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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)

Primary Purpose

Psoriatic Arthritis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adalimumab
Upadacitinib
Placebo to Upadacitinib
Placebo to Adalimumab
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Arthritis, Psoriasis, Anti-inflammatory, Joint disease, Musculoskeletal disease, Anti-Rheumatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rheum Assoc of North Alabama /ID# 163231
  • SunValley Arthritis Center, Lt /ID# 161221
  • AZ Arthritis and Rheumotology Research, PLLC /ID# 159981
  • AZ Arthritis and Rheumotology Research, PLLC /ID# 160033
  • AZ Arthritis and Rheumotology Research, PLLC /ID# 160036
  • AZ Arthritis & Rheuma Research /ID# 160037
  • AZ Arth & Rheum Res /ID# 166381
  • Little Rock Diagnostics Clinic /ID# 165161
  • Covina Arthritis Clinic /ID# 159891
  • St. Joseph Heritage Healthcare /ID# 159980
  • C.V. Mehta MD, Med Corporation /ID# 161216
  • Care Access Research, Huntingt /ID# 160038
  • Kotha and Kotha /ID# 159823
  • TriWest Research Associates- La Mesa /ID# 159887
  • Arthritis & Osteo Medical Ctr /ID# 166760
  • University of California, Los Angeles /ID# 164542
  • VA Sacramento Medical Center /ID# 164196
  • East Bay Rheumatology Medical /ID# 166382
  • Inland Rheum Clin Trials Inc. /ID# 159828
  • Medvin Clinical Research /ID# 160034
  • Denver Arthritis Clinic /ID# 159873
  • Arthritis and Rheum Clin N. CO /ID# 160039
  • Colorado Arthritis Associates /ID# 159847
  • Stamford Therapeutics Consorti /ID# 165131
  • Clinical Res of West FL, Inc. /ID# 159829
  • International Medical Research - Daytona /ID# 160040
  • Omega Research Maitland, LLC /ID# 164193
  • Precision Research Org, LLC /ID# 161287
  • LeJenue Research Associates /ID# 170965
  • Medallion Clinical Research Institute, LLC /ID# 161228
  • Millennium Research /ID# 159822
  • Arthritis Center, Inc. /ID# 163465
  • Gulf Region Clinical Res Inst /ID# 159851
  • BayCare Medical Group /ID# 159792
  • W. Broward Rheum Assoc Inc. /ID# 161388
  • Clinical Research of West Florida, Inc /ID# 160063
  • University of South Florida /ID# 161286
  • BayCare Medical Group, Inc. /ID# 159879
  • Florida Medical Clinic /ID# 159992
  • Institute of Arthritis Researc /ID# 165873
  • Advanced Clinical Research /ID# 159894
  • Great Lakes Clinical Trials /ID# 163435
  • OrthoIllinois /ID# 164546
  • Clinical Investigation Specialists - Skokie /ID# 160062
  • Deerbrook Medical Associates /ID# 159804
  • Graves Gilbert Clinic /ID# 161285
  • Four Rivers Clinical Research /ID# 159982
  • Ochsner Clinic Foundation-New Orleans /ID# 165672
  • Johns Hopkins University /ID# 167665
  • Klein & Associates, M.D., P.A. /ID# 164013
  • The Center for Rheumatology & Bone Research /ID# 159874
  • Tufts Medical Center /ID# 165144
  • Mansfield Health Center /ID# 159805
  • Clinical Pharmacology Study Gr /ID# 158700
  • Univ of Michigan Hospitals /ID# 164014
  • Aa Mrc Llc /Id# 159846
  • Advanced Rheumatology, PC /ID# 159893
  • Beals Institute PC /ID# 163128
  • Shores Rheumatology, PC /ID# 159889
  • St. Luke's Hospital of Duluth /ID# 165671
  • Clayton Medical Associates dba Saint Louis Rheumatology /ID# 159878
  • Clinvest Research LLC /ID# 161227
  • Glacier View Research Institut /ID# 167023
