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 (SELECT-NEXT)

March 17, 2023 updated by: AbbVie

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

661

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

  • Argentina
      • Buenos Aires, Argentina, 1128
        • Mautalen Salud e Investigacion /ID# 141419
      • Cordoba, Argentina, 5000
        • Inst. Rheumatologic Strusberg /ID# 145648
  • Australia
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Coffs Clinical Trials /ID# 138747
      • Kogarah, New South Wales, Australia, 2217
        • Optimus Clinical Research Pty. /ID# 138769
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research /ID# 138773
      • Geelong, Victoria, Australia, 3220
        • Barwon Rheumatology /ID# 138772
  • Austria
      • Vienna, Austria, 1100
        • Rheuma Zentrum Favoriten GmbH /ID# 138787
      • Wien, Austria, 1160
        • Wilhelminenspital der Stadt Wien /ID# 138788
  • Belgium
      • Brugge, Belgium, 8310
        • AZ Sint Lucas /ID# 141338
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6000
        • Rhumaconsult SPRL /ID# 138813
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 138806
  • Bosnia and Herzegovina
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 138819
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 140372
  • Bulgaria
      • Sofia, Bulgaria, 1505
        • Diag Consult Ctr 17 Sofia EOOD /ID# 141006
      • Sofia, Bulgaria, 1612
        • Diagnostic Consultative Center /ID# 138882
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A IM3
        • Manitoba Clinic /ID# 139086
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Eastern Health /ID# 140431
    • Quebec
      • Sainte-foy, Quebec, Canada, G1V 3M7
        • Groupe de Recherche en Maladies Osseuses /ID# 138906
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 3H3
        • Dr. Latha Naik /ID# 139089
  • Croatia
      • Zagreb, Croatia, 10000
        • Klinicka bolnica Sveti Duh /ID# 152812
      • Zagreb, Croatia, 10000
        • Medical Center Kuna-Peric /ID# 140365
      • Zagreb, Croatia, 10000
        • Poliklinika Bonifarm /ID# 141415
    • Primorsko-goranska Zupanija
      • Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
        • Klinicki bolnicki centar Rijeka /ID# 138649
  • Czechia
      • Brno, Czechia, 638 00
        • Revmatologie, s.r.o. /ID# 138899
      • Ostrava, Czechia, 722 00
        • Artroscan s.r.o. /ID# 138833
      • Slany, Czechia, 274 01
        • Nemocnice Slany /ID# 141112
      • Zlin, Czechia, 760 01
        • PV-MEDICAL s.r.o. /ID# 138913
    • Moravskoslezsky Kraj
      • Hlučín, Moravskoslezsky Kraj, Czechia, 748 01
        • L.K.N. Arthrocentrum, s.r.o /ID# 141340
  • Estonia
      • Pärnu, Estonia, 80010
        • Paernu Hospital /ID# 138961
      • Tallinn, Estonia, 10138
        • East Tallinn Central Hospital /ID# 140618
    • Harjumaa
      • Tallinn, Harjumaa, Estonia, 10128
        • Center of Clinical and Basic Research /ID# 141116
  • Finland
      • Helsinki, Finland, 00290
        • Helsinki Univ Central Hospital /ID# 140381
      • Hyvinkaa, Finland, 05800
        • Kiljava Medical Research /ID# 139260
      • Lappeenranta, Finland, 53130
        • South Karelia Central Hospital /ID# 139973
  • France
      • Chambray Les Tours, France, 37170
        • CHRU Tours - Hopital Trousseau /ID# 138969
    • Bouches-du-Rhone
      • Marseille CEDEX 08, Bouches-du-Rhone, France, 13285
        • Hopital Saint Joseph /ID# 149188
  • Germany
      • Berlin, Germany, 10117
        • Charité Universitätsmedizin Campus Mitte /ID# 139052
      • Berlin, Germany, 13125
        • Immanuel-Krankenhaus /ID# 139059
      • Hamburg, Germany, 22763
        • Asklepios Klinik Altona /ID# 140466
      • Planegg, Germany, 82152
        • Welcker, Planegg, DE /ID# 140467
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50937
        • Uniklinik Koln /ID# 139084
  • Greece
      • Heraklion, Greece, 71110
        • University General Hospital of Heraklion "PA.G.N.I" /ID# 139115
  • Hong Kong
      • Sha Tin, Hong Kong
        • Prince of Wales Hospital /ID# 139314
  • Hungary
      • Budapest, Hungary, 1027
        • Revita Reumatologiai Rendelo /ID# 140761
      • Szekesfehervar, Hungary, 8000
        • Fejer Megyei Szent Gyorgy Korh /ID# 138554
  • Ireland
      • Dublin, Ireland, D04 T6F4
        • St Vincent's University Hosp /ID# 138562
  • Italy
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • Universita di Catanzaro Magna Graecia /ID# 139316
  • Kazakhstan
      • Astana, Kazakhstan, 010009
        • JSC Nat Scientific Med Res Ctr /ID# 140575
  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-718
        • Daegu Catholic University Med /ID# 139249
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital /ID# 138653
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital /ID# 138659
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center /ID# 140579
    • Gwang Yeogsi
      • Incheon, Gwang Yeogsi, Korea, Republic of, 22332
        • Inha University Hospital /ID# 149310
    • Gyeonggido
      • Suwon-si, Gyeonggido, Korea, Republic of, 16499
        • Ajou University Hospital /ID# 149311
    • Jeonranamdo
      • Gwangju, Jeonranamdo, Korea, Republic of, 61469
        • Chonnam National University Hospital /ID# 138651
    • Seongdong-gu
      • Seoul, Seongdong-gu, Korea, Republic of, 04763
        • Hanyang University Seoul Hospi /ID# 138655
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
