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A Study to Assess Disease Activity in Adult Participants With Axial Spondyloarthritis Who Receive Upadacitinib in a Real-world Setting
Sponsor: AbbVie
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 that might be difficult to distinguish from other causes of chronic back pain. Many participants report persistent pain, including back pain, which impacts disease activity and and impairs quality of life while evoking typical disease burden 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 disease control, and the association between pain and clinical/patient-reported outcomes in axSpA participants. Upadacitinib is being developed for the treatment of axSpA. Approximately 352 adult participants with active axSpA will be enrolled in Germany. 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. The overall duration of the study is approximately 52 weeks. There may be a higher burden for participants in this study compared to usual standard of care due to study procedures. 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.
Official title: Effectiveness of Upadacitinib in Patients With Axial Spondyloarthritis Suffering From Typical Disease Activity and Pain in a Real-World Setting
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
352
Start Date
2021-11-22
Completion Date
2026-06
Last Updated
2026-02-02
Healthy Volunteers
No
Conditions
Interventions
Upadacitinib
Tablet; Oral
Locations (72)
ACURA Rheumazentrum Baden-Bade /ID# 249751
Baden-Baden, Baden-Wurttemberg, Germany
Heilig, Heidelberg, DE /ID# 240492
Heidelberg, Baden-Wurttemberg, Germany
Rheumatologische Schwerpunktpraxis /ID# 245392
Stuttgart, Baden-Wurttemberg, Germany
Praxis Dr. Haas /ID# 242982
Tübingen, Baden-Wurttemberg, Germany
Praxis Dr. Rinaldi /ID# 242984
Ulm, Baden-Wurttemberg, Germany
Praxis K. Pagel /ID# 240490
Hoppegarten, Brandenburg, Germany
Rheumahaus Studien GbR, Potsdam, DE /ID# 245231
Potsdam, Brandenburg, Germany
Praxis Dr. Sabine Reckert /ID# 245142
Potsdam, Brandenburg, Germany
Fachpraxis fuer Rheumatologie und Osteologie /ID# 243358
Bruchhausen-Vilsen, Lower Saxony, Germany
Stille, Hanover, DE /ID# 252222
Hanover, Lower Saxony, Germany
Praxis. F. Bigdeli-Wilshusen /ID# 272904
Hanover, Lower Saxony, Germany
Medizinische Hochschule Hannover /ID# 262814
Hanover, Lower Saxony, Germany
Rheumatologie Kassel /ID# 275998
Kassel, Lower Saxony, Germany
Krankenhaus Porz am Rhein /ID# 243765
Cologne, North Rhine-Westphalia, Germany
Rheumazentrum Ruhrgebiet /ID# 240460
Herne, North Rhine-Westphalia, Germany
Beyer, Kaiserslautern, DE /ID# 240444
Kaiserslautern, Rhineland-Palatinate, Germany
Krankenhaus der Barmherzigen Brüder Trier /ID# 240524
Trier, Rhineland-Palatinate, Germany
Praxis Bernd Mueller /ID# 240488
Homburg, Saarland, Germany
Rheumapraxis Dr. Prothmann /ID# 240671
Püttlingen, Saarland, Germany
Medizinischen Versorgungszentrums Agilomed /ID# 240481
Chemnitz, Saxony, Germany
Rheumatologisches Medizinisches Versorgungszentrum Dresden /ID# 240516
