035

Centro Hospitalar Lisboa Norte, EPE /ID# 143613, Lisbon

4050-111

Centro Hospitalar Baixo Vouga /ID# 153726, Porto

4200-319

Centro Hospitalar de Sao Joao, EPE /ID# 153575, Porto

4901-858

Unidade Local De Saude Do Alto Minho /ID# 143611, Viana do Castelo

3504-509

Centro Hosp de Tondela-Viseu /ID# 143612, Viseu

00716

Ponce School of Medicine /ID# 145657, Ponce

00909

GCM Medical Group /ID# 143618, San Juan

00935

School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 143619, San Juan

020475

Spitalul Clinic Dr. I. Cantacuzino /ID# 143622, Bucharest

011172

Spitalul Clinic Sf. Maria /ID# 143623, Bucharest

Spitalul Clinic Sf. Maria /ID# 143625, Bucharest

Spitalul Clinic Sf. Maria /ID# 143627, Bucharest

036 01

MEDMAN s.r.o. /ID# 143661, Martin

915 01

Reumatologická ambulancia Reum.hapi s.r.o. /ID# 143657, Nové Mesto nad Váhom

958 01

REUMACENTRUM s.r.o. /ID# 143653, Partizánske

921 01

Slovak research center Team Member, Thermium s.r.o. /ID# 143663, Pieštany

02001

Slovak Research Center /ID# 143659, Púchov

06401

TIMMED spol. s r.o. /ID# 143664, Stará Lubovna

955 01

Reumatologicka ambulancia, LER /ID# 143660, Topoľčany

960 01

ALBAMED s.r.o. /ID# 143654, Zvolen

965 01

Reuma -MUDr. Maria Palasthyova /ID# 143662, Žiar nad Hronom

0132

Jakaranda Hosp, Emmed Research /ID# 143668, Pretoria

Jakaranda Hosp, Emmed Research /ID# 145976, Pretoria

08035

Hospital Univ Vall d'Hebron /ID# 143675, Barcelona

03680

NSC-Strazhesko Ist Cardiology /ID# 152026, Kiev

04070

LLC Revmocentr /ID# 143710, Kyiv

LE1 5WW

Leicester Royal Infirmary /ID# 143718, Leicester

E11 1NR

Whipps Cross Univ Hospital /ID# 143721, London

EH4 2XU

Western General Hospital /ID# 144431, Edinburgh

LS7 4SA

Chapel Allerton Hospital /ID# 143717, Leeds

PO6 3LY

Queen Alexandra Hospital /ID# 143722, Portsmouth

SO16 6YD

Southampton General Hospital /ID# 143716, Southampton

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