Clinical trial NCT02629159: 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
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Musculoskeletal disease
Arthritis
Joint disease
Anti-inflammatory agents
Antirheumatic agents
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-12-14
Enrollment: 1629
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in DAS28 (CRP) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26
timeFrame: Baseline and Week 26
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12
timeFrame: Week 12
measure: Change From Baseline in Duration of Morning Stiffness at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
timeFrame: Baseline and Week 12
measure: Change From Baseline in Patient's Assessment of Pain at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants With No Radiographic Progression at Week 26
timeFrame: Baseline and Week 26
measure: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC /ID# 143136
state: Alabama
city: Mesa
country: United States
facility: AZ Arthritis and Rheum Assoc /ID# 143130
state: Arizona
city: Peoria
country: United States
facility: SunValley Arthritis Center, Lt /ID# 143123
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC /ID# 144881
state: Arizona
city: Phoenix
country: United States
facility: AZ Arthritis and Rheum Researc /ID# 143080
state: Arizona
city: Phoenix
country: United States
facility: AZ Arthritis and Rheum Researc /ID# 143121
state: Arizona
city: Phoenix
country: United States
facility: AZ Arthritis & Rheuma Research /ID# 143131
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center, Inc. /ID# 144877
state: Arizona
city: Sun City
country: United States
facility: AZ Arthritis & Rheum Research /ID# 156093
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center - North Campus /ID# 143114
state: Arizona
city: Beverly Hills
country: United States
facility: Osteoporosis Medical Center /ID# 153935
state: California
city: Encino
country: United States
facility: T. Joseph Raoof, MD, Inc. /ID# 144884
state: California
city: Escondido
country: United States
facility: Rheumatology Ctr of San Diego /ID# 153747
state: California
city: Hemet
country: United States
facility: C.V. Mehta MD, Med Corporation /ID# 143116
state: California
city: La Jolla
country: United States
facility: Allergy and Rheum Med Clin /ID# 146083
state: California
city: La Mesa
country: United States
facility: Kotha and Kotha /ID# 161046
state: California
city: La Mesa
country: United States
facility: TriWest Research Associates- La Mesa /ID# 143115
state: California
city: Los Alamitos
country: United States
facility: Valerius Med Grp & Res Ctr /ID# 143120
state: California
city: Los Angeles
country: United States
facility: Discovery MM Services, Inc /ID# 163504
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances /ID# 143097
state: California
city: Roseville
country: United States
facility: Sierra Rheumatology /ID# 155672
state: California
city: Tustin
country: United States
facility: Robin K. Dore MD, Inc /ID# 143090
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research /ID# 148362
state: California
city: Colorado Springs
country: United States
facility: Arthritis Assoc & Osteo Ctr /ID# 143122
state: Colorado
city: Fort Collins
country: United States
facility: Arthritis and Rheum Clin N. CO /ID# 156094
state: Colorado
city: Aventura
country: United States
facility: AARDS Research, Inc. /ID# 154190
state: Florida
city: Boynton Beach
country: United States
facility: ZASA Clinical Research /ID# 143134
state: Florida
city: Clearwater
country: United States
facility: Clinical Res of West FL, Inc. /ID# 143112
state: Florida
city: Daytona Beach
country: United States
facility: International Medical Research /ID# 143132
state: Florida
city: Miami Lakes
country: United States
facility: Precision Research Org, LLC /ID# 143092
state: Florida
city: Miami
country: United States
facility: Lakes Research, LLC /ID# 145630
state: Florida
city: Miami
country: United States
facility: FL Med Ctr and Research, Inc. /ID# 143081
state: Florida
city: Miami
country: United States
facility: Ctr Arthritis & Rheumatic Dise /ID# 143135
state: Florida
city: Ocoee
country: United States
facility: Advanced Clin Res of Orlando /ID# 154617
