A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone
SELECT-NEXT
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
2 other identifiers
interventional
661
36 countries
160
Brief Summary
The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Dec 2015
Longer than P75 for phase_3 rheumatoid-arthritis
160 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
December 11, 2015
CompletedStudy Start
First participant enrolled
December 17, 2015
CompletedFirst Posted
Study publicly available on registry
February 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2017
CompletedResults Posted
Study results publicly available
October 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2022
CompletedApril 11, 2023
March 1, 2023
1.3 years
December 11, 2015
September 13, 2019
March 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity; * Patient global assessment of disease activity; * Patient assessment of pain; * Health Assessment Questionnaire - Disability Index (HAQ-DI); * High-sensitivity C-reactive protein (hsCRP).
Baseline and Week 12
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of ≤ 3.2 at Week 12. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28 score less than or equal to 3.2 indicates low disease activity.
Week 12
Secondary Outcomes (10)
Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12
Baseline and Week 12
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Baseline and Week 12
Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary (PCS) Score at Week 12
Baseline and Week 12
Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12
Week 12
Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12
Week 12
- +5 more secondary outcomes
Study Arms (4)
Upadacitinib 15 mg
EXPERIMENTALPeriod 1: Participants receive upadacitinib 15 mg once daily for 12 weeks. Period 2: Participants continue to receive upadacitinib 15 mg once daily for an additional 248 weeks.
Upadacitinib 30 mg
EXPERIMENTALPeriod 1: Participants receive upadacitinib 30 mg once daily for 12 weeks. Period 2: Participants continue to receive upadacitinib 30 mg once daily for an additional 248 weeks or until implementation of Protocol Amendment 6 at which time participants switch to receive upadacitinib 15 mg once daily.
Placebo / Upadacitinib 15 mg
EXPERIMENTALPeriod 1: Participants receive placebo once daily for 12 weeks. Period 2: Participants receive upadacitinib 15 mg once daily for 248 weeks.
Placebo / Upadacitinib 30 mg
EXPERIMENTALPeriod 1: Participants receive placebo once daily for 12 weeks. Period 2: Participants receive upadacitinib 30 mg once daily for 248 weeks or until implementation of Protocol Amendment 6 at which time participants switch to receive upadacitinib 15 mg once daily.
Interventions
Tablet; Oral
Eligibility Criteria
You may qualify if:
- Adult male or female, at least 18 years old.
- Diagnosis of rheumatoid arthritis (RA) for greater than or equal to 3 months.
- Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for greater than or equal to 3 months and on a stable dose for greater than or equal to 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.
- 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.
- Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled (up to 20% of study population) if they have documented evidence of intolerance to bDMARDs or limited exposure (less than 3 months) and have satisfied required washout periods.
You may not qualify if:
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
- Subjects who are considered inadequate responders to bDMARD therapy as determined by the Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (167)
AZ Arthritis and Rheum Assoc /ID# 148651
Mesa, Arizona, 85202, United States
SunValley Arthritis Center, Lt /ID# 140452
Peoria, Arizona, 85381, United States
AZ Arthritis and Rheum Researc /ID# 138500
Phoenix, Arizona, 85032-9306, United States
AZ Arthritis and Rheum Researc /ID# 139286
Phoenix, Arizona, 85032-9306, United States
AZ Arthritis & Rheuma Research /ID# 138598
Phoenix, Arizona, 85032, United States
Arizona Research Center, Inc. /ID# 140448
Phoenix, Arizona, 85053-4061, United States
University of Arizona Cancer Center - North Campus /ID# 140451
Tucson, Arizona, 85719-1478, United States
