A Study of the Change in Early and Sustained Pain Control in Axial Spondylarthritis in Adult Participants Receiving Upadacitinib (UPSTAND)

Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Axial Spondylarthritis (UPSTAND)

Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain (IBP) that might be difficult to distinguish from other causes of chronic back pain (CBP). Many participants report persistent pain, including back pain, which impacts disease activity and quality of life including creating burdens such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. This study will assess the real-world effectiveness of upadacitinib on early and sustained pain control, and the association between pain and clinical/patient-reported outcomes in axSpA participants.

Upadacitinib is being developed for the treatment of axSpA. Approximately 650 adult participants with active-axSpA will be enrolled across approximately 19 countries in Europe, North America, South America, and Asia-Pacific.

Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. Participants will be followed for 12 months.

There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

Study Overview

• Status: Completed
• Conditions: Axial Spondylarthritis (axSpA)

• Study Type: Observational
• Enrollment (Actual): 708

Contacts and Locations

Study Locations

• Argentina
  • Río Cuarto, Argentina, 5800
    • Clinica Regional del Sud /ID# 248866
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, 1902
      • Hospital Italiano La Plata /ID# 230779
    • Quilmes, Buenos Aires, Argentina, 1878
      • CER Instituto Medico /ID# 230782
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Instituto CAICI S.R.L /ID# 230781
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Duplicate_CIMER /ID# 230780
• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Paratus Clinical Research Woden /ID# 231460
  • New South Wales
    • Broadmeadow, New South Wales, Australia, 2292
      • Genesis Research Services /ID# 231593
    • Campbelltown, New South Wales, Australia, 2560
      • Campbelltown Hospital /ID# 231462
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital /ID# 232417
    • Paramatta, New South Wales, Australia, 2150
      • BJC Health /ID# 230066
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • Barwon Rheumatology Services /ID# 230068
    • Langwarrin, Victoria, Australia, 3910
      • Peninsula Rheumatology /ID# 240172
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Joint West Rheumatology /ID# 231461
• Belgium
  • Aalst, Belgium, 9300
    • Onze Lieve Vrouw Hospital /ID# 238963
  • Bruges, Belgium, 8000
    • AZ Sint-Jan Brugge /ID# 238964
  • Brussels, Belgium, 1020
    • CHU Brugmann /ID# 238962
  • Genk, Belgium, 3600
    • Reumacentrum /ID# 231437
  • Genk, Belgium, 3600
    • ReumaClinic /ID# 231438
  • Ostend, Belgium, 8400
    • AZ Damiaan /ID# 231441
  • Brussels Capital
    • Anderlecht, Brussels Capital, Belgium, 1070
      • Université Libre de Bruxelles - Hôpital Erasme /ID# 238961
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6000
      • Rhumaconsult SPRL /ID# 231439
  • Liege
    • Liège, Liege, Belgium, 4000
      • CHU de Liège /ID# 231440
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • AZ-Delta /ID# 238966
• Bulgaria
  • Plovdiv, Bulgaria, 4023
    • Medical center Unimed /ID# 249618
  • Plovdiv, Bulgaria, 4000
    • Prof. Anastas Batalov AIPSMP-VBR EOOD /ID# 249788
  • Sofia, Bulgaria, 1000
    • "Ambulatory for individual practice of specialized medical help for internal dis /ID# 249791
  • Sofia, Bulgaria, 1750
    • ASIMP Rheumatology Centre "St. Irina" EOOD /ID# 249789
  • Varna, Bulgaria, 9002
    • AIPSMPR -d-r Gerganov /ID# 249749
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1J9
      • Artus Health Center /ID# 241966
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M3
      • Manitoba Clinic /ID# 246217
    • Winnipeg, Manitoba, Canada, R3N 0K6
      • CIADS Research Co Ltd /ID# 247520
  • Nova Scotia
    • Sydney, Nova Scotia, Canada, B1S 3N1
