A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis (SELECT-AXIS 2)

February 6, 2026 updated by: AbbVie

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

734

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, 5000
        • Hospital Cordoba /ID# 215846
      • Córdoba, Argentina, 5000
        • Instituto Medico Strusberg /ID# 215239
      • San Miguel de Tucumán, Argentina, 4000
        • Cimer /Id# 215240
    • Ciuadad Autonoma de Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina, 1015
        • Organizacion Medica de Investigacion (OMI) /ID# 214557
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 214556
      • Rosario, Santa Fe Province, Argentina, 2000
        • Instituto CAICI /ID# 215242
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Centro de Investigaciones Medicas Tucuman /ID# 214559
  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Emeritus Research Sydney /ID# 215507
      • Paramatta, New South Wales, Australia, 2150
        • BJC Health /ID# 215510
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research /ID# 215506
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre /ID# 215509
      • Geelong, Victoria, Australia, 3220
        • Barwon Rheumatology Services /ID# 215508
  • Belgium
      • Genk, Belgium, 3600
        • ReumaClinic /ID# 215005
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 215004
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 215006
  • Brazil
      • São Paulo, Brazil, 01228-200
        • CPCLIN - Centro de Pesquisas Clínicas /ID# 215175
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 215277
    • Paraná
      • Curitiba, Paraná, Brazil, 80440-080
        • EDUMED Educacao em Saude S/S L /ID# 215111
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
        • LMK Sevicos Medicos S/S /ID# 215112
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 215176
  • Bulgaria
      • Plovdiv, Bulgaria, 4001
        • UMHAT Kaspela EOOD /ID# 214803
      • Plovdiv, Bulgaria, 4023
        • Medical center Unimed /ID# 214816
      • Plovdiv, Bulgaria, 4027
        • MHAT Plovdiv /ID# 214815
      • Rousse, Bulgaria, 7012
        • Medical center Teodora /ID# 214813
      • Sofia, Bulgaria, 1407
        • Medical center Excelsior /ID# 214805
      • Sofia, Bulgaria, 1431
        • UMHAT Sveti Ivan Rilski /ID# 214804
      • Sofia, Bulgaria, 1431
        • UMHAT Sveti Ivan Rilski /ID# 214806
      • Sofia, Bulgaria, 1505
        • Diagnostic consultative center 17 Sofia /ID# 214808
  • Canada
      • Québec, Canada, G1R 3S2
        • Centre de recherche du CHUQ /ID# 215038
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3M9
        • Percuro Clinical Research, Ltd /ID# 215302
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital /ID# 215041
    • Quebec
      • Montreal, Quebec, Canada, H4A 3T2
        • Applied Medical Informatics Research Inc. (AMIR) /ID# 215303
      • Trois-Rivières, Quebec, Canada, G8Z 1Y2
        • Centre de Recherche Musculo-Squelettique /ID# 215096
  • China
      • Kunming, China, 650032
        • First Affiliated Hospital of Kunming Medical University /ID# 217945
    • Anhui
      • Bengbu, Anhui, China, 233004
        • The first affiliated hospital of bengbu medical college /ID# 216609
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital /ID# 216631
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital /ID# 216545
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital /ID# 216645
      • Shantou, Guangdong, China, 515041
        • The First Affiliated Hospital of Shantou University Medical College /ID# 217883
      • Shenzhen, Guangdong, China, 518020
        • Shenzhen People's Hospital /ID# 225438
    • Hunan
      • Zhuzhou, Hunan, China, 412007
        • Zhuzhou Central Hospital /ID# 216644
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014016
        • The First Affiliated Hospital of BaoTou Medical College, Inner Mongolia Universi /ID# 216612
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University /ID# 216607
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Huashan Hospital, Fudan University /ID# 216646
  • Czechia
      • Brno, Czechia, 602 00
        • REVMACLINIC s.r.o. /ID# 215153