Covina Arthritis Clinic /ID# 139881
Covina, California, 91722, United States
T. Joseph Raoof, MD, Inc. /ID# 140964
Encino, California, 91436, United States
Allergy and Rheum Med Clin /ID# 146082
La Jolla, California, 92037, United States
Pacific Arthritis Ctr Med Grp /ID# 138744
Los Angeles, California, 90045, United States
Robin K. Dore MD, Inc /ID# 138688
Tustin, California, 92780, United States
Inland Rheum Clin Trials Inc. /ID# 138853
Upland, California, 91786, United States
Denver Arthritis Clinic /ID# 139876
Denver, Colorado, 80230, United States
Clinical Res of West FL, Inc. /ID# 138854
Clearwater, Florida, 33765, United States
Ctr Arthritis & Rheumatic Dise /ID# 141696
Miami, Florida, 33173, United States
Medallion Clinical Research Institute, LLC /ID# 140074
Naples, Florida, 34102, United States
Suncoast Clinical Research /ID# 138633
New Port Richey, Florida, 34652, United States
Omega Research Consultants /ID# 139877
Orlando, Florida, 32810, United States
Arthritis Center, Inc. /ID# 141363
Palm Harbor, Florida, 34684, United States
Institute of Arthritis Res /ID# 138548
Idaho Falls, Idaho, 83404, United States
OrthoIllinois /ID# 139695
Rockford, Illinois, 61114-4937, United States
Clinical Investigation Special /ID# 139696
Skokie, Illinois, 60076, United States
Springfield Clinic /ID# 138602
Springfield, Illinois, 62702-3749, United States
Deerbrook Medical Associates /ID# 139694
Vernon Hills, Illinois, 60061, United States
Indiana Univ School of Med /ID# 140077
Indianapolis, Indiana, 46202, United States
Bluegrass Community Research /ID# 138295
Lexington, Kentucky, 40515, United States
Four Rivers Clinical Research /ID# 141134
Paducah, Kentucky, 42003, United States
MMP Women's Health /ID# 141542
Portland, Maine, 04102, United States
The Center for Rheumatology & /ID# 139203
Wheaton, Maryland, 20902, United States
Mansfield Health Center /ID# 141357
Mansfield, Massachusetts, 02048, United States
Advanced Rheumatology, PC /ID# 140071
Lansing, Michigan, 48910, United States
Justus J. Fiechtner, MD, PC /ID# 138697
Lansing, Michigan, 48910, United States
Physician Res. Collaboration /ID# 138533
Lincoln, Nebraska, 68516, United States
Westroads Clinical Research /ID# 138304
Omaha, Nebraska, 68114, United States
The Center for Rheumatology /ID# 138746
Albany, New York, 12206, United States
PMG Research of Salisbury /ID# 141023
Salisbury, North Carolina, 28144, United States
PMG Research of Wilmington LLC /ID# 140951
Wilmington, North Carolina, 28401, United States
Cincinnati Rheumatic Disease Study Group, Inc. /ID# 138868
Cincinnati, Ohio, 45242-4468, United States
Arthritis Assoc of NW Ohio /ID# 140953
Toledo, Ohio, 43606, United States
Health Research Oklahoma /ID# 138535
Oklahoma City, Oklahoma, 73103-2400, United States
Altoona Ctr Clinical Res /ID# 138741
Duncansville, Pennsylvania, 16635, United States
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 138689
Summerville, South Carolina, 29486-7887, United States
Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 141021
Hendersonville, Tennessee, 37075-6213, United States
Tekton Research, Inc. /ID# 141428
Austin, Texas, 78745, United States
Trinity Universal Res Assoc /ID# 149271
Carrollton, Texas, 75007, United States
Arth and Osteo Clin Brazo Valley /ID# 147809
College Station, Texas, 77845, United States
Metroplex Clinical Research /ID# 138698
Dallas, Texas, 75231, United States
Baylor College of Medicine /ID# 138682
Houston, Texas, 77030-3411, United States
Houston Institute for Clin Res /ID# 138716
Houston, Texas, 77074, United States
Arthritis Consultants, P.A. /ID# 141138
Killeen, Texas, 76549, United States
Trinity Universal Research Association /ID# 148649
Plano, Texas, 75024-5283, United States
Accurate Clinical Management /ID# 139338
San Antonio, Texas, 78229, United States
Arthritis & Osteoporosis Clinic /ID# 138703
Waco, Texas, 76710, United States
Western Washington Arthritis C /ID# 138728
Bothell, Washington, 98021, United States
Arthritis Northwest, PLLC /ID# 138539
Spokane, Washington, 99204, United States
Aurora Rheumatology and Immunotherapy Center /ID# 139306
Franklin, Wisconsin, 53132, United States
Mautalen Salud e Investigacion /ID# 141419