      • Dr. Juris Lazovskis Inc. /ID# 246574
  • Ontario
    • Dundas, Ontario, Canada, L9H 1B7
      • Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 246213
    • Etobicoke, Ontario, Canada, M9C 5N2
      • Arthur Karasik Medicine Professional Corporation /ID# 241932
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Lau Bacchus Professional Medicine Corp /ID# 242591
    • Mississauga, Ontario, Canada, L5M 2V8
      • Credit Valley Rheumatology /ID# 241948
    • Orillia, Ontario, Canada, L3V 1T5
      • The Waterside Clinic /ID# 248678
    • Windsor, Ontario, Canada, N8X 1T3
      • Dr. Sabeen Anwar Medicine Professional Corporation /ID# 241933
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 249765
    • Montreal, Quebec, Canada, H4A 3T2
      • Applied Medical Informatics Research Inc. (AMIR) /ID# 246284
    • Sainte-Foy, Quebec, Canada, G1V 3M7
      • Groupe de Recherche en Maladies Osseuses Inc /ID# 241111
    • Sherbrooke, Quebec, Canada, J1G 2E8
      • CIUSSS de l'Estrie - CHUS /ID# 247572
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7H 5M7
      • Dr Naik-Medical Professional Corporation-Alliance Health /ID# 246516
• France
  • Aix-en-Provence, France, 13616
    • CH du Pays d'AIX /ID# 229095
  • Arras, France, 62022
    • Centre Hospitalier d'Arras /ID# 228833
  • Clermont-Ferrand, France, 63000
    • CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 229092
  • Corbeil-Essonnes, France, 91106
    • C. H. Sud Francilien /ID# 228826
  • La Roche-sur-Yon, France, 85000
    • CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 230947
  • La Tronche, France, 38700
    • CHU Grenoble - Hopital Michallon /ID# 228792
  • Lille, France, 59037
    • CHU Lille - Hôpital Roger Salengro /ID# 228820
  • Lyon, France, 69009
    • Clinique de la Sauvegarde /ID# 229087
  • Orléans, France, 45067
    • Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 234258
  • Paris, France, 75012
    • AP-HP - Hopital Saint-Antoine /ID# 228795
  • Paris, France, 75013
    • Hopital Pitie Salpetriere /ID# 243309
  • Paris, France, 75015
    • Centre de Soins Osteoarticulaires Ambulatoires /ID# 244737
  • Paris, France, 75018
    • AP-HP - Hopital Bichat - Claude-Bernard /ID# 228837
  • Paris, France, 75020
    • GH Diaconesses Croix Saint-Simon /ID# 238548
  • Rennes, France, 35203
    • CHU de Rennes - Hospital Sud /ID# 228842
  • Rouen, France, 76000
    • Hôpital Charles-Nicolle /ID# 229096
  • Saint-Nazaire, France, 44600
    • CH Saint Nazaire /ID# 233186
  • Doubs
    • Besançon, Doubs, France, 25030
      • CHU de Besancon - Jean Minjoz /ID# 230528
    • Besançon, Doubs, France, 25030
      • CHU de Besancon - Jean Minjoz /ID# 242499
  • Essonne
    • Mennecy, Essonne, France, 91540
      • Cabinet de rhumatologie /ID# 229091
  • Franche-Comte
    • Limoges, Franche-Comte, France, 87042
      • CHU Limoges - Dupuytren 1 /ID# 229094
  • Gironde
    • Bordeaux, Gironde, France, 33076
      • CHU Bordeaux - Hopital Pellegrin /ID# 230548
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • CHU Toulouse - Hopital Purpan /ID# 228818
  • Herault
    • Montpellier, Herault, France, 34295
      • CHU Montpellier - Hôpital Saint Eloi /ID# 228829
    • Montpellier, Herault, France, 34295
      • CHU Montpellier - Hôpital Saint Eloi /ID# 240980
  • Marne
    • Reims, Marne, France, 51100
      • Polyclinique Courlancy /ID# 229093
  • Paris
    • Paris, Paris, France, 75679
      • Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 244006
  • Pays de la Loire Region
    • Saint Priest EN Jarez, Pays de la Loire Region, France, 42270
      • CHU de SAINT ETIENNE - Hopital Nord /ID# 228836
  • Provence-Alpes-Côte d'Azur Region
    • Nice, Provence-Alpes-Côte d'Azur Region, France, 06002
      • CHU Nice -Hopital Pasteur /ID# 229088
  • Rhone
    • Caluire-et-Cuire, Rhone, France, 69300
      • Infirmerie Protestante /ID# 228794
    • Pierre-Bénite, Rhone, France, 69495
      • HCL - Hopital Lyon Sud /ID# 228819
  • Somme
    • Amiens, Somme, France, 80054