Dresden, Saxony, Germany
Hamann & Teich & Boche,Leipzig /ID# 240445
Leipzig, Saxony, Germany
Praxis internistische Rheumatologie /ID# 240515
Leipzig, Saxony, Germany
Praxis Dr. Liebhaber /ID# 240480
Halle, Saxony-Anhalt, Germany
Aurich & Sieburg, Magdeburg /ID# 240518
Magdeburg, Saxony-Anhalt, Germany
Rheumatologische Praxis Dr. Jochen Walter /ID# 250263
Rendsburg, Schleswig-Holstein, Germany
MVZ Ambulantes Rheumazentrum Erfurt /ID# 244448
Erfurt, Thuringia, Germany
Rheumapraxis Weimar /ID# 268387
Weimar, Thuringia, Germany
Kupka & Kupka, Altenburg, DE /ID# 240479
Altenburg, Germany
Marycz, Amberg, DE /ID# 240483
Amberg, Germany
Rheumapraxis am Webereck /ID# 240454
Augsburg, Germany
Praxis S. Bresgulewski /ID# 240662
Bad Bertrich, Germany
Kerckhoff Klinik /ID# 252219
Bad Nauheim, Germany
Rheumapraxis Berlin /ID# 242987
Berlin, Germany
Praxis Dr. med. Angela Seifert /ID# 245107
Berlin, Germany
Praxis Dr. Silke Zinke /ID# 240526
Berlin, Germany
Krankenhaus Waldfriede /ID# 268389
Berlin, Germany
Eisterhues, Braunschweig, DE /ID# 239438
Braunschweig, Germany
MVZ Herzogin Elisabeth Hospital /ID# 267983
Braunschweig, Germany
Dr. Walberer /ID# 249752
Burglengenfeld, Germany
Private Practice - Dr. Sebastian Schuh /ID# 240498
Coburg, Germany
Dres. Karger/Baerlecken /ID# 240442
Cologne, Germany
MVZ-Medizinisches Versorgungszentrum Daun GmbH /ID# 254839
Daun, Germany
Kreiskrankenhaus Demmin /ID# 240451
Demmin, Germany
Praxis Dilltal /ID# 240520
Ehringshausen, Germany
Private Practice - Dr. Daniel Bestler /ID# 251860
Erfurt, Germany
Michael Mueller, Freiberg, DE /ID# 240489
Freiberg, Germany
Praxis Dres. Sensse/Sensse /ID# 240517
Gifhorn, Germany
Private Practice - Dr. Hauke E. Heintz /ID# 254037
Hamburg, Germany
Dres. Weinhardt/Knobel/Doepfer /ID# 248195
Hamburg, Germany
Zentrum fuer Rheumatologie und Schmerzmedizin /ID# 244370
Hanover, Germany
Wernicke, Hohen Neuendorf, DE /ID# 250626
Hohen Neuendorf, Germany
Kremers, Juelich, DE /ID# 243357
Jülich, Germany
Dr. Bolze, Ludwigshafen, DE /ID# 251012
Ludwigshafen, Germany
Praxis Dr. Annekatrin Rossbach /ID# 240495
Mansfeld / Großörner, Germany
Harmuth, Marktredwitz, DE /ID# 240455
Marktredwitz, Germany
RHIO Forschungsinstitut /ID# 240525
Meerbusch, Germany
Prof-med-stud.de /ID# 240458
Munich, Germany
Rheumatologische Facharztpraxis /ID# 240477
Naumburg, Germany
Praxis Dr. med Thilo Klopsch /ID# 240461
Neubrandenburg, Germany
Praxis Hein & Gess /ID# 240456
Nienburg, Germany
MVZ für Rheumatologie Dr. M. Welcker /ID# 240521
Planegg, Germany
Baumann & Lang, Plauen, DE /ID# 244369
Plauen, Germany
Rheumazentrum Ratingen /ID# 240465
Ratingen, Germany
Melzer, Seesen, DE /ID# 240484
Seesen, Germany
Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 240523
Straubing, Germany
Rheumathologie Ulm /ID# 240494
Ulm, Germany
Praxis F. Schattenberg /ID# 257646
Waren, Germany
Krankenhaus St. Josef /ID# 249747
Wuppertal, Germany
Praxis Barmen /ID# 240449
Wuppertal, Germany
Praxis Barmen /ID# 277515
Wuppertal, Germany
Fricke-Wagner, Zwickau, DE /ID# 240452
Zwickau, Germany