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
NCT ID: NCT03086343
Last Updated: 2024-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
657 participants
INTERVENTIONAL
2017-05-09
2023-06-06
Brief Summary
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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
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A Study Investigating the Efficacy and Safety of Upadacitinib (ABT-494) Given With Methotrexate (MTX) in Adults With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone
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A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 15 mg QD for 192 weeks.
Abatacept
IV infusion
Upadacitinib
15 mg extended release tablet
Placebo for upadacitinib
Film-coated tablet
Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
Period 1: One 15 mg upadacitinib oral tablet QD for 24 weeks. Period 2: open label upadacitinib 15 mg QD for 192 weeks.
Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion)
IV infusion
Upadacitinib
15 mg extended release tablet
30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Period 1: One upadacitinib 30 mg oral tablet QD for 24 weeks. Period 2: open label upadacitinib 30 mg (reduced to 15 mg per Amendment 5) QD for 192 weeks.
Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion)
IV infusion
Upadacitinib
15 mg extended release tablet
30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 30 mg (reduced to 15 mg per Amendment 5) QD for 192 weeks.
Abatacept
IV infusion
Upadacitinib
15 mg extended release tablet
Placebo for upadacitinib
Film-coated tablet
Interventions
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Abatacept
IV infusion
Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion)
IV infusion
Upadacitinib
15 mg extended release tablet
Placebo for upadacitinib
Film-coated tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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SunValley Arthritis Center, Lt /ID# 154558
Peoria, Arizona, United States
AZ Arthritis & Rheum Research /ID# 156539
Sun City, Arizona, United States
AZ Arth & Rheum Res /ID# 167161
Tucson, Arizona, United States
CHI St. Vincent Medical Group /ID# 154561
Hot Springs, Arkansas, United States
Saint Jude Heritage /ID# 158833
Fullerton, California, United States
Kotha and Kotha /ID# 154573
La Mesa, California, United States
Denver Arthritis Clinic /ID# 159195
Denver, Colorado, United States
Arthritis and Rheum Clin N. CO /ID# 155673
Fort Collins, Colorado, United States
Scientia Medical Research /ID# 159189
Lakewood, Colorado, United States
Clinical Res of West FL, Inc. /ID# 154576
Clearwater, Florida, United States
Advanced Clin Res of Orlando /ID# 154580
Ocoee, Florida, United States
Gulf Region Clinical Res Inst /ID# 154597
Pensacola, Florida, United States
W. Broward Rheum Assoc Inc. /ID# 158835
Tamarac, Florida, United States
Lovelace Scientific Resources /ID# 154600
Venice, Florida, United States
Jefrey D. Lieberman, MD, P.C. /ID# 157178
Decatur, Georgia, United States
Advanced Clinical Research /ID# 154603
Meridian, Idaho, United States
PMG Research of Christie Clini /ID# 154569
Champaign, Illinois, United States
Bluegrass Community Research /ID# 154604
Lexington, Kentucky, United States
Four Rivers Clinical Research /ID# 154606
Paducah, Kentucky, United States
Ochsner Clinic Foundation /ID# 154585
Baton Rouge, Louisiana, United States
The Center for Rheumatology & Bone Research /ID# 158723
Wheaton, Maryland, United States
West Michigan Rheumatology /ID# 154551
Grand Rapids, Michigan, United States
Advanced Rheumatology, PC /ID# 154589
Lansing, Michigan, United States
Clinvest Research LLC /ID# 154554
Springfield, Missouri, United States
Overlook Medical Center /ID# 154794
Summit, New Jersey, United States
Atlantic Coast Research /ID# 155234
Toms River, New Jersey, United States
Ocean Rheumatology, PA /ID# 162980
