A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis
SELECT-AXIS 2
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects With Axial Spondyloarthritis Followed by a Remission-Withdrawal Period
2 other identifiers
interventional
734
25 countries
212
Brief Summary
This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently. The main objectives of this protocol are:
- To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adults with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2).
- To assess the safety and tolerability of upadacitinib in adults with active axSpA including bDMARD-IR AS (Study 1) and nr-axSpA (Study 2).
- To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and nr-axSpA who have completed the Double-Blind Period (Study 2).
- To evaluate the maintenance of disease control after withdrawal of upadacitinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2019
Longer than P75 for phase_3
212 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
November 18, 2019
CompletedFirst Posted
Study publicly available on registry
November 19, 2019
CompletedStudy Start
First participant enrolled
November 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2021
CompletedResults Posted
Study results publicly available
September 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedFebruary 24, 2026
February 1, 2025
1.8 years
November 18, 2019
August 23, 2022
February 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14
ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of \> 0 units) in the potential remaining domain: * Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); * Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); * Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); * Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Baseline and Week 14
Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14
ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of \> 0 units) in the potential remaining domain: * Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); * Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); * Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); * Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Baseline and Week 14
Secondary Outcomes (35)
Study 1: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14
Baseline and Week 14
Study 1: Change From Baseline in Magnetic Resonance Imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) Score for the Spine at Week 14
Baseline and Week 14
Study 1: Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14
Baseline and Week 14
Study 1: Percentage of Participants With an ASAS20 Response at Week 14
Baseline and Week 14
Study 1: Percentage of Participants With ASDAS Inactive Disease at Week 14
Week 14
- +30 more secondary outcomes
Study Arms (4)
Study 1: Upadacitinib 15 mg
EXPERIMENTALParticipants receive 15 mg upadacitinib orally once a day for 104 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).
Study 1: Placebo
PLACEBO COMPARATORParticipants receive matching placebo for 14 weeks and then switch to receive 15 mg upadacitinib orally once a day for 90 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).
Study 2: Upadacitinib 15 mg
EXPERIMENTALParticipants receive 15 mg upadacitinib orally once a day for 104 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).
Study 2: Placebo
PLACEBO COMPARATORParticipants receive matching placebo for 52 weeks and then switch to receive 15 mg upadacitinib orally once a day for 52 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).
Interventions
Upadacitinib tablet administered orally
Eligibility Criteria
You may qualify if:
- Study 1:
- Must have a clinical diagnosis of ankylosing spondylitis (AS) and meet the modified New York Criteria for AS,
- Must not have total spinal ankylosis
- Must have been previously exposed to 1 or 2 bDMARDs (at least 1 tumor necrosis factor \[TNF\] inhibitor or 1 interleukin \[IL\]-17 inhibitor \[IL-17i\]), and must have discontinued the bDMARD therapy due to either lack of efficacy (after at least 12 weeks of treatment with a bDMARD at an adequate dose) or intolerance (irrespective of treatment duration). Prior exposure to two bDMARDs was allowed for no more than 30% of patients; among patients with prior exposure to two bDMARDs, a lack of efficacy to one bDMARD and intolerance to another was permitted, but a patient could not have a lack of efficacy to two bDMARDs
- Study 2:
- Must have a clinical diagnosis of nr-axSpA fulfilling the 2009 Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS
- Must have objective signs of active inflammation consistent with axSpA on magnetic resonance imaging (MRI) of sacroiliac (SI) joints or based on high sensitivity C-reactive protein (hsCRP) \> the upper limit of normal (ULN).
- Prior treatment with at most one bDMARD (either TNF inhibitor or IL-17i) is allowed for at least 20% but no more than 35% of enrolled patients who had to discontinue the prior bDMARD due to either lack of efficacy (after ≥ 12 weeks at an adequate dose) or intolerance (regardless of treatment duration).
- Must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at the Screening and Baseline Visits.
- Must have a Total Back Pain score ≥ 4 based on a 0 - 10 numerical rating scale at the Screening and Baseline Visits.
- Has had an inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
You may not qualify if:
- Must not have been exposed to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib \[Rinvoq®\], tofacitinib \[Xeljanz®\], baricitinib \[Olumiant®\], filgotinib, ruxolitinib \[Jakafi®\], abrocitinib \[PF-04965842\], and peficitinib \[Smyraf®\]).
- Prior bDMARD therapy must be washed out.
- Participant must not have a history of an allergic reaction or significant sensitivity to constituents of the study drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (212)
Arizona Arthritis & Rheumatology Associates, P.C. /ID# 215282
Flagstaff, Arizona, 86001-6269, United States
AZ Arthritis and Rheumotology Research, PLLC /ID# 215113
Phoenix, Arizona, 85032-9306, United States
Arizona Arthritis & Rheumatology Research, PLLC /ID# 214731
Tucson, Arizona, 85704, United States
Newport Huntington Medical Group /ID# 216281
Huntington Beach, California, 92648-5994, United States
Inland Rheum & Osteo Med Grp /ID# 215807
Upland, California, 91786, United States
Denver Arthritis Clinic /ID# 215346
Denver, Colorado, 80230, United States
Tekton Research /ID# 215054
Fort Collins, Colorado, 80528, United States
Arthritis & Rheumatic Disease Specialties /ID# 215306
Aventura, Florida, 33180, United States
Sweet Hope Research Specialty Inc /ID# 215931
Hialeah, Florida, 33016-1897, United States
Innovation Medical Research Center /ID# 216068
Palmetto Bay, Florida, 33157-1737, United States
Conquest Research /ID# 215804
Winter Park, Florida, 32789, United States
Great Lakes Clinical Trials /ID# 215790
Chicago, Illinois, 60640, United States
Greater Chicago Specialty Physicians /ID# 216213
Schaumburg, Illinois, 60195-3106, United States
Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 215055
Skokie, Illinois, 60076, United States
Klein and Associates MD /ID# 214767
Hagerstown, Maryland, 21740, United States
Tufts Medical Center /ID# 215925
Boston, Massachusetts, 02111-1552, United States
Clinical Pharmacology Study Group /ID# 215293
Worcester, Massachusetts, 01605, United States
Wayne State University Health Center /ID# 215930
Detroit, Michigan, 48201-2153, United States
Advanced Rheumatology, PC /ID# 214973
Lansing, Michigan, 48910, United States
St. Paul Rheumatology /ID# 215537
Eagan, Minnesota, 55121, United States
Clinvest Research LLC /ID# 215785
Springfield, Missouri, 65807, United States
CenterPointe Institute of Research /ID# 215793
St Louis, Missouri, 63128-3841, United States
NYU Langone Orthopedic Center /ID# 215594
New York, New York, 10016-2772, United States
St. Lawrence Health System /ID# 215844
Potsdam, New York, 13676, United States
Cape Fear Arthritis Care /ID# 215927
Leland, North Carolina, 28451, United States
Marietta Memorial Hospital /ID# 215929
Marietta, Ohio, 45750-1635, United States
STAT Research, Inc. /ID# 215264
Springboro, Ohio, 45066, United States
Health Research of Oklahoma /ID# 215117
Oklahoma City, Oklahoma, 73103-2400, United States
Oregon Health and Science University /ID# 216446
Portland, Oregon, 97239, United States
Altoona Ctr Clinical Res /ID# 214770
Duncansville, Pennsylvania, 16635, United States
Tekton Research, Inc. /ID# 214923
Austin, Texas, 78745, United States
Trinity Universal Research Associates - Carrollton /ID# 214948
Carrollton, Texas, 75007, United States
Arthritis and Osteoporosis Clinic Of Brazos Valley /ID# 215805
College Station, Texas, 77845, United States
JPS Rheumatology Clinic /ID# 215962
Fort Worth, Texas, 76104-4917, United States
Memorial Rheumatology /ID# 216311
Houston, Texas, 77024-2420, United States
Biopharma Informatic, LLC /ID# 215885
Houston, Texas, 77043, United States
Biopharma Informatic - Park Row /ID# 215907
Houston, Texas, 77084, United States
West Texas Clinical Research /ID# 215928
Lubbock, Texas, 79410-1198, United States
Trinity Universal Research Associates, Inc /ID# 215189
Plano, Texas, 75024-5283, United States
Rheumatology and Pulmonary Clinic /ID# 214946
Beckley, West Virginia, 25801, United States
West Virginia Research Inst /ID# 214921
South Charleston, West Virginia, 25309, United States
Organizacion Medica de Investigacion (OMI) /ID# 214557
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1015, Argentina
Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 214556
Rosario, Santa Fe Province, 2000, Argentina
Instituto CAICI /ID# 215242
Rosario, Santa Fe Province, 2000, Argentina
Centro de Investigaciones Medicas Tucuman /ID# 214559
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Hospital Cordoba /ID# 215846
Córdoba, 5000, Argentina
Instituto Medico Strusberg /ID# 215239
Córdoba, 5000, Argentina
Cimer /Id# 215240
San Miguel de Tucumán, 4000, Argentina
Emeritus Research Sydney /ID# 215507
Botany, New South Wales, 2019, Australia
BJC Health /ID# 215510
Paramatta, New South Wales, 2150, Australia
Emeritus Research /ID# 215506
Camberwell, Victoria, 3124, Australia
Monash Medical Centre /ID# 215509
Clayton, Victoria, 3168, Australia
Barwon Rheumatology Services /ID# 215508
Geelong, Victoria, 3220, Australia
UZ Gent /ID# 215004
Ghent, Oost-Vlaanderen, 9000, Belgium
Universitair Ziekenhuis Leuven /ID# 215006
Leuven, Vlaams-Brabant, 3000, Belgium
ReumaClinic /ID# 215005
Genk, 3600, Belgium
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 215277
Juiz de Fora, Minas Gerais, 36010-570, Brazil
EDUMED Educacao em Saude S/S L /ID# 215111
Curitiba, Paraná, 80440-080, Brazil
LMK Sevicos Medicos S/S /ID# 215112
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 215176
São José do Rio Preto, São Paulo, 15090-000, Brazil
CPCLIN - Centro de Pesquisas Clínicas /ID# 215175
São Paulo, 01228-200, Brazil
UMHAT Kaspela EOOD /ID# 214803
Plovdiv, 4001, Bulgaria
Medical center Unimed /ID# 214816
Plovdiv, 4023, Bulgaria
MHAT Plovdiv /ID# 214815
Plovdiv, 4027, Bulgaria
Medical center Teodora /ID# 214813
Rousse, 7012, Bulgaria
Medical center Excelsior /ID# 214805
Sofia, 1407, Bulgaria
UMHAT Sveti Ivan Rilski /ID# 214804
Sofia, 1431, Bulgaria
UMHAT Sveti Ivan Rilski /ID# 214806
Sofia, 1431, Bulgaria
Diagnostic consultative center 17 Sofia /ID# 214808
Sofia, 1505, Bulgaria
Percuro Clinical Research, Ltd /ID# 215302
Victoria, British Columbia, V8V 3M9, Canada
Toronto Western Hospital /ID# 215041
Toronto, Ontario, M5T 2S8, Canada
Applied Medical Informatics Research Inc. (AMIR) /ID# 215303
Montreal, Quebec, H4A 3T2, Canada
Centre de Recherche Musculo-Squelettique /ID# 215096
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Centre de recherche du CHUQ /ID# 215038
Québec, G1R 3S2, Canada
The first affiliated hospital of bengbu medical college /ID# 216609
Bengbu, Anhui, 233004, China
Anhui Provincial Hospital /ID# 216631
Hefei, Anhui, 230001, China
Peking Union Medical College Hospital /ID# 216545
Beijing, Beijing Municipality, 100730, China
Guangdong Provincial People's Hospital /ID# 216645
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital of Shantou University Medical College /ID# 217883
Shantou, Guangdong, 515041, China
Shenzhen People's Hospital /ID# 225438
Shenzhen, Guangdong, 518020, China
Zhuzhou Central Hospital /ID# 216644
Zhuzhou, Hunan, 412007, China
The First Affiliated Hospital of BaoTou Medical College, Inner Mongolia Universi /ID# 216612
Baotou, Inner Mongolia, 014016, China
The First Affiliated Hospital of Soochow University /ID# 216607
Suzhou, Jiangsu, 215006, China
Huashan Hospital, Fudan University /ID# 216646
Shanghai, Shanghai Municipality, 200040, China
First Affiliated Hospital of Kunming Medical University /ID# 217945
Kunming, 650032, China
REVMACLINIC s.r.o. /ID# 215153
Brno, 602 00, Czechia
Revmacentrum MUDr. Mostera, s.r.o. /ID# 215161
Brno, 615 00, Czechia
Revmatologie, s.r.o. /ID# 215309
Brno, 638 00, Czechia
CCR Ostrava, s.r.o. /ID# 215226
Ostrava, 702 00, Czechia
ARTHROHELP, s.r.o. /ID# 215224
Pardubice, 530 02, Czechia
Revmatologicky ustav v Praze /ID# 215154
Prague, 128 00, Czechia
PV MEDICAL Services s.r.o. /ID# 215119
Prague, 130 00, Czechia
Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 215652
Prague, 140 00, Czechia
Thomayerova nemocnice /ID# 215118
Prague, 140 59, Czechia
Fakultni Nemocnice v Motole /ID# 215160
Prague, 150 06, Czechia
MEDICAL PLUS, s.r.o. /ID# 215324
Uherské Hradiště, 686 01, Czechia
CHU Toulouse /ID# 214780
Toulouse, Occitanie, 31300, France
CHU Bordeaux - Hopital Pellegrin /ID# 214784
Bordeaux, 33000, France
Hopital Ambroise Pare /ID# 214783
Boulogne-Billancourt, 92104, France
AP-HP - Hopital Cochin /ID# 214782
Paris, 75014, France
Universitaetsklinikum Erlangen /ID# 214281
Erlangen, Bavaria, 91054, Germany
Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 214282
Berlin, 12161, Germany
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214211
Berlin, 12203, Germany
Rheuma Research Lausitz, Dr. Mario Sutowicz /ID# 214218
Cottbus, 30342, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214207
Dresden, 01307, Germany
Praxisgemeinschaft Rheumatologie Nephrologie Erlangen /ID# 214212
Erlangen, 91056, Germany
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 214208
Hamburg, 20095, Germany
Medizinische Hochschule Hannover /ID# 214209
Hanover, 30625, Germany
MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 214261
Planegg, 82152, Germany
Debreceni Egyetem Klinikai Kozpont /ID# 215187
Debrecen, Hajdú-Bihar, 4032, Hungary
Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 215182
Veszprém, Veszprém megye, 8200, Hungary
Rehavita Kft HU /ID# 215188
Kormend, Zala County, 9900, Hungary
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 215183
Budapest, 1023, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 215186
Gyula, 5700, Hungary
Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 215184
Hévíz, 8380, Hungary
Pest Megyei Flor Ferenc Korhaz /ID# 214501
Kistarcsa, 2143, Hungary
CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 215181
Székesfehérvár, 8000, Hungary
The Chaim Sheba Medical Center /ID# 215854
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 216956
Tel Aviv, Tel Aviv, 6423906, Israel
Bnai Zion Medical Center /ID# 215856
Haifa, 3339419, Israel
Meir Medical Center /ID# 217255
Kfar Saba, 4428164, Israel
Daido Clinic /ID# 214735
Nagoya, Aichi-ken, 457-8511, Japan
Matsuyama Red Cross Hospital /ID# 216021
Matsuyama, Ehime, 790-8524, Japan
National Hospital Organization Asahikawa Medical Center /ID# 214930
Asahikawa-shi, Hokkaido, 070-8644, Japan
Hokkaido University Hospital /ID# 215221
Sapporo, Hokkaido, 060-8648, Japan
Kobe University Hospital /ID# 214598
Kobe, Hyōgo, 650-0017, Japan
Hyogo College of Medicine College Hospital /Id# 215638
Nishinomiya-shi, Hyōgo, 663-8501, Japan
Kita-harima Medical Center /ID# 216069
Ono-shi, Hyōgo, 675-1327, Japan
Kuwana City Medical Center /ID# 215196
Kuwana-shi, Mie-ken, 511-0061, Japan
Nagasaki University Hospital /ID# 215947
Nagasaki, Nagasaki, 852-8501, Japan
Sasebo Chuo Hospital /ID# 214703
Sasebo-shi, Nagasaki, 857-1195, Japan
Japanese Red Cross Okayama Hospital /ID# 214732
Okayama, Okayama-ken, 700-8607, Japan
Okinawa Prefectural Chubu Hospital /ID# 215575
Uruma, Okinawa, 904-2293, Japan
National Hospital Organization Osaka Minami Medical Center /ID# 214205
Kawachinagano Shi, Osaka, 586-8521, Japan
Osaka City General Hospital /ID# 215640
Osaka, Osaka, 534-0021, Japan
Juntendo University Hospital /ID# 214929
Bunkyo-ku, Tokyo, 113-8431, Japan
St.Luke's International Hospital /ID# 215414
Chuo-ku, Tokyo, 104-8560, Japan
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 215217
Mexico City, Mexico City, 11850, Mexico
Middlemore Clinical Trials /ID# 215502
Papatoetoe, Auckland, 2025, New Zealand
Waikato Hospital /ID# 215503
Hamilton, Waikato Region, 3240, New Zealand
AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 214354
Poznan, Greater Poland Voivodeship, 61-113, Poland
Nasz Lekarz Przychodnie Medyczne /ID# 214352
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 215093
Wroclaw, Lower Silesian Voivodeship, 51-685, Poland
REUMED Sp.z o.o. Filia nr 1 /ID# 214353
Lublin, Lublin Voivodeship, 20-607, Poland
Osteo-Medic S.C. /ID# 214351
Bialystok, Podlaskie Voivodeship, 15-351, Poland
ETYKA-Osrodek Badan Klinicznych /ID# 215572
Olsztyn, Warmian-Masurian Voivodeship, 10-117, Poland
Chelyabinsk Regional Clinical Hospital /ID# 214463
Chelyabinsk, Chelyabinsk Oblast, 454087, Russia
Immanuel Kant Baltic Federal University /ID# 218259
Kaliningrad, Kaliningrad Oblast, 236016, Russia
LLC Family Outpatient Clinic № /ID# 214455
Korolev, Moscow, 141060, Russia
Research Institute of Rheumatology named after V.A. Nasonova /ID# 214459
Moscow, Moscow, 115522, Russia
LLC Medical Center /ID# 214410
Novosibirsk, Novosibirsk Oblast, 630099, Russia
Nort-Western State Medical University n.a. Mechnikov /ID# 214454
Saint Petersburg, Sankt-Peterburg, 193015, Russia
LLC Novaya Klinika /ID# 214420
Pyatigorsk, Stavropol Kray, 357500, Russia
Family Clinic /ID# 214737
Yekaterinburg, Sverdlovsk Oblast, 620109, Russia
Central City Hospital #7 /ID# 214741
Yekaterinburg, Sverdlovsk Oblast, 620137, Russia
Kazan State Medical University /ID# 214421
Kazan', Tatarstan, Respublika, 420012, Russia
Alliance Biomedical Ural Group /ID# 214457
Izhevsk, Udmurtiya Republic, 426061, Russia
Olla-Med Clinic /ID# 214460
Moscow, 105554, Russia
City Clinical Hospital n.a. O.M. Filatov /ID# 214486
Moscow, 111539, Russia
Omsk Regional Clinic Hospital /ID# 214464
Omsk, 644111, Russia
Orenburg State Medical University /ID# 214408
Orenburg, 460000, Russia
Ryazan State Medical University named after academician I.P. Pavlov /ID# 214418
Ryazan, 390026, Russia
Clinical Rheumatologic Hospital No 25 /ID# 214488
Saint Petersburg, 190068, Russia
RZD-Medicine Saratov /ID# 214465
Saratov, 410004, Russia
Ulyanovsk Regional Clinical Hospital /ID# 214458
Ulyanovsk, 432017, Russia
Univerzitna nemocnica Bratislava Nemocnica Stare Mesto /ID# 214675
Bratislava, 813 69, Slovakia
Reum.hapi s.r.o. /ID# 224268
Nové Mesto nad Váhom, 915 01, Slovakia
Narodny ustav reumatickych chorob /ID# 214674
Piešťany, 921 12, Slovakia
MUDr. Zuzana Cizmarikova s.r.o. /ID# 215220
Poprad, 058 01, Slovakia
ALBAMED s.r.o. /ID# 215248
Zvolen, 960 01, Slovakia
Ajou University Hospital /ID# 214533
Suwon, Gyeonggido, 16499, South Korea
Hanyang University Seoul Hospital /ID# 214297
Seoul, Seoul Teugbyeolsi, 04763, South Korea
Gachon University Gil Medical Center /ID# 214534
Incheon, 21565, South Korea
Seoul National University Hospital /ID# 214532
Seoul, 03080, South Korea
Kyunghee University Hospital at Gangdong /ID# 214296
Seoul, 05278, South Korea
Asan Medical Center /ID# 214294
Seoul, 05505, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214295
Seoul, 06591, South Korea
Hospital Marina Baixa /ID# 215970
Villajoyosa, Alicante, 03570, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 214967
Sabadell, Barcelona, 08208, Spain
Hospital Unversitario Marques de Valdecilla /ID# 214965
Santander, Cantabria, 39008, Spain
Hospital Meixoeiro (CHUVI) /ID# 214969
Vigo, Pontevedra, 36213, Spain
Hospital Universitario Reina Sofia /ID# 214968
Córdoba, 14004, Spain
Hospital Universitario La Paz /ID# 216032
Madrid, 28046, Spain
Hospital Universitario y Politecnico La Fe /ID# 214966
Valencia, 46026, Spain
Kaohsiung Veterans General Hos /ID# 214332
Kaohsiung City, Taichung, 81362, Taiwan
Far Eastern Memorial Hospital /ID# 215384
New Taipei City, 22060, Taiwan
Chung Shan Medical University Hospital /ID# 214018
Taichung, 40201, Taiwan
China Medical University Hospital /ID# 214019
Taichung, 40447, Taiwan
Cathay General Hospital /ID# 214183
Taipei, 10630, Taiwan
Hacettepe Universitesi Tip Fak /ID# 214898
Sihhiye, Ankara, 06100, Turkey (Türkiye)
Istanbul University Cerrahpasa Faculty of Medicine /ID# 214895
Cerrahpaşa, 34098, Turkey (Türkiye)
Mugla Sitki Kocman University Medical Faculty /ID# 215358
Muğla, 48000, Turkey (Türkiye)
MNPE Chernihiv Regional Hospital of the Chernihiv Region Council /ID# 214145
Chernihiv, 14029, Ukraine
State Institution L.T. Malaya Therapy National Institute of the NAMS of Ukraine /ID# 214155
Kharkiv, 61039, Ukraine
CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 214158
Kharkiv, 61058, Ukraine
MNI City Multidisciplinary Hospital #18 /ID# 214154
Kharkiv, 61110, Ukraine
Khmelnytskyi Regional Hospital /ID# 214153
Khmelnytskyi, 29000, Ukraine
MI Kryvyi Rih City Clinical Hospital No.2 /ID# 214152
Kryvyi Rih, 50056, Ukraine
Medical Center LLC Institute of Rheumatology /ID# 214146
Kyiv, 02081, Ukraine
Kyiv Railway Clinical Hosp No.2 /ID# 214779
Kyiv, 03049, Ukraine
Medical Center CONSILIUM MEDICAL /ID# 216234
Kyiv, 04050, Ukraine
MNI KRC Kyiv Regional Clinical Hospital /ID# 214156
Kyiv, 04107, Ukraine
Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 214159
Odesa, 65025, Ukraine
Multifield Medical Centre of ONMU /ID# 214149
Odesa, 65026, Ukraine
PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 214151
Poltava, 36011, Ukraine
Ternopil University Hospital /ID# 214705
Ternopil, 46002, Ukraine
CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 214147
Vinnytsia, 21028, Ukraine
Clinic of Scientific Research Institute of Invalid Rehabilitation /ID# 214148
Vinnytsia, 21029, Ukraine
Minerva Health Centre /ID# 216226
Preston, Lancashire, PR1 6SB, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 214865
Norwich, Norfolk, NR4 7UY, United Kingdom
West Suffolk Hospital /ID# 215529
Bury St Edmunds, Suffolk, IP33 2QZ, United Kingdom
Doncaster Royal Infirmary /ID# 214971
Armthorpe Road, DN2 5LT, United Kingdom
Related Publications (11)
Baraliakos X, Bessette L, de Vlam K, Taylor PC, Biljan A, Urbanik J, Gao T, Jasion VS, Kato K, Lippe R, Magrey M. Impact of Upadacitinib on Reducing Pain in Patients Across the Axial Spondyloarthritis Spectrum: A Post Hoc Analysis of the Phase 2/3 SELECT-AXIS Studies. Rheumatol Ther. 2026 Mar 13. doi: 10.1007/s40744-026-00834-5. Online ahead of print.
