A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug
SELECT - PsA 2
A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)
2 other identifiers
interventional
642
19 countries
165
Brief Summary
This is a Phase 3 multicenter study that included two periods. Period 1 was designed to compare the safety, tolerability, and efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who had an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluated the safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in subjects with PsA who completed Period 1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2017
Longer than P75 for phase_3
165 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
First Submitted
Initial submission to the registry
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2019
CompletedResults Posted
Study results publicly available
January 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedSeptember 11, 2025
August 1, 2025
2.2 years
April 4, 2017
December 27, 2021
August 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 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
Secondary Outcomes (10)
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Baseline and Week 12
Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16
Baseline and Week 16
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16
Baseline and Week 16
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
Baseline and Week 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
Baseline and Week 12
- +5 more secondary outcomes
Study Arms (4)
Upadacitinib 15 mg
EXPERIMENTALAdministered once daily.
Placebo / Upadacitinib 30 mg
PLACEBO COMPARATORAdministered once daily.
Upadacitinib 30 mg
EXPERIMENTALAdministered once daily.
Placebo / Upadacitinib 15 mg
PLACEBO COMPARATORAdministered once daily.
Interventions
Oral tablet
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria
- Participant has active disease at Baseline defined as \>= 3 tender joints (based on 68 joint counts) and \>= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
- 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) or intolerance to treatment with at least 1 bDMARD.
You may not qualify if:
- Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib)
- Current treatment with \> 2 non-biologic DMARDs or use of DMARDs other than Methotrexate (MTX), Sulfasalazine (SSZ), Leflunomide (LEF), apremilast, Hydroxychloroquine (HCQ), bucillamine or iguratimod or use of MTX in combination with LEF at Baseline.
- 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 non-radiographic 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (165)
Alabama Medical Group, PC /ID# 159836
Mobile, Alabama, 36608-1787, United States
Arizona Arthritis & Rheumatology Research, PLLC /ID# 160047
Mesa, Arizona, 85210-6871, United States
Sun Valley Arthritis Center Ltd. /ID# 161203
Peoria, Arizona, 85381, United States
Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 160006
Phoenix, Arizona, 85032-9306, United States
Osteoporosis Medical Center /ID# 161411
Beverly Hills, California, 90211, United States
Covina Arthritis Clinic /ID# 159919
Covina, California, 91722, United States
Triwest Research Associates /ID# 159915
El Cajon, California, 92020, United States
Duplicate_Providence Medical Foundation /ID# 160005
Fullerton, California, 92835, United States
C.V. Mehta MD, Med Corporation /ID# 161192
Hemet, California, 92543, United States
Care Access Research, Huntington Beach /ID# 160049
Huntington Beach, California, 92648, United States
Purushotham & Akther Kotha MD, Inc /ID# 159834
La Mesa, California, 91942, United States
Stanford University School of Med /ID# 161402
