A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs
NCT ID: NCT02706847
Last Updated: 2023-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
499 participants
INTERVENTIONAL
2016-03-15
2022-02-08
Brief Summary
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The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.
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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
NCT02675426
A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs
NCT03086343
A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
NCT02720523
A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)
NCT02955212
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
NCT02629159
Detailed Description
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Period 1 consists of a 12-week double-blind, placebo-controlled treatment phase plus a 12-week double-blind phase where all participants were to receive upadacitinib; at Week 12 participants assigned to placebo will be switched to upadacitinib according to their randomization assignment.
Participants who meet eligibility criteria will be randomized in a 2:2:1:1 ratio to one of four treatment groups:
* Group 1: Upadacitinib 30 mg QD (Day 1 to Week 12) → upadacitinib 30 mg QD (Week 12 and thereafter)
* Group 2: Upadacitinib 15 mg QD (Day 1 to Week 12) → upadacitinib 15 mg QD (Week 12 and thereafter)
* Group 3: Placebo (Day 1 to Week 12) → upadacitinib 30 mg QD (Week 12 and thereafter)
* Group 4: Placebo (Day 1 to Week 12) → upadacitinib 15 mg QD (Week 12 and thereafter)
Participants will continue stable dose of csDMARD therapy for the first 24 weeks of the study.
Participants who complete the Week 24 visit (end of Period 1) will enter the blinded long-term extension portion of the study, Period 2 and continue to receive the same dose of upadacitinib per original randomization assignment in a blinded manner. Starting at Week 24, at least 20% improvement in both swollen joint count (SJC) and tender joint count (TJC) compared to Baseline is required to remain on study drug. Starting at Week 24, initiation of or change in corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or adding or increasing doses in up to 2 csDMARDs (concomitant use of up to 2 csDMARDs except the combination of methotrexate and leflunomide) is allowed as per local label.
With the implementation of Protocol Amendment 4, all participants in the extension period will receive open-label upadacitinib 15 mg QD, including those currently on upadacitinib 30 mg QD.
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 once daily for 24 weeks.
Period 2: Participants will continue on upadacitinib 15 mg once daily from Week 24 to Week 260.
Upadacitinib
Tablet; Oral
Upadacitinib 30 mg
Period 1: Participants receive upadacitinib 30 mg once daily for 24 weeks.
Period 2: Participants continue on upadacitinib 30 mg once daily until implementation of Protocol Amendment 4, then participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Upadacitinib
Tablet; Oral
Placebo / Upadacitnib 15 mg
Period 1: Participants receive placebo once daily for 12 weeks followed by upadacitinib 15 mg once daily for 12 weeks.
Period 2: Participants will continue on upadacitinib 15 mg once daily from Week 24 to Week 260.
Placebo
Tablet; Oral
Upadacitinib
Tablet; Oral
Placebo / Upadacitnib 30 mg
Period 1: Participants receive placebo once daily for 12 weeks followed by upadacitinib 30 mg once daily for 12 weeks.
Period 2: Participants continue on upadacitinib 30 mg once daily until implementation of Protocol Amendment 4, then participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Placebo
Tablet; Oral
Upadacitinib
Tablet; Oral
Interventions
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Placebo
Tablet; Oral
Upadacitinib
Tablet; Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treated for ≥ 3 months with ≥ 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration prior to the first dose of study drug.
* Participant has been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide.
* Meets both of the following criteria:
* ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
* hsCRP ≥ 3mg/L at Screening Visit.
Exclusion Criteria
* History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia \[currently with active symptoms\]). Current diagnosis of secondary Sjogren's Syndrome is permitted.
