A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs

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

The study objective of Period 1 was to compare the safety and efficacy of upadacitinib 15 mg once daily (QD) to abatacept on a background of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in biologic disease-modifying antirheumatic drug (bDMARD)-inadequate response or bDMARD-intolerant participants with moderately to severely active RA. The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD in participants with RA who had completed Period 1.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis (RA)
• Intervention / Treatment: Drug: Abatacept; Drug: Placebo for abatacept; Drug: Upadacitinib; Drug: Placebo for upadacitinib

Detailed Description

This is a Phase 3 multicenter study with 2 periods. Period 1 was a 24-week, randomized, double-blind, parallel-group, active-controlled period designed to compare the safety and efficacy of upadacitinib 15 mg and abatacept for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid RA who had an inadequate response to or intolerance to bDMARD therapy and were currently on a stable dose of csDMARD(s) and had never received abatacept. Period 2 is an open-label, long-term extension study to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg once a day (QD) in participants with RA who had completed Period 1.

• Study Type: Interventional
• Enrollment (Actual): 613
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1417
    • Ctr Privado Med Familiar /ID# 158814
  • Buenos Aires, Argentina, 1426AAL
    • Atencion Integral en Reuma /ID# 155696
  • Buenos Aires, Argentina, C1221ADC
    • Hospital General de Agudos /ID# 167117
  • Caba, Argentina, 1428
    • Inst. de Rehab. Psicofisica /ID# 167768
  • Cordoba, Argentina, 5000
    • Inst. Rheumatologic Strusberg /ID# 159021
  • Cordoba, Argentina, X5003DCE
    • Instituto Medico DAMIC /ID# 167770
  • Ramos Mejía, Argentina, 1704
    • DIM Clinica Privada /ID# 167769
  • Rosario, Santa FE, Argentina, S2000PBJ
    • Instituto CAICI SRL /ID# 159022
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, 1046
      • Aprillus Asistencia e Investig /ID# 159173
• Australia
  • Queensland
    • Maroochydore, Queensland, Australia, 4558
      • Rheumatology Research Unit /ID# 159174
  • South Australia
    • Woodville, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital /ID# 159175
  • Victoria
    • Footscray, Victoria, Australia, 3011
      • Western Health Footscray Hospi /ID# 157968
• Belgium
  • Namur, Belgium, 5000
    • CHU UCL Namur /ID# 157628
• Brazil
  • Espirito Santo
    • Vitoria, Espirito Santo, Brazil, 29055-450
      • CEDOES-Centro de Diagnóstico e Pesquisa da Osteoporose do Espírito Santo LTDA /ID# 155228
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-221
      • Santa Casa de Belo Horizonte /ID# 154631
    • Juiz de Fora, Minas Gerais, Brazil, 36010-570
      • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 154564
  • Parana
    • Curitiba, Parana, Brazil, 80030-110
      • Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 154634
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre /ID# 161211
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
      • LMK Sevicos Medicos S/S /ID# 159176
  • Sao Paulo
    • Santo André, Sao Paulo, Brazil, 09190-510
      • CEMEC - Centro Multidisciplinar de Estudos Clínicos /ID# 154632
    • São Paulo, Sao Paulo, Brazil, 04266-010
      • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 159587
• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • MHAT Trimontsium /ID# 155226
  • Sofia, Bulgaria, 1505
    • Diag Consult Ctr 17 Sofia EOOD /ID# 169298
  • Sofia, Bulgaria, 1612
    • UMHAT Sv. Ivan Rilski /ID# 155000
  • Sofia, Bulgaria, 1784
    • Medical Centre Synexus Sofia /ID# 201807
• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 6L2
      • The Waterside Clinic /ID# 159178
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Adachi Medicine Prof. Corp /ID# 158024
  • Quebec
    • Montreal, Quebec, Canada, H2L 1S6
      • Institut de Rhum. de Montreal /ID# 155001
    • Sainte-foy, Quebec, Canada, G1V 3M7