Stanford, California, 94305-2200, United States
Inland Rheum Clin Trials Inc. /ID# 159839
Upland, California, 91786, United States
Medvin Clinical Research /ID# 160045
Whittier, California, 90606, United States
Denver Arthritis Clinic /ID# 159899
Denver, Colorado, 80230, United States
Colorado Arthritis Associates /ID# 159856
Lakewood, Colorado, 80228, United States
Duplicate_Arthritis & Rheumatic Disease Specialties /ID# 161409
Aventura, Florida, 33180, United States
International Medical Research /ID# 160051
Daytona Beach, Florida, 32117, United States
Precision Research Organization /ID# 161293
Miami Lakes, Florida, 33016-1501, United States
Duplicate_Suncoast Clinical Research /ID# 161417
New Port Richey, Florida, 34652, United States
Millennium Research /ID# 159833
Ormond Beach, Florida, 32174, United States
Arthritis Center, Inc. /ID# 163463
Palm Harbor, Florida, 34684, United States
Gulf Region Clinical Res Inst /ID# 159860
Pensacola, Florida, 32514, United States
Sarasota Arthritis Center /ID# 159854
Sarasota, Florida, 34239, United States
BayCare Medical Group /ID# 161405
St. Petersburg, Florida, 33705, United States
West Broward Rheumatology Associates /ID# 161412
Tamarac, Florida, 33321, United States
Clinical Research of West Florida - Tampa /ID# 160069
Tampa, Florida, 33606-1246, United States
Clinical Research of West Florida, Inc /ID# 159840
Tampa, Florida, 33606-1246, United States
USF Health Morsani Center for /ID# 161291
Tampa, Florida, 33612, United States
BayCare Medical Group, Inc. /ID# 159912
Tampa, Florida, 33614-7101, United States
Florida Medical Clinic /ID# 160013
Zephyrhills, Florida, 33542, United States
Jefrey D. Lieberman, MD, P.C. /ID# 159842
Decatur, Georgia, 30033, United States
Atlanta Research Center for Rheumatology /ID# 161201
Marietta, Georgia, 20060, United States
Velocity Clinical Research - Boise /ID# 159922
Meridian, Idaho, 83642, United States
Great Lakes Clinical Trials /ID# 163438
Chicago, Illinois, 60640, United States
Deerbrook Medical Associates /ID# 159815
Libertyville, Illinois, 60048, United States
Duplicate_Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 160068
Skokie, Illinois, 60076, United States
The Arthritis & Diabetes Clinic, Inc. /ID# 161294
Monroe, Louisiana, 71203, United States
Arthritis Treatment Center /ID# 160053
Frederick, Maryland, 21204, United States
The Center for Rheumatology and Bone Research /ID# 159900
Wheaton, Maryland, 20902, United States
Clinical Pharmacology Study Group /ID# 158712
Worcester, Massachusetts, 01605, United States
Clinvest Research LLC /ID# 161208
Springfield, Missouri, 65807, United States
Westroads Clinical Research /ID# 160004
Omaha, Nebraska, 68114, United States
Atlantic Coast Research /ID# 159810
Toms River, New Jersey, 08755, United States
Duplicate_Arthritis and Osteo Assoc /ID# 160015
Las Cruces, New Mexico, 88011, United States
Center for Rheumatology LLP /ID# 167046
Albany, New York, 12203-3710, United States
St. Lawrence Health System /ID# 159857
Potsdam, New York, 13676, United States
DJL Clinical Research, PLLC /ID# 161414
Charlotte, North Carolina, 28211, United States
Physicians East, PA /ID# 159898
Greenville, North Carolina, 27834, United States
Shanahan Rheuma & Immuno /ID# 160012
Raleigh, North Carolina, 27617, United States
PMG Research of Wilmington LLC /ID# 161403
Wilmington, North Carolina, 28401, United States
Trinity Health Med Arts Clinic /ID# 159811
Minot, North Dakota, 58701, United States
STAT Research, Inc. /ID# 161416
Vandalia, Ohio, 45377-9464, United States
Health Research of Oklahoma /ID# 159913
Oklahoma City, Oklahoma, 73103-2400, United States