  • Westroads Clinical Research /ID# 159979
  • Dartmouth-Hitchcock Medical Center /ID# 161235
  • Arthritis and Osteoporosis Associates /ID# 159802
  • Atlantic Coast Research /ID# 159799
  • Ocean Rheumatology, PA /ID# 163898
  • Arthritis and Osteo Assoc /ID# 159994
  • Santa Fe Rheumatology /ID# 163783
  • NYU Langone Rheum Assoc /ID# 159985
  • NYU Langone Medical Center /ID# 163230
  • St. Lawrence Health System /ID# 159848
  • American Health Research /ID# 164354
  • DJL Clinical Research, PLLC /ID# 161390
  • M3-Emerging Medical Research, LLC /ID# 161391
  • Physicians East, PA /ID# 159872
  • Cape Fear Arthritis Care /ID# 161224
  • Shanahan Rheuma & Immuno /ID# 159987
  • Trinity Health Med Arts Clinic /ID# 159800
  • MetroHealth Medical Center /ID# 159888
  • The Ohio State University /ID# 159892
  • Clinical Research Source, Inc. /ID# 164545
  • STAT Research, Inc. /ID# 161392
  • Health Research of Oklahoma /ID# 159880
  • Altoona Ctr Clinical Res /ID# 159852
  • PA Regional Center /ID# 165670
  • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163464
  • West Tennessee Research Inst /ID# 159871
  • Rheumatology Consultants, PLLC /ID# 159796
  • Dr. Ramesh Gupta /ID# 160061
  • Accurate Clinical Management /ID# 159905
  • Diagnostic Group Integrated He /ID# 159794
  • Arth and Osteo Clin Brazo Valley /ID# 163436
  • PCCR Solution /ID# 205723
  • Adriana Pop-Moody MD Clinic PA /ID# 159984
  • Metroplex Clinical Research /ID# 159785
  • Rheumatic Disease Clin Res Ctr /ID# 161240
  • Rheumatology Clinic of Houston /ID# 161234
  • "DMCR-Texas Cent for Drug Dev /ID# 164191
  • West Texas Clinical Research /ID# 205722
  • P&I Clinical Research /ID# 159826
  • SW Rheumatology Res. LLC /ID# 159993
  • Trinity Universal Research Association /ID# 205721
  • Arthritis & Osteo Ctr of S. TX /ID# 163784
  • Arthritis Clinic of Central TX /ID# 164049
  • DM Clinical Research /ID# 161735
  • Arthritis & Osteoporosis Clinic /ID# 159786
  • Arthritis Clinic of N. VA, P.C /ID# 159849
  • Ctr for Arth and Rheum Disease /ID# 159830
  • Swedish Medical Center /ID# 159890
  • Arthritis Northwest, PLLC /ID# 166380
  • West Virginia Research Inst /ID# 159791
  • Aurora Rheumatology and Immunotherapy Center /ID# 160043
  • Centro Medico Privado/Reuma /ID# 159775
  • Centro Integral de Medicina Respiratoria (CIMER) /ID# 211237
  • Organizacion Medica de Investigacion (OMI) /ID# 160118
  • Hospital General de Agudos Ram /ID# 164378
  • Psoriahue Med Interdisciplinar /ID# 160506
  • Inst. de Rehab. Psicofisica /ID# 165154
  • Instituto CAICI /ID# 160119
  • Centro Integral de Medicina Re /ID# 160258
  • Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 165795
  • Emeritus Research Sydney /ID# 166780
  • The Queen Elizabeth Hospital /ID# 169333
  • Barwon Rheumatology /ID# 166782
  • Heidelberg Repatriation Hospital /ID# 167450
  • Brest Regional Hospital /ID# 164535
  • Healthcare Institution /ID# 164536
  • First City Clinical Hospital /ID# 164534
  • Reuma clinic /ID# 164243
  • University Clinical Centre of the Republic of Srpska /ID# 164503
  • University Clinical Hospital Mostar /ID# 165799
  • Clinical Center University of Sarajevo /ID# 164502
  • Instituto de Ciencias Farmacêuticas /ID# 163274
  • CIP - Centro Internacional de Pesquisa /ID# 161821
  • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 161819