18 Years
99 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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Arthritis Research of Florida /ID# 142811
Palm Harbor, Florida, United States
Rheum Assoc of North Alabama /ID# 145959
Huntsville, Alabama, United States
AZ Arthritis and Rheum Assoc /ID# 148593
Mesa, Arizona, United States
AZ Arthritis and Rheum Researc /ID# 142816
Phoenix, Arizona, United States
AZ Arthritis and Rheum Researc /ID# 146075
Phoenix, Arizona, United States
AZ Arthritis and Rheum Researc /ID# 148592
Phoenix, Arizona, United States
Arizona Research Center, Inc. /ID# 142741
Phoenix, Arizona, United States
AZ Arthr & Rheum Research /ID# 155256
Prescott, Arizona, United States
AZ Arthritis & Rheum Research /ID# 156090
Sun City, Arizona, United States
NEA Baptist Clinic /ID# 149280
Jonesboro, Arkansas, United States
Covina Arthritis Clinic /ID# 142794
Covina, California, United States
Rheumatology Ctr of San Diego /ID# 153576
Escondido, California, United States
St. Joseph Heritage Healthcare /ID# 149273
Fullerton, California, United States
TriWest Research Associates- La Mesa /ID# 142792
La Mesa, California, United States
Arthritis & Osteo Medical Ctr /ID# 142770
La Palma, California, United States
Valerius Med Grp & Res Ctr /ID# 142799
Los Alamitos, California, United States
Pacific Arthritis Ctr Med Grp /ID# 142783
Los Angeles, California, United States
University of California, Los Angeles /ID# 148348
Los Angeles, California, United States
Desert Medical Advances /ID# 142765
Palm Desert, California, United States
Stanford University School of Med /ID# 142761
Stanford, California, United States
Robin K. Dore MD, Inc /ID# 150908
Tustin, California, United States
Inland Rheum Clin Trials Inc. /ID# 142787
Upland, California, United States
Medvin Clinical Research /ID# 142814
Whittier, California, United States
Arthritis Assoc & Osteo Ctr /ID# 142809
Colorado Springs, Colorado, United States
Denver Arthritis Clinic /ID# 142771
Denver, Colorado, United States
New England Research Associates, LLC /ID# 142763
Bridgeport, Connecticut, United States
Delaware Arthritis /ID# 142803
Lewes, Delaware, United States
Lakes Research, LLC /ID# 142755
Miami, Florida, United States
Medallion Clinical Research Institute, LLC /ID# 142740
Naples, Florida, United States
Omega Research Consultants /ID# 142780
Orlando, Florida, United States
Millennium Research /ID# 142782
Ormond Beach, Florida, United States
Arthritis Center, Inc. /ID# 142822
Palm Harbor, Florida, United States
Advent Clinical Research /ID# 142817
Pinellas Park, Florida, United States
St. Anthony Comprehsve Res Ins /ID# 148349
St. Petersburg, Florida, United States
University of South Florida /ID# 145611
Tampa, Florida, United States
BayCare Medical Group, Inc. /ID# 142747
Tampa, Florida, United States
Lovelace Scientific Resources /ID# 142779
Venice, Florida, United States
Jefrey D. Lieberman, MD, P.C. /ID# 151713
Decatur, Georgia, United States
Marietta Rheumatology Assoc /ID# 151347
Marietta, Georgia, United States
St. Luke's Clinic - Rheumatolo /ID# 150923
Boise, Idaho, United States
Institute of Arthritis Res /ID# 142810
Idaho Falls, Idaho, United States
Advanced Clinical Research /ID# 153089
Meridian, Idaho, United States
Great Lakes Clinical Trials /ID# 148341
Chicago, Illinois, United States
Clinical Investigation Special /ID# 149270
Skokie, Illinois, United States
Springfield Clinic /ID# 142818
Springfield, Illinois, United States
Deerbrook Medical Associates /ID# 151712
Vernon Hills, Illinois, United States
The Arthritis & Diabetes Clinic, Inc. /ID# 142793
Monroe, Louisiana, United States
Vanguard Medical Research, LLC /ID# 153123