state: Florida
city: Orlando
country: United States
facility: Rheum Assoc of Central FL /ID# 145632
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants /ID# 145635
state: Florida
city: Orlando
country: United States
facility: HMD Research LLC /ID# 163292
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Research of Florida /ID# 143125
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center, Inc. /ID# 145647
state: Florida
city: Saint Petersburg
country: United States
facility: St. Anthony Comprehsve Res Ins /ID# 143095
state: Florida
city: Tampa
country: United States
facility: Clinical Research West FL /ID# 148358
state: Florida
city: Tampa
country: United States
facility: SW FL Clin Res Ctr, Tampa, FL /ID# 143117
state: Florida
city: Tampa
country: United States
facility: BayCare Medical Group, Inc. /ID# 143085
state: Florida
city: Venice
country: United States
facility: Lovelace Scientific Resources /ID# 143106
state: Florida
city: Atlanta
country: United States
facility: Arthritis and Rheumatology /ID# 155668
state: Georgia
city: Gainesville
country: United States
facility: Arthritis Center of North GA /ID# 155258
state: Georgia
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology Grp /ID# 147170
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research /ID# 153090
state: Idaho
city: Chicago
country: United States
facility: Great Lakes Clinical Trials /ID# 148357
state: Illinois
city: Frederick
country: United States
facility: Arthritis Treatment Center /ID# 155260
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology & /ID# 151356
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Gr /ID# 143082
state: Massachusetts
city: Lansing
country: United States
facility: Advanced Rheumatology, PC /ID# 143118
state: Michigan
city: Saint Clair Shores
country: United States
facility: Shores Rheumatology, PC /ID# 162977
state: Michigan
city: Duluth
country: United States
facility: St. Luke's Hospital /ID# 156750
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Med Clinics /ID# 145636
state: Mississippi
city: Lincoln
country: United States
facility: Physician Res. Collaboration /ID# 143087
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research Inc. /ID# 156394
state: Nebraska
city: Toms River
country: United States
facility: Atlantic Coast Research /ID# 148355
state: New Jersey
city: Toms River
country: United States
facility: Ocean Rheumatology, PA /ID# 143111
state: New Jersey
city: Voorhees
country: United States
facility: Arthritis Rheumatic Back Disorder /ID# 143102
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc /ID# 143083
state: New Mexico
city: Las Cruces
country: United States
facility: Arthritis and Osteo Assoc /ID# 143127
state: New Mexico
city: Potsdam
country: United States
facility: St. Lawrence Health System /ID# 161619
state: New York
city: Charlotte
country: United States
facility: Joint & Muscle Research Instit /ID# 143119
state: North Carolina
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC /ID# 143101
state: North Carolina
city: Durham
country: United States
facility: EmergeOrtho, P.A. /ID# 143100
state: North Carolina
city: Leland
country: United States
facility: Cape Fear Arthritis Care /ID# 148361
state: North Carolina
city: New Bern
country: United States
facility: Coastal Carolina Health Care /ID# 148359
state: North Carolina
city: Raleigh
country: United States
facility: Shanahan Rheuma & Immuno /ID# 145643
state: North Carolina
city: Dayton
country: United States
facility: Clinical Research Solutions, LLC /ID# 154619
state: Ohio
city: Toledo
country: United States
facility: Arthritis Assoc of NW Ohio /ID# 143094
state: Ohio
city: Tulsa
country: United States
facility: Healthcare Research Consultant /ID# 143129
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Ctr Clinical Res /ID# 143110
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Ctr Reading /ID# 143133
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Arthritis Center /ID# 153730
state: South Carolina
city: Greenville
country: United States
facility: Innovative Clinical Research /ID# 145637
state: South Carolina
city: Summerville
country: United States
facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 143091
state: South Carolina