Buenos Aires, 1128, Argentina
Inst. Rheumatologic Strusberg /ID# 145648
Córdoba, 5000, Argentina
Coffs Clinical Trials /ID# 138747
Coffs Harbour, New South Wales, 2450, Australia
Optimus Clinical Research Pty. /ID# 138769
Kogarah, New South Wales, 2217, Australia
Emeritus Research /ID# 138773
Camberwell, Victoria, 3124, Australia
Barwon Rheumatology /ID# 138772
Geelong, Victoria, 3220, Australia
Rheuma Zentrum Favoriten GmbH /ID# 138787
Vienna, 1100, Austria
Wilhelminenspital der Stadt Wien /ID# 138788
Vienna, 1160, Austria
Rhumaconsult SPRL /ID# 138813
Charleroi, Hainaut, 6000, Belgium
UZ Gent /ID# 138806
Ghent, Oost-Vlaanderen, 9000, Belgium
AZ Sint Lucas /ID# 141338
Bruges, 8310, Belgium
University Clinical Centre of the Republic of Srpska /ID# 138819
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 140372
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
Diag Consult Ctr 17 Sofia EOOD /ID# 141006
Sofia, 1505, Bulgaria
Diagnostic Consultative Center /ID# 138882
Sofia, 1612, Bulgaria
Manitoba Clinic /ID# 139086
Winnipeg, Manitoba, R3A IM3, Canada
Eastern Health /ID# 140431
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Groupe de Recherche en Maladies Osseuses /ID# 138906
Sainte-Foy, Quebec, G1V 3M7, Canada
Dr. Latha Naik /ID# 139089
Saskatoon, Saskatchewan, S7K 3H3, Canada
Klinicki bolnicki centar Rijeka /ID# 138649
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
Klinicka bolnica Sveti Duh /ID# 152812
Zagreb, 10000, Croatia
Medical Center Kuna-Peric /ID# 140365
Zagreb, 10000, Croatia
Poliklinika Bonifarm /ID# 141415
Zagreb, 10000, Croatia
L.K.N. Arthrocentrum, s.r.o /ID# 141340
Hlučín, Moravskoslezský kraj, 748 01, Czechia
Revmatologie, s.r.o. /ID# 138899
Brno, 638 00, Czechia
Artroscan s.r.o. /ID# 138833
Ostrava, 722 00, Czechia
Nemocnice Slany /ID# 141112
Slaný, 274 01, Czechia
PV-MEDICAL s.r.o. /ID# 138913
Zlín, 760 01, Czechia
Center of Clinical and Basic Research /ID# 141116
Tallinn, Harju, 10128, Estonia
Paernu Hospital /ID# 138961
Pärnu, 80010, Estonia
East Tallinn Central Hospital /ID# 140618
Tallinn, 10138, Estonia
Helsinki Univ Central Hospital /ID# 140381
Helsinki, 00290, Finland
Kiljava Medical Research /ID# 139260
Hyvinkää, 05800, Finland
South Karelia Central Hospital /ID# 139973
Lappeenranta, 53130, Finland
Hopital Saint Joseph /ID# 149188
Marseille, Bouches-du-Rhone, 13285, France
CHRU Tours - Hopital Trousseau /ID# 138969
Chambray-lès-Tours, 37170, France
Uniklinik Koln /ID# 139084
Cologne, North Rhine-Westphalia, 50937, Germany
Charité Universitätsmedizin Campus Mitte /ID# 139052
Berlin, 10117, Germany
Immanuel-Krankenhaus /ID# 139059
Berlin, 13125, Germany
Asklepios Klinik Altona /ID# 140466
Hamburg, 22763, Germany
Welcker, Planegg, DE /ID# 140467
Planegg, 82152, Germany
University General Hospital of Heraklion "PA.G.N.I" /ID# 139115
Heraklion, 71110, Greece
Prince of Wales Hospital /ID# 139314
Shatin, Hong Kong
Revita Reumatologiai Rendelo /ID# 140761
Budapest, 1027, Hungary
Fejer Megyei Szent Gyorgy Korh /ID# 138554
Székesfehérvár, 8000, Hungary
St Vincent's University Hosp /ID# 138562
Dublin, D04 T6F4, Ireland
Universita di Catanzaro Magna Graecia /ID# 139316
Catanzaro, Calabria, 88100, Italy
JSC Nat Scientific Med Res Ctr /ID# 140575
Astana, 010009, Kazakhstan
LTD M+M Centers /ID# 138818
Ādaži, 2164, Latvia
Klaipeda University Hospital /ID# 141416
Klaipėda, 92288, Lithuania
Vilnius University Hospital /ID# 141348
Vilnius, LT-08661, Lithuania
Centro Peninsular de Investigación Clínica SCP /ID# 148160
Colonia Centro, Yucatán, 97000, Mexico
Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 138841
Mexico City, 06090, Mexico
Porter Rheumatology Ltd /ID# 138347
Nelson, 7010, New Zealand
NZOZ Nasz Lekarz /ID# 138374
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
McBk Sc /Id# 138360
Grodzisk Mazowiecki, Masovian Voivodeship, 05-825, Poland
Osteo-Medic spolka cywilna /ID# 138371
Bialystok, Podlaskie Voivodeship, 15-351, Poland
NZOZ Centrum Reumatologiczne /ID# 138353
Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Rheuma Medicus /ID# 138372
Warsaw, 02-118, Poland
Instituto Portugues De Reumatologia /ID# 148315
Lisbon, Lisbon District, 1050-034, Portugal
Centro Hospitalar Lisboa Ocidental, EPE /ID# 140594
Lisbon, Lisbon District, 1349-019, Portugal
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139328
San Juan, 00935, Puerto Rico
Spitalul Clinic Judetean de Urgenta /ID# 138407
Cluj-Napoca, 400006, Romania
Spitalul Municipal Ploiesti /ID# 138405
Ploieşti, 100337, Romania
Spitalul Clinic Judetean de Ur /ID# 138393
Sibiu, 550245, Romania
LLC Novaya Klinika /ID# 139269
Pyatigorsk, Stavropol Kray, 357500, Russia
Kazan State Medical University /ID# 138413
Kazan', Tatarstan, Respublika, 420012, Russia
Republican Clin Hos n.a. Baran /ID# 139273
Petrozavodsk, 185019, Russia
Samara Regional Clinical Hosp /ID# 148642
Samara, 443095, Russia
Ulyanovsk Regional Clin Hosp /ID# 139279
Ulyanovsk, 432018, Russia
Voronezh State Medical Univers /ID# 148431
Voronezh, 394036, Russia
Yaroslavi State Medical Univer /ID# 139908
Yaroslavl, 150000, Russia
ARTROMAC n.o. /ID# 138428
Košice, 040 11, Slovakia
Nemocnica Kosice Saca, a.s. /ID# 138918
Košice, 040 15, Slovakia
Slovak research center Team Member, Thermium s.r.o. /ID# 139924
Pieštany, 921 01, Slovakia
Narodny ustav reumatickych chorob Piestany /ID# 138427
Pieštany, 921 12, Slovakia
REUMA-GLOBAL, s.r.o. /ID# 139912
Trnava, 91701, Slovakia
St. Augustine's Medical Centre /ID# 141352
Berea, KwaZulu-Natal, NL 4001, South Africa
Arthritis Clinical Research Tr /ID# 138945
Cape Town, Western Cape, 7405, South Africa
Winelands Medical Research Ctr /ID# 138944
Stellenbosch, Western Cape, 7600, South Africa
Inha University Hospital /ID# 149310
Incheon, Gwang Yeogsi, 22332, South Korea
Ajou University Hospital /ID# 149311
Suwon, Gyeonggido, 16499, South Korea
Chonnam National University Hospital /ID# 138651
Gwangju, Jeonranamdo, 61469, South Korea
Hanyang University Seoul Hospi /ID# 138655
Seoul, Seongdong-gu, 04763, South Korea
Cath Univ Seoul St Mary's Hosp /ID# 138652
Seoul, Seoul Teugbyeolsi, 06591, South Korea
Daegu Catholic University Med /ID# 139249
Daegu, 705-718, South Korea
Chungnam National University Hospital /ID# 138653
Daejeon, 35015, South Korea
Seoul National University Hospital /ID# 138659
Seoul, 03080, South Korea
Asan Medical Center /ID# 140579
Seoul, 05505, South Korea
Hospital Regional de Malaga /ID# 138975
Málaga, Malaga, 29009, Spain
Hospital General Univ de Elche /ID# 138991
Elche, 03202, Spain
Hospital Clin Univ San Carlos /ID# 138993
Madrid, 28040, Spain
Hosp Nuestra Senora Esperanza /ID# 138997
Santiago de Compostela, 15705, Spain
HFR Fribourg - Hopital Canton /ID# 139155
Fribourg, 1708, Switzerland
China Medical University Hosp /ID# 139232
Taichung, Taichung, 40447, Taiwan
National Cheng Kung University Hospital /ID# 140868
Tainan, Tainan, 70403, Taiwan
National Taiwan Univ Hosp /ID# 141443
Taipei City, Taipei, 10002, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 140869
Kaohsiung City, 80708, Taiwan
Far Eastern Memorial Hospital /ID# 140871
New Taipei City, 22060, Taiwan
Taipei Veterans General Hosp /ID# 139234
Taipei, 11217, Taiwan
Ankara Numune Training and Res /ID# 139237
Ankara, 06100, Turkey (Türkiye)
LLC Revmocentr /ID# 139872
Kyiv, 04070, Ukraine
MNCE "Lviv City Clinical Hospital #4" /ID# 139873
Lviv, 79007, Ukraine
Odessa National Medical Univ /ID# 139179
Odesa, 65026, Ukraine
Leicester Royal Infirmary /ID# 139184
Leicester, England, LE1 5WW, United Kingdom
Whipps Cross Univ Hospital /ID# 139523
London, London, City of, E11 1NR, United Kingdom
The Royal Free Hospital /ID# 139191
London, London, City of, NW3 2QG, United Kingdom
Western General Hospital /ID# 139524
Edinburgh, EH4 2XU, United Kingdom
Southampton General Hospital /ID# 139169
Southampton, SO16 6YD, United Kingdom
Warrington + Halton Hosp NHS /ID# 139195
Warrington, WA5 1LZ, United Kingdom
Related Publications (15)
Burmester GR, Kremer JM, Van den Bosch F, Kivitz A, Bessette L, Li Y, Zhou Y, Othman AA, Pangan AL, Camp HS. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
PMID: 29908669BACKGROUNDBurmester 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, Van den Bosch F, Tesser J, Shmagel A, Liu Y, Khan N, Camp HS, Kivitz A. Upadacitinib in Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs: Efficacy and Safety Through 5 Years (SELECT-NEXT). J Rheumatol. 2024 Jul 1;51(7):663-672. doi: 10.3899/jrheum.2023-1062.