Shreveport, Louisiana, United States
MMP Women's Health /ID# 145612
Portland, Maine, United States
The Center for Rheumatology & /ID# 142742
Wheaton, Maryland, United States
Mansfield Health Center /ID# 147628
Mansfield, Massachusetts, United States
Clinical Pharmacology Study Gr /ID# 142744
Worcester, Massachusetts, United States
June DO, PC /ID# 142756
Lansing, Michigan, United States
North Mississippi Med Clinics /ID# 142781
Tupelo, Mississippi, United States
Clayton Medical Associates dba Saint Louis Rheumatology /ID# 142745
St Louis, Missouri, United States
Barbara Caciolo, MD /ID# 142749
St Louis, Missouri, United States
Westroads Clinical Research /ID# 142802
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center /ID# 145958
Lebanon, New Hampshire, United States
Atlantic Coast Research /ID# 148347
Toms River, New Jersey, United States
Ocean Rheumatology, PA /ID# 142785
Toms River, New Jersey, United States
The Center for Rheumatology /ID# 142784
Albany, New York, United States
North Shore University Hospital /ID# 142772
New Hyde Park, New York, United States
Buffalo Rheumatology /ID# 142766
Orchard Park, New York, United States
Joint & Muscle Research Instit /ID# 142797
Charlotte, North Carolina, United States
DJL Clinical Research, PLLC /ID# 142769
Charlotte, North Carolina, United States
Cape Fear Arthritis Care /ID# 148344
Leland, North Carolina, United States
Coastal Carolina Health Care /ID# 148351
New Bern, North Carolina, United States
Shanahan Rheuma & Immuno /ID# 142812
Raleigh, North Carolina, United States
Trinity Health Med Arts Clinic /ID# 142754
Minot, North Dakota, United States
Cincinnati Rheumatic Disease Study Group, Inc. /ID# 142791
Cincinnati, Ohio, United States
STAT Research, Inc. /ID# 142821
Vandalia, Ohio, United States
Health Research Oklahoma /ID# 142751
Oklahoma City, Oklahoma, United States
Healthcare Research Consultant /ID# 142815
Tulsa, Oklahoma, United States
East Penn Rheumatology Assoc /ID# 142790
Bethlehem, Pennsylvania, United States
Clinical Research Ctr Reading /ID# 151714
Wyomissing, Pennsylvania, United States
Columbia Arthritis Center /ID# 153728
Columbia, South Carolina, United States
West Tennessee Research Inst /ID# 142739
Jackson, Tennessee, United States
Arthritis Associates, PLLC /ID# 142774
Kingsport, Tennessee, United States
Arthritis Associates, PLLC /ID# 155462
Kingsport, Tennessee, United States
Dr. Ramesh Gupta /ID# 142767
Memphis, Tennessee, United States
Tekton Research, Inc. /ID# 142805
Austin, Texas, United States
Diagnostic Group Integrated He /ID# 148340
Beaumont, Texas, United States
Arth and Osteo Clin Brazo Valley /ID# 148343
College Station, Texas, United States
Arthritis Care and Diagnostic /ID# 151344
Dallas, Texas, United States
Metroplex Clinical Research /ID# 142758
Dallas, Texas, United States
Rheumatic Disease Clin Res Ctr /ID# 150914
Houston, Texas, United States
Baylor College of Medicine /ID# 142753
Houston, Texas, United States
Rheumatology Clinic of Houston /ID# 150915
Houston, Texas, United States
Houston Institute for Clin Res /ID# 142768
Houston, Texas, United States
Pioneer Research Solutions, Inc. /ID# 151346
Houston, Texas, United States
Arthritis & Osteoporosis Assoc /ID# 147567
Lubbock, Texas, United States
P&I Clinical Research /ID# 151345
Lufkin, Texas, United States
SW Rheumatology Res. LLC /ID# 142813
Mesquite, Texas, United States
Trinity Universal Research Association /ID# 149278
Plano, Texas, United States
Arthritis & Osteo Ctr of S. TX /ID# 142773
San Antonio, Texas, United States
Arthritis Clinic of Central TX /ID# 148346
San Marcos, Texas, United States
DM Clinical Research /ID# 151007
Tomball, Texas, United States
