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
SELECT-COMPARE
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)
2 other identifiers
interventional
1,629
41 countries
359
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Dec 2015
Longer than P75 for phase_3 rheumatoid-arthritis
359 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 10, 2015
CompletedFirst Posted
Study publicly available on registry
December 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2017
CompletedResults Posted
Study results publicly available
October 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
ExpectedAugust 5, 2025
August 1, 2025
1.9 years
December 10, 2015
September 13, 2019
August 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Baseline and Week 12
Percentage of Participants 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.
Week 12
Secondary Outcomes (12)
Change From Baseline in DAS28 (CRP) at Week 12
Baseline and Week 12
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26
Baseline and Week 26
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Baseline and Week 12
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Baseline and Week 12
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
Baseline and Week 12
- +7 more secondary outcomes
Study Arms (3)
Placebo followed by ABT-494
PLACEBO COMPARATORParticipants 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.
Adalimumab
ACTIVE COMPARATORParticipants 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.
Upadacitinib
EXPERIMENTALParticipants 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.
Interventions
Administered by subcutaneous injection once every other week
Administered by subcutaneous injection once every other week
Tablets taken orally once a day
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (370)
Achieve Clinical Research, LLC /ID# 143136
Birmingham, Alabama, 35216, United States
AZ Arthritis and Rheum Assoc /ID# 143130
Mesa, Arizona, 85202, United States
SunValley Arthritis Center, Lt /ID# 143123
Peoria, Arizona, 85381, United States
Elite Clinical Studies, LLC /ID# 144881
Phoenix, Arizona, 85018, United States
AZ Arthritis and Rheum Researc /ID# 143080
Phoenix, Arizona, 85032-9306, United States
AZ Arthritis and Rheum Researc /ID# 143121
Phoenix, Arizona, 85032-9306, United States
AZ Arthritis & Rheuma Research /ID# 143131
Phoenix, Arizona, 85032, United States
Arizona Research Center, Inc. /ID# 144877
Phoenix, Arizona, 85053-4061, United States
AZ Arthritis & Rheum Research /ID# 156093
Sun City, Arizona, 85351, United States
University of Arizona Cancer Center - North Campus /ID# 143114
Tucson, Arizona, 85719-1478, United States
Osteoporosis Medical Center /ID# 153935
Beverly Hills, California, 90211, United States
T. Joseph Raoof, MD, Inc. /ID# 144884
Encino, California, 91436, United States
Rheumatology Ctr of San Diego /ID# 153747
Escondido, California, 92025, United States
C.V. Mehta MD, Med Corporation /ID# 143116
Hemet, California, 92543, United States
Allergy and Rheum Med Clin /ID# 146083
La Jolla, California, 92037, United States
Kotha and Kotha /ID# 161046
La Mesa, California, 91942, United States
TriWest Research Associates- La Mesa /ID# 143115
La Mesa, California, 91942, United States
Valerius Med Grp & Res Ctr /ID# 143120
Los Alamitos, California, 90720-5402, United States
Discovery MM Services, Inc /ID# 163504
Los Angeles, California, 11373, United States
Desert Medical Advances /ID# 143097
Palm Desert, California, 92260, United States
Sierra Rheumatology /ID# 155672
Roseville, California, 95661, United States
Robin K. Dore MD, Inc /ID# 143090
Tustin, California, 92780, United States
Medvin Clinical Research /ID# 148362
Whittier, California, 90606, United States
Arthritis Assoc & Osteo Ctr /ID# 143122
Colorado Springs, Colorado, 80920, United States
Arthritis and Rheum Clin N. CO /ID# 156094
Fort Collins, Colorado, 80528, United States
AARDS Research, Inc. /ID# 154190
Aventura, Florida, 33180, United States
ZASA Clinical Research /ID# 143134
Boynton Beach, Florida, 33472, United States
Clinical Res of West FL, Inc. /ID# 143112
Clearwater, Florida, 33765, United States
International Medical Research /ID# 143132
Daytona Beach, Florida, 32117, United States
