A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
NCT ID: NCT03104400
Last Updated: 2025-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1705 participants
INTERVENTIONAL
2017-04-27
2024-09-09
Brief Summary
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The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.
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Detailed Description
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Period 1 includes 24 weeks of randomized, double-blind, placebo-controlled and active comparator-controlled treatment followed by 32 weeks of active comparator-controlled upadacitinib; at Week 24 participants assigned to placebo will be switched to upadacitinib according to their randomization assignment.
Participants who meet eligibility criteria will be randomized in a 2:2:2:1:1 ratio to one of five treatment groups:
* Group 1: Upadacitinib 15 mg QD
* Group 2: Upadacitinib 30 mg QD
* Group 3: Adalimumab 40 mg every other week (EOW)
* Group 4: Placebo followed by upadacitinib 15 mg QD
* Group 5: Placebo followed by upadacitinib 30 mg QD
Randomization will be stratified by extent of psoriasis (≥ 3% body surface area \[BSA\] or \< 3% BSA), current use of at least 1 non-biologic DMARD, presence of dactylitis, and presence of enthesitis, except for participants from China and Japan, where randomization for each country will be stratified by extent of psoriasis (≥ 3% BSA or \< 3% BSA) only.
Participants who complete the Week 56 visit (end of Period 1) will enter the long-term extension portion of the study, Period 2 (total treatment up to approximately 5 years), and continue study treatment as assigned in Period 1 in a blinded manner until the last subject completes the last visit of Period 1 (Week 56), when study drug assignment in both periods will be unblinded and participants will be dispensed study drug in an open-label fashion until the completion of Period 2.
At Week 16, rescue therapy will be offered to participants classified as non-responders (defined as not achieving at least 20% improvement in tender joint count (TJC) and / or swollen joint count (SJC) at both Week 12 and Week 16). Starting at Week 36, participants who fail to demonstrate at least 20% improvement in either or both TJC and SJC compared to Baseline at 2 consecutive visits will be discontinued from study drug treatment. Additionally, in participants continuing on study drug, starting at the Week 36 visit, initiation of or change in background PsA medication(s) is allowed as per local label.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Upadacitinib 15 mg
Period 1: Participants receive upadacitinib 15 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks.
Period 2: Participants will continue to receive upadacitinib 15 mg once daily.
Upadacitinib
Oral tablet
Placebo to Adalimumab
Administered by subcutaneous injection
Upadacitinib 30 mg
Period 1: Participants receive upadacitinib 30 mg orally once a day and matching placebo to adalimumab by subcutaneous injection every other week for 56 weeks.
Period 2: Participants will continue to receive upadacitinib 30 mg once daily.
Upadacitinib
Oral tablet
Placebo to Adalimumab
Administered by subcutaneous injection
Adalimumab
Period 1: Participants receive adalimumab 40 mg by subcutaneous injection every other week and matching placebo to upadacitinib orally QD for 56 weeks.
Period 2: Participants continue to receive adalimumab 40 mg every other week.
Adalimumab
Administered by subcutaneous injection
Placebo to Upadacitinib
Oral tablet
Placebo / Upadacitinib 15 mg
Period 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 15 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks.
Period 2: Participants will continue to receive upadacitinib 15 mg once daily.
Upadacitinib
Oral tablet
Placebo to Upadacitinib
Oral tablet
Placebo to Adalimumab
Administered by subcutaneous injection
Placebo / Upadacitinib 30 mg
Period 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 30 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks.
Period 2: Participants will continue to receive upadacitinib 30 mg once daily.
Upadacitinib
Oral tablet
Placebo to Upadacitinib
Oral tablet
Placebo to Adalimumab
Administered by subcutaneous injection
Interventions
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Adalimumab
Administered by subcutaneous injection
Upadacitinib
Oral tablet
Placebo to Upadacitinib
Oral tablet
Placebo to Adalimumab
Administered by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant has active disease at Baseline defined as \>= 3 tender joints (based on 68 joint counts) and \>= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits.
* Presence of either at Screening:
1. \>= 1 erosion on x-ray as determined by central imaging review or;
2. high-sensitivity C-reactive protein (hs-CRP) \> laboratory defined upper limit of normal (ULN).
* Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
* Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) to previous or current treatment with at least 1 non-biologic DMARD at maximally tolerated dose (methotrexate (MTX), sulfasalazine (SSZ), leflunomide (LEF), cyclosporine, apremilast, bucillamin or iguratimod), or participant has an intolerance to or contraindication for DMARDs as defined by the investigator.
* Participant who is on current treatment with concomitant non-biologic DMARDs at study entry must be on \<= 2 non-biologic DMARDs (except the combination of MTX and leflunomide). The following non-biologic DMARDs are allowed: MTX, sulfasalazine, leflunomide, apremilast, hydroxychloroquine (HCQ) , bucillamine or iguratimod, and have been ongoing for \>= 12 weeks and at stable dose for \>= 4 weeks prior to the Baseline Visit. No other DMARDs are permitted during the study.
i. Participants who need to discontinue DMARDs prior to the Baseline Visit to comply with this inclusion criterion must follow the procedure specified below or at least five times the mean terminal elimination half-life of a drug:
1. \>= 8 weeks for LEF if no elimination procedure was followed, or adhere to an elimination procedure (i.e., 11 days with cholestyramine, or 30 days washout with activated charcoal or as per local label);
2. \>= 4 weeks for all others.