Arthritis & Osteoporosis Clinic /ID# 142760
Waco, Texas, United States
Western Washington Arthritis C /ID# 142776
Bothell, Washington, United States
Arthritis Northwest, PLLC /ID# 150924
Spokane, Washington, United States
The Vancouver Clinic, INC. PS /ID# 147946
Vancouver, Washington, United States
West Virginia Research Inst /ID# 153087
South Charleston, West Virginia, United States
Aurora Rheumatology and Immunotherapy Center /ID# 142820
Franklin, Wisconsin, United States
The Queen Elizabeth Hospital /ID# 142419
Woodville, South Australia, Australia
Emeritus Research /ID# 142416
Camberwell, Victoria, Australia
Medizinische Universität Wien /ID# 142424
Vienna, Vienna, Austria
Universitaetsklinik fuer Inner /ID# 142423
Graz, , Austria
Rheuma Zentrum Favoriten GmbH /ID# 142421
Vienna, , Austria
Rheuma-Zentrum Wien-Oberlaa /ID# 142425
Vienna, , Austria
Wilhelminenspital der Stadt Wien /ID# 142422
Vienna, , Austria
Cliniques Universitaires Saint Luc /ID# 142426
Woluwe-Saint-Lambert, Brussels Capital, Belgium
Rhumaconsult SPRL /ID# 151378
Charleroi, Hainaut, Belgium
UZ Gent /ID# 142429
Ghent, Oost-Vlaanderen, Belgium
ReumaClinic Genk /ID# 142431
Genk, , Belgium
AZ Damiaan /ID# 142427
Ostend, , Belgium
Ciads /Id# 142526
Winnipeg, Manitoba, Canada
Revmatologie MUDr. Klara Sirova /ID# 142536
Ostrava, , Czechia
Medical Plus, s.r.o. /ID# 148345
Uherské Hradište, , Czechia
MediTrials /ID# 151777
Tartu, Tartu, Estonia
East Tallinn Central Hospital /ID# 142543
Tallinn, , Estonia
Kiljava Medical Research /ID# 142546
Hyvinkää, , Finland
Paijat-Hame Central Hospital /ID# 149185
Lahti, , Finland
CHR Orleans - Hopital de la Source /ID# 142557
Orléans, Centre-Val de Loire, France
Hopital Universitaire Purpan /ID# 144697
Toulouse, Haute-Garonne, France
Hopital Saint Eloi /ID# 142552
Montpellier, Herault, France
Centre Hospitalier Le Mans /ID# 145956
Le Mans, Sarthe, France
CHU Bordeaux-Hopital Pellegrin /ID# 144700
Bordeaux, , France
Centre Hospitalier Jean Rougie /ID# 142556
Cahors, , France
Hopital Edouard Herriot /ID# 144698
Lyon, , France
Uniklinik Koln /ID# 142563
Cologne, North Rhine-Westphalia, Germany
Rheumazentrum Ruhrgebiet /ID# 145600
Herne, North Rhine-Westphalia, Germany
Charité Universitätsmedizin Campus Mitte /ID# 142559
Berlin, , Germany
Rheumaforschungszentrum II /ID# 142560
Hamburg, , Germany
Schoen Klinikum Hamburg Eilbek /ID# 142566
Hamburg, , Germany
Asklepios Klinik Altona /ID# 142561
Hamburg, , Germany
LMU Klinikum der Universität München /ID# 142564
Munich, , Germany
MVZ Planegg /ID# 142565
Planegg, , Germany
Knappschaftsklinikum Saar /ID# 142562
Püttlingen, , Germany
General Hospital of Athens Laiko /ID# 142579
Athens, Attica, Greece
Vital Medical Center Orvosi es /ID# 142586
Veszprém, Veszprém megye, Hungary
Revita Reumatologiai Rendelo /ID# 142590
Budapest, , Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142587
Debrecen, , Hungary
Bekes Megyei Pandy Kalman Korh /ID# 142588
Gyula, , Hungary
St Vincent's University Hosp /ID# 142593
Dublin, , Ireland
Tel Aviv Sourasky Medical Ctr /ID# 142597
Tel Aviv, Tel Aviv, Israel
Bnai Zion Medical Center /ID# 151945
Haifa, , Israel
The Lady Davis Carmel MC /ID# 142599
Haifa, , Israel
LTD M+M Centers /ID# 142624
Ādaži, , Latvia
P. Stradins Clinical Univ Hosp /ID# 142623
Riga, , Latvia
Arthritis Clinic Ltd /ID# 153560
Riga, , Latvia
Timaru Medical Specialists Ltd /ID# 142657
Timaru, , New Zealand
Pratia MCM Krakow /ID# 142664
Krakow, Lesser Poland Voivodeship, Poland
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 142665
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Medyczne Pratia Warszawa /ID# 142667
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne AMED Warszawa Targowek /ID# 142663