        • Cath Univ Seoul St Mary's Hosp /ID# 138652
  • Latvia
      • Adazi, Latvia, 2164
        • LTD M+M Centers /ID# 138818
  • Lithuania
      • Klaipeda, Lithuania, 92288
        • Klaipeda University Hospital /ID# 141416
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital /ID# 141348
  • Mexico
      • Mexico City, Mexico, 06090
        • Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 138841
    • Yucatan
      • Colonia Centro, Yucatan, Mexico, 97000
        • Centro Peninsular de Investigación Clínica SCP /ID# 148160
  • New Zealand
      • Nelson, New Zealand, 7010
        • Porter Rheumatology Ltd /ID# 138347
  • Poland
      • Warsaw, Poland, 02-118
        • Rheuma Medicus /ID# 138372
    • Kujawsko-pomorskie
      • Toruń, Kujawsko-pomorskie, Poland, 87-100
        • NZOZ Nasz Lekarz /ID# 138374
    • Mazowieckie
      • Grodzisk Mazowiecki, Mazowieckie, Poland, 05-825
        • McBk Sc /Id# 138360
    • Podlaskie
      • Białystok, Podlaskie, Poland, 15-351
        • Osteo-Medic spolka cywilna /ID# 138371
    • Warminsko-mazurskie
      • Elblag, Warminsko-mazurskie, Poland, 82-300
        • NZOZ Centrum Reumatologiczne /ID# 138353
  • Portugal
    • Lisboa
      • Lisbon, Lisboa, Portugal, 1050-034
        • Instituto Portugues De Reumatologia /ID# 148315
      • Lisbon, Lisboa, Portugal, 1349-019
        • Centro Hospitalar Lisboa Ocidental, EPE /ID# 140594
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139328
  • Romania
      • Cluj, Romania, 400006
        • Spitalul Clinic Judetean de Urgenta /ID# 138407
      • Ploiesti, Romania, 100337
        • Spitalul Municipal Ploiesti /ID# 138405
      • Sibiu, Romania, 550245
        • Spitalul Clinic Judetean de Ur /ID# 138393
  • Russian Federation
      • Petrozavodsk, Russian Federation, 185019
        • Republican Clin Hos n.a. Baran /ID# 139273
      • Samara, Russian Federation, 443095
        • Samara Regional Clinical Hosp /ID# 148642
      • Ulyanovsk, Russian Federation, 432018
        • Ulyanovsk Regional Clin Hosp /ID# 139279
      • Voronezh, Russian Federation, 394036
        • Voronezh State Medical Univers /ID# 148431
      • Yaroslavl, Russian Federation, 150000
        • Yaroslavi State Medical Univer /ID# 139908
    • Stavropol Skiy Kray
      • Pyatigorsk, Stavropol Skiy Kray, Russian Federation, 357500
        • LLC Novaya Klinika /ID# 139269
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420012
        • Kazan State Medical University /ID# 138413
  • Slovakia
      • Kosice, Slovakia, 040 11
        • ARTROMAC n.o. /ID# 138428
      • Kosice, Slovakia, 040 15
        • Nemocnica Kosice Saca, a.s. /ID# 138918
      • Pieštany, Slovakia, 921 01
        • Slovak research center Team Member, Thermium s.r.o. /ID# 139924
      • Pieštany, Slovakia, 921 12
        • Narodny ustav reumatickych chorob Piestany /ID# 138427
      • Trnava, Slovakia, 91701
        • REUMA-GLOBAL, s.r.o. /ID# 139912
  • South Africa
    • Kwazulu-Natal
      • Berea, Kwazulu-Natal, South Africa, NL 4001
        • St. Augustine's Medical Centre /ID# 141352
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7405
        • Arthritis Clinical Research Tr /ID# 138945
      • Stellenbosch, Western Cape, South Africa, 7600
        • Winelands Medical Research Ctr /ID# 138944
  • Spain
      • Elche, Spain, 03202
        • Hospital General Univ de Elche /ID# 138991
      • Madrid, Spain, 28040
        • Hospital Clin Univ San Carlos /ID# 138993
      • Santiago de Compostela, Spain, 15705
        • Hosp Nuestra Senora Esperanza /ID# 138997
    • Malaga
      • Málaga, Malaga, Spain, 29009
        • Hospital Regional de Malaga /ID# 138975
  • Switzerland
      • Fribourg, Switzerland, 1708
        • HFR Fribourg - Hopital Canton /ID# 139155
  • Taiwan
      • Kaohsiung, Taiwan, 80708
        • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 140869
      • New Taipei City, Taiwan, 22060
        • Far Eastern Memorial Hospital /ID# 140871
      • Taipei City, Taiwan, 11217
        • Taipei Veterans General Hosp /ID# 139234
    • Taichung
      • Taichung City, Taichung, Taiwan, 40447
        • China Medical University Hosp /ID# 139232
    • Tainan
      • Tainan City, Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital /ID# 140868
    • Taipei
      • Taipei City, Taipei, Taiwan, 10002
        • National Taiwan Univ Hosp /ID# 141443
  • Turkey
      • Ankara, Turkey, 06100
        • Ankara Numune Training and Res /ID# 139237
  • Ukraine
      • Kyiv, Ukraine, 04070
        • LLC Revmocentr /ID# 139872
      • Lviv, Ukraine, 79007
        • MNCE "Lviv City Clinical Hospital #4" /ID# 139873
      • Odesa, Ukraine, 65026
        • Odessa National Medical Univ /ID# 139179
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital /ID# 139524
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital /ID# 139169
      • Warrington, United Kingdom, WA5 1LZ
        • Warrington + Halton Hosp NHS /ID# 139195
    • England
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary /ID# 139184
    • London, City Of
      • London, London, City Of, United Kingdom, E11 1NR
        • Whipps Cross Univ Hospital /ID# 139523
      • London, London, City Of, United Kingdom, NW3 2QG
        • The Royal Free Hospital /ID# 139191
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85202
        • AZ Arthritis and Rheum Assoc /ID# 148651
      • Peoria, Arizona, United States, 85381
        • SunValley Arthritis Center, Lt /ID# 140452
      • Phoenix, Arizona, United States, 85032-9306
