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
NCT ID: NCT02675426
Last Updated: 2023-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
661 participants
INTERVENTIONAL
2015-12-17
2022-03-10
Brief Summary
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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
NCT02706847
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 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
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 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
Detailed Description
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Period 2 is a 248-week blinded long-term extension period to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 30 mg once daily and upadacitinib 15 mg once daily in participants who completed Period 1.
Participants were to be randomized in a 2:2:1:1 ratio using interactive response technology (IRT) to receive double-blind study drug in one of the following treatment groups:
* Group 1: Upadacitinib 30 mg QD in Period 1 → Upadacitinib 30 mg QD in Period 2
* Group 2: Upadacitinib 15 mg QD in Period 1 → Upadacitinib 15 mg QD in Period 2
* Group 3: Placebo in Period 1 → Upadacitinib 30 mg QD in Period 2
* Group 4: Placebo in Period 1 → Upadacitinib 15 mg QD in Period 2
Randomization was stratified by prior exposure to biological disease-modifying anti-rheumatic drug (bDMARD) (yes/no) and geographic region.
Following Protocol Amendment 6.0 approval in December 2019, all participants still on study received open-label upadacitinib 15 mg QD, including those on upadacitinib 30 mg QD, with the earliest switch occurring at the Week 168 visit.
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 12 weeks.
Period 2: Participants continue to receive upadacitinib 15 mg once daily for an additional 248 weeks.
Upadacitinib
Tablet; Oral
Upadacitinib 30 mg
Period 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.
Upadacitinib
Tablet; Oral
Placebo / Upadacitinib 15 mg
Period 1: Participants receive placebo once daily for 12 weeks.
Period 2: Participants receive upadacitinib 15 mg once daily for 248 weeks.
Placebo
Tablet; Oral
Upadacitinib
Tablet; Oral
Placebo / Upadacitinib 30 mg
Period 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.
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
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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AZ Arthritis and Rheum Assoc /ID# 148651
Mesa, Arizona, United States
SunValley Arthritis Center, Lt /ID# 140452
Peoria, Arizona, United States
AZ Arthritis and Rheum Researc /ID# 138500
Phoenix, Arizona, United States
AZ Arthritis and Rheum Researc /ID# 139286
Phoenix, Arizona, United States
AZ Arthritis & Rheuma Research /ID# 138598
Phoenix, Arizona, United States
Arizona Research Center, Inc. /ID# 140448
Phoenix, Arizona, United States
University of Arizona Cancer Center - North Campus /ID# 140451
Tucson, Arizona, United States
Covina Arthritis Clinic /ID# 139881
Covina, California, United States
T. Joseph Raoof, MD, Inc. /ID# 140964
Encino, California, United States
Allergy and Rheum Med Clin /ID# 146082
La Jolla, California, United States
Pacific Arthritis Ctr Med Grp /ID# 138744
Los Angeles, California, United States
Robin K. Dore MD, Inc /ID# 138688
Tustin, California, United States
Inland Rheum Clin Trials Inc. /ID# 138853
Upland, California, United States
Denver Arthritis Clinic /ID# 139876
Denver, Colorado, United States
Clinical Res of West FL, Inc. /ID# 138854
Clearwater, Florida, United States
Ctr Arthritis & Rheumatic Dise /ID# 141696
Miami, Florida, United States
Medallion Clinical Research Institute, LLC /ID# 140074
Naples, Florida, United States
Suncoast Clinical Research /ID# 138633
New Port Richey, Florida, United States