Altoona Ctr Clinical Res /ID# 159861
Duncansville, Pennsylvania, 16635, United States
University of Pittsburgh MC /ID# 161193
Pittsburgh, Pennsylvania, 15260, United States
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163462
Summerville, South Carolina, 29486-7887, United States
Rheumatology Consultants, PLLC /ID# 161408
Knoxville, Tennessee, 37909, United States
Dr. Ramesh Gupta /ID# 160067
Memphis, Tennessee, 38119, United States
Tekton Research, Inc. /ID# 160008
Austin, Texas, 78745, United States
Diagnostic Group /ID# 161406
Beaumont, Texas, 77701, United States
Arthritis and Osteoporosis Clinic Of Brazos Valley /ID# 163439
College Station, Texas, 77845, United States
Adriana Pop-Moody MD Clinic PA /ID# 160009
Corpus Christi, Texas, 78404, United States
Metroplex Clinical Research /ID# 159818
Dallas, Texas, 75231, United States
Rheumatic Disease Clin Res Ctr /ID# 161252
Houston, Texas, 77004, United States
Accurate Clinical Research /ID# 160052
Houston, Texas, 77089, United States
P&I Clinical Research /ID# 159837
Lufkin, Texas, 75904-3132, United States
SW Rheumatology Res. LLC /ID# 160014
Mesquite, Texas, 75150, United States
DM Clinical Research - Tomball /ID# 161753
Tomball, Texas, 77375, United States
Arthritis & Osteoporosis Clinic /ID# 161400
Waco, Texas, 76710, United States
Arthritis Clinic of N. VA, P.C /ID# 159858
Arlington, Virginia, 22205, United States
Duplicate_Swedish Medical Center /ID# 159918
Seattle, Washington, 98104, United States
Emeritus Research Sydney /ID# 166751
Botany, New South Wales, 2019, Australia
The Queen Elizabeth Hospital /ID# 200840
Woodville South, South Australia, 5011, Australia
Box Hill Hospital /ID# 166752
Box Hill, Victoria, 3128, Australia
Heidelberg Repatriation Hospital /ID# 167441
Heidelberg West, Victoria, 3081, Australia
ReumaClinic /ID# 164214
Genk, Limburg, 3600, Belgium
UZ Gent /ID# 164210
Ghent, Oost-Vlaanderen, 9000, Belgium
CIP - Centro Internacional de Pesquisa /ID# 161808
Goiânia, Goiás, 74110-120, Brazil
Faculdade de Medicina do ABC /ID# 163489
Santo André, La Spezia, 09060-870, Brazil
Hospital de Clínicas da Universidade Federal de Uberlândia /ID# 161794
Uberlândia, Minas Gerais, 38400-902, Brazil
Hospital de Clinicas de Porto Alegre /ID# 161795
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
LMK Sevicos Medicos S/S /ID# 161806
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
Duplicate_Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 163317
Ribeirão Preto, São Paulo, 14051-140, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 161793
São Paulo, 05403-000, Brazil
Percuro Clinical Research, Ltd /ID# 157835
Victoria, British Columbia, V8V 3M9, Canada
CIADS Research Co Ltd /ID# 157843
Winnipeg, Manitoba, R3N 0K6, Canada
The Waterside Clinic /ID# 157838
Orillia, Ontario, L3V 1T5, Canada
Groupe de Recherche en Maladies Osseuses Inc /ID# 157836
Sainte-Foy, Quebec, G1V 3M7, Canada
Centre de Recherche Musculo-Squelettique /ID# 163557
Trois-Rivières, Quebec, G8Z 1Y2, Canada
CTR Estudios Clinicos /ID# 206038
Providencia, Aysén, 7500571, Chile
Duplicate_Clinica Dermacross /ID# 169537
Santiago, 7640881, Chile
Duplicate_Centro Internacional de Estudios Clinicos /ID# 169543
Santiago, 8420383, Chile
Prosalud Ltda. /ID# 169542
Santiago, ZC:7510047, Chile
Revmatologie Bruntal, s.r.o /ID# 159632
Prostějov, 796 01, Czechia
Medical Plus, s.r.o. /ID# 159631
Uherské Hradiště, 686 01, Czechia
Hopital Saint Joseph /ID# 163755
Marseille, Bouches-du-Rhone, 13008, France
CHU Toulouse /ID# 163743
Toulouse, Occitanie, 31300, France
Centre Hospitalier du Mans /ID# 163746
Le Mans, Sarthe, 72037, France
