A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX
2 other identifiers
interventional
648
23 countries
147
Brief Summary
The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX. The study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Mar 2016
Longer than P75 for phase_3 rheumatoid-arthritis
147 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 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2017
CompletedResults Posted
Study results publicly available
October 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2022
CompletedJanuary 30, 2024
January 1, 2024
1.5 years
February 18, 2016
September 13, 2019
January 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 14. 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 14
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 14
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 14. 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 14
Secondary Outcomes (7)
Change From Baseline in in Disease Activity Score 28 (CRP) at Week 14
Baseline to week 14
Change From Baseline in Heath Assessment Questionnaire and Disability Index (HAQ-DI) at Week 14
Baseline to week 14
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 14
Baseline to week 14
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 14
Week 14
Change From Baseline in Duration of Morning Stiffness at Week 14
Baseline to week 14
- +2 more secondary outcomes
Study Arms (4)
Upadacitinib 30 mg
EXPERIMENTALPeriod 1: Participants receive upadacitnib 30 mg once daily and placebo to methotrexate once weekly for 14 weeks. Period 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Upadacitinib 15 mg
EXPERIMENTALPeriod 1: Participants receive upadacitnib 15 mg once daily and placebo to methotrexate once weekly for 14 weeks. Period 2: Participants receive upadacitinib 15 mg once daily up to Week 260.
Methotrexate / Upadacitinib 30 mg
EXPERIMENTALPeriod 1: Participants receive methotrexate once weekly and placebo to upadacitinib once daily for 14 weeks. Period 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Methotrexate / Upadacitinib 15 mg
EXPERIMENTALPeriod 1: Participants receive methotrexate once weekly and placebo to upadacitinib for 14 weeks. Period 2: Participants receive upadacitinib 15 mg once daily up to Week 260.
Interventions
Tablet; Oral
Tablet; Oral
Capsule; Oral
Eligibility Criteria
You may qualify if:
- Diagnosis of RA for \>= 3 months.
- Subjects must have been on oral or parenteral MTX therapy \>= 3 months and on a stable dose for \>= 4 weeks prior to first dose of study drug.
- Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) \>= 4 weeks prior to first dose of study drug.
- Meets the following minimum disease activity criteria: \>= 6 swollen joints (based on 66 joint counts) and \>= 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
You may not qualify if:
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).
- Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (153)
Rheum Assoc of North Alabama /ID# 146009
Huntsville, Alabama, 35801, United States
Alabama Medical Group, PC /ID# 153941
Mobile, Alabama, 36608-1787, United States
ArthroCare Arthritis Care & Re /ID# 143751
Gilbert, Arizona, 85234, United States
Elite Clinical Studies, LLC /ID# 143760