  • EDUMED Educacao em Saude S/S L /ID# 161816
  • Instituto de Educação e Pesquisa do Hospital Moinhos de Vento /ID# 161813
  • Hospital de Clinicas de Porto Alegre /ID# 161820
  • LMK Sevicos Medicos S/S /ID# 161812
  • Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163273
  • Faculdade de Medicina do ABC /ID# 163491
  • CEMEC - Centro Multidisciplinar de Estudos Clínicos do ABC /ID# 161810
  • CPCLIN - Centro de Pesquisas Clínicas /ID# 161818
  • Department of Rheumatology, Mu /ID# 169606
  • Excelsior Medical Center /ID# 169609
  • Multiprofile Hospital for Active Treatment - Sofia at Military Medical Academy /ID# 169608
  • UMHAT Sv. Ivan Rilski /ID# 202393
  • Medical Centre Synexus Sofia /ID# 202394
  • Medical Centre Synexus Sofia, branch Stara Zagora /ID# 202524
  • Diagnostic Consultative Center /ID# 169607
  • Percuro Clinical Research, Ltd /ID# 157823
  • Manitoba Clinic /ID# 157829
  • Ciads /Id# 157831
  • The Waterside Clinic /ID# 157826
  • Groupe de Recherche en Maladies Osseuses Inc /ID# 157824
  • Ctr. de Recherche Musculo-Sque /ID# 207069
  • M y F Estudios Clínicos Ltda. /ID# 168722
  • CTR Estudios SpA /ID# 206217
  • Centro Inter Estud Clin CIEC /ID# 168725
  • Prosalud Ltda. /ID# 169546
  • Clinica Dermacross S.A /ID# 168726
  • 1st Aff Hosp of Bengbu Medical College /ID# 201021
  • Peking University Third Hospital /ID# 201973
  • The First Affiliated Hospital of Shantou University Medical College /ID# 203371
  • Zhuzhou Central Hospital /ID# 200201
  • The First Affiliated Hospital of Baotou Medical College, Inner Monggolia Univers /ID# 171204
  • The First People's Hospital of Linyi /ID# 201970
  • Huashan Hospital of Fudan University /ID# 202191
  • Shanghai Changhai Hospital /ID# 200202
  • West China Hospital /ID# 200199
  • Ningbo First Hospital /ID# 201874
  • The Aff Hosp Inner Mongolia /ID# 207787
  • First Affiliated Hospital of Kunming Medical University /ID# 201264
  • Affiliated hospital of nantong university /ID# 208234
  • The First Affiliated Hospital of Soochow University /ID# 201875
  • People's Hospital of Xinjiang /ID# 201592
  • Centro de Investigacion en Reumatologia CIREEM /ID# 166030
  • Fundacion Centro de Investigac /Id# 168201
  • Ctr Int de Reum del Caribe SAS /ID# 164051
  • Preventive Care Sas /Id# 163781
  • Hospital Pablo Tobon Uribe /ID# 164233
  • Poliklinika Repromed /ID# 203555
  • Klinicki bolnicki centar Rijeka /ID# 161159
  • Medical Center Kuna-Peric /ID# 161160
  • Poliklinika Bonifarm /ID# 206662
  • Revmatologicka ambulance /ID# 159637
  • Revmatologicka ambulance /ID# 159671
  • Revmatologie Bruntal, s.r.o /ID# 159636
  • Artroscan s.r.o. /ID# 159634
  • Medical Plus, s.r.o. /ID# 159635
  • Center of Clinical and Basic Research /ID# 163870
  • MediTrials /ID# 163706
  • East Tallinn Central Hospital /ID# 163790
  • Rheumazentrum Ruhrgebiet /ID# 163930
  • Immanuel-Krankenhaus /ID# 163931
  • University Clinic Carl Gustav /ID# 163926
  • Polikilinik fuer Rheumatologie /ID# 163933
  • Cent fur Innovative Diagnostik /ID# 163927
  • Hamburger Rheuma Forschungszentrum II im MVZ Rheumatologie und Autoimmunmedizin /ID# 204421
  • Dr. med. Jochen Walter FA fuer /ID# 168638
  • Med. Universitaetsklinik Inner /ID# 163929
  • General Hospital of Athens Laiko /ID# 163476
  • General Hospital of Athens Laiko /ID# 163478