Toms River, New Jersey, United States
Arthritis and Osteo Assoc /ID# 154560
Las Cruces, New Mexico, United States
The Center for Rheumatology /ID# 162979
Albany, New York, United States
NYU Langone Rheum Assoc /ID# 155236
Lake Success, New York, United States
NYU Langone Medical Center /ID# 158829
New York, New York, United States
Physicians East, PA /ID# 154565
Greenville, North Carolina, United States
PMG Research of Salisbury /ID# 154605
Salisbury, North Carolina, United States
PMG Research of Wilmington LLC /ID# 154584
Wilmington, North Carolina, United States
Wake Forest Baptist Medical Center /ID# 154586
Winston-Salem, North Carolina, United States
Oregon Health and Science University /ID# 163822
Portland, Oregon, United States
East Penn Rheumatology Assoc /ID# 159193
Bethlehem, Pennsylvania, United States
Altoona Ctr Clinical Res /ID# 154572
Duncansville, Pennsylvania, United States
University of Pittsburgh MC /ID# 157434
Pittsburgh, Pennsylvania, United States
West Tennessee Research Inst /ID# 158721
Jackson, Tennessee, United States
Adriana Pop-Moody MD Clinic PA /ID# 154607
Corpus Christi, Texas, United States
P&I Clinical Research /ID# 159191
Lufkin, Texas, United States
DM Clinical Research /ID# 158722
Tomball, Texas, United States
Care Access Research /ID# 158098
Salt Lake City, Utah, United States
Aprillus Asistencia e Investig /ID# 159173
Capital Federal, Buenos Aires, Argentina
Ctr Privado Med Familiar /ID# 158814
Buenos Aires, , Argentina
Atencion Integral en Reuma /ID# 155696
Buenos Aires, , Argentina
Hospital General de Agudos /ID# 167117
Buenos Aires, , Argentina
Inst. de Rehab. Psicofisica /ID# 167768
CABA, , Argentina
Inst. Rheumatologic Strusberg /ID# 159021
Córdoba, , Argentina
Instituto Medico DAMIC /ID# 167770
Córdoba, , Argentina
DIM Clinica Privada /ID# 167769
Ramos Mejía, , Argentina
Instituto CAICI SRL /ID# 159022
Rosario, Santa FE, , Argentina
Rheumatology Research Unit /ID# 159174
Maroochydore, Queensland, Australia
The Queen Elizabeth Hospital /ID# 159175
Woodville, South Australia, Australia
Western Health Footscray Hospi /ID# 157968
Footscray, Victoria, Australia
CHU UCL Namur /ID# 157628
Namur, , Belgium
CEDOES-Centro de Diagnóstico e Pesquisa da Osteoporose do Espírito Santo LTDA /ID# 155228
Vitória, Espírito Santo, Brazil
Santa Casa de Belo Horizonte /ID# 154631
Belo Horizonte, Minas Gerais, Brazil
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 154564
Juiz de Fora, Minas Gerais, Brazil
Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 154634
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre /ID# 161211
Porto Alegre, Rio Grande do Sul, Brazil
LMK Sevicos Medicos S/S /ID# 159176
Porto Alegre, Rio Grande do Sul, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos /ID# 154632
Santo André, São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 159587
São Paulo, São Paulo, Brazil
MHAT Trimontsium /ID# 155226
Plovdiv, , Bulgaria
Diag Consult Ctr 17 Sofia EOOD /ID# 169298
Sofia, , Bulgaria
UMHAT Sv. Ivan Rilski /ID# 155000
Sofia, , Bulgaria
Medical Centre Synexus Sofia /ID# 201807
Sofia, , Bulgaria
The Waterside Clinic /ID# 159178
Barrie, Ontario, Canada
Adachi Medicine Prof. Corp /ID# 158024
Hamilton, Ontario, Canada
Institut de Rhum. de Montreal /ID# 155001
Montreal, Quebec, Canada
Groupe de Recherche en Maladies Osseuses /ID# 154601
Sainte-Foy, Quebec, Canada
Revmatologicky ustav Praha /ID# 154612
Prague, Praha 2, Czechia
Medical Plus, s.r.o. /ID# 155230
Uherské Hradište, , Czechia
Uniklinik Koln /ID# 156047
Cologne, North Rhine-Westphalia, Germany
Praxis fuer Rheumatologie /ID# 156156
Berlin, , Germany
Rheumaforschungszentrum II /ID# 157177
Hamburg, , Germany
Welcker, Planegg, DE /ID# 160185
Planegg, , Germany
University General Hospital of Heraklion "PA.G.N.I" /ID# 163916
Heraklion, , Greece
Budai Irgalmasrendi Korhaz /ID# 154457
Budapest, , Hungary
