Clinical trial NCT04169373: A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spondyloarthritis
Keywords: Upadacitinib
Axial Spondyloarthritis (axSpA)
Spondyloarthritis
Ankylosing Spondylitis (AS)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-11-19
Enrollment: 734
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Study 1 (bDMARD-IR AS) is comprised of a 14-week randomized, double-blind, parallel-group, placebo-controlled period (the Double-Blind Period); a 90-week open-label, long-term extension period (the Open-Label Extension Period); and a 30-day Follow-Up Visit (F/U Visit).

Study 2 (nr-axSpA) is comprised of a 52-week randomized, double-blind, parallel-group, placebo-controlled period (the Double-Blind Period); a 52-week open-label, long-term extension period (the Open-Label Extension Period); and a 30-day F/U Visit.

In the Double-Blind Period for both studies, participants are randomized in a 1:1 ratio to receive either upadacitinib or placebo once daily (QD).

Participants in the placebo group switch to upadacitinib 15 mg QD at Week 14 in the Open-Label Extension Period for Study 1 (bDMARD-IR AS) and Week 52 in the Open-Label Extension Period for Study 2 (nr-axSpA).

Participants in remission at Week 104 have the option to enroll in a remission-withdrawal period.

Study M19-944 protocol uses a common screening platform for determining eligibility into Study 1 and Study 2. Each study has its own objectives, hypothesis testing, randomization, data collection, and adequate power for primary and secondary endpoints. Analysis and reporting are conducted separately and independently for each study.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14
timeFrame: Baseline and Week 14
measure: Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14
timeFrame: Baseline and Week 14
Secondary outcomes:
measure: Study 1: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14
timeFrame: Baseline and Week 14
measure: Study 1: Change From Baseline in Magnetic Resonance Imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) Score for the Spine at Week 14
timeFrame: Baseline and Week 14
measure: Study 1: Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14
timeFrame: Baseline and Week 14
measure: Study 1: Percentage of Participants With an ASAS20 Response at Week 14
timeFrame: Baseline and Week 14
measure: Study 1: Percentage of Participants With ASDAS Inactive Disease at Week 14
timeFrame: Week 14
measure: Study 1: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14
timeFrame: Baseline and Week 14
measure: Study 1: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14
timeFrame: Baseline and Week 14
measure: Study 1: Percentage of Participants With ASDAS Low Disease Activity at Week 14
timeFrame: Week 14
measure: Study 1: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
timeFrame: Baseline and Week 14
measure: Study 1: Percentage of Participants With ASAS Partial Remission at Week 14
timeFrame: Week 14
measure: Study 1: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Week 14
timeFrame: Baseline and Week 14
measure: Study 1: Change From Baseline in ASAS Health Index at Week 14
timeFrame: Baseline and Week 14
measure: Study 1: Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14
timeFrame: Baseline and Week 14
measure: Study 1: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14
timeFrame: Baseline and Week 14
measure: Study 1: Change From Baseline in MRI SPARCC Score for Sacroiliac Joints at Week 14
timeFrame: Baseline and Week 14
measure: Study 2: Change From Baseline in ASDAS at Week 14
timeFrame: Baseline and Week 14
measure: Study 2: Change From Baseline in MRI SPARCC Score for SI Joints at Week 14
timeFrame: Baseline and Week 14
measure: Study 2: Percentage of Participants With BASDAI 50 Response at Week 14
timeFrame: Baseline and Week 14
measure: Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 14
timeFrame: Week 14
measure: Study 2: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14
timeFrame: Baseline and Week 14
measure: Study 2: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14
timeFrame: Baseline and Week 14
measure: Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 14
timeFrame: Week 14
measure: Study 2: Percentage of Participants With ASAS Partial Remission at Week 14
timeFrame: Week 14
measure: Study 2: Change From Baseline in BASFI at Week 14
timeFrame: Baseline and Week 14
measure: Study 2: Change From Baseline in ASQoL at Week 14
timeFrame: Baseline and Week 14
measure: Study 2: Change From Baseline in ASAS Health Index at Week 14
timeFrame: Baseline and Week 14
measure: Study 2: Percentage of Participants Achieving an ASAS20 Response at Week 14
timeFrame: Baseline and Week 14
measure: Study 2: Change From Baseline in BASMI(Lin) at Week 14
timeFrame: Baseline and Week 14
measure: Study 2: Change From Baseline in MASES at Week 14
timeFrame: Baseline and Week 14
measure: Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 52
timeFrame: Baseline and Week 52
measure: Study 2: Change From Baseline in MRI SPARCC Score for the Spine at Week 14