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Pratia Gdynia /ID# 142666
Gdynia, Pomeranian Voivodeship, Poland
Centro Hospitalar De Vila Nova /ID# 142670
Vila Nova de Gaia, Porto District, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 142668
Lisbon, , Portugal
GCM Medical Group /ID# 142671
San Juan, , Puerto Rico
Family Outpatient clinic#4,LLC /ID# 150910
Korolev, Moscow, Russia
ARTROMAC n.o. /ID# 142692
Košice, , Slovakia
Nemocnica Kosice Saca, a.s. /ID# 142693
Košice, , Slovakia
Narodny ustav reumatickych chorob Piestany /ID# 142691
Pieštany, , Slovakia
Hanyang University Seoul Hospi /ID# 150883
Seoul, Seongdong-gu, South Korea
Inha University Hospital /ID# 150881
Incheon, , South Korea
Seoul National University Hospital /ID# 142622
Seoul, , South Korea
H. Un. Marques de Valdecilla /ID# 142706
Santander, Cantabria, Spain
Hospital Regional de Malaga /ID# 142707
Málaga, Malaga, Spain
Comple Hosp Univ de A Coruna /ID# 142708
A Coruña, , Spain
Hospital Clin Univ San Carlos /ID# 142711
Madrid, , Spain
Clinica Gaias /ID# 142709
Santiago de Compostela, , Spain
Hospital Universitario La Fe /ID# 142716
Valencia, , Spain
Sahlgrenska University Hosp /ID# 142720
Gothenburg, , Sweden
Capio Movement Halmstad /ID# 148236
Halmstad, , Sweden
Orebro Universitetssjukhuset /ID# 142718
Örebro, , Sweden
Vastmanlands Sjukhus /ID# 142721
Västerås, , Sweden
Universitaetsspital Basel /ID# 145610
Basel, , Switzerland
HFR Fribourg - Hopital Canton /ID# 142723
Fribourg, , Switzerland
Hacettepe University Medical Faculty /ID# 142729
Ankara, , Turkey (Türkiye)
Ankara Ataturk Training & Res /ID# 142727
Ankara, , Turkey (Türkiye)
Ondokuz mayis University Facul /ID# 142728
Samsun, , Turkey (Türkiye)
Whipps Cross Univ Hospital /ID# 145957
London, London, City of, United Kingdom
The Royal Free Hospital /ID# 142733
London, London, City of, United Kingdom
Mid Essex Hospitals NHS Trust /ID# 148992
Chelmsford, , United Kingdom
Western General Hospital /ID# 142732
Edinburgh, , United Kingdom
West Suffolk Hospital /ID# 148993
Ipswich, , United Kingdom
Arrowe Park Hospital /ID# 148991
Metropolitan Borough of Wirral, , United Kingdom
Queen Alexandra Hospital /ID# 142735
Portsmouth, , United Kingdom
Countries
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References
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Genovese MC, Fleischmann R, Combe B, Hall S, Rubbert-Roth A, Zhang Y, Zhou Y, Mohamed MF, Meerwein S, Pangan AL. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140-6736(18)31116-4. Epub 2018 Jun 18.
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.
van Vollenhoven RF, Hall S, Wells AF, Meerwein S, Song Y, Tanjinatus O, Fleischmann R. Long-term sustainability of response to upadacitinib among patients with active rheumatoid arthritis refractory to biological treatments: results up to 5 years from SELECT-BEYOND. RMD Open. 2024 Jul 24;10(3):e004037. doi: 10.1136/rmdopen-2023-004037.
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.
Fleischmann 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.
Conaghan 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.
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.
Kakehasi 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.
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.
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
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Related Info.
Other Identifiers
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2015-003335-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M13-542
Identifier Type: -
Identifier Source: org_study_id
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