  • University General Hospital Attikon /ID# 163477
  • Naval Hospital of Athens /ID# 163486
  • University General Hospital of Heraklion PA.G.N.I /ID# 163472
  • Reg Gen Univ Hosp Larissa /ID# 163496
  • Prince of Wales Hospital /ID# 163506
  • Queen Mary Hospital /ID# 162492
  • Tuen Mun Hospital /ID# 162493
  • Synexus Magyarorszag Kft. - Gyula DRS /ID# 202209
  • Qualiclinic Kft. /ID# 163278
  • Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatok.- Klinikai Kutatasi O. /ID# 202584
  • Synexus Magyarorszag Kft. - Zalaegerszeg AS /ID# 201884
  • Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz /ID# 170719
  • Revita Reumatologiai Rendelo /ID# 163277
  • Obudai Egeszsegugyi Centrum Kft. /ID# 163279
  • Synexus Magyarorszag Kft. /ID# 203012
  • Debreceni Egyetem Kenezy Gyula /ID# 163276
  • Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 163275
  • St Vincent's University Hosp /ID# 161073
  • Croom Orthopaedic Hospital /ID# 164998
  • Tel Aviv Sourasky Medical Center /ID# 169845
  • The Lady Davis Carmel MC /ID# 170262
  • Sheba Medical Center /ID# 202532
  • AOU Federico II /ID# 202411
  • Azienda Unita Sanitaria Locale/IRCCS c/o Arcispedale Santa Maria Nuova /ID# 161090
  • Policlinico Universitario Campus Bio-Medico /ID# 162306
  • Ospedali Riuniti Universita /ID# 161085
  • Azienda Ospedaliera Universitaria Policlinico "G. Rodolico - San Marco" /Id# 161084
  • Nagoya City University Hospital /ID# 162564
  • Fukuoka University Hospital /ID# 162086
  • Hospital of the University of Occupational and Environmental Health /ID# 161473
  • Mie University Hospital /ID# 162080
  • National Hospital Organization Osaka Minami Medical Center /ID# 162590
  • St.Luke's International Hospital /ID# 162016
  • Ajou University Hospital /ID# 163891
  • Inha University Hospital /ID# 163890
  • M &M Centrs /Id# 161483
  • D.Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 161488
  • Clinic ORTO /ID# 161486
  • P. Stradins Clinical Univ Hosp /ID# 164442
  • VAKK dr. Kildos Clinic /ID# 167257
  • Klaipeda University Hospital /ID# 167258
  • Public Institution Republican /ID# 165155
  • Vilnius University Hospital /ID# 165123
  • Hospital Raja Permaisuri Bainun /ID# 161099
  • Hospital Tuanku Ja afar /ID# 161096
  • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 164006
  • Instituto Jalisciense de Metabolismo SC /ID# 164005
  • Invest y Biomed de Chihuahua /ID# 164007
  • Medisch Centrum Leeuwarden /ID# 161575
  • Erasmus Medisch Centrum /ID# 161092
  • Maasstad Ziekenhuis /ID# 160168
  • Waikato Hospital /ID# 166415
  • North Shore Hospital /ID# 169409
  • Middlemore Hospital /ID# 166414
  • Porter Rheumatology Ltd /ID# 200421
  • Timaru Rheumatology Studies /ID# 166413
  • Helse Forde /ID# 167853
  • St. Olavs Hospital HF /ID# 163321
  • Synexus Polska Sp. z o.o. /ID# 204506
  • NZOZ Nasz Lekarz /ID# 163774
  • Salve Medica Sp. z o.o. S.K. /ID# 206300
  • Malopolskie Centrum Kliniczne /ID# 163777
  • Synexus Polska Sp. z o.o. Oddzial w Gdansku /ID# 206299
  • Synexus Polska Sp. z o.o. Oddzial w Gdyni /ID# 207157
  • Synexus Polska Sp. z o.o. Oddzial Katowice /ID# 204510
  • ETYKA-Osrodek Badan Klinicznyc /ID# 163776
  • Centrum Kliniczno-Badawcze /ID# 161830
  • Krakowskie Centrum Medyczne /ID# 206302
  • Synexus Polska Sp. z o.o. Oddzial w Poznaniu /ID# 207158