      • Groupe de Recherche en Maladies Osseuses /ID# 154601
• Czechia
  • Uherské Hradište, Czechia, 686 01
    • Medical Plus, s.r.o. /ID# 155230
  • Praha 2
    • Prague 2, Praha 2, Czechia, 128 00
      • Revmatologicky ustav Praha /ID# 154612
• Germany
  • Berlin, Germany, 12163
    • Praxis fuer Rheumatologie /ID# 156156
  • Hamburg, Germany, 20095
    • Rheumaforschungszentrum II /ID# 157177
  • Planegg, Germany, 82152
    • Welcker, Planegg, DE /ID# 160185
  • Nordrhein-Westfalen
    • Köln, Nordrhein-Westfalen, Germany, 50937
      • Uniklinik Koln /ID# 156047
• Greece
  • Heraklion, Greece, 71110
    • University General Hospital of Heraklion "PA.G.N.I" /ID# 163916
• Hungary
  • Budapest, Hungary, 1023
    • Budai Irgalmasrendi Korhaz /ID# 154457
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft. /ID# 156159
  • Debrecen, Hungary, 4031
    • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 159183
  • Eger, Hungary, 3300
    • Markhot Ferenc Oktatokorhaz es Rendelointezet /ID# 159689
  • Szolnok, Hungary, 5000
    • MAV Korhaz ess Rendelointezet /ID# 154455
• Ireland
  • Manorhamilton, Ireland
    • Our Lady's Hospital /ID# 161149
• Israel
  • Ashkelon, Israel, 78278
    • Barzilai Medical Center /ID# 161685
  • Haifa, Israel, 3436212
    • The Lady Davis Carmel MC /ID# 161686
  • Kfar Saba, Israel, 44281
    • Meir Medical Center /ID# 162774
  • Ramat Gan, Israel, 5262100
    • Sheba Medical Center /ID# 163154
• Italy
  • Catania, Italy, 95123
    • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 161172
  • Milan, Italy, 20122
    • ASST G. Pini /ID# 162223
  • Marche
    • Ancona, Marche, Italy, 60126
      • A.O. Univ. Ospedali Riuniti /ID# 161707
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas /ID# 154999
  • Piemonte
    • Turin, Piemonte, Italy, 10126
      • AOU Citta della Salute Scienza /ID# 154577
  • Roma
    • Rome, Roma, Italy, 00168
      • Presidio Columbus, Fondazione Policlinico Gemelli Universita Cattolica S. Cuore /ID# 162252
• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center /ID# 154639
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 07061
      • SMG-SNU Boramae Medical Center /ID# 155788
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 07345
      • The Catholic University of Korea, Yeouido St. Mary's Hospital /ID# 155231
• Latvia
  • Liepaja, Latvia, 3401
    • D.Saulites-Kandevicas PP /ID# 154578
  • Riga, Latvia, 1038
    • Riga East Clinical Univ Hosp /ID# 155024
• Mexico
  • Mexico City, Mexico, 03100
    • RM Pharma Specialists S.A de C.V /ID# 159588
  • Mexico City, Mexico, 11650
    • Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiova /ID# 160126
  • Ciudad De Mexico
    • Mexico City, Ciudad De Mexico, Mexico, 11850
      • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 154579
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37000
      • Morales Vargas Centro de Investigacion S.C. /ID# 200800
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • Centro Integral en Reumatología S.A de C.V /ID# 204493
• Netherlands
  • Amsterdam, Netherlands, 1056 AB
    • Reade /ID# 161002
  • Haarlem, Netherlands, 2035 RC
    • Spaarne Gasthuis /ID# 161003
  • Leeuwarden, Netherlands, 8934 AD
    • Medisch Centrum Leeuwarden /ID# 156043
  • Fryslan
    • Sneek, Fryslan, Netherlands, 8601 ZK
      • Antonius Ziekenhuis /ID# 155737
• New Zealand
  • Timaru, New Zealand, 7910
    • Timaru Medical Specialists Ltd /ID# 159184
  • Wellington, New Zealand, 6021
    • Wellington Hospital (Capital and Coast District Health Board) /ID# 154591
• Poland
  • Lodz, Poland, 91-363
    • Centrum Med Amed Oddzial Lodzi /ID# 154458
  • Lodzkie
    • Lodz, Lodzkie, Poland, 91-211
      • Salve Medica Sp. z o.o. S.K. /ID# 202473
  • Malopolskie
    • Cracow, Malopolskie, Poland, 30-149
      • Malopolskie Centrum Kliniczne /ID# 157180
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 03-291
      • Centrum Medyczne AMED Warszawa Targowek /ID# 159589
  • Podlaskie
    • Białystok, Podlaskie, Poland, 15-099
      • Gabinet Internistyczno Reum. /ID# 157433
    • Białystok, Podlaskie, Poland, 15-879
