Clinical trial NCT04846244: A Study of the Change in Early and Sustained Pain Control in Axial Spondylarthritis in Adult Participants Receiving Upadacitinib
Official title: Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Axial Spondylarthritis (UPSTAND)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Axial Spondylarthritis (axSpA)
Keywords: Axial Spondylarthritis (axSpA)
Upadacitinib
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-04-15
Enrollment: 708
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants with a Total Spinal Pain Score < 4 and >= 2 Unit (0 - 10) Improvement
timeFrame: Baseline (Week 0) to Week 12
measure: 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
timeFrame: Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Hospital Italiano La Plata /ID# 230779
state: Buenos Aires
city: Quilmes
country: Argentina
facility: CER Instituto Medico /ID# 230782
state: Buenos Aires
city: Rosario
country: Argentina
facility: Instituto CAICI S.R.L /ID# 230781
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Duplicate_CIMER /ID# 230780
state: Tucuman
city: Rio Cuarto
country: Argentina
facility: Clinica Regional del Sud /ID# 248866
city: Phillip
country: Australia
facility: Paratus Clinical Research Woden /ID# 231460
state: Australian Capital Territory
city: Broadmeadow
country: Australia
facility: Genesis Research Services /ID# 231593
state: New South Wales
city: Campbelltown
country: Australia
facility: Campbelltown Hospital /ID# 231462
state: New South Wales
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital /ID# 232417
state: New South Wales
city: Paramatta
country: Australia
facility: BJC Health /ID# 230066
state: New South Wales
city: Geelong
country: Australia
facility: Barwon Rheumatology Services /ID# 230068
state: Victoria
city: Langwarrin
country: Australia
facility: Peninsula Rheumatology /ID# 240172
state: Victoria
city: Murdoch
country: Australia
facility: Joint West Rheumatology /ID# 231461
state: Western Australia
city: Anderlecht
country: Belgium
facility: Université Libre de Bruxelles - Hôpital Erasme /ID# 238961
state: Bruxelles-Capitale
city: Charleroi
country: Belgium
facility: Rhumaconsult SPRL /ID# 231439
state: Hainaut
city: Liège
country: Belgium
facility: CHU de Liège /ID# 231440
state: Liege
city: Roeselare
country: Belgium
facility: AZ-Delta /ID# 238966
state: West-Vlaanderen
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Hospital /ID# 238963
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge /ID# 238964
city: Bruxelles
country: Belgium
facility: CHU Brugmann /ID# 238962
city: Genk
country: Belgium
facility: Reumacentrum /ID# 231437
city: Genk
country: Belgium
facility: ReumaClinic /ID# 231438
city: Oostende
country: Belgium
facility: AZ Damiaan /ID# 231441
city: Plovdiv
country: Bulgaria
facility: Prof. Anastas Batalov AIPSMP-VBR EOOD /ID# 249788
city: Plovdiv
country: Bulgaria
facility: Medical center Unimed /ID# 249618
city: Sofiya
country: Bulgaria
facility: "Ambulatory for individual practice of specialized medical help for internal dis /ID# 249791
city: Sofiya
country: Bulgaria
facility: ASIMP Rheumatology Centre "St. Irina" EOOD /ID# 249789
city: Varna
country: Bulgaria
facility: AIPSMPR -d-r Gerganov /ID# 249749
city: Vancouver
country: Canada
facility: Artus Health Center /ID# 241966
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Clinic /ID# 246217
state: Manitoba
city: Winnipeg
country: Canada
facility: CIADS Research Co Ltd /ID# 247520
state: Manitoba
city: Sydney
country: Canada
facility: Dr. Juris Lazovskis Inc. /ID# 246574
state: Nova Scotia
city: Dundas
country: Canada
facility: Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 246213
state: Ontario
city: Etobicoke
country: Canada
facility: Arthur Karasik Medicine Professional Corporation /ID# 241932
state: Ontario
city: Hamilton
country: Canada
facility: Lau Bacchus Professional Medicine Corp /ID# 242591
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Rheumatology /ID# 241948
state: Ontario
city: Orillia
country: Canada
facility: The Waterside Clinic /ID# 248678
state: Ontario
city: Windsor
country: Canada
facility: Dr. Sabeen Anwar Medicine Professional Corporation /ID# 241933
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 249765
state: Quebec
city: Montréal
country: Canada
facility: Applied Medical Informatics Research Inc. (AMIR) /ID# 246284
state: Quebec
city: Sainte-foy
country: Canada
facility: Groupe de Recherche en Maladies Osseuses Inc /ID# 241111
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS /ID# 247572
state: Quebec
city: Saskatoon
country: Canada
facility: Dr Naik-Medical Professional Corporation-Alliance Health /ID# 246516
state: Saskatchewan
city: Besancon
country: France
facility: CHU de Besancon - Jean Minjoz /ID# 230528
state: Doubs
city: Besancon
country: France
facility: CHU de Besancon - Jean Minjoz /ID# 242499
state: Doubs
city: Mennecy
country: France
facility: Cabinet de rhumatologie /ID# 229091
state: Essonne
city: Limoges CEDEX 1
country: France
facility: CHU Limoges - Dupuytren 1 /ID# 229094
state: Franche-Comte
city: Bordeaux CEDEX
country: France
