Back to resultsA Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)
Primary Purpose
Rheumatoid Arthritis
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo for Adalimumab
Adalimumab
Placebo for Upadacitinib
Upadacitinib
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Musculoskeletal disease, Arthritis, Joint disease, Anti-inflammatory agents, Antirheumatic agents
Eligibility Criteria
Inclusion Criteria:
- Adult male or female, at least 18 years old.
- Diagnosis of RA for greater than or equal to 3 months.
- Subjects must have been on oral or parenteral methotrexate (MTX) therapy greater than or equal to 3 months and on a stable prescription of greater than or equal to 15 to 25 mg/week (or greater than or equal to 10 mg/week in subjects intolerant of MTX at doses greater than or equal to 12.5 mg/week) for at least 4 weeks prior to the first dose of study drug. In addition all subjects should take a dietary supplement of folic acid or folinic acid throughout the study participation.
- Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
- At least one of the following at Screening: greater than or equal to 3 bone erosions on x-ray OR greater than or equal to 1 bone erosion and a positive rheumatoid factor OR greater than or equal to 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibodies.
- Subjects with prior exposure to only one biological disease-modifying anti-rheumatic drugs (bDMARD) (except adalimumab) may be enrolled (up to 20% of total study population) if they have documented evidence of intolerance to the bDMARD or limited exposure (less than 3 months), but required washout periods need to be satisfied.
- Except for MTX, subject must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).
Exclusion Criteria:
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- Subjects who have been exposed to adalimumab or who are considered inadequate responders to bDMARD therapy as determined by the Investigator.
- History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
Sites / Locations
- Achieve Clinical Research, LLC /ID# 143136
- AZ Arthritis and Rheum Assoc /ID# 143130
- SunValley Arthritis Center, Lt /ID# 143123
- Elite Clinical Studies, LLC /ID# 144881
- AZ Arthritis and Rheum Researc /ID# 143080
- AZ Arthritis and Rheum Researc /ID# 143121
- AZ Arthritis & Rheuma Research /ID# 143131
- Arizona Research Center, Inc. /ID# 144877
- AZ Arthritis & Rheum Research /ID# 156093
- University of Arizona Cancer Center - North Campus /ID# 143114
- Osteoporosis Medical Center /ID# 153935
- T. Joseph Raoof, MD, Inc. /ID# 144884
- Rheumatology Ctr of San Diego /ID# 153747
- C.V. Mehta MD, Med Corporation /ID# 143116
- Allergy and Rheum Med Clin /ID# 146083
- Kotha and Kotha /ID# 161046
- TriWest Research Associates- La Mesa /ID# 143115
- Valerius Med Grp & Res Ctr /ID# 143120
- Discovery MM Services, Inc /ID# 163504
- Desert Medical Advances /ID# 143097
- Sierra Rheumatology /ID# 155672
- Robin K. Dore MD, Inc /ID# 143090
- Medvin Clinical Research /ID# 148362
- Arthritis Assoc & Osteo Ctr /ID# 143122
- Arthritis and Rheum Clin N. CO /ID# 156094
- AARDS Research, Inc. /ID# 154190
- ZASA Clinical Research /ID# 143134
- Clinical Res of West FL, Inc. /ID# 143112
- International Medical Research /ID# 143132
- Precision Research Org, LLC /ID# 143092
- Lakes Research, LLC /ID# 145630
- FL Med Ctr and Research, Inc. /ID# 143081
- Ctr Arthritis & Rheumatic Dise /ID# 143135
- Advanced Clin Res of Orlando /ID# 154617
- Rheum Assoc of Central FL /ID# 145632
- Omega Research Consultants /ID# 145635
- HMD Research LLC /ID# 163292
- Arthritis Research of Florida /ID# 143125
- Arthritis Center, Inc. /ID# 145647
- St. Anthony Comprehsve Res Ins /ID# 143095
- Clinical Research West FL /ID# 148358
- SW FL Clin Res Ctr, Tampa, FL /ID# 143117
- BayCare Medical Group, Inc. /ID# 143085
- Lovelace Scientific Resources /ID# 143106
- Arthritis and Rheumatology /ID# 155668
- Arthritis Center of North GA /ID# 155258
- North Georgia Rheumatology Grp /ID# 147170
- Advanced Clinical Research /ID# 153090
- Great Lakes Clinical Trials /ID# 148357
- Arthritis Treatment Center /ID# 155260
- The Center for Rheumatology & /ID# 151356
- Clinical Pharmacology Study Gr /ID# 143082
- Advanced Rheumatology, PC /ID# 143118
- Shores Rheumatology, PC /ID# 162977
- St. Luke's Hospital /ID# 156750
- North Mississippi Med Clinics /ID# 145636
- Physician Res. Collaboration /ID# 143087
- Quality Clinical Research Inc. /ID# 156394
- Atlantic Coast Research /ID# 148355
- Ocean Rheumatology, PA /ID# 143111
- Arthritis Rheumatic Back Disorder /ID# 143102
- Albuquerque Clinical Trials, Inc /ID# 143083
- Arthritis and Osteo Assoc /ID# 143127
- St. Lawrence Health System /ID# 161619
- Joint & Muscle Research Instit /ID# 143119
- DJL Clinical Research, PLLC /ID# 143101
- EmergeOrtho, P.A. /ID# 143100
- Cape Fear Arthritis Care /ID# 148361
- Coastal Carolina Health Care /ID# 148359
- Shanahan Rheuma & Immuno /ID# 145643
- Clinical Research Solutions, LLC /ID# 154619
- Arthritis Assoc of NW Ohio /ID# 143094
- Healthcare Research Consultant /ID# 143129
- Altoona Ctr Clinical Res /ID# 143110
- Clinical Research Ctr Reading /ID# 143133
- Columbia Arthritis Center /ID# 153730
- Innovative Clinical Research /ID# 145637
- Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 143091
- Arthritis Associates, PLLC /ID# 155490
- Rheumatology Consultants, PLLC /ID# 153731
- Dr. Ramesh Gupta /ID# 143099
- Austin Regional Clinic /ID# 143084
- Diagnostic Group Integrated He /ID# 148356
- Arthritis Care and Diagnostic /ID# 150677
- Metroplex Clinical Research /ID# 145631
- Doctor's Hosp at Renaissance /ID# 154616
- MedResearch Inc. /ID# 154618
- Accurate Clinical Management /ID# 145644
- Accurate Clinical Research /ID# 145645
- Rheumatology Clinic of Houston /ID# 150921
- Houston Institute for Clin Res /ID# 144879
- Pioneer Research Solutions, Inc. /ID# 145640
- Arthritis Consultants, P.A. /ID# 144880
- Arthritis & Osteoporosis Assoc /ID# 147364
- P&I Clinical Research /ID# 161625
- SW Rheumatology Res. LLC /ID# 143126
- Discovery MM Services, Inc. /ID# 162578
- Discovery MM Services, Inc. /ID# 163183
- Discovery MM Services, Inc. /ID# 163184
- Sun Research Institute /ID# 159539
- Accurate Clinical Management /ID# 143089
- Arthritis & Osteo Ctr of S. TX /ID# 143103
- DM Clinical Research /ID# 151357
- Arthritis Clinic of N. VA, P.C /ID# 143109
- Ctr for Arth and Rheum Disease /ID# 143113
- Arthritis Northwest, PLLC /ID# 143088
- The Vancouver Clinic, INC. PS /ID# 143107
- West Virginia Research Inst /ID# 153088
- Rheumatology and Immunotherapy Center /ID# 145646
- Aprillus Asistencia e Investig /ID# 148406
- Mautalen Salud e Investigacion /ID# 142843
- Fundacion Sanatorio Guemes /ID# 148405
- Consultorio Reumatologic Pampa /ID# 144853
- Cemic /Id# 148404
- Org Medica de Investigacion /ID# 144855
- Inst. Rheumatologic Strusberg /ID# 145601
- Consultora Integral de Salud S /ID# 144856
- Instituto CAICI /ID# 144854
- Cordis S.A. /Id# 152622
- Iari /Id# 151293
- Centro Integral de Reumatologi /ID# 142845
- Centro Medico Privado/Reuma /ID# 142842
- Centro de Enfermedades /ID# 153542
- Royal Prince Alfred Hospital /ID# 144857
- Emeritus Research /ID# 142848
- LKH-Univ. Klinikum Graz /ID# 142851
- First City Clinical Hospital /ID# 158011
- Cliniques Universitaires Saint Luc /ID# 142858
- Rhumaconsult SPRL /ID# 142860
- CHU de Liege /ID# 148401