Omega Research Consultants /ID# 139877
Orlando, Florida, United States
Arthritis Center, Inc. /ID# 141363
Palm Harbor, Florida, United States
Institute of Arthritis Res /ID# 138548
Idaho Falls, Idaho, United States
OrthoIllinois /ID# 139695
Rockford, Illinois, United States
Clinical Investigation Special /ID# 139696
Skokie, Illinois, United States
Springfield Clinic /ID# 138602
Springfield, Illinois, United States
Deerbrook Medical Associates /ID# 139694
Vernon Hills, Illinois, United States
Indiana Univ School of Med /ID# 140077
Indianapolis, Indiana, United States
Bluegrass Community Research /ID# 138295
Lexington, Kentucky, United States
Four Rivers Clinical Research /ID# 141134
Paducah, Kentucky, United States
MMP Women's Health /ID# 141542
Portland, Maine, United States
The Center for Rheumatology & /ID# 139203
Wheaton, Maryland, United States
Mansfield Health Center /ID# 141357
Mansfield, Massachusetts, United States
Advanced Rheumatology, PC /ID# 140071
Lansing, Michigan, United States
Justus J. Fiechtner, MD, PC /ID# 138697
Lansing, Michigan, United States
Physician Res. Collaboration /ID# 138533
Lincoln, Nebraska, United States
Westroads Clinical Research /ID# 138304
Omaha, Nebraska, United States
The Center for Rheumatology /ID# 138746
Albany, New York, United States
PMG Research of Salisbury /ID# 141023
Salisbury, North Carolina, United States
PMG Research of Wilmington LLC /ID# 140951
Wilmington, North Carolina, United States
Cincinnati Rheumatic Disease Study Group, Inc. /ID# 138868
Cincinnati, Ohio, United States
Arthritis Assoc of NW Ohio /ID# 140953
Toledo, Ohio, United States
Health Research Oklahoma /ID# 138535
Oklahoma City, Oklahoma, United States
Altoona Ctr Clinical Res /ID# 138741
Duncansville, Pennsylvania, United States
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 138689
Summerville, South Carolina, United States
Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 141021
Hendersonville, Tennessee, United States
Tekton Research, Inc. /ID# 141428
Austin, Texas, United States
Trinity Universal Res Assoc /ID# 149271
Carrollton, Texas, United States
Arth and Osteo Clin Brazo Valley /ID# 147809
College Station, Texas, United States
Metroplex Clinical Research /ID# 138698
Dallas, Texas, United States
Baylor College of Medicine /ID# 138682
Houston, Texas, United States
Houston Institute for Clin Res /ID# 138716
Houston, Texas, United States
Arthritis Consultants, P.A. /ID# 141138
Killeen, Texas, United States
Trinity Universal Research Association /ID# 148649
Plano, Texas, United States
Accurate Clinical Management /ID# 139338
San Antonio, Texas, United States
Arthritis & Osteoporosis Clinic /ID# 138703
Waco, Texas, United States
Western Washington Arthritis C /ID# 138728
Bothell, Washington, United States
Arthritis Northwest, PLLC /ID# 138539
Spokane, Washington, United States
Aurora Rheumatology and Immunotherapy Center /ID# 139306
Franklin, Wisconsin, United States
Mautalen Salud e Investigacion /ID# 141419
Buenos Aires, , Argentina
Inst. Rheumatologic Strusberg /ID# 145648
Córdoba, , Argentina
Coffs Clinical Trials /ID# 138747
Coffs Harbour, New South Wales, Australia
Optimus Clinical Research Pty. /ID# 138769
Kogarah, New South Wales, Australia
Emeritus Research /ID# 138773
Camberwell, Victoria, Australia
Barwon Rheumatology /ID# 138772
Geelong, Victoria, Australia
Rheuma Zentrum Favoriten GmbH /ID# 138787
Vienna, , Austria
Wilhelminenspital der Stadt Wien /ID# 138788
Vienna, , Austria
Rhumaconsult SPRL /ID# 138813
Charleroi, Hainaut, Belgium
UZ Gent /ID# 138806
Ghent, Oost-Vlaanderen, Belgium
AZ Sint Lucas /ID# 141338
Bruges, , Belgium
University Clinical Centre of the Republic of Srpska /ID# 138819
Banja Luka, Republika Srpska, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 140372
Banja Luka, Republika Srpska, Bosnia and Herzegovina