      • Brno, Czechia, 615 00
        • Revmacentrum MUDr. Mostera, s.r.o. /ID# 215161
      • Brno, Czechia, 638 00
        • Revmatologie, s.r.o. /ID# 215309
      • Ostrava, Czechia, 702 00
        • CCR Ostrava, s.r.o. /ID# 215226
      • Pardubice, Czechia, 530 02
        • ARTHROHELP, s.r.o. /ID# 215224
      • Prague, Czechia, 128 00
        • Revmatologicky ustav v Praze /ID# 215154
      • Prague, Czechia, 130 00
        • PV MEDICAL Services s.r.o. /ID# 215119
      • Prague, Czechia, 140 00
        • Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 215652
      • Prague, Czechia, 140 59
        • Thomayerova nemocnice /ID# 215118
      • Prague, Czechia, 150 06
        • Fakultni Nemocnice v Motole /ID# 215160
      • Uherské Hradiště, Czechia, 686 01
        • MEDICAL PLUS, s.r.o. /ID# 215324
  • France
      • Bordeaux, France, 33000
        • CHU Bordeaux - Hopital Pellegrin /ID# 214784
      • Boulogne-Billancourt, France, 92104
        • Hopital Ambroise Pare /ID# 214783
      • Paris, France, 75014
        • AP-HP - Hopital Cochin /ID# 214782
    • Occitanie
      • Toulouse, Occitanie, France, 31300
        • CHU Toulouse /ID# 214780
  • Germany
      • Berlin, Germany, 12161
        • Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 214282
      • Berlin, Germany, 12203
        • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214211
      • Cottbus, Germany, 30342
        • Rheuma Research Lausitz, Dr. Mario Sutowicz /ID# 214218
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214207
      • Erlangen, Germany, 91056
        • Praxisgemeinschaft Rheumatologie Nephrologie Erlangen /ID# 214212
      • Hamburg, Germany, 20095
        • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 214208
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover /ID# 214209
      • Planegg, Germany, 82152
        • MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 214261
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Universitaetsklinikum Erlangen /ID# 214281
  • Hungary
      • Budapest, Hungary, 1023
        • Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 215183
      • Gyula, Hungary, 5700
        • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 215186
      • Hévíz, Hungary, 8380
        • Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 215184
      • Kistarcsa, Hungary, 2143
        • Pest Megyei Flor Ferenc Korhaz /ID# 214501
      • Székesfehérvár, Hungary, 8000
        • CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 215181
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont /ID# 215187
    • Veszprém megye
      • Veszprém, Veszprém megye, Hungary, 8200
        • Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 215182
    • Zala County
      • Kormend, Zala County, Hungary, 9900
        • Rehavita Kft HU /ID# 215188
  • Israel
      • Haifa, Israel, 3339419
        • Bnai Zion Medical Center /ID# 215856
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center /ID# 217255
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • The Chaim Sheba Medical Center /ID# 215854
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 216956
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 457-8511
        • Daido Clinic /ID# 214735
    • Ehime
      • Matsuyama, Ehime, Japan, 790-8524
        • Matsuyama Red Cross Hospital /ID# 216021
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 070-8644
        • National Hospital Organization Asahikawa Medical Center /ID# 214930
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital /ID# 215221
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0017
        • Kobe University Hospital /ID# 214598
      • Nishinomiya-shi, Hyōgo, Japan, 663-8501
        • Hyogo College of Medicine College Hospital /Id# 215638
      • Ono-shi, Hyōgo, Japan, 675-1327
        • Kita-harima Medical Center /ID# 216069
    • Mie-ken
      • Kuwana-shi, Mie-ken, Japan, 511-0061
        • Kuwana City Medical Center /ID# 215196
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital /ID# 215947
      • Sasebo-shi, Nagasaki, Japan, 857-1195
        • Sasebo Chuo Hospital /ID# 214703
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8607
