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