Obudai Egeszsegugyi Centrum Kft. /ID# 156159
Budapest, , Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 159183
Debrecen, , Hungary
Markhot Ferenc Oktatokorhaz es Rendelointezet /ID# 159689
Eger, , Hungary
MAV Korhaz ess Rendelointezet /ID# 154455
Szolnok, , Hungary
Our Lady's Hospital /ID# 161149
Manorhamilton, , Ireland
Barzilai Medical Center /ID# 161685
Ashkelon, , Israel
The Lady Davis Carmel MC /ID# 161686
Haifa, , Israel
Meir Medical Center /ID# 162774
Kfar Saba, , Israel
Sheba Medical Center /ID# 163154
Ramat Gan, , Israel
Istituto Clinico Humanitas /ID# 154999
Rozzano, Milano, Italy
AOU Citta della Salute Scienza /ID# 154577
Turin, Piedmont, Italy
Presidio Columbus, Fondazione Policlinico Gemelli Universita Cattolica S. Cuore /ID# 162252
Rome, Roma, Italy
A.O. Univ. Ospedali Riuniti /ID# 161707
Ancona, The Marches, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 161172
Catania, , Italy
ASST G. Pini /ID# 162223
Milan, , Italy
D.Saulites-Kandevicas PP /ID# 154578
Liepāja, , Latvia
Riga East Clinical Univ Hosp /ID# 155024
Riga, , Latvia
Morales Vargas Centro de Investigacion S.C. /ID# 200800
León, Guanajuato, Mexico
Centro Integral en Reumatología S.A de C.V /ID# 204493
Guadalajara, Jalisco, Mexico
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 154579
Mexico City, Mexico City, Mexico
RM Pharma Specialists S.A de C.V /ID# 159588
Mexico City, , Mexico
Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiova /ID# 160126
Mexico City, , Mexico
Antonius Ziekenhuis /ID# 155737
Sneek, Provincie Friesland, Netherlands
Reade /ID# 161002
Amsterdam, , Netherlands
Spaarne Gasthuis /ID# 161003
Haarlem, , Netherlands
Medisch Centrum Leeuwarden /ID# 156043
Leeuwarden, , Netherlands
Timaru Medical Specialists Ltd /ID# 159184
Timaru, , New Zealand
Wellington Hospital (Capital and Coast District Health Board) /ID# 154591
Wellington, , New Zealand
Medyczne Centrum Hetmanska /ID# 155746
Poznan, Greater Poland Voivodeship, Poland
Malopolskie Centrum Kliniczne /ID# 157180
Krakow, Lesser Poland Voivodeship, Poland
Centrum Medyczne AMED Warszawa Targowek /ID# 159589
Warsaw, Masovian Voivodeship, Poland
Gabinet Internistyczno Reum. /ID# 157433
Bialystok, Podlaskie Voivodeship, Poland
ClinicMed Daniluk, Nowak Sp.j. /ID# 202998
Bialystok, Podlaskie Voivodeship, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni /ID# 202472
Gdynia, Pomeranian Voivodeship, Poland
Centrum Med Amed Oddzial Lodzi /ID# 154458
Lodz, , Poland
Salve Medica Sp. z o.o. S.K. /ID# 202473
Lodz, Łódź Voivodeship, Poland
Instituto Portugues De Reumatologia /ID# 155698
Lisbon, Lisbon District, Portugal
Centro Hospitalar Lisboa Ocidental, EPE /ID# 200035
Lisbon, Lisbon District, Portugal
Hospital Garcia de Orta, E.P.E /ID# 164056
Almada, Setúbal District, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 200037
Lisbon, , Portugal
Unidade Local De Saude Do Alto Minho /ID# 200036
Viana do Castelo, , Portugal
Centro Hosp de Tondela-Viseu /ID# 155699
Viseu, , Portugal
Dr. Ramon L. Ortega-Colon, MD /ID# 158097
Carolina, , Puerto Rico
GCM Medical Group /ID# 156158
San Juan, , Puerto Rico
Spitalul Clinic Dr. I. Cantacuzino /ID# 155893
Bucharest, București, Romania
Spitalul Clinic Sf. Maria /ID# 167245
Bucharest, , Romania
Family Outpatient clinic#4 LLC /ID# 203524
Korolev, Moscow, Russia
LLC Medical Center /ID# 203523
Novosibirsk, Novosibirsk Oblast, Russia
Alliance Biomedical Ural Group /ID# 154609
Izhevsk, Udmurtiya Republic, Russia
State Budget Healthcare Instit /ID# 154593
Moscow, , Russia
Nort-Western State Medical Uni /ID# 154610
Saint Petersburg, , Russia
Novamed,spol.s.r.o. /ID# 157928
Banská Bystrica, , Slovakia
Univerzitna Nemocnica Bratislava /ID# 161143
Bratislava, , Slovakia
Narodny ustav reumatickych chorob Piestany /ID# 156864
Pieštany, , Slovakia
SMG-SNU Boramae Medical Center /ID# 155788
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital /ID# 155231