        • AZ Arthritis and Rheum Researc /ID# 138500
      • Phoenix, Arizona, United States, 85032-9306
        • AZ Arthritis and Rheum Researc /ID# 139286
      • Phoenix, Arizona, United States, 85032
        • AZ Arthritis & Rheuma Research /ID# 138598
      • Phoenix, Arizona, United States, 85053-4061
        • Arizona Research Center, Inc. /ID# 140448
      • Tucson, Arizona, United States, 85719-1478
        • University of Arizona Cancer Center - North Campus /ID# 140451
    • California
      • Covina, California, United States, 91722
        • Covina Arthritis Clinic /ID# 139881
      • Encino, California, United States, 91436
        • T. Joseph Raoof, MD, Inc. /ID# 140964
      • La Jolla, California, United States, 92037
        • Allergy and Rheum Med Clin /ID# 146082
      • Los Angeles, California, United States, 90045
        • Pacific Arthritis Ctr Med Grp /ID# 138744
      • Tustin, California, United States, 92780
        • Robin K. Dore MD, Inc /ID# 138688
      • Upland, California, United States, 91786
        • Inland Rheum Clin Trials Inc. /ID# 138853
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic /ID# 139876
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Res of West FL, Inc. /ID# 138854
      • Miami, Florida, United States, 33173
        • Ctr Arthritis & Rheumatic Dise /ID# 141696
      • Naples, Florida, United States, 34102
        • Medallion Clinical Research Institute, LLC /ID# 140074
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research /ID# 138633
      • Orlando, Florida, United States, 32810
        • Omega Research Consultants /ID# 139877
      • Palm Harbor, Florida, United States, 34684
        • Arthritis Center, Inc. /ID# 141363
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Institute of Arthritis Res /ID# 138548
    • Illinois
      • Rockford, Illinois, United States, 61114-4937
        • OrthoIllinois /ID# 139695
      • Skokie, Illinois, United States, 60076
        • Clinical Investigation Special /ID# 139696
      • Springfield, Illinois, United States, 62702-3749
        • Springfield Clinic /ID# 138602
      • Vernon Hills, Illinois, United States, 60061
        • Deerbrook Medical Associates /ID# 139694
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univ School of Med /ID# 140077
    • Kentucky
      • Lexington, Kentucky, United States, 40515
        • Bluegrass Community Research /ID# 138295
      • Paducah, Kentucky, United States, 42003
        • Four Rivers Clinical Research /ID# 141134
    • Maine
      • Portland, Maine, United States, 04102
        • MMP Women's Health /ID# 141542
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • The Center for Rheumatology & /ID# 139203
    • Massachusetts
      • Mansfield, Massachusetts, United States, 02048
        • Mansfield Health Center /ID# 141357
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Advanced Rheumatology, PC /ID# 140071
      • Lansing, Michigan, United States, 48910
        • Justus J. Fiechtner, MD, PC /ID# 138697
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Physician Res. Collaboration /ID# 138533
      • Omaha, Nebraska, United States, 68114
        • Westroads Clinical Research /ID# 138304
    • New York
      • Albany, New York, United States, 12206
        • The Center for Rheumatology /ID# 138746
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • PMG Research of Salisbury /ID# 141023
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington LLC /ID# 140951
    • Ohio
      • Cincinnati, Ohio, United States, 45242-4468
        • Cincinnati Rheumatic Disease Study Group, Inc. /ID# 138868
      • Toledo, Ohio, United States, 43606
        • Arthritis Assoc of NW Ohio /ID# 140953
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103-2400
        • Health Research Oklahoma /ID# 138535
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Ctr Clinical Res /ID# 138741
    • South Carolina
      • Summerville, South Carolina, United States, 29486-7887
        • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 138689
    • Tennessee
      • Hendersonville, Tennessee, United States, 37075-6213
        • Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 141021
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research, Inc. /ID# 141428
      • Carrollton, Texas, United States, 75007
        • Trinity Universal Res Assoc /ID# 149271
      • College Station, Texas, United States, 77845
        • Arth and Osteo Clin Brazo Valley /ID# 147809
      • Dallas, Texas, United States, 75231
        • Metroplex Clinical Research /ID# 138698
      • Houston, Texas, United States, 77030-3411
        • Baylor College of Medicine /ID# 138682
      • Houston, Texas, United States, 77074
        • Houston Institute for Clin Res /ID# 138716
      • Killeen, Texas, United States, 76549
        • Arthritis Consultants, P.A. /ID# 141138
      • Plano, Texas, United States, 75024-5283
        • Trinity Universal Research Association /ID# 148649
      • San Antonio, Texas, United States, 78229
        • Accurate Clinical Management /ID# 139338
      • Waco, Texas, United States, 76710
        • Arthritis & Osteoporosis Clinic /ID# 138703
    • Washington
      • Bothell, Washington, United States, 98021
        • Western Washington Arthritis C /ID# 138728
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest, PLLC /ID# 138539
    • Wisconsin
      • Franklin, Wisconsin, United States, 53132
        • Aurora Rheumatology and Immunotherapy Center /ID# 139306

