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 (SELECT-BEYOND)

January 12, 2023 updated by: AbbVie

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

499

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital /ID# 142419
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research /ID# 142416
  • Austria
      • Graz, Austria, 8036
        • Universitaetsklinik fuer Inner /ID# 142423
      • Vienna, Austria, 1100
        • Rheuma Zentrum Favoriten GmbH /ID# 142421
      • Wien, Austria, 1100
        • Rheuma-Zentrum Wien-Oberlaa /ID# 142425
      • Wien, Austria, 1160
        • Wilhelminenspital der Stadt Wien /ID# 142422
    • Wien
      • Vienna, Wien, Austria, 1090
        • Medizinische Universität Wien /ID# 142424
  • Belgium
      • Genk, Belgium, 3600
        • ReumaClinic Genk /ID# 142431
      • Oostende, Belgium, 8400
        • AZ Damiaan /ID# 142427
    • Bruxelles-Capitale
      • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
        • Cliniques Universitaires Saint Luc /ID# 142426
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6000
        • Rhumaconsult SPRL /ID# 151378
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 142429
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3N 0K6
        • Ciads /Id# 142526
  • Czechia
      • Ostrava, Czechia, 702 00
        • Revmatologie MUDr. Klara Sirova /ID# 142536
      • Uherské Hradište, Czechia, 686 01
        • Medical Plus, s.r.o. /ID# 148345
  • Estonia
      • Tallinn, Estonia, 10138
        • East Tallinn Central Hospital /ID# 142543
    • Tartumaa
      • Tartu, Tartumaa, Estonia, 50406
        • MediTrials /ID# 151777
  • Finland
      • Hyvinkaa, Finland, 05800
        • Kiljava Medical Research /ID# 142546
      • Lahti, Finland, 15850
        • Paijat-Hame Central Hospital /ID# 149185
  • France
      • Bordeaux, France, 33076
        • CHU Bordeaux-Hopital Pellegrin /ID# 144700
      • Cahors, France, 46005
        • Centre Hospitalier Jean Rougie /ID# 142556
      • Lyon, France, 69437
        • Hopital Edouard Herriot /ID# 144698
    • Centre-Val De Loire
      • Orleans CEDEX 2, Centre-Val De Loire, France, 45067
        • CHR Orleans - Hopital de la Source /ID# 142557
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Hopital Universitaire Purpan /ID# 144697
    • Herault
      • Montpellier CEDEX 5, Herault, France, 34295
        • Hopital Saint Eloi /ID# 142552
    • Sarthe
      • Le Mans CEDEX 9, Sarthe, France, 72037
        • Centre Hospitalier Le Mans /ID# 145956
  • Germany
      • Berlin, Germany, 10117
        • Charité Universitätsmedizin Campus Mitte /ID# 142559
      • Hamburg, Germany, 20095
        • Rheumaforschungszentrum II /ID# 142560
      • Hamburg, Germany, 22081
        • Schoen Klinikum Hamburg Eilbek /ID# 142566
      • Hamburg, Germany, 22763
        • Asklepios Klinik Altona /ID# 142561
      • Munich, Germany, 80337
        • LMU Klinikum der Universität München /ID# 142564
      • Planegg, Germany, 82152
        • MVZ Planegg /ID# 142565
      • Püttlingen, Germany, 66346
        • Knappschaftsklinikum Saar /ID# 142562
    • Nordrhein-Westfalen
      • Herne, Nordrhein-Westfalen, Germany, 44649
        • Rheumazentrum Ruhrgebiet /ID# 145600
      • Köln, Nordrhein-Westfalen, Germany, 50937
        • Uniklinik Koln /ID# 142563
  • Greece
    • Attiki
      • Athens, Attiki, Greece, 115 27
        • General Hospital of Athens Laiko /ID# 142579
  • Hungary
      • Budapest, Hungary, 1027
        • Revita Reumatologiai Rendelo /ID# 142590
      • Debrecen, Hungary, 4031
        • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142587
      • Gyula, Hungary, 5700
        • Bekes Megyei Pandy Kalman Korh /ID# 142588
    • Veszprem
      • Veszprém, Veszprem, Hungary, 8200
        • Vital Medical Center Orvosi es /ID# 142586
  • Ireland
      • Dublin, Ireland, D04 T6F4
        • St Vincent's University Hosp /ID# 142593
  • Israel
      • Haifa, Israel, 3339419
        • Bnai Zion Medical Center /ID# 151945
      • Haifa, Israel, 3436212
        • The Lady Davis Carmel MC /ID# 142599
    • Tel-Aviv
      • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Ctr /ID# 142597
  • Korea, Republic of
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital /ID# 150881
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital /ID# 142622
    • Seongdong-gu
      • Seoul, Seongdong-gu, Korea, Republic of, 04763
        • Hanyang University Seoul Hospi /ID# 150883
  • Latvia
      • Adazi, Latvia, 2164
        • LTD M+M Centers /ID# 142624
      • Riga, Latvia, LV-1002
