AzTrials
AzTrials

Rheumatoid ArthritisPhase 3SELECT-NEXTNCT02675426

A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

A Phase 3 study testing Upadacitinib in people with Rheumatoid Arthritis, run by AbbVie at 167 sites in 38 countries.

Completed

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

Official record
Search all trials

Trial summary

The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Upadacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
661 participants
Where
167 sitesin 38 countries
Study dates
17 Dec 2015to 10 Mar 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult male or female, at least 18 years old.
  • Diagnosis of rheumatoid arthritis (RA) for greater than or equal to 3 months.
  • Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for greater than or equal to 3 months and on a stable dose for greater than or equal to 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.
  • Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
  • Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled (up to 20% of study population) if they have documented evidence of intolerance to bDMARDs or limited exposure (less than 3 months) and have satisfied required washout periods.

Who cannot join

  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
  • History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
  • Subjects who are considered inadequate responders to bDMARD therapy as determined by the Investigator.

Trial locations and contacts

167 sites in 38 countries.

167 sites in 38 countries

United States57 sites

  • The Center for Rheumatology /ID# 138746

    Albany, New York, 12206

  • Tekton Research, Inc. /ID# 141428

    Austin, Texas, 78745

  • Western Washington Arthritis C /ID# 138728

    Bothell, Washington, 98021

  • Trinity Universal Res Assoc /ID# 149271

    Carrollton, Texas, 75007

  • Cincinnati Rheumatic Disease Study Group, Inc. /ID# 138868

    Cincinnati, Ohio, 45242-4468

  • Clinical Res of West FL, Inc. /ID# 138854

    Clearwater, Florida, 33765

  • Arth and Osteo Clin Brazo Valley /ID# 147809

    College Station, Texas, 77845

  • Covina Arthritis Clinic /ID# 139881

    Covina, California, 91722

  • Metroplex Clinical Research /ID# 138698

    Dallas, Texas, 75231

  • Denver Arthritis Clinic /ID# 139876

    Denver, Colorado, 80230

  • Altoona Ctr Clinical Res /ID# 138741

    Duncansville, Pennsylvania, 16635

  • T. Joseph Raoof, MD, Inc. /ID# 140964

    Encino, California, 91436

  • Aurora Rheumatology and Immunotherapy Center /ID# 139306

    Franklin, Wisconsin, 53132

  • Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 141021

    Hendersonville, Tennessee, 37075-6213

  • Baylor College of Medicine /ID# 138682

    Houston, Texas, 77030-3411

  • Houston Institute for Clin Res /ID# 138716

    Houston, Texas, 77074

  • Institute of Arthritis Res /ID# 138548

    Idaho Falls, Idaho, 83404

  • Indiana Univ School of Med /ID# 140077

    Indianapolis, Indiana, 46202

  • Arthritis Consultants, P.A. /ID# 141138

    Killeen, Texas, 76549

  • Allergy and Rheum Med Clin /ID# 146082

    La Jolla, California, 92037

  • Advanced Rheumatology, PC /ID# 140071

    Lansing, Michigan, 48910

  • Justus J. Fiechtner, MD, PC /ID# 138697

    Lansing, Michigan, 48910

  • Bluegrass Community Research /ID# 138295

    Lexington, Kentucky, 40515

  • Physician Res. Collaboration /ID# 138533

    Lincoln, Nebraska, 68516

  • Pacific Arthritis Ctr Med Grp /ID# 138744

    Los Angeles, California, 90045

  • Mansfield Health Center /ID# 141357

