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

Primary Purpose

Spondyloarthritis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Upadacitinib
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondyloarthritis focused on measuring Upadacitinib, Axial Spondyloarthritis (axSpA), Spondyloarthritis, Ankylosing Spondylitis (AS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Arthritis & Rheumatology Associates, P.C. /ID# 215282
  • AZ Arthritis and Rheumotology Research, PLLC /ID# 215113
  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 214731
  • Newport Huntington Medical Group /ID# 216281
  • Inland Rheum & Osteo Med Grp /ID# 215807
  • Denver Arthritis Clinic /ID# 215346
  • Tekton Research /ID# 215054
  • Arthritis & Rheumatic Disease Specialties /ID# 215306
  • Sweet Hope Research Specialty Inc /ID# 215931
  • Innovation Medical Research Center /ID# 216068
  • Conquest Research /ID# 215804
  • Great Lakes Clinical Trials /ID# 215790
  • Greater Chicago Specialty Physicians /ID# 216213
  • Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 215055
  • Klein and Associates MD /ID# 214767
  • Tufts Medical Center /ID# 215925
  • Clinical Pharmacology Study Group /ID# 215293
  • Wayne State University Health Center /ID# 215930
  • Advanced Rheumatology, PC /ID# 214973
  • St. Paul Rheumatology /ID# 215537
  • CenterPointe Institute of Research /ID# 215793
  • Clinvest Research LLC /ID# 215785
  • NYU Langone Orthopedic Center /ID# 215594
  • St. Lawrence Health System /ID# 215844
  • Cape Fear Arthritis Care /ID# 215927
  • Marietta Memorial Hospital /ID# 215929
  • STAT Research, Inc. /ID# 215264
  • Health Research of Oklahoma /ID# 215117
  • Oregon Health and Science University /ID# 216446
  • Altoona Ctr Clinical Res /ID# 214770
  • Tekton Research, Inc. /ID# 214923
  • Trinity Universal Research Associates - Carrollton /ID# 214948
  • Arthritis and Osteoporosis Clinic Of Brazos Valley /ID# 215805
  • JPS Rheumatology Clinic /ID# 215962
  • Memorial Rheumatology /ID# 216311
  • Biopharma Informatic, LLC /ID# 215885
  • Biopharma Informatic - Park Row /ID# 215907
  • West Texas Clinical Research /ID# 215928
  • Trinity Universal Research Associates, Inc /ID# 215189
  • Rheumatology and Pulmonary Clinic /ID# 214946
  • West Virginia Research Inst /ID# 214921
  • Organizacion Medica de Investigacion (OMI) /ID# 214557
  • Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 214556
  • Instituto CAICI /ID# 215242
  • Centro de Investigaciones Medicas Tucuman /ID# 214559
  • Hospital Cordoba /ID# 215846
  • Instituto Medico Strusberg /ID# 215239
  • Cimer /Id# 215240
  • Emeritus Research Sydney /ID# 215507
  • BJC Health /ID# 215510
  • Emeritus Research /ID# 215506
  • Monash Medical Centre /ID# 215509
  • Barwon Rheumatology Services /ID# 215508
  • UZ Gent /ID# 215004
  • Universitair Ziekenhuis Leuven /ID# 215006
  • ReumaClinic /ID# 215005
  • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 215277
  • EDUMED Educacao em Saude S/S L /ID# 215111
  • LMK Sevicos Medicos S/S /ID# 215112
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 215176
  • CPCLIN - Centro de Pesquisas Clínicas /ID# 215175
  • UMHAT Kaspela EOOD /ID# 214803
  • Medical center Unimed /ID# 214816
  • MHAT Plovdiv /ID# 214815
  • Medical center Teodora /ID# 214813
  • Medical center Excelsior /ID# 214805
  • UMHAT Sveti Ivan Rilski /ID# 214804
  • UMHAT Sveti Ivan Rilski /ID# 214806
  • Diagnostic consultative center 17 Sofia /ID# 214808
  • Percuro Clinical Research, Ltd /ID# 215302
  • Toronto Western Hospital /ID# 215041
  • Applied Medical Informatics Research Inc. (AMIR) /ID# 215303