        • P. Stradins Clinical Univ Hosp /ID# 142623
      • Riga, Latvia, LV-1050
        • Arthritis Clinic Ltd /ID# 153560
  • New Zealand
      • Timaru, New Zealand, 7910
        • Timaru Medical Specialists Ltd /ID# 142657
  • Poland
    • Dolnoslaskie
      • Wrocław, Dolnoslaskie, Poland, 51-685
        • WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 142665
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-510
        • Pratia MCM Krakow /ID# 142664
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 01-869
        • Centrum Medyczne Pratia Warszawa /ID# 142667
      • Warszawa, Mazowieckie, Poland, 03-291
        • Centrum Medyczne AMED Warszawa Targowek /ID# 142663
    • Pomorskie
      • Gdynia, Pomorskie, Poland, 81-338
        • Centrum Medyczne Pratia Gdynia /ID# 142666
  • Portugal
      • Lisboa, Portugal, 1649-035
        • Centro Hospitalar Lisboa Norte, EPE /ID# 142668
    • Porto
      • Vila Nova De Gaia, Porto, Portugal, 4434-502
        • Centro Hospitalar De Vila Nova /ID# 142670
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • GCM Medical Group /ID# 142671
  • Russian Federation
    • Moskva
      • Korolev, Moskva, Russian Federation, 141060
        • Family Outpatient clinic#4,LLC /ID# 150910
  • Slovakia
      • Kosice, Slovakia, 040 11
        • ARTROMAC n.o. /ID# 142692
      • Kosice, Slovakia, 040 15
        • Nemocnica Kosice Saca, a.s. /ID# 142693
      • Pieštany, Slovakia, 921 12
        • Narodny ustav reumatickych chorob Piestany /ID# 142691
  • Spain
      • A Coruna, Spain, 15006
        • Comple Hosp Univ de A Coruna /ID# 142708
      • Madrid, Spain, 28040
        • Hospital Clin Univ San Carlos /ID# 142711
      • Santiago de Compostela, Spain, 15702
        • Clinica Gaias /ID# 142709
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe /ID# 142716
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • H. Un. Marques de Valdecilla /ID# 142706
    • Malaga
      • Málaga, Malaga, Spain, 29009
        • Hospital Regional de Malaga /ID# 142707
  • Sweden
      • Goteborg, Sweden, 413 45
        • Sahlgrenska University Hosp /ID# 142720
      • Halmstad, Sweden, 302 33
        • Capio Movement Halmstad /ID# 148236
      • Orebro, Sweden, 70185
        • Orebro Universitetssjukhuset /ID# 142718
      • Vasteras, Sweden, 72189
        • Vastmanlands Sjukhus /ID# 142721
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitaetsspital Basel /ID# 145610
      • Fribourg, Switzerland, 1708
        • HFR Fribourg - Hopital Canton /ID# 142723
  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University Medical Faculty /ID# 142729
      • Ankara, Turkey, 06800
        • Ankara Ataturk Training & Res /ID# 142727
      • Samsun, Turkey, 55139
        • Ondokuz mayis University Facul /ID# 142728
  • United Kingdom
      • Chelmsford, United Kingdom, CM1 7ET
        • Mid Essex Hospitals NHS Trust /ID# 148992
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital /ID# 142732
      • Ipswich, United Kingdom, IP33 2QZ
        • West Suffolk Hospital /ID# 148993
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital /ID# 142735
      • Wirral, United Kingdom, CH49 5PE
        • Arrowe Park Hospital /ID# 148991
    • London, City Of
      • London, London, City Of, United Kingdom, E11 1NR
        • Whipps Cross Univ Hospital /ID# 145957
      • London, London, City Of, United Kingdom, NW3 2QG
        • The Royal Free Hospital /ID# 142733
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Rheum Assoc of North Alabama /ID# 145959
    • Arizona
      • Mesa, Arizona, United States, 85202
        • AZ Arthritis and Rheum Assoc /ID# 148593
      • Phoenix, Arizona, United States, 85032-9306
        • AZ Arthritis and Rheum Researc /ID# 142816
      • Phoenix, Arizona, United States, 85032-9306
        • AZ Arthritis and Rheum Researc /ID# 146075
      • Phoenix, Arizona, United States, 85032-9306
        • AZ Arthritis and Rheum Researc /ID# 148592
      • Phoenix, Arizona, United States, 85053-4061
        • Arizona Research Center, Inc. /ID# 142741
      • Prescott, Arizona, United States, 86305
        • AZ Arthr & Rheum Research /ID# 155256
      • Sun City, Arizona, United States, 85351
        • AZ Arthritis & Rheum Research /ID# 156090
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Clinic /ID# 149280
    • California
      • Covina, California, United States, 91722
        • Covina Arthritis Clinic /ID# 142794
      • Escondido, California, United States, 92025
        • Rheumatology Ctr of San Diego /ID# 153576
      • Fullerton, California, United States, 92835