Phoenix, Arizona, 85018, United States
University of Arizona Cancer Center - North Campus /ID# 147175
Tucson, Arizona, 85719-1478, United States
NEA Baptist Womens Clinic /ID# 148904
Jonesboro, Arkansas, 72401, United States
C.V. Mehta MD, Med Corporation /ID# 143762
Hemet, California, 92543, United States
Arthritis Assoc & Osteo Ctr /ID# 147176
Colorado Springs, Colorado, 80920, United States
Ctr Rheum, Immuno, Arthritis /ID# 143766
Fort Lauderdale, Florida, 33309, United States
South Florida Research Ph I-IV /ID# 151983
Miami Springs, Florida, 33166-7225, United States
Advent Clinical Research /ID# 143767
Pinellas Park, Florida, 33781, United States
Sarasota Arthritis Center /ID# 146011
Sarasota, Florida, 34239, United States
W. Broward Rheum Assoc Inc. /ID# 146010
Tamarac, Florida, 33321, United States
Clinical Research West FL /ID# 148726
Tampa, Florida, 33603, United States
SW FL Clin Res Ctr, Tampa, FL /ID# 143763
Tampa, Florida, 33609, United States
University of South Florida /ID# 146004
Tampa, Florida, 33612, United States
BayCare Medical Group, Inc. /ID# 151985
Tampa, Florida, 33614-7101, United States
BayCare Medical Group, Inc. /ID# 163595
Tampa, Florida, 33614-7101, United States
Jefrey D. Lieberman, MD, P.C. /ID# 151816
Decatur, Georgia, 30033, United States
Great Lakes Clinical Trials /ID# 150935
Chicago, Illinois, 60640, United States
PRN Professional Research Network of Kansas, LLC /ID# 143761
Wichita, Kansas, 67205, United States
Ochsner Clinic Foundation /ID# 153573
Baton Rouge, Louisiana, 70836-6455, United States
The Arthritis & Diabetes Clinic, Inc. /ID# 160809
Monroe, Louisiana, 71203, United States
Vanguard Medical Research, LLC /ID# 153124
Shreveport, Louisiana, 71011, United States
Mansfield Health Center /ID# 161627
Mansfield, Massachusetts, 02048, United States
Quality Clinical Research Inc. /ID# 156415
Omaha, Nebraska, 68114, United States
Dartmouth-Hitchcock Medical Center /ID# 146008
Lebanon, New Hampshire, 03756, United States
Albuquerque Clinical Trials, Inc /ID# 147618
Albuquerque, New Mexico, 87102, United States
Arthritis and Osteo Assoc /ID# 147177
Las Cruces, New Mexico, 88011, United States
Coastal Carolina Health Care /ID# 149275
New Bern, North Carolina, 28562, United States
STAT Research, Inc. /ID# 143770
Vandalia, Ohio, 45377-9464, United States
Health Research Oklahoma /ID# 159550
Oklahoma City, Oklahoma, 73103-2400, United States
Healthcare Research Consultant /ID# 147632
Tulsa, Oklahoma, 74135, United States
Innovative Clinical Research /ID# 143757
Greenville, South Carolina, 29601, United States
Nashville Arthritis and Rheumatology /ID# 162641
Nashville, Tennessee, 37203, United States
Tekton Research, Inc. /ID# 159554
Austin, Texas, 78745, United States
Diagnostic Group Integrated He /ID# 148725
Beaumont, Texas, 77701, United States
Trinity Universal Res Assoc /ID# 150138
Carrollton, Texas, 75007, United States
Arth and Osteo Clin Brazo Valley /ID# 160810
College Station, Texas, 77845, United States
Adriana Pop-Moody MD Clinic PA /ID# 147627
Corpus Christi, Texas, 78404, United States
Accurate Clinical Management /ID# 143768
Houston, Texas, 77004, United States
Accurate Clinical Research /ID# 143769
Houston, Texas, 77089, United States
Pioneer Research Solutions, Inc. /ID# 143765
Houston, Texas, 77098-5294, United States
P&I Clinical Research /ID# 151358
Lufkin, Texas, 75904-3132, United States
SW Rheumatology Res. LLC /ID# 147620
Mesquite, Texas, 75150, United States
Sun Research Institute /ID# 159553
San Antonio, Texas, 78215, United States
Arthritis Clinic of Central TX /ID# 149266
San Marcos, Texas, 78666, United States
Adv Rheumatology of Houston /ID# 162609
The Woodlands, Texas, 77382, United States
DM Clinical Research /ID# 151359
Tomball, Texas, 77375, United States
Arthritis & Osteoporosis Clinic /ID# 143752
Waco, Texas, 76710, United States
Ctr for Arth and Rheum Disease /ID# 143759
Chesapeake, Virginia, 23320, United States
Aurora Rheumatology and Immunotherapy Center /ID# 160811
Franklin, Wisconsin, 53132, United States
Mautalen Salud e Investigacion /ID# 145980
Buenos Aires, 1128, Argentina
Ctr Privado Med Familiar /ID# 149183
Buenos Aires, 1417, Argentina
Consultorio Reumatologic Pampa /ID# 145979
Buenos Aires, 1428, Argentina
Centro de Educación Médica e Investigaciones Clínicas "Norberto Quimo" - CEMIC /ID# 149176
Buenos Aires, 1431, Argentina
Cordis S.A. /Id# 152621
Salta, 4400, Argentina
Centro de Enfermedades /ID# 153543
Santa Fe, 2000, Argentina
Royal Prince Alfred Hospital /ID# 146028
Camperdown, New South Wales, 2050, Australia
Rheuma-Zentrum Wien-Oberlaa /ID# 144728
Vienna, 1100, Austria
Algemeen Stedelijk Ziekenhuis /ID# 148720
Aalst, Oost-Vlaanderen, 9300, Belgium
ReumaClinic Genk /ID# 146030
Genk, 3600, Belgium
Diag Consult Ctr 17 Sofia EOOD /ID# 144730
Sofia, 1505, Bulgaria
UMHAT Sv. Ivan Rilski /ID# 147351
Sofia, 1612, Bulgaria
Reg. Clinical Hosptial Concepcion /ID# 151267
Concepción, 4070038, Chile
Quantum Research LTDA. /ID# 145984
Puerto Varas, 5550170, Chile
Quantum Research Stgo. /ID# 145983
Santiago, 7500588, Chile
CTCenter MaVe, s.r.o. /ID# 144823
Olomouc, Olomoucký kraj, 779 00, Czechia
Nuselská poliklinika, Revmatologie /ID# 145986
Prague, Praha 4, 140 00, Czechia
Thomayerova nemocnice /ID# 144736
Prague, Praha 4, 140 00, Czechia
RHEUMA s.r.o. /ID# 144737
Břeclav, 690 02, Czechia
Medical Plus, s.r.o. /ID# 144821
Uherské Hradište, 686 01, Czechia
MediTrials /ID# 159745
Tartu, Tartu, 50406, Estonia
North Estonian Medical Centre /ID# 145455
Tallinn, 13419, Estonia
General Hospital of Athens "Ippokratio" /ID# 144739
Athens, 11527, Greece
Vital Medical Center Orvosi es /ID# 144740
Veszprém, Veszprém megye, 8200, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont /ID# 144743
Budapest, 1134, Hungary
Pest Megyei Flor Ferenc Korhaz /ID# 144742
Kistarcsa, 2143, Hungary
Fejer Megyei Szent Gyorgy Korh /ID# 144741
Székesfehérvár, 8000, Hungary
Barzilai Medical Center /ID# 144744
Ashkelon, 78278, Israel
Bnai Zion Medical Center /ID# 144745
Haifa, 3339419, Israel
The Lady Davis Carmel MC /ID# 147174
Haifa, 3436212, Israel
Sheba Medical Center /ID# 144824
Ramat Gan, 5262100, Israel
Universita di Catanzaro Magna Graecia /ID# 144747
Catanzaro, Calabria, 88100, Italy
A.O.U.I. di Verona Policlinico /ID# 144746
Verona, 37134, Italy
Kondo Clinic for Rheum & Ortho /ID# 148268
Fukuoka, Fukuoka, 810-0001, Japan
NHO Kyushu Medical Center /ID# 148279
Fukuoka, Fukuoka, 810-8563, Japan
NHO Kyushu Medical Center /ID# 148280
Fukuoka, Fukuoka, 810-8563, Japan
