A Study of the Change in Early and Sustained Pain Control in Axial Spondylarthritis in Adult Participants Receiving Upadacitinib
NCT ID: NCT04846244
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
708 participants
OBSERVATIONAL
2021-04-30
2025-03-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants Receiving Upadacitinib
Participants receiving Upadacitinib for axial spondyloarthritis (axSpA).
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Hospital Italiano La Plata /ID# 230779
La Plata, Buenos Aires, Argentina
CER Instituto Medico /ID# 230782
Quilmes, Buenos Aires, Argentina
Instituto CAICI S.R.L /ID# 230781
Rosario, Santa Fe Province, Argentina
Duplicate_CIMER /ID# 230780
San Miguel de Tucumán, Tucumán Province, Argentina
Clinica Regional del Sud /ID# 248866
Río Cuarto, , Argentina
Paratus Clinical Research Woden /ID# 231460
Phillip, Australian Capital Territory, Australia
Genesis Research Services /ID# 231593
Broadmeadow, New South Wales, Australia
Campbelltown Hospital /ID# 231462
Campbelltown, New South Wales, Australia
Royal Prince Alfred Hospital /ID# 232417
Camperdown, New South Wales, Australia
BJC Health /ID# 230066
Paramatta, New South Wales, Australia
Barwon Rheumatology Services /ID# 230068
Geelong, Victoria, Australia
Peninsula Rheumatology /ID# 240172
Langwarrin, Victoria, Australia
Joint West Rheumatology /ID# 231461
Murdoch, Western Australia, Australia
Université Libre de Bruxelles - Hôpital Erasme /ID# 238961
Anderlecht, Brussels Capital, Belgium
Rhumaconsult SPRL /ID# 231439
Charleroi, Hainaut, Belgium
CHU de Liège /ID# 231440
Liège, Liege, Belgium
AZ-Delta /ID# 238966
Roeselare, West-Vlaanderen, Belgium
Onze Lieve Vrouw Hospital /ID# 238963
Aalst, , Belgium
AZ Sint-Jan Brugge /ID# 238964
Bruges, , Belgium
CHU Brugmann /ID# 238962
Brussels, , Belgium
Reumacentrum /ID# 231437
Genk, , Belgium
ReumaClinic /ID# 231438
Genk, , Belgium
AZ Damiaan /ID# 231441
Ostend, , Belgium
Prof. Anastas Batalov AIPSMP-VBR EOOD /ID# 249788
Plovdiv, , Bulgaria
Medical center Unimed /ID# 249618
Plovdiv, , Bulgaria
"Ambulatory for individual practice of specialized medical help for internal dis /ID# 249791
Sofia, , Bulgaria
ASIMP Rheumatology Centre "St. Irina" EOOD /ID# 249789
Sofia, , Bulgaria
AIPSMPR -d-r Gerganov /ID# 249749
Varna, , Bulgaria
Artus Health Center /ID# 241966
Vancouver, British Columbia, Canada
Manitoba Clinic /ID# 246217
Winnipeg, Manitoba, Canada
CIADS Research Co Ltd /ID# 247520
Winnipeg, Manitoba, Canada
Dr. Juris Lazovskis Inc. /ID# 246574
Sydney, Nova Scotia, Canada
Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 246213
Dundas, Ontario, Canada
Arthur Karasik Medicine Professional Corporation /ID# 241932
Etobicoke, Ontario, Canada
Lau Bacchus Professional Medicine Corp /ID# 242591
Hamilton, Ontario, Canada
Credit Valley Rheumatology /ID# 241948
Mississauga, Ontario, Canada
The Waterside Clinic /ID# 248678
Orillia, Ontario, Canada
Dr. Sabeen Anwar Medicine Professional Corporation /ID# 241933
Windsor, Ontario, Canada
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 249765
Montreal, Quebec, Canada
Applied Medical Informatics Research Inc. (AMIR) /ID# 246284
Montreal, Quebec, Canada
Groupe de Recherche en Maladies Osseuses Inc /ID# 241111
Sainte-Foy, Quebec, Canada
CIUSSS de l'Estrie - CHUS /ID# 247572
Sherbrooke, Quebec, Canada
Dr Naik-Medical Professional Corporation-Alliance Health /ID# 246516
Saskatoon, Saskatchewan, Canada
CHU de Besancon - Jean Minjoz /ID# 230528
Besançon, Doubs, France
CHU de Besancon - Jean Minjoz /ID# 242499
Besançon, Doubs, France
Cabinet de rhumatologie /ID# 229091
Mennecy, Essonne, France
CHU Limoges - Dupuytren 1 /ID# 229094
Limoges, Franche-Comte, France
CHU Bordeaux - Hopital Pellegrin /ID# 230548
Bordeaux, Gironde, France
CHU Toulouse - Hopital Purpan /ID# 228818
Toulouse, Haute-Garonne, France
CHU Montpellier - Hôpital Saint Eloi /ID# 228829
Montpellier, Herault, France
CHU Montpellier - Hôpital Saint Eloi /ID# 240980
Montpellier, Herault, France
Polyclinique Courlancy /ID# 229093