        • St. Joseph Heritage Healthcare /ID# 149273
      • La Mesa, California, United States, 91942
        • TriWest Research Associates- La Mesa /ID# 142792
      • La Palma, California, United States, 90623-1728
        • Arthritis & Osteo Medical Ctr /ID# 142770
      • Los Alamitos, California, United States, 90720-5402
        • Valerius Med Grp & Res Ctr /ID# 142799
      • Los Angeles, California, United States, 90045
        • Pacific Arthritis Ctr Med Grp /ID# 142783
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles /ID# 148348
      • Palm Desert, California, United States, 92260
        • Desert Medical Advances /ID# 142765
      • Stanford, California, United States, 94305-2200
        • Stanford University School of Med /ID# 142761
      • Tustin, California, United States, 92780
        • Robin K. Dore MD, Inc /ID# 150908
      • Upland, California, United States, 91786
        • Inland Rheum Clin Trials Inc. /ID# 142787
      • Whittier, California, United States, 90606
        • Medvin Clinical Research /ID# 142814
    • Colorado
      • Colorado Springs, Colorado, United States, 80920
        • Arthritis Assoc & Osteo Ctr /ID# 142809
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic /ID# 142771
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606-1827
        • New England Research Associates, LLC /ID# 142763
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Delaware Arthritis /ID# 142803
    • Florida
      • Miami, Florida, United States, 33014
        • Lakes Research, LLC /ID# 142755
      • Naples, Florida, United States, 34102
        • Medallion Clinical Research Institute, LLC /ID# 142740
      • Orlando, Florida, United States, 32810
        • Omega Research Consultants /ID# 142780
      • Ormond Beach, Florida, United States, 32174
        • Millennium Research /ID# 142782
      • Palm Harbor, Florida, United States, 34684-2672
        • Arthritis Research of Florida /ID# 142811
      • Palm Harbor, Florida, United States, 34684
        • Arthritis Center, Inc. /ID# 142822
      • Pinellas Park, Florida, United States, 33781
        • Advent Clinical Research /ID# 142817
      • Saint Petersburg, Florida, United States, 33705
        • St. Anthony Comprehsve Res Ins /ID# 148349
      • Tampa, Florida, United States, 33612
        • University of South Florida /ID# 145611
      • Tampa, Florida, United States, 33614-7101
        • BayCare Medical Group, Inc. /ID# 142747
      • Venice, Florida, United States, 34292
        • Lovelace Scientific Resources /ID# 142779
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Jefrey D. Lieberman, MD, P.C. /ID# 151713
      • Marietta, Georgia, United States, 30060
        • Marietta Rheumatology Assoc /ID# 151347
    • Idaho
      • Boise, Idaho, United States, 83702
        • St. Luke's Clinic - Rheumatolo /ID# 150923
      • Idaho Falls, Idaho, United States, 83404
        • Institute of Arthritis Res /ID# 142810
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research /ID# 153089
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials /ID# 148341
      • Skokie, Illinois, United States, 60076
        • Clinical Investigation Special /ID# 149270
      • Springfield, Illinois, United States, 62702-3749
        • Springfield Clinic /ID# 142818
      • Vernon Hills, Illinois, United States, 60061
        • Deerbrook Medical Associates /ID# 151712
    • Louisiana
      • Monroe, Louisiana, United States, 71203
        • The Arthritis & Diabetes Clinic, Inc. /ID# 142793
      • Shreveport, Louisiana, United States, 71011
        • Vanguard Medical Research, LLC /ID# 153123
    • Maine
      • Portland, Maine, United States, 04102
        • MMP Women's Health /ID# 145612
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • The Center for Rheumatology & /ID# 142742
    • Massachusetts
      • Mansfield, Massachusetts, United States, 02048
        • Mansfield Health Center /ID# 147628
      • Worcester, Massachusetts, United States, 01605
        • Clinical Pharmacology Study Gr /ID# 142744
    • Michigan
      • Lansing, Michigan, United States, 48910
        • June DO, PC /ID# 142756
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Med Clinics /ID# 142781
    • Missouri
      • Saint Louis, Missouri, United States, 63119-3845
        • Clayton Medical Associates dba Saint Louis Rheumatology /ID# 142745
      • Saint Louis, Missouri, United States, 63139-2338
        • Barbara Caciolo, MD /ID# 142749
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Westroads Clinical Research /ID# 142802