Aso Iizuka Hospital /ID# 148272
Iizuka-shi, Fukuoka, 820-8505, Japan
Inoue Hospital /ID# 148069
Takasaki, Gunma, 3700053, Japan
Bay Side Misato Medical Center /ID# 148281
Kochi, Kochi, 781-0112, Japan
Center for Arthritis and Clinical Rheumatology Matsubara Clinic /ID# 148269
Kumamoto, Kumamoto, 862-0920, Japan
Kumamoto Shinto General Hospital /ID# 148286
Kumamoto, Kumamoto, 8628655, Japan
Nagasaki University Hospital /ID# 149859
Nagasaki, Nagasaki, 852-8501, Japan
Sasebo Chuo Hospital /ID# 148275
Sasebo, Nagasaki, 857-1195, Japan
Osaka Red Cross Hospital /ID# 148267
Osaka, Osaka, 543-8555, Japan
Seirei Hamamatsu General Hosp /ID# 148270
Hamamatsu, 430-8558, Japan
Ohira Orthopaedic Hospital /ID# 157944
Hyūga, 883-0043, Japan
Shirahama Hamayu Hospital /ID# 148277
Nishimura, 649-2211, Japan
Sanuki Municipal Hospital /ID# 158080
Sanuki, 769-2321, Japan
Hokkaido University Hospital /ID# 148285
Sapporo, 060-8648, Japan
Hokkaido Medical Center for Rheumatic Diseases /ID# 148274
Sapporo, 063-0811, Japan
Miyasato Clinic /ID# 148271
Shūnan, 745-0824, Japan
Takaoka Rheumatic Orthopedic Clinic /ID# 148068
Takaoka, 933-0874, Japan
Matsuta Clinic /ID# 148278
Tokyo, 155-0032, Japan
National Hospital Organization Shimoshizu National Hospital /ID# 148273
Yotsukaidō, 284-0003, Japan
Desarrollos Biomedicos y Biotc /ID# 147379
Monterrey, Nuevo León, 64060, Mexico
Cryptex Investigación Clínica S.A de C.V /ID# 147095
Mexico City, 06100, Mexico
Medyczne Centrum Hetmanska /ID# 144751
Poznan, Greater Poland Voivodeship, 60-218, Poland
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 157622
Wroclaw, Lower Silesian Voivodeship, 51-685, Poland
REUMED Sp.z o.o. Filia nr 1 /ID# 144752
Lublin, Lublin Voivodeship, 20-607, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 149521
Warsaw, Masovian Voivodeship, 02-507, Poland
Osteo-Medic spolka cywilna /ID# 144753
Bialystok, Podlaskie Voivodeship, 15-351, Poland
Centrum Badań Klinicznych Pi-House /ID# 149520
Gdansk, Pomeranian Voivodeship, 80-546, Poland
NZOZ Centrum Reumatologiczne /ID# 144749
Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Instituto Portugues De Reumatologia /ID# 149281
Lisbon, Lisbon District, 1050-034, Portugal
Centro Hospitalar De Vila Nova /ID# 146036
Vila Nova de Gaia, Porto District, 4434-502, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 146035
Lisbon, 1649-035, Portugal
Centro Hospitalar Baixo Vouga /ID# 152916
Porto, 4050-111, Portugal
Dr. Ramon L. Ortega-Colon, MD /ID# 145989
Carolina, 00983, Puerto Rico
Ponce School of Medicine /ID# 145990
Ponce, 00716, Puerto Rico
Spitalul Municipal Ploiesti /ID# 144756
Ploieşti, 100337, Romania
Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 147255
Moscow, Moscow, 119049, Russia
LLC Medical Center /ID# 144758
Novosibirsk, Novosibirsk Oblast, 630099, Russia
Perm Clinical Center of FMBA /ID# 145993
Perm, Permskiy Kray, 614109, Russia
Tver Regional Clinical Hosp. /ID# 147254
Tver', Tver Oblast, 170036, Russia
Сity Clinical Hospital 4 /ID# 145994
Ivanovo, 153005, Russia
City Clinical Hospital Botkina /ID# 145995
Moscow, 125284, Russia
City Clinical Hospital #5 /ID# 149832
Nizhny Novgorod, 603005, Russia
Orenburg State Medical Academy /ID# 145992
Orenburg, 460000, Russia
Republican Clin Hos n.a. Baran /ID# 147251
