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
SELECT-BEYOND
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)
2 other identifiers
interventional
499
25 countries
184
Brief Summary
The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 rheumatoid-arthritis
Started Mar 2016
Longer than P75 for phase_3 rheumatoid-arthritis
184 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
February 18, 2016
CompletedFirst Posted
Study publicly available on registry
March 11, 2016
CompletedStudy Start
First participant enrolled
March 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2017
CompletedResults Posted
Study results publicly available
October 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2022
CompletedFebruary 8, 2023
January 1, 2023
1.1 years
February 18, 2016
September 13, 2019
January 12, 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 mm), 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 (6)
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 Score (PCS) at Week 12
Baseline and Week 12
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Baseline and Week 12
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Baseline and Week 12
- +1 more secondary outcomes
Study Arms (4)
Upadacitinib 15 mg
EXPERIMENTALPeriod 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 30 mg
EXPERIMENTALPeriod 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.
Placebo / Upadacitnib 15 mg
PLACEBO COMPARATORPeriod 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 / Upadacitnib 30 mg
PLACEBO COMPARATORPeriod 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.
Interventions
Tablet; Oral
Eligibility Criteria
You may qualify if:
- Diagnosis of rheumatoid arthritis (RA) for≥ 3 months.
- 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.
You may not qualify if:
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (188)
Rheum Assoc of North Alabama /ID# 145959
Huntsville, Alabama, 35801, United States
AZ Arthritis and Rheum Assoc /ID# 148593
Mesa, Arizona, 85202, United States
AZ Arthritis and Rheum Researc /ID# 142816
Phoenix, Arizona, 85032-9306, United States
AZ Arthritis and Rheum Researc /ID# 146075
Phoenix, Arizona, 85032-9306, United States
AZ Arthritis and Rheum Researc /ID# 148592
Phoenix, Arizona, 85032-9306, United States
Arizona Research Center, Inc. /ID# 142741
Phoenix, Arizona, 85053-4061, United States
AZ Arthr & Rheum Research /ID# 155256
Prescott, Arizona, 86305, United States
AZ Arthritis & Rheum Research /ID# 156090
Sun City, Arizona, 85351, United States
NEA Baptist Clinic /ID# 149280
Jonesboro, Arkansas, 72401, United States
Covina Arthritis Clinic /ID# 142794
Covina, California, 91722, United States
Rheumatology Ctr of San Diego /ID# 153576
Escondido, California, 92025, United States
St. Joseph Heritage Healthcare /ID# 149273
Fullerton, California, 92835, United States
TriWest Research Associates- La Mesa /ID# 142792
La Mesa, California, 91942, United States
Arthritis & Osteo Medical Ctr /ID# 142770
La Palma, California, 90623-1728, United States
Valerius Med Grp & Res Ctr /ID# 142799
Los Alamitos, California, 90720-5402, United States
Pacific Arthritis Ctr Med Grp /ID# 142783
Los Angeles, California, 90045, United States
University of California, Los Angeles /ID# 148348
Los Angeles, California, 90095, United States
Desert Medical Advances /ID# 142765
Palm Desert, California, 92260, United States
Stanford University School of Med /ID# 142761
Stanford, California, 94305-2200, United States
Robin K. Dore MD, Inc /ID# 150908
Tustin, California, 92780, United States