      • CHU Amiens-Picardie Site Sud /ID# 228821
• Greece
  • Aigáleo, Greece, 12242
    • Vougiouklakeio S.A. /ID# 246476
  • Athens, Greece, 11521
    • Naval Hospital of Athens /ID# 241129
  • Athens, Greece, 14561
    • KAT Atttica General Hospital /ID# 243063
  • Kalamaria, Greece, 55134
    • Duplicate_General Hospital of Thessaloniki Agios Pavlos /ID# 243823
  • Marousi, Greece, 15123
    • Iaso /ID# 245137
  • Pátrai, Greece, 26443
    • Olympion General Clinic SA /ID# 251794
  • RION Patras Achaia, Greece, 26504
    • University General Hospital of Patras /ID# 243795
  • Thessaloniki, Greece, 54636
    • Euromedica Blue Cross Gen Clin /ID# 244945
  • Thessaloniki, Greece, 54642
    • General Hospital of Thessaloniki Hippokrateio /ID# 243796
  • Thessaloniki, Greece, 54645
    • Euromedica General Clinic /ID# 241126
  • Attica
    • Athens, Attica, Greece, 11527
      • General Hospital of Athens Ippokratio /ID# 241133
    • Athens, Attica, Greece, 11527
      • General Hospital of Athens Laiko /ID# 241128
  • Crete
    • Heraklion, Crete, Greece, 71500
      • University General Hospital of Heraklion PA.G.N.I /ID# 241124
  • Thessaloniki
    • Efkarpia (Thessalonikis), Thessaloniki, Greece, 56429
      • 424 General MILITARY Hospital /ID# 241127
• Hungary
  • Budapest, Hungary, 1134
    • Magyar Honvedseg Egeszsegugyi Kozpont /ID# 239939
  • Debrecen, Hungary, 4031
    • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 239937
  • Hévíz, Hungary, 8380
    • Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 239940
  • Kecskemét, Hungary, 6000
    • Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 239938
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Debreceni Egyetem Klinikai Kozpont /ID# 239936
• Israel
  • Central District
    • Kfar Saba, Central District, Israel, 4428164
      • Meir Medical Center /ID# 241868
  • H_efa
    • Hadera, H_efa, Israel, 38100
      • Hillel Yaffe Medical Center /ID# 241869
    • Haifa, H_efa, Israel, 3339419
      • Bnai Zion Medical Center /ID# 241866
    • Haifa, H_efa, Israel, 34362
      • The Lady Davis Carmel Medical Center /ID# 241867
  • Northern District
    • Nahariya, Northern District, Israel, 2210001
      • Galilee Medical Center /ID# 241870
    • Tiberias, Northern District, Israel, 15208
      • The Baruch Padeh Medical Center Poriya /ID# 249797
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 241305
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 241864
• Kuwait
  • ADAN, Kuwait
    • Adan Hospital /ID# 229679
  • Al Jahra, Kuwait, 52700
    • Jahra Hospital /ID# 229671
  • Hawalli, Kuwait, 46300
    • Mubarak Hospital /ID# 250478
  • Hawalli, Kuwait, 46300
    • Mubarak Hospital /ID# 251777
  • Kuwait City, Kuwait, 85000
    • Farwaniya Hospital /ID# 231445
• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44650
      • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 238815
    • Guadalajara, Jalisco, Mexico, 44650
      • Private Office Dr. Orozco /ID# 255210
• Poland
  • Krakow, Poland, 30-040
    • Ma?opolskie Badania Kliniczne Sp. z o.o. /ID# 255509
  • Oława, Poland, 55-200
    • Jerzy ?wierkot Indywidualna Specjalistyczna Praktyka Lekarska /ID# 244289
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 61-545
      • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 243225
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-637
      • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji /ID# 243232
• Russia
  • Moscow, Russia, 123182
    • City Clinical Hospital #52 /ID# 238477
  • Orenburg, Russia, 460000
    • Orenburg State Medical University /ID# 233183
  • Petrozavodsk, Russia, 185019
    • Republican hospital named after V.A. Baranov /ID# 231173
  • Saint Petersburg, Russia, 190068
    • Clinical Rheumatologic Hospital No 25 /ID# 231171
  • Saint Petersburg, Russia, 194044
    • Military Medical Academy n.a. Kirov /ID# 242363
  • Samara, Russia, 443079
    • Clinic of Samara State Medical University /ID# 241166
  • Surgut, Russia, 628400