        • Japanese Red Cross Okayama Hospital /ID# 214732
    • Okinawa
      • Uruma, Okinawa, Japan, 904-2293
        • Okinawa Prefectural Chubu Hospital /ID# 215575
    • Osaka
      • Kawachinagano Shi, Osaka, Japan, 586-8521
        • National Hospital Organization Osaka Minami Medical Center /ID# 214205
      • Osaka, Osaka, Japan, 534-0021
        • Osaka City General Hospital /ID# 215640
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital /ID# 214929
      • Chuo-ku, Tokyo, Japan, 104-8560
        • St.Luke's International Hospital /ID# 215414
  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 11850
        • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 215217
  • New Zealand
    • Auckland
      • Papatoetoe, Auckland, New Zealand, 2025
        • Middlemore Clinical Trials /ID# 215502
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3240
        • Waikato Hospital /ID# 215503
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-113
        • AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 214354
    • Kuyavian-Pomeranian Voivodeship
      • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
        • Nasz Lekarz Przychodnie Medyczne /ID# 214352
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 51-685
        • WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 215093
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-607
        • REUMED Sp.z o.o. Filia nr 1 /ID# 214353
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-351
        • Osteo-Medic S.C. /ID# 214351
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-117
        • ETYKA-Osrodek Badan Klinicznych /ID# 215572
  • Russia
      • Moscow, Russia, 105554
        • Olla-Med Clinic /ID# 214460
      • Moscow, Russia, 111539
        • City Clinical Hospital n.a. O.M. Filatov /ID# 214486
      • Omsk, Russia, 644111
        • Omsk Regional Clinic Hospital /ID# 214464
      • Orenburg, Russia, 460000
        • Orenburg State Medical University /ID# 214408
      • Ryazan, Russia, 390026
        • Ryazan State Medical University named after academician I.P. Pavlov /ID# 214418
      • Saint Petersburg, Russia, 190068
        • Clinical Rheumatologic Hospital No 25 /ID# 214488
      • Saratov, Russia, 410004
        • RZD-Medicine Saratov /ID# 214465
      • Ulyanovsk, Russia, 432017
        • Ulyanovsk Regional Clinical Hospital /ID# 214458
    • Chelyabinsk Oblast
      • Chelyabinsk, Chelyabinsk Oblast, Russia, 454087
        • Chelyabinsk Regional Clinical Hospital /ID# 214463
    • Kaliningrad Oblast
      • Kaliningrad, Kaliningrad Oblast, Russia, 236016
        • Immanuel Kant Baltic Federal University /ID# 218259
    • Moscow
      • Korolev, Moscow, Russia, 141060
        • LLC Family Outpatient Clinic № /ID# 214455
      • Moscow, Moscow, Russia, 115522
        • Research Institute of Rheumatology named after V.A. Nasonova /ID# 214459
    • Novosibirsk Oblast
      • Novosibirsk, Novosibirsk Oblast, Russia, 630099
        • LLC Medical Center /ID# 214410
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 193015
        • Nort-Western State Medical University n.a. Mechnikov /ID# 214454
    • Stavropol Kray
      • Pyatigorsk, Stavropol Kray, Russia, 357500
        • LLC Novaya Klinika /ID# 214420
    • Sverdlovsk Oblast
      • Yekaterinburg, Sverdlovsk Oblast, Russia, 620109
        • Family Clinic /ID# 214737
      • Yekaterinburg, Sverdlovsk Oblast, Russia, 620137
        • Central City Hospital #7 /ID# 214741
    • Tatarstan, Respublika
      • Kazan', Tatarstan, Respublika, Russia, 420012
        • Kazan State Medical University /ID# 214421
    • Udmurtiya Republic
      • Izhevsk, Udmurtiya Republic, Russia, 426061
        • Alliance Biomedical Ural Group /ID# 214457
  • Slovakia
      • Bratislava, Slovakia, 813 69
        • Univerzitna nemocnica Bratislava Nemocnica Stare Mesto /ID# 214675
      • Nové Mesto nad Váhom, Slovakia, 915 01
        • Reum.hapi s.r.o. /ID# 224268
      • Piešťany, Slovakia, 921 12
        • Narodny ustav reumatickych chorob /ID# 214674
      • Poprad, Slovakia, 058 01
        • MUDr. Zuzana Cizmarikova s.r.o. /ID# 215220
      • Zvolen, Slovakia, 960 01