- UZ Gent /ID# 142859
- CHU Ambroise Pare /ID# 152953
- University Clinical Centre of the Republic of Srpska /ID# 142862
- University Clinical Centre of the Republic of Srpska /ID# 142863
- Clinical Center University of Sarajevo /ID# 142865
- CIP - Centro Internacional de Pesquisa /ID# 142872
- Hc Ufmg /Id# 142868
- Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 142871
- Hospital de Clinicas de Porto Alegre /ID# 142870
- LMK Sevicos Medicos S/S /ID# 142869
- CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 142867
- CCBR Brasil /ID# 150918
- MHAT Trimontsium /ID# 142874
- UMHAT Pulmed OOD /ID# 142877
- MHAT Kaspela /ID# 142873
- Diagnostic Consultative Center /ID# 142875
- UMHAT Sv. Ivan Rilski /ID# 142876
- Manitoba Clinic /ID# 161434
- Ciads /Id# 142880
- St. Clare's Mercy Hospital /ID# 142879
- Adachi Medicine Prof. Corp /ID# 154205
- CA Ctr for Clin Trials CCCT /ID# 157379
- Groupe de Recherche en Maladies Osseuses /ID# 142878
- Ctr de Inv Clinica del Sur /ID# 142888
- Reg. Clinical Hosptial Concepcion /ID# 151271
- Corp de Beneficencia Osorno /ID# 147941
- Someal /Id# 144704
- Quantum Research LTDA. /ID# 142893
- Quantum Research Stgo. /ID# 157933
- Soc. de Prestaciones medicas y Paramedicas Goecke /ID# 142890
- Clinica DermaCross /ID# 142892
- Investigaciones Medicas SSMSO /ID# 151686
- Centro Inter Estud Clin CIEC /ID# 144777
- Centro Medico de Reumatologia /ID# 148402
- Cinvec /Id# 144705
- Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 142898
- Ctr Int de Reum del Caribe SAS /ID# 142894
- Fund Inst de Reum F. Chalem /ID# 149847
- Riesgo de Fractura S.A - CAYRE /ID# 142896
- Medicity S.A.S. /ID# 144860
- Centro Integral de Reumatologi /ID# 142897
- Klinicki bolnicki centar Rijeka /ID# 160232
- Klinicki bolnicki centar Split /ID# 152530
- Clinical Hospital Dubrava /ID# 142900
- Medical Center Kuna-Peric /ID# 142901
- Poliklinika Bonifarm /ID# 142899
- L.K.N. Arthrocentrum, s.r.o /ID# 145961
- CTCenter MaVe, s.r.o. /ID# 142905
- Revmatologicky ustav Praha /ID# 142904
- Nuselská poliklinika, Revmatologie /ID# 144862
- Revmatologická ambulance /ID# 145963
- Thomayerova nemocnice /ID# 145962
- REVMACLINIC s.r.o. /ID# 142906
- Revmatologie Bruntal, s.r.o /ID# 142903
- Revmatologicka a interni ambul /ID# 142907
- Revmatologie MUDr. Klara Sirov /ID# 142908
- Arthromed, s.r.o. /ID# 144706
- Aarhus University Hospital /ID# 158838
- Regionhospital Silkeborg /ID# 142914
- Center of Clinical and Basic Research /ID# 142922
- MediTrials /ID# 151870
- Paernu Hospital /ID# 142921
- East Tallinn Central Hospital /ID# 142923
- North Estonian Medical Centre /ID# 145454
- Hopital Universitaire Purpan /ID# 144707
- CHRU Lille - Hôpital Claude Huriez /ID# 151312
- Hopital Saint Eloi /ID# 142925
- CHU Bordeaux-Hopital Pellegrin /ID# 145618
- Hopital de la Cote de Nacre /ID# 145616
- CHU Gabriel Montpied /ID# 145619
- Hopital de la Conception /ID# 142926
- Hopital Pitie Salpetriere /ID# 145605
- CHU de Rennes - Hospital Sud /ID# 151957
- CHU Strasbourg Hautepierre Hos /ID# 144708
- Rheumazentrum Ruhrgebiet /ID# 145620
- Uniklinik Koln /ID# 145964
- Praxis Walter, Rendsburg /ID# 142932
- Med Versorgungszentrum AGILOME /ID# 154975
- Rheumaforschungszentrum II /ID# 142930
- LMU Klinikum der Universität München /ID# 142931
- General Hospital of Athens Laiko /ID# 142934
- University General Hospital Attikon /ID# 142933
- General Hospital of Athens Ippokratio /ID# 142935
- Queen Mary Hospital /ID# 142938
- Tuen Mun Hospital /ID# 142939
- CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 142951
- Qualiclinic Kft. /ID# 142953
- Markusovszky Egyetemi Oktatókórház /ID# 145621
- Vital Medical Center Orvosi es /ID# 145950
- Budai Irgalmasrendi Korhaz /ID# 142952
- Revita Reumatologiai Rendelo /ID# 142950
- Synexus Magyarorszag Kft. /ID# 153061
- Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142948
- Hevizgyogyfurdo es Szent Andra /ID# 142949
- Kiskunhalasi Semmelweis Korhaz /ID# 151944
- Pest Megyei Flor Ferenc Korhaz /ID# 142954
- St Vincent's University Hosp /ID# 142957
- Tel Aviv Sourasky Medical Ctr /ID# 144709
- Rambam Health Care Campus /ID# 152050
- Bnai Zion Medical Center /ID# 151958
- The Lady Davis Carmel MC /ID# 142960
- Sheba Medical Center /ID# 145965
- Istituto Clinico Humanitas /ID# 147528
- AOU Citta della Salute Scienza /ID# 150070
- Azienda Ospedaliera Luigi Sacc /ID# 142966
- A.O.U.I. di Verona Policlinico /ID# 142963
- JSC Nat Scientific Med Res Ctr /ID# 142971
- Karaganda State Medical Univ /ID# 153433
- Semey State Medical University /ID# 152659
- Regional Clinical Hospital /ID# 147168
- Kyungpook National Univ Hosp /ID# 162073
- Chungnam National University Hospital /ID# 142977
- Inha University Hospital /ID# 150886
- Chonnam National University Hospital /ID# 142975
- Hanyang University Seoul Hospi /ID# 142979
- Cath Univ Seoul St Mary's Hosp /ID# 142976
- Daegu Catholic University Med /ID# 142973
- Seoul National University Hospital /ID# 142978
- Asan Medical Center /ID# 142974
- LTD M+M Centers /ID# 142984
- Daugavpils Regional Hospital /ID# 142982
- D.Saulites-Kandevicas PP /ID# 142985
- Clinic ORTO /ID# 142983
- Riga East Clinical Univ Hosp /ID# 142981
- Hosp Lithuanian Univ Health Sc /ID# 142986
- Vilnius University Hospital /ID# 142987
- Hospital Raja Perempuan Zainab II /ID# 157862
- Hospital Selayang /ID# 156756
- Hospital Umum Sarawak /ID# 142990
- Hospital Putrajaya /ID# 142989
- Hospital Tuanku Ja afar /ID# 142988
- Clinstile, S.A. de C.V. /ID# 144866
- Hosp. Univ. Dr. Jose E. Gonz /ID# 142992
- Invest y Biomed de Chihuahua /ID# 142996
- RM Pharma Specialists, S.A de C.V /ID# 142994
- Hospital de Jesús Nazareno /ID# 142993
- Centro Peninsular de Investiga /ID# 148159
- Waikato Hospital /ID# 143002
- Porter Rheumatology Ltd /ID# 143001
- Timaru Medical Specialists Ltd /ID# 143000
- WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 145622
- NZOZ Nasz Lekarz /ID# 143004
- REUMED Sp.z o.o. Filia nr 1 /ID# 148189
- Malopolskie Centrum Kliniczne /ID# 152782
- Pratia MCM Krakow /ID# 143005
- McBk Sc /Id# 143003
- Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 151960
- Centrum Medyczne AMED Warszawa Targowek /ID# 157621
- Osteo-Medic spolka cywilna /ID# 143006
- Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163293
- Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163294
- Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163295
- Silmedic Sp z o.o /ID# 152914
- ClinicMed Badurski i wspolnicy SJ /ID# 163300
- Solumed Sp. zoo Cent Medyczne /ID# 152783
- Rheuma Medicus /ID# 143007
- Instituto Portugues De Reumatologia /ID# 148316
- Centro Hospitalar De Vila Nova /ID# 143010
- CCA Braga - Hospital de Braga /ID# 148317
- Hospital CUF Descobertas /ID# 160539
- Centro Hospitalar de Sao Joao, EPE /ID# 152871
- Unidade Local De Saude Do Alto Minho /ID# 143009
- Ponce School of Medicine /ID# 151961
- GCM Medical Group /ID# 143011
- Spitalul Clinic Dr. I. Cantacuzino /ID# 143012
- Spitalul Clinic Dr. I. Cantacuzino /ID# 143017
- Spitalul Clinic Sf. Maria /ID# 144868
- Spitalul Clinic Sf. Maria /ID# 144869
- Spitalul Clinic Sf. Maria /ID# 145966
- Spitalul Clinic de Recuperare /ID# 144867
- Ecomed SRL /ID# 144870
- Family Outpatient clinic#4,LLC /ID# 148319
- Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 143138
- Perm Clinical Center of FMBA /ID# 145627
- LLC Novaya Klinika /ID# 143019
- Kazan State Medical University /ID# 144871
- Tver Regional Clinical Hosp. /ID# 143026
- Сity Clinical Hospital #4 /ID# 143023
- Russian National Research Medi /ID# 143028
- City Clinical Hospital Botkina /ID# 145628
- Moscow State Univ Med and Dent /ID# 145623
- City Clinical Hospital #5 /ID# 148318
- Orenburg State Medical Academy /ID# 143018
- Ryazan State Medical Universit /ID# 143031
- II Dzhan Research Center /ID# 143027
- NW State Med Univ NA Mechnikov /ID# 143022
- Republican clinical hospital n /ID# 145626
- Ulyanovsk Regional Clin Hosp /ID# 143030
- Institute for Rheumatology /ID# 143032
- Institute for Rheumatology /ID# 143035
- Institute for Rheumatology /ID# 143036
- Institute for Rheumatology /ID# 143037
- Special Hospital for Rheuma /ID# 143034
- Clinical Center of Vojvodina /ID# 143033
- MEDMAN s.r.o. /ID# 143045
- Reumatologická ambulancia Reum.hapi s.r.o. /ID# 147169
- REUMACENTRUM s.r.o. /ID# 143041
- Slovak research center Team Member, Thermium s.r.o. /ID# 147614
- Reumex, s.r.o. /ID# 143043
- Reumatologicka ambulancia /ID# 144873
- TIMMED spol. s r.o. /ID# 144872
- Reumatologicka ambulancia, LER /ID# 143044
- ALBAMED s.r.o. /ID# 143042
- Greenacres Hospital /ID# 144710
- Wits Clinical Research Site /ID# 148320
- University of Pretoria /ID# 148353
- Jakaranda Hosp, Emmed Research /ID# 143046
- Jakaranda Hosp, Emmed Research /ID# 145968
- St. Augustine's Hospital /ID# 143047
- Synexus Helderberg Clinical Tr /ID# 148322
- Arthritis Clinical Research Tr /ID# 144874
- Tiervlei Trial Centre /ID# 153085
- Winelands Medical Research Ctr /ID# 143048
- H. Un. Marques de Valdecilla /ID# 143050
- Comple Hosp Univ de A Coruna /ID# 143051
- Hospital Universitario Reina S /ID# 153566
- Clinica Gaias /ID# 143052
- Complejo Hosp Santiago /ID# 153727
- China Medical University Hosp /ID# 143058
- National Taiwan Univ Hosp /ID# 143056
- Kaohsiung Medical University /ID# 143059
- Kaohsiung Chang Gung Memorial Hospital /ID# 143055
- Far Eastern Memorial Hospital /ID# 143061
- Chung Shan Medical University /ID# 143060
- Taipei Veterans General Hosp /ID# 157940
- Linkou Chang Gung Memorial Ho /ID# 143057
- Istanbul Universitesi Cerrahpa /ID# 156088
- Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastırma Hastanesi /ID# 143063
- Izmir Katip Celebi Ataturk Training & Research Hospital /ID# 143062
- LLC Revmocentr /ID# 143067
- Lviv Regional Clinical Hospita /ID# 154450
- Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 143071
- Regional Clinical Hospital /ID# 152025
- NSC-Strazhesko Ist Cardiology /ID# 152030
- Lviv Municipal City Clinical /ID# 143068
- Odessa National Medical Univ /ID# 143072
- Zaporizhzhia Regional Clinical /ID# 143069
- The Royal Free Hospital /ID# 143074
- Queen Alexandra Hospital /ID# 143077
- Warrington + Halton Hosp NHS /ID# 143075
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Placebo followed by ABT-494
Adalimumab
Upadacitinib
Arm Description
Participants were to receive placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were to be switched to 15 mg upadacitinib orally QD. At Week 26, all remaining participants were to be switched to 15 mg upadacitinib QD until Week 48 (end of Period 1). Participants who complete Period 1 will continue to receive 15 mg upadacitinib orally QD for up to 5 years in Period 2.
Participants were to receive placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were to be switched to 15 mg upadacitinib orally QD. At Week 26 remaining participants who did not achieve low disease activity (defined as Clinical Disease Activity Index [CDAI] ≤ 10) were to be switched to 15 mg upadacitinib orally QD until Week 48. Participants who complete Period 1 will continue to receive the same treatment assigned at the end of Period 1 (15 mg upadacitinib QD or 40 mg adalimumab eow) for up to 5 years in Period 2.
Participants were to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were to be switched to 40 mg adalimumab eow. At Week 26 remaining participants who did not achieve low disease activity (defined as CDAI ≤ 10) were to be switched to 40 mg adalimumab eow until Week 48. Participants who complete Period 1 will continue to receive the same treatment assigned at the end of Period 1 (15 mg upadacitinib QD or 40 mg adalimumab eow) for up to 5 years in Period 2.
Outcomes
Primary Outcome Measures
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) 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).
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12
The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission, based on a Disease Activity Score 28 (DAS28)-CRP score of < 2.6 at Week 12.
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than 2.6 indicates clinical remission.
Secondary Outcome Measures
Change From Baseline in DAS28 (CRP) at Week 12
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26
The mTSS measures the level of joint damage from radiographs of the hands and feet, assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score.
Joint erosion severity was assessed in 16 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 280 (worst).
JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A negative change from Baseline in mTSS indicates improvement in joint damage whereas a change from Baseline greater than 0 indicates progression.
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 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).
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.
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity.
Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12
Low disease activity based on the clinical disease activity index (CDAI) is defined as a CDAI score ≤ 10.
CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
Change From Baseline in Duration of Morning Stiffness at Week 12
Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days. A negative change from Baseline indicates improvement.
Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from Baseline indicates improvement.
Change From Baseline in Patient's Assessment of Pain at Week 12
Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale (VAS) from 0 to 100. A score of 0 indicates "no pain" and a score of 100 indicates "worst possible pain." A negative change from Baseline indicates improvement.
Percentage of Participants With No Radiographic Progression at Week 26
No radiographic progression is defined as a change from Baseline in mTSS ≤ 0. The mTSS measures the level of joint damage from radiographs of the hands and feet, which were assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score and ranges from 0 (normal) to 448 (worst).
Joint erosion severity was assessed in 16 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 280 (worst).
Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02629159
Brief Title
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate
Acronym
SELECT-COMPARE
Official Title
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
October 27, 2017 (Actual)
Study Completion Date
September 30, 2027 (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
The purpose of this study was to assess efficacy, including inhibition of radiographic progression, and safety with upadacitinib versus placebo and versus an active comparator, adalimumab, in adults with with moderately to severely active rheumatoid arthritis (RA) who are on a stable background of methotrexate (MTX and who have an inadequate response to MTX.
Detailed Description
This study consists of a 48-week double-blind treatment period (Period 1) and a long-term extension period (Period 2).
Period 1 is a 48-week randomized, double-blind, parallel-group, placebo-controlled and active comparator-controlled period designed to compare the safety and efficacy of upadacitinib versus placebo, and versus adalimumab. Participants will be randomized in a 2:2:1 ratio to one of three treatment groups:
Placebo (up to Week 26)
Upadacitinib 15 mg once daily (QD)
Adalimumab 40 mg every other week (eow)
Participants randomized to placebo who do not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline will be switched to blinded upadacitinib treatment. At Week 26, all participants still receiving placebo will be switched to blinded upadacitinib treatment regardless of clinical response.
Participants randomized to adalimumab who do not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline will be switched to blinded upadacitinib. Participants still receiving adalimumab at Week 26 who do not achieve low disease activity (LDA) according to Clinical Disease Activity Index (CDAI; LDA is defined as CDAI ≤ 10) will be switched to blinded upadacitinib treatment to Week 48.
Participants randomized to upadacitinib who do not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline will be switched to blinded adalimumab; participants still receiving upadacitinib at Week 26 who do not achieve LDA (CDAI ≤ 10) will be switched to blinded adalimumab treatment to Week 48.
Participants who complete the Week 48 visit (end of Period 1) will enter the long-term extension phase of the study (Period 2), for up to 5 years. Participants will continue study treatment as assigned at the end of Period 1. Starting at the Week 48 and thereafter, at least 20% improvement in both TJC and SJC compared to Baseline is required to remain on study drug. Anyone who does not fulfill this criterion at 2 consecutive visits (starting at Week 48) will be discontinued.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Musculoskeletal disease, Arthritis, Joint disease, Anti-inflammatory agents, Antirheumatic agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1629 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo followed by ABT-494
Arm Type
Placebo Comparator
Arm Description
Participants were to receive placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were to be switched to 15 mg upadacitinib orally QD. At Week 26, all remaining participants were to be switched to 15 mg upadacitinib QD until Week 48 (end of Period 1).
Participants who complete Period 1 will continue to receive 15 mg upadacitinib orally QD for up to 5 years in Period 2.
Arm Title
Adalimumab
Arm Type
Active Comparator
Arm Description
Participants were to receive placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were to be switched to 15 mg upadacitinib orally QD. At Week 26 remaining participants who did not achieve low disease activity (defined as Clinical Disease Activity Index [CDAI] ≤ 10) were to be switched to 15 mg upadacitinib orally QD until Week 48.
Participants who complete Period 1 will continue to receive the same treatment assigned at the end of Period 1 (15 mg upadacitinib QD or 40 mg adalimumab eow) for up to 5 years in Period 2.
Arm Title
Upadacitinib
Arm Type
Experimental
Arm Description
Participants were to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were to be switched to 40 mg adalimumab eow. At Week 26 remaining participants who did not achieve low disease activity (defined as CDAI ≤ 10) were to be switched to 40 mg adalimumab eow until Week 48.
Participants who complete Period 1 will continue to receive the same treatment assigned at the end of Period 1 (15 mg upadacitinib QD or 40 mg adalimumab eow) for up to 5 years in Period 2.
Intervention Type
Drug
Intervention Name(s)
Placebo for Adalimumab
Intervention Description
Administered by subcutaneous injection once every other week
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Intervention Description
Administered by subcutaneous injection once every other week
Intervention Type
Drug
Intervention Name(s)
Placebo for Upadacitinib
Intervention Description
Tablets taken orally once a day
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494
Intervention Description
Tablets taken orally once a day
Primary Outcome Measure Information:
Title
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Description
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) 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).
Time Frame
Baseline and Week 12
Title
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12
Description
The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission, based on a Disease Activity Score 28 (DAS28)-CRP score of < 2.6 at Week 12.
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than 2.6 indicates clinical remission.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in DAS28 (CRP) at Week 12
Description
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26
Description
The mTSS measures the level of joint damage from radiographs of the hands and feet, assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score.
Joint erosion severity was assessed in 16 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 280 (worst).
JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A negative change from Baseline in mTSS indicates improvement in joint damage whereas a change from Baseline greater than 0 indicates progression.
Time Frame
Baseline and Week 26
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 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
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
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
Description
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity.
Time Frame
Week 12
Title
Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12
Description
Low disease activity based on the clinical disease activity index (CDAI) is defined as a CDAI score ≤ 10.
CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
Time Frame
Week 12
Title
Change From Baseline in Duration of Morning Stiffness at Week 12
Description
Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days. A negative change from Baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Description
The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from Baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Patient's Assessment of Pain at Week 12
Description
Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale (VAS) from 0 to 100. A score of 0 indicates "no pain" and a score of 100 indicates "worst possible pain." A negative change from Baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With No Radiographic Progression at Week 26
Description
No radiographic progression is defined as a change from Baseline in mTSS ≤ 0. The mTSS measures the level of joint damage from radiographs of the hands and feet, which were assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score and ranges from 0 (normal) to 448 (worst).
Joint erosion severity was assessed in 16 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 280 (worst).
Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
Time Frame
Baseline and Week 26
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult male or female, at least 18 years old.
Diagnosis of RA for greater than or equal to 3 months.
Subjects must have been on oral or parenteral methotrexate (MTX) therapy greater than or equal to 3 months and on a stable prescription of greater than or equal to 15 to 25 mg/week (or greater than or equal to 10 mg/week in subjects intolerant of MTX at doses greater than or equal to 12.5 mg/week) for at least 4 weeks prior to the first dose of study drug. In addition all subjects should take a dietary supplement of folic acid or folinic acid throughout the study participation.
Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
At least one of the following at Screening: greater than or equal to 3 bone erosions on x-ray OR greater than or equal to 1 bone erosion and a positive rheumatoid factor OR greater than or equal to 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibodies.
Subjects with prior exposure to only one biological disease-modifying anti-rheumatic drugs (bDMARD) (except adalimumab) may be enrolled (up to 20% of total study population) if they have documented evidence of intolerance to the bDMARD or limited exposure (less than 3 months), but required washout periods need to be satisfied.
Except for MTX, subject must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).
Exclusion Criteria:
Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
Subjects who have been exposed to adalimumab or who are considered inadequate responders to bDMARD therapy as determined by the Investigator.
History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Achieve Clinical Research, LLC /ID# 143136
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
AZ Arthritis and Rheum Assoc /ID# 143130
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
SunValley Arthritis Center, Lt /ID# 143123
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Elite Clinical Studies, LLC /ID# 144881
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
AZ Arthritis and Rheum Researc /ID# 143080
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Facility Name
AZ Arthritis and Rheum Researc /ID# 143121
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Facility Name
AZ Arthritis & Rheuma Research /ID# 143131
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Arizona Research Center, Inc. /ID# 144877
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053-4061
Country
United States
Facility Name
AZ Arthritis & Rheum Research /ID# 156093
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
University of Arizona Cancer Center - North Campus /ID# 143114
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719-1478
Country
United States
Facility Name
Osteoporosis Medical Center /ID# 153935
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
T. Joseph Raoof, MD, Inc. /ID# 144884
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Rheumatology Ctr of San Diego /ID# 153747
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
C.V. Mehta MD, Med Corporation /ID# 143116
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Facility Name
Allergy and Rheum Med Clin /ID# 146083
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Kotha and Kotha /ID# 161046
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
TriWest Research Associates- La Mesa /ID# 143115
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Valerius Med Grp & Res Ctr /ID# 143120
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-5402
Country
United States
Facility Name
Discovery MM Services, Inc /ID# 163504
City
Los Angeles
State/Province
California
ZIP/Postal Code
11373
Country
United States
Facility Name
Desert Medical Advances /ID# 143097
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Sierra Rheumatology /ID# 155672
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Robin K. Dore MD, Inc /ID# 143090
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Medvin Clinical Research /ID# 148362
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
Arthritis Assoc & Osteo Ctr /ID# 143122
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Arthritis and Rheum Clin N. CO /ID# 156094
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
AARDS Research, Inc. /ID# 154190
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
ZASA Clinical Research /ID# 143134
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Clinical Res of West FL, Inc. /ID# 143112
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
International Medical Research /ID# 143132
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Precision Research Org, LLC /ID# 143092
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016-1501
Country
United States
Facility Name
Lakes Research, LLC /ID# 145630
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
FL Med Ctr and Research, Inc. /ID# 143081
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Ctr Arthritis & Rheumatic Dise /ID# 143135
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Advanced Clin Res of Orlando /ID# 154617
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761-4547
Country
United States
Facility Name
Rheum Assoc of Central FL /ID# 145632
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Omega Research Consultants /ID# 145635
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
HMD Research LLC /ID# 163292
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Arthritis Research of Florida /ID# 143125
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684-2672
Country
United States
Facility Name
Arthritis Center, Inc. /ID# 145647
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
St. Anthony Comprehsve Res Ins /ID# 143095
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Clinical Research West FL /ID# 148358
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
SW FL Clin Res Ctr, Tampa, FL /ID# 143117
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
BayCare Medical Group, Inc. /ID# 143085
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614-7101
Country
United States
Facility Name
Lovelace Scientific Resources /ID# 143106
City
Venice
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
Facility Name
Arthritis and Rheumatology /ID# 155668
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Arthritis Center of North GA /ID# 155258
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
North Georgia Rheumatology Grp /ID# 147170
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Advanced Clinical Research /ID# 153090
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Great Lakes Clinical Trials /ID# 148357
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Arthritis Treatment Center /ID# 155260
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
The Center for Rheumatology & /ID# 151356
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Clinical Pharmacology Study Gr /ID# 143082
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Advanced Rheumatology, PC /ID# 143118
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Shores Rheumatology, PC /ID# 162977
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
St. Luke's Hospital /ID# 156750
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
North Mississippi Med Clinics /ID# 145636
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Physician Res. Collaboration /ID# 143087
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Quality Clinical Research Inc. /ID# 156394
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Atlantic Coast Research /ID# 148355
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Ocean Rheumatology, PA /ID# 143111
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Arthritis Rheumatic Back Disorder /ID# 143102
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc /ID# 143083
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Arthritis and Osteo Assoc /ID# 143127
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
St. Lawrence Health System /ID# 161619
City
Potsdam
State/Province
New York
ZIP/Postal Code
13676
Country
United States
Facility Name
Joint & Muscle Research Instit /ID# 143119
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
DJL Clinical Research, PLLC /ID# 143101
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210-8508
Country
United States
Facility Name
EmergeOrtho, P.A. /ID# 143100
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Cape Fear Arthritis Care /ID# 148361
City
Leland
State/Province
North Carolina
ZIP/Postal Code
28451
Country
United States
Facility Name
Coastal Carolina Health Care /ID# 148359
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Shanahan Rheuma & Immuno /ID# 145643
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617
Country
United States
Facility Name
Clinical Research Solutions, LLC /ID# 154619
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Arthritis Assoc of NW Ohio /ID# 143094
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Healthcare Research Consultant /ID# 143129
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Altoona Ctr Clinical Res /ID# 143110
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Clinical Research Ctr Reading /ID# 143133
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Columbia Arthritis Center /ID# 153730
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Innovative Clinical Research /ID# 145637
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 143091
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486-7887
Country
United States
Facility Name
Arthritis Associates, PLLC /ID# 155490
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Rheumatology Consultants, PLLC /ID# 153731
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Dr. Ramesh Gupta /ID# 143099
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Austin Regional Clinic /ID# 143084
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Diagnostic Group Integrated He /ID# 148356
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Arthritis Care and Diagnostic /ID# 150677
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Metroplex Clinical Research /ID# 145631
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Doctor's Hosp at Renaissance /ID# 154616
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
MedResearch Inc. /ID# 154618
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Facility Name
Accurate Clinical Management /ID# 145644
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Accurate Clinical Research /ID# 145645
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Rheumatology Clinic of Houston /ID# 150921
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Houston Institute for Clin Res /ID# 144879
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Pioneer Research Solutions, Inc. /ID# 145640
City
Houston
State/Province
Texas
ZIP/Postal Code
77098-5294
Country
United States
Facility Name
Arthritis Consultants, P.A. /ID# 144880
City
Killeen
State/Province
Texas
ZIP/Postal Code
76549
Country
United States
Facility Name
Arthritis & Osteoporosis Assoc /ID# 147364
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
P&I Clinical Research /ID# 161625
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904-3132
Country
United States
Facility Name
SW Rheumatology Res. LLC /ID# 143126
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Discovery MM Services, Inc. /ID# 162578
City
Missouri City
State/Province
Texas
ZIP/Postal Code
77459-4750
Country
United States
Facility Name
Discovery MM Services, Inc. /ID# 163183
City
Missouri City
State/Province
Texas
ZIP/Postal Code
77459-4750
Country
United States
Facility Name
Discovery MM Services, Inc. /ID# 163184
City
Missouri City
State/Province
Texas
ZIP/Postal Code
77459-4750
Country
United States
Facility Name
Sun Research Institute /ID# 159539
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Accurate Clinical Management /ID# 143089
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Arthritis & Osteo Ctr of S. TX /ID# 143103
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
Facility Name
DM Clinical Research /ID# 151357
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Arthritis Clinic of N. VA, P.C /ID# 143109
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Ctr for Arth and Rheum Disease /ID# 143113
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Arthritis Northwest, PLLC /ID# 143088
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
The Vancouver Clinic, INC. PS /ID# 143107
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
West Virginia Research Inst /ID# 153088
City
South Charleston
State/Province
West Virginia
ZIP/Postal Code
25309
Country
United States
Facility Name
Rheumatology and Immunotherapy Center /ID# 145646
City
Franklin
State/Province
Wisconsin
ZIP/Postal Code
53132
Country
United States
Facility Name
Aprillus Asistencia e Investig /ID# 148406
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1046
Country
Argentina
Facility Name
Mautalen Salud e Investigacion /ID# 142843
City
Buenos Aires
ZIP/Postal Code
1128
Country
Argentina
Facility Name
Fundacion Sanatorio Guemes /ID# 148405
City
Buenos Aires
ZIP/Postal Code
1180
Country
Argentina
Facility Name
Consultorio Reumatologic Pampa /ID# 144853
City
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
Cemic /Id# 148404
City
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Org Medica de Investigacion /ID# 144855
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Inst. Rheumatologic Strusberg /ID# 145601
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Consultora Integral de Salud S /ID# 144856
City
Cordoba
ZIP/Postal Code
5900
Country
Argentina
Facility Name
Instituto CAICI /ID# 144854
City
Rosario, Santa FE
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Cordis S.A. /Id# 152622
City
Salta
ZIP/Postal Code
4400
Country
Argentina
Facility Name
Iari /Id# 151293
City
San Fernando
ZIP/Postal Code
1646
Country
Argentina
Facility Name
Centro Integral de Reumatologi /ID# 142845
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Centro Medico Privado/Reuma /ID# 142842
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Centro de Enfermedades /ID# 153542
City
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Royal Prince Alfred Hospital /ID# 144857
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Emeritus Research /ID# 142848
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
LKH-Univ. Klinikum Graz /ID# 142851
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
First City Clinical Hospital /ID# 158011
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
Cliniques Universitaires Saint Luc /ID# 142858
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Rhumaconsult SPRL /ID# 142860
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
CHU de Liege /ID# 148401
City
Liège
State/Province
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
UZ Gent /ID# 142859
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU Ambroise Pare /ID# 152953
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
University Clinical Centre of the Republic of Srpska /ID# 142862
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Centre of the Republic of Srpska /ID# 142863
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Clinical Center University of Sarajevo /ID# 142865
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
CIP - Centro Internacional de Pesquisa /ID# 142872
City
Goiânia
State/Province
Goias
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
Hc Ufmg /Id# 142868
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 142871
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre /ID# 142870
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
LMK Sevicos Medicos S/S /ID# 142869
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90480-000
Country
Brazil
Facility Name
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 142867
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
CCBR Brasil /ID# 150918
City
Rio de Janeiro
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
MHAT Trimontsium /ID# 142874
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
UMHAT Pulmed OOD /ID# 142877
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MHAT Kaspela /ID# 142873
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
Diagnostic Consultative Center /ID# 142875
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
UMHAT Sv. Ivan Rilski /ID# 142876
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Manitoba Clinic /ID# 161434
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A IM3
Country
Canada
Facility Name
Ciads /Id# 142880
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3N 0K6
Country
Canada
Facility Name
St. Clare's Mercy Hospital /ID# 142879
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 5B8
Country
Canada
Facility Name
Adachi Medicine Prof. Corp /ID# 154205
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
CA Ctr for Clin Trials CCCT /ID# 157379
City
Thornhill
State/Province
Ontario
ZIP/Postal Code
L4J 1W3
Country
Canada
Facility Name
Groupe de Recherche en Maladies Osseuses /ID# 142878
City
Sainte-foy
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Ctr de Inv Clinica del Sur /ID# 142888
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4781156
Country
Chile
Facility Name
Reg. Clinical Hosptial Concepcion /ID# 151271
City
Concepcion
ZIP/Postal Code
4070038
Country
Chile
Facility Name
Corp de Beneficencia Osorno /ID# 147941
City
Osorno
ZIP/Postal Code
1710216
Country
Chile
Facility Name
Someal /Id# 144704
City
Providencia-santiago
ZIP/Postal Code
7510186
Country
Chile
Facility Name
Quantum Research LTDA. /ID# 142893
City
Puerto Varas
ZIP/Postal Code
5550170
Country
Chile
Facility Name
Quantum Research Stgo. /ID# 157933
City
Santiago
ZIP/Postal Code
7500588
Country
Chile
Facility Name
Soc. de Prestaciones medicas y Paramedicas Goecke /ID# 142890
City
Santiago
ZIP/Postal Code
7510047
Country
Chile
Facility Name
Clinica DermaCross /ID# 142892
City
Santiago
ZIP/Postal Code
7640881
Country
Chile
Facility Name
Investigaciones Medicas SSMSO /ID# 151686
City
Santiago
ZIP/Postal Code
8207257
Country
Chile
Facility Name
Centro Inter Estud Clin CIEC /ID# 144777
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Centro Medico de Reumatologia /ID# 148402
City
Temuco
ZIP/Postal Code
4790928
Country
Chile
Facility Name
Cinvec /Id# 144705
City
Vina Del Mar
ZIP/Postal Code
2520997
Country
Chile
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 142898
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Ctr Int de Reum del Caribe SAS /ID# 142894
City
Barranquilla
ZIP/Postal Code
80002
Country
Colombia
Facility Name
Fund Inst de Reum F. Chalem /ID# 149847
City
Bogota DC
Country
Colombia
Facility Name
Riesgo de Fractura S.A - CAYRE /ID# 142896
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Medicity S.A.S. /ID# 144860
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Facility Name
Centro Integral de Reumatologi /ID# 142897
City
Medellín
ZIP/Postal Code
50021
Country
Colombia
Facility Name
Klinicki bolnicki centar Rijeka /ID# 160232
City
Rijeka
State/Province
Primorsko-goranska Zupanija
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Klinicki bolnicki centar Split /ID# 152530
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Clinical Hospital Dubrava /ID# 142900
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Medical Center Kuna-Peric /ID# 142901
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Poliklinika Bonifarm /ID# 142899
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
L.K.N. Arthrocentrum, s.r.o /ID# 145961
City
Hlučín
State/Province
Moravskoslezsky Kraj
ZIP/Postal Code
748 01
Country
Czechia
Facility Name
CTCenter MaVe, s.r.o. /ID# 142905
City
Olomouc
State/Province
Olomoucky Kraj
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Revmatologicky ustav Praha /ID# 142904
City
Prague 2
State/Province
Praha 2
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
Nuselská poliklinika, Revmatologie /ID# 144862
City
Prague 4
State/Province
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Revmatologická ambulance /ID# 145963
City
Prague 4
State/Province
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Thomayerova nemocnice /ID# 145962
City
Prague 4
State/Province
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
REVMACLINIC s.r.o. /ID# 142906
City
Brno
ZIP/Postal Code
611 41
Country
Czechia
Facility Name
Revmatologie Bruntal, s.r.o /ID# 142903
City
Bruntál
ZIP/Postal Code
79201
Country
Czechia
Facility Name
Revmatologicka a interni ambul /ID# 142907
City
Kladno
ZIP/Postal Code
272 01
Country
Czechia
Facility Name
Revmatologie MUDr. Klara Sirov /ID# 142908
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Arthromed, s.r.o. /ID# 144706
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Aarhus University Hospital /ID# 158838
City
Aarhus N
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Regionhospital Silkeborg /ID# 142914
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Facility Name
Center of Clinical and Basic Research /ID# 142922
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
10128
Country
Estonia
Facility Name
MediTrials /ID# 151870
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Paernu Hospital /ID# 142921
City
Pärnu
ZIP/Postal Code
80010
Country
Estonia
Facility Name
East Tallinn Central Hospital /ID# 142923
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
North Estonian Medical Centre /ID# 145454
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Hopital Universitaire Purpan /ID# 144707
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
CHRU Lille - Hôpital Claude Huriez /ID# 151312
City
Lille CEDEX
State/Province
Hauts-de-France
ZIP/Postal Code
59045
Country
France
Facility Name
Hopital Saint Eloi /ID# 142925
City
Montpellier CEDEX 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Bordeaux-Hopital Pellegrin /ID# 145618
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital de la Cote de Nacre /ID# 145616
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU Gabriel Montpied /ID# 145619
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Hopital de la Conception /ID# 142926
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hopital Pitie Salpetriere /ID# 145605
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU de Rennes - Hospital Sud /ID# 151957
City
Rennes
ZIP/Postal Code
35203
Country
France
Facility Name
CHU Strasbourg Hautepierre Hos /ID# 144708
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Rheumazentrum Ruhrgebiet /ID# 145620
City
Herne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44649
Country
Germany
Facility Name
Uniklinik Koln /ID# 145964
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Praxis Walter, Rendsburg /ID# 142932
City
Rendsburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24768
Country
Germany
Facility Name
Med Versorgungszentrum AGILOME /ID# 154975
City
Chemnitz
ZIP/Postal Code
9126
Country
Germany
Facility Name
Rheumaforschungszentrum II /ID# 142930
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
LMU Klinikum der Universität München /ID# 142931
City
Munich
ZIP/Postal Code
80337
Country
Germany
Facility Name
General Hospital of Athens Laiko /ID# 142934
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 27
Country
Greece
Facility Name
University General Hospital Attikon /ID# 142933
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Facility Name
General Hospital of Athens Ippokratio /ID# 142935
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Queen Mary Hospital /ID# 142938
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Tuen Mun Hospital /ID# 142939
City
Tuen Mun
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 142951
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Qualiclinic Kft. /ID# 142953
City
Budapest III
State/Province
Pest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatókórház /ID# 145621
City
Szombathely
State/Province
Vas
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Vital Medical Center Orvosi es /ID# 145950
City
Veszprém
State/Province
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Budai Irgalmasrendi Korhaz /ID# 142952
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Revita Reumatologiai Rendelo /ID# 142950
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Synexus Magyarorszag Kft. /ID# 153061
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142948
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Hevizgyogyfurdo es Szent Andra /ID# 142949
City
Heviz
ZIP/Postal Code
8380
Country
Hungary
Facility Name
Kiskunhalasi Semmelweis Korhaz /ID# 151944
City
Kiskunhalas
ZIP/Postal Code
6400
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz /ID# 142954
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
St Vincent's University Hosp /ID# 142957
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
Tel Aviv Sourasky Medical Ctr /ID# 144709
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 152050
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Bnai Zion Medical Center /ID# 151958
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
The Lady Davis Carmel MC /ID# 142960
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Sheba Medical Center /ID# 145965
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Istituto Clinico Humanitas /ID# 147528
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
AOU Citta della Salute Scienza /ID# 150070
City
Turin
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliera Luigi Sacc /ID# 142966
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
A.O.U.I. di Verona Policlinico /ID# 142963
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
JSC Nat Scientific Med Res Ctr /ID# 142971
City
Astana
ZIP/Postal Code
010009
Country
Kazakhstan
Facility Name
Karaganda State Medical Univ /ID# 153433
City
Karaganda
ZIP/Postal Code
100008
Country
Kazakhstan
Facility Name
Semey State Medical University /ID# 152659
City
Semey
ZIP/Postal Code
071403
Country
Kazakhstan
Facility Name
Regional Clinical Hospital /ID# 147168
City
Shymkent
ZIP/Postal Code
160000
Country
Kazakhstan
Facility Name
Kyungpook National Univ Hosp /ID# 162073
City
Daegu
State/Province
Daegu Gwang Yeogsi
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital /ID# 142977
City
Jung-gu
State/Province
Daejeon Gwang Yeogsi
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Inha University Hospital /ID# 150886
City
Jung-gu
State/Province
Incheon Gwang Yeogsi
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital /ID# 142975
City
Gwangju
State/Province
Jeonranamdo
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospi /ID# 142979
City
Seongdong-gu
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Cath Univ Seoul St Mary's Hosp /ID# 142976
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Daegu Catholic University Med /ID# 142973
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 142978
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 142974
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
LTD M+M Centers /ID# 142984
City
Adazi
ZIP/Postal Code
2164
Country
Latvia
Facility Name
Daugavpils Regional Hospital /ID# 142982
City
Daugavpils
ZIP/Postal Code
5417
Country
Latvia
Facility Name
D.Saulites-Kandevicas PP /ID# 142985
City
Liepaja
ZIP/Postal Code
3401
Country
Latvia
Facility Name
Clinic ORTO /ID# 142983
City
Riga
ZIP/Postal Code
1005
Country
Latvia
Facility Name
Riga East Clinical Univ Hosp /ID# 142981
City
Riga
ZIP/Postal Code
1038
Country
Latvia
Facility Name
Hosp Lithuanian Univ Health Sc /ID# 142986
City
Kovno
State/Province
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Vilnius University Hospital /ID# 142987
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Hospital Raja Perempuan Zainab II /ID# 157862
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
15586
Country
Malaysia
Facility Name
Hospital Selayang /ID# 156756
City
Batu Caves
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Hospital Umum Sarawak /ID# 142990
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Hospital Putrajaya /ID# 142989
City
Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
Hospital Tuanku Ja afar /ID# 142988
City
Seremban
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
Clinstile, S.A. de C.V. /ID# 144866
City
Cuauhtemoc
State/Province
Ciudad De Mexico
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Hosp. Univ. Dr. Jose E. Gonz /ID# 142992
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64320
Country
Mexico
Facility Name
Invest y Biomed de Chihuahua /ID# 142996
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
RM Pharma Specialists, S.A de C.V /ID# 142994
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Hospital de Jesús Nazareno /ID# 142993
City
Mexico City
ZIP/Postal Code
06090
Country
Mexico
Facility Name
Centro Peninsular de Investiga /ID# 148159
City
Mérida
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Waikato Hospital /ID# 143002
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Porter Rheumatology Ltd /ID# 143001
City
Nelson
ZIP/Postal Code
7010
Country
New Zealand
Facility Name
Timaru Medical Specialists Ltd /ID# 143000
City
Timaru
ZIP/Postal Code
7910
Country
New Zealand
Facility Name
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 145622
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
51-685
Country
Poland
Facility Name
NZOZ Nasz Lekarz /ID# 143004
City
Toruń
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
REUMED Sp.z o.o. Filia nr 1 /ID# 148189
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-607
Country
Poland
Facility Name
Malopolskie Centrum Kliniczne /ID# 152782
City
Cracow
State/Province
Malopolskie
ZIP/Postal Code
30-149
Country
Poland
Facility Name
Pratia MCM Krakow /ID# 143005
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Facility Name
McBk Sc /Id# 143003
City
Grodzisk Mazowiecki
State/Province
Mazowieckie
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 151960
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Centrum Medyczne AMED Warszawa Targowek /ID# 157621
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-291
Country
Poland
Facility Name
Osteo-Medic spolka cywilna /ID# 143006
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163293
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-384
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163294
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-384
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163295
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-384
Country
Poland
Facility Name
Silmedic Sp z o.o /ID# 152914
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-282
Country
Poland
Facility Name
ClinicMed Badurski i wspolnicy SJ /ID# 163300
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Solumed Sp. zoo Cent Medyczne /ID# 152783
City
Poznan
ZIP/Postal Code
60-425
Country
Poland
Facility Name
Rheuma Medicus /ID# 143007
City
Warsaw
ZIP/Postal Code
02-118
Country
Poland
Facility Name
Instituto Portugues De Reumatologia /ID# 148316
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1050-034
Country
Portugal
Facility Name
Centro Hospitalar De Vila Nova /ID# 143010
City
Vila Nova De Gaia
State/Province
Porto
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
CCA Braga - Hospital de Braga /ID# 148317
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Hospital CUF Descobertas /ID# 160539
City
Lisbon
ZIP/Postal Code
1998-018
Country
Portugal
Facility Name
Centro Hospitalar de Sao Joao, EPE /ID# 152871
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Unidade Local De Saude Do Alto Minho /ID# 143009
City
Viana Do Castelo
ZIP/Postal Code
4901-858
Country
Portugal
Facility Name
Ponce School of Medicine /ID# 151961
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
GCM Medical Group /ID# 143011
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Spitalul Clinic Dr. I. Cantacuzino /ID# 143012
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Spitalul Clinic Dr. I. Cantacuzino /ID# 143017
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Spitalul Clinic Sf. Maria /ID# 144868
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Spitalul Clinic Sf. Maria /ID# 144869
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Spitalul Clinic Sf. Maria /ID# 145966
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Spitalul Clinic de Recuperare /ID# 144867
City
Iasi
ZIP/Postal Code
700656
Country
Romania
Facility Name
Ecomed SRL /ID# 144870
City
Oradea
ZIP/Postal Code
410028
Country
Romania
Facility Name
Family Outpatient clinic#4,LLC /ID# 148319
City
Korolev
State/Province
Moskva
ZIP/Postal Code
141060
Country
Russian Federation
Facility Name
Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 143138
City
Moscow
State/Province
Moskva
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Perm Clinical Center of FMBA /ID# 145627
City
Perm
State/Province
Permskiy Kray
ZIP/Postal Code
614109
Country
Russian Federation
Facility Name
LLC Novaya Klinika /ID# 143019
City
Pyatigorsk
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Kazan State Medical University /ID# 144871
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Tver Regional Clinical Hosp. /ID# 143026
City
Tver
State/Province
Tverskaya Oblast
ZIP/Postal Code
170036
Country
Russian Federation
Facility Name
Сity Clinical Hospital #4 /ID# 143023
City
Ivanovo
ZIP/Postal Code
153005
Country
Russian Federation
Facility Name
Russian National Research Medi /ID# 143028
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
City Clinical Hospital Botkina /ID# 145628
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Moscow State Univ Med and Dent /ID# 145623
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
City Clinical Hospital #5 /ID# 148318
City
Nizhnij Novgorod
ZIP/Postal Code
603005
Country
Russian Federation
Facility Name
Orenburg State Medical Academy /ID# 143018
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Facility Name
Ryazan State Medical Universit /ID# 143031
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
II Dzhan Research Center /ID# 143027
City
St. Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
NW State Med Univ NA Mechnikov /ID# 143022
City
St. Petersburg
ZIP/Postal Code
193015
Country
Russian Federation
Facility Name
Republican clinical hospital n /ID# 145626
City
UFA
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clin Hosp /ID# 143030
City
Ulyanovsk
ZIP/Postal Code
432018
Country
Russian Federation
Facility Name
Institute for Rheumatology /ID# 143032
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Rheumatology /ID# 143035
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Rheumatology /ID# 143036
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Rheumatology /ID# 143037
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Special Hospital for Rheuma /ID# 143034
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21101
Country
Serbia
Facility Name
Clinical Center of Vojvodina /ID# 143033
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21137
Country
Serbia
Facility Name
MEDMAN s.r.o. /ID# 143045
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
Facility Name
Reumatologická ambulancia Reum.hapi s.r.o. /ID# 147169
City
Nové Mesto Nad Váhom
ZIP/Postal Code
915 01
Country
Slovakia
Facility Name
REUMACENTRUM s.r.o. /ID# 143041
City
Partizanske
ZIP/Postal Code
958 01
Country
Slovakia
Facility Name
Slovak research center Team Member, Thermium s.r.o. /ID# 147614
City
Pieštany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
Reumex, s.r.o. /ID# 143043
City
Rimavska Sobota
ZIP/Postal Code
97 101
Country
Slovakia
Facility Name
Reumatologicka ambulancia /ID# 144873
City
Sabinov
ZIP/Postal Code
083 01
Country
Slovakia
Facility Name
TIMMED spol. s r.o. /ID# 144872
City
Stará Lubovna
ZIP/Postal Code
06401
Country
Slovakia
Facility Name
Reumatologicka ambulancia, LER /ID# 143044
City
Topolcany
ZIP/Postal Code
955 01
Country
Slovakia
Facility Name
ALBAMED s.r.o. /ID# 143042
City
Zvolen
ZIP/Postal Code
960 01
Country
Slovakia
Facility Name
Greenacres Hospital /ID# 144710
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Wits Clinical Research Site /ID# 148320
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
University of Pretoria /ID# 148353
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Jakaranda Hosp, Emmed Research /ID# 143046
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0132
Country
South Africa
Facility Name
Jakaranda Hosp, Emmed Research /ID# 145968
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0132
Country
South Africa
Facility Name
St. Augustine's Hospital /ID# 143047
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Synexus Helderberg Clinical Tr /ID# 148322
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Arthritis Clinical Research Tr /ID# 144874
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Tiervlei Trial Centre /ID# 153085
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Winelands Medical Research Ctr /ID# 143048
City
Stellenbosch
State/Province
Western Cape
ZIP/Postal Code
7600
Country
South Africa
Facility Name
H. Un. Marques de Valdecilla /ID# 143050
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Comple Hosp Univ de A Coruna /ID# 143051
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Reina S /ID# 153566
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Clinica Gaias /ID# 143052
City
Santiago de Compostela
ZIP/Postal Code
15702
Country
Spain
Facility Name
Complejo Hosp Santiago /ID# 153727
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
China Medical University Hosp /ID# 143058
City
Taichung City
State/Province
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan Univ Hosp /ID# 143056
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Kaohsiung Medical University /ID# 143059
City
Kaohsiung
ZIP/Postal Code
80708
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital /ID# 143055
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital /ID# 143061
City
New Taipei City
ZIP/Postal Code
22060
Country
Taiwan
Facility Name
Chung Shan Medical University /ID# 143060
City
Taichung City
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 157940
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Ho /ID# 143057
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Istanbul Universitesi Cerrahpa /ID# 156088
City
Cerrahpasa
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastırma Hastanesi /ID# 143063
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Facility Name
Izmir Katip Celebi Ataturk Training & Research Hospital /ID# 143062
City
Izmir
ZIP/Postal Code
35360
Country
Turkey
Facility Name
LLC Revmocentr /ID# 143067
City
Kiev
State/Province
Kyiv
ZIP/Postal Code
04070
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospita /ID# 154450
City
Lviv
State/Province
Lvivska Oblast
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 143071
City
Vinnytsia
State/Province
Vinnytska Oblast
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Regional Clinical Hospital /ID# 152025
City
Ivano-frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
NSC-Strazhesko Ist Cardiology /ID# 152030
City
Kiev
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Lviv Municipal City Clinical /ID# 143068
City
Lviv
ZIP/Postal Code
79007
Country
Ukraine
Facility Name
Odessa National Medical Univ /ID# 143072
City
Odesa
ZIP/Postal Code
65026
Country
Ukraine
Facility Name
Zaporizhzhia Regional Clinical /ID# 143069
City
Zaporizhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
The Royal Free Hospital /ID# 143074
City
London
State/Province
London, City Of
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Queen Alexandra Hospital /ID# 143077
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Warrington + Halton Hosp NHS /ID# 143075
City
Warrington
ZIP/Postal Code
WA5 1LZ
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, analyses plans, 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
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
31287230
Citation
Fleischmann R, Pangan AL, Song IH, Mysler E, Bessette L, Peterfy C, Durez P, Ostor AJ, Li Y, Zhou Y, Othman AA, Genovese MC. Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double-Blind, Randomized Controlled Trial. Arthritis Rheumatol. 2019 Nov;71(11):1788-1800. doi: 10.1002/art.41032. Epub 2019 Aug 28.
Results Reference
background
PubMed Identifier
36125701
Citation
Bergman M, Buch MH, Tanaka Y, Citera G, Bahlas S, Wong E, Song Y, Zueger P, Ali M, Strand V. Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials. Rheumatol Ther. 2022 Dec;9(6):1517-1529. doi: 10.1007/s40744-022-00483-4. Epub 2022 Sep 20.
Results Reference
derived
PubMed Identifier
36018230
Citation
Mysler E, Tanaka Y, Kavanaugh A, Aletaha D, Taylor PC, Song IH, Shaw T, Song Y, DeMasi R, Ali M, Fleischmann R. Impact of initial therapy with upadacitinib or adalimumab on achievement of 48-week treatment goals in patients with rheumatoid arthritis: post hoc analysis of SELECT-COMPARE. Rheumatology (Oxford). 2023 May 2;62(5):1804-1813. doi: 10.1093/rheumatology/keac477.
Results Reference
derived
PubMed Identifier
34897366
Citation
Peterfy CG, Strand V, Friedman A, Hall S, Mysler E, Durez P, Baraliakos X, Enejosa JV, Shaw T, Li Y, Chen S, Song IH. Inhibition of structural joint damage progression with upadacitinib in rheumatoid arthritis: 1-year outcomes from the SELECT phase 3 program. Rheumatology (Oxford). 2022 Aug 3;61(8):3246-3256. doi: 10.1093/rheumatology/keab861.
Results Reference
derived
PubMed Identifier
34041702
Citation
Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.
Results Reference
derived
PubMed Identifier
33590829
Citation
Strand V, Tundia N, Bergman M, Ostor A, Durez P, Song IH, Enejosa J, Schlacher C, Song Y, Fleischmann R. Upadacitinib improves patient-reported outcomes vs placebo or adalimumab in patients with rheumatoid arthritis: results from SELECT-COMPARE. Rheumatology (Oxford). 2021 Dec 1;60(12):5583-5594. doi: 10.1093/rheumatology/keab158.
Results Reference
derived
PubMed Identifier
33148701
Citation
Fleischmann RM, Blanco R, Hall S, Thomson GTD, Van den Bosch FE, Zerbini C, Bessette L, Enejosa J, Li Y, Song Y, DeMasi R, Song IH. Switching between Janus kinase inhibitor upadacitinib and adalimumab following insufficient response: efficacy and safety in patients with rheumatoid arthritis. Ann Rheum Dis. 2021 Apr;80(4):432-439. doi: 10.1136/annrheumdis-2020-218412. Epub 2020 Nov 4.
Results Reference
derived
PubMed Identifier
33115760
Citation
Cohen SB, van Vollenhoven RF, Winthrop KL, Zerbini CAF, Tanaka Y, Bessette L, Zhang Y, Khan N, Hendrickson B, Enejosa JV, Burmester GR. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2021 Mar;80(3):304-311. doi: 10.1136/annrheumdis-2020-218510. Epub 2020 Oct 28. Erratum In: Ann Rheum Dis. 2021 May;80(5):e83.
Results Reference
derived
PubMed Identifier
31610021
Citation
Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.
Results Reference
derived
PubMed Identifier
31362993
Citation
Fleischmann RM, Genovese MC, Enejosa JV, Mysler E, Bessette L, Peterfy C, Durez P, Ostor A, Li Y, Song IH. Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response. Ann Rheum Dis. 2019 Nov;78(11):1454-1462. doi: 10.1136/annrheumdis-2019-215764. Epub 2019 Jul 30.
Results Reference
derived
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M14-465
Description
Related Info
Learn more about this trial
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate
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