Petrozavodsk, 185019, Russia
Samara Regional Clinical Hosp /ID# 150934
Samara, 443095, Russia
Reg Clin Hosp n.a. Kuvatova G. /ID# 144757
Ufa, 450005, Russia
Yaroslavi State Medical Univer /ID# 147253
Yaroslavl, 150000, Russia
Institute for Rheumatology /ID# 144759
Belgrade, Beograd, 11000, Serbia
Institute for Rheumatology /ID# 144761
Belgrade, Beograd, 11000, Serbia
Institute for Rheumatology /ID# 144762
Belgrade, Beograd, 11000, Serbia
Special Hospital for Rheuma /ID# 144760
Novi Sad, Vojvodina, 21000, Serbia
Wits Clinical Research Site /ID# 149835
Johannesburg, Gauteng, 2193, South Africa
University of Pretoria /ID# 148740
Pretoria, Gauteng, 0001, South Africa
Synexus Helderberg Clinical Tr /ID# 148724
Cape Town, Western Cape, 7130, South Africa
Tiervlei Trial Centre /ID# 153086
Cape Town, Western Cape, 7530, South Africa
Hospital Plató /ID# 145999
Barcelona, 08006, Spain
Hospital Univ Germans Trias I /ID# 146037
Barcelona, 08916, Spain
Hospital Infanta Luisa /ID# 144771
Seville, 41010, Spain
Hospital Universitario de Valm /ID# 144770
Seville, 41014, Spain
Hospital Universitario La Fe /ID# 158013
Valencia, 46026, Spain
Uludağ Üniversitesi Atatürk Rehabilitasyon Uygulama ve Araştırma Merkezi /ID# 144772
Osmangazi, Bursa, 16080, Turkey (Türkiye)
Lviv Regional Clinical Hospita /ID# 154448
Lviv, Lviv Oblast, 79013, Ukraine
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 146002
Vinnytsia, Vinnytsia Oblast, 21018, Ukraine
Regional Clinical Hospital /ID# 152007
Ivano-Frankivsk, 76018, Ukraine
NSC-Strazhesko Ist Cardiology /ID# 152004
Kiev, 03680, Ukraine
Zaporizhzhia Regional Clinical /ID# 146000
Zaporizhia, 69600, Ukraine
Related Publications (15)
Smolen JS, Pangan AL, Emery P, Rigby W, Tanaka Y, Vargas JI, Zhang Y, Damjanov N, Friedman A, Othman AA, Camp HS, Cohen S. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019 Jun 8;393(10188):2303-2311. doi: 10.1016/S0140-6736(19)30419-2. Epub 2019 May 23.
PMID: 31130260BACKGROUNDBurmester 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: 40875187DERIVEDSmolen JS, Emery P, Rigby W, Tanaka Y, Vargas JI, Jain M, Kato K, Carter KM, Khan N, Phillips C, Meerwein S, Cohen SB. Upadacitinib as monotherapy in patients with rheumatoid arthritis and prior inadequate response to methotrexate: results at 260 weeks from the SELECT-MONOTHERAPY randomised study. RMD Open. 2025 May 11;11(2):e005051. doi: 10.1136/rmdopen-2024-005051.
PMID: 40350200DERIVEDRubbert-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: 34041702DERIVEDStrand V, Tundia N, Wells A, Buch MH, Radominski SC, Camp HS, Friedman A, Suboticki JL, Dunlap K, Goldschmidt D, Bergman M. Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY. Rheumatology (Oxford). 2021 Jul 1;60(7):3209-3221. doi: 10.1093/rheumatology/keaa770.
PMID: 33313898DERIVEDCohen 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.
PMID: 33115760DERIVEDNader 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)
Intervention 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 23, 2016
Primary Completion
October 2, 2017
Study Completion
August 10, 2022
Last Updated
January 30, 2024
Results First Posted
October 7, 2019
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- 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.