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

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

Period 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.
Drug: Upadacitinib
Tablet; Oral
Other Names:
  • ABT-494
  • Rinvoq
Experimental: Upadacitinib 30 mg

Period 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.
Drug: Upadacitinib
Tablet; Oral
Other Names:
  • ABT-494
  • Rinvoq
Experimental: Placebo / Upadacitinib 15 mg

Period 1: Participants receive placebo once daily for 12 weeks.

Period 2: Participants receive upadacitinib 15 mg once daily for 248 weeks.
Drug: Upadacitinib
Tablet; Oral
Other Names:
  • ABT-494
  • Rinvoq
Drug: Placebo
Tablet; Oral
Experimental: Placebo / Upadacitinib 30 mg

Period 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.
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), 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
Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12
Time Frame: 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.
Week 12
Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12
Time Frame: 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.
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), 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
Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary (PCS) Score 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 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.
Baseline and Week 12
Change From Baseline in Duration of Morning Stiffness at Week 12
Time Frame: Baseline and 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.
Baseline and Week 12
Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12
Time Frame: Baseline and 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.
Baseline and week 12
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
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

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)

December 17, 2015

Primary Completion (Actual)

April 21, 2017

Study Completion (Actual)

March 10, 2022

Study Registration Dates

First Submitted

December 11, 2015

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 5, 2016

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M13-549
  • 2015-003332-13 (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, 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.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • 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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