Reims, Marne, France
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 244006
Paris, Paris, France
CHU de SAINT ETIENNE - Hopital Nord /ID# 228836
Saint Priest EN Jarez, Pays de la Loire Region, France
CHU Nice -Hopital Pasteur /ID# 229088
Nice, Provence-Alpes-Côte d'Azur Region, France
Infirmerie Protestante /ID# 228794
Caluire-et-Cuire, Rhone, France
HCL - Hopital Lyon Sud /ID# 228819
Pierre-Bénite, Rhone, France
CHU Amiens-Picardie Site Sud /ID# 228821
Amiens, Somme, France
CH du Pays d'AIX /ID# 229095
Aix-en-Provence, , France
Centre Hospitalier d'Arras /ID# 228833
Arras, , France
CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 229092
Clermont-Ferrand, , France
C. H. Sud Francilien /ID# 228826
Corbeil-Essonnes, , France
CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 230947
La Roche-sur-Yon, , France
CHU Grenoble - Hopital Michallon /ID# 228792
La Tronche, , France
CHU Lille - Hôpital Roger Salengro /ID# 228820
Lille, , France
Clinique de la Sauvegarde /ID# 229087
Lyon, , France
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 234258
Orléans, , France
AP-HP - Hopital Saint-Antoine /ID# 228795
Paris, , France
Hopital Pitie Salpetriere /ID# 243309
Paris, , France
Centre de Soins Osteoarticulaires Ambulatoires /ID# 244737
Paris, , France
AP-HP - Hopital Bichat - Claude-Bernard /ID# 228837
Paris, , France
GH Diaconesses Croix Saint-Simon /ID# 238548
Paris, , France
CHU de Rennes - Hospital Sud /ID# 228842
Rennes, , France
Hôpital Charles-Nicolle /ID# 229096
Rouen, , France
CH Saint Nazaire /ID# 233186
Saint-Nazaire, , France
General Hospital of Athens Ippokratio /ID# 241133
Athens, Attica, Greece
General Hospital of Athens Laiko /ID# 241128
Athens, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 241124
Heraklion, Crete, Greece
424 General MILITARY Hospital /ID# 241127
Efkarpia (Thessalonikis), Thessaloniki, Greece
Vougiouklakeio S.A. /ID# 246476
Aigáleo, , Greece
Naval Hospital of Athens /ID# 241129
Athens, , Greece
KAT Atttica General Hospital /ID# 243063
Athens, , Greece
Duplicate_General Hospital of Thessaloniki Agios Pavlos /ID# 243823
Kalamaria, , Greece
Iaso /ID# 245137
Marousi, , Greece
Olympion General Clinic SA /ID# 251794
Pátrai, , Greece
University General Hospital of Patras /ID# 243795
RION Patras Achaia, , Greece
Euromedica Blue Cross Gen Clin /ID# 244945
Thessaloniki, , Greece
General Hospital of Thessaloniki Hippokrateio /ID# 243796
Thessaloniki, , Greece
Euromedica General Clinic /ID# 241126
Thessaloniki, , Greece
Debreceni Egyetem Klinikai Kozpont /ID# 239936
Debrecen, Hajdú-Bihar, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont /ID# 239939
Budapest, , Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 239937
Debrecen, , Hungary
Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 239940
Hévíz, , Hungary
Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 239938
Kecskemét, , Hungary
Meir Medical Center /ID# 241868
Kfar Saba, Central District, Israel
Hillel Yaffe Medical Center /ID# 241869
Hadera, H_efa, Israel
Bnai Zion Medical Center /ID# 241866
Haifa, H_efa, Israel
The Lady Davis Carmel Medical Center /ID# 241867
Haifa, H_efa, Israel
Galilee Medical Center /ID# 241870
Nahariya, Northern District, Israel
The Baruch Padeh Medical Center Poriya /ID# 249797
Tiberias, Northern District, Israel
The Chaim Sheba Medical Center /ID# 241305
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 241864
Tel Aviv, Tel Aviv, Israel
Adan Hospital /ID# 229679
ADAN, , Kuwait
Jahra Hospital /ID# 229671
Al Jahra, , Kuwait
Mubarak Hospital /ID# 250478
Hawalli, , Kuwait
Mubarak Hospital /ID# 251777
Hawalli, , Kuwait
Farwaniya Hospital /ID# 231445
Kuwait City, , Kuwait
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 238815
Guadalajara, Jalisco, Mexico
Private Office Dr. Orozco /ID# 255210
Guadalajara, Jalisco, Mexico
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 243225
Poznan, Greater Poland Voivodeship, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji /ID# 243232
Warsaw, Masovian Voivodeship, Poland