Lakes Research, LLC /ID# 145630
Miami, Florida, 33014, United States
FL Med Ctr and Research, Inc. /ID# 143081
Miami, Florida, 33142, United States
Ctr Arthritis & Rheumatic Dise /ID# 143135
Miami, Florida, 33173, United States
Precision Research Org, LLC /ID# 143092
Miami Lakes, Florida, 33016-1501, United States
Advanced Clin Res of Orlando /ID# 154617
Ocoee, Florida, 34761-4547, United States
Rheum Assoc of Central FL /ID# 145632
Orlando, Florida, 32806, United States
Omega Research Consultants /ID# 145635
Orlando, Florida, 32810, United States
HMD Research LLC /ID# 163292
Orlando, Florida, 32819, United States
Arthritis Research of Florida /ID# 143125
Palm Harbor, Florida, 34684-2672, United States
Arthritis Center, Inc. /ID# 145647
Palm Harbor, Florida, 34684, United States
St. Anthony Comprehsve Res Ins /ID# 143095
St. Petersburg, Florida, 33705, United States
Clinical Research West FL /ID# 148358
Tampa, Florida, 33603, United States
SW FL Clin Res Ctr, Tampa, FL /ID# 143117
Tampa, Florida, 33609, United States
BayCare Medical Group, Inc. /ID# 143085
Tampa, Florida, 33614-7101, United States
Lovelace Scientific Resources /ID# 143106
Venice, Florida, 34292, United States
Arthritis and Rheumatology /ID# 155668
Atlanta, Georgia, 30342, United States
Arthritis Center of North GA /ID# 155258
Gainesville, Georgia, 30501, United States
North Georgia Rheumatology Grp /ID# 147170
Lawrenceville, Georgia, 30045, United States
Advanced Clinical Research /ID# 153090
Meridian, Idaho, 83642, United States
Great Lakes Clinical Trials /ID# 148357
Chicago, Illinois, 60640, United States
Arthritis Treatment Center /ID# 155260
Frederick, Maryland, 21204, United States
The Center for Rheumatology & /ID# 151356
Wheaton, Maryland, 20902, United States
Clinical Pharmacology Study Gr /ID# 143082
Worcester, Massachusetts, 01605, United States
Advanced Rheumatology, PC /ID# 143118
Lansing, Michigan, 48910, United States
Shores Rheumatology, PC /ID# 162977
Saint Clair Shores, Michigan, 48081, United States
St. Luke's Hospital /ID# 156750
Duluth, Minnesota, 55805, United States
North Mississippi Med Clinics /ID# 145636
Tupelo, Mississippi, 38801, United States
Physician Res. Collaboration /ID# 143087
Lincoln, Nebraska, 68516, United States
Quality Clinical Research Inc. /ID# 156394
Omaha, Nebraska, 68114, United States
Atlantic Coast Research /ID# 148355
Toms River, New Jersey, 08755, United States
Ocean Rheumatology, PA /ID# 143111
Toms River, New Jersey, 08755, United States
Arthritis Rheumatic Back Disorder /ID# 143102
Voorhees Township, New Jersey, 08043, United States
Albuquerque Clinical Trials, Inc /ID# 143083
Albuquerque, New Mexico, 87102, United States
Arthritis and Osteo Assoc /ID# 143127
Las Cruces, New Mexico, 88011, United States
St. Lawrence Health System /ID# 161619
Potsdam, New York, 13676, United States
Joint & Muscle Research Instit /ID# 143119
Charlotte, North Carolina, 28204, United States
DJL Clinical Research, PLLC /ID# 143101
Charlotte, North Carolina, 28210-8508, United States
EmergeOrtho, P.A. /ID# 143100
Durham, North Carolina, 27704, United States
Cape Fear Arthritis Care /ID# 148361
Leland, North Carolina, 28451, United States
Coastal Carolina Health Care /ID# 148359
New Bern, North Carolina, 28562, United States
Shanahan Rheuma & Immuno /ID# 145643
Raleigh, North Carolina, 27617, United States
Clinical Research Solutions, LLC /ID# 154619
Dayton, Ohio, 45409, United States
Arthritis Assoc of NW Ohio /ID# 143094
Toledo, Ohio, 43606, United States
Healthcare Research Consultant /ID# 143129
Tulsa, Oklahoma, 74135, United States
Altoona Ctr Clinical Res /ID# 143110
Duncansville, Pennsylvania, 16635, United States
Clinical Research Ctr Reading /ID# 143133
Wyomissing, Pennsylvania, 19610, United States
Columbia Arthritis Center /ID# 153730
Columbia, South Carolina, 29204, United States
Innovative Clinical Research /ID# 145637
Greenville, South Carolina, 29601, United States
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 143091
Summerville, South Carolina, 29486-7887, United States
Arthritis Associates, PLLC /ID# 155490
Kingsport, Tennessee, 37660, United States
Rheumatology Consultants, PLLC /ID# 153731
Knoxville, Tennessee, 37909, United States
Dr. Ramesh Gupta /ID# 143099
Memphis, Tennessee, 38119, United States
Austin Regional Clinic /ID# 143084
Austin, Texas, 78731, United States
Diagnostic Group Integrated He /ID# 148356
Beaumont, Texas, 77701, United States
Arthritis Care and Diagnostic /ID# 150677
Dallas, Texas, 75231, United States
Metroplex Clinical Research /ID# 145631
Dallas, Texas, 75231, United States
Doctor's Hosp at Renaissance /ID# 154616
Edinburg, Texas, 78539, United States
MedResearch Inc. /ID# 154618
El Paso, Texas, 79935, United States
Accurate Clinical Management /ID# 145644
Houston, Texas, 77004, United States
Accurate Clinical Research /ID# 145645
Houston, Texas, 77034, United States
Rheumatology Clinic of Houston /ID# 150921
Houston, Texas, 77065, United States
Houston Institute for Clin Res /ID# 144879
Houston, Texas, 77074, United States
Pioneer Research Solutions, Inc. /ID# 145640
Houston, Texas, 77098-5294, United States
Arthritis Consultants, P.A. /ID# 144880
Killeen, Texas, 76549, United States
Arthritis & Osteoporosis Assoc /ID# 147364
Lubbock, Texas, 79424, United States
P&I Clinical Research /ID# 161625
Lufkin, Texas, 75904-3132, United States
SW Rheumatology Res. LLC /ID# 143126
Mesquite, Texas, 75150, United States
Discovery MM Services, Inc. /ID# 162578
Missouri City, Texas, 77459-4750, United States
Discovery MM Services, Inc. /ID# 163183
Missouri City, Texas, 77459-4750, United States
Discovery MM Services, Inc. /ID# 163184
Missouri City, Texas, 77459-4750, United States
Sun Research Institute /ID# 159539
San Antonio, Texas, 78215, United States
Accurate Clinical Management /ID# 143089
San Antonio, Texas, 78229, United States
Arthritis & Osteo Ctr of S. TX /ID# 143103
San Antonio, Texas, 78232, United States
DM Clinical Research /ID# 151357
Tomball, Texas, 77375, United States
Arthritis Clinic of N. VA, P.C /ID# 143109
Arlington, Virginia, 22205, United States
Ctr for Arth and Rheum Disease /ID# 143113
Chesapeake, Virginia, 23320, United States
Arthritis Northwest, PLLC /ID# 143088
Spokane, Washington, 99204, United States
The Vancouver Clinic, INC. PS /ID# 143107
Vancouver, Washington, 98664, United States
West Virginia Research Inst /ID# 153088
South Charleston, West Virginia, 25309, United States
Rheumatology and Immunotherapy Center /ID# 145646
Franklin, Wisconsin, 53132, United States
Aprillus Asistencia e Investig /ID# 148406
Capital Federal, Buenos Aires, 1046, Argentina
Mautalen Salud e Investigacion /ID# 142843
Buenos Aires, 1128, Argentina
Fundacion Sanatorio Guemes /ID# 148405
Buenos Aires, 1180, Argentina
Consultorio Reumatologic Pampa /ID# 144853
Buenos Aires, 1428, Argentina
Cemic /Id# 148404
Buenos Aires, 1431, Argentina
Org Medica de Investigacion /ID# 144855
Buenos Aires, C1015ABO, Argentina
Inst. Rheumatologic Strusberg /ID# 145601
Córdoba, 5000, Argentina
Consultora Integral de Salud S /ID# 144856
Córdoba, 5900, Argentina
Instituto CAICI /ID# 144854
Rosario, Santa FE, 2000, Argentina
Cordis S.A. /Id# 152622
Salta, 4400, Argentina
Iari /Id# 151293
San Fernando, 1646, Argentina
Centro Integral de Reumatologi /ID# 142845
San Miguel de Tucumán, 4000, Argentina
Centro Medico Privado/Reuma /ID# 142842
San Miguel de Tucumán, 4000, Argentina
Centro de Enfermedades /ID# 153542
Santa Fe, 2000, Argentina
Royal Prince Alfred Hospital /ID# 144857
Camperdown, New South Wales, 2050, Australia
Emeritus Research /ID# 142848
Camberwell, Victoria, 3124, Australia
LKH-Univ. Klinikum Graz /ID# 142851
Graz, 8036, Austria
First City Clinical Hospital /ID# 158011
Minsk, 220013, Belarus
Cliniques Universitaires Saint Luc /ID# 142858
Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium
Rhumaconsult SPRL /ID# 142860
Charleroi, Hainaut, 6000, Belgium
CHU de Liege /ID# 148401
Liège, Liege, 4000, Belgium
UZ Gent /ID# 142859
Ghent, Oost-Vlaanderen, 9000, Belgium
CHU Ambroise Pare /ID# 152953
Mons, 7000, Belgium
University Clinical Centre of the Republic of Srpska /ID# 142862
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 142863
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
Clinical Center University of Sarajevo /ID# 142865
Sarajevo, 71000, Bosnia and Herzegovina
CIP - Centro Internacional de Pesquisa /ID# 142872
Goiânia, Goiás, 74110-120, Brazil