    • Budgetary Institution of the Khanty-Mansiysk Autonomous Okrug-Yugra Surgut Dist /ID# 242369
  • Tomsk, Russia, 634009
    • Nebbiolo Clinical Research Center /ID# 231167
  • Ulyanovsk, Russia, 432017
    • Ulyanovsk Regional Clinical Hospital /ID# 238334
  • Yaroslavl, Russia, 150000
    • Yaroslavl State Medicat University /ID# 231168
  • Buryatiya, Respublika
    • Ulan-Ude, Buryatiya, Respublika, Russia, 670002
      • ChUZ Clinical Hospital RZD-Medicine /ID# 233185
  • Chelyabinsk Oblast
    • Chelyabinsk, Chelyabinsk Oblast, Russia, 454087
      • Chelyabinsk Regional Clinical Hospital /ID# 244741
  • Kaliningrad Oblast
    • Kaliningrad, Kaliningrad Oblast, Russia, 236016
      • Regional Clinical Hospital of Kaliningrad region /ID# 238475
  • Komi
    • Syktyvkar, Komi, Russia, 167031
      • LLC MC RevmaMed /ID# 238478
  • Mordoviya, Respublika
    • Saransk, Mordoviya, Respublika, Russia, 430901
      • GBUZ RM Mordovia Republican Central Clinical Hospital /ID# 244738
  • Moscow
    • Moscow, Moscow, Russia, 115522
      • Research Institute of Rheumatology named after V.A. Nasonova /ID# 238479
  • Moscow Oblast
    • Moscow, Moscow Oblast, Russia, 129110
      • Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 232510
  • Samara Oblast
    • Samara, Samara Oblast, Russia, 443095
      • Samara Regional Clinical Hospital n.a. V. D. Seredavin /ID# 231169
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 193015
      • Nort-Western State Medical University n.a. Mechnikov /ID# 231172
• Spain
  • Almería, Spain, 04009
    • Hospital Universitario Torrecardenas /ID# 252804
  • Badajoz, Spain, 06010
    • Complejos Hospitalario Universitario de Badajoz /ID# 249036
  • Granada, Spain, 18016
    • Hospital Campus de la Salud /ID# 252805
  • Huelva, Spain, 21005
    • Hospital Juan Ramon Jimenez /ID# 249040
  • Jaén, Spain, 23007
    • Hospital Universitario de Jaen /ID# 249041
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti /ID# 255820
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal /ID# 249035
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre /ID# 249033
  • Palencia, Spain, 34005
    • Hospital Río Carrión /ID# 249027
  • Santa Cruz de Tenerife, Spain, 38010
    • Hospital Universitario Nuestra Señora de Candelaria /ID# 249044
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena /ID# 249039
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 249038
  • Valladolid, Spain, 47003
    • Hospital Clinico Universitario de Valladolid /ID# 252001
  • Zamora, Spain, 49022
    • Hospital Virgen de la Concha /ID# 249026
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15076
      • Complejo Hospitalario Universitario de Santiago /ID# 249025
  • Badajoz
    • Mérida, Badajoz, Spain, 06800
      • Hospital de Mérida /ID# 249037
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol /ID# 249030
    • Terrassa, Barcelona, Spain, 08221
      • Hospital Universitario Mutua Terrassa /ID# 249031
  • La Rioja
    • Logroño, La Rioja, Spain, 26006
      • Hospital San Pedro /ID# 249028
  • Las Palmas
    • Palma de Mallorca, Las Palmas, Spain, 07198
      • Hospital Universitario Son Llàtzer /ID# 249032
  • Madrid
    • San Sebastián de los Reyes, Madrid, Spain, 28702
      • Hospital Infanta Sofia /ID# 249034
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Clinico Universitario Virgen de la Arrixaca /ID# 249042
  • Santa Cruz De Tenerife
    • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Hospital Universitario Canarias /ID# 249043
• Switzerland
  • Canton Ticino
    • Locarno, Canton Ticino, Switzerland, 6600
      • Studio Zanisi /ID# 255681
  • Canton of St. Gallen
    • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
      • Kantonsspital St. Gallen /ID# 230696
  • Thurgau
    • Weinfelden, Thurgau, Switzerland, 8570
      • Rheumatologisches Versorgungszentrum Weinfelden /ID# 239435
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Cleveland Clinic Abu Dhabi /ID# 256292
  • Dubai, United Arab Emirates
    • AlAin Hospital /ID# 233803