Exclusion Criteria
* Current treatment with \> 2 non-biologic DMARDs; or use of DMARDs other than methotrexate, sulfasalazine, leflunomide, apremilast, hydroxychloroquine, bucillamine, or iguratimod; or use of methotrexate in combination with leflunomide.
* History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Rheum Assoc of North Alabama /ID# 163231
Huntsville, Alabama, United States
SunValley Arthritis Center, Lt /ID# 161221
Peoria, Arizona, United States
AZ Arthritis and Rheumotology Research, PLLC /ID# 159981
Phoenix, Arizona, United States
AZ Arthritis and Rheumotology Research, PLLC /ID# 160033
Phoenix, Arizona, United States
AZ Arthritis and Rheumotology Research, PLLC /ID# 160036
Phoenix, Arizona, United States
AZ Arthritis & Rheuma Research /ID# 160037
Phoenix, Arizona, United States
AZ Arth & Rheum Res /ID# 166381
Tucson, Arizona, United States
Little Rock Diagnostics Clinic /ID# 165161
Little Rock, Arkansas, United States
Covina Arthritis Clinic /ID# 159891
Covina, California, United States
St. Joseph Heritage Healthcare /ID# 159980
Fullerton, California, United States
C.V. Mehta MD, Med Corporation /ID# 161216
Hemet, California, United States
Care Access Research, Huntingt /ID# 160038
Huntington Beach, California, United States
Kotha and Kotha /ID# 159823
La Mesa, California, United States
TriWest Research Associates- La Mesa /ID# 159887
La Mesa, California, United States
Arthritis & Osteo Medical Ctr /ID# 166760
La Palma, California, United States
University of California, Los Angeles /ID# 164542
Los Angeles, California, United States
VA Sacramento Medical Center /ID# 164196
Mather, California, United States
East Bay Rheumatology Medical /ID# 166382
San Leandro, California, United States
Inland Rheum Clin Trials Inc. /ID# 159828
Upland, California, United States
Medvin Clinical Research /ID# 160034
Whittier, California, United States
Denver Arthritis Clinic /ID# 159873
Denver, Colorado, United States
Arthritis and Rheum Clin N. CO /ID# 160039
Fort Collins, Colorado, United States
Colorado Arthritis Associates /ID# 159847
Lakewood, Colorado, United States
Stamford Therapeutics Consorti /ID# 165131
Stamford, Connecticut, United States
Clinical Res of West FL, Inc. /ID# 159829
Clearwater, Florida, United States
International Medical Research - Daytona /ID# 160040
Daytona Beach, Florida, United States
Omega Research Maitland, LLC /ID# 164193
DeBary, Florida, United States
LeJenue Research Associates /ID# 170965
Miami, Florida, United States
Precision Research Org, LLC /ID# 161287
Miami Lakes, Florida, United States
Medallion Clinical Research Institute, LLC /ID# 161228
Naples, Florida, United States
Millennium Research /ID# 159822
Ormond Beach, Florida, United States
Arthritis Center, Inc. /ID# 163465
Palm Harbor, Florida, United States
Gulf Region Clinical Res Inst /ID# 159851
Pensacola, Florida, United States
BayCare Medical Group /ID# 159792
St. Petersburg, Florida, United States
W. Broward Rheum Assoc Inc. /ID# 161388
Tamarac, Florida, United States
Clinical Research of West Florida, Inc /ID# 160063
Tampa, Florida, United States
University of South Florida /ID# 161286
Tampa, Florida, United States
BayCare Medical Group, Inc. /ID# 159879
Tampa, Florida, United States
Florida Medical Clinic /ID# 159992
Zephyrhills, Florida, United States
Institute of Arthritis Researc /ID# 165873
Idaho Falls, Idaho, United States
Advanced Clinical Research /ID# 159894
Meridian, Idaho, United States
Great Lakes Clinical Trials /ID# 163435
Chicago, Illinois, United States
OrthoIllinois /ID# 164546
Rockford, Illinois, United States
Clinical Investigation Specialists - Skokie /ID# 160062
Skokie, Illinois, United States
Deerbrook Medical Associates /ID# 159804
Vernon Hills, Illinois, United States
Graves Gilbert Clinic /ID# 161285
Bowling Green, Kentucky, United States
Four Rivers Clinical Research /ID# 159982
Paducah, Kentucky, United States
Ochsner Clinic Foundation-New Orleans /ID# 165672
New Orleans, Louisiana, United States
Johns Hopkins University /ID# 167665
Baltimore, Maryland, United States
Klein & Associates, M.D., P.A. /ID# 164013
Cumberland, Maryland, United States
The Center for Rheumatology & Bone Research /ID# 159874
Wheaton, Maryland, United States