facility: CHU Bordeaux - Hopital Pellegrin /ID# 230548
state: Gironde
city: TOULOUSE Cedex 9
country: France
facility: CHU Toulouse - Hopital Purpan /ID# 228818
state: Haute-Garonne
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hôpital Saint Eloi /ID# 228829
state: Herault
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hôpital Saint Eloi /ID# 240980
state: Herault
city: St. Priest En Jarez
country: France
facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 228836
state: Loire
city: Reims
country: France
facility: Polyclinique Courlancy /ID# 229093
state: Marne
city: Paris CEDEX 14
country: France
facility: Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 244006
state: Paris
city: Nice CEDEX 1
country: France
facility: CHU Nice -Hopital Pasteur /ID# 229088
state: Provence-Alpes-Cote-d Azur
city: Caluire Et Cuire
country: France
facility: Infirmerie Protestante /ID# 228794
state: Rhone
city: Pierre Benite CEDEX
country: France
facility: HCL - Hopital Lyon Sud /ID# 228819
state: Rhone
city: Amiens CEDEX 1
country: France
facility: CHU Amiens-Picardie Site Sud /ID# 228821
state: Somme
city: Aix En Provence Cedex 1
country: France
facility: CH du Pays d'AIX /ID# 229095
city: Arras
country: France
facility: Centre Hospitalier d'Arras /ID# 228833
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 229092
city: Corbeil Essonnes
country: France
facility: C. H. Sud Francilien /ID# 228826
city: La Roche Sur Yon
country: France
facility: CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 230947
city: La Tronche
country: France
facility: CHU Grenoble - Hopital Michallon /ID# 228792
city: Lille
country: France
facility: CHU Lille - Hôpital Roger Salengro /ID# 228820
city: Lyon
country: France
facility: Clinique de la Sauvegarde /ID# 229087
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 234258
city: Paris
country: France
facility: AP-HP - Hopital Saint-Antoine /ID# 228795
city: Paris
country: France
facility: Hopital Pitie Salpetriere /ID# 243309
city: Paris
country: France
facility: Centre de Soins Osteoarticulaires Ambulatoires /ID# 244737
city: Paris
country: France
facility: AP-HP - Hopital Bichat - Claude-Bernard /ID# 228837
city: Paris
country: France
facility: GH Diaconesses Croix Saint-Simon /ID# 238548
city: Rennes CEDEX 2
country: France
facility: CHU de Rennes - Hospital Sud /ID# 228842
city: Rouen
country: France
facility: Hôpital Charles-Nicolle /ID# 229096
city: St Nazaire
country: France
facility: CH Saint Nazaire /ID# 233186
city: Athens
country: Greece
facility: General Hospital of Athens Ippokratio /ID# 241133
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 241128
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion PA.G.N.I /ID# 241124
state: Kriti
city: Efkarpia (Thessalonikis)
country: Greece
facility: 424 General MILITARY Hospital /ID# 241127
state: Thessaloniki
city: Athens
country: Greece
facility: Naval Hospital of Athens /ID# 241129
city: Athens
country: Greece
facility: KAT Atttica General Hospital /ID# 243063
city: Egaleo
country: Greece
facility: Vougiouklakeio S.A. /ID# 246476
city: Kalamaria
country: Greece
facility: Duplicate_General Hospital of Thessaloniki Agios Pavlos /ID# 243823
city: Maroussi
country: Greece
facility: Iaso /ID# 245137
city: Patras
country: Greece
facility: Olympion General Clinic SA /ID# 251794
city: RION Patras Achaia
country: Greece
facility: University General Hospital of Patras /ID# 243795
city: Thessaloniki
country: Greece
facility: Euromedica Blue Cross Gen Clin /ID# 244945
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Hippokrateio /ID# 243796
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic /ID# 241126
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont /ID# 239936
state: Hajdu-Bihar
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont /ID# 239939
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 239937
city: Heviz
country: Hungary
facility: Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 239940
city: Kecskemet
country: Hungary
facility: Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 239938
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center /ID# 241869
state: H_efa
city: Haifa
country: Israel
facility: Bnai Zion Medical Center /ID# 241866
state: H_efa
city: Haifa
country: Israel
facility: The Lady Davis Carmel Medical Center /ID# 241867
state: H_efa
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 241868
state: HaMerkaz
city: Nahariya
country: Israel
facility: Galilee Medical Center /ID# 241870
state: HaTsafon
city: Tiberias
country: Israel
facility: The Baruch Padeh Medical Center Poriya /ID# 249797
state: HaTsafon
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 241305
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 241864
state: Tel-Aviv
city: Adan
country: Kuwait
facility: Adan Hospital /ID# 229679
city: Hawalli
country: Kuwait
facility: Mubarak Hospital /ID# 250478
city: Hawalli
country: Kuwait
facility: Mubarak Hospital /ID# 251777
city: Jahra
country: Kuwait
facility: Jahra Hospital /ID# 229671
city: Kuwait City
country: Kuwait
facility: Farwaniya Hospital /ID# 231445
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 238815