        • ALBAMED s.r.o. /ID# 215248
  • South Korea
      • Incheon, South Korea, 21565
        • Gachon University Gil Medical Center /ID# 214534
      • Seoul, South Korea, 03080
        • Seoul National University Hospital /ID# 214532
      • Seoul, South Korea, 05278
        • Kyunghee University Hospital at Gangdong /ID# 214296
      • Seoul, South Korea, 05505
        • Asan Medical Center /ID# 214294
      • Seoul, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214295
    • Gyeonggido
      • Suwon, Gyeonggido, South Korea, 16499
        • Ajou University Hospital /ID# 214533
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 04763
        • Hanyang University Seoul Hospital /ID# 214297
  • Spain
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia /ID# 214968
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz /ID# 216032
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe /ID# 214966
    • Alicante
      • Villajoyosa, Alicante, Spain, 03570
        • Hospital Marina Baixa /ID# 215970
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 214967
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Unversitario Marques de Valdecilla /ID# 214965
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36213
        • Hospital Meixoeiro (CHUVI) /ID# 214969
  • Taiwan
      • New Taipei City, Taiwan, 22060
        • Far Eastern Memorial Hospital /ID# 215384
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University Hospital /ID# 214018
      • Taichung, Taiwan, 40447
        • China Medical University Hospital /ID# 214019
      • Taipei, Taiwan, 10630
        • Cathay General Hospital /ID# 214183
    • Taichung
      • Kaohsiung City, Taichung, Taiwan, 81362
        • Kaohsiung Veterans General Hos /ID# 214332
  • Turkey (Türkiye)
      • Cerrahpaşa, Turkey (Türkiye), 34098
        • Istanbul University Cerrahpasa Faculty of Medicine /ID# 214895
      • Muğla, Turkey (Türkiye), 48000
        • Mugla Sitki Kocman University Medical Faculty /ID# 215358
    • Ankara
      • Sihhiye, Ankara, Turkey (Türkiye), 06100
        • Hacettepe Universitesi Tip Fak /ID# 214898
  • Ukraine
      • Chernihiv, Ukraine, 14029
        • MNPE Chernihiv Regional Hospital of the Chernihiv Region Council /ID# 214145
      • Kharkiv, Ukraine, 61039
        • State Institution L.T. Malaya Therapy National Institute of the NAMS of Ukraine /ID# 214155
      • Kharkiv, Ukraine, 61058
        • CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 214158
      • Kharkiv, Ukraine, 61110
        • MNI City Multidisciplinary Hospital #18 /ID# 214154
      • Khmelnytskyi, Ukraine, 29000
        • Khmelnytskyi Regional Hospital /ID# 214153
      • Kryvyi Rih, Ukraine, 50056
        • MI Kryvyi Rih City Clinical Hospital No.2 /ID# 214152
      • Kyiv, Ukraine, 02081
        • Medical Center LLC Institute of Rheumatology /ID# 214146
      • Kyiv, Ukraine, 03049
        • Kyiv Railway Clinical Hosp No.2 /ID# 214779
      • Kyiv, Ukraine, 04050
        • Medical Center CONSILIUM MEDICAL /ID# 216234
      • Kyiv, Ukraine, 04107
        • MNI KRC Kyiv Regional Clinical Hospital /ID# 214156
      • Odesa, Ukraine, 65025
        • Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 214159
      • Odesa, Ukraine, 65026
        • Multifield Medical Centre of ONMU /ID# 214149
      • Poltava, Ukraine, 36011
        • PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 214151
      • Ternopil, Ukraine, 46002
        • Ternopil University Hospital /ID# 214705
      • Vinnytsia, Ukraine, 21028
        • CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 214147
      • Vinnytsia, Ukraine, 21029
        • Clinic of Scientific Research Institute of Invalid Rehabilitation /ID# 214148
  • United Kingdom
      • Armthorpe Road, United Kingdom, DN2 5LT
        • Doncaster Royal Infirmary /ID# 214971
    • Lancashire
      • Preston, Lancashire, United Kingdom, PR1 6SB
        • Minerva Health Centre /ID# 216226
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 214865
    • Suffolk
      • Bury St Edmunds, Suffolk, United Kingdom, IP33 2QZ
        • West Suffolk Hospital /ID# 215529
  • United States
    • Arizona
      • Flagstaff, Arizona, United States, 86001-6269