  • Centre de Recherche Musculo-Squelettique /ID# 215096
  • Centre de recherche du CHUQ /ID# 215038
  • The first affiliated hospital of bengbu medical college /ID# 216609
  • Anhui Provincial Hospital /ID# 216631
  • Peking Union Medical College Hospital /ID# 216545
  • Guangdong Provincial People's Hospital /ID# 216645
  • The First Affiliated Hospital of Shantou University Medical College /ID# 217883
  • Shenzhen People's Hospital /ID# 225438
  • Zhuzhou Central Hospital /ID# 216644
  • The First Affiliated Hospital of BaoTou Medical College, Inner Mongolia Universi /ID# 216612
  • The First Affiliated Hospital of Soochow University /ID# 216607
  • Huashan Hospital, Fudan University /ID# 216646
  • First Affiliated Hospital of Kunming Medical University /ID# 217945
  • REVMACLINIC s.r.o. /ID# 215153
  • Revmacentrum MUDr. Mostera, s.r.o. /ID# 215161
  • Revmatologie, s.r.o. /ID# 215309
  • CCR Ostrava, s.r.o. /ID# 215226
  • ARTHROHELP, s.r.o. /ID# 215224
  • Revmatologicky ustav v Praze /ID# 215154
  • PV MEDICAL Services s.r.o. /ID# 215119
  • Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 215652
  • Thomayerova nemocnice /ID# 215118
  • Fakultni Nemocnice v Motole /ID# 215160
  • MEDICAL PLUS, s.r.o. /ID# 215324
  • CHU Toulouse /ID# 214780
  • CHU Bordeaux - Hopital Pellegrin /ID# 214784
  • Hopital Ambroise Pare /ID# 214783
  • AP-HP - Hopital Cochin /ID# 214782
  • Universitaetsklinikum Erlangen /ID# 214281
  • Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 214282
  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214211
  • Rheuma Research Lausitz, Dr. Mario Sutowicz /ID# 214218
  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214207
  • Praxisgemeinschaft Rheumatologie Nephrologie Erlangen /ID# 214212
  • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 214208
  • Medizinische Hochschule Hannover /ID# 214209
  • MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 214261
  • Debreceni Egyetem Klinikai Kozpont /ID# 215187
  • Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 215182
  • Rehavita Kft HU /ID# 215188
  • Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 215183
  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 215186
  • Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 215184
  • Pest Megyei Flor Ferenc Korhaz /ID# 214501
  • CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 215181
  • The Chaim Sheba Medical Center /ID# 215854
  • Tel Aviv Sourasky Medical Center /ID# 216956
  • Bnai Zion Medical Center /ID# 215856
  • Meir Medical Center /ID# 217255
  • Daido Clinic /ID# 214735
  • Matsuyama Red Cross Hospital /ID# 216021
  • National Hospital Organization Asahikawa Medical Center /ID# 214930
  • Hokkaido University Hospital /ID# 215221
  • Kobe University Hospital /ID# 214598
  • Hyogo College of Medicine College Hospital /Id# 215638
  • Kita-harima Medical Center /ID# 216069
  • Kuwana City Medical Center /ID# 215196
  • Nagasaki University Hospital /ID# 215947
  • Sasebo Chuo Hospital /ID# 214703
  • Japanese Red Cross Okayama Hospital /ID# 214732
  • Okinawa Prefectural Chubu Hospital /ID# 215575
  • National Hospital Organization Osaka Minami Medical Center /ID# 214205
  • Osaka City General Hospital /ID# 215640
  • Juntendo University Hospital /ID# 214929
  • St.Luke's International Hospital /ID# 215414
  • Ajou University Hospital /ID# 214533
  • Hanyang University Seoul Hospital /ID# 214297
  • Gachon University Gil Medical Center /ID# 214534
  • Seoul National University Hospital /ID# 214532
  • Kyunghee University Hospital at Gangdong /ID# 214296
  • Asan Medical Center /ID# 214294
  • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214295
  • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 215217
  • Middlemore Clinical Trials /ID# 215502
  • Waikato Hospital /ID# 215503
  • WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 215093
  • Nasz Lekarz Przychodnie Medyczne /ID# 214352
  • REUMED Sp.z o.o. Filia nr 1 /ID# 214353
  • Osteo-Medic S.C. /ID# 214351
  • ETYKA-Osrodek Badan Klinicznych /ID# 215572
  • AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 214354
  • Chelyabinsk Regional Clinical Hospital /ID# 214463
  • Immanuel Kant Baltic Federal University /ID# 218259
  • LLC Family Outpatient Clinic № /ID# 214455
  • Research Institute of Rheumatology named after V.A. Nasonova /ID# 214459
  • LLC Medical Center /ID# 214410
  • Nort-Western State Medical University n.a. Mechnikov /ID# 214454
  • LLC Novaya Klinika /ID# 214420
  • Family Clinic /ID# 214737
  • Central City Hospital #7 /ID# 214741
  • Kazan State Medical University /ID# 214421
  • Alliance Biomedical Ural Group /ID# 214457
  • Olla-Med Clinic /ID# 214460
  • City Clinical Hospital n.a. O.M. Filatov /ID# 214486
  • Omsk Regional Clinic Hospital /ID# 214464
  • Orenburg State Medical University /ID# 214408
  • Ryazan State Medical University named after academician I.P. Pavlov /ID# 214418
  • RZD-Medicine Saratov /ID# 214465
  • Clinical Rheumatologic Hospital No 25 /ID# 214488
  • Ulyanovsk Regional Clinical Hospital /ID# 214458
  • Univerzitna nemocnica Bratislava Nemocnica Stare Mesto /ID# 214675
  • Reum.hapi s.r.o. /ID# 224268
  • Narodny ustav reumatickych chorob /ID# 214674
  • MUDr. Zuzana Cizmarikova s.r.o. /ID# 215220
  • ALBAMED s.r.o. /ID# 215248
  • Hospital Marina Baixa /ID# 215970
  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 214967
  • Hospital Unversitario Marques de Valdecilla /ID# 214965
  • Hospital Meixoeiro (CHUVI) /ID# 214969
  • Hospital Universitario Reina Sofia /ID# 214968
  • Hospital Universitario La Paz /ID# 216032
  • Hospital Universitario y Politecnico La Fe /ID# 214966
  • Kaohsiung Veterans General Hos /ID# 214332
  • Far Eastern Memorial Hospital /ID# 215384
  • China Medical University Hospital /ID# 214019
  • Chung Shan Medical University Hospital /ID# 214018
  • Cathay General Hospital /ID# 214183
  • Hacettepe Universitesi Tip Fak /ID# 214898
  • Istanbul University Cerrahpasa Faculty of Medicine /ID# 214895
  • Mugla Sitki Kocman University Medical Faculty /ID# 215358
  • MNPE Chernihiv Regional Hospital of the Chernihiv Region Council /ID# 214145
  • State Institution L.T. Malaya Therapy National Institute of the NAMS of Ukraine /ID# 214155
  • CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 214158
  • MNI City Multidisciplinary Hospital #18 /ID# 214154
  • Khmelnytskyi Regional Hospital /ID# 214153
  • MI Kryvyi Rih City Clinical Hospital No.2 /ID# 214152
  • Medical Center LLC Institute of Rheumatology /ID# 214146
  • Kyiv Railway Clinical Hosp No.2 /ID# 214779
  • Medical Center CONSILIUM MEDICAL /ID# 216234
  • MNI KRC Kyiv Regional Clinical Hospital /ID# 214156
  • Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 214159
  • Multifield Medical Centre of ONMU /ID# 214149
  • PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 214151
  • Ternopil University Hospital /ID# 214705
  • CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 214147
  • Clinic of Scientific Research Institute of Invalid Rehabilitation /ID# 214148
  • Minerva Health Centre /ID# 216226
  • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 214865
  • West Suffolk Hospital /ID# 215529
  • Doncaster Royal Infirmary /ID# 214971

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Study 1: Upadacitinib 15 mg

Study 1: Placebo

Study 2: Upadacitinib 15 mg

Study 2: Placebo

Arm Description

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14
ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units) in the potential remaining domain: Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14
ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units) in the potential remaining domain: Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).

Secondary Outcome Measures

Study 1: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at 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: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Study 1: Change From Baseline in Magnetic Resonance Imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) Score for the Spine at 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.
Study 1: Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at 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.
Study 1: Percentage of Participants With an ASAS20 Response at 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).
Study 1: Percentage of Participants With ASDAS Inactive Disease at 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: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Study 1: Change From Baseline in Patient's Assessment of Total Back Pain at 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.
Study 1: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at 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.
Study 1: Percentage of Participants With ASDAS Low Disease Activity at 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: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Study 1: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at 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.
Study 1: Percentage of Participants With ASAS Partial Remission at 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).
Study 1: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at 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.
Study 1: Change From Baseline in ASAS Health Index at 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.
Study 1: Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14
The BASMI is a composite score based on 5 direct measurements of spinal mobility: cervical rotation (measured in degrees), tragus to wall distance (in centimeters [cm]) lumbar side flexion (in cm), lumbar flexion (modified Schober's) (in cm) and 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.
Study 1: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at 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.
Study 1: Change From Baseline in MRI SPARCC Score for Sacroiliac Joints at 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.
Study 2: Change From Baseline in ASDAS at 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: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Study 2: Change From Baseline in MRI SPARCC Score for SI Joints at 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.
Study 2: Percentage of Participants With BASDAI 50 Response at 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.
Study 2: Percentage of Participants With ASDAS Inactive Disease at 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: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Study 2: Change From Baseline in Patient's Assessment of Total Back Pain at 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.
Study 2: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at 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.
Study 2: Percentage of Participants With ASDAS Low Disease Activity at 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: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Study 2: Percentage of Participants With ASAS Partial Remission at 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).
Study 2: Change From Baseline in BASFI at 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.
Study 2: Change From Baseline in ASQoL at 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.
Study 2: Change From Baseline in ASAS Health Index at 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.
Study 2: Percentage of Participants Achieving an ASAS20 Response at 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).
Study 2: Change From Baseline in BASMI(Lin) at Week 14
The BASMI is a composite score based on 5 direct measurements of spinal mobility: cervical rotation (measured in degrees), tragus to wall distance (in centimeters [cm]) lumbar side flexion (in cm), lumbar flexion (modified Schober's) (in cm) and 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.
Study 2: Change From Baseline in MASES at 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.
Study 2: Percentage of Participants Achieving an ASAS40 Response at 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).
Study 2: Change From Baseline in MRI SPARCC Score for the Spine at 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.
Study 2: Percentage of Participants Who Initiated Rescue Treatment Between Week 24 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.
Study 2: Percentage of Participants With ASDAS Major Improvement at 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: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Study 2: Percentage of Participants With ASDAS Inactive Disease at 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: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Study 2: Percentage of Participants With ASDAS Low Disease Activity at 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: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.