state: Jalisco
city: Guadalajara
country: Mexico
facility: Private Office Dr. Orozco /ID# 255210
state: Jalisco
city: Warsaw
country: Poland
facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji /ID# 243232
state: Mazowieckie
city: Poznan
country: Poland
facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 243225
state: Wielkopolskie
city: Cracow
country: Poland
facility: Ma?opolskie Badania Kliniczne Sp. z o.o. /ID# 255509
city: Oława
country: Poland
facility: Jerzy ?wierkot Indywidualna Specjalistyczna Praktyka Lekarska /ID# 244289
city: Ulan-Ude
country: Russian Federation
facility: ChUZ Clinical Hospital RZD-Medicine /ID# 233185
state: Buryatiya, Respublika
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Hospital /ID# 244741
state: Chelyabinskaya Oblast
city: Kaliningrad
country: Russian Federation
facility: Regional Clinical Hospital of Kaliningrad region /ID# 238475
state: Kaliningradskaya Oblast
city: Syktyvkar
country: Russian Federation
facility: LLC MC RevmaMed /ID# 238478
state: Komi, Respublika
city: Saransk
country: Russian Federation
facility: GBUZ RM Mordovia Republican Central Clinical Hospital /ID# 244738
state: Mordoviya, Respublika
city: Moscow
country: Russian Federation
facility: Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 232510
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: Research Institute of Rheumatology named after V.A. Nasonova /ID# 238479
state: Moskva
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Hospital n.a. V. D. Seredavin /ID# 231169
state: Samarskaya Oblast
city: St. Petersburg
country: Russian Federation
facility: Nort-Western State Medical University n.a. Mechnikov /ID# 231172
state: Sankt-Peterburg
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #52 /ID# 238477
city: Orenburg
country: Russian Federation
facility: Orenburg State Medical University /ID# 233183
city: Petrozavodsk
country: Russian Federation
facility: Republican hospital named after V.A. Baranov /ID# 231173
city: Samara
country: Russian Federation
facility: Clinic of Samara State Medical University /ID# 241166
city: St. Petersburg
country: Russian Federation
facility: Clinical Rheumatologic Hospital No 25 /ID# 231171
city: St. Petersburg
country: Russian Federation
facility: Military Medical Academy n.a. Kirov /ID# 242363
city: Surgut
country: Russian Federation
facility: Budgetary Institution of the Khanty-Mansiysk Autonomous Okrug-Yugra Surgut Dist /ID# 242369
city: Tomsk
country: Russian Federation
facility: Nebbiolo Clinical Research Center /ID# 231167
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk Regional Clinical Hospital /ID# 238334
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl State Medicat University /ID# 231168
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago /ID# 249025
state: A Coruna
city: Mérida
country: Spain
facility: Hospital de Mérida /ID# 249037
state: Badajoz
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol /ID# 249030
state: Barcelona
city: Terrasa
country: Spain
facility: Hospital Universitario Mutua Terrassa /ID# 249031
state: Barcelona
city: Logroño
country: Spain
facility: Hospital San Pedro /ID# 249028
state: La Rioja
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Llàtzer /ID# 249032
state: Las Palmas
city: San Sebastián de Los Reyes
country: Spain
facility: Hospital Infanta Sofia /ID# 249034
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca /ID# 249042
state: Murcia
city: San Cristóbal de La Laguna
country: Spain
facility: Hospital Universitario Canarias /ID# 249043
state: Santa Cruz De Tenerife
city: Almeria
country: Spain
facility: Hospital Universitario Torrecardenas /ID# 252804
city: Badajoz
country: Spain
facility: Complejos Hospitalario Universitario de Badajoz /ID# 249036
city: Granada
country: Spain
facility: Hospital Campus de la Salud /ID# 252805
city: Huelva
country: Spain
facility: Hospital Juan Ramon Jimenez /ID# 249040
city: Jaen
country: Spain
facility: Hospital Universitario de Jaen /ID# 249041
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti /ID# 255820
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal /ID# 249035
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 249033
city: Palencia
country: Spain
facility: Hospital Río Carrión /ID# 249027
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria /ID# 249044
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena /ID# 249039
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 249038
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid /ID# 252001
city: Zamora
country: Spain
facility: Hospital Virgen de la Concha /ID# 249026
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen /ID# 230696
state: Sankt Gallen
city: Weinfelden
country: Switzerland
facility: Rheumatologisches Versorgungszentrum Weinfelden /ID# 239435
state: Thurgau
city: Locarno
country: Switzerland
facility: Studio Zanisi /ID# 255681
state: Ticino
city: Abu Dhabi
country: United Arab Emirates
facility: Cleveland Clinic Abu Dhabi /ID# 256292
city: Dubai
country: United Arab Emirates
facility: AlAin Hospital /ID# 233803
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: