AzTrials
AzTrials

Rheumatoid ArthritisPhase 3NCT02706951

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)

A Phase 3 study testing Methotrexate and Upadacitinib in people with Rheumatoid Arthritis, run by AbbVie at 153 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Methotrexate and Upadacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
648 participants
Where
153 sitesin 25 countries
Study dates
23 Mar 2016to 10 Aug 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of RA for >= 3 months.
  • Subjects must have been on oral or parenteral MTX therapy >= 3 months and on a stable dose for >= 4 weeks prior to first dose of study drug.
  • Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) >= 4 weeks prior to first dose of study drug.
  • Meets the following minimum disease activity criteria: >= 6 swollen joints (based on 66 joint counts) and >= 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.

Who cannot join

  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
  • Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).
  • Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted.

Trial locations and contacts

153 sites in 25 countries.

153 sites in 25 countries

United States52 sites

  • Albuquerque Clinical Trials, Inc /ID# 147618

    Albuquerque, New Mexico, 87102

  • Tekton Research, Inc. /ID# 159554

    Austin, Texas, 78745

  • Ochsner Clinic Foundation /ID# 153573

    Baton Rouge, Louisiana, 70836-6455

  • Diagnostic Group Integrated He /ID# 148725

    Beaumont, Texas, 77701

  • Trinity Universal Res Assoc /ID# 150138

    Carrollton, Texas, 75007

  • Ctr for Arth and Rheum Disease /ID# 143759

    Chesapeake, Virginia, 23320

  • Great Lakes Clinical Trials /ID# 150935

    Chicago, Illinois, 60640

  • Arth and Osteo Clin Brazo Valley /ID# 160810

    College Station, Texas, 77845

  • Arthritis Assoc & Osteo Ctr /ID# 147176

    Colorado Springs, Colorado, 80920

  • Adriana Pop-Moody MD Clinic PA /ID# 147627

    Corpus Christi, Texas, 78404

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

    Decatur, Georgia, 30033

  • Ctr Rheum, Immuno, Arthritis /ID# 143766

    Fort Lauderdale, Florida, 33309

  • Aurora Rheumatology and Immunotherapy Center /ID# 160811

    Franklin, Wisconsin, 53132

  • ArthroCare Arthritis Care & Re /ID# 143751

    Gilbert, Arizona, 85234

  • Innovative Clinical Research /ID# 143757

    Greenville, South Carolina, 29601

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

    Hemet, California, 92543

  • Accurate Clinical Management /ID# 143768

    Houston, Texas, 77004

  • Accurate Clinical Research /ID# 143769

    Houston, Texas, 77089

  • Pioneer Research Solutions, Inc. /ID# 143765

    Houston, Texas, 77098-5294

  • Rheum Assoc of North Alabama /ID# 146009

    Huntsville, Alabama, 35801

  • NEA Baptist Womens Clinic /ID# 148904

    Jonesboro, Arkansas, 72401

  • Arthritis and Osteo Assoc /ID# 147177

    Las Cruces, New Mexico, 88011

  • Dartmouth-Hitchcock Medical Center /ID# 146008

    Lebanon, New Hampshire, 03756

  • P&I Clinical Research /ID# 151358

    Lufkin, Texas, 75904-3132

  • Mansfield Health Center /ID# 161627

    Mansfield, Massachusetts, 02048

  • SW Rheumatology Res. LLC /ID# 147620

    Mesquite, Texas, 75150

  • South Florida Research Ph I-IV /ID# 151983

    Miami Springs, Florida, 33166-7225

  • Alabama Medical Group, PC /ID# 153941

    Mobile, Alabama, 36608-1787

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

    Monroe, Louisiana, 71203

  • Nashville Arthritis and Rheumatology /ID# 162641

    Nashville, Tennessee, 37203

  • Coastal Carolina Health Care /ID# 149275

    New Bern, North Carolina, 28562

  • Health Research Oklahoma /ID# 159550

    Oklahoma City, Oklahoma, 73103-2400

  • Quality Clinical Research Inc. /ID# 156415

    Omaha, Nebraska, 68114

  • Elite Clinical Studies, LLC /ID# 143760

    Phoenix, Arizona, 85018

  • Advent Clinical Research /ID# 143767

    Pinellas Park, Florida, 33781

  • Sun Research Institute /ID# 159553

    San Antonio, Texas, 78215

  • Arthritis Clinic of Central TX /ID# 149266

    San Marcos, Texas, 78666

  • Sarasota Arthritis Center /ID# 146011

    Sarasota, Florida, 34239

  • Vanguard Medical Research, LLC /ID# 153124

    Shreveport, Louisiana, 71011

  • W. Broward Rheum Assoc Inc. /ID# 146010

    Tamarac, Florida, 33321

  • Clinical Research West FL /ID# 148726

    Tampa, Florida, 33603

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

    Tampa, Florida, 33609

  • University of South Florida /ID# 146004

    Tampa, Florida, 33612

  • BayCare Medical Group, Inc. /ID# 151985

    Tampa, Florida, 33614-7101

  • BayCare Medical Group, Inc. /ID# 163595

    Tampa, Florida, 33614-7101

  • Adv Rheumatology of Houston /ID# 162609

    The Woodlands, Texas, 77382

  • DM Clinical Research /ID# 151359

    Tomball, Texas, 77375

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

    Tucson, Arizona, 85719-1478

  • Healthcare Research Consultant /ID# 147632

    Tulsa, Oklahoma, 74135

  • STAT Research, Inc. /ID# 143770

    Vandalia, Ohio, 45377-9464

  • Arthritis & Osteoporosis Clinic /ID# 143752

    Waco, Texas, 76710

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

    Wichita, Kansas, 67205

Other trials in United States

Japan21 sites

  • Kondo Clinic for Rheum & Ortho /ID# 148268

    Fukuoka, Fukuoka, 810-0001

  • NHO Kyushu Medical Center /ID# 148279

    Fukuoka, Fukuoka, 810-8563

  • NHO Kyushu Medical Center /ID# 148280

    Fukuoka, Fukuoka, 810-8563

  • Seirei Hamamatsu General Hosp /ID# 148270

    Hamamatsu, 430-8558

  • Ohira Orthopaedic Hospital /ID# 157944

    Hyūga, 883-0043

  • Aso Iizuka Hospital /ID# 148272

    Iizuka-shi, Fukuoka, 820-8505

  • Bay Side Misato Medical Center /ID# 148281

    Kochi, Kochi, 781-0112

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

    Kumamoto, Kumamoto, 862-0920

  • Kumamoto Shinto General Hospital /ID# 148286

    Kumamoto, Kumamoto, 8628655

  • Nagasaki University Hospital /ID# 149859

    Nagasaki, Nagasaki, 852-8501

  • Shirahama Hamayu Hospital /ID# 148277

    Nishimura, 649-2211

  • Osaka Red Cross Hospital /ID# 148267

    Osaka, Osaka, 543-8555

  • Sanuki Municipal Hospital /ID# 158080

    Sanuki, 769-2321

  • Hokkaido University Hospital /ID# 148285

    Sapporo, 060-8648

  • Hokkaido Medical Center for Rheumatic Diseases /ID# 148274

    Sapporo, 063-0811

  • Sasebo Chuo Hospital /ID# 148275

    Sasebo, Nagasaki, 857-1195

  • Miyasato Clinic /ID# 148271

    Shūnan, 745-0824

  • Takaoka Rheumatic Orthopedic Clinic /ID# 148068

    Takaoka, 933-0874

  • Inoue Hospital /ID# 148069

    Takasaki, Gunma, 3700053

  • Matsuta Clinic /ID# 148278

    Tokyo, 155-0032

  • National Hospital Organization Shimoshizu National Hospital /ID# 148273

    Yotsukaidō, 284-0003

Other trials in Japan

Russia12 sites

  • Сity Clinical Hospital 4 /ID# 145994

    Ivanovo, 153005

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

    Moscow, Moscow, 119049

  • City Clinical Hospital Botkina /ID# 145995

    Moscow, 125284

  • City Clinical Hospital #5 /ID# 149832

    Nizhny Novgorod, 603005

  • LLC Medical Center /ID# 144758

    Novosibirsk, Novosibirsk Oblast, 630099

  • Orenburg State Medical Academy /ID# 145992

    Orenburg, 460000

  • Perm Clinical Center of FMBA /ID# 145993

    Perm, Permskiy Kray, 614109

  • Republican Clin Hos n.a. Baran /ID# 147251

    Petrozavodsk, 185019

  • Samara Regional Clinical Hosp /ID# 150934

    Samara, 443095

  • Tver Regional Clinical Hosp. /ID# 147254

    Tver', Tver Oblast, 170036

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

    Ufa, 450005

  • Yaroslavi State Medical Univer /ID# 147253

    Yaroslavl, 150000

Other trials in Russia

Poland7 sites

  • Osteo-Medic spolka cywilna /ID# 144753

    Bialystok, Podlaskie Voivodeship, 15-351

  • NZOZ Centrum Reumatologiczne /ID# 144749

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • Centrum Badań Klinicznych Pi-House /ID# 149520

    Gdansk, Pomeranian Voivodeship, 80-546

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

    Lublin, Lublin Voivodeship, 20-607

  • Medyczne Centrum Hetmanska /ID# 144751

    Poznan, Greater Poland Voivodeship, 60-218

  • Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 149521

    Warsaw, Masovian Voivodeship, 02-507

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

    Wroclaw, Lower Silesian Voivodeship, 51-685

Other trials in Poland

Argentina6 sites

  • Mautalen Salud e Investigacion /ID# 145980

    Buenos Aires, 1128

  • Ctr Privado Med Familiar /ID# 149183

    Buenos Aires, 1417

  • Consultorio Reumatologic Pampa /ID# 145979

    Buenos Aires, 1428

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

    Buenos Aires, 1431

  • Cordis S.A. /Id# 152621

    Salta, 4400

  • Centro de Enfermedades /ID# 153543

    Santa Fe, 2000

Other trials in Argentina

Czechia5 sites

  • RHEUMA s.r.o. /ID# 144737

    Břeclav, 690 02

  • CTCenter MaVe, s.r.o. /ID# 144823

    Olomouc, Olomouc Region, 779 00

  • Nuselská poliklinika, Revmatologie /ID# 145986

    Prague, Praha 4, 140 00

  • Thomayerova nemocnice /ID# 144736

    Prague, Praha 4, 140 00

  • Medical Plus, s.r.o. /ID# 144821

    Uherské Hradište, 686 01

Other trials in Czechia

Spain5 sites

  • Hospital Plató /ID# 145999

    Barcelona, 08006

  • Hospital Univ Germans Trias I /ID# 146037

    Barcelona, 08916

  • Hospital Infanta Luisa /ID# 144771

    Seville, 41010

  • Hospital Universitario de Valm /ID# 144770

    Seville, 41014

  • Hospital Universitario La Fe /ID# 158013

    Valencia, 46026

Other trials in Spain

Ukraine5 sites

  • Regional Clinical Hospital /ID# 152007

    Ivano-Frankivsk, 76018

  • NSC-Strazhesko Ist Cardiology /ID# 152004

    Kiev, 03680

  • Lviv Regional Clinical Hospita /ID# 154448

    Lviv, Lviv Oblast, 79013

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

    Vinnytsia, Vinnytsia Oblast, 21018

  • Zaporizhzhia Regional Clinical /ID# 146000

    Zaporizhia, 69600

Other trials in Ukraine

Hungary4 sites

  • Magyar Honvedseg Egeszsegugyi Kozpont /ID# 144743

    Budapest, 1134

  • Pest Megyei Flor Ferenc Korhaz /ID# 144742

    Kistarcsa, 2143

  • Fejer Megyei Szent Gyorgy Korh /ID# 144741

    Székesfehérvár, 8000

  • Vital Medical Center Orvosi es /ID# 144740

    Veszprém, Veszprém megye, 8200

Other trials in Hungary

Israel4 sites

  • Barzilai Medical Center /ID# 144744

    Ashkelon, 78278

  • Bnai Zion Medical Center /ID# 144745

    Haifa, 3339419

  • The Lady Davis Carmel MC /ID# 147174

    Haifa, 3436212

  • Sheba Medical Center /ID# 144824

    Ramat Gan, 5262100

Other trials in Israel

Portugal4 sites

  • Instituto Portugues De Reumatologia /ID# 149281

    Lisbon, Lisbon District, 1050-034

  • Centro Hospitalar Lisboa Norte, EPE /ID# 146035

    Lisbon, 1649-035

  • Centro Hospitalar Baixo Vouga /ID# 152916

    Porto, 4050-111

  • Centro Hospitalar De Vila Nova /ID# 146036

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

Serbia4 sites

  • Institute for Rheumatology /ID# 144759

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 144761

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 144762

    Belgrade, Beograd, 11000

  • Special Hospital for Rheuma /ID# 144760

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

South Africa4 sites

  • Synexus Helderberg Clinical Tr /ID# 148724

    Cape Town, Western Cape, 7130

  • Tiervlei Trial Centre /ID# 153086

    Cape Town, Western Cape, 7530

  • Wits Clinical Research Site /ID# 149835

    Johannesburg, Gauteng, 2193

  • University of Pretoria /ID# 148740

    Pretoria, Gauteng, 0001

Other trials in South Africa

Chile3 sites

  • Reg. Clinical Hosptial Concepcion /ID# 151267

    Concepción, 4070038

  • Quantum Research LTDA. /ID# 145984

    Puerto Varas, 5550170

  • Quantum Research Stgo. /ID# 145983

    Santiago, 7500588

Other trials in Chile

Belgium2 sites

  • Algemeen Stedelijk Ziekenhuis /ID# 148720

    Aalst, Oost-Vlaanderen, 9300

  • ReumaClinic Genk /ID# 146030

    Genk, 3600

Other trials in Belgium

Bulgaria2 sites

  • Diag Consult Ctr 17 Sofia EOOD /ID# 144730

    Sofia, 1505

  • UMHAT Sv. Ivan Rilski /ID# 147351

    Sofia, 1612

Other trials in Bulgaria

Estonia2 sites

  • North Estonian Medical Centre /ID# 145455

    Tallinn, 13419

  • MediTrials /ID# 159745

    Tartu, Tartu, 50406

Other trials in Estonia

Italy2 sites

  • Universita di Catanzaro Magna Graecia /ID# 144747

    Catanzaro, Calabria, 88100

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

    Verona, 37134

Other trials in Italy

Mexico2 sites

  • Cryptex Investigación Clínica S.A de C.V /ID# 147095

    Mexico City, 06100

  • Desarrollos Biomedicos y Biotc /ID# 147379

    Monterrey, Nuevo León, 64060

Other trials in Mexico

Puerto Rico2 sites

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

    Carolina, 00983

  • Ponce School of Medicine /ID# 145990

    Ponce, 00716

Other trials in Puerto Rico

Australia1 site

  • Royal Prince Alfred Hospital /ID# 146028

    Camperdown, New South Wales, 2050

Other trials in Australia

Austria1 site

  • Rheuma-Zentrum Wien-Oberlaa /ID# 144728

    Vienna, 1100

Other trials in Austria

Greece1 site

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

    Athens, 11527

Other trials in Greece

Romania1 site

  • Spitalul Municipal Ploiesti /ID# 144756

    Ploieşti, 100337

Other trials in Romania

Turkey (Türkiye)1 site

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

    Osmangazi, Bursa, 16080

Other trials in Turkey (Türkiye)

About this study

Official title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX

The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX.

The study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.

Read the detailed description

The study includes a 35-day screening period; a 14-week randomized, double-blind, parallel-group, controlled treatment period (Period 1); a 246-week blinded extension period (Period 2); and a 30-day follow-up visit.

Participants who met eligibility criteria were to be randomized in a 2:2:1:1 ratio to one of four treatment groups:

  • Group 1: upadacitinib 30 mg QD (Period 1) → upadacitinib 30 mg QD (Period 2)
  • Group 2: upadacitinib 15 mg QD (Period 1) → upadacitinib 15 mg QD (Period 2)
  • Group 3: MTX (Period 1) → upadacitinib 30 mg QD (Period 2)
  • Group 4: MTX (Period 1) → upadacitinib 15 mg QD (Period 2)

Starting with implementation of Protocol Amendment 5, all participants in the extension period will receive open-label upadacitinib 15 mg QD, including those currently on upadacitinib 30 mg QD.

