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

July 17, 2024 updated by: AbbVie

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
657

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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, 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: Abatacept
IV infusion
Drug: Upadacitinib
15 mg extended release tablet
Other Names:
  • ABT-494
Drug: Placebo for upadacitinib
Film-coated tablet
Experimental: 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.
Drug: Upadacitinib
15 mg extended release tablet
Other Names:
  • ABT-494
Drug: Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion)
IV infusion
Experimental: 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.
Drug: Upadacitinib
15 mg extended release tablet
Other Names:
  • ABT-494
Drug: Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion)
IV infusion
Active Comparator: 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.
Drug: Abatacept
IV infusion
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Non-inferiority)
Time Frame: Baseline and Week 12
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Superiority)
Time Frame: Baseline and Week 12
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)
Time Frame: At Week 12
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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