    Mansfield, Massachusetts, 02048

  • AZ Arthritis and Rheum Assoc /ID# 148651

    Mesa, Arizona, 85202

  • Ctr Arthritis & Rheumatic Dise /ID# 141696

    Miami, Florida, 33173

  • Medallion Clinical Research Institute, LLC /ID# 140074

    Naples, Florida, 34102

  • Suncoast Clinical Research /ID# 138633

    New Port Richey, Florida, 34652

  • Health Research Oklahoma /ID# 138535

    Oklahoma City, Oklahoma, 73103-2400

  • Westroads Clinical Research /ID# 138304

    Omaha, Nebraska, 68114

  • Omega Research Consultants /ID# 139877

    Orlando, Florida, 32810

  • Four Rivers Clinical Research /ID# 141134

    Paducah, Kentucky, 42003

  • Arthritis Center, Inc. /ID# 141363

    Palm Harbor, Florida, 34684

  • SunValley Arthritis Center, Lt /ID# 140452

    Peoria, Arizona, 85381

  • AZ Arthritis and Rheum Researc /ID# 138500

    Phoenix, Arizona, 85032-9306

  • AZ Arthritis and Rheum Researc /ID# 139286

    Phoenix, Arizona, 85032-9306

  • AZ Arthritis & Rheuma Research /ID# 138598

    Phoenix, Arizona, 85032

  • Arizona Research Center, Inc. /ID# 140448

    Phoenix, Arizona, 85053-4061

  • Trinity Universal Research Association /ID# 148649

    Plano, Texas, 75024-5283

  • MMP Women's Health /ID# 141542

    Portland, Maine, 04102

  • OrthoIllinois /ID# 139695

    Rockford, Illinois, 61114-4937

  • PMG Research of Salisbury /ID# 141023

    Salisbury, North Carolina, 28144

  • Accurate Clinical Management /ID# 139338

    San Antonio, Texas, 78229

  • Clinical Investigation Special /ID# 139696

    Skokie, Illinois, 60076

  • Arthritis Northwest, PLLC /ID# 138539

    Spokane, Washington, 99204

  • Springfield Clinic /ID# 138602

    Springfield, Illinois, 62702-3749

  • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 138689

    Summerville, South Carolina, 29486-7887

  • Arthritis Assoc of NW Ohio /ID# 140953

    Toledo, Ohio, 43606

  • University of Arizona Cancer Center - North Campus /ID# 140451

    Tucson, Arizona, 85719-1478

  • Robin K. Dore MD, Inc /ID# 138688

    Tustin, California, 92780

  • Inland Rheum Clin Trials Inc. /ID# 138853

    Upland, California, 91786

  • Deerbrook Medical Associates /ID# 139694

    Vernon Hills, Illinois, 60061

  • Arthritis & Osteoporosis Clinic /ID# 138703

    Waco, Texas, 76710

  • The Center for Rheumatology & /ID# 139203

    Wheaton, Maryland, 20902

  • PMG Research of Wilmington LLC /ID# 140951

    Wilmington, North Carolina, 28401

Other trials in United States

South Korea9 sites

  • Daegu Catholic University Med /ID# 139249

    Daegu, 705-718

  • Chungnam National University Hospital /ID# 138653

    Daejeon, 35015

  • Chonnam National University Hospital /ID# 138651

    Gwangju, Jeonranamdo, 61469

  • Inha University Hospital /ID# 149310

    Incheon, Gwang Yeogsi, 22332

  • Hanyang University Seoul Hospi /ID# 138655

    Seoul, Seongdong-gu, 04763

  • Cath Univ Seoul St Mary's Hosp /ID# 138652

    Seoul, Seoul Teugbyeolsi, 06591

  • Seoul National University Hospital /ID# 138659

    Seoul, 03080

  • Asan Medical Center /ID# 140579

    Seoul, 05505

  • Ajou University Hospital /ID# 149311

    Suwon, Gyeonggido, 16499

Other trials in South Korea

Russia7 sites

  • Kazan State Medical University /ID# 138413

    Kazan', Tatarstan, Respublika, 420012

  • Republican Clin Hos n.a. Baran /ID# 139273

    Petrozavodsk, 185019

  • LLC Novaya Klinika /ID# 139269

    Pyatigorsk, Stavropol Kray, 357500

  • Samara Regional Clinical Hosp /ID# 148642

    Samara, 443095

  • Ulyanovsk Regional Clin Hosp /ID# 139279