PMID: 38621793DERIVEDRubbert-Roth A, Kakehasi AM, Takeuchi T, Schmalzing M, Palac H, Coombs D, Liu J, Anyanwu SI, Lippe R, Curtis JR. Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis. Rheumatol Ther. 2024 Feb;11(1):97-112. doi: 10.1007/s40744-023-00621-6. Epub 2023 Nov 20.
PMID: 37982966DERIVEDCharles-Schoeman C, Choy E, McInnes IB, Mysler E, Nash P, Yamaoka K, Lippe R, Khan N, Shmagel AK, Palac H, Suboticki J, Curtis JR. MACE and VTE across upadacitinib clinical trial programmes in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. RMD Open. 2023 Nov;9(4):e003392. doi: 10.1136/rmdopen-2023-003392.
PMID: 37945286DERIVEDFleischmann R, Curtis JR, Charles-Schoeman C, Mysler E, Yamaoka K, Richez C, Palac H, Dilley D, Liu J, Strengholt S, Burmester G. Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme. Ann Rheum Dis. 2023 Sep;82(9):1130-1141. doi: 10.1136/ard-2023-223916. Epub 2023 Jun 12.
PMID: 37308218DERIVEDConaghan PG, Pavelka K, Hsieh SC, Bonnington TL, Kent TC, Marchbank K, Edwards CJ. Evaluating the efficacy of upadacitinib in patients with moderate rheumatoid arthritis: a post-hoc analysis of the SELECT phase 3 trials. Rheumatol Adv Pract. 2023 Feb 8;7(1):rkad017. doi: 10.1093/rap/rkad017. eCollection 2023.
PMID: 36794283DERIVEDBurmester GR, Cohen SB, Winthrop KL, Nash P, Irvine AD, Deodhar A, Mysler E, Tanaka Y, Liu J, Lacerda AP, Palac H, Shaw T, Mease PJ, Guttman-Yassky E. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1):e002735. doi: 10.1136/rmdopen-2022-002735.
PMID: 36754548DERIVEDKakehasi AM, Radominski SC, Baravalle MD, Palazuelos FCI, Garcia-Garcia C, Arruda MS, Curi M, Liu J, Qiao M, Velez-Sanchez P, Vargas JI. Safety of upadacitinib in Latin American patients with rheumatoid arthritis: an integrated safety analysis of the SELECT phase 3 clinical program. Clin Rheumatol. 2023 May;42(5):1249-1258. doi: 10.1007/s10067-023-06513-y. Epub 2023 Jan 30.
PMID: 36715850DERIVEDBergman M, Buch MH, Tanaka Y, Citera G, Bahlas S, Wong E, Song Y, Zueger P, Ali M, Strand V. Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials. Rheumatol Ther. 2022 Dec;9(6):1517-1529. doi: 10.1007/s40744-022-00483-4. Epub 2022 Sep 20.
PMID: 36125701DERIVEDBergman M, Tundia N, Yang M, Orvis E, Clewell J, Bensimon A. Economic Benefit from Improvements in Quality of Life with Upadacitinib: Comparisons with Tofacitinib and Methotrexate in Patients with Rheumatoid Arthritis. Adv Ther. 2021 Dec;38(12):5649-5661. doi: 10.1007/s12325-021-01930-4. Epub 2021 Oct 12.
PMID: 34636000DERIVEDYamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.
PMID: 34041702DERIVEDCohen 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.
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Related Links
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
December 11, 2015
First Posted
February 5, 2016
Study Start
December 17, 2015
Primary Completion
April 21, 2017
Study Completion
March 10, 2022
Last Updated
April 11, 2023
Results First Posted
October 7, 2019
Record last verified: 2023-03
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
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.