A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) (SELECT - PsA 1)

September 2, 2025 updated by: AbbVie

A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) - SELECT - PsA 1

This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression.

The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study includes a 35-day screening period, a 56-week blinded period (Period 1), a long-term extension period of up to a total treatment duration of approximately 5 years (Period 2), a 30-day follow-up call or visit, and a 70-day follow-up call.

Period 1 includes 24 weeks of randomized, double-blind, placebo-controlled and active comparator-controlled treatment followed by 32 weeks of active comparator-controlled upadacitinib; at Week 24 participants assigned to placebo will be switched to upadacitinib according to their randomization assignment.

Participants who meet eligibility criteria will be randomized in a 2:2:2:1:1 ratio to one of five treatment groups:

  • Group 1: Upadacitinib 15 mg QD
  • Group 2: Upadacitinib 30 mg QD
  • Group 3: Adalimumab 40 mg every other week (EOW)
  • Group 4: Placebo followed by upadacitinib 15 mg QD
  • Group 5: Placebo followed by upadacitinib 30 mg QD

Randomization will be stratified by extent of psoriasis (≥ 3% body surface area [BSA] or < 3% BSA), current use of at least 1 non-biologic DMARD, presence of dactylitis, and presence of enthesitis, except for participants from China and Japan, where randomization for each country will be stratified by extent of psoriasis (≥ 3% BSA or < 3% BSA) only.

Participants who complete the Week 56 visit (end of Period 1) will enter the long-term extension portion of the study, Period 2 (total treatment up to approximately 5 years), and continue study treatment as assigned in Period 1 in a blinded manner until the last subject completes the last visit of Period 1 (Week 56), when study drug assignment in both periods will be unblinded and participants will be dispensed study drug in an open-label fashion until the completion of Period 2.

At Week 16, rescue therapy will be offered to participants classified as non-responders (defined as not achieving at least 20% improvement in tender joint count (TJC) and / or swollen joint count (SJC) at both Week 12 and Week 16). Starting at Week 36, participants who fail to demonstrate at least 20% improvement in either or both TJC and SJC compared to Baseline at 2 consecutive visits will be discontinued from study drug treatment. Additionally, in participants continuing on study drug, starting at the Week 36 visit, initiation of or change in background PsA medication(s) is allowed as per local label.

Study Type

Interventional

Enrollment (Actual)