    Ulyanovsk, 432018

  • Voronezh State Medical Univers /ID# 148431

    Voronezh, 394036

  • Yaroslavi State Medical Univer /ID# 139908

    Yaroslavl, 150000

Other trials in Russia

Taiwan6 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 140869

    Kaohsiung City, 80708

  • Far Eastern Memorial Hospital /ID# 140871

    New Taipei City, 22060

  • China Medical University Hosp /ID# 139232

    Taichung, Taichung, 40447

  • National Cheng Kung University Hospital /ID# 140868

    Tainan, Tainan, 70403

  • Taipei Veterans General Hosp /ID# 139234

    Taipei, 11217

  • National Taiwan Univ Hosp /ID# 141443

    Taipei City, Taipei, 10002

Other trials in Taiwan

United Kingdom6 sites

  • Western General Hospital /ID# 139524

    Edinburgh, EH4 2XU

  • Leicester Royal Infirmary /ID# 139184

    Leicester, England, LE1 5WW

  • Whipps Cross Univ Hospital /ID# 139523

    London, London, City of, E11 1NR

  • The Royal Free Hospital /ID# 139191

    London, London, City of, NW3 2QG

  • Southampton General Hospital /ID# 139169

    Southampton, SO16 6YD

  • Warrington + Halton Hosp NHS /ID# 139195

    Warrington, WA5 1LZ

Other trials in United Kingdom

Czechia5 sites

  • Revmatologie, s.r.o. /ID# 138899

    Brno, 638 00

  • L.K.N. Arthrocentrum, s.r.o /ID# 141340

    Hlučín, Moravian-Silesian Region, 748 01

  • Artroscan s.r.o. /ID# 138833

    Ostrava, 722 00

  • Nemocnice Slany /ID# 141112

    Slaný, 274 01

  • PV-MEDICAL s.r.o. /ID# 138913

    Zlín, 760 01

Other trials in Czechia

Germany5 sites

  • Charité Universitätsmedizin Campus Mitte /ID# 139052

    Berlin, 10117

  • Immanuel-Krankenhaus /ID# 139059

    Berlin, 13125

  • Uniklinik Koln /ID# 139084

    Cologne, North Rhine-Westphalia, 50937

  • Asklepios Klinik Altona /ID# 140466

    Hamburg, 22763

  • Welcker, Planegg, DE /ID# 140467

    Planegg, 82152

Other trials in Germany

Poland5 sites

  • Osteo-Medic spolka cywilna /ID# 138371

    Bialystok, Podlaskie Voivodeship, 15-351

  • NZOZ Centrum Reumatologiczne /ID# 138353

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • McBk Sc /Id# 138360

    Grodzisk Mazowiecki, Masovian Voivodeship, 05-825

  • NZOZ Nasz Lekarz /ID# 138374

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Rheuma Medicus /ID# 138372

    Warsaw, 02-118

Other trials in Poland

Slovakia5 sites

  • ARTROMAC n.o. /ID# 138428

    Košice, 040 11

  • Nemocnica Kosice Saca, a.s. /ID# 138918

    Košice, 040 15

  • Slovak research center Team Member, Thermium s.r.o. /ID# 139924

    Pieštany, 921 01

  • Narodny ustav reumatickych chorob Piestany /ID# 138427

    Pieštany, 921 12

  • REUMA-GLOBAL, s.r.o. /ID# 139912

    Trnava, 91701

Other trials in Slovakia

Australia4 sites

  • Emeritus Research /ID# 138773

    Camberwell, Victoria, 3124

  • Coffs Clinical Trials /ID# 138747

    Coffs Harbour, New South Wales, 2450

  • Barwon Rheumatology /ID# 138772

    Geelong, Victoria, 3220

  • Optimus Clinical Research Pty. /ID# 138769

    Kogarah, New South Wales, 2217

Other trials in Australia

Canada4 sites

  • Groupe de Recherche en Maladies Osseuses /ID# 138906

    Sainte-Foy, Quebec, G1V 3M7

  • Dr. Latha Naik /ID# 139089

    Saskatoon, Saskatchewan, S7K 3H3

  • Eastern Health /ID# 140431

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Manitoba Clinic /ID# 139086

    Winnipeg, Manitoba, R3A IM3

Other trials in Canada

Croatia4 sites

  • Klinicki bolnicki centar Rijeka /ID# 138649

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicka bolnica Sveti Duh /ID# 152812