Inland Rheum Clin Trials Inc. /ID# 142787
Upland, California, 91786, United States
Medvin Clinical Research /ID# 142814
Whittier, California, 90606, United States
Arthritis Assoc & Osteo Ctr /ID# 142809
Colorado Springs, Colorado, 80920, United States
Denver Arthritis Clinic /ID# 142771
Denver, Colorado, 80230, United States
New England Research Associates, LLC /ID# 142763
Bridgeport, Connecticut, 06606-1827, United States
Delaware Arthritis /ID# 142803
Lewes, Delaware, 19958, United States
Lakes Research, LLC /ID# 142755
Miami, Florida, 33014, United States
Medallion Clinical Research Institute, LLC /ID# 142740
Naples, Florida, 34102, United States
Omega Research Consultants /ID# 142780
Orlando, Florida, 32810, United States
Millennium Research /ID# 142782
Ormond Beach, Florida, 32174, United States
Arthritis Research of Florida /ID# 142811
Palm Harbor, Florida, 34684-2672, United States
Arthritis Center, Inc. /ID# 142822
Palm Harbor, Florida, 34684, United States
Advent Clinical Research /ID# 142817
Pinellas Park, Florida, 33781, United States
St. Anthony Comprehsve Res Ins /ID# 148349
St. Petersburg, Florida, 33705, United States
University of South Florida /ID# 145611
Tampa, Florida, 33612, United States
BayCare Medical Group, Inc. /ID# 142747
Tampa, Florida, 33614-7101, United States
Lovelace Scientific Resources /ID# 142779
Venice, Florida, 34292, United States
Jefrey D. Lieberman, MD, P.C. /ID# 151713
Decatur, Georgia, 30033, United States
Marietta Rheumatology Assoc /ID# 151347
Marietta, Georgia, 30060, United States
St. Luke's Clinic - Rheumatolo /ID# 150923
Boise, Idaho, 83702, United States
Institute of Arthritis Res /ID# 142810
Idaho Falls, Idaho, 83404, United States
Advanced Clinical Research /ID# 153089
Meridian, Idaho, 83642, United States
Great Lakes Clinical Trials /ID# 148341
Chicago, Illinois, 60640, United States
Clinical Investigation Special /ID# 149270
Skokie, Illinois, 60076, United States
Springfield Clinic /ID# 142818
Springfield, Illinois, 62702-3749, United States
Deerbrook Medical Associates /ID# 151712
Vernon Hills, Illinois, 60061, United States
The Arthritis & Diabetes Clinic, Inc. /ID# 142793
Monroe, Louisiana, 71203, United States
Vanguard Medical Research, LLC /ID# 153123
Shreveport, Louisiana, 71011, United States
MMP Women's Health /ID# 145612
Portland, Maine, 04102, United States
The Center for Rheumatology & /ID# 142742
Wheaton, Maryland, 20902, United States
Mansfield Health Center /ID# 147628
Mansfield, Massachusetts, 02048, United States
Clinical Pharmacology Study Gr /ID# 142744
Worcester, Massachusetts, 01605, United States
June DO, PC /ID# 142756
Lansing, Michigan, 48910, United States
North Mississippi Med Clinics /ID# 142781
Tupelo, Mississippi, 38801, United States
Clayton Medical Associates dba Saint Louis Rheumatology /ID# 142745
St Louis, Missouri, 63119-3845, United States
Barbara Caciolo, MD /ID# 142749
St Louis, Missouri, 63139-2338, United States
Westroads Clinical Research /ID# 142802
Omaha, Nebraska, 68114, United States
Dartmouth-Hitchcock Medical Center /ID# 145958
Lebanon, New Hampshire, 03756, United States
Atlantic Coast Research /ID# 148347
Toms River, New Jersey, 08755, United States
Ocean Rheumatology, PA /ID# 142785
Toms River, New Jersey, 08755, United States
The Center for Rheumatology /ID# 142784
Albany, New York, 12206, United States
North Shore University Hospital /ID# 142772
New Hyde Park, New York, 11040, United States
Buffalo Rheumatology /ID# 142766
Orchard Park, New York, 14127, United States
Joint & Muscle Research Instit /ID# 142797
Charlotte, North Carolina, 28204, United States