Being tested
Methotrexate, Upadacitinib, Placebo Upadacitinib, Placebo Methotrexate
Keywords
Musculoskeletal Disease, Arthritis, Joint Disease, Anti-inflammatory agents, Antirheumatic agents, Upadacitinib, ABT-494
Medical subject headings
Arthritis, Rheumatoid, Musculoskeletal Diseases, Arthritis, Joint Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethotrexateDrug

    Capsule; Oral

  • UpadacitinibDrug

    Also called ABT-494, Rinvoq

    Tablet; Oral

  • Placebo UpadacitinibDrug

    Tablet; Oral

  • Placebo MethotrexateDrug

    Capsule; Oral

Study groups in NCT02706951
Study groupRoleWhat they receive
Upadacitinib 30 mgExperimentalPeriod 1: Participants receive upadacitnib 30 mg once daily and placebo to methotrexate once weekly for 14 weeks. Period 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Receives: Drug: Upadacitinib; Drug: Placebo Methotrexate
Upadacitinib 15 mgExperimentalPeriod 1: Participants receive upadacitnib 15 mg once daily and placebo to methotrexate once weekly for 14 weeks. Period 2: Participants receive upadacitinib 15 mg once daily up to Week 260.
Receives: Drug: Upadacitinib; Drug: Placebo Methotrexate
Methotrexate / Upadacitinib 30 mgExperimentalPeriod 1: Participants receive methotrexate once weekly and placebo to upadacitinib once daily for 14 weeks. Period 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Receives: Drug: Methotrexate; Drug: Upadacitinib; Drug: Placebo Upadacitinib; Drug: Placebo Methotrexate
Methotrexate / Upadacitinib 15 mgExperimentalPeriod 1: Participants receive methotrexate once weekly and placebo to upadacitinib for 14 weeks. Period 2: Participants receive upadacitinib 15 mg once daily up to Week 260.
Receives: Drug: Methotrexate; Drug: Upadacitinib; Drug: Placebo Upadacitinib; Drug: Placebo Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14

    The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 14. Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:

    1. ≥ 20% improvement in 68-tender joint count;
    2. ≥ 20% improvement in 66-swollen joint count; and
    3. ≥ 20% improvement in at least 3 of the 5 following parameters:
    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).

    Measured: Baseline and week 14

  2. Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 14

    The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of ≤ 3.2 at Week 14.

    The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.

    A DAS28 score less than or equal to 3.2 indicates low disease activity.

    Measured: Week 14

Secondary outcomes (7)

  1. Change From Baseline in in Disease Activity Score 28 (CRP) at Week 14

    The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline in DAS28 (CRP) indicates improvement in disease activity.

    Measured: Baseline to week 14

  2. Change From Baseline in Heath Assessment Questionnaire and Disability Index (HAQ-DI) at Week 14

    The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.

    Measured: Baseline to week 14

  3. Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 14

    The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).

    The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.

    Measured: Baseline to week 14

  4. Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 14

    The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.

    A DAS28 score less than 2.6 indicates clinical remission.

    Measured: Week 14

  5. Change From Baseline in Duration of Morning Stiffness at Week 14

    Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days. A negative change from Baseline indicates improvement.

    Measured: Baseline to week 14

  6. Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 14

    Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:

    1. ≥ 50% improvement in 68-tender joint count;
    2. ≥ 50% improvement in 66-swollen joint count; and
    3. ≥ 50% improvement in at least 3 of the 5 following parameters:
    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).

    Measured: Baseline and week 14

  7. Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 14

    Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:

    1. ≥ 70% improvement in 68-tender joint count;
    2. ≥ 70% improvement in 66-swollen joint count; and
    3. ≥ 70% improvement in at least 3 of the 5 following parameters:
    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).

    Measured: Baseline and week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2016 (estimated)
  2. Study start23 Mar 2016
  3. Primary completion2 Oct 2017
  4. Study completion10 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
648 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02706951
Sponsor's protocol ID
M15-555
Other IDs
2015-003376-75, 2015
Status last verified
Jan 2024
First submitted
18 Feb 2016
Last updated
30 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • Smolen JS, Pangan AL, Emery P, Rigby W, Tanaka Y, Vargas JI, Zhang Y, Damjanov N, Friedman A, Othman AA, Camp HS, Cohen S. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019 Jun 8;393(10188):2303-2311. doi: 10.1016/S0140-6736(19)30419-2. Epub 2019 May 23.

    PubMed 31130260

  • Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.

    PubMed 40875187

  • Smolen JS, Emery P, Rigby W, Tanaka Y, Vargas JI, Jain M, Kato K, Carter KM, Khan N, Phillips C, Meerwein S, Cohen SB. Upadacitinib as monotherapy in patients with rheumatoid arthritis and prior inadequate response to methotrexate: results at 260 weeks from the SELECT-MONOTHERAPY randomised study. RMD Open. 2025 May 11;11(2):e005051. doi: 10.1136/rmdopen-2024-005051.