      • ClinicMed Daniluk, Nowak Sp.j. /ID# 202998
  • Pomorskie
    • Gdynia, Pomorskie, Poland, 81-537
      • Synexus Polska Sp. z o.o. Oddzial w Gdyni /ID# 202472
  • Wielkopolskie
    • Poznań, Wielkopolskie, Poland, 60-218
      • Medyczne Centrum Hetmanska /ID# 155746
• Portugal
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Lisboa Norte, EPE /ID# 200037
  • Viana Do Castelo, Portugal, 4901-858
    • Unidade Local De Saude Do Alto Minho /ID# 200036
  • Viseu, Portugal, 3504-509
    • Centro Hosp de Tondela-Viseu /ID# 155699
  • Lisboa
    • Lisbon, Lisboa, Portugal, 1050-034
      • Instituto Portugues De Reumatologia /ID# 155698
    • Lisbon, Lisboa, Portugal, 1349-019
      • Centro Hospitalar Lisboa Ocidental, EPE /ID# 200035
  • Setubal
    • Almada, Setubal, Portugal, 2805-267
      • Hospital Garcia de Orta, E.P.E /ID# 164056
• Puerto Rico
  • Carolina, Puerto Rico, 00983
    • Dr. Ramon L. Ortega-Colon, MD /ID# 158097
  • San Juan, Puerto Rico, 00909
    • GCM Medical Group /ID# 156158
• Romania
  • Bucuresti, Romania, 011172
    • Spitalul Clinic Sf. Maria /ID# 167245
  • Bucuresti
    • Bucharest, Bucuresti, Romania, 020475
      • Spitalul Clinic Dr. I. Cantacuzino /ID# 155893
• Russian Federation
  • Moscow, Russian Federation, 121374
    • State Budget Healthcare Instit /ID# 154593
  • St. Petersburg, Russian Federation, 191015
    • Nort-Western State Medical Uni /ID# 154610
  • Moskva
    • Korolev, Moskva, Russian Federation, 141060
      • Family Outpatient clinic#4 LLC /ID# 203524
  • Novosibirskaya Oblast
    • Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630099
      • LLC Medical Center /ID# 203523
  • Udmurtskaya Respublika
    • Izhevsk, Udmurtskaya Respublika, Russian Federation, 426061
      • Alliance Biomedical Ural Group /ID# 154609
• Slovakia
  • Banska Bystrica, Slovakia, 97405
    • Novamed,spol.s.r.o. /ID# 157928
  • Bratislava, Slovakia, 82606
    • Univerzitna Nemocnica Bratislava /ID# 161143
  • Pieštany, Slovakia, 921 12
    • Narodny ustav reumatickych chorob Piestany /ID# 156864
• Spain
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina S /ID# 155701
  • Elche, Spain, 03202
    • Hospital General Univ de Elche /ID# 158825
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 163636
  • Sabadell, Barcelona, Spain, 08208
    • Corp Sanitaria Parc Tauli /ID# 163634
  • Santiago de Compostela, Spain, 15706
    • Complejo Hospitalario /ID# 155700
  • Sevilla, Spain, 41010
    • Hospital Infanta Luisa /ID# 154641
• Sweden
  • Goteborg, Sweden, 413 45
    • Sahlgrenska University Hosp /ID# 162775
  • Vasteras, Sweden, 72189
    • Vastmanlands Sjukhus /ID# 159186
  • Skane Lan
    • Malmö, Skane Lan, Sweden, 214 28
      • Skanes Universitetssjukhus /ID# 165133
  • Stockholms Lan
    • Stockholm, Stockholms Lan, Sweden, 113 65
      • Akademiskt specialistcentrum Centrum for reumatologi /ID# 156046
• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital of Basel /ID# 160860
  • Fribourg, Switzerland, 1708
    • HFR Fribourg - Hopital Canton /ID# 160970
  • Geneve
    • Genève, Geneve, Switzerland, 1205
      • Hopitaux Universitaires de Geneve /ID# 159083
  • Sankt Gallen
    • St. Gallen, Sankt Gallen, Switzerland, 9007
      • Kantonsspital St. Gallen /ID# 155232
• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Medical Faculty /ID# 167995
  • Ankara, Turkey, 6100
    • Ankara Univ Medical Faculty /ID# 162691
  • Antalya, Turkey, 06100
    • Akdeniz University Faculty /ID# 163153
  • Istanbul, Turkey, 34147
    • Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastırma Hastanesi /ID# 169479
• United Kingdom
  • Dundee, United Kingdom, DD1 9SY
    • Ninewells Hospital /ID# 156050
  • Londonderry, United Kingdom, BT47 6SB
    • Altnagelvin Area Hospital /ID# 156540
  • Preston, United Kingdom
    • Lancashire Care NHS Foundation /ID# 156042
  • Truro, United Kingdom, TR1 3LJ
    • Royal Cornwall Hospital /ID# 157785
  • London, City Of
    • London, London, City Of, United Kingdom, E11 1NR
      • Whipps Cross Univ Hospital /ID# 205985
• United States
  • Arizona
    • Peoria, Arizona, United States, 85381