city: Kingsport
country: United States
facility: Arthritis Associates, PLLC /ID# 155490
state: Tennessee
city: Knoxville
country: United States
facility: Rheumatology Consultants, PLLC /ID# 153731
state: Tennessee
city: Memphis
country: United States
facility: Dr. Ramesh Gupta /ID# 143099
state: Tennessee
city: Austin
country: United States
facility: Austin Regional Clinic /ID# 143084
state: Texas
city: Beaumont
country: United States
facility: Diagnostic Group Integrated He /ID# 148356
state: Texas
city: Dallas
country: United States
facility: Arthritis Care and Diagnostic /ID# 150677
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research /ID# 145631
state: Texas
city: Edinburg
country: United States
facility: Doctor's Hosp at Renaissance /ID# 154616
state: Texas
city: El Paso
country: United States
facility: MedResearch Inc. /ID# 154618
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management /ID# 145644
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research /ID# 145645
state: Texas
city: Houston
country: United States
facility: Rheumatology Clinic of Houston /ID# 150921
state: Texas
city: Houston
country: United States
facility: Houston Institute for Clin Res /ID# 144879
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc. /ID# 145640
state: Texas
city: Killeen
country: United States
facility: Arthritis Consultants, P.A. /ID# 144880
state: Texas
city: Lubbock
country: United States
facility: Arthritis & Osteoporosis Assoc /ID# 147364
state: Texas
city: Lufkin
country: United States
facility: P&I Clinical Research /ID# 161625
state: Texas
city: Mesquite
country: United States
facility: SW Rheumatology Res. LLC /ID# 143126
state: Texas
city: Missouri City
country: United States
facility: Discovery MM Services, Inc. /ID# 162578
state: Texas
city: Missouri City
country: United States
facility: Discovery MM Services, Inc. /ID# 163183
state: Texas
city: Missouri City
country: United States
facility: Discovery MM Services, Inc. /ID# 163184
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute /ID# 159539
state: Texas
city: San Antonio
country: United States
facility: Accurate Clinical Management /ID# 143089
state: Texas
city: San Antonio
country: United States
facility: Arthritis & Osteo Ctr of S. TX /ID# 143103
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research /ID# 151357
state: Texas
city: Arlington
country: United States
facility: Arthritis Clinic of N. VA, P.C /ID# 143109
state: Virginia
city: Chesapeake
country: United States
facility: Ctr for Arth and Rheum Disease /ID# 143113
state: Virginia
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC /ID# 143088
state: Washington
city: Vancouver
country: United States
facility: The Vancouver Clinic, INC. PS /ID# 143107
state: Washington
city: South Charleston
country: United States
facility: West Virginia Research Inst /ID# 153088
state: West Virginia
city: Franklin
country: United States
facility: Rheumatology and Immunotherapy Center /ID# 145646
state: Wisconsin
city: Capital Federal
country: Argentina
facility: Aprillus Asistencia e Investig /ID# 148406
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigacion /ID# 142843
city: Buenos Aires
country: Argentina
facility: Fundacion Sanatorio Guemes /ID# 148405
city: Buenos Aires
country: Argentina
facility: Consultorio Reumatologic Pampa /ID# 144853
city: Buenos Aires
country: Argentina
facility: Cemic /Id# 148404
city: Buenos Aires
country: Argentina
facility: Org Medica de Investigacion /ID# 144855
city: Cordoba
country: Argentina
facility: Inst. Rheumatologic Strusberg /ID# 145601
city: Cordoba
country: Argentina
facility: Consultora Integral de Salud S /ID# 144856
city: Rosario, Santa FE
country: Argentina
facility: Instituto CAICI /ID# 144854
city: Salta
country: Argentina
facility: Cordis S.A. /Id# 152622
city: San Fernando
country: Argentina
facility: Iari /Id# 151293
city: San Miguel de Tucuman
country: Argentina
facility: Centro Integral de Reumatologi /ID# 142845
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico Privado/Reuma /ID# 142842
city: Santa Fe
country: Argentina
facility: Centro de Enfermedades /ID# 153542
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital /ID# 144857
state: New South Wales