Full Information

First Posted
November 18, 2019
Last Updated
May 4, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04169373
Brief Title
A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis
Acronym
SELECT-AXIS 2
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 26, 2019 (Actual)
Primary Completion Date
September 2, 2021 (Actual)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis
Keywords
Upadacitinib, Axial Spondyloarthritis (axSpA), Spondyloarthritis, Ankylosing Spondylitis (AS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
734 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study 1: Upadacitinib 15 mg
Arm Type
Experimental
Arm Description
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).
Arm Title
Study 1: Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Study 2: Upadacitinib 15 mg
Arm Type
Experimental
Arm Description
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).
Arm Title
Study 2: Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494, RINVOQ
Intervention Description
Upadacitinib tablet administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for upadacitinib tablet administered orally
Primary Outcome Measure Information:
Title
Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14
Description
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).
Time Frame
Baseline and Week 14
Title
Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14
Description
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).
Time Frame
Baseline and Week 14
Secondary Outcome Measure Information:
Title
Study 1: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14
Description
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Time Frame
Baseline and Week 14
Title
Study 1: Change From Baseline in Magnetic Resonance Imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) Score for the Spine at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 1: Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 1: Percentage of Participants With an ASAS20 Response at Week 14
Description
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).
Time Frame
Baseline and Week 14
Title
Study 1: Percentage of Participants With ASDAS Inactive Disease at Week 14
Description
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Time Frame
Week 14
Title
Study 1: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 1: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 1: Percentage of Participants With ASDAS Low Disease Activity at Week 14
Description
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Time Frame
Week 14
Title
Study 1: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 1: Percentage of Participants With ASAS Partial Remission at Week 14
Description
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).
Time Frame
Week 14
Title
Study 1: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 1: Change From Baseline in ASAS Health Index at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 1: Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14
Description
The BASMI is a composite score based on 5 direct measurements of spinal mobility: cervical rotation (measured in degrees), tragus to wall distance (in centimeters [cm]) lumbar side flexion (in cm), lumbar flexion (modified Schober's) (in cm) and 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.
Time Frame
Baseline and Week 14
Title
Study 1: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 1: Change From Baseline in MRI SPARCC Score for Sacroiliac Joints at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 2: Change From Baseline in ASDAS at Week 14
Description
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Time Frame
Baseline and Week 14
Title
Study 2: Change From Baseline in MRI SPARCC Score for SI Joints at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 2: Percentage of Participants With BASDAI 50 Response at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 14
Description
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Time Frame
Week 14
Title
Study 2: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 2: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 14
Description
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Time Frame
Week 14
Title
Study 2: Percentage of Participants With ASAS Partial Remission at Week 14
Description
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).
Time Frame
Week 14
Title
Study 2: Change From Baseline in BASFI at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 2: Change From Baseline in ASQoL at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 2: Change From Baseline in ASAS Health Index at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 2: Percentage of Participants Achieving an ASAS20 Response at Week 14
Description
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).
Time Frame
Baseline and Week 14
Title
Study 2: Change From Baseline in BASMI(Lin) at Week 14
Description
The BASMI is a composite score based on 5 direct measurements of spinal mobility: cervical rotation (measured in degrees), tragus to wall distance (in centimeters [cm]) lumbar side flexion (in cm), lumbar flexion (modified Schober's) (in cm) and 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.
Time Frame
Baseline and Week 14
Title
Study 2: Change From Baseline in MASES at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 52
Description
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).
Time Frame
Baseline and Week 52
Title
Study 2: Change From Baseline in MRI SPARCC Score for the Spine at Week 14
Description
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.
Time Frame
Baseline and Week 14
Title
Study 2: Percentage of Participants Who Initiated Rescue Treatment Between Week 24 and Week 52
Description
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.
Time Frame
Week 24, Week 32, Week 40, and Week 52
Title
Study 2: Percentage of Participants With ASDAS Major Improvement at Week 52
Description
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Time Frame
Baseline and Week 52
Title
Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 52
Description
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Time Frame
Week 52
Title
Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 52
Description
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) 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.
Time Frame
Week 52

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
35908570
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.
Results Reference
derived
PubMed Identifier
35788492
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.
Results Reference
derived
Links:
URL
http://www.rxabbvie.com
Description
Related Info

Learn more about this trial

A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis

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