CHRU Tours - Hopital Trousseau /ID# 163772
Chambray-lès-Tours, 37170, France
Duplicate_CHU-Hospital Henri Mondor /ID# 163895
Créteil, 94010, France
Duplicate_AP-HP - Hopital Lariboisiere /ID# 163773
Paris, 75010, France
General Hospital of Athens Laiko /ID# 163474
Athens, Attica, 11527, Greece
Naval Hospital of Athens /ID# 163495
Athens, 11521, Greece
Reg Gen Univ Hosp Larissa /ID# 163493
Larissa, 41110, Greece
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 162573
Győr, Győr-Moson-Sopron, 9024, Hungary
Vital Medicina Kft /ID# 162571
Veszprém, Veszprém megye, 8200, Hungary
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 170911
Budapest, 1023, Hungary
Revita Reumatologiai Rendelo /ID# 162575
Budapest, 1027, Hungary
Obudai Egeszsegugyi Centrum Kft. /ID# 162576
Budapest, 1036, Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 162572
Debrecen, 4031, Hungary
MÁV Kórház /ID# 162574
Szolnok, 5000, Hungary
Azienda Ospedaliera Universitaria Federico II /ID# 202410
Napoli, L Aquila, 80131, Italy
Duplicate_Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 164123
Rome, Roma, 00128, Italy
Duplicate_Fondazione PTV Policlinico Tor Vergata /ID# 162749
Rome, Roma, 00133, Italy
Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 162748
Ancona, 60126, Italy
Duplicate_A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 164126
Catania, 95123, Italy
Duplicate_AOU Arcispedale Sant Anna di /ID# 164127
Cona, 44124, Italy
ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 164125
Milan, 20122, Italy
Duplicate_Azienda Unita Sanitaria Locale/IRCCS /ID# 162751
Reggio Emilia, 42123, Italy
Daido Hospital /ID# 163639
Nagoya, Aichi-ken, 457-8511, Japan
Nagoya City University Hospital /ID# 162563
Nagoya, Aichi-ken, 467-8602, Japan
Fukuoka University Hospital /ID# 161774
Fukuoka, Fukuoka, 814-0180, Japan
Duplicate_Kitakyushu Municipal Medical Center /ID# 163516
Kitakyushu-shi, Fukuoka, 802-8561, Japan
Hospital of the University of Occupational and Environmental Health, Japan /ID# 161472
Kitakyushu-shi, Fukuoka, 807-8556, Japan
Asahikawa Medical University Hospital /ID# 200684
Asahikawa-shi, Hokkaido, 078-8510, Japan
Mie University Hospital /ID# 162085
Tsu, Mie-ken, 514-8507, Japan
Tohoku University Hospital /ID# 164035
Sendai, Miyagi, 9808574, Japan
Oribe Clinic of Rheumatism and Medicine /ID# 163704
Ōita, Oita Prefecture, 870-0823, Japan
Kansai Medical University Hospital /ID# 162081
Hirakata-shi, Osaka, 573-1191, Japan
National Hospital Organization Osaka Minami Medical Center /ID# 162589
Kawachinagano Shi, Osaka, 586-8521, Japan
Osaka Metropolitan University Hospital /ID# 162082
Osaka, Osaka, 545-8586, Japan
Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 161773
Osaka, Osaka, 550-0006, Japan
Juntendo University Hospital /ID# 162089
Bunkyo-ku, Tokyo, 113-8431, Japan
St.Luke's International Hospital /ID# 162013
Chuo-ku, Tokyo, 104-8560, Japan
Keio University Hospital /ID# 162130
Shinjuku-ku, Tokyo, 160-8582, Japan
Medisch Centrum Leeuwarden /ID# 163049
Leeuwarden, South Holland, 8934 AD, Netherlands
Duplicate_Erasmus Medisch Centrum /ID# 163052
Rotterdam, South Holland, 3015 GD, Netherlands
Maasstad Ziekenhuis /ID# 163050
Rotterdam, South Holland, 3079 DZ, Netherlands
Sint Maartenskliniek /ID# 163703
Ubbergen, 6574 NA, Netherlands
Duplicate_Middlemore Hospital /ID# 166411
Otahuhu, Auckland, 2025, New Zealand
Timaru Medical Specialists Ltd /ID# 166410
Timaru, Canterbury, 7910, New Zealand
Waikato Hospital /ID# 166412
Hamilton, Waikato Region, 3240, New Zealand
Porter Rheumatology Ltd /ID# 200422
Nelson, 7010, New Zealand
Duplicate_Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 165897
