A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

PHASE3CompletedINTERVENTIONAL
Enrollment

648

Participants

Timeline

Start Date

March 23, 2016

Primary Completion Date

October 2, 2017

Study Completion Date

August 10, 2022

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Methotrexate

Capsule; Oral

DRUG

Upadacitinib

Tablet; Oral

DRUG

Placebo Upadacitinib

Tablet; Oral

DRUG

Placebo Methotrexate

Capsule; Oral

Trial Locations (153)

1100

Rheuma-Zentrum Wien-Oberlaa /ID# 144728, Vienna

1128

Mautalen Salud e Investigacion /ID# 145980, Buenos Aires

1134

Magyar Honvedseg Egeszsegugyi Kozpont /ID# 144743, Budapest

1417

Ctr Privado Med Familiar /ID# 149183, Buenos Aires

1428

Consultorio Reumatologic Pampa /ID# 145979, Buenos Aires

1431

"Centro de Educación Médica e Investigaciones Clínicas Norberto Quimo - CEMIC /ID# 149176", Buenos Aires

1505

Diag Consult Ctr 17 Sofia EOOD /ID# 144730, Sofia

1612

UMHAT Sv. Ivan Rilski /ID# 147351, Sofia

2000

Centro de Enfermedades /ID# 153543, Santa Fe

2050

Royal Prince Alfred Hospital /ID# 146028, Camperdown

2143

Pest Megyei Flor Ferenc Korhaz /ID# 144742, Kistarcsa

2193

Wits Clinical Research Site /ID# 149835, Johannesburg

3600

ReumaClinic Genk /ID# 146030, Genk

4400

Cordis S.A. /Id# 152621, Salta

7130

Synexus Helderberg Clinical Tr /ID# 148724, Cape Town

7530

Tiervlei Trial Centre /ID# 153086, Cape Town

8000

Fejer Megyei Szent Gyorgy Korh /ID# 144741, Székesfehérvár

8200

Vital Medical Center Orvosi es /ID# 144740, Veszprém

9300

Algemeen Stedelijk Ziekenhuis /ID# 148720, Aalst

11000

Institute for Rheumatology /ID# 144759, Belgrade

Institute for Rheumatology /ID# 144761, Belgrade

Institute for Rheumatology /ID# 144762, Belgrade

11527

"General Hospital of Athens Ippokratio /ID# 144739", Athens

13419

North Estonian Medical Centre /ID# 145455, Tallinn

16080

Uludağ Üniversitesi Atatürk Rehabilitasyon Uygulama ve Araştırma Merkezi /ID# 144772, Osmangazi