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center /ID# 145958
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Atlantic Coast Research /ID# 148347
      • Toms River, New Jersey, United States, 08755
        • Ocean Rheumatology, PA /ID# 142785
    • New York
      • Albany, New York, United States, 12206
        • The Center for Rheumatology /ID# 142784
      • New Hyde Park, New York, United States, 11040
        • North Shore University Hospital /ID# 142772
      • Orchard Park, New York, United States, 14127
        • Buffalo Rheumatology /ID# 142766
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Joint & Muscle Research Instit /ID# 142797
      • Charlotte, North Carolina, United States, 28210-8508
        • DJL Clinical Research, PLLC /ID# 142769
      • Leland, North Carolina, United States, 28451
        • Cape Fear Arthritis Care /ID# 148344
      • New Bern, North Carolina, United States, 28562
        • Coastal Carolina Health Care /ID# 148351
      • Raleigh, North Carolina, United States, 27617
        • Shanahan Rheuma & Immuno /ID# 142812
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Trinity Health Med Arts Clinic /ID# 142754
    • Ohio
      • Cincinnati, Ohio, United States, 45242-4468
        • Cincinnati Rheumatic Disease Study Group, Inc. /ID# 142791
      • Vandalia, Ohio, United States, 45377-9464
        • STAT Research, Inc. /ID# 142821
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103-2400
        • Health Research Oklahoma /ID# 142751
      • Tulsa, Oklahoma, United States, 74135
        • Healthcare Research Consultant /ID# 142815
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • East Penn Rheumatology Assoc /ID# 142790
      • Wyomissing, Pennsylvania, United States, 19610
        • Clinical Research Ctr Reading /ID# 151714
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Columbia Arthritis Center /ID# 153728
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • West Tennessee Research Inst /ID# 142739
      • Kingsport, Tennessee, United States, 37660
        • Arthritis Associates, PLLC /ID# 142774
      • Kingsport, Tennessee, United States, 37660
        • Arthritis Associates, PLLC /ID# 155462
      • Memphis, Tennessee, United States, 38119
        • Dr. Ramesh Gupta /ID# 142767
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research, Inc. /ID# 142805
      • Beaumont, Texas, United States, 77701
        • Diagnostic Group Integrated He /ID# 148340
      • College Station, Texas, United States, 77845
        • Arth and Osteo Clin Brazo Valley /ID# 148343
      • Dallas, Texas, United States, 75231
        • Arthritis Care and Diagnostic /ID# 151344
      • Dallas, Texas, United States, 75231
        • Metroplex Clinical Research /ID# 142758
      • Houston, Texas, United States, 77004
        • Rheumatic Disease Clin Res Ctr /ID# 150914
      • Houston, Texas, United States, 77030-3411
        • Baylor College of Medicine /ID# 142753
      • Houston, Texas, United States, 77065
        • Rheumatology Clinic of Houston /ID# 150915
      • Houston, Texas, United States, 77074
        • Houston Institute for Clin Res /ID# 142768
      • Houston, Texas, United States, 77098-5294
        • Pioneer Research Solutions, Inc. /ID# 151346
      • Lubbock, Texas, United States, 79424
        • Arthritis & Osteoporosis Assoc /ID# 147567
      • Lufkin, Texas, United States, 75904-3132
        • P&I Clinical Research /ID# 151345
      • Mesquite, Texas, United States, 75150
        • SW Rheumatology Res. LLC /ID# 142813
      • Plano, Texas, United States, 75024-5283
        • Trinity Universal Research Association /ID# 149278
      • San Antonio, Texas, United States, 78232
        • Arthritis & Osteo Ctr of S. TX /ID# 142773
      • San Marcos, Texas, United States, 78666
        • Arthritis Clinic of Central TX /ID# 148346
      • Tomball, Texas, United States, 77375
        • DM Clinical Research /ID# 151007
      • Waco, Texas, United States, 76710
        • Arthritis & Osteoporosis Clinic /ID# 142760
    • Washington
      • Bothell, Washington, United States, 98021
        • Western Washington Arthritis C /ID# 142776
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest, PLLC /ID# 150924
      • Vancouver, Washington, United States, 98664
        • The Vancouver Clinic, INC. PS /ID# 147946
    • West Virginia
      • South Charleston, West Virginia, United States, 25309
        • West Virginia Research Inst /ID# 153087
    • Wisconsin
      • Franklin, Wisconsin, United States, 53132
        • Aurora Rheumatology and Immunotherapy Center /ID# 142820