  • Medycyna Kliniczna /ID# 166288
  • Synexus Polska Sp. z.o.o. /ID# 203987
  • Reumatika - Centrum Reumatologii NZOZ /ID# 161831
  • Instituto Portugues De Reumatologia /ID# 165858
  • Centro Hospitalar Lisboa Ocidental, EPE /ID# 165861
  • Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 165862
  • Centro Hospitalar Lisboa Norte, EPE /ID# 165860
  • Hospital CUF Descobertas /ID# 165866
  • Hospital Beatriz Angelo /ID# 165865
  • Unidade Local De Saude Do Alto Minho /ID# 165863
  • Cruz-Santana, Carolina, PR /ID# 163307
  • Ponce Medical School Foundation /ID# 163920
  • GCM Medical Group, PSC /ID# 162160
  • Family Outpatient clinic#4 LLC /ID# 164530
  • LLC Medical Center /ID# 164529
  • Kazan State Medical University /ID# 164531
  • Moscow S.P.Botkin City Clinica /ID# 164533
  • State budgetary institution /ID# 164532
  • Institute for Rheumatology /ID# 166217
  • Institute for Rheumatology /ID# 166223
  • Institute for Rheumatology /ID# 166229
  • Institute for Rheumatology /ID# 166231
  • Military Medical Academy /ID# 166293
  • Singapore General Hospital /ID# 161094
  • Tan Tock Seng Hospital /ID# 161095
  • MEDMAN s.r.o. /ID# 165892
  • Reumatologická ambulancia Reum.hapi s.r.o. /ID# 166486
  • Slovak research center Team Member, Thermium s.r.o. /ID# 166489
  • Univ Medical Ctr Ljubljana /ID# 164212
  • University Medical Ctr Maribor /ID# 169260
  • General Hospital Murska Sobota /ID# 164211
  • Greenacres Hospital /ID# 164190
  • Wits Clinical Research Site /ID# 163919
  • University of Pretoria /ID# 163852
  • Jakaranda Hospital /ID# 164242
  • Arthritis Clinical Research Tr /ID# 163855
  • Winelands Medical Research Ctr /ID# 163853
  • Hospital Universitario A Coruña - CHUAC /ID# 161129
  • Hospital Campus de la Salud /ID# 170760
  • Hospital Universitario Ramon y Cajal /ID# 161130
  • Hospital Universitario 12 de Octubre /ID# 163198
  • Kantonsspital St. Gallen /ID# 158131
  • HFR Fribourg - Hopital Canton /ID# 162090
  • China Medical University Hosp /ID# 159402
  • Chung Shan Medical University /ID# 159403
  • National Taiwan University Hospital /ID# 160878
  • Taipei Veterans General Hosp /ID# 166222
  • Linkou Chang Gung Memorial Ho /ID# 166221
  • Cukurova Universitesi Tip Fakultesi /ID# 162516
  • Hacettepe Universitesi Tip Fak /ID# 162518
  • Bakirkoy Dr. Sadi Konuk Training & Research Hospital /ID# 162517
  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 163383
  • Necmettin Erbakan Universitesi /ID# 163382
  • Sakarya Universitesi Egitim /ID# 163397
  • State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 164170
  • Lviv Regional Clinical Hospita /ID# 164178
  • Kharkiv Regional Council Regional Clinical Hospital /ID# 210189
  • NSC Strazhesko Ist Cardiology /ID# 164043
  • Med Ctr of Private High Ed Ins /ID# 208527
  • Medical Center of LLC Medbud-Clinic /ID# 208528
  • Kyiv Railway Clinical Hosp No.2 /ID# 208951
  • LLC Revmocentr /ID# 164177
  • MNI KRC Kyiv Regional Clinical Hospital /ID# 210188
  • Odessa National Medical Univ /ID# 164244
  • Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 164245
  • Whipps Cross Univ Hospital /ID# 161055
  • Guy's and St Thomas' NHS Found /ID# 161065
  • Christchurch Hospital /ID# 162702
  • UH Coventry & Warwickshire /ID# 162701
  • Glasgow Royal Infirmary /ID# 162703
  • Luton & Dunstable University Hospital /ID# 162704

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Upadacitinib 15 mg

Upadacitinib 30 mg

Adalimumab

Placebo / Upadacitinib 15 mg

Placebo / Upadacitinib 30 mg

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 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).

Secondary Outcome Measures

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at 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.
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
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).
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at 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%.
Change From Baseline in Modified PsA Total Sharp/Van Der Heijde Score (mTSS) at 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.
Percentage of Participants Achieving Minimal Disease Activity (MDA) at 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)
Percentage of Participants With Resolution of Enthesitis at 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).
Percentage of Participants With an ACR20 Response at Week 12 - Non-inferiority Versus Adalimumab
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 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).
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at 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.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at 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.
Percentage of Participants With an ACR20 Response at Week 12 - Superiority Versus Adalimumab
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 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).
Percentage of Participants With Resolution of Dactylitis at 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.
Change From Baseline in Patient's Assessment of Pain - Superiority Versus Adalimumab
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.
Change From Baseline in HAQ-DI - Superiority Versus Adalimumab
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.
Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire at 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.
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: ≥ 50% improvement in 68-tender joint count; ≥ 50% improvement in 66-swollen joint count; and ≥ 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).
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria: ≥ 70% improvement in 68-tender joint count; ≥ 70% improvement in 66-swollen joint count; and ≥ 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).
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 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).

Full Information

First Posted
April 4, 2017
Last Updated
September 9, 2022
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03104400
Brief Title
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)
Acronym
SELECT - PsA 1
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 27, 2017 (Actual)
Primary Completion Date
September 26, 2019 (Actual)
Study Completion Date
August 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Arthritis, Psoriasis, Anti-inflammatory, Joint disease, Musculoskeletal disease, Anti-Rheumatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1705 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Upadacitinib 15 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Upadacitinib 30 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Adalimumab
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo / Upadacitinib 15 mg
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Placebo / Upadacitinib 30 mg
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira®
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT 494, RINVOQ®
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo to Upadacitinib
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo to Adalimumab
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 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).
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
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
Description
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).
Time Frame
Baseline and Week 16
Title
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16
Description
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%.
Time Frame
Baseline and Week 16
Title
Change From Baseline in Modified PsA Total Sharp/Van Der Heijde Score (mTSS) at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Description
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)
Time Frame
Week 24
Title
Percentage of Participants With Resolution of Enthesitis at Week 24
Description
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).
Time Frame
Week 24
Title
Percentage of Participants With an ACR20 Response at Week 12 - Non-inferiority Versus Adalimumab
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 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).
Time Frame
Baseline and Week 12
Title
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With an ACR20 Response at Week 12 - Superiority Versus Adalimumab
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 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).
Time Frame
Baseline and Week 12
Title
Percentage of Participants With Resolution of Dactylitis at Week 24
Description
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.
Time Frame
Week 24
Title
Change From Baseline in Patient's Assessment of Pain - Superiority Versus Adalimumab
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in HAQ-DI - Superiority Versus Adalimumab
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: ≥ 50% improvement in 68-tender joint count; ≥ 50% improvement in 66-swollen joint count; and ≥ 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).
Time Frame
Baseline and Week 12
Title
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Description
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria: ≥ 70% improvement in 68-tender joint count; ≥ 70% improvement in 66-swollen joint count; and ≥ 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).
Time Frame
Baseline and Week 12
Title
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2
Description
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 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).
Time Frame
Baseline and Week 2