    PubMed 40350200

  • Rubbert-Roth A, Kakehasi AM, Takeuchi T, Schmalzing M, Palac H, Coombs D, Liu J, Anyanwu SI, Lippe R, Curtis JR. Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis. Rheumatol Ther. 2024 Feb;11(1):97-112. doi: 10.1007/s40744-023-00621-6. Epub 2023 Nov 20.

    PubMed 37982966

  • Charles-Schoeman C, Choy E, McInnes IB, Mysler E, Nash P, Yamaoka K, Lippe R, Khan N, Shmagel AK, Palac H, Suboticki J, Curtis JR. MACE and VTE across upadacitinib clinical trial programmes in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. RMD Open. 2023 Nov;9(4):e003392. doi: 10.1136/rmdopen-2023-003392.

    PubMed 37945286

  • Fleischmann R, Curtis JR, Charles-Schoeman C, Mysler E, Yamaoka K, Richez C, Palac H, Dilley D, Liu J, Strengholt S, Burmester G. Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme. Ann Rheum Dis. 2023 Sep;82(9):1130-1141. doi: 10.1136/ard-2023-223916. Epub 2023 Jun 12.

    PubMed 37308218

  • Conaghan PG, Pavelka K, Hsieh SC, Bonnington TL, Kent TC, Marchbank K, Edwards CJ. Evaluating the efficacy of upadacitinib in patients with moderate rheumatoid arthritis: a post-hoc analysis of the SELECT phase 3 trials. Rheumatol Adv Pract. 2023 Feb 8;7(1):rkad017. doi: 10.1093/rap/rkad017. eCollection 2023.

    PubMed 36794283

  • Burmester GR, Cohen SB, Winthrop KL, Nash P, Irvine AD, Deodhar A, Mysler E, Tanaka Y, Liu J, Lacerda AP, Palac H, Shaw T, Mease PJ, Guttman-Yassky E. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1):e002735. doi: 10.1136/rmdopen-2022-002735.

    PubMed 36754548

  • Kakehasi AM, Radominski SC, Baravalle MD, Palazuelos FCI, Garcia-Garcia C, Arruda MS, Curi M, Liu J, Qiao M, Velez-Sanchez P, Vargas JI. Safety of upadacitinib in Latin American patients with rheumatoid arthritis: an integrated safety analysis of the SELECT phase 3 clinical program. Clin Rheumatol. 2023 May;42(5):1249-1258. doi: 10.1007/s10067-023-06513-y. Epub 2023 Jan 30.

    PubMed 36715850

  • Bergman M, Buch MH, Tanaka Y, Citera G, Bahlas S, Wong E, Song Y, Zueger P, Ali M, Strand V. Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials. Rheumatol Ther. 2022 Dec;9(6):1517-1529. doi: 10.1007/s40744-022-00483-4. Epub 2022 Sep 20.

    PubMed 36125701

  • Bergman M, Tundia N, Yang M, Orvis E, Clewell J, Bensimon A. Economic Benefit from Improvements in Quality of Life with Upadacitinib: Comparisons with Tofacitinib and Methotrexate in Patients with Rheumatoid Arthritis. Adv Ther. 2021 Dec;38(12):5649-5661. doi: 10.1007/s12325-021-01930-4. Epub 2021 Oct 12.

    PubMed 34636000

  • Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.

    PubMed 34041702

  • Strand V, Tundia N, Wells A, Buch MH, Radominski SC, Camp HS, Friedman A, Suboticki JL, Dunlap K, Goldschmidt D, Bergman M. Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY. Rheumatology (Oxford). 2021 Jul 1;60(7):3209-3221. doi: 10.1093/rheumatology/keaa770.

    PubMed 33313898

  • Cohen SB, van Vollenhoven RF, Winthrop KL, Zerbini CAF, Tanaka Y, Bessette L, Zhang Y, Khan N, Hendrickson B, Enejosa JV, Burmester GR. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2021 Mar;80(3):304-311. doi: 10.1136/annrheumdis-2020-218510. Epub 2020 Oct 28.

    PubMed 33115760

  • Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.

    PubMed 31610021

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methotrexate and Upadacitinib in people with Rheumatoid Arthritis, run by AbbVie at 153 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in United States, Japan, Russia, Poland, Argentina and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14 (time frame: Baseline and week 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02706951, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.

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