timeFrame: Baseline and Week 14
measure: Study 2: Percentage of Participants Who Initiated Rescue Treatment Between Week 24 and Week 52
timeFrame: Week 24, Week 32, Week 40, and Week 52
measure: Study 2: Percentage of Participants With ASDAS Major Improvement at Week 52
timeFrame: Baseline and Week 52
measure: Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 52
timeFrame: Week 52
measure: Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C. /ID# 215282
state: Arizona
city: Phoenix
country: United States
facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 215113
state: Arizona
city: Tucson
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 214731
state: Arizona
city: Huntington Beach
country: United States
facility: Newport Huntington Medical Group /ID# 216281
state: California
city: Upland
country: United States
facility: Inland Rheum & Osteo Med Grp /ID# 215807
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic /ID# 215346
state: Colorado
city: Fort Collins
country: United States
facility: Tekton Research /ID# 215054
state: Colorado
city: Aventura
country: United States
facility: Arthritis & Rheumatic Disease Specialties /ID# 215306
state: Florida
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty Inc /ID# 215931
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center /ID# 216068
state: Florida
city: Winter Park
country: United States
facility: Conquest Research /ID# 215804
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials /ID# 215790
state: Illinois
city: Schaumburg
country: United States
facility: Greater Chicago Specialty Physicians /ID# 216213
state: Illinois
city: Skokie
country: United States
facility: Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 215055
state: Illinois
city: Hagerstown
country: United States
facility: Klein and Associates MD /ID# 214767
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center /ID# 215925
state: Massachusetts
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group /ID# 215293
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University Health Center /ID# 215930
state: Michigan
city: Lansing
country: United States
facility: Advanced Rheumatology, PC /ID# 214973
state: Michigan
city: Eagan
country: United States
facility: St. Paul Rheumatology /ID# 215537
state: Minnesota
city: Saint Louis
country: United States
facility: CenterPointe Institute of Research /ID# 215793
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC /ID# 215785
state: Missouri
city: New York
country: United States
facility: NYU Langone Orthopedic Center /ID# 215594
state: New York
city: Potsdam
country: United States
facility: St. Lawrence Health System /ID# 215844
state: New York
city: Leland
country: United States
facility: Cape Fear Arthritis Care /ID# 215927
state: North Carolina
city: Marietta
country: United States
facility: Marietta Memorial Hospital /ID# 215929
state: Ohio
city: Springboro
country: United States
facility: STAT Research, Inc. /ID# 215264
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma /ID# 215117
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University /ID# 216446
state: Oregon
city: Duncansville
country: United States
facility: Altoona Ctr Clinical Res /ID# 214770
state: Pennsylvania
city: Austin
country: United States
facility: Tekton Research, Inc. /ID# 214923
state: Texas
city: Carrollton
country: United States
facility: Trinity Universal Research Associates - Carrollton /ID# 214948
state: Texas
city: College Station
country: United States
facility: Arthritis and Osteoporosis Clinic Of Brazos Valley /ID# 215805
state: Texas
city: Fort Worth
country: United States
facility: JPS Rheumatology Clinic /ID# 215962
state: Texas
city: Houston
country: United States
facility: Memorial Rheumatology /ID# 216311
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC /ID# 215885
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic - Park Row /ID# 215907
state: Texas
city: Lubbock
country: United States
facility: West Texas Clinical Research /ID# 215928
state: Texas
city: Plano
country: United States
facility: Trinity Universal Research Associates, Inc /ID# 215189
state: Texas
city: Beckley
country: United States
facility: Rheumatology and Pulmonary Clinic /ID# 214946
state: West Virginia
city: South Charleston
country: United States
facility: West Virginia Research Inst /ID# 214921
state: West Virginia
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Organizacion Medica de Investigacion (OMI) /ID# 214557
state: Ciuadad Autonoma De Buenos Aires
city: Rosario
country: Argentina
facility: Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 214556
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto CAICI /ID# 215242
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman /ID# 214559
state: Tucuman
city: Cordoba
country: Argentina
facility: Hospital Cordoba /ID# 215846
city: Cordoba
country: Argentina
facility: Instituto Medico Strusberg /ID# 215239
city: San Miguel de Tucuman
country: Argentina
facility: Cimer /Id# 215240
city: Botany
country: Australia