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with Radiographic Axial Spondylarthritis (r-axSpA) who have been prescribed upadacitinib in the course of routine practice according to relevant approved licenses.

Description

Inclusion Criteria:

• Clinical diagnosis of Axial Spondylarthritis (axSpA) according to the ASAS criteria.
• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 at Baseline.
• Total back pain score >= 4 at Baseline.
• Inadequate response to at least two nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to contraindication for NSAIDs as defined by the investigator.
• Upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies.

Exclusion Criteria:

• Prior exposure to any Janus kinase (JAK) inhibitor.
• Participants demonstrating active symptoms of fibromyalgia as per clinical diagnosis.
• Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
• Unwillingness or inability to comply with the study requirements, including completion of patient reported outcome questionnaires.
• Participants who cannot be treated with upadacitinib according to the applicable approved label (e.g., contraindications).
• Vulnerable or protected adult patients with lack of capability to give informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants Receiving Upadacitinib; Participants receiving Upadacitinib for axial spondyloarthritis (axSpA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with a Total Spinal Pain Score < 4 and >= 2 Unit (0 - 10) Improvement	Total spinal pain consists of the mean of two 0-10 numerical rating scale (NRS) questions: total back pain during the previous week and nocturnal back pain during the previous week.	Baseline (Week 0) to Week 12
Percentage of Participants Maintaining Total Spinal Pain < 4 Among Participants Who Achieved Total Spinal Pain < 4 and >= 2 unit (0 - 10) Improvement from Baseline at Week 12	Total spinal pain score consists of the mean of two 0-10 NRS questions: total back pain during the previous week and nocturnal back pain during the previous week.	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Participant's Assessment of Total Spinal Pain	Total spinal pain consists of the mean of two 0-10 NRS questions: total back pain during the previous week and nocturnal back pain during the previous week.	Baseline to Week 52
Change in Patient's Assessment of Total Back Pain NRS	Pain will be measured using a 0 - 10 numerical rating scale (NRS) for total back pain (0 = no pain and 10 = most severe pain).	Baseline (Week 0) to Week 52
Change in Patient's Assessment of Nocturnal Back Pain NRS	Pain will be measured using a 0 - 10 numerical rating scale (NRS) for nocturnal back pain (0 = no pain and 10 = most severe pain).	Baseline (Week 0) to Week 52
Change in painDETECT Questionnaire (PD-Q) Score	The PD-Q is a patient-based questionnaire used to determine the prevalence of neuropathic pain components in low back pain participants. Scores range from -1 to 38, with higher scores indicating a greater likelihood of the participant's pain having a neuropathic component.	Baseline (Week 0) to Week 52
Change in Widespread Pain Index (WPI)	The WPI quantifies the extent of bodily pain on a 0 to 19 scale by asking participants if they have had pain or tenderness in 19 different body regions (shoulder girdle, hip, jaw, upper arm, upper leg, lower arm, and lower leg on each side of the body, as well as upper back, lower back, chest, neck, and abdomen) over the past week, with each painful or tender region scoring 1 point.	Baseline (Week 0) to Week 52
Percentage of Participants Achieving Pittsburgh Sleep Quality Index (PSQI) score < 5	The PSQI consists of 19 individual items across 7 components: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. Each component is scored from 0 (no difficulty) to 3 (severe difficulty) and summed to produce a total global score (range 0 to 21). A score of less than 5 is indicative of no clinical sleep impairment	Up to Week 52
Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity .[ASDAS LDA (< 2.1)]	The ASDAS combines the following 5 disease activity variables: back pain (BASDAI Question 2 NRS score 0 - 10), peripheral pain/swelling (BASDAI Question 3 NRS score 0 - 10), duration of morning stiffness (BASDAI Question 6 NRS score 0 - 10), PtGA, and high-sensitivity c reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). Low disease is defined as an ASDAS < 2.1.	Up to Week 52
Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Inactive Disease [ASDAS ID (<1.3)]	The ASDAS combines the following 5 disease activity variables: back pain (BASDAI Question 2 NRS score 0 - 10), peripheral pain/swelling (BASDAI Question 3 NRS score 0 - 10), duration of morning stiffness (BASDAI Question 6 NRS score 0 - 10), PtGA, and high-sensitivity c reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). Inactive disease is defined as an ASDAS < 1.3.	Up to Week 52