Diag Consult Ctr 17 Sofia EOOD /ID# 141006
Sofia, , Bulgaria
Diagnostic Consultative Center /ID# 138882
Sofia, , Bulgaria
Manitoba Clinic /ID# 139086
Winnipeg, Manitoba, Canada
Eastern Health /ID# 140431
St. John's, Newfoundland and Labrador, Canada
Groupe de Recherche en Maladies Osseuses /ID# 138906
Sainte-Foy, Quebec, Canada
Dr. Latha Naik /ID# 139089
Saskatoon, Saskatchewan, Canada
Klinicki bolnicki centar Rijeka /ID# 138649
Rijeka, Primorje-Gorski Kotar County, Croatia
Klinicka bolnica Sveti Duh /ID# 152812
Zagreb, , Croatia
Medical Center Kuna-Peric /ID# 140365
Zagreb, , Croatia
Poliklinika Bonifarm /ID# 141415
Zagreb, , Croatia
L.K.N. Arthrocentrum, s.r.o /ID# 141340
Hlučín, Moravskoslezský kraj, Czechia
Revmatologie, s.r.o. /ID# 138899
Brno, , Czechia
Artroscan s.r.o. /ID# 138833
Ostrava, , Czechia
Nemocnice Slany /ID# 141112
Slaný, , Czechia
PV-MEDICAL s.r.o. /ID# 138913
Zlín, , Czechia
Center of Clinical and Basic Research /ID# 141116
Tallinn, Harju, Estonia
Paernu Hospital /ID# 138961
Pärnu, , Estonia
East Tallinn Central Hospital /ID# 140618
Tallinn, , Estonia
Helsinki Univ Central Hospital /ID# 140381
Helsinki, , Finland
Kiljava Medical Research /ID# 139260
Hyvinkää, , Finland
South Karelia Central Hospital /ID# 139973
Lappeenranta, , Finland
Hopital Saint Joseph /ID# 149188
Marseille, Bouches-du-Rhone, France
CHRU Tours - Hopital Trousseau /ID# 138969
Chambray-lès-Tours, , France
Uniklinik Koln /ID# 139084
Cologne, North Rhine-Westphalia, Germany
Charité Universitätsmedizin Campus Mitte /ID# 139052
Berlin, , Germany
Immanuel-Krankenhaus /ID# 139059
Berlin, , Germany
Asklepios Klinik Altona /ID# 140466
Hamburg, , Germany
Welcker, Planegg, DE /ID# 140467
Planegg, , Germany
University General Hospital of Heraklion "PA.G.N.I" /ID# 139115
Heraklion, , Greece
Prince of Wales Hospital /ID# 139314
Shatin, , Hong Kong
Revita Reumatologiai Rendelo /ID# 140761
Budapest, , Hungary
Fejer Megyei Szent Gyorgy Korh /ID# 138554
Székesfehérvár, , Hungary
St Vincent's University Hosp /ID# 138562
Dublin, , Ireland
Universita di Catanzaro Magna Graecia /ID# 139316
Catanzaro, Calabria, Italy
JSC Nat Scientific Med Res Ctr /ID# 140575
Astana, , Kazakhstan
LTD M+M Centers /ID# 138818
Ādaži, , Latvia
Klaipeda University Hospital /ID# 141416
Klaipėda, , Lithuania
Vilnius University Hospital /ID# 141348
Vilnius, , Lithuania
Centro Peninsular de Investigación Clínica SCP /ID# 148160
Colonia Centro, Yucatán, Mexico
Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 138841
Mexico City, , Mexico
Porter Rheumatology Ltd /ID# 138347
Nelson, , New Zealand
NZOZ Nasz Lekarz /ID# 138374
Torun, Kuyavian-Pomeranian Voivodeship, Poland
McBk Sc /Id# 138360
Grodzisk Mazowiecki, Masovian Voivodeship, Poland
Osteo-Medic spolka cywilna /ID# 138371
Bialystok, Podlaskie Voivodeship, Poland
NZOZ Centrum Reumatologiczne /ID# 138353
Elblag, Warmian-Masurian Voivodeship, Poland
Rheuma Medicus /ID# 138372
Warsaw, , Poland
Instituto Portugues De Reumatologia /ID# 148315
Lisbon, Lisbon District, Portugal
Centro Hospitalar Lisboa Ocidental, EPE /ID# 140594
Lisbon, Lisbon District, Portugal
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139328
San Juan, , Puerto Rico
Spitalul Clinic Judetean de Urgenta /ID# 138407
Cluj-Napoca, , Romania
Spitalul Municipal Ploiesti /ID# 138405
Ploieşti, , Romania
Spitalul Clinic Judetean de Ur /ID# 138393
Sibiu, , Romania
LLC Novaya Klinika /ID# 139269
Pyatigorsk, Stavropol Kray, Russia
Kazan State Medical University /ID# 138413
Kazan', Tatarstan, Respublika, Russia
Republican Clin Hos n.a. Baran /ID# 139273
Petrozavodsk, , Russia
Samara Regional Clinical Hosp /ID# 148642
Samara, , Russia
Ulyanovsk Regional Clin Hosp /ID# 139279
Ulyanovsk, , Russia
Voronezh State Medical Univers /ID# 148431
Voronezh, , Russia