Hc Ufmg /Id# 142868
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 142871
Curitiba, Paraná, 80030-110, Brazil
Hospital de Clinicas de Porto Alegre /ID# 142870
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
LMK Sevicos Medicos S/S /ID# 142869
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 142867
São Paulo, São Paulo, 04266-010, Brazil
CCBR Brasil /ID# 150918
Rio de Janeiro, 22271-100, Brazil
MHAT Trimontsium /ID# 142874
Plovdiv, 4000, Bulgaria
UMHAT Pulmed OOD /ID# 142877
Plovdiv, 4000, Bulgaria
MHAT Kaspela /ID# 142873
Plovdiv, 4001, Bulgaria
Diagnostic Consultative Center /ID# 142875
Sofia, 1612, Bulgaria
UMHAT Sv. Ivan Rilski /ID# 142876
Sofia, 1612, Bulgaria
Manitoba Clinic /ID# 161434
Winnipeg, Manitoba, R3A IM3, Canada
Ciads /Id# 142880
Winnipeg, Manitoba, R3N 0K6, Canada
St. Clare's Mercy Hospital /ID# 142879
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Adachi Medicine Prof. Corp /ID# 154205
Hamilton, Ontario, L8N 1Y2, Canada
CA Ctr for Clin Trials CCCT /ID# 157379
Thornhill, Ontario, L4J 1W3, Canada
Groupe de Recherche en Maladies Osseuses /ID# 142878
Sainte-Foy, Quebec, G1V 3M7, Canada
Ctr de Inv Clinica del Sur /ID# 142888
Temuco, Región de la Araucanía, 4781156, Chile
Reg. Clinical Hosptial Concepcion /ID# 151271
Concepción, 4070038, Chile
Corp de Beneficencia Osorno /ID# 147941
Osorno, 1710216, Chile
Someal /Id# 144704
Providencia-santiago, 7510186, Chile
Quantum Research LTDA. /ID# 142893
Puerto Varas, 5550170, Chile
Quantum Research Stgo. /ID# 157933
Santiago, 7500588, Chile
Soc. de Prestaciones medicas y Paramedicas Goecke /ID# 142890
Santiago, 7510047, Chile
Clinica DermaCross /ID# 142892
Santiago, 7640881, Chile
Investigaciones Medicas SSMSO /ID# 151686
Santiago, 8207257, Chile
Centro Inter Estud Clin CIEC /ID# 144777
Santiago, 8420383, Chile
Centro Medico de Reumatologia /ID# 148402
Temuco, 4790928, Chile
Cinvec /Id# 144705
Viña del Mar, 2520997, Chile
Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 142898
Bogota, Cundinamarca, 110221, Colombia
Ctr Int de Reum del Caribe SAS /ID# 142894
Barranquilla, 80002, Colombia
Fund Inst de Reum F. Chalem /ID# 149847
Bogota DC, Colombia
Riesgo de Fractura S.A - CAYRE /ID# 142896
Bogotá, 110221, Colombia
Medicity S.A.S. /ID# 144860
Bucaramanga, 680003, Colombia
Centro Integral de Reumatologi /ID# 142897
Medellín, 50021, Colombia
Klinicki bolnicki centar Rijeka /ID# 160232
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
Klinicki bolnicki centar Split /ID# 152530
Split, 21000, Croatia
Clinical Hospital Dubrava /ID# 142900
Zagreb, 10000, Croatia
Medical Center Kuna-Peric /ID# 142901
Zagreb, 10000, Croatia
Poliklinika Bonifarm /ID# 142899
Zagreb, 10000, Croatia
L.K.N. Arthrocentrum, s.r.o /ID# 145961
Hlučín, Moravskoslezský kraj, 748 01, Czechia
CTCenter MaVe, s.r.o. /ID# 142905
Olomouc, Olomoucký kraj, 779 00, Czechia
Revmatologicky ustav Praha /ID# 142904
Prague, Praha 2, 128 00, Czechia
Nuselská poliklinika, Revmatologie /ID# 144862
Prague, Praha 4, 140 00, Czechia
Revmatologická ambulance /ID# 145963
Prague, Praha 4, 140 00, Czechia
Thomayerova nemocnice /ID# 145962
Prague, Praha 4, 140 00, Czechia
REVMACLINIC s.r.o. /ID# 142906
Brno, 611 41, Czechia
Revmatologie Bruntal, s.r.o /ID# 142903
Bruntál, 79201, Czechia
Revmatologicka a interni ambul /ID# 142907
Kladno, 272 01, Czechia
Revmatologie MUDr. Klara Sirov /ID# 142908
Ostrava, 702 00, Czechia
Arthromed, s.r.o. /ID# 144706
Pardubice, 530 02, Czechia
Aarhus University Hospital /ID# 158838
Aarhus N, Central Jutland, 8200, Denmark
Regionhospital Silkeborg /ID# 142914
Silkeborg, 8600, Denmark
Center of Clinical and Basic Research /ID# 142922
Tallinn, Harju, 10128, Estonia
MediTrials /ID# 151870
Tartu, Tartu, 50406, Estonia
Paernu Hospital /ID# 142921
Pärnu, 80010, Estonia
East Tallinn Central Hospital /ID# 142923
Tallinn, 10138, Estonia
North Estonian Medical Centre /ID# 145454
Tallinn, 13419, Estonia
Hopital Universitaire Purpan /ID# 144707
Toulouse, Haute-Garonne, 31059, France
CHRU Lille - Hôpital Claude Huriez /ID# 151312
Lille, Hauts-de-France, 59045, France
Hopital Saint Eloi /ID# 142925
Montpellier, Herault, 34295, France
CHU Bordeaux-Hopital Pellegrin /ID# 145618
Bordeaux, 33076, France