city: Camberwell
country: Australia
facility: Emeritus Research /ID# 142848
state: Victoria
city: Graz
country: Austria
facility: LKH-Univ. Klinikum Graz /ID# 142851
city: Minsk
country: Belarus
facility: First City Clinical Hospital /ID# 158011
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint Luc /ID# 142858
state: Bruxelles-Capitale
city: Charleroi
country: Belgium
facility: Rhumaconsult SPRL /ID# 142860
state: Hainaut
city: Liège
country: Belgium
facility: CHU de Liege /ID# 148401
state: Liege
city: Gent
country: Belgium
facility: UZ Gent /ID# 142859
state: Oost-Vlaanderen
city: Mons
country: Belgium
facility: CHU Ambroise Pare /ID# 152953
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska /ID# 142862
state: Republika Srpska
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska /ID# 142863
state: Republika Srpska
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo /ID# 142865
city: Goiânia
country: Brazil
facility: CIP - Centro Internacional de Pesquisa /ID# 142872
state: Goias
city: Belo Horizonte
country: Brazil
facility: Hc Ufmg /Id# 142868
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 142871
state: Parana
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre /ID# 142870
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: LMK Sevicos Medicos S/S /ID# 142869
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 142867
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: CCBR Brasil /ID# 150918
city: Plovdiv
country: Bulgaria
facility: MHAT Trimontsium /ID# 142874
city: Plovdiv
country: Bulgaria
facility: UMHAT Pulmed OOD /ID# 142877
city: Plovdiv
country: Bulgaria
facility: MHAT Kaspela /ID# 142873
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center /ID# 142875
city: Sofia
country: Bulgaria
facility: UMHAT Sv. Ivan Rilski /ID# 142876
city: Winnipeg
country: Canada
facility: Manitoba Clinic /ID# 161434
state: Manitoba
city: Winnipeg
country: Canada
facility: Ciads /Id# 142880
state: Manitoba
city: St. John's
country: Canada
facility: St. Clare's Mercy Hospital /ID# 142879
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Adachi Medicine Prof. Corp /ID# 154205
state: Ontario
city: Thornhill
country: Canada
facility: CA Ctr for Clin Trials CCCT /ID# 157379
state: Ontario
city: Sainte-foy
country: Canada
facility: Groupe de Recherche en Maladies Osseuses /ID# 142878
state: Quebec
city: Temuco
country: Chile
facility: Ctr de Inv Clinica del Sur /ID# 142888
state: Araucania
city: Concepcion
country: Chile
facility: Reg. Clinical Hosptial Concepcion /ID# 151271
city: Osorno
country: Chile
facility: Corp de Beneficencia Osorno /ID# 147941
city: Providencia-santiago
country: Chile
facility: Someal /Id# 144704
city: Puerto Varas
country: Chile
facility: Quantum Research LTDA. /ID# 142893
city: Santiago
country: Chile
facility: Quantum Research Stgo. /ID# 157933
city: Santiago
country: Chile
facility: Soc. de Prestaciones medicas y Paramedicas Goecke /ID# 142890
city: Santiago
country: Chile
facility: Clinica DermaCross /ID# 142892
city: Santiago
country: Chile
facility: Investigaciones Medicas SSMSO /ID# 151686
city: Santiago
country: Chile
facility: Centro Inter Estud Clin CIEC /ID# 144777
city: Temuco
country: Chile
facility: Centro Medico de Reumatologia /ID# 148402
city: Vina Del Mar
country: Chile
facility: Cinvec /Id# 144705
city: Bogota
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 142898
state: Cundinamarca
city: Barranquilla
country: Colombia
facility: Ctr Int de Reum del Caribe SAS /ID# 142894
city: Bogota DC
country: Colombia
facility: Fund Inst de Reum F. Chalem /ID# 149847
city: Bogota
country: Colombia
facility: Riesgo de Fractura S.A - CAYRE /ID# 142896
city: Bucaramanga
country: Colombia
facility: Medicity S.A.S. /ID# 144860
city: Medellín
country: Colombia
facility: Centro Integral de Reumatologi /ID# 142897
city: Rijeka
country: Croatia
facility: Klinicki bolnicki centar Rijeka /ID# 160232
state: Primorsko-goranska Zupanija
city: Split
country: Croatia
facility: Klinicki bolnicki centar Split /ID# 152530
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava /ID# 142900
city: Zagreb
country: Croatia
facility: Medical Center Kuna-Peric /ID# 142901
city: Zagreb
country: Croatia
facility: Poliklinika Bonifarm /ID# 142899