Yaroslavi State Medical Univer /ID# 139908
Yaroslavl, , Russia
ARTROMAC n.o. /ID# 138428
Košice, , Slovakia
Nemocnica Kosice Saca, a.s. /ID# 138918
Košice, , Slovakia
Slovak research center Team Member, Thermium s.r.o. /ID# 139924
Pieštany, , Slovakia
Narodny ustav reumatickych chorob Piestany /ID# 138427
Pieštany, , Slovakia
REUMA-GLOBAL, s.r.o. /ID# 139912
Trnava, , Slovakia
St. Augustine's Medical Centre /ID# 141352
Berea, KwaZulu-Natal, South Africa
Arthritis Clinical Research Tr /ID# 138945
Cape Town, Western Cape, South Africa
Winelands Medical Research Ctr /ID# 138944
Stellenbosch, Western Cape, South Africa
Inha University Hospital /ID# 149310
Incheon, Gwang Yeogsi, South Korea
Ajou University Hospital /ID# 149311
Suwon, Gyeonggido, South Korea
Chonnam National University Hospital /ID# 138651
Gwangju, Jeonranamdo, South Korea
Hanyang University Seoul Hospi /ID# 138655
Seoul, Seongdong-gu, South Korea
Cath Univ Seoul St Mary's Hosp /ID# 138652
Seoul, Seoul Teugbyeolsi, South Korea
Daegu Catholic University Med /ID# 139249
Daegu, , South Korea
Chungnam National University Hospital /ID# 138653
Daejeon, , South Korea
Seoul National University Hospital /ID# 138659
Seoul, , South Korea
Asan Medical Center /ID# 140579
Seoul, , South Korea
Hospital Regional de Malaga /ID# 138975
Málaga, Malaga, Spain
Hospital General Univ de Elche /ID# 138991
Elche, , Spain
Hospital Clin Univ San Carlos /ID# 138993
Madrid, , Spain
Hosp Nuestra Senora Esperanza /ID# 138997
Santiago de Compostela, , Spain
HFR Fribourg - Hopital Canton /ID# 139155
Fribourg, , Switzerland
China Medical University Hosp /ID# 139232
Taichung, Taichung, Taiwan
National Cheng Kung University Hospital /ID# 140868
Tainan City, Tainan, Taiwan
National Taiwan Univ Hosp /ID# 141443
Taipei City, Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 140869
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital /ID# 140871
New Taipei City, , Taiwan
Taipei Veterans General Hosp /ID# 139234
Taipei, , Taiwan
Ankara Numune Training and Res /ID# 139237
Ankara, , Turkey (Türkiye)
LLC Revmocentr /ID# 139872
Kyiv, , Ukraine
MNCE "Lviv City Clinical Hospital #4" /ID# 139873
Lviv, , Ukraine
Odessa National Medical Univ /ID# 139179
Odesa, , Ukraine
Leicester Royal Infirmary /ID# 139184
Leicester, England, United Kingdom
Whipps Cross Univ Hospital /ID# 139523
London, London, City of, United Kingdom
The Royal Free Hospital /ID# 139191
London, London, City of, United Kingdom
Western General Hospital /ID# 139524
Edinburgh, , United Kingdom
Southampton General Hospital /ID# 139169
Southampton, , United Kingdom
Warrington + Halton Hosp NHS /ID# 139195
Warrington, , United Kingdom
Countries
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References
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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.
Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.
Burmester GR, 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.
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.
Bergman 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.
Yamaoka 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.
Cohen 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.
Strand V, Pope J, Tundia N, Friedman A, Camp HS, Pangan A, Ganguli A, Fuldeore M, Goldschmidt D, Schiff M. Upadacitinib improves patient-reported outcomes in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: results from SELECT-NEXT. Arthritis Res Ther. 2019 Dec 9;21(1):272. doi: 10.1186/s13075-019-2037-1.
Nader 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info.
Other Identifiers
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2015-003332-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M13-549
Identifier Type: -
Identifier Source: org_study_id
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