    Zagreb, 10000

  • Medical Center Kuna-Peric /ID# 140365

    Zagreb, 10000

  • Poliklinika Bonifarm /ID# 141415

    Zagreb, 10000

Other trials in Croatia

Spain4 sites

  • Hospital General Univ de Elche /ID# 138991

    Elche, 03202

  • Hospital Clin Univ San Carlos /ID# 138993

    Madrid, 28040

  • Hospital Regional de Malaga /ID# 138975

    Málaga, Malaga, 29009

  • Hosp Nuestra Senora Esperanza /ID# 138997

    Santiago de Compostela, 15705

Other trials in Spain

Belgium3 sites

  • AZ Sint Lucas /ID# 141338

    Bruges, 8310

  • Rhumaconsult SPRL /ID# 138813

    Charleroi, Hainaut, 6000

  • UZ Gent /ID# 138806

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

Estonia3 sites

  • Paernu Hospital /ID# 138961

    Pärnu, 80010

  • Center of Clinical and Basic Research /ID# 141116

    Tallinn, Harju, 10128

  • East Tallinn Central Hospital /ID# 140618

    Tallinn, 10138

Other trials in Estonia

Finland3 sites

  • Helsinki Univ Central Hospital /ID# 140381

    Helsinki, 00290

  • Kiljava Medical Research /ID# 139260

    Hyvinkää, 05800

  • South Karelia Central Hospital /ID# 139973

    Lappeenranta, 53130

Other trials in Finland

Romania3 sites

  • Spitalul Clinic Judetean de Urgenta /ID# 138407

    Cluj-Napoca, 400006

  • Spitalul Municipal Ploiesti /ID# 138405

    Ploieşti, 100337

  • Spitalul Clinic Judetean de Ur /ID# 138393

    Sibiu, 550245

Other trials in Romania

South Africa3 sites

  • St. Augustine's Medical Centre /ID# 141352

    Berea, KwaZulu-Natal, NL 4001

  • Arthritis Clinical Research Tr /ID# 138945

    Cape Town, Western Cape, 7405

  • Winelands Medical Research Ctr /ID# 138944

    Stellenbosch, Western Cape, 7600

Other trials in South Africa

Ukraine3 sites

  • LLC Revmocentr /ID# 139872

    Kyiv, 04070

  • MNCE "Lviv City Clinical Hospital #4" /ID# 139873

    Lviv, 79007

  • Odessa National Medical Univ /ID# 139179

    Odesa, 65026

Other trials in Ukraine

Argentina2 sites

  • Mautalen Salud e Investigacion /ID# 141419

    Buenos Aires, 1128

  • Inst. Rheumatologic Strusberg /ID# 145648

    Córdoba, 5000

Other trials in Argentina

Austria2 sites

  • Rheuma Zentrum Favoriten GmbH /ID# 138787

    Vienna, 1100

  • Wilhelminenspital der Stadt Wien /ID# 138788

    Vienna, 1160

Other trials in Austria

Bosnia and Herzegovina2 sites

  • University Clinical Centre of the Republic of Srpska /ID# 138819

    Banja Luka, Republika Srpska, 78000

  • University Clinical Centre of the Republic of Srpska /ID# 140372

    Banja Luka, Republika Srpska, 78000

Other trials in Bosnia and Herzegovina

Bulgaria2 sites

  • Diag Consult Ctr 17 Sofia EOOD /ID# 141006

    Sofia, 1505

  • Diagnostic Consultative Center /ID# 138882

    Sofia, 1612

Other trials in Bulgaria

France2 sites

  • CHRU Tours - Hopital Trousseau /ID# 138969

    Chambray-lès-Tours, 37170

  • Hopital Saint Joseph /ID# 149188

    Marseille, Bouches-du-Rhone, 13285

Other trials in France

Hungary2 sites

  • Revita Reumatologiai Rendelo /ID# 140761

    Budapest, 1027

  • Fejer Megyei Szent Gyorgy Korh /ID# 138554

    Székesfehérvár, 8000

Other trials in Hungary

Lithuania2 sites

  • Klaipeda University Hospital /ID# 141416

    Klaipėda, 92288

  • Vilnius University Hospital /ID# 141348

    Vilnius, LT-08661

Other trials in Lithuania

Mexico2 sites

  • Centro Peninsular de Investigación Clínica SCP /ID# 148160

    Colonia Centro, Yucatán, 97000

  • Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 138841

    Mexico City, 06090

Other trials in Mexico

Portugal2 sites

  • Instituto Portugues De Reumatologia /ID# 148315

    Lisbon, Lisbon District, 1050-034

  • Centro Hospitalar Lisboa Ocidental, EPE /ID# 140594

    Lisbon, Lisbon District, 1349-019

Other trials in Portugal

Greece1 site

  • University General Hospital of Heraklion "PA.G.N.I" /ID# 139115

    Heraklion, 71110

Other trials in Greece

Hong Kong1 site

  • Prince of Wales Hospital /ID# 139314

    Shatin

Other trials in Hong Kong

Ireland1 site

  • St Vincent's University Hosp /ID# 138562

    Dublin, D04 T6F4

Other trials in Ireland

Italy1 site

  • Universita di Catanzaro Magna Graecia /ID# 139316

    Catanzaro, Calabria, 88100

Other trials in Italy

Kazakhstan1 site

  • JSC Nat Scientific Med Res Ctr /ID# 140575

    Astana, 010009

Other trials in Kazakhstan

Latvia1 site

  • LTD M+M Centers /ID# 138818

    Adazi, 2164

Other trials in Latvia

New Zealand1 site

  • Porter Rheumatology Ltd /ID# 138347

    Nelson, 7010

Other trials in New Zealand

Puerto Rico1 site

  • School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139328

    San Juan, 00935

Other trials in Puerto Rico

Switzerland1 site

  • HFR Fribourg - Hopital Canton /ID# 139155

    Fribourg, 1708

Other trials in Switzerland

Turkey (Türkiye)1 site

  • Ankara Numune Training and Res /ID# 139237

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.

Read the detailed description

This Phase 3 multicenter study includes two periods. Period 1 is a 12-week, randomized, double-blind, parallel-group, placebo-controlled period designed to compare the safety and efficacy of upadacitinib 30 mg once daily and upadacitinib 15 mg once daily versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis (RA) who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.

Period 2 is a 248-week blinded long-term extension period to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 30 mg once daily and upadacitinib 15 mg once daily in participants who completed Period 1.

Participants were to be randomized in a 2:2:1:1 ratio using interactive response technology (IRT) to receive double-blind study drug in one of the following treatment groups:

  • Group 1: Upadacitinib 30 mg QD in Period 1 → Upadacitinib 30 mg QD in Period 2
  • Group 2: Upadacitinib 15 mg QD in Period 1 → Upadacitinib 15 mg QD in Period 2
  • Group 3: Placebo in Period 1 → Upadacitinib 30 mg QD in Period 2
  • Group 4: Placebo in Period 1 → Upadacitinib 15 mg QD in Period 2

Randomization was stratified by prior exposure to biological disease-modifying anti-rheumatic drug (bDMARD) (yes/no) and geographic region.

Following Protocol Amendment 6.0 approval in December 2019, all participants still on study received open-label upadacitinib 15 mg QD, including those on upadacitinib 30 mg QD, with the earliest switch occurring at the Week 168 visit.

Being tested
Placebo, Upadacitinib
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.

  • PlaceboDrug

    Tablet; Oral

  • UpadacitinibDrug

    Also called ABT-494, Rinvoq

    Tablet; Oral

Study groups in NCT02675426
Study groupRoleWhat they receive
Upadacitinib 15 mgExperimentalPeriod 1: Participants receive upadacitinib 15 mg once daily for 12 weeks. Period 2: Participants continue to receive upadacitinib 15 mg once daily for an additional 248 weeks.
Receives: Drug: Upadacitinib
Upadacitinib 30 mgExperimentalPeriod 1: Participants receive upadacitinib 30 mg once daily for 12 weeks. Period 2: Participants continue to receive upadacitinib 30 mg once daily for an additional 248 weeks or until implementation of Protocol Amendment 6 at which time participants switch to receive upadacitinib 15 mg once daily.
Receives: Drug: Upadacitinib
Placebo / Upadacitinib 15 mgExperimentalPeriod 1: Participants receive placebo once daily for 12 weeks. Period 2: Participants receive upadacitinib 15 mg once daily for 248 weeks.
Receives: Drug: Placebo; Drug: Upadacitinib
Placebo / Upadacitinib 30 mgExperimentalPeriod 1: Participants receive placebo once daily for 12 weeks. Period 2: Participants receive upadacitinib 30 mg once daily for 248 weeks or until implementation of Protocol Amendment 6 at which time participants switch to receive upadacitinib 15 mg once daily.
Receives: Drug: Placebo; Drug: Upadacitinib

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 12

    The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. 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 12

  2. Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12

    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 12.

    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), 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 12

Secondary outcomes (10)

  1. Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12

    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), 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 and Week 12

  2. Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12

    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 and Week 12

  3. Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary (PCS) Score at Week 12

    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 summary 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 and Week 12

  4. Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12

    Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6.

    DAS28 (CRP) 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), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.

    Measured: Week 12

  5. Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12

    Low disease activity based on the clinical disease activity index (CDAI) is defined as a CDAI score ≤ 10.

    CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.

    Measured: Week 12

  6. Change From Baseline in Duration of Morning Stiffness at Week 12

    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.

    Measured: Baseline and Week 12

  7. Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12

    The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a five point Likert scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from Baseline indicates improvement.

    Measured: Baseline and week 12

  8. Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12

    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 12

  9. Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12

    Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 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 12

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

    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 1

Timeline

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

  1. First posted5 Feb 2016 (estimated)
  2. Study start17 Dec 2015
  3. Primary completion21 Apr 2017
  4. Study completion10 Mar 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
661 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02675426
Sponsor's protocol ID
M13-549
Other IDs
2015-003332-13, 2015
Acronym
SELECT-NEXT
Status last verified
Mar 2023
First submitted
11 Dec 2015
Last updated
11 Apr 2023
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, analyses plans, 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

  • Burmester GR, Kremer JM, Van den Bosch F, Kivitz A, Bessette L, Li Y, Zhou Y, Othman AA, Pangan AL, Camp HS. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.

    PubMed 29908669

  • 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

  • Burmester GR, Van den Bosch F, Tesser J, Shmagel A, Liu Y, Khan N, Camp HS, Kivitz A. Upadacitinib in Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs: Efficacy and Safety Through 5 Years (SELECT-NEXT). J Rheumatol. 2024 Jul 1;51(7):663-672. doi: 10.3899/jrheum.2023-1062.

    PubMed 38621793

  • 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

  • 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

  • Strand V, Pope J, Tundia N, Friedman A, Camp HS, Pangan A, Ganguli A, Fuldeore M, Goldschmidt D, Schiff M. Upadacitinib improves patient-reported outcomes in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: results from SELECT-NEXT. Arthritis Res Ther. 2019 Dec 9;21(1):272. doi: 10.1186/s13075-019-2037-1.

    PubMed 31815649

  • 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 Upadacitinib in people with Rheumatoid Arthritis, run by AbbVie at 167 sites in 38 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 5 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 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in United States, South Korea, Russia, Taiwan, United Kingdom and 33 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 12 (time frame: Baseline and Week 12). 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 NCT02675426, 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 11 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in