21000

Special Hospital for Rheuma /ID# 144760, Novi Sad

21018

Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 146002, Vinnytsia

23320

Ctr for Arth and Rheum Disease /ID# 143759, Chesapeake

28562

Coastal Carolina Health Care /ID# 149275, New Bern

29601

Innovative Clinical Research /ID# 143757, Greenville

30033

Jefrey D. Lieberman, MD, P.C. /ID# 151816, Decatur

33309

Ctr Rheum, Immuno, Arthritis /ID# 143766, Fort Lauderdale

33321

W. Broward Rheum Assoc Inc. /ID# 146010, Tamarac

33603

Clinical Research West FL /ID# 148726, Tampa

33609

SW FL Clin Res Ctr, Tampa, FL /ID# 143763, Tampa

33612

University of South Florida /ID# 146004, Tampa

33781

Advent Clinical Research /ID# 143767, Pinellas Park

34239

Sarasota Arthritis Center /ID# 146011, Sarasota

35801

Rheum Assoc of North Alabama /ID# 146009, Huntsville

37134

A.O.U.I. di Verona Policlinico /ID# 144746, Verona

37203

Nashville Arthritis and Rheumatology /ID# 162641, Nashville

41010

Hospital Infanta Luisa /ID# 144771, Seville

41014

Hospital Universitario de Valm /ID# 144770, Seville

46026

Hospital Universitario La Fe /ID# 158013, Valencia

50406

MediTrials /ID# 159745, Tartu

53132

Aurora Rheumatology and Immunotherapy Center /ID# 160811, Franklin

60640

Great Lakes Clinical Trials /ID# 150935, Chicago

64060

Desarrollos Biomedicos y Biotc /ID# 147379, Monterrey

67205

PRN Professional Research Network of Kansas, LLC /ID# 143761, Wichita

68114

Quality Clinical Research Inc. /ID# 156415, Omaha

69600

Zaporizhzhia Regional Clinical /ID# 146000, Zaporizhia

71011

Vanguard Medical Research, LLC /ID# 153124, Shreveport

71203

The Arthritis & Diabetes Clinic, Inc. /ID# 160809, Monroe

72401

NEA Baptist Womens Clinic /ID# 148904, Jonesboro

74135

Healthcare Research Consultant /ID# 147632, Tulsa

75007

Trinity Universal Res Assoc /ID# 150138, Carrollton

75150

SW Rheumatology Res. LLC /ID# 147620, Mesquite

76018

Regional Clinical Hospital /ID# 152007, Ivano-Frankivsk

76710

Arthritis & Osteoporosis Clinic /ID# 143752, Waco

77004

Accurate Clinical Management /ID# 143768, Houston

77089

Accurate Clinical Research /ID# 143769, Houston

77375

DM Clinical Research /ID# 151359, Tomball

77382

Adv Rheumatology of Houston /ID# 162609, The Woodlands

77701

Diagnostic Group Integrated He /ID# 148725, Beaumont

77845

Arth and Osteo Clin Brazo Valley /ID# 160810, College Station

78215

Sun Research Institute /ID# 159553, San Antonio

78278

Barzilai Medical Center /ID# 144744, Ashkelon

78404

Adriana Pop-Moody MD Clinic PA /ID# 147627, Corpus Christi

78666

Arthritis Clinic of Central TX /ID# 149266, San Marcos

78745

Tekton Research, Inc. /ID# 159554, Austin

79013

Lviv Regional Clinical Hospita /ID# 154448, Lviv

80920

Arthritis Assoc & Osteo Ctr /ID# 147176, Colorado Springs

85018

Elite Clinical Studies, LLC /ID# 143760, Phoenix

85234

ArthroCare Arthritis Care & Re /ID# 143751, Gilbert

87102

Albuquerque Clinical Trials, Inc /ID# 147618, Albuquerque

88011

Arthritis and Osteo Assoc /ID# 147177, Las Cruces

88100

Universita di Catanzaro Magna Graecia /ID# 144747, Catanzaro

92543

C.V. Mehta MD, Med Corporation /ID# 143762, Hemet

100337

Spitalul Municipal Ploiesti /ID# 144756, Ploieşti

119049

Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 147255, Moscow

125284

City Clinical Hospital Botkina /ID# 145995, Moscow

150000

Yaroslavi State Medical Univer /ID# 147253, Yaroslavl

153005

Сity Clinical Hospital 4 /ID# 145994, Ivanovo

170036

Tver Regional Clinical Hosp. /ID# 147254, Tver'