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 154639
Seoul, , South Korea
Hospital Universitario Reina S /ID# 155701
Córdoba, , Spain
Hospital General Univ de Elche /ID# 158825
Elche, , Spain
Hospital Universitario La Paz /ID# 163636
Madrid, , Spain
Corp Sanitaria Parc Tauli /ID# 163634
Sabadell, Barcelona, , Spain
Complejo Hospitalario /ID# 155700
Santiago de Compostela, , Spain
Hospital Infanta Luisa /ID# 154641
Seville, , Spain
Skanes Universitetssjukhus /ID# 165133
Malmo, Skåne County, Sweden
Akademiskt specialistcentrum Centrum for reumatologi /ID# 156046
Stockholm, Stockholm County, Sweden
Sahlgrenska University Hosp /ID# 162775
Gothenburg, , Sweden
Vastmanlands Sjukhus /ID# 159186
Västerås, , Sweden
Hopitaux Universitaires de Geneve /ID# 159083
Geneva, Canton of Geneva, Switzerland
Kantonsspital St. Gallen /ID# 155232
Sankt Gallen, Canton of St. Gallen, Switzerland
University Hospital of Basel /ID# 160860
Basel, , Switzerland
HFR Fribourg - Hopital Canton /ID# 160970
Fribourg, , Switzerland
Hacettepe University Medical Faculty /ID# 167995
Ankara, , Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 162691
Ankara, , Turkey (Türkiye)
Akdeniz University Faculty /ID# 163153
Antalya, , Turkey (Türkiye)
Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastırma Hastanesi /ID# 169479
Istanbul, , Turkey (Türkiye)
Whipps Cross Univ Hospital /ID# 205985
London, London, City of, United Kingdom
Ninewells Hospital /ID# 156050
Dundee, , United Kingdom
Altnagelvin Area Hospital /ID# 156540
Londonderry, , United Kingdom
Lancashire Care NHS Foundation /ID# 156042
Preston, , United Kingdom
Royal Cornwall Hospital /ID# 157785
Truro, , United Kingdom
Countries
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References
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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.
Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.
Rubbert-Roth A, Kato K, Haraoui B, Rischmueller M, Liu Y, Khan N, Camp HS, Xavier RM. Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis Refractory to Biologic DMARDs: Results Through Week 216 from the SELECT-CHOICE Study. Rheumatol Ther. 2024 Oct;11(5):1197-1215. doi: 10.1007/s40744-024-00694-x. Epub 2024 Jul 20.
Rubbert-Roth A, Kakehasi AM, Takeuchi T, Schmalzing M, Palac H, Coombs D, Liu J, Anyanwu SI, Lippe R, Curtis JR. Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis. Rheumatol Ther. 2024 Feb;11(1):97-112. doi: 10.1007/s40744-023-00621-6. Epub 2023 Nov 20.
Charles-Schoeman C, Choy E, McInnes IB, Mysler E, Nash P, Yamaoka K, Lippe R, Khan N, Shmagel AK, Palac H, Suboticki J, Curtis JR. MACE and VTE across upadacitinib clinical trial programmes in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. RMD Open. 2023 Nov;9(4):e003392. doi: 10.1136/rmdopen-2023-003392.
Fleischmann R, Curtis JR, Charles-Schoeman C, Mysler E, Yamaoka K, Richez C, Palac H, Dilley D, Liu J, Strengholt S, Burmester G. Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme. Ann Rheum Dis. 2023 Sep;82(9):1130-1141. doi: 10.1136/ard-2023-223916. Epub 2023 Jun 12.
Burmester GR, Cohen SB, Winthrop KL, Nash P, Irvine AD, Deodhar A, Mysler E, Tanaka Y, Liu J, Lacerda AP, Palac H, Shaw T, Mease PJ, Guttman-Yassky E. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1):e002735. doi: 10.1136/rmdopen-2022-002735.
Kakehasi AM, Radominski SC, Baravalle MD, Palazuelos FCI, Garcia-Garcia C, Arruda MS, Curi M, Liu J, Qiao M, Velez-Sanchez P, Vargas JI. Safety of upadacitinib in Latin American patients with rheumatoid arthritis: an integrated safety analysis of the SELECT phase 3 clinical program. Clin Rheumatol. 2023 May;42(5):1249-1258. doi: 10.1007/s10067-023-06513-y. Epub 2023 Jan 30.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-000933-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-925
Identifier Type: -
Identifier Source: org_study_id
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