Hopital de la Cote de Nacre /ID# 145616
Caen, 14033, France
CHU Gabriel Montpied /ID# 145619
Clermont-Ferrand, 63000, France
Hopital de la Conception /ID# 142926
Marseille, 13005, France
Hopital Pitie Salpetriere /ID# 145605
Paris, 75651, France
CHU de Rennes - Hospital Sud /ID# 151957
Rennes, 35203, France
CHU Strasbourg Hautepierre Hos /ID# 144708
Strasbourg, 67200, France
Uniklinik Koln /ID# 145964
Cologne, North Rhine-Westphalia, 50937, Germany
Rheumazentrum Ruhrgebiet /ID# 145620
Herne, North Rhine-Westphalia, 44649, Germany
Praxis Walter, Rendsburg /ID# 142932
Rendsburg, Schleswig-Holstein, 24768, Germany
Med Versorgungszentrum AGILOME /ID# 154975
Chemnitz, 9126, Germany
Rheumaforschungszentrum II /ID# 142930
Hamburg, 20095, Germany
LMU Klinikum der Universität München /ID# 142931
Munich, 80337, Germany
General Hospital of Athens Laiko /ID# 142934
Athens, Attica, 115 27, Greece
University General Hospital Attikon /ID# 142933
Athens, Attica, 12462, Greece
General Hospital of Athens Ippokratio /ID# 142935
Athens, 11527, Greece
Queen Mary Hospital /ID# 142938
Hong Kong, 999077, Hong Kong
Tuen Mun Hospital /ID# 142939
Tuenmen, 999077, Hong Kong
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 142951
Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary
Qualiclinic Kft. /ID# 142953
Budapest III, Pest County, 1036, Hungary
Markusovszky Egyetemi Oktatókórház /ID# 145621
Szombathely, Vas County, 9700, Hungary
Vital Medical Center Orvosi es /ID# 145950
Veszprém, Veszprém megye, 8200, Hungary
Budai Irgalmasrendi Korhaz /ID# 142952
Budapest, 1023, Hungary
Revita Reumatologiai Rendelo /ID# 142950
Budapest, 1027, Hungary
Synexus Magyarorszag Kft. /ID# 153061
Budapest, 1036, Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142948
Debrecen, 4031, Hungary
Hevizgyogyfurdo es Szent Andra /ID# 142949
Hévíz, 8380, Hungary
Kiskunhalasi Semmelweis Korhaz /ID# 151944
Kiskunhalas, 6400, Hungary
Pest Megyei Flor Ferenc Korhaz /ID# 142954
Kistarcsa, 2143, Hungary
St Vincent's University Hosp /ID# 142957
Dublin, D04 T6F4, Ireland
Tel Aviv Sourasky Medical Ctr /ID# 144709
Tel Aviv, Tel Aviv, 6423906, Israel
Rambam Health Care Campus /ID# 152050
Haifa, 3109601, Israel
Bnai Zion Medical Center /ID# 151958
Haifa, 3339419, Israel
The Lady Davis Carmel MC /ID# 142960
Haifa, 3436212, Israel
Sheba Medical Center /ID# 145965
Ramat Gan, 5262100, Israel
Istituto Clinico Humanitas /ID# 147528
Rozzano, Milano, 20089, Italy
AOU Citta della Salute Scienza /ID# 150070
Turin, Piedmont, 10126, Italy
Azienda Ospedaliera Luigi Sacc /ID# 142966
Milan, 20157, Italy
A.O.U.I. di Verona Policlinico /ID# 142963
Verona, 37134, Italy
JSC Nat Scientific Med Res Ctr /ID# 142971
Astana, 010009, Kazakhstan
Karaganda State Medical Univ /ID# 153433
Karaganda, 100008, Kazakhstan
Semey State Medical University /ID# 152659
Semey, 071403, Kazakhstan
Regional Clinical Hospital /ID# 147168
Shymkent, 160000, Kazakhstan
LTD M+M Centers /ID# 142984
Ādaži, 2164, Latvia
Daugavpils Regional Hospital /ID# 142982
Daugavpils, 5417, Latvia
D.Saulites-Kandevicas PP /ID# 142985
Liepāja, 3401, Latvia
Clinic ORTO /ID# 142983
Riga, 1005, Latvia
Riga East Clinical Univ Hosp /ID# 142981
Riga, 1038, Latvia
Hosp Lithuanian Univ Health Sc /ID# 142986
Kaunas, Kaunas County, 50009, Lithuania
Vilnius University Hospital /ID# 142987
Vilnius, LT-08661, Lithuania
Hospital Raja Perempuan Zainab II /ID# 157862
Kota Bharu, Kelantan, 15586, Malaysia
Hospital Selayang /ID# 156756
Batu Caves, 68100, Malaysia
Hospital Umum Sarawak /ID# 142990
Kuching, 93586, Malaysia
Hospital Putrajaya /ID# 142989
Putrajaya, 62250, Malaysia
Hospital Tuanku Ja afar /ID# 142988
Seremban, 70300, Malaysia
Clinstile, S.A. de C.V. /ID# 144866
Cuauhtémoc, Mexico City, 06700, Mexico
Hosp. Univ. Dr. Jose E. Gonz /ID# 142992
Monterrey, Nuevo León, 64320, Mexico
Invest y Biomed de Chihuahua /ID# 142996
Chihuahua City, 31000, Mexico
RM Pharma Specialists, S.A de C.V /ID# 142994
Mexico City, 03100, Mexico
Hospital de Jesús Nazareno /ID# 142993
Mexico City, 06090, Mexico
Centro Peninsular de Investiga /ID# 148159
Mérida, 97000, Mexico
Waikato Hospital /ID# 143002
Hamilton, Waikato Region, 3204, New Zealand
Porter Rheumatology Ltd /ID# 143001
Nelson, 7010, New Zealand
Timaru Medical Specialists Ltd /ID# 143000
Timaru, 7910, New Zealand
NZOZ Nasz Lekarz /ID# 143004
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Malopolskie Centrum Kliniczne /ID# 152782
Krakow, Lesser Poland Voivodeship, 30-149, Poland
Pratia MCM Krakow /ID# 143005
Krakow, Lesser Poland Voivodeship, 30-510, Poland
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 145622
Wroclaw, Lower Silesian Voivodeship, 51-685, Poland
REUMED Sp.z o.o. Filia nr 1 /ID# 148189
Lublin, Lublin Voivodeship, 20-607, Poland
McBk Sc /Id# 143003
Grodzisk Mazowiecki, Masovian Voivodeship, 05-825, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 151960
Warsaw, Masovian Voivodeship, 02-507, Poland
Centrum Medyczne AMED Warszawa Targowek /ID# 157621
Warsaw, Masovian Voivodeship, 03-291, Poland
Osteo-Medic spolka cywilna /ID# 143006
Bialystok, Podlaskie Voivodeship, 15-351, Poland
Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163293
Gdynia, Pomeranian Voivodeship, 81-384, Poland
Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163294
Gdynia, Pomeranian Voivodeship, 81-384, Poland
Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163295
Gdynia, Pomeranian Voivodeship, 81-384, Poland
Silmedic Sp z o.o /ID# 152914
Katowice, Silesian Voivodeship, 40-282, Poland
ClinicMed Badurski i wspolnicy SJ /ID# 163300
Bialystok, 15-879, Poland
Solumed Sp. zoo Cent Medyczne /ID# 152783
Poznan, 60-425, Poland
Rheuma Medicus /ID# 143007
Warsaw, 02-118, Poland
Instituto Portugues De Reumatologia /ID# 148316
Lisbon, Lisbon District, 1050-034, Portugal
Centro Hospitalar De Vila Nova /ID# 143010
Vila Nova de Gaia, Porto District, 4434-502, Portugal
CCA Braga - Hospital de Braga /ID# 148317
Braga, 4710-243, Portugal
Hospital CUF Descobertas /ID# 160539
Lisbon, 1998-018, Portugal
Centro Hospitalar de Sao Joao, EPE /ID# 152871
Porto, 4200-319, Portugal
Unidade Local De Saude Do Alto Minho /ID# 143009
Viana do Castelo, 4901-858, Portugal
Ponce School of Medicine /ID# 151961
Ponce, 00716, Puerto Rico
GCM Medical Group /ID# 143011
San Juan, 00909, Puerto Rico
Spitalul Clinic Dr. I. Cantacuzino /ID# 143012
Bucharest, București, 020475, Romania
Spitalul Clinic Dr. I. Cantacuzino /ID# 143017
Bucharest, București, 020475, Romania
Spitalul Clinic Sf. Maria /ID# 144868
Bucharest, 011172, Romania
Spitalul Clinic Sf. Maria /ID# 144869
Bucharest, 011172, Romania
Spitalul Clinic Sf. Maria /ID# 145966
Bucharest, 011172, Romania
Spitalul Clinic de Recuperare /ID# 144867
Iași, 700656, Romania
Ecomed SRL /ID# 144870
Oradea, 410028, Romania
Family Outpatient clinic#4,LLC /ID# 148319
Korolev, Moscow, 141060, Russia
Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 143138
Moscow, Moscow, 119049, Russia
Perm Clinical Center of FMBA /ID# 145627
Perm, Permskiy Kray, 614109, Russia
LLC Novaya Klinika /ID# 143019
Pyatigorsk, Stavropol Kray, 357500, Russia
Kazan State Medical University /ID# 144871
Kazan', Tatarstan, Respublika, 420012, Russia
Tver Regional Clinical Hosp. /ID# 143026
Tver', Tver Oblast, 170036, Russia
Сity Clinical Hospital #4 /ID# 143023
Ivanovo, 153005, Russia
Russian National Research Medi /ID# 143028
Moscow, 117997, Russia
City Clinical Hospital Botkina /ID# 145628
Moscow, 125284, Russia
Moscow State Univ Med and Dent /ID# 145623
Moscow, 127473, Russia
City Clinical Hospital #5 /ID# 148318
Nizhny Novgorod, 603005, Russia
Orenburg State Medical Academy /ID# 143018
Orenburg, 460000, Russia
Ryazan State Medical Universit /ID# 143031
Ryazan, 390026, Russia
II Dzhan Research Center /ID# 143027
Saint Petersburg, 192242, Russia
NW State Med Univ NA Mechnikov /ID# 143022
Saint Petersburg, 193015, Russia
Republican clinical hospital n /ID# 145626
Ufa, 450005, Russia
Ulyanovsk Regional Clin Hosp /ID# 143030
Ulyanovsk, 432018, Russia
Institute for Rheumatology /ID# 143032
Belgrade, Beograd, 11000, Serbia
Institute for Rheumatology /ID# 143035
Belgrade, Beograd, 11000, Serbia
Institute for Rheumatology /ID# 143036
Belgrade, Beograd, 11000, Serbia
Institute for Rheumatology /ID# 143037
Belgrade, Beograd, 11000, Serbia
Special Hospital for Rheuma /ID# 143034
Novi Sad, Vojvodina, 21101, Serbia
Clinical Center of Vojvodina /ID# 143033
Novi Sad, Vojvodina, 21137, Serbia
MEDMAN s.r.o. /ID# 143045