Tufts Medical Center /ID# 165144
Boston, Massachusetts, United States
Mansfield Health Center /ID# 159805
Mansfield, Massachusetts, United States
Clinical Pharmacology Study Gr /ID# 158700
Worcester, Massachusetts, United States
Univ of Michigan Hospitals /ID# 164014
Ann Arbor, Michigan, United States
Aa Mrc Llc /Id# 159846
Grand Blanc, Michigan, United States
Advanced Rheumatology, PC /ID# 159893
Lansing, Michigan, United States
Beals Institute PC /ID# 163128
Lansing, Michigan, United States
Shores Rheumatology, PC /ID# 159889
Saint Clair Shores, Michigan, United States
St. Luke's Hospital of Duluth /ID# 165671
Duluth, Minnesota, United States
Clinvest Research LLC /ID# 161227
Springfield, Missouri, United States
Clayton Medical Associates dba Saint Louis Rheumatology /ID# 159878
St Louis, Missouri, United States
Glacier View Research Institut /ID# 167023
Kalispell, Montana, United States
Westroads Clinical Research /ID# 159979
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center /ID# 161235
Lebanon, New Hampshire, United States
Arthritis and Osteoporosis Associates /ID# 159802
Freehold, New Jersey, United States
Atlantic Coast Research /ID# 159799
Toms River, New Jersey, United States
Ocean Rheumatology, PA /ID# 163898
Toms River, New Jersey, United States
Arthritis and Osteo Assoc /ID# 159994
Las Cruces, New Mexico, United States
Santa Fe Rheumatology /ID# 163783
Santa Fe, New Mexico, United States
NYU Langone Rheum Assoc /ID# 159985
Lake Success, New York, United States
NYU Langone Medical Center /ID# 163230
New York, New York, United States
St. Lawrence Health System /ID# 159848
Potsdam, New York, United States
American Health Research /ID# 164354
Charlotte, North Carolina, United States
DJL Clinical Research, PLLC /ID# 161390
Charlotte, North Carolina, United States
M3-Emerging Medical Research, LLC /ID# 161391
Durham, North Carolina, United States
Physicians East, PA /ID# 159872
Greenville, North Carolina, United States
Cape Fear Arthritis Care /ID# 161224
Leland, North Carolina, United States
Shanahan Rheuma & Immuno /ID# 159987
Raleigh, North Carolina, United States
Trinity Health Med Arts Clinic /ID# 159800
Minot, North Dakota, United States
MetroHealth Medical Center /ID# 159888
Cleveland, Ohio, United States
The Ohio State University /ID# 159892
Columbus, Ohio, United States
Clinical Research Source, Inc. /ID# 164545
Perrysburg, Ohio, United States
STAT Research, Inc. /ID# 161392
Vandalia, Ohio, United States
Health Research of Oklahoma /ID# 159880
Oklahoma City, Oklahoma, United States
Altoona Ctr Clinical Res /ID# 159852
Duncansville, Pennsylvania, United States
PA Regional Center /ID# 165670
Wyomissing, Pennsylvania, United States
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163464
Summerville, South Carolina, United States
West Tennessee Research Inst /ID# 159871
Jackson, Tennessee, United States
Rheumatology Consultants, PLLC /ID# 159796
Knoxville, Tennessee, United States
Dr. Ramesh Gupta /ID# 160061
Memphis, Tennessee, United States
Accurate Clinical Management /ID# 159905
Baytown, Texas, United States
Diagnostic Group Integrated He /ID# 159794
Beaumont, Texas, United States
Arth and Osteo Clin Brazo Valley /ID# 163436
College Station, Texas, United States
PCCR Solution /ID# 205723
Colleyville, Texas, United States
Adriana Pop-Moody MD Clinic PA /ID# 159984
Corpus Christi, Texas, United States
Metroplex Clinical Research /ID# 159785
Dallas, Texas, United States
Rheumatic Disease Clin Res Ctr /ID# 161240
Houston, Texas, United States
Rheumatology Clinic of Houston /ID# 161234
Houston, Texas, United States
"DMCR-Texas Cent for Drug Dev /ID# 164191
Houston, Texas, United States
West Texas Clinical Research /ID# 205722
Lubbock, Texas, United States
P&I Clinical Research /ID# 159826
Lufkin, Texas, United States
SW Rheumatology Res. LLC /ID# 159993
Mesquite, Texas, United States
Trinity Universal Research Association /ID# 205721
Plano, Texas, United States
Arthritis & Osteo Ctr of S. TX /ID# 163784
San Antonio, Texas, United States
Arthritis Clinic of Central TX /ID# 164049
San Marcos, Texas, United States
DM Clinical Research /ID# 161735
Tomball, Texas, United States
Arthritis & Osteoporosis Clinic /ID# 159786