city: Hlučín
country: Czechia
facility: L.K.N. Arthrocentrum, s.r.o /ID# 145961
state: Moravskoslezsky Kraj
city: Olomouc
country: Czechia
facility: CTCenter MaVe, s.r.o. /ID# 142905
state: Olomoucky Kraj
city: Prague 2
country: Czechia
facility: Revmatologicky ustav Praha /ID# 142904
state: Praha 2
city: Prague 4
country: Czechia
facility: Nuselská poliklinika, Revmatologie /ID# 144862
state: Praha 4
city: Prague 4
country: Czechia
facility: Revmatologická ambulance /ID# 145963
state: Praha 4
city: Prague 4
country: Czechia
facility: Thomayerova nemocnice /ID# 145962
state: Praha 4
city: Brno
country: Czechia
facility: REVMACLINIC s.r.o. /ID# 142906
city: Bruntál
country: Czechia
facility: Revmatologie Bruntal, s.r.o /ID# 142903
city: Kladno
country: Czechia
facility: Revmatologicka a interni ambul /ID# 142907
city: Ostrava
country: Czechia
facility: Revmatologie MUDr. Klara Sirov /ID# 142908
city: Pardubice
country: Czechia
facility: Arthromed, s.r.o. /ID# 144706
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital /ID# 158838
state: Midtjylland
city: Silkeborg
country: Denmark
facility: Regionhospital Silkeborg /ID# 142914
city: Tallinn
country: Estonia
facility: Center of Clinical and Basic Research /ID# 142922
state: Harjumaa
city: Tartu
country: Estonia
facility: MediTrials /ID# 151870
state: Tartumaa
city: Pärnu
country: Estonia
facility: Paernu Hospital /ID# 142921
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital /ID# 142923
city: Tallinn
country: Estonia
facility: North Estonian Medical Centre /ID# 145454
city: Toulouse
country: France
facility: Hopital Universitaire Purpan /ID# 144707
state: Haute-Garonne
city: Lille CEDEX
country: France
facility: CHRU Lille - Hôpital Claude Huriez /ID# 151312
state: Hauts-de-France
city: Montpellier CEDEX 5
country: France
facility: Hopital Saint Eloi /ID# 142925
state: Herault
city: Bordeaux
country: France
facility: CHU Bordeaux-Hopital Pellegrin /ID# 145618
city: Caen
country: France
facility: Hopital de la Cote de Nacre /ID# 145616
city: Clermont Ferrand
country: France
facility: CHU Gabriel Montpied /ID# 145619
city: Marseille
country: France
facility: Hopital de la Conception /ID# 142926
city: Paris
country: France
facility: Hopital Pitie Salpetriere /ID# 145605
city: Rennes
country: France
facility: CHU de Rennes - Hospital Sud /ID# 151957
city: Strasbourg
country: France
facility: CHU Strasbourg Hautepierre Hos /ID# 144708
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet /ID# 145620
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Uniklinik Koln /ID# 145964
state: Nordrhein-Westfalen
city: Rendsburg
country: Germany
facility: Praxis Walter, Rendsburg /ID# 142932
state: Schleswig-Holstein
city: Chemnitz
country: Germany
facility: Med Versorgungszentrum AGILOME /ID# 154975
city: Hamburg
country: Germany
facility: Rheumaforschungszentrum II /ID# 142930
city: Munich
country: Germany
facility: LMU Klinikum der Universität München /ID# 142931
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 142934
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 142933
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Ippokratio /ID# 142935
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital /ID# 142938
city: Tuen Mun
country: Hong Kong
facility: Tuen Mun Hospital /ID# 142939
city: Miskolc
country: Hungary
facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 142951
state: Borsod-Abauj-Zemplen
city: Budapest III
country: Hungary
facility: Qualiclinic Kft. /ID# 142953
state: Pest
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatókórház /ID# 145621
state: Vas
city: Veszprém
country: Hungary
facility: Vital Medical Center Orvosi es /ID# 145950
state: Veszprem
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Korhaz /ID# 142952
city: Budapest
country: Hungary
facility: Revita Reumatologiai Rendelo /ID# 142950
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft. /ID# 153061
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142948
city: Heviz
country: Hungary
facility: Hevizgyogyfurdo es Szent Andra /ID# 142949
city: Kiskunhalas
country: Hungary
facility: Kiskunhalasi Semmelweis Korhaz /ID# 151944
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz /ID# 142954
city: Dublin