Ma?opolskie Badania Kliniczne Sp. z o.o. /ID# 255509
Krakow, , Poland
Jerzy ?wierkot Indywidualna Specjalistyczna Praktyka Lekarska /ID# 244289
Oława, , Poland
ChUZ Clinical Hospital RZD-Medicine /ID# 233185
Ulan-Ude, Buryatiya, Respublika, Russia
Chelyabinsk Regional Clinical Hospital /ID# 244741
Chelyabinsk, Chelyabinsk Oblast, Russia
Regional Clinical Hospital of Kaliningrad region /ID# 238475
Kaliningrad, Kaliningrad Oblast, Russia
LLC MC RevmaMed /ID# 238478
Syktyvkar, Komi, Russia
GBUZ RM Mordovia Republican Central Clinical Hospital /ID# 244738
Saransk, Mordoviya, Respublika, Russia
Research Institute of Rheumatology named after V.A. Nasonova /ID# 238479
Moscow, Moscow, Russia
Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 232510
Moscow, Moscow Oblast, Russia
Samara Regional Clinical Hospital n.a. V. D. Seredavin /ID# 231169
Samara, Samara Oblast, Russia
Nort-Western State Medical University n.a. Mechnikov /ID# 231172
Saint Petersburg, Sankt-Peterburg, Russia
City Clinical Hospital #52 /ID# 238477
Moscow, , Russia
Orenburg State Medical University /ID# 233183
Orenburg, , Russia
Republican hospital named after V.A. Baranov /ID# 231173
Petrozavodsk, , Russia
Clinical Rheumatologic Hospital No 25 /ID# 231171
Saint Petersburg, , Russia
Military Medical Academy n.a. Kirov /ID# 242363
Saint Petersburg, , Russia
Clinic of Samara State Medical University /ID# 241166
Samara, , Russia
Budgetary Institution of the Khanty-Mansiysk Autonomous Okrug-Yugra Surgut Dist /ID# 242369
Surgut, , Russia
Nebbiolo Clinical Research Center /ID# 231167
Tomsk, , Russia
Ulyanovsk Regional Clinical Hospital /ID# 238334
Ulyanovsk, , Russia
Yaroslavl State Medicat University /ID# 231168
Yaroslavl, , Russia
Complejo Hospitalario Universitario de Santiago /ID# 249025
Santiago de Compostela, A Coruna, Spain
Hospital de Mérida /ID# 249037
Mérida, Badajoz, Spain
Hospital Universitario Germans Trias i Pujol /ID# 249030
Badalona, Barcelona, Spain
Hospital Universitario Mutua Terrassa /ID# 249031
Terrassa, Barcelona, Spain
Hospital San Pedro /ID# 249028
Logroño, La Rioja, Spain
Hospital Universitario Son Llàtzer /ID# 249032
Palma de Mallorca, Las Palmas, Spain
Hospital Infanta Sofia /ID# 249034
San Sebastián de los Reyes, Madrid, Spain
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 249042
El Palmar, Murcia, Spain
Hospital Universitario Canarias /ID# 249043
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital Universitario Torrecardenas /ID# 252804
Almería, , Spain
Complejos Hospitalario Universitario de Badajoz /ID# 249036
Badajoz, , Spain
Hospital Campus de la Salud /ID# 252805
Granada, , Spain
Hospital Juan Ramon Jimenez /ID# 249040
Huelva, , Spain
Hospital Universitario de Jaen /ID# 249041
Jaén, , Spain
Hospital Universitario Lucus Augusti /ID# 255820
Lugo, , Spain
Hospital Universitario Ramon y Cajal /ID# 249035
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 249033
Madrid, , Spain
Hospital Río Carrión /ID# 249027
Palencia, , Spain
Hospital Universitario Nuestra Señora de Candelaria /ID# 249044
Santa Cruz de Tenerife, , Spain
Hospital Universitario Virgen Macarena /ID# 249039
Seville, , Spain
Hospital Universitario Virgen del Rocio /ID# 249038
Seville, , Spain
Hospital Clinico Universitario de Valladolid /ID# 252001
Valladolid, , Spain
Hospital Virgen de la Concha /ID# 249026
Zamora, , Spain
Kantonsspital St. Gallen /ID# 230696
Sankt Gallen, Canton of St. Gallen, Switzerland
Studio Zanisi /ID# 255681
Locarno, Canton Ticino, Switzerland
Rheumatologisches Versorgungszentrum Weinfelden /ID# 239435
Weinfelden, Thurgau, Switzerland
Cleveland Clinic Abu Dhabi /ID# 256292
Abu Dhabi, , United Arab Emirates
AlAin Hospital /ID# 233803
Dubai, , United Arab Emirates
Countries
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Related Links
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Other Identifiers
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P20-410
Identifier Type: -
Identifier Source: org_study_id
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