1705

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, 1015
        • Organizacion Medica de Investigacion (OMI) /ID# 160118
      • Buenos Aires, Argentina, 1221
        • Hospital General de Agudos Ram /ID# 164378
      • Buenos Aires, Argentina, 1425
        • Psoriahue Med Interdisciplinar /ID# 160506
      • CABA, Argentina, 1428
        • Inst. de Rehab. Psicofisica /ID# 165154
      • Rosario, Santa FE, Argentina, 2000
        • Instituto CAICI /ID# 160119
      • SAN Miguel de Tucuman, Latam, Argentina, 4000
        • Centro Integral de Medicina Re /ID# 160258
      • Santa Fe, Argentina, 2000
        • Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 165795
    • Ciuadad Autonoma de Buenos Aires
      • San Miguel de Tucumán, Ciuadad Autonoma de Buenos Aires, Argentina, 4000
        • Centro Medico Privado/Reuma /ID# 159775
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Centro Integral de Medicina Respiratoria (CIMER) /ID# 211237
  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Emeritus Research Sydney /ID# 166780
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital /ID# 169333
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Barwon Rheumatology /ID# 166782
      • Heidelberg West, Victoria, Australia, 3081
        • Heidelberg Repatriation Hospital /ID# 167450
  • Belarus
      • Brest, Belarus, 224027
        • Brest Regional Hospital /ID# 164535
      • Grodno, Belarus, 230017
        • Healthcare Institution /ID# 164536
      • Minsk, Belarus, 220013
        • First City Clinical Hospital /ID# 164534
  • Belgium
      • Genk, Belgium, 3600
        • Reuma clinic /ID# 164243
  • Bosnia and Herzegovina
      • Mostar, Bosnia and Herzegovina, 88000
        • University Clinical Hospital Mostar /ID# 165799
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo /ID# 164502
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 164503
  • Brazil
      • São Paulo, Brazil, 01244-030
        • CPCLIN - Centro de Pesquisas Clínicas /ID# 161818
    • Goiás
      • Aparecida de Goiânia, Goiás, Brazil, 74935-530
        • Instituto de Ciencias Farmacêuticas /ID# 163274
      • Goiânia, Goiás, Brazil, 74110-120
        • CIP - Centro Internacional de Pesquisa /ID# 161821
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 161819
    • Paraná
      • Curitiba, Paraná, Brazil, 80440-080
        • EDUMED Educacao em Saude S/S L /ID# 161816
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
        • Instituto de Educação e Pesquisa do Hospital Moinhos de Vento /ID# 161813
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre /ID# 161820
      • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
        • LMK Sevicos Medicos S/S /ID# 161812
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163273
      • Santo André, São Paulo, Brazil, 09060-870
        • Faculdade de Medicina do ABC /ID# 163491
      • Santo André, São Paulo, Brazil, 09190-510
        • CEMEC - Centro Multidisciplinar de Estudos Clínicos do ABC /ID# 161810
  • Bulgaria
      • Plovdiv, Bulgaria, 4003
        • Department of Rheumatology, Mu /ID# 169606
      • Sofia, Bulgaria, 1407
        • Excelsior Medical Center /ID# 169609
      • Sofia, Bulgaria, 1606
        • Multiprofile Hospital for Active Treatment - Sofia at Military Medical Academy /ID# 169608
      • Sofia, Bulgaria, 1612
        • UMHAT Sv. Ivan Rilski /ID# 202393
      • Sofia, Bulgaria, 1784
        • Medical Centre Synexus Sofia /ID# 202394
      • Stara Zagora, Bulgaria, 6000
        • Medical Centre Synexus Sofia, branch Stara Zagora /ID# 202524
      • Varna, Bulgaria, 9000
        • Diagnostic Consultative Center /ID# 169607
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3M9
        • Percuro Clinical Research, Ltd /ID# 157823
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Manitoba Clinic /ID# 157829
      • Winnipeg, Manitoba, Canada, R3N 0K6
        • Ciads /Id# 157831
    • Ontario
      • Barrie, Ontario, Canada, L4M 6L2
        • The Waterside Clinic /ID# 157826
    • Quebec
      • Sainte-Foy, Quebec, Canada, G1V 3M7
        • Groupe de Recherche en Maladies Osseuses Inc /ID# 157824
      • Trois-Rivières, Quebec, Canada, G8Z 1Y2
        • Ctr. de Recherche Musculo-Sque /ID# 207069
  • Chile
      • Providencia, Chile, 7500571
        • CTR Estudios SpA /ID# 206217
      • Santiago, Chile, 8420383
        • Centro Inter Estud Clin CIEC /ID# 168725
      • Santiago, Chile, ZC:7510047
        • Prosalud Ltda. /ID# 169546
      • Vitacura Santiago, Chile, 7640881
        • Clinica Dermacross S.A /ID# 168726
    • Santiago Metropolitan
      • Ñuñoa, Santiago Metropolitan, Chile, 7750495
        • M y F Estudios Clínicos Ltda. /ID# 168722
  • China
      • Hohhot, China, 010050
        • The Aff Hosp Inner Mongolia /ID# 207787
      • Kunming, China, 650032
        • First Affiliated Hospital of Kunming Medical University /ID# 201264
      • Nantong, China, 226001
        • Affiliated hospital of nantong university /ID# 208234
      • Suzhou, China, 215006
        • The First Affiliated Hospital of Soochow University /ID# 201875
      • Ürümqi, China, 830001
        • People's Hospital of Xinjiang /ID# 201592
    • Anhui
      • Bengbu, Anhui, China, 233004
        • 1st Aff Hosp of Bengbu Medical College /ID# 201021
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital /ID# 201973
    • Guangdong
      • Shantou, Guangdong, China, 515041
        • The First Affiliated Hospital of Shantou University Medical College /ID# 203371
    • Hunan
      • Zhuzhou, Hunan, China, 412007
        • Zhuzhou Central Hospital /ID# 200201
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014016
        • The First Affiliated Hospital of Baotou Medical College, Inner Monggolia Univers /ID# 171204
    • Shandong
      • Linyi, Shandong, China, 276034
        • The First People's Hospital of Linyi /ID# 201970
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Huashan Hospital of Fudan University /ID# 202191
      • Shanghai, Shanghai Municipality, China, 200433
        • Shanghai Changhai Hospital /ID# 200202
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital /ID# 200199
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First Hospital /ID# 201874
  • Colombia
      • Antioquia, Colombia, 050022
        • Fundacion Centro de Investigac /Id# 168201
      • Barranquilla, Colombia, 80002
        • Ctr Int de Reum del Caribe SAS /ID# 164051
      • Chía, Colombia, 250001
        • Preventive Care Sas /Id# 163781
      • Medellín, Colombia
        • Hospital Pablo Tobon Uribe /ID# 164233
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110231
        • Centro de Investigacion en Reumatologia CIREEM /ID# 166030
  • Croatia
      • Zagreb, Croatia, 10000
        • Medical Center Kuna-Peric /ID# 161160
      • Zagreb, Croatia, 10000
        • Poliklinika Bonifarm /ID# 206662
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Poliklinika Repromed /ID# 203555
    • Primorje-Gorski Kotar County
      • Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
        • Klinicki bolnicki centar Rijeka /ID# 161159
  • Czechia
      • Bruntál, Czechia, 79201
        • Revmatologie Bruntal, s.r.o /ID# 159636
      • Ostrava, Czechia, 722 00
        • Artroscan s.r.o. /ID# 159634
      • Uherské Hradište, Czechia, 686 01
        • Medical Plus, s.r.o. /ID# 159635
    • Praha 4
      • Prague, Praha 4, Czechia, 140 00
        • Revmatologicka ambulance /ID# 159637
      • Prague, Praha 4, Czechia, 140 00
        • Revmatologicka ambulance /ID# 159671
  • Estonia
      • Tallinn, Estonia, 10138
        • East Tallinn Central Hospital /ID# 163790
    • Harju
      • Tallinn, Harju, Estonia, 10128
        • Center of Clinical and Basic Research /ID# 163870
    • Tartu
      • Tartu, Tartu, Estonia, 50406
        • MediTrials /ID# 163706
  • Germany
      • Buch, Germany, 13125
        • Immanuel-Krankenhaus /ID# 163931
      • Dresden, Germany, 01307
        • University Clinic Carl Gustav /ID# 163926
      • Düsseldorf, Germany, 40225
        • Polikilinik fuer Rheumatologie /ID# 163933
      • Frankfurt, Germany, 60590
        • Cent fur Innovative Diagnostik /ID# 163927
      • Hamburg, Germany, 20095
        • Hamburger Rheuma Forschungszentrum II im MVZ Rheumatologie und Autoimmunmedizin /ID# 204421
      • Rendsburg, Germany, 24768
        • Dr. med. Jochen Walter FA fuer /ID# 168638
      • Tübingen, Germany, 72076
        • Med. Universitaetsklinik Inner /ID# 163929
    • North Rhine-Westphalia
      • Herne, North Rhine-Westphalia, Germany, 44649
        • Rheumazentrum Ruhrgebiet /ID# 163930
  • Greece
      • Athens, Greece, 11521
        • Naval Hospital of Athens /ID# 163486
      • Heraklion, Greece, 71110
        • University General Hospital of Heraklion PA.G.N.I /ID# 163472
      • Larissa, Greece, 41110
        • Reg Gen Univ Hosp Larissa /ID# 163496
    • Attica
      • Athens, Attica, Greece, 115 27
        • General Hospital of Athens Laiko /ID# 163476
      • Athens, Attica, Greece, 115 27
        • General Hospital of Athens Laiko /ID# 163478
      • Athens, Attica, Greece, 12462
        • University General Hospital Attikon /ID# 163477
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Prince of Wales Hospital /ID# 163506
      • Hong Kong, Hong Kong, 999077
        • Queen Mary Hospital /ID# 162492
      • Tuenmen, Hong Kong, 999077
        • Tuen Mun Hospital /ID# 162493
  • Hungary
      • Budapest, Hungary, 1023
        • Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz /ID# 170719
      • Budapest, Hungary, 1027
        • Revita Reumatologiai Rendelo /ID# 163277
      • Budapest, Hungary, 1036
        • Obudai Egeszsegugyi Centrum Kft. /ID# 163279
      • Budapest, Hungary, 1036
        • Synexus Magyarorszag Kft. /ID# 203012
      • Debrecen, Hungary, 4031
        • Debreceni Egyetem Kenezy Gyula /ID# 163276
      • Veszprém, Hungary, 8200
        • Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 163275
    • Bekes County
      • Gyula, Bekes County, Hungary, 5700
        • Synexus Magyarorszag Kft. - Gyula DRS /ID# 202209
    • Pest County
      • Budapest III, Pest County, Hungary, 1036
        • Qualiclinic Kft. /ID# 163278
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatok.- Klinikai Kutatasi O. /ID# 202584
    • Zala County
      • Zalaegerszeg, Zala County, Hungary, 8900
        • Synexus Magyarorszag Kft. - Zalaegerszeg AS /ID# 201884
  • Ireland
      • Dublin, Ireland, D04 T6F4
        • St Vincent's University Hosp /ID# 161073
      • Limerick, Ireland, V35 F434
        • Croom Orthopaedic Hospital /ID# 164998
  • Israel
      • Haifa, Israel, 3436212
        • The Lady Davis Carmel MC /ID# 170262
      • Ramat Gan, Israel, 5239424
        • Sheba Medical Center /ID# 202532
    • Tel Aviv
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 169845
  • Italy
      • Ancona, Italy, 60023
        • Ospedali Riuniti Universita /ID# 161085
      • Catania, Italy, 95123
        • Azienda Ospedaliera Universitaria Policlinico "G. Rodolico - San Marco" /Id# 161084
    • Campania
      • Naples, Campania, Italy, 80131
        • AOU Federico II /ID# 202411
    • Emilia-Romagna
      • Reggio Emilia, Emilia-Romagna, Italy, 42123
        • Azienda Unita Sanitaria Locale/IRCCS c/o Arcispedale Santa Maria Nuova /ID# 161090
    • Lazio
      • Rome, Lazio, Italy, 00128
        • Policlinico Universitario Campus Bio-Medico /ID# 162306
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Nagoya City University Hospital /ID# 162564
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital /ID# 162086
      • Kitakyushu-shi, Fukuoka, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health /ID# 161473
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Mie University Hospital /ID# 162080
    • Osaka
      • Kawachinagano-shi, Osaka, Japan, 586-8521
        • National Hospital Organization Osaka Minami Medical Center /ID# 162590
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-8560
        • St.Luke's International Hospital /ID# 162016
  • Latvia
      • Liepāja, Latvia, 3401
        • D.Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 161488
      • Riga, Latvia, 1005
        • Clinic ORTO /ID# 161486
      • Riga, Latvia, LV-1002
        • P. Stradins Clinical Univ Hosp /ID# 164442
      • Ādaži, Latvia, LV2167
        • M &M Centrs /Id# 161483
  • Lithuania
      • Kaunas, Lithuania, 50128
        • VAKK dr. Kildos Clinic /ID# 167257
      • Klaipėda, Lithuania, 92288
        • Klaipeda University Hospital /ID# 167258
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital /ID# 165123
      • Šiauliai, Lithuania, 76231
        • Public Institution Republican /ID# 165155
  • Malaysia
      • Seremban, Malaysia, 70300
        • Hospital Tuanku Ja afar /ID# 161096
    • Perak
      • Ipoh, Perak, Malaysia, 30450
        • Hospital Raja Permaisuri Bainun /ID# 161099
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Invest y Biomed de Chihuahua /ID# 164007
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Instituto Jalisciense de Metabolismo SC /ID# 164005
    • Mexico City
      • Mexico City, Mexico City, Mexico, 11850
        • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 164006
  • Netherlands
      • Leeuwarden, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden /ID# 161575
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus Medisch Centrum /ID# 161092
      • Rotterdam, Netherlands, 3079 DZ
        • Maasstad Ziekenhuis /ID# 160168
  • New Zealand
      • Auckland, New Zealand, 0622
        • North Shore Hospital /ID# 169409
      • Auckland, New Zealand, 2025
        • Middlemore Hospital /ID# 166414
      • Nelson, New Zealand, 7010
        • Porter Rheumatology Ltd /ID# 200421
      • Timaru, New Zealand, 7910
        • Timaru Rheumatology Studies /ID# 166413
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3204
        • Waikato Hospital /ID# 166415
  • Norway
    • Sogn Og Fjordane
      • Førde, Sogn Og Fjordane, Norway, 6812
        • Helse Forde /ID# 167853
    • Sor-Trondelag
      • Trondheim, Sor-Trondelag, Norway, 7006
        • St. Olavs Hospital HF /ID# 163321
  • Poland
      • Elblag, Poland, 82-300
        • Centrum Kliniczno-Badawcze /ID# 161830
      • Krakow, Poland, 31-501
        • Krakowskie Centrum Medyczne /ID# 206302
      • Poznan, Poland, 60-702
        • Synexus Polska Sp. z o.o. Oddzial w Poznaniu /ID# 207158
      • Warsaw, Poland, 00-874
        • Medycyna Kliniczna /ID# 166288
      • Warsaw, Poland, 01-192
        • Synexus Polska Sp. z.o.o. /ID# 203987
      • Warsaw, Poland, 02-691
        • Reumatika - Centrum Reumatologii NZOZ /ID# 161831
    • Kuyavian-Pomeranian Voivodeship
      • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
        • NZOZ Nasz Lekarz /ID# 163774
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-149
        • Malopolskie Centrum Kliniczne /ID# 163777
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-381
        • Synexus Polska Sp. z o.o. /ID# 204506
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-382
        • Synexus Polska Sp. z o.o. Oddzial w Gdansku /ID# 206299
      • Gdynia, Pomeranian Voivodeship, Poland, 81-537
        • Synexus Polska Sp. z o.o. Oddzial w Gdyni /ID# 207157
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-040
        • Synexus Polska Sp. z o.o. Oddzial Katowice /ID# 204510
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-117
        • ETYKA-Osrodek Badan Klinicznyc /ID# 163776
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 91-211
        • Salve Medica Sp. z o.o. S.K. /ID# 206300
  • Portugal
      • Lisbon, Portugal, 1998-018
        • Hospital CUF Descobertas /ID# 165866
      • Lisbon, Portugal, 1649-035
        • Centro Hospitalar Lisboa Norte, EPE /ID# 165860
      • Loures, Portugal, 2674-514
        • Hospital Beatriz Angelo /ID# 165865
      • Viana do Castelo, Portugal, 4901-858
        • Unidade Local De Saude Do Alto Minho /ID# 165863
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1050-034
        • Instituto Portugues De Reumatologia /ID# 165858
      • Lisbon, Lisbon District, Portugal, 1349-019
        • Centro Hospitalar Lisboa Ocidental, EPE /ID# 165861
    • Porto District
      • Vila Nova de Gaia, Porto District, Portugal, 4434-502
        • Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 165862
  • Puerto Rico
      • Carolina, Puerto Rico, 00985
        • Cruz-Santana, Carolina, PR /ID# 163307
      • Ponce, Puerto Rico, 00716-0377
        • Ponce Medical School Foundation /ID# 163920
      • San Juan, Puerto Rico, 00917
        • GCM Medical Group, PSC /ID# 162160
  • Russia
      • Moscow, Russia, 125284
        • Moscow S.P.Botkin City Clinica /ID# 164533
      • Saint Petersburg, Russia, 192242
        • State budgetary institution /ID# 164532
    • Moscow
      • Korolev, Moscow, Russia, 141060
        • Family Outpatient clinic#4 LLC /ID# 164530
    • Novosibirsk Oblast
      • Novosibirsk, Novosibirsk Oblast, Russia, 630099
        • LLC Medical Center /ID# 164529
    • Tatarstan, Respublika
      • Kazan', Tatarstan, Respublika, Russia, 420012
        • Kazan State Medical University /ID# 164531
  • Serbia
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Rheumatology /ID# 166217
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Rheumatology /ID# 166223
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Rheumatology /ID# 166229
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Rheumatology /ID# 166231
      • Belgrade, Beograd, Serbia, 11000
        • Military Medical Academy /ID# 166293
  • Singapore
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital /ID# 161095
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 169068
        • Singapore General Hospital /ID# 161094
  • Slovakia
      • Martin, Slovakia, 036 01
        • MEDMAN s.r.o. /ID# 165892
      • Nové Mesto nad Váhom, Slovakia, 915 01
        • Reumatologická ambulancia Reum.hapi s.r.o. /ID# 166486
      • Pieštany, Slovakia, 921 01
        • Slovak research center Team Member, Thermium s.r.o. /ID# 166489
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Univ Medical Ctr Ljubljana /ID# 164212
      • Maribor, Slovenia, 2000
        • University Medical Ctr Maribor /ID# 169260
      • Murska Sobota, Slovenia, 9000
        • General Hospital Murska Sobota /ID# 164211
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6045
        • Greenacres Hospital /ID# 164190
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research Site /ID# 163919
      • Pretoria, Gauteng, South Africa, 0001
        • University of Pretoria /ID# 163852
      • Pretoria, Gauteng, South Africa, 0002
        • Jakaranda Hospital /ID# 164242
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7405
        • Arthritis Clinical Research Tr /ID# 163855
      • Stellenbosch, Western Cape, South Africa, 7600
        • Winelands Medical Research Ctr /ID# 163853
  • South Korea
    • Gyeonggido
      • Suwon, Gyeonggido, South Korea, 16499
        • Ajou University Hospital /ID# 163891
    • Incheon Gwang Yeogsi
      • Junggu, Incheon Gwang Yeogsi, South Korea, 22332
        • Inha University Hospital /ID# 163890
  • Spain
      • Granada, Spain, 18016
        • Hospital Campus de la Salud /ID# 170760
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal /ID# 161130
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre /ID# 163198
    • A Coruna
      • A Coruña, A Coruna, Spain, 15006
        • Hospital Universitario A Coruña - CHUAC /ID# 161129
  • Switzerland
      • Fribourg, Switzerland, 1708
        • HFR Fribourg - Hopital Canton /ID# 162090
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen /ID# 158131
  • Taiwan
      • Taichung, Taiwan, 404
        • Chung Shan Medical University /ID# 159403
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital /ID# 160878
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hosp /ID# 166222
      • Taoyuan, Taiwan, 33305
        • Linkou Chang Gung Memorial Ho /ID# 166221
    • Taichung
      • Taichung, Taichung, Taiwan, 40447
        • China Medical University Hosp /ID# 159402
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34147
        • Bakirkoy Dr. Sadi Konuk Training & Research Hospital /ID# 162517
      • Istanbul, Turkey (Türkiye), 34899
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 163383
      • Meram Konya, Turkey (Türkiye), 42080
        • Necmettin Erbakan Universitesi /ID# 163382
      • Sakarya, Turkey (Türkiye), 54100
        • Sakarya Universitesi Egitim /ID# 163397
    • Adana
      • Saricam Adana, Adana, Turkey (Türkiye), 01330
        • Cukurova Universitesi Tip Fakultesi /ID# 162516
    • Ankara
      • Sihhiye, Ankara, Turkey (Türkiye), 06100
        • Hacettepe Universitesi Tip Fak /ID# 162518
  • Ukraine
      • Kharkiv, Ukraine, 61058
        • Kharkiv Regional Council Regional Clinical Hospital /ID# 210189
      • Kiev, Ukraine, 03680
        • NSC Strazhesko Ist Cardiology /ID# 164043
      • Kyiv, Ukraine, 02002
        • Med Ctr of Private High Ed Ins /ID# 208527
      • Kyiv, Ukraine, 03037
        • Medical Center of LLC Medbud-Clinic /ID# 208528
      • Kyiv, Ukraine, 03049
        • Kyiv Railway Clinical Hosp No.2 /ID# 208951
      • Kyiv, Ukraine, 04070
        • LLC Revmocentr /ID# 164177
      • Kyiv, Ukraine, 04107
        • MNI KRC Kyiv Regional Clinical Hospital /ID# 210188
      • Odesa, Ukraine, 65026
        • Odessa National Medical Univ /ID# 164244
      • Vinnytsia, Ukraine, 21018
        • Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 164245
    • Kharkivs’ka Oblast’
      • Kharkiv, Kharkivs’ka Oblast’, Ukraine, 61039
        • State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 164170
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ukraine, 79013
        • Lviv Regional Clinical Hospita /ID# 164178
  • United Kingdom
      • Christchurch, United Kingdom, BH23 2JX
        • Christchurch Hospital /ID# 162702
      • Coventry, United Kingdom, CV2 2DX
        • UH Coventry & Warwickshire /ID# 162701
      • Glasgow, United Kingdom, G4 0SF
        • Glasgow Royal Infirmary /ID# 162703
      • Luton, United Kingdom, LU4 0DZ
        • Luton & Dunstable University Hospital /ID# 162704
    • London, City of
      • London, London, City of, United Kingdom, E11 1NR
        • Whipps Cross Univ Hospital /ID# 161055
      • London, London, City of, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Found /ID# 161065
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Rheum Assoc of North Alabama /ID# 163231
    • Arizona
      • Peoria, Arizona, United States, 85381
        • SunValley Arthritis Center, Lt /ID# 161221
      • Phoenix, Arizona, United States, 85032-9306
        • AZ Arthritis and Rheumotology Research, PLLC /ID# 159981
      • Phoenix, Arizona, United States, 85032-9306
        • AZ Arthritis and Rheumotology Research, PLLC /ID# 160033
      • Phoenix, Arizona, United States, 85032-9306
        • AZ Arthritis and Rheumotology Research, PLLC /ID# 160036
      • Phoenix, Arizona, United States, 85032
        • AZ Arthritis & Rheuma Research /ID# 160037
      • Tucson, Arizona, United States, 85704
        • AZ Arth & Rheum Res /ID# 166381
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Little Rock Diagnostics Clinic /ID# 165161
    • California
      • Covina, California, United States, 91722
        • Covina Arthritis Clinic /ID# 159891
      • Fullerton, California, United States, 92835
        • St. Joseph Heritage Healthcare /ID# 159980
      • Hemet, California, United States, 92543
        • C.V. Mehta MD, Med Corporation /ID# 161216
      • Huntington Beach, California, United States, 92648
        • Care Access Research, Huntingt /ID# 160038
      • La Mesa, California, United States, 91942
        • Kotha and Kotha /ID# 159823
      • La Mesa, California, United States, 91942
        • TriWest Research Associates- La Mesa /ID# 159887
      • La Palma, California, United States, 90623-1728
        • Arthritis & Osteo Medical Ctr /ID# 166760
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles /ID# 164542
      • Mather, California, United States, 95655
        • VA Sacramento Medical Center /ID# 164196
      • San Leandro, California, United States, 94578
        • East Bay Rheumatology Medical /ID# 166382
      • Upland, California, United States, 91786
        • Inland Rheum Clin Trials Inc. /ID# 159828
      • Whittier, California, United States, 90606
        • Medvin Clinical Research /ID# 160034
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic /ID# 159873
      • Fort Collins, Colorado, United States, 80528
        • Arthritis and Rheum Clin N. CO /ID# 160039
      • Lakewood, Colorado, United States, 80228
        • Colorado Arthritis Associates /ID# 159847
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Stamford Therapeutics Consorti /ID# 165131
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Res of West FL, Inc. /ID# 159829
      • Daytona Beach, Florida, United States, 32117
        • International Medical Research - Daytona /ID# 160040
      • DeBary, Florida, United States, 32713-2260
        • Omega Research Maitland, LLC /ID# 164193
      • Miami, Florida, United States, 33126
        • LeJenue Research Associates /ID# 170965
      • Miami Lakes, Florida, United States, 33016-1501
        • Precision Research Org, LLC /ID# 161287
      • Naples, Florida, United States, 34102
        • Medallion Clinical Research Institute, LLC /ID# 161228
      • Ormond Beach, Florida, United States, 32174
        • Millennium Research /ID# 159822
      • Palm Harbor, Florida, United States, 34684
        • Arthritis Center, Inc. /ID# 163465
      • Pensacola, Florida, United States, 32514
        • Gulf Region Clinical Res Inst /ID# 159851
      • St. Petersburg, Florida, United States, 33705
        • BayCare Medical Group /ID# 159792
      • Tamarac, Florida, United States, 33321
        • W. Broward Rheum Assoc Inc. /ID# 161388
      • Tampa, Florida, United States, 33606-1246
        • Clinical Research of West Florida, Inc /ID# 160063
      • Tampa, Florida, United States, 33612
        • University of South Florida /ID# 161286
      • Tampa, Florida, United States, 33614-7101
        • BayCare Medical Group, Inc. /ID# 159879
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic /ID# 159992
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Institute of Arthritis Researc /ID# 165873
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research /ID# 159894
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials /ID# 163435
      • Rockford, Illinois, United States, 61114-4937
        • OrthoIllinois /ID# 164546
      • Skokie, Illinois, United States, 60076
        • Clinical Investigation Specialists - Skokie /ID# 160062
      • Vernon Hills, Illinois, United States, 60061
        • Deerbrook Medical Associates /ID# 159804
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves Gilbert Clinic /ID# 161285
      • Paducah, Kentucky, United States, 42001
        • Four Rivers Clinical Research /ID# 159982
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation-New Orleans /ID# 165672
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University /ID# 167665
      • Cumberland, Maryland, United States, 21502
        • Klein & Associates, M.D., P.A. /ID# 164013
      • Wheaton, Maryland, United States, 20902
        • The Center for Rheumatology & Bone Research /ID# 159874
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center /ID# 165144
      • Mansfield, Massachusetts, United States, 02048
        • Mansfield Health Center /ID# 159805
      • Worcester, Massachusetts, United States, 01605
        • Clinical Pharmacology Study Gr /ID# 158700
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Univ of Michigan Hospitals /ID# 164014
      • Grand Blanc, Michigan, United States, 48439
        • Aa Mrc Llc /Id# 159846
      • Lansing, Michigan, United States, 48910
        • Advanced Rheumatology, PC /ID# 159893
      • Lansing, Michigan, United States, 48917
        • Beals Institute PC /ID# 163128
      • Saint Clair Shores, Michigan, United States, 48081
        • Shores Rheumatology, PC /ID# 159889
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Luke's Hospital of Duluth /ID# 165671
    • Missouri
      • Springfield, Missouri, United States, 65810-2607
        • Clinvest Research LLC /ID# 161227
      • St Louis, Missouri, United States, 63119-3845
        • Clayton Medical Associates dba Saint Louis Rheumatology /ID# 159878
    • Montana
      • Kalispell, Montana, United States, 59901
        • Glacier View Research Institut /ID# 167023
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Westroads Clinical Research /ID# 159979
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center /ID# 161235
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Arthritis and Osteoporosis Associates /ID# 159802
      • Toms River, New Jersey, United States, 08755
        • Atlantic Coast Research /ID# 159799
      • Toms River, New Jersey, United States, 08755
        • Ocean Rheumatology, PA /ID# 163898
    • New Mexico
      • Las Cruces, New Mexico, United States, 88011
        • Arthritis and Osteo Assoc /ID# 159994
      • Santa Fe, New Mexico, United States, 87505
        • Santa Fe Rheumatology /ID# 163783
    • New York
      • Lake Success, New York, United States, 11554
        • NYU Langone Rheum Assoc /ID# 159985
      • New York, New York, United States, 10016-6402
        • NYU Langone Medical Center /ID# 163230
      • Potsdam, New York, United States, 13676
        • St. Lawrence Health System /ID# 159848
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • American Health Research /ID# 164354
      • Charlotte, North Carolina, United States, 28210-8508
        • DJL Clinical Research, PLLC /ID# 161390
      • Durham, North Carolina, United States, 27704
        • M3-Emerging Medical Research, LLC /ID# 161391
      • Greenville, North Carolina, United States, 27834
        • Physicians East, PA /ID# 159872
      • Leland, North Carolina, United States, 28451
        • Cape Fear Arthritis Care /ID# 161224
      • Raleigh, North Carolina, United States, 27617
        • Shanahan Rheuma & Immuno /ID# 159987
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Trinity Health Med Arts Clinic /ID# 159800
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center /ID# 159888
      • Columbus, Ohio, United States, 43210
        • The Ohio State University /ID# 159892
      • Perrysburg, Ohio, United States, 43551
        • Clinical Research Source, Inc. /ID# 164545
      • Vandalia, Ohio, United States, 45377-9464
        • STAT Research, Inc. /ID# 161392
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103-2400
        • Health Research of Oklahoma /ID# 159880
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Ctr Clinical Res /ID# 159852
      • Wyomissing, Pennsylvania, United States, 19610
        • PA Regional Center /ID# 165670
    • South Carolina
      • Summerville, South Carolina, United States, 29486-7887
        • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163464
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • West Tennessee Research Inst /ID# 159871
      • Knoxville, Tennessee, United States, 37909
        • Rheumatology Consultants, PLLC /ID# 159796
      • Memphis, Tennessee, United States, 38119
        • Dr. Ramesh Gupta /ID# 160061
    • Texas
      • Baytown, Texas, United States, 77521
        • Accurate Clinical Management /ID# 159905
      • Beaumont, Texas, United States, 77701
        • Diagnostic Group Integrated He /ID# 159794
      • College Station, Texas, United States, 77845
        • Arth and Osteo Clin Brazo Valley /ID# 163436
      • Colleyville, Texas, United States, 76034
        • PCCR Solution /ID# 205723
      • Corpus Christi, Texas, United States, 78404
        • Adriana Pop-Moody MD Clinic PA /ID# 159984
      • Dallas, Texas, United States, 75231
        • Metroplex Clinical Research /ID# 159785
      • Houston, Texas, United States, 77004
        • Rheumatic Disease Clin Res Ctr /ID# 161240
      • Houston, Texas, United States, 77065
        • Rheumatology Clinic of Houston /ID# 161234
      • Houston, Texas, United States, 77081
        • "DMCR-Texas Cent for Drug Dev /ID# 164191
      • Lubbock, Texas, United States, 79410-1198
        • West Texas Clinical Research /ID# 205722
      • Lufkin, Texas, United States, 75904-3132
        • P&I Clinical Research /ID# 159826
      • Mesquite, Texas, United States, 75150
        • SW Rheumatology Res. LLC /ID# 159993
      • Plano, Texas, United States, 75024-5283
        • Trinity Universal Research Association /ID# 205721
      • San Antonio, Texas, United States, 78232
        • Arthritis & Osteo Ctr of S. TX /ID# 163784
      • San Marcos, Texas, United States, 78666
        • Arthritis Clinic of Central TX /ID# 164049
      • Tomball, Texas, United States, 77375
        • DM Clinical Research /ID# 161735
      • Waco, Texas, United States, 76710
        • Arthritis & Osteoporosis Clinic /ID# 159786
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Arthritis Clinic of N. VA, P.C /ID# 159849
      • Chesapeake, Virginia, United States, 23320
        • Ctr for Arth and Rheum Disease /ID# 159830
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center /ID# 159890
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest, PLLC /ID# 166380
    • West Virginia
      • South Charleston, West Virginia, United States, 25309
        • West Virginia Research Inst /ID# 159791
    • Wisconsin
      • Franklin, Wisconsin, United States, 53132
        • Aurora Rheumatology and Immunotherapy Center /ID# 160043

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria.
  • Participant has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits.

  • Presence of either at Screening:

    1. >= 1 erosion on x-ray as determined by central imaging review or;
    2. high-sensitivity C-reactive protein (hs-CRP) > laboratory defined upper limit of normal (ULN).
  • Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
  • Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) to previous or current treatment with at least 1 non-biologic DMARD at maximally tolerated dose (methotrexate (MTX), sulfasalazine (SSZ), leflunomide (LEF), cyclosporine, apremilast, bucillamin or iguratimod), or participant has an intolerance to or contraindication for DMARDs as defined by the investigator.

  • Participant who is on current treatment with concomitant non-biologic DMARDs at study entry must be on <= 2 non-biologic DMARDs (except the combination of MTX and leflunomide). The following non-biologic DMARDs are allowed: MTX, sulfasalazine, leflunomide, apremilast, hydroxychloroquine (HCQ) , bucillamine or iguratimod, and have been ongoing for >= 12 weeks and at stable dose for >= 4 weeks prior to the Baseline Visit. No other DMARDs are permitted during the study.

    i. Participants who need to discontinue DMARDs prior to the Baseline Visit to comply with this inclusion criterion must follow the procedure specified below or at least five times the mean terminal elimination half-life of a drug:

    1. >= 8 weeks for LEF if no elimination procedure was followed, or adhere to an elimination procedure (i.e., 11 days with cholestyramine, or 30 days washout with activated charcoal or as per local label);

    2. >= 4 weeks for all others.

      Exclusion Criteria:

  • Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib).
  • Current treatment with > 2 non-biologic DMARDs; or use of DMARDs other than methotrexate, sulfasalazine, leflunomide, apremilast, hydroxychloroquine, bucillamine, or iguratimod; or use of methotrexate in combination with leflunomide.
  • History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.

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 orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks.

Period 2: Participants will continue to receive upadacitinib 15 mg once daily.
Drug: Upadacitinib
Oral tablet
Other Names:
  • RINVOQ®
  • ABT 494
Drug: Placebo to Adalimumab
Administered by subcutaneous injection
Experimental: Upadacitinib 30 mg

Period 1: Participants receive upadacitinib 30 mg orally once a day and matching placebo to adalimumab by subcutaneous injection every other week for 56 weeks.

Period 2: Participants will continue to receive upadacitinib 30 mg once daily.
Drug: Upadacitinib
Oral tablet
Other Names:
  • RINVOQ®
  • ABT 494
Drug: Placebo to Adalimumab
Administered by subcutaneous injection
Active Comparator: Adalimumab

Period 1: Participants receive adalimumab 40 mg by subcutaneous injection every other week and matching placebo to upadacitinib orally QD for 56 weeks.

Period 2: Participants continue to receive adalimumab 40 mg every other week.
Drug: Adalimumab
Administered by subcutaneous injection
Other Names:
  • Humira®
Drug: Placebo to Upadacitinib
Oral tablet
Placebo Comparator: Placebo / Upadacitinib 15 mg

Period 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 15 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks.

Period 2: Participants will continue to receive upadacitinib 15 mg once daily.
Drug: Upadacitinib
Oral tablet
Other Names:
  • RINVOQ®
  • ABT 494
Drug: Placebo to Adalimumab
Administered by subcutaneous injection
Drug: Placebo to Upadacitinib
Oral tablet
Placebo Comparator: Placebo / Upadacitinib 30 mg

Period 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 30 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks.

Period 2: Participants will continue to receive upadacitinib 30 mg once daily.
Drug: Upadacitinib
Oral tablet
Other Names:
  • RINVOQ®
  • ABT 494
Drug: Placebo to Adalimumab
Administered by subcutaneous injection
Drug: Placebo to Upadacitinib
Oral tablet

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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Time Frame: Baseline and Week 12

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:

  1. ≥ 50% improvement in 68-tender joint count;
  2. ≥ 50% improvement in 66-swollen joint count; and

  3. ≥ 50% improvement in at least 3 of the 5 following parameters:

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).
Baseline and Week 12
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Time Frame: Baseline and Week 12

Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:

  1. ≥ 70% improvement in 68-tender joint count;
  2. ≥ 70% improvement in 66-swollen joint count; and

  3. ≥ 70% improvement in at least 3 of the 5 following parameters:

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).
Baseline and Week 12
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Time Frame: Baseline and Week 12

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.

A negative change from Baseline in the overall score indicates improvement.
Baseline and Week 12
Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16
Time Frame: Baseline and Week 16
The sIGA is a 5 point scale ranging from 0 to 4, based on the investigator's assessment of the average elevation, erythema, and scaling of all psoriatic lesions at the current visit. A lower score indicates less severe psoriasis (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe).
Baseline and Week 16
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
Time Frame: Baseline and Week 12

The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).

The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.
Baseline and Week 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
Time Frame: Baseline and Week 12
The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 'not at all' to 4 'very much'. The FACIT Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.
Baseline and Week 12
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Time Frame: Week 24

A participant was classified as achieving MDA if 5 of the following 7 criteria were met:

  • Tender joint count (out of 68 joints) ≤ 1
  • Swollen joint count (out of 66 joints) ≤ 1
  • PASI score ≤ 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis ≤ 3%
  • Patient's assessment of pain ≤ 1.5 (NRS from 0 to 10)
  • Patient's Global Assessment of disease activity ≤ 2 (NRS from 0 to 10)
  • HAQ-DI score ≤ 0.5 (index score ranges from 0 to 3)
  • Leeds Enthesitis Index ≤ 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, with an overall score range from 0 to 6)
Week 24
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16
Time Frame: Baseline and Week 16

PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked).

The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from Baseline in PASI score, and was assessed in participants with Baseline psoriasis BSA involvement ≥ 3%.
Baseline and Week 16
Change From Baseline in Modified PsA Total Sharp/Van Der Heijde Score (mTSS) at Week 24
Time Frame: Baseline and Week 24

The Sharp-van der Heijde modified scoring method for PsA measures the level of joint damage from radiographs of the hands and feet, and was assessed by 2 independent, blinded readers.

Joint erosion severity was assessed in 20 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 320 (worst).

Joint space narrowing (JSN) was assessed in 20 joints of each hand and wrist, and 6 joints of each foot, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 208 (worst).

Joints with gross osteolysis or pencil in cup were assigned the maximum score for both erosions and JSN.

The total mTSS score is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 528 (worst). A negative change from Baseline indicates improvement in joint damage.
Baseline and Week 24
Percentage of Participants With Resolution of Enthesitis at Week 24
Time Frame: Week 24

Resolution of enthesitis is defined as a Leeds Enthesitis Index (LEI) score = 0.

LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions. Tenderness on examination is recorded as either present (coded as 1), absent (coded as 0), or not assessed for each of the 6 sites. The LEI is calculated by taking the sum of the scores from the 6 sites. The LEI ranges from 0 to 6 (worst).
Week 24
Percentage of Participants With an ACR20 Response at Week 12 - Non-inferiority Versus Adalimumab
Time Frame: Baseline and 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 With an ACR20 Response at Week 12 - Superiority Versus Adalimumab
Time Frame: Baseline and 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 With Resolution of Dactylitis at Week 24
Time Frame: Week 24

Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0.

The Leeds Dactylitis Index (LDI) is a score based on finger circumference and tenderness, assessed and summed across all dactylitic digits (fingers and toes). The presence of a dactylitic digit is defined as at least one affected AND tender digit with circumference increase over reference digit ≥ 10%. The reference digit circumference is either the contralateral digit (unaffected digit on opposite hand or foot) if available, or from a standard reference table if otherwise. Tenderness of affected digits is assessed on a scale from 0 [none] to 3 [worst].

The ratio of circumference between an affected digit and reference digit is multiplied by the tenderness score for each affected digit. The results from each involved digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis.
Week 24
Change From Baseline in Patient's Assessment of Pain - Superiority Versus Adalimumab
Time Frame: Baseline and Week 12
Participants were asked to indicate the severity of their arthritis pain within the previous week on a numerical rating scale (NRS) from 0 to 10. A score of 0 indicates "no pain" and a score of 10 indicates "worst possible pain." A negative change from Baseline indicates improvement.
Baseline and Week 12
Change From Baseline in HAQ-DI - Superiority Versus Adalimumab
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 Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire at Week 16
Time Frame: Baseline and Week 16
The SAPS is an 11-item self-assessment of psoriasis symptoms that includes questions on: pain, itching, redness, scaling, flaking, bleeding, burning, stinging, tenderness, pain due to skin cracking, and joint pain. Each item is scored from 0 to 10, with 0 being least severe and 10 being most severe. The total score is generated by summing the 11 items and ranges from 0 to 110 (worst). A negative change from Baseline in the total score indicates improvement.
Baseline and Week 16
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2
Time Frame: Baseline and Week 2

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 2

Collaborators and Investigators

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

Sponsor

AbbVie

Investigators

  • 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

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)

April 27, 2017

Primary Completion (Actual)

September 26, 2019

Study Completion (Actual)

September 9, 2024

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Estimated)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M15-572
  • 2016-004130-24 (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
  • 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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