Waco, Texas, United States
Arthritis Clinic of N. VA, P.C /ID# 159849
Arlington, Virginia, United States
Ctr for Arth and Rheum Disease /ID# 159830
Chesapeake, Virginia, United States
Swedish Medical Center /ID# 159890
Seattle, Washington, United States
Arthritis Northwest, PLLC /ID# 166380
Spokane, Washington, United States
West Virginia Research Inst /ID# 159791
South Charleston, West Virginia, United States
Aurora Rheumatology and Immunotherapy Center /ID# 160043
Franklin, Wisconsin, United States
Centro Medico Privado/Reuma /ID# 159775
San Miguel de Tucumán, Ciuadad Autonoma de Buenos Aires, Argentina
Centro Integral de Medicina Respiratoria (CIMER) /ID# 211237
San Miguel de Tucumán, Tucumán Province, Argentina
Organizacion Medica de Investigacion (OMI) /ID# 160118
Buenos Aires, , Argentina
Hospital General de Agudos Ram /ID# 164378
Buenos Aires, , Argentina
Psoriahue Med Interdisciplinar /ID# 160506
Buenos Aires, , Argentina
Inst. de Rehab. Psicofisica /ID# 165154
CABA, , Argentina
Instituto CAICI /ID# 160119
Rosario, Santa FE, , Argentina
Centro Integral de Medicina Re /ID# 160258
SAN Miguel de Tucuman, Latam, , Argentina
Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 165795
Santa Fe, , Argentina
Emeritus Research Sydney /ID# 166780
Botany, New South Wales, Australia
The Queen Elizabeth Hospital /ID# 169333
Woodville, South Australia, Australia
Barwon Rheumatology /ID# 166782
Geelong, Victoria, Australia
Heidelberg Repatriation Hospital /ID# 167450
Heidelberg West, Victoria, Australia
Brest Regional Hospital /ID# 164535
Brest, , Belarus
Healthcare Institution /ID# 164536
Grodno, , Belarus
First City Clinical Hospital /ID# 164534
Minsk, , Belarus
Reuma clinic /ID# 164243
Genk, , Belgium
University Clinical Centre of the Republic of Srpska /ID# 164503
Banja Luka, Republika Srpska, Bosnia and Herzegovina
University Clinical Hospital Mostar /ID# 165799
Mostar, , Bosnia and Herzegovina
Clinical Center University of Sarajevo /ID# 164502
Sarajevo, , Bosnia and Herzegovina
Instituto de Ciencias Farmacêuticas /ID# 163274
Aparecida de Goiânia, Goiás, Brazil
CIP - Centro Internacional de Pesquisa /ID# 161821
Goiânia, Goiás, Brazil
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 161819
Juiz de Fora, Minas Gerais, Brazil
EDUMED Educacao em Saude S/S L /ID# 161816
Curitiba, Paraná, Brazil
Instituto de Educação e Pesquisa do Hospital Moinhos de Vento /ID# 161813
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre /ID# 161820
Porto Alegre, Rio Grande do Sul, Brazil
LMK Sevicos Medicos S/S /ID# 161812
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163273
Ribeirão Preto, São Paulo, Brazil
Faculdade de Medicina do ABC /ID# 163491
Santo André, São Paulo, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos do ABC /ID# 161810
Santo André, São Paulo, Brazil
CPCLIN - Centro de Pesquisas Clínicas /ID# 161818
São Paulo, , Brazil
Department of Rheumatology, Mu /ID# 169606
Plovdiv, , Bulgaria
Excelsior Medical Center /ID# 169609
Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment - Sofia at Military Medical Academy /ID# 169608
Sofia, , Bulgaria
UMHAT Sv. Ivan Rilski /ID# 202393
Sofia, , Bulgaria
Medical Centre Synexus Sofia /ID# 202394
Sofia, , Bulgaria
Medical Centre Synexus Sofia, branch Stara Zagora /ID# 202524
Stara Zagora, , Bulgaria
Diagnostic Consultative Center /ID# 169607
Varna, , Bulgaria
Percuro Clinical Research, Ltd /ID# 157823
Victoria, British Columbia, Canada
Manitoba Clinic /ID# 157829
Winnipeg, Manitoba, Canada
Ciads /Id# 157831
Winnipeg, Manitoba, Canada
The Waterside Clinic /ID# 157826
Barrie, Ontario, Canada
Groupe de Recherche en Maladies Osseuses Inc /ID# 157824
Sainte-Foy, Quebec, Canada
Ctr. de Recherche Musculo-Sque /ID# 207069
Trois-Rivières, Quebec, Canada
M y F Estudios Clínicos Ltda. /ID# 168722
Ñuñoa, Santiago Metropolitan, Chile
CTR Estudios SpA /ID# 206217
Providencia, , Chile
Centro Inter Estud Clin CIEC /ID# 168725
Santiago, , Chile
Prosalud Ltda. /ID# 169546
Santiago, , Chile
Clinica Dermacross S.A /ID# 168726
Vitacura Santiago, , Chile
1st Aff Hosp of Bengbu Medical College /ID# 201021
Bengbu, Anhui, China
Peking University Third Hospital /ID# 201973
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Shantou University Medical College /ID# 203371