185019

Republican Clin Hos n.a. Baran /ID# 147251, Petrozavodsk

443095

Samara Regional Clinical Hosp /ID# 150934, Samara

450005

Reg Clin Hosp n.a. Kuvatova G. /ID# 144757, Ufa

460000

Orenburg State Medical Academy /ID# 145992, Orenburg

603005

City Clinical Hospital #5 /ID# 149832, Nizhny Novgorod

614109

Perm Clinical Center of FMBA /ID# 145993, Perm

630099

LLC Medical Center /ID# 144758, Novosibirsk

3339419

Bnai Zion Medical Center /ID# 144745, Haifa

3436212

The Lady Davis Carmel MC /ID# 147174, Haifa

3700053

Inoue Hospital /ID# 148069, Takasaki

4070038

Reg. Clinical Hosptial Concepcion /ID# 151267, Concepción

5262100

Sheba Medical Center /ID# 144824, Ramat Gan

5550170

Quantum Research LTDA. /ID# 145984, Puerto Varas

7500588

Quantum Research Stgo. /ID# 145983, Santiago

8628655

Kumamoto Shinto General Hospital /ID# 148286, Kumamoto

36608-1787

Alabama Medical Group, PC /ID# 153941, Mobile

85719-1478

University of Arizona Cancer Center - North Campus /ID# 147175, Tucson

33166-7225

South Florida Research Ph I-IV /ID# 151983, Miami Springs

33614-7101

BayCare Medical Group, Inc. /ID# 151985, Tampa

BayCare Medical Group, Inc. /ID# 163595, Tampa

70836-6455

Ochsner Clinic Foundation /ID# 153573, Baton Rouge

02048

Mansfield Health Center /ID# 161627, Mansfield

03756

Dartmouth-Hitchcock Medical Center /ID# 146008, Lebanon

45377-9464

STAT Research, Inc. /ID# 143770, Vandalia

73103-2400

Health Research Oklahoma /ID# 159550, Oklahoma City

77098-5294

Pioneer Research Solutions, Inc. /ID# 143765, Houston

75904-3132

P&I Clinical Research /ID# 151358, Lufkin

779 00

CTCenter MaVe, s.r.o. /ID# 144823, Olomouc

140 00

Nuselská poliklinika, Revmatologie /ID# 145986, Prague

Thomayerova nemocnice /ID# 144736, Prague

690 02

RHEUMA s.r.o. /ID# 144737, Břeclav

686 01

Medical Plus, s.r.o. /ID# 144821, Uherské Hradište

810-0001

Kondo Clinic for Rheum & Ortho /ID# 148268, Fukuoka

810-8563

NHO Kyushu Medical Center /ID# 148279, Fukuoka

NHO Kyushu Medical Center /ID# 148280, Fukuoka

820-8505

Aso Iizuka Hospital /ID# 148272, Iizuka-shi

781-0112

Bay Side Misato Medical Center /ID# 148281, Kochi

862-0920

Center for Arthritis and Clinical Rheumatology Matsubara Clinic /ID# 148269, Kumamoto

852-8501

Nagasaki University Hospital /ID# 149859, Nagasaki

857-1195

Sasebo Chuo Hospital /ID# 148275, Sasebo

543-8555

Osaka Red Cross Hospital /ID# 148267, Osaka

430-8558

Seirei Hamamatsu General Hosp /ID# 148270, Hamamatsu

883-0043

Ohira Orthopaedic Hospital /ID# 157944, Hyūga

649-2211

Shirahama Hamayu Hospital /ID# 148277, Nishimura

769-2321

Sanuki Municipal Hospital /ID# 158080, Sanuki

060-8648

Hokkaido University Hospital /ID# 148285, Sapporo

063-0811

Hokkaido Medical Center for Rheumatic Diseases /ID# 148274, Sapporo

745-0824

Miyasato Clinic /ID# 148271, Shūnan

933-0874

Takaoka Rheumatic Orthopedic Clinic /ID# 148068, Takaoka

155-0032

Matsuta Clinic /ID# 148278, Tokyo

284-0003

National Hospital Organization Shimoshizu National Hospital /ID# 148273, Yotsukaidō

06100

Cryptex Investigación Clínica S.A de C.V /ID# 147095, Mexico City

60-218

Medyczne Centrum Hetmanska /ID# 144751, Poznan

51-685

WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 157622, Wroclaw

20-607

REUMED Sp.z o.o. Filia nr 1 /ID# 144752, Lublin

02-507

Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 149521, Warsaw

15-351

Osteo-Medic spolka cywilna /ID# 144753, Bialystok

80-546

Centrum Badań Klinicznych Pi-House /ID# 149520, Gdansk

82-300

NZOZ Centrum Reumatologiczne /ID# 144749, Elblag

1050-034

Instituto Portugues De Reumatologia /ID# 149281, Lisbon

4434-502

Centro Hospitalar De Vila Nova /ID# 146036, Vila Nova de Gaia

1649-035

Centro Hospitalar Lisboa Norte, EPE /ID# 146035, Lisbon

4050-111

Centro Hospitalar Baixo Vouga /ID# 152916, Porto

00983

Dr. Ramon L. Ortega-Colon, MD /ID# 145989, Carolina

00716

Ponce School of Medicine /ID# 145990, Ponce

0001

University of Pretoria /ID# 148740, Pretoria

08006

Hospital Plató /ID# 145999, Barcelona

08916

Hospital Univ Germans Trias I /ID# 146037, Barcelona

03680

NSC-Strazhesko Ist Cardiology /ID# 152004, Kiev

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY