AzTrials
AzTrials

Rheumatoid ArthritisPhase 3SELECT-BEYONDNCT02706847

A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs

A Phase 3 study testing Upadacitinib in people with Rheumatoid Arthritis, run by AbbVie at 188 sites in 27 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 study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an… 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?
Upadacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
499 participants
Where
188 sitesin 27 countries
Study dates
15 Mar 2016to 8 Feb 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 rheumatoid arthritis (RA) for≥ 3 months.
  • Treated for ≥ 3 months with ≥ 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration prior to the first dose of study drug.
  • Participant has been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide.
  • Meets both of the following criteria:
  • ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
  • hsCRP ≥ 3mg/L at Screening Visit.

Who cannot join

  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
  • History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms]). Current diagnosis of secondary Sjogren's Syndrome is permitted.

Trial locations and contacts

188 sites in 27 countries.

188 sites in 27 countries

United States103 sites

  • The Center for Rheumatology /ID# 142784

    Albany, New York, 12206

  • Tekton Research, Inc. /ID# 142805

    Austin, Texas, 78745

  • Diagnostic Group Integrated He /ID# 148340

    Beaumont, Texas, 77701

  • East Penn Rheumatology Assoc /ID# 142790

    Bethlehem, Pennsylvania, 18015

  • St. Luke's Clinic - Rheumatolo /ID# 150923

    Boise, Idaho, 83702

  • Western Washington Arthritis C /ID# 142776

    Bothell, Washington, 98021

  • New England Research Associates, LLC /ID# 142763

    Bridgeport, Connecticut, 06606-1827

  • Joint & Muscle Research Instit /ID# 142797

    Charlotte, North Carolina, 28204

  • DJL Clinical Research, PLLC /ID# 142769

    Charlotte, North Carolina, 28210-8508

  • Great Lakes Clinical Trials /ID# 148341

    Chicago, Illinois, 60640

  • Cincinnati Rheumatic Disease Study Group, Inc. /ID# 142791

    Cincinnati, Ohio, 45242-4468

  • Arth and Osteo Clin Brazo Valley /ID# 148343

    College Station, Texas, 77845

  • Arthritis Assoc & Osteo Ctr /ID# 142809

    Colorado Springs, Colorado, 80920

  • Columbia Arthritis Center /ID# 153728

    Columbia, South Carolina, 29204

  • Covina Arthritis Clinic /ID# 142794

    Covina, California, 91722

  • Arthritis Care and Diagnostic /ID# 151344

    Dallas, Texas, 75231

  • Metroplex Clinical Research /ID# 142758

    Dallas, Texas, 75231

  • Jefrey D. Lieberman, MD, P.C. /ID# 151713

    Decatur, Georgia, 30033

  • Denver Arthritis Clinic /ID# 142771

    Denver, Colorado, 80230

  • Rheumatology Ctr of San Diego /ID# 153576

    Escondido, California, 92025

  • Aurora Rheumatology and Immunotherapy Center /ID# 142820

    Franklin, Wisconsin, 53132

  • St. Joseph Heritage Healthcare /ID# 149273

    Fullerton, California, 92835

  • Rheumatic Disease Clin Res Ctr /ID# 150914

    Houston, Texas, 77004

  • Baylor College of Medicine /ID# 142753

    Houston, Texas, 77030-3411

  • Rheumatology Clinic of Houston /ID# 150915

    Houston, Texas, 77065

  • Houston Institute for Clin Res /ID# 142768

    Houston, Texas, 77074

  • Pioneer Research Solutions, Inc. /ID# 151346

    Houston, Texas, 77098-5294

  • Rheum Assoc of North Alabama /ID# 145959

    Huntsville, Alabama, 35801

  • Institute of Arthritis Res /ID# 142810

    Idaho Falls, Idaho, 83404

  • West Tennessee Research Inst /ID# 142739

    Jackson, Tennessee, 38305

  • NEA Baptist Clinic /ID# 149280

    Jonesboro, Arkansas, 72401

  • Arthritis Associates, PLLC /ID# 142774

    Kingsport, Tennessee, 37660

  • Arthritis Associates, PLLC /ID# 155462

    Kingsport, Tennessee, 37660

  • TriWest Research Associates- La Mesa /ID# 142792

    La Mesa, California, 91942

  • Arthritis & Osteo Medical Ctr /ID# 142770

    La Palma, California, 90623-1728

  • June DO, PC /ID# 142756

    Lansing, Michigan, 48910

  • Dartmouth-Hitchcock Medical Center /ID# 145958

    Lebanon, New Hampshire, 03756

  • Cape Fear Arthritis Care /ID# 148344

    Leland, North Carolina, 28451

  • Delaware Arthritis /ID# 142803

    Lewes, Delaware, 19958

  • Valerius Med Grp & Res Ctr /ID# 142799

    Los Alamitos, California, 90720-5402

  • Pacific Arthritis Ctr Med Grp /ID# 142783

    Los Angeles, California, 90045

  • University of California, Los Angeles /ID# 148348

    Los Angeles, California, 90095

  • Arthritis & Osteoporosis Assoc /ID# 147567

    Lubbock, Texas, 79424

  • P&I Clinical Research /ID# 151345

    Lufkin, Texas, 75904-3132

  • Mansfield Health Center /ID# 147628

    Mansfield, Massachusetts, 02048

  • Marietta Rheumatology Assoc /ID# 151347

    Marietta, Georgia, 30060

  • Dr. Ramesh Gupta /ID# 142767

    Memphis, Tennessee, 38119

  • Advanced Clinical Research /ID# 153089

    Meridian, Idaho, 83642

  • AZ Arthritis and Rheum Assoc /ID# 148593

    Mesa, Arizona, 85202

  • SW Rheumatology Res. LLC /ID# 142813

    Mesquite, Texas, 75150

  • Lakes Research, LLC /ID# 142755

    Miami, Florida, 33014

  • Trinity Health Med Arts Clinic /ID# 142754

    Minot, North Dakota, 58701

  • The Arthritis & Diabetes Clinic, Inc. /ID# 142793

    Monroe, Louisiana, 71203

  • Medallion Clinical Research Institute, LLC /ID# 142740

    Naples, Florida, 34102

  • Coastal Carolina Health Care /ID# 148351

    New Bern, North Carolina, 28562

  • North Shore University Hospital /ID# 142772

    New Hyde Park, New York, 11040

  • Health Research Oklahoma /ID# 142751

    Oklahoma City, Oklahoma, 73103-2400

  • Westroads Clinical Research /ID# 142802

    Omaha, Nebraska, 68114

  • Buffalo Rheumatology /ID# 142766

    Orchard Park, New York, 14127

  • Omega Research Consultants /ID# 142780

    Orlando, Florida, 32810

  • Millennium Research /ID# 142782

    Ormond Beach, Florida, 32174

  • Desert Medical Advances /ID# 142765

    Palm Desert, California, 92260

  • Arthritis Research of Florida /ID# 142811

    Palm Harbor, Florida, 34684-2672

  • Arthritis Center, Inc. /ID# 142822

    Palm Harbor, Florida, 34684

  • AZ Arthritis and Rheum Researc /ID# 142816

    Phoenix, Arizona, 85032-9306

  • AZ Arthritis and Rheum Researc /ID# 146075

    Phoenix, Arizona, 85032-9306

  • AZ Arthritis and Rheum Researc /ID# 148592

    Phoenix, Arizona, 85032-9306

  • Arizona Research Center, Inc. /ID# 142741

    Phoenix, Arizona, 85053-4061

  • Advent Clinical Research /ID# 142817

    Pinellas Park, Florida, 33781

  • Trinity Universal Research Association /ID# 149278

    Plano, Texas, 75024-5283

  • MMP Women's Health /ID# 145612

    Portland, Maine, 04102

  • AZ Arthr & Rheum Research /ID# 155256

    Prescott, Arizona, 86305

  • Shanahan Rheuma & Immuno /ID# 142812

    Raleigh, North Carolina, 27617

  • Arthritis & Osteo Ctr of S. TX /ID# 142773

    San Antonio, Texas, 78232

  • Arthritis Clinic of Central TX /ID# 148346

    San Marcos, Texas, 78666

  • Vanguard Medical Research, LLC /ID# 153123

    Shreveport, Louisiana, 71011

  • Clinical Investigation Special /ID# 149270

    Skokie, Illinois, 60076

  • West Virginia Research Inst /ID# 153087

    South Charleston, West Virginia, 25309

  • Arthritis Northwest, PLLC /ID# 150924

    Spokane, Washington, 99204

  • Springfield Clinic /ID# 142818

    Springfield, Illinois, 62702-3749

  • Clayton Medical Associates dba Saint Louis Rheumatology /ID# 142745

    St Louis, Missouri, 63119-3845

  • Barbara Caciolo, MD /ID# 142749

    St Louis, Missouri, 63139-2338

  • St. Anthony Comprehsve Res Ins /ID# 148349

    St. Petersburg, Florida, 33705

  • Stanford University School of Med /ID# 142761

    Stanford, California, 94305-2200

  • AZ Arthritis & Rheum Research /ID# 156090

    Sun City, Arizona, 85351

  • University of South Florida /ID# 145611

    Tampa, Florida, 33612

  • BayCare Medical Group, Inc. /ID# 142747

    Tampa, Florida, 33614-7101

  • DM Clinical Research /ID# 151007

    Tomball, Texas, 77375

  • Atlantic Coast Research /ID# 148347

    Toms River, New Jersey, 08755

  • Ocean Rheumatology, PA /ID# 142785

    Toms River, New Jersey, 08755

  • Healthcare Research Consultant /ID# 142815

    Tulsa, Oklahoma, 74135

  • North Mississippi Med Clinics /ID# 142781

    Tupelo, Mississippi, 38801

  • Robin K. Dore MD, Inc /ID# 150908

    Tustin, California, 92780

  • Inland Rheum Clin Trials Inc. /ID# 142787

    Upland, California, 91786

  • The Vancouver Clinic, INC. PS /ID# 147946

    Vancouver, Washington, 98664

  • STAT Research, Inc. /ID# 142821

    Vandalia, Ohio, 45377-9464

  • Lovelace Scientific Resources /ID# 142779

    Venice, Florida, 34292

  • Deerbrook Medical Associates /ID# 151712

    Vernon Hills, Illinois, 60061

  • Arthritis & Osteoporosis Clinic /ID# 142760

    Waco, Texas, 76710

  • The Center for Rheumatology & /ID# 142742

    Wheaton, Maryland, 20902

  • Medvin Clinical Research /ID# 142814

    Whittier, California, 90606

  • Clinical Pharmacology Study Gr /ID# 142744

    Worcester, Massachusetts, 01605

  • Clinical Research Ctr Reading /ID# 151714

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Germany9 sites

  • Charité Universitätsmedizin Campus Mitte /ID# 142559

    Berlin, 10117

  • Uniklinik Koln /ID# 142563

    Cologne, North Rhine-Westphalia, 50937

  • Rheumaforschungszentrum II /ID# 142560

    Hamburg, 20095

  • Schoen Klinikum Hamburg Eilbek /ID# 142566

    Hamburg, 22081

  • Asklepios Klinik Altona /ID# 142561

    Hamburg, 22763

  • Rheumazentrum Ruhrgebiet /ID# 145600

    Herne, North Rhine-Westphalia, 44649

  • LMU Klinikum der Universität München /ID# 142564

    Munich, 80337

  • MVZ Planegg /ID# 142565

    Planegg, 82152

  • Knappschaftsklinikum Saar /ID# 142562

    Püttlingen, 66346

Other trials in Germany

France7 sites

  • CHU Bordeaux-Hopital Pellegrin /ID# 144700

    Bordeaux, 33076

  • Centre Hospitalier Jean Rougie /ID# 142556

    Cahors, 46005

  • Centre Hospitalier Le Mans /ID# 145956

    Le Mans, Sarthe, 72037

  • Hopital Edouard Herriot /ID# 144698

    Lyon, 69437

  • Hopital Saint Eloi /ID# 142552

    Montpellier, Herault, 34295

  • CHR Orleans - Hopital de la Source /ID# 142557

    Orléans, Centre-Val de Loire, 45067

  • Hopital Universitaire Purpan /ID# 144697

    Toulouse, Haute-Garonne, 31059

Other trials in France

United Kingdom7 sites

  • Mid Essex Hospitals NHS Trust /ID# 148992

    Chelmsford, CM1 7ET

  • Western General Hospital /ID# 142732

    Edinburgh, EH4 2XU

  • West Suffolk Hospital /ID# 148993

    Ipswich, IP33 2QZ

  • Whipps Cross Univ Hospital /ID# 145957

    London, London, City of, E11 1NR

  • The Royal Free Hospital /ID# 142733

    London, London, City of, NW3 2QG

  • Arrowe Park Hospital /ID# 148991

    Metropolitan Borough of Wirral, CH49 5PE

  • Queen Alexandra Hospital /ID# 142735

    Portsmouth, PO6 3LY

Other trials in United Kingdom

Spain6 sites

  • Comple Hosp Univ de A Coruna /ID# 142708

    A Coruña, 15006

  • Hospital Clin Univ San Carlos /ID# 142711

    Madrid, 28040

  • Hospital Regional de Malaga /ID# 142707

    Málaga, Malaga, 29009

  • H. Un. Marques de Valdecilla /ID# 142706

    Santander, Cantabria, 39008

  • Clinica Gaias /ID# 142709

    Santiago de Compostela, 15702

  • Hospital Universitario La Fe /ID# 142716

    Valencia, 46026

Other trials in Spain

Austria5 sites

  • Universitaetsklinik fuer Inner /ID# 142423

    Graz, 8036

  • Medizinische Universität Wien /ID# 142424

    Vienna, State of Vienna, 1090

  • Rheuma Zentrum Favoriten GmbH /ID# 142421

    Vienna, 1100

  • Rheuma-Zentrum Wien-Oberlaa /ID# 142425

    Vienna, 1100

  • Wilhelminenspital der Stadt Wien /ID# 142422

    Vienna, 1160

Other trials in Austria

Belgium5 sites

  • Rhumaconsult SPRL /ID# 151378

    Charleroi, Hainaut, 6000

  • ReumaClinic Genk /ID# 142431

    Genk, 3600

  • UZ Gent /ID# 142429

    Ghent, Oost-Vlaanderen, 9000

  • AZ Damiaan /ID# 142427

    Ostend, 8400

  • Cliniques Universitaires Saint Luc /ID# 142426

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Poland5 sites

  • Centrum Medyczne Pratia Gdynia /ID# 142666

    Gdynia, Pomeranian Voivodeship, 81-338

  • Pratia MCM Krakow /ID# 142664

    Krakow, Lesser Poland Voivodeship, 30-510

  • Centrum Medyczne Pratia Warszawa /ID# 142667

    Warsaw, Masovian Voivodeship, 01-869

  • Centrum Medyczne AMED Warszawa Targowek /ID# 142663

    Warsaw, Masovian Voivodeship, 03-291

  • WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 142665

    Wroclaw, Lower Silesian Voivodeship, 51-685

Other trials in Poland

Hungary4 sites

  • Revita Reumatologiai Rendelo /ID# 142590

    Budapest, 1027

  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142587

    Debrecen, 4031

  • Bekes Megyei Pandy Kalman Korh /ID# 142588

    Gyula, 5700

  • Vital Medical Center Orvosi es /ID# 142586

    Veszprém, Veszprém megye, 8200

Other trials in Hungary

Sweden4 sites

  • Sahlgrenska University Hosp /ID# 142720

    Gothenburg, 413 45

  • Capio Movement Halmstad /ID# 148236

    Halmstad, 302 33

  • Orebro Universitetssjukhuset /ID# 142718

    Örebro, 70185

  • Vastmanlands Sjukhus /ID# 142721

    Västerås, 72189

Other trials in Sweden

Israel3 sites

  • Bnai Zion Medical Center /ID# 151945

    Haifa, 3339419

  • The Lady Davis Carmel MC /ID# 142599

    Haifa, 3436212

  • Tel Aviv Sourasky Medical Ctr /ID# 142597

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Latvia3 sites

  • LTD M+M Centers /ID# 142624

    Adazi, 2164

  • P. Stradins Clinical Univ Hosp /ID# 142623

    Riga, LV-1002

  • Arthritis Clinic Ltd /ID# 153560

    Riga, LV-1050

Other trials in Latvia

Slovakia3 sites

  • ARTROMAC n.o. /ID# 142692

    Košice, 040 11

  • Nemocnica Kosice Saca, a.s. /ID# 142693

    Košice, 040 15

  • Narodny ustav reumatickych chorob Piestany /ID# 142691

    Pieštany, 921 12

Other trials in Slovakia

South Korea3 sites

  • Inha University Hospital /ID# 150881

    Incheon, 22332

  • Hanyang University Seoul Hospi /ID# 150883

    Seoul, Seongdong-gu, 04763

  • Seoul National University Hospital /ID# 142622

    Seoul, 03080

Other trials in South Korea

Turkey (Türkiye)3 sites

  • Hacettepe University Medical Faculty /ID# 142729

    Ankara, 06100

  • Ankara Ataturk Training & Res /ID# 142727

    Ankara, 06800

  • Ondokuz mayis University Facul /ID# 142728

    Samsun, 55139

Other trials in Turkey (Türkiye)

Australia2 sites

  • Emeritus Research /ID# 142416

    Camberwell, Victoria, 3124

  • The Queen Elizabeth Hospital /ID# 142419

    Woodville, South Australia, 5011

Other trials in Australia

Czechia2 sites

  • Revmatologie MUDr. Klara Sirova /ID# 142536

    Ostrava, 702 00

  • Medical Plus, s.r.o. /ID# 148345

    Uherské Hradište, 686 01

Other trials in Czechia

Estonia2 sites

  • East Tallinn Central Hospital /ID# 142543

    Tallinn, 10138

  • MediTrials /ID# 151777

    Tartu, Tartu, 50406

Other trials in Estonia

Finland2 sites

  • Kiljava Medical Research /ID# 142546

    Hyvinkää, 05800

  • Paijat-Hame Central Hospital /ID# 149185

    Lahti, 15850

Other trials in Finland

Portugal2 sites

  • Centro Hospitalar Lisboa Norte, EPE /ID# 142668

    Lisbon, 1649-035

  • Centro Hospitalar De Vila Nova /ID# 142670

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

Switzerland2 sites

  • Universitaetsspital Basel /ID# 145610

    Basel, 4031

  • HFR Fribourg - Hopital Canton /ID# 142723

    Fribourg, 1708

Other trials in Switzerland

Canada1 site

  • Ciads /Id# 142526

    Winnipeg, Manitoba, R3N 0K6

Other trials in Canada

Greece1 site

  • General Hospital of Athens Laiko /ID# 142579

    Athens, Attica, 115 27

Other trials in Greece

Ireland1 site

  • St Vincent's University Hosp /ID# 142593

    Dublin, D04 T6F4

Other trials in Ireland

New Zealand1 site

  • Timaru Medical Specialists Ltd /ID# 142657

    Timaru, 7910

Other trials in New Zealand

Puerto Rico1 site

  • GCM Medical Group /ID# 142671

    San Juan, 00909

Other trials in Puerto Rico

Russia1 site

  • Family Outpatient clinic#4,LLC /ID# 150910

    Korolev, Moscow, 141060

Other trials in Russia

About this study

Official title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.

The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.

Read the detailed description

This study includes a 35-day screening period; a 24-week randomized, double-blind, parallel-group, placebo controlled treatment period (Period 1); a 236-week blinded long-term extension period (Period 2); and a 30-day follow-up period (call or visit).

Period 1 consists of a 12-week double-blind, placebo-controlled treatment phase plus a 12-week double-blind phase where all participants were to receive upadacitinib; at Week 12 participants assigned to placebo will be switched to upadacitinib according to their randomization assignment.

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

  • Group 1: Upadacitinib 30 mg QD (Day 1 to Week 12) → upadacitinib 30 mg QD (Week 12 and thereafter)
  • Group 2: Upadacitinib 15 mg QD (Day 1 to Week 12) → upadacitinib 15 mg QD (Week 12 and thereafter)
  • Group 3: Placebo (Day 1 to Week 12) → upadacitinib 30 mg QD (Week 12 and thereafter)
  • Group 4: Placebo (Day 1 to Week 12) → upadacitinib 15 mg QD (Week 12 and thereafter)

Participants will continue stable dose of csDMARD therapy for the first 24 weeks of the study.

Participants who complete the Week 24 visit (end of Period 1) will enter the blinded long-term extension portion of the study, Period 2 and continue to receive the same dose of upadacitinib per original randomization assignment in a blinded manner. Starting at Week 24, at least 20% improvement in both swollen joint count (SJC) and tender joint count (TJC) compared to Baseline is required to remain on study drug. Starting at Week 24, initiation of or change in corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or adding or increasing doses in up to 2 csDMARDs (concomitant use of up to 2 csDMARDs except the combination of methotrexate and leflunomide) is allowed as per local label.

With the implementation of Protocol Amendment 4, all participants in the extension period will receive open-label upadacitinib 15 mg QD, including those currently on upadacitinib 30 mg QD.

Being tested
Placebo, Upadacitinib
Keywords
Musculoskeletal Disease, Arthritis, Joint Disease, Anti-inflammatory agents, Antirheumatic agents, ABT-494, upadacitinib
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 NCT02706847
Study groupRoleWhat they receive
Upadacitinib 15 mgExperimentalPeriod 1: Participants receive upadacitinib 15 mg once daily for 24 weeks. Period 2: Participants will continue on upadacitinib 15 mg once daily from Week 24 to Week 260.
Receives: Drug: Upadacitinib
Upadacitinib 30 mgExperimentalPeriod 1: Participants receive upadacitinib 30 mg once daily for 24 weeks. Period 2: Participants continue on upadacitinib 30 mg once daily until implementation of Protocol Amendment 4, then participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Receives: Drug: Upadacitinib
Placebo / Upadacitnib 15 mgPlacebo comparatorPeriod 1: Participants receive placebo once daily for 12 weeks followed by upadacitinib 15 mg once daily for 12 weeks. Period 2: Participants will continue on upadacitinib 15 mg once daily from Week 24 to Week 260.
Receives: Drug: Placebo; Drug: Upadacitinib
Placebo / Upadacitnib 30 mgPlacebo comparatorPeriod 1: Participants receive placebo once daily for 12 weeks followed by upadacitinib 30 mg once daily for 12 weeks. Period 2: Participants continue on upadacitinib 30 mg once daily until implementation of Protocol Amendment 4, then participants begin to receive upadacitinib 15 mg once daily up to Week 260.
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 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 12

Secondary outcomes (6)

  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 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 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 Score (PCS) 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 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 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

  5. 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

  6. 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 posted11 Mar 2016 (estimated)
  2. Study start15 Mar 2016
  3. Primary completion3 Apr 2017
  4. Study completion8 Feb 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
499 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02706847
Sponsor's protocol ID
M13-542
Other IDs
2015-003335-35, 2015
Acronym
SELECT-BEYOND
Status last verified
Jan 2023
First submitted
18 Feb 2016
Last updated
8 Feb 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 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

  • Genovese MC, Fleischmann R, Combe B, Hall S, Rubbert-Roth A, Zhang Y, Zhou Y, Mohamed MF, Meerwein S, Pangan AL. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140-6736(18)31116-4. Epub 2018 Jun 18.

    PubMed 29908670

  • 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

  • van Vollenhoven RF, Hall S, Wells AF, Meerwein S, Song Y, Tanjinatus O, Fleischmann R. Long-term sustainability of response to upadacitinib among patients with active rheumatoid arthritis refractory to biological treatments: results up to 5 years from SELECT-BEYOND. RMD Open. 2024 Jul 24;10(3):e004037. doi: 10.1136/rmdopen-2023-004037.

    PubMed 39053948

  • 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

  • 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, Schiff M, Tundia N, Friedman A, Meerwein S, Pangan A, Ganguli A, Fuldeore M, Song Y, Pope J. Effects of upadacitinib on patient-reported outcomes: results from SELECT-BEYOND, a phase 3 randomized trial in patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs. Arthritis Res Ther. 2019 Dec 2;21(1):263. doi: 10.1186/s13075-019-2059-8.

    PubMed 31791386

  • 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 188 sites in 27 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 6 inclusion and 2 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 188 sites in United States, Germany, France, United Kingdom, Spain and 22 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. Some participants in this study may receive a placebo. 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 NCT02706847, which also lists 14 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 8 Feb 2023.

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