        • Arizona Arthritis & Rheumatology Associates, P.C. /ID# 215282
      • Phoenix, Arizona, United States, 85032-9306
        • AZ Arthritis and Rheumotology Research, PLLC /ID# 215113
      • Tucson, Arizona, United States, 85704
        • Arizona Arthritis & Rheumatology Research, PLLC /ID# 214731
    • California
      • Huntington Beach, California, United States, 92648-5994
        • Newport Huntington Medical Group /ID# 216281
      • Upland, California, United States, 91786
        • Inland Rheum & Osteo Med Grp /ID# 215807
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic /ID# 215346
      • Fort Collins, Colorado, United States, 80528
        • Tekton Research /ID# 215054
    • Florida
      • Aventura, Florida, United States, 33180
        • Arthritis & Rheumatic Disease Specialties /ID# 215306
      • Hialeah, Florida, United States, 33016-1897
        • Sweet Hope Research Specialty Inc /ID# 215931
      • Palmetto Bay, Florida, United States, 33157-1737
        • Innovation Medical Research Center /ID# 216068
      • Winter Park, Florida, United States, 32789
        • Conquest Research /ID# 215804
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials /ID# 215790
      • Schaumburg, Illinois, United States, 60195-3106
        • Greater Chicago Specialty Physicians /ID# 216213
      • Skokie, Illinois, United States, 60076
        • Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 215055
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Klein and Associates MD /ID# 214767
    • Massachusetts
      • Boston, Massachusetts, United States, 02111-1552
        • Tufts Medical Center /ID# 215925
      • Worcester, Massachusetts, United States, 01605
        • Clinical Pharmacology Study Group /ID# 215293
    • Michigan
      • Detroit, Michigan, United States, 48201-2153
        • Wayne State University Health Center /ID# 215930
      • Lansing, Michigan, United States, 48910
        • Advanced Rheumatology, PC /ID# 214973
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • St. Paul Rheumatology /ID# 215537
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest Research LLC /ID# 215785
      • St Louis, Missouri, United States, 63128-3841
        • CenterPointe Institute of Research /ID# 215793
    • New York
      • New York, New York, United States, 10016-2772
        • NYU Langone Orthopedic Center /ID# 215594
      • Potsdam, New York, United States, 13676
        • St. Lawrence Health System /ID# 215844
    • North Carolina
      • Leland, North Carolina, United States, 28451
        • Cape Fear Arthritis Care /ID# 215927
    • Ohio
      • Marietta, Ohio, United States, 45750-1635
        • Marietta Memorial Hospital /ID# 215929
      • Springboro, Ohio, United States, 45066
        • STAT Research, Inc. /ID# 215264
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103-2400
        • Health Research of Oklahoma /ID# 215117
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University /ID# 216446
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Ctr Clinical Res /ID# 214770
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research, Inc. /ID# 214923
      • Carrollton, Texas, United States, 75007
        • Trinity Universal Research Associates - Carrollton /ID# 214948
      • College Station, Texas, United States, 77845
        • Arthritis and Osteoporosis Clinic Of Brazos Valley /ID# 215805
      • Fort Worth, Texas, United States, 76104-4917
        • JPS Rheumatology Clinic /ID# 215962
      • Houston, Texas, United States, 77024-2420
        • Memorial Rheumatology /ID# 216311
      • Houston, Texas, United States, 77043
        • Biopharma Informatic, LLC /ID# 215885
      • Houston, Texas, United States, 77084
        • Biopharma Informatic - Park Row /ID# 215907
      • Lubbock, Texas, United States, 79410-1198
        • West Texas Clinical Research /ID# 215928
      • Plano, Texas, United States, 75024-5283
        • Trinity Universal Research Associates, Inc /ID# 215189
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Rheumatology and Pulmonary Clinic /ID# 214946
      • South Charleston, West Virginia, United States, 25309
        • West Virginia Research Inst /ID# 214921