Martin, 036 01, Slovakia
Reumatologická ambulancia Reum.hapi s.r.o. /ID# 147169
Nové Mesto nad Váhom, 915 01, Slovakia
REUMACENTRUM s.r.o. /ID# 143041
Partizánske, 958 01, Slovakia
Slovak research center Team Member, Thermium s.r.o. /ID# 147614
Pieštany, 921 01, Slovakia
Reumex, s.r.o. /ID# 143043
Rimavská Sobota, 97 101, Slovakia
Reumatologicka ambulancia /ID# 144873
Sabinov, 083 01, Slovakia
TIMMED spol. s r.o. /ID# 144872
Stará Lubovna, 06401, Slovakia
Reumatologicka ambulancia, LER /ID# 143044
Topoľčany, 955 01, Slovakia
ALBAMED s.r.o. /ID# 143042
Zvolen, 960 01, Slovakia
Greenacres Hospital /ID# 144710
Port Elizabeth, Eastern Cape, 6045, South Africa
Wits Clinical Research Site /ID# 148320
Johannesburg, Gauteng, 2193, South Africa
University of Pretoria /ID# 148353
Pretoria, Gauteng, 0001, South Africa
Jakaranda Hosp, Emmed Research /ID# 143046
Pretoria, Gauteng, 0132, South Africa
Jakaranda Hosp, Emmed Research /ID# 145968
Pretoria, Gauteng, 0132, South Africa
St. Augustine's Hospital /ID# 143047
Durban, KwaZulu-Natal, 4001, South Africa
Synexus Helderberg Clinical Tr /ID# 148322
Cape Town, Western Cape, 7130, South Africa
Arthritis Clinical Research Tr /ID# 144874
Cape Town, Western Cape, 7405, South Africa
Tiervlei Trial Centre /ID# 153085
Cape Town, Western Cape, 7530, South Africa
Winelands Medical Research Ctr /ID# 143048
Stellenbosch, Western Cape, 7600, South Africa
Kyungpook National Univ Hosp /ID# 162073
Daegu, Daegu Gwang Yeogsi, 41944, South Korea
Chungnam National University Hospital /ID# 142977
Junggu, Daejeon Gwang Yeogsi, 35015, South Korea
Inha University Hospital /ID# 150886
Junggu, Incheon Gwang Yeogsi, 22332, South Korea
Chonnam National University Hospital /ID# 142975
Gwangju, Jeonranamdo, 61469, South Korea
Hanyang University Seoul Hospi /ID# 142979
Seongdong-gu, Seoul Teugbyeolsi, 04763, South Korea
Cath Univ Seoul St Mary's Hosp /ID# 142976
Seoul, Seoul Teugbyeolsi, 06591, South Korea
Daegu Catholic University Med /ID# 142973
Daegu, 705-718, South Korea
Seoul National University Hospital /ID# 142978
Seoul, 03080, South Korea
Asan Medical Center /ID# 142974
Seoul, 05505, South Korea
H. Un. Marques de Valdecilla /ID# 143050
Santander, Cantabria, 39008, Spain
Comple Hosp Univ de A Coruna /ID# 143051
A Coruña, 15006, Spain
Hospital Universitario Reina S /ID# 153566
Córdoba, 14004, Spain
Clinica Gaias /ID# 143052
Santiago de Compostela, 15702, Spain
Complejo Hosp Santiago /ID# 153727
Santiago de Compostela, 15706, Spain
China Medical University Hosp /ID# 143058
Taichung, Taichung, 40447, Taiwan
National Taiwan Univ Hosp /ID# 143056
Taipei City, Taipei, 10002, Taiwan
Kaohsiung Medical University /ID# 143059
Kaohsiung City, 80708, Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 143055
Kaohsiung City, 833, Taiwan
Far Eastern Memorial Hospital /ID# 143061
New Taipei City, 22060, Taiwan
Chung Shan Medical University /ID# 143060
Taichung, 40201, Taiwan
Taipei Veterans General Hosp /ID# 157940
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Ho /ID# 143057
Taoyuan, 33305, Taiwan
Istanbul Universitesi Cerrahpa /ID# 156088
Cerrahpaşa, 34098, Turkey (Türkiye)
Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastırma Hastanesi /ID# 143063
Istanbul, 34147, Turkey (Türkiye)
Izmir Katip Celebi Ataturk Training & Research Hospital /ID# 143062
Izmir, 35360, Turkey (Türkiye)
LLC Revmocentr /ID# 143067
Kiev, Kyiv Oblast, 04070, Ukraine
Lviv Regional Clinical Hospita /ID# 154450
Lviv, Lviv Oblast, 79013, Ukraine
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 143071
Vinnytsia, Vinnytsia Oblast, 21018, Ukraine
Regional Clinical Hospital /ID# 152025
Ivano-Frankivsk, 76018, Ukraine
NSC-Strazhesko Ist Cardiology /ID# 152030
Kiev, 03680, Ukraine
Lviv Municipal City Clinical /ID# 143068
Lviv, 79007, Ukraine
Odessa National Medical Univ /ID# 143072
Odesa, 65026, Ukraine
Zaporizhzhia Regional Clinical /ID# 143069
Zaporizhia, 69600, Ukraine
The Royal Free Hospital /ID# 143074
London, London, City of, NW3 2QG, United Kingdom
Queen Alexandra Hospital /ID# 143077
Portsmouth, PO6 3LY, United Kingdom
Warrington + Halton Hosp NHS /ID# 143075
Warrington, WA5 1LZ, United Kingdom
Related Publications (19)
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.
PMID: 31287230BACKGROUNDBurmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.
PMID: 40875187DERIVEDFleischmann R, Swierkot J, Penn SK, Durez P, Bessette L, Bu X, Khan N, Li Y, Peterfy CG, Tanaka Y, Mysler E. Long-term safety and efficacy of upadacitinib versus adalimumab in patients with rheumatoid arthritis: 5-year data from the phase 3, randomised SELECT-COMPARE study. RMD Open. 2024 May 28;10(2):e004007. doi: 10.1136/rmdopen-2023-004007.
PMID: 38806190DERIVEDFleischmann R, Blanco R, Van den Bosch F, Bessette L, Song Y, Penn SK, McDearmon-Blondell E, Khan N, Chan K, Mysler E. Long-term Efficacy and Safety Following Switch Between Upadacitinib and Adalimumab in Patients with Rheumatoid Arthritis: 5-Year Data from SELECT-COMPARE. Rheumatol Ther. 2024 Jun;11(3):599-615. doi: 10.1007/s40744-024-00658-1. Epub 2024 Mar 18.
PMID: 38498140DERIVEDRubbert-Roth A, Kakehasi AM, Takeuchi T, Schmalzing M, Palac H, Coombs D, Liu J, Anyanwu SI, Lippe R, Curtis JR. Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis. Rheumatol Ther. 2024 Feb;11(1):97-112. doi: 10.1007/s40744-023-00621-6. Epub 2023 Nov 20.
PMID: 37982966DERIVEDCharles-Schoeman C, Choy E, McInnes IB, Mysler E, Nash P, Yamaoka K, Lippe R, Khan N, Shmagel AK, Palac H, Suboticki J, Curtis JR. MACE and VTE across upadacitinib clinical trial programmes in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. RMD Open. 2023 Nov;9(4):e003392. doi: 10.1136/rmdopen-2023-003392.
PMID: 37945286DERIVEDFleischmann R, Curtis JR, Charles-Schoeman C, Mysler E, Yamaoka K, Richez C, Palac H, Dilley D, Liu J, Strengholt S, Burmester G. Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme. Ann Rheum Dis. 2023 Sep;82(9):1130-1141. doi: 10.1136/ard-2023-223916. Epub 2023 Jun 12.
PMID: 37308218DERIVEDConaghan PG, Pavelka K, Hsieh SC, Bonnington TL, Kent TC, Marchbank K, Edwards CJ. Evaluating the efficacy of upadacitinib in patients with moderate rheumatoid arthritis: a post-hoc analysis of the SELECT phase 3 trials. Rheumatol Adv Pract. 2023 Feb 8;7(1):rkad017. doi: 10.1093/rap/rkad017. eCollection 2023.
PMID: 36794283DERIVEDBurmester GR, Cohen SB, Winthrop KL, Nash P, Irvine AD, Deodhar A, Mysler E, Tanaka Y, Liu J, Lacerda AP, Palac H, Shaw T, Mease PJ, Guttman-Yassky E. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1):e002735. doi: 10.1136/rmdopen-2022-002735.
PMID: 36754548DERIVEDKakehasi AM, Radominski SC, Baravalle MD, Palazuelos FCI, Garcia-Garcia C, Arruda MS, Curi M, Liu J, Qiao M, Velez-Sanchez P, Vargas JI. Safety of upadacitinib in Latin American patients with rheumatoid arthritis: an integrated safety analysis of the SELECT phase 3 clinical program. Clin Rheumatol. 2023 May;42(5):1249-1258. doi: 10.1007/s10067-023-06513-y. Epub 2023 Jan 30.
PMID: 36715850DERIVEDBergman 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.
PMID: 36125701DERIVEDMysler 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.
PMID: 36018230DERIVEDPeterfy 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.
PMID: 34897366DERIVEDYamaoka 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.
PMID: 34041702DERIVEDStrand 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.
PMID: 33590829DERIVEDFleischmann 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.
PMID: 33148701DERIVEDCohen 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.
PMID: 33115760DERIVEDNader 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.
PMID: 31610021DERIVEDFleischmann 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.
PMID: 31362993DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2015
First Posted
December 14, 2015
Study Start
December 1, 2015
Primary Completion
October 27, 2017
Study Completion (Estimated)
September 30, 2027
Last Updated
August 5, 2025
Results First Posted
October 7, 2019
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- 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/
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.