Shantou, Guangdong, China
Zhuzhou Central Hospital /ID# 200201
Zhuzhou, Hunan, China
The First Affiliated Hospital of Baotou Medical College, Inner Monggolia Univers /ID# 171204
Baotou, Inner Mongolia, China
The First People's Hospital of Linyi /ID# 201970
Linyi, Shandong, China
Huashan Hospital of Fudan University /ID# 202191
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital /ID# 200202
Shanghai, Shanghai Municipality, China
West China Hospital /ID# 200199
Chengdu, Sichuan, China
Ningbo First Hospital /ID# 201874
Ningbo, Zhejiang, China
The Aff Hosp Inner Mongolia /ID# 207787
Hohhot, , China
First Affiliated Hospital of Kunming Medical University /ID# 201264
Kunming, , China
Affiliated hospital of nantong university /ID# 208234
Nantong, , China
The First Affiliated Hospital of Soochow University /ID# 201875
Suzhou, , China
People's Hospital of Xinjiang /ID# 201592
Ürümqi, , China
Centro de Investigacion en Reumatologia CIREEM /ID# 166030
Bogota, Cundinamarca, Colombia
Fundacion Centro de Investigac /Id# 168201
Antioquia, , Colombia
Ctr Int de Reum del Caribe SAS /ID# 164051
Barranquilla, , Colombia
Preventive Care Sas /Id# 163781
Chía, , Colombia
Hospital Pablo Tobon Uribe /ID# 164233
Medellín, , Colombia
Poliklinika Repromed /ID# 203555
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Rijeka /ID# 161159
Rijeka, Primorje-Gorski Kotar County, Croatia
Medical Center Kuna-Peric /ID# 161160
Zagreb, , Croatia
Poliklinika Bonifarm /ID# 206662
Zagreb, , Croatia
Revmatologicka ambulance /ID# 159637
Prague, Praha 4, Czechia
Revmatologicka ambulance /ID# 159671
Prague, Praha 4, Czechia
Revmatologie Bruntal, s.r.o /ID# 159636
Bruntál, , Czechia
Artroscan s.r.o. /ID# 159634
Ostrava, , Czechia
Medical Plus, s.r.o. /ID# 159635
Uherské Hradište, , Czechia
Center of Clinical and Basic Research /ID# 163870
Tallinn, Harju, Estonia
MediTrials /ID# 163706
Tartu, Tartu, Estonia
East Tallinn Central Hospital /ID# 163790
Tallinn, , Estonia
Rheumazentrum Ruhrgebiet /ID# 163930
Herne, North Rhine-Westphalia, Germany
Immanuel-Krankenhaus /ID# 163931
Buch, , Germany
University Clinic Carl Gustav /ID# 163926
Dresden, , Germany
Polikilinik fuer Rheumatologie /ID# 163933
Düsseldorf, , Germany
Cent fur Innovative Diagnostik /ID# 163927
Frankfurt, , Germany
Hamburger Rheuma Forschungszentrum II im MVZ Rheumatologie und Autoimmunmedizin /ID# 204421
Hamburg, , Germany
Dr. med. Jochen Walter FA fuer /ID# 168638
Rendsburg, , Germany
Med. Universitaetsklinik Inner /ID# 163929
Tübingen, , Germany
General Hospital of Athens Laiko /ID# 163476
Athens, Attica, Greece
General Hospital of Athens Laiko /ID# 163478
Athens, Attica, Greece
University General Hospital Attikon /ID# 163477
Athens, Attica, Greece
Naval Hospital of Athens /ID# 163486
Athens, , Greece
University General Hospital of Heraklion PA.G.N.I /ID# 163472
Heraklion, , Greece
Reg Gen Univ Hosp Larissa /ID# 163496
Larissa, , Greece
Prince of Wales Hospital /ID# 163506
Hong Kong, , Hong Kong
Queen Mary Hospital /ID# 162492
Hong Kong, , Hong Kong
Tuen Mun Hospital /ID# 162493
Tuenmen, , Hong Kong
Synexus Magyarorszag Kft. - Gyula DRS /ID# 202209
Gyula, Bekes County, Hungary
Qualiclinic Kft. /ID# 163278
Budapest III, Pest County, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatok.- Klinikai Kutatasi O. /ID# 202584
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Synexus Magyarorszag Kft. - Zalaegerszeg AS /ID# 201884
Zalaegerszeg, Zala County, Hungary
Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz /ID# 170719
Budapest, , Hungary
Revita Reumatologiai Rendelo /ID# 163277
Budapest, , Hungary
Obudai Egeszsegugyi Centrum Kft. /ID# 163279
Budapest, , Hungary
Synexus Magyarorszag Kft. /ID# 203012
Budapest, , Hungary
Debreceni Egyetem Kenezy Gyula /ID# 163276
Debrecen, , Hungary
Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 163275
Veszprém, , Hungary
St Vincent's University Hosp /ID# 161073
Dublin, , Ireland
Croom Orthopaedic Hospital /ID# 164998
Limerick, , Ireland
Tel Aviv Sourasky Medical Center /ID# 169845
Tel Aviv, Tel Aviv, Israel
The Lady Davis Carmel MC /ID# 170262
Haifa, , Israel
Sheba Medical Center /ID# 202532
Ramat Gan, , Israel
AOU Federico II /ID# 202411