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study 1: Upadacitinib 15 mg
Participants 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).
Drug: Upadacitinib
Upadacitinib tablet administered orally
Other Names:
  • RINVOQ
  • ABT-494
Placebo Comparator: Study 1: Placebo
Participants 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).
Drug: Upadacitinib
Upadacitinib tablet administered orally
Other Names:
  • RINVOQ
  • ABT-494
Drug: Placebo
Placebo for upadacitinib tablet administered orally
Experimental: Study 2: Upadacitinib 15 mg
Participants 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).
Drug: Upadacitinib
Upadacitinib tablet administered orally
Other Names:
  • RINVOQ
  • ABT-494
Placebo Comparator: Study 2: Placebo
Participants 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).
Drug: Upadacitinib
Upadacitinib tablet administered orally
Other Names:
  • RINVOQ
  • ABT-494
Drug: Placebo
Placebo for upadacitinib tablet administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14
Time Frame: Baseline and 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 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14
Time Frame: Baseline and 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study 1: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14
Time Frame: Baseline and Week 14

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:

  1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
  2. Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
  3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe])
  4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
  5. High-sensitivity C-reactive protein (hs-CRP) in mg/L.

The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.
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
Time Frame: Baseline and Week 14

In the SPARCC MRI assessment of the spine, the entire spine was evaluated for active inflammation (bone marrow edema). Six discovertebral units (DVU) representing the 6 most abnormal DVUs were selected to calculate the MRI Spine SPARCC score. For each of the 6 DVUs, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all three dimensions.

Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least one quadrant of a DVU slice, it was also scored for intensity and depth of the edema representing that slice: An additional score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. Slices that included a lesion demonstrating continuous increased signal of depth ≥ 1 cm extending from the endplate were scored as an additional 1 per slice.

The maximum (worst) overall score for all 6 DVUs is 108. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 1: Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14
Time Frame: Baseline and Week 14

The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.

A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score.
Baseline and Week 14
Study 1: Percentage of Participants With an ASAS20 Response at Week 14
Time Frame: Baseline and Week 14

ASAS20 response was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 units [on a scale of 0 to 10]) in the remaining domain:

  • Patient's global assessment of disease activity, measured on a 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 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 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 1: Percentage of Participants With ASDAS Inactive Disease at Week 14
Time Frame: Week 14

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:

  1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
  2. Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
  3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe])
  4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
  5. High-sensitivity C-reactive protein (hs-CRP) in mg/L.

The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score < 1.3.
Week 14
Study 1: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14
Time Frame: Baseline and Week 14
Participants assessed their total back pain during the last week on a 0 to 10 numerical rating scale (NRS), where 0 represents no pain and 10 represents most severe pain.
Baseline and Week 14
Study 1: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14
Time Frame: Baseline and Week 14
Participants assessed the amount of back pain at night over the last week on a 0 to 10 NRS, where 0 represents no pain and 10 represents most severe pain.
Baseline and Week 14
Study 1: Percentage of Participants With ASDAS Low Disease Activity at Week 14
Time Frame: Week 14

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:

  1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
  2. Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
  3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe])
  4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
  5. High-sensitivity C-reactive protein (hs-CRP) in mg/L.

The overall score ranges from 0 with no defined upper score. ASDAS Low Disease Activity is defined as an ASDAS score < 2.1.
Week 14
Study 1: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
Time Frame: Baseline and Week 14
The Bath Ankylosing Spondylitis Functional Index is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities such as putting on socks, bending, reaching, getting up from the floor or an armless chair, standing, climbing and other physical activities. Each item is scored on a NRS ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations. A negative change from Baseline in BASFI indicates improvement.
Baseline and Week 14
Study 1: Percentage of Participants With ASAS Partial Remission at Week 14
Time Frame: Week 14

ASAS partial remission (PR) is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains:

  • 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).
Week 14
Study 1: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Week 14
Time Frame: Baseline and Week 14

The ASQoL consists of 18 items related to quality of life, including the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. Each item is answered as yes (scored as 1) or no (scored as 0).

Scores are summed to obtain the overall score which ranges from 0 to 18, where higher scores indicate a worse quality of life. A negative change from Baseline in ASQoL indicates improvement in quality of life.
Baseline and Week 14
Study 1: Change From Baseline in ASAS Health Index at Week 14
Time Frame: Baseline and Week 14
The ASAS health index (HI) measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 1: Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14
Time Frame: Baseline and Week 14

The BASMI is a composite score based on 5 direct measurements of spinal mobility:

  1. cervical rotation (measured in degrees),
  2. tragus to wall distance (in centimeters [cm])
  3. lumbar side flexion (in cm),
  4. lumbar flexion (modified Schober's) (in cm) and
  5. intermalleolar distance (in cm).

Each measurement is converted to a linear score between 0 and 10. The total BASMI(lin) score is the average of the 5 scores and ranges from 0 to 10; the higher the BASMI(lin) score the more severe the patient's limitation of movement due to their ankylosing spondylitis. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 1: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14
Time Frame: Baseline and Week 14
The MASES evaluation was conducted to assess the presence or absence of enthesitis (inflammation of the entheses, or sites where tendons or ligaments insert into the bone) at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right. Each site was scored for presence (1) or absence (0) of enthesitis. The MASES is the sum of the 13 site scores, and ranges from 0 to 13, with higher scores indicating more inflammation of the entheses. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 1: Change From Baseline in MRI SPARCC Score for Sacroiliac Joints at Week 14
Time Frame: Baseline and Week 14

In the SPARCC MRI assessment of the sacroiliac (SI) joints 6 consecutive sacroiliac joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema.

Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema, intensity of edema (a score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice), and a lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant.

The total maximum (worst) score for all SI joints across 6 slices is 72. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 2: Change From Baseline in ASDAS at Week 14
Time Frame: Baseline and Week 14

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:

  1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
  2. Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
  3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe])
  4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
  5. High-sensitivity C-reactive protein (hs-CRP) in mg/L.

The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.
Baseline and Week 14
Study 2: Change From Baseline in MRI SPARCC Score for SI Joints at Week 14
Time Frame: Baseline and Week 14

In the SPARCC MRI assessment of the sacroiliac (SI) joints 6 consecutive sacroiliac joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema.

Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema, intensity of edema (a score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice), and a lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant.

The total maximum (worst) score for all SI joints across 6 slices is 72. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 2: Percentage of Participants With BASDAI 50 Response at Week 14
Time Frame: Baseline and Week 14

The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.

A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score.
Baseline and Week 14
Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 14
Time Frame: Week 14

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:

  1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
  2. Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
  3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe])
  4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
  5. High-sensitivity C-reactive protein (hs-CRP) in mg/L.

The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score < 1.3.
Week 14
Study 2: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14
Time Frame: Baseline and Week 14
Participants assessed their total back pain during the last week on a 0 to 10 numerical rating scale (NRS), where 0 represents no pain and 10 represents most severe pain.
Baseline and Week 14
Study 2: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14
Time Frame: Baseline and Week 14
Participants assessed the amount of back pain at night over the last week on a 0 to 10 NRS, where 0 represents no pain and 10 represents most severe pain.
Baseline and Week 14
Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 14
Time Frame: Week 14

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:

  1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
  2. Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
  3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe])
  4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
  5. High-sensitivity C-reactive protein (hs-CRP) in mg/L.

The overall score ranges from 0 with no defined upper score. ASDAS Low Disease Activity is defined as an ASDAS score < 2.1.
Week 14
Study 2: Percentage of Participants With ASAS Partial Remission at Week 14
Time Frame: Week 14

ASAS partial remission (PR) is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains:

  • 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).
Week 14
Study 2: Change From Baseline in BASFI at Week 14
Time Frame: Baseline and Week 14
The Bath Ankylosing Spondylitis Functional Index is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities such as putting on socks, bending, reaching, getting up from the floor or an armless chair, standing, climbing and other physical activities. Each item is scored on a NRS ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations. A negative change from Baseline in BASFI indicates improvement.
Baseline and Week 14
Study 2: Change From Baseline in ASQoL at Week 14
Time Frame: Baseline and Week 14

The ASQoL consists of 18 items related to quality of life, including the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. Each item is answered as yes (scored as 1) or no (scored as 0).