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	The BASDAI consists of 6 questions on a 0 to 10 NRS (0 being no problem and 10 being very severe problems) pertaining to the 5 major symptoms of r-axSpA: fatigue, spinal pain, peripheral joint pain/swelling, areas of localized tenderness (also called enthesitis, or inflammation of tendons and ligaments), morning stiffness duration, and morning stiffness severity. The overall BASDAI score ranges from 0 to 10, with higher scores indicating greater disease activity.	Baseline (Week 0) to Week 52
Change in 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS)	The SF-12 is a generic health-related QoL instrument consisting of a subset of 12 questions from the 36-Item Short Form Health Survey (SF-36). It assesses quality of life (QoL) across 8 domains: physical functioning, role physical, role emotional, social functioning, bodily pain, vitality, mental health, and general health. The SF-12 is used to derive the PCS with higher scores indicating a higher QoL.	Baseline (Week 0) to Week 52
Change in 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS)	The SF-12 is a generic health-related QoL instrument consisting of a subset of 12 questions from the 36-Item Short Form Health Survey (SF-36). It assesses quality of life (QoL) across 8 domains: physical functioning, role physical, role emotional, social functioning, bodily pain, vitality, mental health, and general health. The SF-12 is used to derive the MCS with higher scores indicating a higher QoL.	Baseline (Week 0) to Week 52
Percentage of Participants Achieving [Hospital Anxiety and Depression Scale (HADS) score <= 7] for a participants with HADS score > 7 at Baseline	The HADS assesses participant mental health status (consists of anxiety [Hospital Anxiety and Depression Scale-Anxiety (HADS-A)] and depression [Hospital Anxiety and Depression Scale-Depression (HADS-D)] subscales). The range for both subscales is 0 - 21, with 0 - 7 = normal, 8 - 10 = borderline abnormal, and 11 - 21 = abnormal.	Up to Week 52
Change in Bath Ankylosing Spondylitis Functional Index (BASFI)	The BASFI is a validated patient-reported outcome (PRO) instrument for use in the r-axSpA participant population. It consists of 10 items measured on a 0 to 10 NRS, which assesses the ability to perform activities known to be problematic to r-axSpA patients such as dressing, bending, reaching, turning, and climbing steps. The total scores range from 0 to 10 with higher scores indicating worse physical functioning in r-axSpA participants.	Baseline (Week 0) to Week 52
Change in ASDAS	The ASDAS combines the following 5 disease activity variables: back pain (BASDAI Question 2 NRS score 0 - 10), peripheral pain/swelling (BASDAI Question 3 NRS score 0 - 10), duration of morning stiffness (BASDAI Question 6 NRS score 0 - 10), PtGA, and high-sensitivity c reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).	Baseline (Week 0) to Week 52
Change in C-Reactive Protein (CRP)	Change in CRP.	Baseline (Week 0) to Week 52
Percentage of Participants with Discontinuation of Nonsteroidal Anti-Inflammatory Drug (NSAID) Among Participants using NSAIDs at Baseline	Discontinuation of NSAID among participants using NSAIDs at Baseline.	Up to Week 52
Percentage of Participants using NSAIDs as Needed or Continuously	Percentage of participants using NSAIDs as needed or continuously.	Baseline (Week 0) to Week 52
Change in Total Daily Dose of NSAIDs	Change in total daily dose of NSAIDs.	Baseline (Week 0) to Week 52
Percentage of Participants Achieving Enthesitis Resolution [Maastricht Ankylosing Spondylitis Enthesitis Score (MASES = 0)] among Participants with any Enthesitis (MASES ≥ 1) at Baseline	The MASES evaluates the presence or absence of enthesitis 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).	Baseline (Week 0) to Week 52
Percentage of Participants with New Onset of Extra-articular Manifestations (EAMs) Among Participants with no History of EAMs	Percentage of participants with new onset for participants with no history of EAMs (e.g., uveitis and inflammatory bowel disease [IBD]).	Up to Week 52
Percentage of Participants with Recurrence of EAMs among Participants with Previous History of EAMs	Percentage of participants with recurrence for participants with previous history of EAMs (e.g., uveitis and IBD).	Up to Week 52

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): March 24, 2025
• Study Completion (Actual): March 24, 2025

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Upadacitinib; RINVOQ; Axial Spondylarthritis (axSpA)
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Infections; Bone Diseases, Infectious; Spinal Diseases; Spondylitis; Spondylarthritis
• Other Study ID Numbers: P20-410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No