Naples, Campania, Italy
Azienda Unita Sanitaria Locale/IRCCS c/o Arcispedale Santa Maria Nuova /ID# 161090
Reggio Emilia, Emilia-Romagna, Italy
Policlinico Universitario Campus Bio-Medico /ID# 162306
Rome, Lazio, Italy
Ospedali Riuniti Universita /ID# 161085
Ancona, , Italy
Azienda Ospedaliera Universitaria Policlinico "G. Rodolico - San Marco" /Id# 161084
Catania, , Italy
Nagoya City University Hospital /ID# 162564
Nagoya, Aichi-ken, Japan
Fukuoka University Hospital /ID# 162086
Fukuoka, Fukuoka, Japan
Hospital of the University of Occupational and Environmental Health /ID# 161473
Kitakyushu-shi, Fukuoka, Japan
Mie University Hospital /ID# 162080
Tsu, Mie-ken, Japan
National Hospital Organization Osaka Minami Medical Center /ID# 162590
Kawachinagano-shi, Osaka, Japan
St.Luke's International Hospital /ID# 162016
Chuo-ku, Tokyo, Japan
M &M Centrs /Id# 161483
Ādaži, , Latvia
D.Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 161488
Liepāja, , Latvia
Clinic ORTO /ID# 161486
Riga, , Latvia
P. Stradins Clinical Univ Hosp /ID# 164442
Riga, , Latvia
VAKK dr. Kildos Clinic /ID# 167257
Kaunas, , Lithuania
Klaipeda University Hospital /ID# 167258
Klaipėda, , Lithuania
Public Institution Republican /ID# 165155
Šiauliai, , Lithuania
Vilnius University Hospital /ID# 165123
Vilnius, , Lithuania
Hospital Raja Permaisuri Bainun /ID# 161099
Ipoh, Perak, Malaysia
Hospital Tuanku Ja afar /ID# 161096
Seremban, , Malaysia
Instituto Jalisciense de Metabolismo SC /ID# 164005
Guadalajara, Jalisco, Mexico
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 164006
Mexico City, Mexico City, Mexico
Invest y Biomed de Chihuahua /ID# 164007
Chihuahua City, , Mexico
Medisch Centrum Leeuwarden /ID# 161575
Leeuwarden, , Netherlands
Erasmus Medisch Centrum /ID# 161092
Rotterdam, , Netherlands
Maasstad Ziekenhuis /ID# 160168
Rotterdam, , Netherlands
Waikato Hospital /ID# 166415
Hamilton, Waikato Region, New Zealand
North Shore Hospital /ID# 169409
Auckland, , New Zealand
Middlemore Hospital /ID# 166414
Auckland, , New Zealand
Porter Rheumatology Ltd /ID# 200421
Nelson, , New Zealand
Timaru Rheumatology Studies /ID# 166413
Timaru, , New Zealand
Helse Forde /ID# 167853
Førde, Sogn Og Fjordane, Norway
St. Olavs Hospital HF /ID# 163321
Trondheim, Sor-Trondelag, Norway
NZOZ Nasz Lekarz /ID# 163774
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Malopolskie Centrum Kliniczne /ID# 163777
Krakow, Lesser Poland Voivodeship, Poland
Synexus Polska Sp. z o.o. /ID# 204506
Wroclaw, Lower Silesian Voivodeship, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdansku /ID# 206299
Gdansk, Pomeranian Voivodeship, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni /ID# 207157
Gdynia, Pomeranian Voivodeship, Poland
Synexus Polska Sp. z o.o. Oddzial Katowice /ID# 204510
Katowice, Silesian Voivodeship, Poland
ETYKA-Osrodek Badan Klinicznyc /ID# 163776
Olsztyn, Warmian-Masurian Voivodeship, Poland
Centrum Kliniczno-Badawcze /ID# 161830
Elblag, , Poland
Krakowskie Centrum Medyczne /ID# 206302
Krakow, , Poland
Synexus Polska Sp. z o.o. Oddzial w Poznaniu /ID# 207158
Poznan, , Poland
Medycyna Kliniczna /ID# 166288
Warsaw, , Poland
Synexus Polska Sp. z.o.o. /ID# 203987
Warsaw, , Poland
Reumatika - Centrum Reumatologii NZOZ /ID# 161831
Warsaw, , Poland
Salve Medica Sp. z o.o. S.K. /ID# 206300
Lodz, Łódź Voivodeship, Poland
Instituto Portugues De Reumatologia /ID# 165858
Lisbon, Lisbon District, Portugal
Centro Hospitalar Lisboa Ocidental, EPE /ID# 165861
Lisbon, Lisbon District, Portugal
Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 165862
Vila Nova de Gaia, Porto District, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 165860
Lisbon, , Portugal
Hospital CUF Descobertas /ID# 165866
Lisbon, , Portugal
Hospital Beatriz Angelo /ID# 165865
Loures, , Portugal
Unidade Local De Saude Do Alto Minho /ID# 165863
Viana do Castelo, , Portugal
Cruz-Santana, Carolina, PR /ID# 163307
Carolina, , Puerto Rico
Ponce Medical School Foundation /ID# 163920
Ponce, , Puerto Rico
GCM Medical Group, PSC /ID# 162160
San Juan, , Puerto Rico
Family Outpatient clinic#4 LLC /ID# 164530
Korolev, Moscow, Russia
LLC Medical Center /ID# 164529
Novosibirsk, Novosibirsk Oblast, Russia
Kazan State Medical University /ID# 164531