facility: Emeritus Research Sydney /ID# 215507
state: New South Wales
city: Paramatta
country: Australia
facility: BJC Health /ID# 215510
state: New South Wales
city: Camberwell
country: Australia
facility: Emeritus Research /ID# 215506
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre /ID# 215509
state: Victoria
city: Geelong
country: Australia
facility: Barwon Rheumatology Services /ID# 215508
state: Victoria
city: Gent
country: Belgium
facility: UZ Gent /ID# 215004
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 215006
state: Vlaams-Brabant
city: Genk
country: Belgium
facility: ReumaClinic /ID# 215005
city: Juiz de Fora
country: Brazil
facility: CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 215277
state: Minas Gerais
city: Curitiba
country: Brazil
facility: EDUMED Educacao em Saude S/S L /ID# 215111
state: Parana
city: Porto Alegre
country: Brazil
facility: LMK Sevicos Medicos S/S /ID# 215112
state: Rio Grande Do Sul
city: Sao Jose Do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 215176
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: CPCLIN - Centro de Pesquisas Clínicas /ID# 215175
city: Plovdiv
country: Bulgaria
facility: UMHAT Kaspela EOOD /ID# 214803
city: Plovdiv
country: Bulgaria
facility: Medical center Unimed /ID# 214816
city: Plovdiv
country: Bulgaria
facility: MHAT Plovdiv /ID# 214815
city: Ruse
country: Bulgaria
facility: Medical center Teodora /ID# 214813
city: Sofia
country: Bulgaria
facility: Medical center Excelsior /ID# 214805
city: Sofia
country: Bulgaria
facility: UMHAT Sveti Ivan Rilski /ID# 214804
city: Sofia
country: Bulgaria
facility: UMHAT Sveti Ivan Rilski /ID# 214806
city: Sofia
country: Bulgaria
facility: Diagnostic consultative center 17 Sofia /ID# 214808
city: Victoria
country: Canada
facility: Percuro Clinical Research, Ltd /ID# 215302
state: British Columbia
city: Toronto
country: Canada
facility: Toronto Western Hospital /ID# 215041
state: Ontario
city: Montréal
country: Canada
facility: Applied Medical Informatics Research Inc. (AMIR) /ID# 215303
state: Quebec
city: Trois-rivières
country: Canada
facility: Centre de Recherche Musculo-Squelettique /ID# 215096
state: Quebec
city: Quebec
country: Canada
facility: Centre de recherche du CHUQ /ID# 215038
city: Bengbu
country: China
facility: The first affiliated hospital of bengbu medical college /ID# 216609
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital /ID# 216631
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital /ID# 216545
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital /ID# 216645
state: Guangdong
city: Shantou
country: China
facility: The First Affiliated Hospital of Shantou University Medical College /ID# 217883
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital /ID# 225438
state: Guangdong
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital /ID# 216644
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hospital of BaoTou Medical College, Inner Mongolia Universi /ID# 216612
state: Inner Mongolia
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University /ID# 216607
state: Jiangsu
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University /ID# 216646
state: Shanghai
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University /ID# 217945
city: Brno
country: Czechia
facility: REVMACLINIC s.r.o. /ID# 215153
city: Brno
country: Czechia
facility: Revmacentrum MUDr. Mostera, s.r.o. /ID# 215161
city: Brno
country: Czechia
facility: Revmatologie, s.r.o. /ID# 215309
city: Ostrava
country: Czechia
facility: CCR Ostrava, s.r.o. /ID# 215226
city: Pardubice
country: Czechia
facility: ARTHROHELP, s.r.o. /ID# 215224
city: Praha
country: Czechia
facility: Revmatologicky ustav v Praze /ID# 215154
city: Praha
country: Czechia
facility: PV MEDICAL Services s.r.o. /ID# 215119
city: Praha
country: Czechia
facility: Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 215652
city: Praha
country: Czechia
facility: Thomayerova nemocnice /ID# 215118
city: Praha
country: Czechia
facility: Fakultni Nemocnice v Motole /ID# 215160
city: Uherske Hradiste
country: Czechia
facility: MEDICAL PLUS, s.r.o. /ID# 215324
city: Toulouse
country: France
facility: CHU Toulouse /ID# 214780
state: Occitanie
city: Bordeaux
country: France
facility: CHU Bordeaux - Hopital Pellegrin /ID# 214784
city: Boulogne Billancourt
country: France
facility: Hopital Ambroise Pare /ID# 214783
city: Paris
country: France
facility: AP-HP - Hopital Cochin /ID# 214782
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen /ID# 214281
state: Bayern
city: Berlin
country: Germany
facility: Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 214282
city: Berlin
country: Germany
facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214211
city: Cottbus
country: Germany
facility: Rheuma Research Lausitz, Dr. Mario Sutowicz /ID# 214218
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214207
city: Erlangen
country: Germany
facility: Praxisgemeinschaft Rheumatologie Nephrologie Erlangen /ID# 214212
city: Hamburg
country: Germany
facility: MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 214208
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover /ID# 214209
city: Planegg
country: Germany
facility: MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 214261
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont /ID# 215187
state: Hajdu-Bihar
city: Veszprém
country: Hungary
facility: Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 215182
state: Veszprem
city: Kormend
country: Hungary
facility: Rehavita Kft HU /ID# 215188
state: Zala
city: Budapest
country: Hungary
facility: Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 215183
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 215186
city: Heviz
country: Hungary
facility: Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 215184
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz /ID# 214501
city: Szekesfehervar
country: Hungary
facility: CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 215181
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 215854
state: Tel-Aviv
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 216956
state: Tel-Aviv
city: Haifa
country: Israel
facility: Bnai Zion Medical Center /ID# 215856
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 217255
city: Nagoya-shi
country: Japan
facility: Daido Clinic /ID# 214735
state: Aichi
city: Matsuyama-shi
country: Japan
facility: Matsuyama Red Cross Hospital /ID# 216021
state: Ehime
city: Asahikawa-shi
country: Japan
facility: National Hospital Organization Asahikawa Medical Center /ID# 214930
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 215221
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe University Hospital /ID# 214598
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Hyogo College of Medicine College Hospital /Id# 215638
state: Hyogo
city: Ono-shi
country: Japan
facility: Kita-harima Medical Center /ID# 216069
state: Hyogo
city: Kuwana-shi
country: Japan
facility: Kuwana City Medical Center /ID# 215196
state: Mie
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital /ID# 215947
state: Nagasaki
city: Sasebo-shi
country: Japan
facility: Sasebo Chuo Hospital /ID# 214703
state: Nagasaki
city: Okayama-shi
country: Japan
facility: Japanese Red Cross Okayama Hospital /ID# 214732
state: Okayama
city: Uruma-shi
country: Japan
facility: Okinawa Prefectural Chubu Hospital /ID# 215575
state: Okinawa
city: Kawachinagano Shi
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center /ID# 214205
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital /ID# 215640
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 214929
state: Tokyo
city: Chuo-ku
country: Japan
facility: St.Luke's International Hospital /ID# 215414
state: Tokyo
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital /ID# 214533
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital /ID# 214297
state: Seoul Teugbyeolsi
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center /ID# 214534
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 214532
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Hospital at Gangdong /ID# 214296
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 214294
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214295
city: Mexico City
country: Mexico
facility: CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 215217
state: Ciudad De Mexico
city: Papatoetoe
country: New Zealand
facility: Middlemore Clinical Trials /ID# 215502
state: Auckland
city: Hamilton
country: New Zealand
facility: Waikato Hospital /ID# 215503
state: Waikato
city: Wroclaw
country: Poland
facility: WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 215093
state: Dolnoslaskie
city: Torun
country: Poland
facility: Nasz Lekarz Przychodnie Medyczne /ID# 214352
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: REUMED Sp.z o.o. Filia nr 1 /ID# 214353
state: Lubelskie
city: Bialystok
country: Poland
facility: Osteo-Medic S.C. /ID# 214351
state: Podlaskie
city: Olsztyn
country: Poland
facility: ETYKA-Osrodek Badan Klinicznych /ID# 215572
state: Warminsko-mazurskie
city: Poznan
country: Poland
facility: AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 214354
state: Wielkopolskie
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Hospital /ID# 214463
state: Chelyabinskaya Oblast
city: Kaliningrad
country: Russian Federation
facility: Immanuel Kant Baltic Federal University /ID# 218259
state: Kaliningradskaya Oblast
city: Korolev
country: Russian Federation
facility: LLC Family Outpatient Clinic № /ID# 214455
state: Moskva
city: Moscow
country: Russian Federation
facility: Research Institute of Rheumatology named after V.A. Nasonova /ID# 214459
state: Moskva
city: Novosibirsk
country: Russian Federation
facility: LLC Medical Center /ID# 214410
state: Novosibirskaya Oblast
city: St. Petersburg
country: Russian Federation
facility: Nort-Western State Medical University n.a. Mechnikov /ID# 214454
state: Sankt-Peterburg
city: Pyatigorsk
country: Russian Federation
facility: LLC Novaya Klinika /ID# 214420
state: Stavropol Skiy Kray
city: Yekaterinburg