PMID: 41824252DERIVEDBurmester 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: 40875187DERIVEDNavarro-Compan V, Van den Bosch F, Sampaio-Barros PD, Ostor AJK, Parikh B, Kato K, Gao T, Stigler J, Ramiro S. Efficacy of upadacitinib in subgroups of patients with axial spondyloarthritis with early versus established disease. RMD Open. 2025 Mar 4;11(1):e005110. doi: 10.1136/rmdopen-2024-005110.
PMID: 40037923DERIVEDVan den Bosch F, Deodhar A, Poddubnyy D, Maksymowych WP, van der Heijde D, Kim TH, Kishimoto M, Baraliakos X, Bu X, Lagunes-Galindo I, Song IH, Wung P, Kato K, Shmagel A. Upadacitinib in active non-radiographic axial spondyloarthritis: 2-year data from the phase 3 SELECT-AXIS 2 study. Arthritis Res Ther. 2025 Feb 4;27(1):23. doi: 10.1186/s13075-024-03441-3.
PMID: 39905436DERIVEDBaraliakos X, van der Heijde D, Sieper J, Inman RD, Kameda H, Maksymowych WP, Lagunes-Galindo I, Bu X, Wung P, Kato K, Shmagel A, Deodhar A. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis refractory to biologic therapy: 2-year clinical and radiographic results from the open-label extension of the SELECT-AXIS 2 study. Arthritis Res Ther. 2024 Nov 12;26(1):197. doi: 10.1186/s13075-024-03412-8.
PMID: 39533349DERIVEDBurmester GR, Stigler J, Rubbert-Roth A, Tanaka Y, Azevedo VF, Coombs D, Lagunes I, Lippe R, Wung P, Gensler LS. Safety Profile of Upadacitinib up to 5 Years in Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis: An Integrated Analysis of Clinical Trials. Rheumatol Ther. 2024 Jun;11(3):737-753. doi: 10.1007/s40744-024-00671-4. Epub 2024 Apr 29.
PMID: 38683479DERIVEDRubbert-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: 37982966DERIVEDKiltz U, Kishimoto M, Walsh JA, Sampaio-Barros P, Mittal M, Saffore CD, Wung P, Ganz F, Biljan A, Poddubnyy D. Effect of Upadacitinib on Quality of Life and Work Productivity in Active Non-radiographic Axial Spondyloarthritis: Results From Randomized Phase 3 Trial SELECT-AXIS 2. Rheumatol Ther. 2023 Aug;10(4):887-899. doi: 10.1007/s40744-023-00550-4. Epub 2023 May 16.
PMID: 37191738DERIVEDNavarro-Compan V, Baraliakos X, Magrey M, Ostor A, Saffore CD, Mittal M, Song IH, Ganz F, Stigler J, Deodhar A. Effect of Upadacitinib on Disease Activity, Pain, Fatigue, Function, Health-Related Quality of Life and Work Productivity for Biologic Refractory Ankylosing Spondylitis. Rheumatol Ther. 2023 Jun;10(3):679-691. doi: 10.1007/s40744-023-00536-2. Epub 2023 Feb 23.
PMID: 36820984DERIVEDDeodhar A, Van den Bosch F, Poddubnyy D, Maksymowych WP, van der Heijde D, Kim TH, Kishimoto M, Blanco R, Duan Y, Li Y, Pangan AL, Wung P, Song IH. Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022 Jul 30;400(10349):369-379. doi: 10.1016/S0140-6736(22)01212-0.
PMID: 35908570DERIVEDvan der Heijde D, Baraliakos X, Sieper J, Deodhar A, Inman RD, Kameda H, Zeng X, Sui Y, Bu X, Pangan AL, Wung P, Song IH. Efficacy and safety of upadacitinib for active ankylosing spondylitis refractory to biological therapy: a double-blind, randomised, placebo-controlled phase 3 trial. Ann Rheum Dis. 2022 Nov;81(11):1515-1523. doi: 10.1136/ard-2022-222608. Epub 2022 Jul 4.
PMID: 35788492DERIVED
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
November 18, 2019
First Posted
November 19, 2019
Study Start
November 26, 2019
Primary Completion
September 2, 2021
Study Completion
February 28, 2025
Last Updated
February 24, 2026
Results First Posted
September 21, 2022
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.