Scores are summed to obtain the overall score which ranges from 0 to 18, where higher scores indicate a worse quality of life. A negative change from Baseline in ASQoL indicates improvement in quality of life.
Baseline and Week 14
Study 2: Change From Baseline in ASAS Health Index at Week 14
Time Frame: Baseline and Week 14
The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 2: Percentage of Participants Achieving an ASAS20 Response at Week 14
Time Frame: Baseline and Week 14

ASAS20 response was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 units [on a scale of 0 to 10]) in the remaining domain:

  • Patient's global assessment of disease activity, measured on a 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 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 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: Change From Baseline in BASMI(Lin) at Week 14
Time Frame: Baseline and Week 14

The BASMI is a composite score based on 5 direct measurements of spinal mobility:

  1. cervical rotation (measured in degrees),
  2. tragus to wall distance (in centimeters [cm])
  3. lumbar side flexion (in cm),
  4. lumbar flexion (modified Schober's) (in cm) and
  5. intermalleolar distance (in cm).

Each measurement is converted to a linear score between 0 and 10. The total BASMI(lin) score is the average of the 5 scores and ranges from 0 to 10; the higher the BASMI(lin) score the more severe the patient's limitation of movement due to their ankylosing spondylitis. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 2: Change From Baseline in MASES at Week 14
Time Frame: Baseline and Week 14
The MASES evaluation was conducted to assess the presence or absence of enthesitis (inflammation of the entheses, or sites where tendons or ligaments insert into the bone) at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right. Each site was scored for presence (1) or absence (0) of enthesitis. The MASES is the sum of the 13 site scores, and ranges from 0 to 13, with higher scores indicating more inflammation of the entheses. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 2: Change From Baseline in MRI SPARCC Score for the Spine at Week 14
Time Frame: Baseline and Week 14

In the SPARCC MRI assessment of the spine, the entire spine is evaluated for active inflammation (bone marrow edema). Six discovertebral units (DVU) representing the 6 most abnormal DVUs were selected to calculate the MRI Spine SPARCC score. For each of the 6 DVUs, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all three dimensions.

Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least one quadrant of a DVU slice, it was also scored for intensity and depth of the edema representing that slice: An additional score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. Slices that included a lesion demonstrating continuous increased signal of depth ≥ 1 cm extending from the endplate were scored as an additional 1 per slice.

The maximum (worst) overall score for all 6 DVUs is 108. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 52
Time Frame: Baseline and Week 52

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 52
Study 2: Percentage of Participants With ASDAS Major Improvement at Week 52
Time Frame: Baseline and Week 52

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:

  1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
  2. Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
  3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe])
  4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
  5. High-sensitivity C-reactive protein (hs-CRP) in mg/L.

The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). Major Improvement is defined as a change from Baseline of ≤ -2.0.
Baseline and Week 52
Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 52
Time Frame: Week 52

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:

  1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
  2. Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
  3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe])
  4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
  5. High-sensitivity C-reactive protein (hs-CRP) in mg/L.

The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score < 1.3.
Week 52
Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 52
Time Frame: Week 52

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:

  1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
  2. Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
  3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe])
  4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
  5. High-sensitivity C-reactive protein (hs-CRP) in mg/L.

The overall score ranges from 0 with no defined upper score. ASDAS Low Disease Activity is defined as an ASDAS score < 2.1.
Week 52
Study 2: Percentage of Participants Who Initiated Rescue Treatment Between Week 24 and Week 52
Time Frame: Week 24, Week 32, Week 40, and Week 52
Participants who did not achieve an ASAS20 response at any 2 consecutive scheduled visits from Week 24 through Week 52 were to be rescued with standard of care treatment as described in the protocol.
Week 24, Week 32, Week 40, and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2019

Primary Completion (Actual)

September 2, 2021

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

November 18, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 19, 2019

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M19-944
  • 2022-501018-78-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing 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/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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