country: Russian Federation
facility: Family Clinic /ID# 214737
state: Sverdlovskaya Oblast
city: Yekaterinburg
country: Russian Federation
facility: Central City Hospital #7 /ID# 214741
state: Sverdlovskaya Oblast
city: Kazan
country: Russian Federation
facility: Kazan State Medical University /ID# 214421
state: Tatarstan, Respublika
city: Izhevsk
country: Russian Federation
facility: Alliance Biomedical Ural Group /ID# 214457
state: Udmurtskaya Respublika
city: Moscow
country: Russian Federation
facility: Olla-Med Clinic /ID# 214460
city: Moscow
country: Russian Federation
facility: City Clinical Hospital n.a. O.M. Filatov /ID# 214486
city: Omsk
country: Russian Federation
facility: Omsk Regional Clinic Hospital /ID# 214464
city: Orenburg
country: Russian Federation
facility: Orenburg State Medical University /ID# 214408
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University named after academician I.P. Pavlov /ID# 214418
city: Saratov
country: Russian Federation
facility: RZD-Medicine Saratov /ID# 214465
city: St. Petersburg
country: Russian Federation
facility: Clinical Rheumatologic Hospital No 25 /ID# 214488
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk Regional Clinical Hospital /ID# 214458
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava Nemocnica Stare Mesto /ID# 214675
city: Nove Mesto nad Vahom
country: Slovakia
facility: Reum.hapi s.r.o. /ID# 224268
city: Piestany
country: Slovakia
facility: Narodny ustav reumatickych chorob /ID# 214674
city: Poprad
country: Slovakia
facility: MUDr. Zuzana Cizmarikova s.r.o. /ID# 215220
city: Zvolen
country: Slovakia
facility: ALBAMED s.r.o. /ID# 215248
city: Villajoyosa
country: Spain
facility: Hospital Marina Baixa /ID# 215970
state: Alicante
city: Sabadell
country: Spain
facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 214967
state: Barcelona
city: Santander
country: Spain
facility: Hospital Unversitario Marques de Valdecilla /ID# 214965
state: Cantabria
city: Vigo
country: Spain
facility: Hospital Meixoeiro (CHUVI) /ID# 214969
state: Pontevedra
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia /ID# 214968
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 216032
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 214966
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hos /ID# 214332
state: Taichung
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital /ID# 215384
city: Taichung City
country: Taiwan
facility: China Medical University Hospital /ID# 214019
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital /ID# 214018
city: Taipei
country: Taiwan
facility: Cathay General Hospital /ID# 214183
city: Sihhiye
country: Turkey
facility: Hacettepe Universitesi Tip Fak /ID# 214898
state: Ankara
city: Cerrahpasa
country: Turkey
facility: Istanbul University Cerrahpasa Faculty of Medicine /ID# 214895
city: Mugla
country: Turkey
facility: Mugla Sitki Kocman University Medical Faculty /ID# 215358
city: Chernihiv
country: Ukraine
facility: MNPE Chernihiv Regional Hospital of the Chernihiv Region Council /ID# 214145
city: Kharkiv
country: Ukraine
facility: State Institution L.T. Malaya Therapy National Institute of the NAMS of Ukraine /ID# 214155
city: Kharkiv
country: Ukraine
facility: CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 214158
city: Kharkiv
country: Ukraine
facility: MNI City Multidisciplinary Hospital #18 /ID# 214154
city: Khmelnytskyi
country: Ukraine
facility: Khmelnytskyi Regional Hospital /ID# 214153
city: Kryvyi Rih
country: Ukraine
facility: MI Kryvyi Rih City Clinical Hospital No.2 /ID# 214152
city: Kyiv
country: Ukraine
facility: Medical Center LLC Institute of Rheumatology /ID# 214146
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hosp No.2 /ID# 214779
city: Kyiv
country: Ukraine
facility: Medical Center CONSILIUM MEDICAL /ID# 216234
city: Kyiv
country: Ukraine
facility: MNI KRC Kyiv Regional Clinical Hospital /ID# 214156
city: Odesa
country: Ukraine
facility: Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 214159
city: Odesa
country: Ukraine
facility: Multifield Medical Centre of ONMU /ID# 214149
city: Poltava
country: Ukraine
facility: PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 214151
city: Ternopil
country: Ukraine
facility: Ternopil University Hospital /ID# 214705
city: Vinnytsia
country: Ukraine
facility: CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 214147
city: Vinnytsia
country: Ukraine
facility: Clinic of Scientific Research Institute of Invalid Rehabilitation /ID# 214148
city: Preston
country: United Kingdom
facility: Minerva Health Centre /ID# 216226
state: Lancashire
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 214865
state: Norfolk
city: Bury St Edmunds
country: United Kingdom
facility: West Suffolk Hospital /ID# 215529
state: Suffolk
city: Armthorpe Road
country: United Kingdom
facility: Doncaster Royal Infirmary /ID# 214971
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: Deodhar 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.
citation: van 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.