Vila Nova de Gaia, Porto District, 4434-502, Portugal
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 165898
Ponte de Lima, Viana do Castelo District, 4990-041, Portugal
Instituto Portugues De Reumatologia /ID# 165894
Lisbon, 1050-034, Portugal
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 165896
Lisbon, 1349-019, Portugal
Unidade Local de Saude de Santa Maria, EPE /ID# 165895
Lisbon, 1649-035, Portugal
Alma M. Cruz Santana, MD-Private practice /ID# 163308
Carolina, 00985, Puerto Rico
Ponce Medical School Foundation /ID# 163918
Ponce, 00716-0377, Puerto Rico
GCM Medical Group PSC /ID# 163716
San Juan, 00917-3104, Puerto Rico
Duplicate_Ajou University Hospital /ID# 163893
Suwon, Gyeonggido, 16499, South Korea
Duplicate_Inha University Hospital /ID# 163892
Junggu, Incheon Gwang Yeogsi, 22332, South Korea
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 163138
El Palmar, Murcia, 30120, Spain
Duplicate_Hospital Universitario A Coruna - CHUAC /ID# 161019
A Coruña, 15006, Spain
Duplicate_Hospital Universitario Reina Sofia /ID# 170764
Córdoba, 14004, Spain
Hospital Campus de la Salud /ID# 170768
Granada, 18016, Spain
Hospital Universitario Ramon y Cajal /ID# 161020
Madrid, 28034, Spain
Royal United Hospitals Bath /ID# 161054
Bath, Bath And North East Somerset, BA1 3NG, United Kingdom
Barts Health NHS Trust /ID# 161053
London, London, City of, E1 2ES, United Kingdom
Guys and St Thomas NHS Foundation Trust /ID# 161063
London, London, City of, SE1 9RT, United Kingdom
Duplicate_NHS Greater Glasgow and Clyde /ID# 162712
Glasgow, G12 0XH, United Kingdom
Duplicate_Bedfordshire Hospitals NHS Foundation Trust /ID# 162713
Luton, LU4 0DZ, United Kingdom
Duplicate_Christchurch University Hospitals Dorset NHS University Hospitals Dors /ID# 162711
Poole, BH15 2JB, United Kingdom
Related Publications (14)
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.
PMID: 40875187DERIVEDBurmester 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.
PMID: 38683479DERIVEDCantini 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.
PMID: 38331400DERIVEDRubbert-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: 37945286DERIVEDMease P, Setty A, Papp K, Van den Bosch F, Tsuji S, Keiserman M, Carter K, Li Y, McCaskill R, McDearmon-Blondell E, Wung P, Tillett W. Upadacitinib in patients with psoriatic arthritis and inadequate response to biologics: 3-year results from the open-label extension of the randomised controlled phase 3 SELECT-PsA 2 study. Clin Exp Rheumatol. 2023 Nov;41(11):2286-2297. doi: 10.55563/clinexprheumatol/8l7bbk. Epub 2023 Jul 5.
PMID: 37404160DERIVEDBurmester 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: 36754548DERIVEDMease 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.
PMID: 35606663DERIVEDBurmester 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.
PMID: 34970731DERIVEDNash 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.
PMID: 34864911DERIVEDStrand V, Van den Bosch F, Ranza R, Leung YY, Drescher E, Zueger P, Saffore CD, Lertratanakul A, Lippe R, Nash P. Patient-Reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: SELECT-PsA 2. Rheumatol Ther. 2021 Dec;8(4):1827-1844. doi: 10.1007/s40744-021-00377-x. Epub 2021 Oct 18.
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PMID: 33272960DERIVED
MeSH Terms
Conditions
Interventions
Condition 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
April 4, 2017
First Posted
April 7, 2017
Study Start
May 1, 2017
Primary Completion
July 23, 2019
Study Completion
September 30, 2024
Last Updated
September 11, 2025
Results First Posted
January 25, 2022
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.