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
36243812
Citation
McInnes IB, Kato K, Magrey M, Merola JF, Kishimoto M, Haaland D, Chen L, Duan Y, Liu J, Lippe R, Wung P. Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis: 2-Year Results from the Phase 3 SELECT-PsA 1 Study. Rheumatol Ther. 2023 Feb;10(1):275-292. doi: 10.1007/s40744-022-00499-w. Epub 2022 Oct 15.
Results Reference
derived
PubMed Identifier
35606663
Citation
Mease P, Kavanaugh A, Gladman D, FitzGerald O, Soriano ER, Nash P, Feng D, Lertratanakul A, Douglas K, Lippe R, Gossec L. Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials. Rheumatol Ther. 2022 Aug;9(4):1181-1191. doi: 10.1007/s40744-022-00449-6. Epub 2022 May 23.
Results Reference
derived
PubMed Identifier
34970731
Citation
Burmester GR, Winthrop K, Blanco R, Nash P, Goupille P, Azevedo VF, Salvarani C, Rubbert-Roth A, Lesser E, Lippe R, Lertratanakul A, Mccaskill RM, Liu J, Ruderman EM. Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials. Rheumatol Ther. 2022 Apr;9(2):521-539. doi: 10.1007/s40744-021-00410-z. Epub 2021 Dec 30.
Results Reference
derived
PubMed Identifier
34864911
Citation
Nash P, Richette P, Gossec L, Marchesoni A, Ritchlin C, Kato K, McDearmon-Blondell EL, Lesser E, McCaskill R, Feng D, Anderson JK, Ruderman EM. Upadacitinib as monotherapy and in combination with non-biologic disease-modifying antirheumatic drugs for psoriatic arthritis. Rheumatology (Oxford). 2022 Aug 3;61(8):3257-3268. doi: 10.1093/rheumatology/keab905.
Results Reference
derived
PubMed Identifier
34636026
Citation
Strand V, Mease PJ, Soriano ER, Kishimoto M, Salvarani C, Saffore CD, Zueger P, McDearmon-Blondell E, Kato K, Gladman DD. Improvement in Patient-Reported Outcomes in Patients with Psoriatic Arthritis Treated with Upadacitinib Versus Placebo or Adalimumab: Results from SELECT-PsA 1. Rheumatol Ther. 2021 Dec;8(4):1789-1808. doi: 10.1007/s40744-021-00379-9. Epub 2021 Oct 12.
Results Reference
derived
PubMed Identifier
34464029
Citation
Muensterman E, Engelhardt B, Gopalakrishnan S, Anderson JK, Mohamed MF. Upadacitinib pharmacokinetics and exposure-response analyses of efficacy and safety in psoriatic arthritis patients - Analyses of phase III clinical trials. Clin Transl Sci. 2022 Jan;15(1):267-278. doi: 10.1111/cts.13146. Epub 2021 Oct 27.
Results Reference
derived
PubMed Identifier
33789011
Citation
McInnes IB, Anderson JK, Magrey M, Merola JF, Liu Y, Kishimoto M, Jeka S, Pacheco-Tena C, Wang X, Chen L, Zueger P, Liu J, Pangan AL, Behrens F. Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis. N Engl J Med. 2021 Apr 1;384(13):1227-1239. doi: 10.1056/NEJMoa2022516.
Results Reference
derived
Links:
URL
https://www.rxabbvie.com
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Learn more about this trial

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)

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