country: Ireland
facility: St Vincent's University Hosp /ID# 142957
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Ctr /ID# 144709
state: Tel-Aviv
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 152050
city: Haifa
country: Israel
facility: Bnai Zion Medical Center /ID# 151958
city: Haifa
country: Israel
facility: The Lady Davis Carmel MC /ID# 142960
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 145965
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas /ID# 147528
state: Milano
city: Turin
country: Italy
facility: AOU Citta della Salute Scienza /ID# 150070
state: Piemonte
city: Milan
country: Italy
facility: Azienda Ospedaliera Luigi Sacc /ID# 142966
city: Verona
country: Italy
facility: A.O.U.I. di Verona Policlinico /ID# 142963
city: Astana
country: Kazakhstan
facility: JSC Nat Scientific Med Res Ctr /ID# 142971
city: Karaganda
country: Kazakhstan
facility: Karaganda State Medical Univ /ID# 153433
city: Semey
country: Kazakhstan
facility: Semey State Medical University /ID# 152659
city: Shymkent
country: Kazakhstan
facility: Regional Clinical Hospital /ID# 147168
city: Daegu
country: Korea, Republic of
facility: Kyungpook National Univ Hosp /ID# 162073
state: Daegu Gwang Yeogsi
city: Jung-gu
country: Korea, Republic of
facility: Chungnam National University Hospital /ID# 142977
state: Daejeon Gwang Yeogsi
city: Jung-gu
country: Korea, Republic of
facility: Inha University Hospital /ID# 150886
state: Incheon Gwang Yeogsi
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital /ID# 142975
state: Jeonranamdo
city: Seongdong-gu
country: Korea, Republic of
facility: Hanyang University Seoul Hospi /ID# 142979
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Cath Univ Seoul St Mary's Hosp /ID# 142976
state: Seoul Teugbyeolsi
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Med /ID# 142973
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 142978
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 142974
city: Adazi
country: Latvia
facility: LTD M+M Centers /ID# 142984
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital /ID# 142982
city: Liepaja
country: Latvia
facility: D.Saulites-Kandevicas PP /ID# 142985
city: Riga
country: Latvia
facility: Clinic ORTO /ID# 142983
city: Riga
country: Latvia
facility: Riga East Clinical Univ Hosp /ID# 142981
city: Kovno
country: Lithuania
facility: Hosp Lithuanian Univ Health Sc /ID# 142986
state: Kaunas
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital /ID# 142987
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II /ID# 157862
state: Kelantan
city: Batu Caves
country: Malaysia
facility: Hospital Selayang /ID# 156756
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak /ID# 142990
city: Putrajaya
country: Malaysia
facility: Hospital Putrajaya /ID# 142989
city: Seremban
country: Malaysia
facility: Hospital Tuanku Ja afar /ID# 142988
city: Cuauhtemoc
country: Mexico
facility: Clinstile, S.A. de C.V. /ID# 144866
state: Ciudad De Mexico
city: Monterrey
country: Mexico
facility: Hosp. Univ. Dr. Jose E. Gonz /ID# 142992
state: Nuevo Leon
city: Chihuahua
country: Mexico
facility: Invest y Biomed de Chihuahua /ID# 142996
city: Mexico City
country: Mexico
facility: RM Pharma Specialists, S.A de C.V /ID# 142994
city: Mexico City
country: Mexico
facility: Hospital de Jesús Nazareno /ID# 142993
city: Mérida
country: Mexico
facility: Centro Peninsular de Investiga /ID# 148159
city: Hamilton
country: New Zealand
facility: Waikato Hospital /ID# 143002
state: Waikato
city: Nelson
country: New Zealand
facility: Porter Rheumatology Ltd /ID# 143001
city: Timaru
country: New Zealand
facility: Timaru Medical Specialists Ltd /ID# 143000
city: Wrocław
country: Poland
facility: WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 145622
state: Dolnoslaskie
city: Toruń
country: Poland
facility: NZOZ Nasz Lekarz /ID# 143004
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: REUMED Sp.z o.o. Filia nr 1 /ID# 148189
state: Lubelskie
city: Cracow
country: Poland
facility: Malopolskie Centrum Kliniczne /ID# 152782
state: Malopolskie
city: Krakow
country: Poland
facility: Pratia MCM Krakow /ID# 143005
state: Malopolskie
city: Grodzisk Mazowiecki
country: Poland
facility: McBk Sc /Id# 143003
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 151960
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED Warszawa Targowek /ID# 157621
state: Mazowieckie
city: Białystok
country: Poland
facility: Osteo-Medic spolka cywilna /ID# 143006
state: Podlaskie
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163293
state: Pomorskie
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163294
state: Pomorskie
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163295
state: Pomorskie
city: Katowice
country: Poland
facility: Silmedic Sp z o.o /ID# 152914
state: Slaskie
city: Bialystok
country: Poland
facility: ClinicMed Badurski i wspolnicy SJ /ID# 163300
city: Poznan
country: Poland
facility: Solumed Sp. zoo Cent Medyczne /ID# 152783
city: Warsaw
country: Poland
facility: Rheuma Medicus /ID# 143007
city: Lisbon
country: Portugal
facility: Instituto Portugues De Reumatologia /ID# 148316
state: Lisboa
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar De Vila Nova /ID# 143010
state: Porto
city: Braga
country: Portugal
facility: CCA Braga - Hospital de Braga /ID# 148317
city: Lisbon
country: Portugal
facility: Hospital CUF Descobertas /ID# 160539
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao, EPE /ID# 152871
city: Viana Do Castelo
country: Portugal
facility: Unidade Local De Saude Do Alto Minho /ID# 143009
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine /ID# 151961
city: San Juan
country: Puerto Rico
facility: GCM Medical Group /ID# 143011
city: Bucharest
country: Romania
facility: Spitalul Clinic Dr. I. Cantacuzino /ID# 143012
state: Bucuresti
city: Bucharest
country: Romania
facility: Spitalul Clinic Dr. I. Cantacuzino /ID# 143017
state: Bucuresti
city: Bucuresti
country: Romania
facility: Spitalul Clinic Sf. Maria /ID# 144868
city: Bucuresti
country: Romania
facility: Spitalul Clinic Sf. Maria /ID# 144869
city: Bucuresti
country: Romania
facility: Spitalul Clinic Sf. Maria /ID# 145966
city: Iasi
country: Romania
facility: Spitalul Clinic de Recuperare /ID# 144867
city: Oradea
country: Romania
facility: Ecomed SRL /ID# 144870
city: Korolev
country: Russian Federation
facility: Family Outpatient clinic#4,LLC /ID# 148319
state: Moskva
city: Moscow
country: Russian Federation
facility: Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 143138
state: Moskva
city: Perm
country: Russian Federation
facility: Perm Clinical Center of FMBA /ID# 145627
state: Permskiy Kray
city: Pyatigorsk
country: Russian Federation
facility: LLC Novaya Klinika /ID# 143019
state: Stavropol Skiy Kray
city: Kazan
country: Russian Federation
facility: Kazan State Medical University /ID# 144871
state: Tatarstan, Respublika
city: Tver
country: Russian Federation
facility: Tver Regional Clinical Hosp. /ID# 143026
state: Tverskaya Oblast
city: Ivanovo
country: Russian Federation
facility: Сity Clinical Hospital #4 /ID# 143023
city: Moscow
country: Russian Federation
facility: Russian National Research Medi /ID# 143028
city: Moscow
country: Russian Federation
facility: City Clinical Hospital Botkina /ID# 145628
city: Moscow
country: Russian Federation
facility: Moscow State Univ Med and Dent /ID# 145623
city: Nizhnij Novgorod
country: Russian Federation
facility: City Clinical Hospital #5 /ID# 148318
city: Orenburg
country: Russian Federation
facility: Orenburg State Medical Academy /ID# 143018
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical Universit /ID# 143031
city: St. Petersburg
country: Russian Federation
facility: II Dzhan Research Center /ID# 143027
city: St. Petersburg
country: Russian Federation
facility: NW State Med Univ NA Mechnikov /ID# 143022
city: UFA
country: Russian Federation
facility: Republican clinical hospital n /ID# 145626
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk Regional Clin Hosp /ID# 143030
city: Belgrade
country: Serbia
facility: Institute for Rheumatology /ID# 143032
state: Beograd
city: Belgrade
country: Serbia
facility: Institute for Rheumatology /ID# 143035
state: Beograd
city: Belgrade
country: Serbia
facility: Institute for Rheumatology /ID# 143036
state: Beograd
city: Belgrade
country: Serbia
facility: Institute for Rheumatology /ID# 143037
state: Beograd
city: Novi Sad
country: Serbia
facility: Special Hospital for Rheuma /ID# 143034
state: Vojvodina
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina /ID# 143033
state: Vojvodina
city: Martin
country: Slovakia
facility: MEDMAN s.r.o. /ID# 143045
city: Nové Mesto Nad Váhom
country: Slovakia
facility: Reumatologická ambulancia Reum.hapi s.r.o. /ID# 147169
city: Partizanske
country: Slovakia
facility: REUMACENTRUM s.r.o. /ID# 143041
city: Pieštany
country: Slovakia
facility: Slovak research center Team Member, Thermium s.r.o. /ID# 147614
city: Rimavska Sobota
country: Slovakia
facility: Reumex, s.r.o. /ID# 143043
city: Sabinov
country: Slovakia
facility: Reumatologicka ambulancia /ID# 144873
city: Stará Lubovna
country: Slovakia
facility: TIMMED spol. s r.o. /ID# 144872
city: Topolcany
country: Slovakia
facility: Reumatologicka ambulancia, LER /ID# 143044
city: Zvolen
country: Slovakia
facility: ALBAMED s.r.o. /ID# 143042
city: Port Elizabeth
country: South Africa
facility: Greenacres Hospital /ID# 144710
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: Wits Clinical Research Site /ID# 148320
state: Gauteng
city: Pretoria
country: South Africa
facility: University of Pretoria /ID# 148353
state: Gauteng
city: Pretoria
country: South Africa
facility: Jakaranda Hosp, Emmed Research /ID# 143046
state: Gauteng
city: Pretoria
country: South Africa
facility: Jakaranda Hosp, Emmed Research /ID# 145968
state: Gauteng
city: Durban
country: South Africa
facility: St. Augustine's Hospital /ID# 143047
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Synexus Helderberg Clinical Tr /ID# 148322
state: Western Cape
city: Cape Town
country: South Africa
facility: Arthritis Clinical Research Tr /ID# 144874
state: Western Cape
city: Cape Town
country: South Africa
facility: Tiervlei Trial Centre /ID# 153085
state: Western Cape
city: Stellenbosch
country: South Africa
facility: Winelands Medical Research Ctr /ID# 143048
state: Western Cape
city: Santander
country: Spain
facility: H. Un. Marques de Valdecilla /ID# 143050
state: Cantabria
city: A Coruna
country: Spain
facility: Comple Hosp Univ de A Coruna /ID# 143051
city: Cordoba
country: Spain
facility: Hospital Universitario Reina S /ID# 153566
city: Santiago de Compostela
country: Spain
facility: Clinica Gaias /ID# 143052
city: Santiago de Compostela
country: Spain
facility: Complejo Hosp Santiago /ID# 153727
city: Taichung City
country: Taiwan
facility: China Medical University Hosp /ID# 143058
state: Taichung
city: Taipei City
country: Taiwan
facility: National Taiwan Univ Hosp /ID# 143056
state: Taipei
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University /ID# 143059
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital /ID# 143055
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital /ID# 143061
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University /ID# 143060
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hosp /ID# 157940
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Ho /ID# 143057
city: Cerrahpasa
country: Turkey
facility: Istanbul Universitesi Cerrahpa /ID# 156088
city: Istanbul
country: Turkey
facility: Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastırma Hastanesi /ID# 143063
city: Izmir
country: Turkey
facility: Izmir Katip Celebi Ataturk Training & Research Hospital /ID# 143062
city: Kiev
country: Ukraine
facility: LLC Revmocentr /ID# 143067
state: Kyiv
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospita /ID# 154450
state: Lvivska Oblast
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 143071
state: Vinnytska Oblast
city: Ivano-frankivsk
country: Ukraine
facility: Regional Clinical Hospital /ID# 152025
city: Kiev
country: Ukraine
facility: NSC-Strazhesko Ist Cardiology /ID# 152030
city: Lviv
country: Ukraine
facility: Lviv Municipal City Clinical /ID# 143068
city: Odesa
country: Ukraine
facility: Odessa National Medical Univ /ID# 143072
city: Zaporizhia
country: Ukraine
facility: Zaporizhzhia Regional Clinical /ID# 143069
city: London
country: United Kingdom
facility: The Royal Free Hospital /ID# 143074
state: London, City Of
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital /ID# 143077
city: Warrington
country: United Kingdom
facility: Warrington + Halton Hosp NHS /ID# 143075
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.