Kazan', Tatarstan, Respublika, Russia
Moscow S.P.Botkin City Clinica /ID# 164533
Moscow, , Russia
State budgetary institution /ID# 164532
Saint Petersburg, , Russia
Institute for Rheumatology /ID# 166217
Belgrade, Beograd, Serbia
Institute for Rheumatology /ID# 166223
Belgrade, Beograd, Serbia
Institute for Rheumatology /ID# 166229
Belgrade, Beograd, Serbia
Institute for Rheumatology /ID# 166231
Belgrade, Beograd, Serbia
Military Medical Academy /ID# 166293
Belgrade, Beograd, Serbia
Singapore General Hospital /ID# 161094
Singapore, Central Singapore, Singapore
Tan Tock Seng Hospital /ID# 161095
Singapore, , Singapore
MEDMAN s.r.o. /ID# 165892
Martin, , Slovakia
Reumatologická ambulancia Reum.hapi s.r.o. /ID# 166486
Nové Mesto nad Váhom, , Slovakia
Slovak research center Team Member, Thermium s.r.o. /ID# 166489
Pieštany, , Slovakia
Univ Medical Ctr Ljubljana /ID# 164212
Ljubljana, , Slovenia
University Medical Ctr Maribor /ID# 169260
Maribor, , Slovenia
General Hospital Murska Sobota /ID# 164211
Murska Sobota, , Slovenia
Greenacres Hospital /ID# 164190
Port Elizabeth, Eastern Cape, South Africa
Wits Clinical Research Site /ID# 163919
Johannesburg, Gauteng, South Africa
University of Pretoria /ID# 163852
Pretoria, Gauteng, South Africa
Jakaranda Hospital /ID# 164242
Pretoria, Gauteng, South Africa
Arthritis Clinical Research Tr /ID# 163855
Cape Town, Western Cape, South Africa
Winelands Medical Research Ctr /ID# 163853
Stellenbosch, Western Cape, South Africa
Ajou University Hospital /ID# 163891
Suwon, Gyeonggido, South Korea
Inha University Hospital /ID# 163890
Junggu, Incheon Gwang Yeogsi, South Korea
Hospital Universitario A Coruña - CHUAC /ID# 161129
A Coruña, A Coruna, Spain
Hospital Campus de la Salud /ID# 170760
Granada, , Spain
Hospital Universitario Ramon y Cajal /ID# 161130
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 163198
Madrid, , Spain
Kantonsspital St. Gallen /ID# 158131
Sankt Gallen, Canton of St. Gallen, Switzerland
HFR Fribourg - Hopital Canton /ID# 162090
Fribourg, , Switzerland
China Medical University Hosp /ID# 159402
Taichung, Taichung, Taiwan
Chung Shan Medical University /ID# 159403
Taichung, , Taiwan
National Taiwan University Hospital /ID# 160878
Taipei, , Taiwan
Taipei Veterans General Hosp /ID# 166222
Taipei, , Taiwan
Linkou Chang Gung Memorial Ho /ID# 166221
Taoyuan, , Taiwan
Cukurova Universitesi Tip Fakultesi /ID# 162516
Saricam Adana, Adana, Turkey (Türkiye)
Hacettepe Universitesi Tip Fak /ID# 162518
Sihhiye, Ankara, Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Training & Research Hospital /ID# 162517
Istanbul, , Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 163383
Istanbul, , Turkey (Türkiye)
Necmettin Erbakan Universitesi /ID# 163382
Meram Konya, , Turkey (Türkiye)
Sakarya Universitesi Egitim /ID# 163397
Sakarya, , Turkey (Türkiye)
State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 164170
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Lviv Regional Clinical Hospita /ID# 164178
Lviv, Lviv Oblast, Ukraine
Kharkiv Regional Council Regional Clinical Hospital /ID# 210189
Kharkiv, , Ukraine
NSC Strazhesko Ist Cardiology /ID# 164043
Kiev, , Ukraine
Med Ctr of Private High Ed Ins /ID# 208527
Kyiv, , Ukraine
Medical Center of LLC Medbud-Clinic /ID# 208528
Kyiv, , Ukraine
Kyiv Railway Clinical Hosp No.2 /ID# 208951
Kyiv, , Ukraine
LLC Revmocentr /ID# 164177
Kyiv, , Ukraine
MNI KRC Kyiv Regional Clinical Hospital /ID# 210188
Kyiv, , Ukraine
Odessa National Medical Univ /ID# 164244
Odesa, , Ukraine
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 164245
Vinnytsia, , Ukraine
Whipps Cross Univ Hospital /ID# 161055
London, London, City of, United Kingdom
Guy's and St Thomas' NHS Found /ID# 161065
London, London, City of, United Kingdom
Christchurch Hospital /ID# 162702
Christchurch, , United Kingdom
UH Coventry & Warwickshire /ID# 162701
Coventry, , United Kingdom
Glasgow Royal Infirmary /ID# 162703
Glasgow, , United Kingdom
Luton & Dunstable University Hospital /ID# 162704
Luton, , United Kingdom
Countries
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References
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Burmester 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.