      • SunValley Arthritis Center, Lt /ID# 154558
    • Sun City, Arizona, United States, 85351
      • AZ Arthritis & Rheum Research /ID# 156539
    • Tucson, Arizona, United States, 85704
      • AZ Arth & Rheum Res /ID# 167161
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913-6999
      • CHI St. Vincent Medical Group /ID# 154561
  • California
    • Fullerton, California, United States, 92835
      • Saint Jude Heritage /ID# 158833
    • La Mesa, California, United States, 91942
      • Kotha and Kotha /ID# 154573
  • Colorado
    • Denver, Colorado, United States, 80230
      • Denver Arthritis Clinic /ID# 159195
    • Fort Collins, Colorado, United States, 80528
      • Arthritis and Rheum Clin N. CO /ID# 155673
    • Lakewood, Colorado, United States, 80228
      • Scientia Medical Research /ID# 159189
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Res of West FL, Inc. /ID# 154576
    • Ocoee, Florida, United States, 34761-4547
      • Advanced Clin Res of Orlando /ID# 154580
    • Pensacola, Florida, United States, 32514
      • Gulf Region Clinical Res Inst /ID# 154597
    • Tamarac, Florida, United States, 33321
      • W. Broward Rheum Assoc Inc. /ID# 158835
    • Venice, Florida, United States, 34292
      • Lovelace Scientific Resources /ID# 154600
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Jefrey D. Lieberman, MD, P.C. /ID# 157178
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research /ID# 154603
  • Illinois
    • Champaign, Illinois, United States, 61820
      • PMG Research of Christie Clini /ID# 154569
  • Kentucky
    • Lexington, Kentucky, United States, 40515
      • Bluegrass Community Research /ID# 154604
    • Paducah, Kentucky, United States, 42003
      • Four Rivers Clinical Research /ID# 154606
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70836-6455
      • Ochsner Clinic Foundation /ID# 154585
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology & Bone Research /ID# 158723
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • West Michigan Rheumatology /ID# 154551
    • Lansing, Michigan, United States, 48910
      • Advanced Rheumatology, PC /ID# 154589
  • Missouri
    • Springfield, Missouri, United States, 65810-2607
      • Clinvest Research LLC /ID# 154554
  • New Jersey
    • Summit, New Jersey, United States, 07901-3561
      • Overlook Medical Center /ID# 154794
    • Toms River, New Jersey, United States, 08755
      • Atlantic Coast Research /ID# 155234
    • Toms River, New Jersey, United States, 08755
      • Ocean Rheumatology, PA /ID# 162980
  • New Mexico
    • Las Cruces, New Mexico, United States, 88011
      • Arthritis and Osteo Assoc /ID# 154560
  • New York
    • Albany, New York, United States, 12206
      • The Center for Rheumatology /ID# 162979
    • Lake Success, New York, United States, 11554
      • NYU Langone Rheum Assoc /ID# 155236
    • New York, New York, United States, 10016-6402
      • NYU Langone Medical Center /ID# 158829
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Physicians East, PA /ID# 154565
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury /ID# 154605
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington LLC /ID# 154584
    • Winston-Salem, North Carolina, United States, 27157-0001
      • Wake Forest Baptist Medical Center /ID# 154586
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University /ID# 163822
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • East Penn Rheumatology Assoc /ID# 159193
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Ctr Clinical Res /ID# 154572
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh MC /ID# 157434
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • West Tennessee Research Inst /ID# 158721
  • Texas
    • Corpus Christi, Texas, United States, 78404
      • Adriana Pop-Moody MD Clinic PA /ID# 154607
    • Lufkin, Texas, United States, 75904-3132
      • P&I Clinical Research /ID# 159191
    • Tomball, Texas, United States, 77375
      • DM Clinical Research /ID# 158722
  • Utah
    • Salt Lake City, Utah, United States, 84124-1377
      • Care Access Research /ID# 158098