DJL Clinical Research, PLLC /ID# 142769
Charlotte, North Carolina, 28210-8508, United States
Cape Fear Arthritis Care /ID# 148344
Leland, North Carolina, 28451, United States
Coastal Carolina Health Care /ID# 148351
New Bern, North Carolina, 28562, United States
Shanahan Rheuma & Immuno /ID# 142812
Raleigh, North Carolina, 27617, United States
Trinity Health Med Arts Clinic /ID# 142754
Minot, North Dakota, 58701, United States
Cincinnati Rheumatic Disease Study Group, Inc. /ID# 142791
Cincinnati, Ohio, 45242-4468, United States
STAT Research, Inc. /ID# 142821
Vandalia, Ohio, 45377-9464, United States
Health Research Oklahoma /ID# 142751
Oklahoma City, Oklahoma, 73103-2400, United States
Healthcare Research Consultant /ID# 142815
Tulsa, Oklahoma, 74135, United States
East Penn Rheumatology Assoc /ID# 142790
Bethlehem, Pennsylvania, 18015, United States
Clinical Research Ctr Reading /ID# 151714
Wyomissing, Pennsylvania, 19610, United States
Columbia Arthritis Center /ID# 153728
Columbia, South Carolina, 29204, United States
West Tennessee Research Inst /ID# 142739
Jackson, Tennessee, 38305, United States
Arthritis Associates, PLLC /ID# 142774
Kingsport, Tennessee, 37660, United States
Arthritis Associates, PLLC /ID# 155462
Kingsport, Tennessee, 37660, United States
Dr. Ramesh Gupta /ID# 142767
Memphis, Tennessee, 38119, United States
Tekton Research, Inc. /ID# 142805
Austin, Texas, 78745, United States
Diagnostic Group Integrated He /ID# 148340
Beaumont, Texas, 77701, United States
Arth and Osteo Clin Brazo Valley /ID# 148343
College Station, Texas, 77845, United States
Arthritis Care and Diagnostic /ID# 151344
Dallas, Texas, 75231, United States
Metroplex Clinical Research /ID# 142758
Dallas, Texas, 75231, United States
Rheumatic Disease Clin Res Ctr /ID# 150914
Houston, Texas, 77004, United States
Baylor College of Medicine /ID# 142753
Houston, Texas, 77030-3411, United States
Rheumatology Clinic of Houston /ID# 150915
Houston, Texas, 77065, United States
Houston Institute for Clin Res /ID# 142768
Houston, Texas, 77074, United States
Pioneer Research Solutions, Inc. /ID# 151346
Houston, Texas, 77098-5294, United States
Arthritis & Osteoporosis Assoc /ID# 147567
Lubbock, Texas, 79424, United States
P&I Clinical Research /ID# 151345
Lufkin, Texas, 75904-3132, United States
SW Rheumatology Res. LLC /ID# 142813
Mesquite, Texas, 75150, United States
Trinity Universal Research Association /ID# 149278
Plano, Texas, 75024-5283, United States
Arthritis & Osteo Ctr of S. TX /ID# 142773
San Antonio, Texas, 78232, United States
Arthritis Clinic of Central TX /ID# 148346
San Marcos, Texas, 78666, United States
DM Clinical Research /ID# 151007
Tomball, Texas, 77375, United States
Arthritis & Osteoporosis Clinic /ID# 142760
Waco, Texas, 76710, United States
Western Washington Arthritis C /ID# 142776
Bothell, Washington, 98021, United States
Arthritis Northwest, PLLC /ID# 150924
Spokane, Washington, 99204, United States
The Vancouver Clinic, INC. PS /ID# 147946
Vancouver, Washington, 98664, United States
West Virginia Research Inst /ID# 153087
South Charleston, West Virginia, 25309, United States
Aurora Rheumatology and Immunotherapy Center /ID# 142820
Franklin, Wisconsin, 53132, United States
The Queen Elizabeth Hospital /ID# 142419
Woodville, South Australia, 5011, Australia
Emeritus Research /ID# 142416
Camberwell, Victoria, 3124, Australia
Medizinische Universität Wien /ID# 142424
Vienna, Vienna, 1090, Austria
Universitaetsklinik fuer Inner /ID# 142423
Graz, 8036, Austria
Rheuma Zentrum Favoriten GmbH /ID# 142421
Vienna, 1100, Austria
Rheuma-Zentrum Wien-Oberlaa /ID# 142425
Vienna, 1100, Austria
Wilhelminenspital der Stadt Wien /ID# 142422
Vienna, 1160, Austria
Cliniques Universitaires Saint Luc /ID# 142426
Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium
Rhumaconsult SPRL /ID# 151378
Charleroi, Hainaut, 6000, Belgium
UZ Gent /ID# 142429
Ghent, Oost-Vlaanderen, 9000, Belgium
ReumaClinic Genk /ID# 142431
Genk, 3600, Belgium
AZ Damiaan /ID# 142427
Ostend, 8400, Belgium
Ciads /Id# 142526
Winnipeg, Manitoba, R3N 0K6, Canada
Revmatologie MUDr. Klara Sirova /ID# 142536
Ostrava, 702 00, Czechia
Medical Plus, s.r.o. /ID# 148345
Uherské Hradište, 686 01, Czechia
MediTrials /ID# 151777
Tartu, Tartu, 50406, Estonia
East Tallinn Central Hospital /ID# 142543
Tallinn, 10138, Estonia
Kiljava Medical Research /ID# 142546
Hyvinkää, 05800, Finland
Paijat-Hame Central Hospital /ID# 149185
Lahti, 15850, Finland
CHR Orleans - Hopital de la Source /ID# 142557
Orléans, Centre-Val de Loire, 45067, France
Hopital Universitaire Purpan /ID# 144697
Toulouse, Haute-Garonne, 31059, France
Hopital Saint Eloi /ID# 142552
Montpellier, Herault, 34295, France
Centre Hospitalier Le Mans /ID# 145956
Le Mans, Sarthe, 72037, France
CHU Bordeaux-Hopital Pellegrin /ID# 144700
Bordeaux, 33076, France
Centre Hospitalier Jean Rougie /ID# 142556
Cahors, 46005, France
Hopital Edouard Herriot /ID# 144698
Lyon, 69437, France
Uniklinik Koln /ID# 142563
Cologne, North Rhine-Westphalia, 50937, Germany
Rheumazentrum Ruhrgebiet /ID# 145600
Herne, North Rhine-Westphalia, 44649, Germany
Charité Universitätsmedizin Campus Mitte /ID# 142559
Berlin, 10117, Germany
Rheumaforschungszentrum II /ID# 142560
Hamburg, 20095, Germany
Schoen Klinikum Hamburg Eilbek /ID# 142566
Hamburg, 22081, Germany
Asklepios Klinik Altona /ID# 142561
Hamburg, 22763, Germany
LMU Klinikum der Universität München /ID# 142564
Munich, 80337, Germany
MVZ Planegg /ID# 142565
Planegg, 82152, Germany
Knappschaftsklinikum Saar /ID# 142562
Püttlingen, 66346, Germany
General Hospital of Athens Laiko /ID# 142579
Athens, Attica, 115 27, Greece
Vital Medical Center Orvosi es /ID# 142586
Veszprém, Veszprém megye, 8200, Hungary
Revita Reumatologiai Rendelo /ID# 142590
Budapest, 1027, Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142587
Debrecen, 4031, Hungary
Bekes Megyei Pandy Kalman Korh /ID# 142588
Gyula, 5700, Hungary
St Vincent's University Hosp /ID# 142593
Dublin, D04 T6F4, Ireland
Tel Aviv Sourasky Medical Ctr /ID# 142597
Tel Aviv, Tel Aviv, 6423906, Israel
Bnai Zion Medical Center /ID# 151945
Haifa, 3339419, Israel
The Lady Davis Carmel MC /ID# 142599
Haifa, 3436212, Israel
LTD M+M Centers /ID# 142624
Ādaži, 2164, Latvia
P. Stradins Clinical Univ Hosp /ID# 142623
Riga, LV-1002, Latvia
Arthritis Clinic Ltd /ID# 153560
Riga, LV-1050, Latvia
Timaru Medical Specialists Ltd /ID# 142657
Timaru, 7910, New Zealand
Pratia MCM Krakow /ID# 142664
Krakow, Lesser Poland Voivodeship, 30-510, Poland
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 142665
Wroclaw, Lower Silesian Voivodeship, 51-685, Poland
Centrum Medyczne Pratia Warszawa /ID# 142667
Warsaw, Masovian Voivodeship, 01-869, Poland
Centrum Medyczne AMED Warszawa Targowek /ID# 142663
Warsaw, Masovian Voivodeship, 03-291, Poland
Centrum Medyczne Pratia Gdynia /ID# 142666
Gdynia, Pomeranian Voivodeship, 81-338, Poland
Centro Hospitalar De Vila Nova /ID# 142670
Vila Nova de Gaia, Porto District, 4434-502, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 142668
Lisbon, 1649-035, Portugal
GCM Medical Group /ID# 142671
San Juan, 00909, Puerto Rico
Family Outpatient clinic#4,LLC /ID# 150910
Korolev, Moscow, 141060, Russia
ARTROMAC n.o. /ID# 142692
Košice, 040 11, Slovakia
Nemocnica Kosice Saca, a.s. /ID# 142693
Košice, 040 15, Slovakia
Narodny ustav reumatickych chorob Piestany /ID# 142691
Pieštany, 921 12, Slovakia
Hanyang University Seoul Hospi /ID# 150883
Seoul, Seongdong-gu, 04763, South Korea
Inha University Hospital /ID# 150881
Incheon, 22332, South Korea
Seoul National University Hospital /ID# 142622
Seoul, 03080, South Korea
H. Un. Marques de Valdecilla /ID# 142706
Santander, Cantabria, 39008, Spain
Hospital Regional de Malaga /ID# 142707
Málaga, Malaga, 29009, Spain
Comple Hosp Univ de A Coruna /ID# 142708
A Coruña, 15006, Spain
Hospital Clin Univ San Carlos /ID# 142711
Madrid, 28040, Spain
Clinica Gaias /ID# 142709
Santiago de Compostela, 15702, Spain
Hospital Universitario La Fe /ID# 142716
Valencia, 46026, Spain
Sahlgrenska University Hosp /ID# 142720
Gothenburg, 413 45, Sweden
Capio Movement Halmstad /ID# 148236
Halmstad, 302 33, Sweden
Orebro Universitetssjukhuset /ID# 142718
Örebro, 70185, Sweden
Vastmanlands Sjukhus /ID# 142721
Västerås, 72189, Sweden
Universitaetsspital Basel /ID# 145610
Basel, 4031, Switzerland
HFR Fribourg - Hopital Canton /ID# 142723
Fribourg, 1708, Switzerland
Hacettepe University Medical Faculty /ID# 142729
Ankara, 06100, Turkey (Türkiye)
Ankara Ataturk Training & Res /ID# 142727
Ankara, 06800, Turkey (Türkiye)
Ondokuz mayis University Facul /ID# 142728
Samsun, 55139, Turkey (Türkiye)
Whipps Cross Univ Hospital /ID# 145957
London, London, City of, E11 1NR, United Kingdom
The Royal Free Hospital /ID# 142733
London, London, City of, NW3 2QG, United Kingdom
Mid Essex Hospitals NHS Trust /ID# 148992
Chelmsford, CM1 7ET, United Kingdom
Western General Hospital /ID# 142732
Edinburgh, EH4 2XU, United Kingdom
West Suffolk Hospital /ID# 148993
Ipswich, IP33 2QZ, United Kingdom
Arrowe Park Hospital /ID# 148991
Metropolitan Borough of Wirral, CH49 5PE, United Kingdom
Queen Alexandra Hospital /ID# 142735
Portsmouth, PO6 3LY, United Kingdom
Related Publications (14)
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.
PMID: 29908670BACKGROUNDBurmester 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: 40875187DERIVEDvan 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.
PMID: 39053948DERIVEDRubbert-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: 36125701DERIVEDYamaoka 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.
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PMID: 33115760DERIVEDStrand V, Schiff M, Tundia N, Friedman A, Meerwein S, Pangan A, Ganguli A, Fuldeore M, Song Y, Pope J. Effects of upadacitinib on patient-reported outcomes: results from SELECT-BEYOND, a phase 3 randomized trial in patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs. Arthritis Res Ther. 2019 Dec 2;21(1):263. doi: 10.1186/s13075-019-2059-8.
PMID: 31791386DERIVEDNader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.
PMID: 31610021DERIVED
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
February 18, 2016
First Posted
March 11, 2016
Study Start
March 15, 2016
Primary Completion
April 3, 2017
Study Completion
February 8, 2022
Last Updated
February 8, 2023
Results First Posted
October 7, 2019
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- For details on when studies are available for sharing, please refer to the link below.
- 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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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 and 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.