Burmester GR, Stigler J, Rubbert-Roth A, Tanaka Y, Azevedo VF, Coombs D, Lagunes I, Lippe R, Wung P, Gensler LS. Safety Profile of Upadacitinib up to 5 Years in Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis: An Integrated Analysis of Clinical Trials. Rheumatol Ther. 2024 Jun;11(3):737-753. doi: 10.1007/s40744-024-00671-4. Epub 2024 Apr 29.
Cantini F, Marchesoni A, Novelli L, Gualberti G, Marando F, McDearmon-Blondell EL, Gao T, McGonagle D, Salvarani C. Effects of upadacitinib on enthesitis in patients with psoriatic arthritis: a post hoc analysis of SELECT-PsA 1 and 2 trials. Rheumatology (Oxford). 2024 Nov 1;63(11):3146-3154. doi: 10.1093/rheumatology/keae057.
Rubbert-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.
Charles-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.
Baraliakos X, Ranza R, Ostor A, Ciccia F, Coates LC, Rednic S, Walsh JA, Douglas K, Gao T, Kato K, Song IH, Ganz F, Deodhar A. Efficacy and safety of upadacitinib in patients with active psoriatic arthritis and axial involvement: results from two phase 3 studies. Arthritis Res Ther. 2023 Apr 10;25(1):56. doi: 10.1186/s13075-023-03027-5.
Burmester 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.
McInnes IB, Kato K, Magrey M, Merola JF, Kishimoto M, Haaland D, Chen L, Duan Y, Liu J, Lippe R, Wung P. Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis: 2-Year Results from the Phase 3 SELECT-PsA 1 Study. Rheumatol Ther. 2023 Feb;10(1):275-292. doi: 10.1007/s40744-022-00499-w. Epub 2022 Oct 15.
Mease P, Kavanaugh A, Gladman D, FitzGerald O, Soriano ER, Nash P, Feng D, Lertratanakul A, Douglas K, Lippe R, Gossec L. Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials. Rheumatol Ther. 2022 Aug;9(4):1181-1191. doi: 10.1007/s40744-022-00449-6. Epub 2022 May 23.
Burmester GR, Winthrop K, Blanco R, Nash P, Goupille P, Azevedo VF, Salvarani C, Rubbert-Roth A, Lesser E, Lippe R, Lertratanakul A, Mccaskill RM, Liu J, Ruderman EM. Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials. Rheumatol Ther. 2022 Apr;9(2):521-539. doi: 10.1007/s40744-021-00410-z. Epub 2021 Dec 30.
Nash P, Richette P, Gossec L, Marchesoni A, Ritchlin C, Kato K, McDearmon-Blondell EL, Lesser E, McCaskill R, Feng D, Anderson JK, Ruderman EM. Upadacitinib as monotherapy and in combination with non-biologic disease-modifying antirheumatic drugs for psoriatic arthritis. Rheumatology (Oxford). 2022 Aug 3;61(8):3257-3268. doi: 10.1093/rheumatology/keab905.
Strand V, Mease PJ, Soriano ER, Kishimoto M, Salvarani C, Saffore CD, Zueger P, McDearmon-Blondell E, Kato K, Gladman DD. Improvement in Patient-Reported Outcomes in Patients with Psoriatic Arthritis Treated with Upadacitinib Versus Placebo or Adalimumab: Results from SELECT-PsA 1. Rheumatol Ther. 2021 Dec;8(4):1789-1808. doi: 10.1007/s40744-021-00379-9. Epub 2021 Oct 12.
Muensterman E, Engelhardt B, Gopalakrishnan S, Anderson JK, Mohamed MF. Upadacitinib pharmacokinetics and exposure-response analyses of efficacy and safety in psoriatic arthritis patients - Analyses of phase III clinical trials. Clin Transl Sci. 2022 Jan;15(1):267-278. doi: 10.1111/cts.13146. Epub 2021 Oct 27.
McInnes IB, Anderson JK, Magrey M, Merola JF, Liu Y, Kishimoto M, Jeka S, Pacheco-Tena C, Wang X, Chen L, Zueger P, Liu J, Pangan AL, Behrens F. Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis. N Engl J Med. 2021 Apr 1;384(13):1227-1239. doi: 10.1056/NEJMoa2022516.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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2016-004130-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-572
Identifier Type: -
Identifier Source: org_study_id
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