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Upadacitinib 15 mg

Period 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.
Drug: Upadacitinib
Tablet; Oral
Other Names:
  • ABT-494
  • RINVOQ®
EXPERIMENTAL: Upadacitinib 30 mg

Period 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.
Drug: Upadacitinib
Tablet; Oral
Other Names:
  • ABT-494
  • RINVOQ®
PLACEBO_COMPARATOR: Placebo / Upadacitnib 15 mg

Period 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.
Drug: Upadacitinib
Tablet; Oral
Other Names:
  • ABT-494
  • RINVOQ®
Drug: Placebo
Tablet; Oral
PLACEBO_COMPARATOR: Placebo / Upadacitnib 30 mg

Period 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.
Drug: Upadacitinib
Tablet; Oral
Other Names:
  • ABT-494
  • RINVOQ®
Drug: Placebo
Tablet; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Time Frame: Baseline and 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).
Baseline and Week 12
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
Time Frame: 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.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
Time Frame: Baseline and 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.
Baseline and Week 12
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1
Time Frame: Baseline and 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).
Baseline and week 1
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Time Frame: Baseline and 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).
Baseline and Week 12
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Time Frame: Baseline and 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).
Baseline and Week 12
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Time Frame: Baseline and 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.
Baseline and Week 12
Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12
Time Frame: Baseline and 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.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 15, 2016

Primary Completion (ACTUAL)

April 3, 2017

Study Completion (ACTUAL)

February 8, 2022

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

March 8, 2016

First Posted (ESTIMATE)

March 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M13-542
  • 2015-003335-35 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing, please refer to the link below.

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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