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Main Inclusion Criteria:

• Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months who also fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA
• Participants have been treated for ≥ 3 months prior to the screening visit with ≥ 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration and have never received abatacept prior to the first dose of study drug
• Participants have 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 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 and high-sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening

Main Exclusion Criteria:

• Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib, tofacitinib, baricitinib and filgotinib)
• Prior exposure to abatacept
• History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted
• Laboratory values meeting the following criteria within the Screening period prior to the first dose of study drug: serum aspartate transaminase > 2 × upper limit of normal (ULN); serum alanine transaminase > 2 × ULN; estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease formula < 40 mL/minute/1.73 meter (m)^2; total white blood cell count < 2,500/ μL; absolute neutrophil count < 1,500/μL; platelet count < 100,000/μL; absolute lymphocyte count < 800/μL; and hemoglobin < 10 g/dL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Abatacept; 500 mg (for body weight <60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight >100 kg) intravenous (IV) infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20	Drug: Abatacept; IV infusion; Drug: Placebo for abatacept; IV infusion
Experimental: Upadacitinib 15 mg; One 15 mg tablet taken once per day by mouth for 24 weeks	Drug: Upadacitinib; 15 mg extended release tablet; Other Names: ABT-494; Drug: Placebo for upadacitinib; Film-coated tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Non-inferiority)	The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (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 indicates improvement in disease activity.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Superiority)	The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (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 indicates improvement in disease activity.	Baseline and Week 12
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Superiority)	The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS 28 score less than 2.6 indicates clinical remission.	At Week 12

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General Publications

• Rubbert-Roth A, Enejosa J, Pangan AL, Haraoui B, Rischmueller M, Khan N, Zhang Y, Martin N, Xavier RM. Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis. N Engl J Med. 2020 Oct 15;383(16):1511-1521. doi: 10.1056/NEJMoa2008250.
• Bergman M, Tundia N, Martin N, Suboticki JL, Patel J, Goldschmidt D, Song Y, Wright GC. Patient-reported outcomes of upadacitinib versus abatacept in patients with rheumatoid arthritis and an inadequate response to biologic disease-modifying antirheumatic drugs: 12- and 24-week results of a phase 3 trial. Arthritis Res Ther. 2022 Jun 24;24(1):155. doi: 10.1186/s13075-022-02813-x. Erratum In: Arthritis Res Ther. 2022 Nov 3;24(1):248.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2017
• Primary Completion (Actual): June 13, 2019
• Study Completion (Actual): June 6, 2023

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Arthritis; Joint Disease; Anti-inflammatory agents; Musculoskeletal Disease; Antirheumatic agents
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Immune Checkpoint Inhibitors; Janus Kinase Inhibitors; Abatacept; Upadacitinib
• Other Study ID Numbers: M15-925; 2016-000933-37 (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: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• 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