A Study to Assess Disease Activity in Adult Participants With Axial Spondyloarthritis Who Receive Upadacitinib in a Real-world Setting

Last updated: March 13, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ankylosing Spondylitis

Treatment

Upadacitinib

Clinical Study ID

NCT05094128
P21-007
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of axSpA upon physician's judgement.

  • Physician decision on participant treatment with upadacitinib must have been reachedprior to and independently of recruitment in the study.

  • Upadacitinib prescribed in accordance with the local label.

Exclusion

Exclusion Criteria:

  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited toupadacitinib, tofacitinib, baricitinib, and filgotinib).

  • Participants with primary fibromyalgia (upon physician´s judgement)

  • Participation in a clinical trial of an investigational drug, concurrently or withinthe last 30 days or five half-lives of the drug (whichever is longer) prior to thefirst dose of study drug or is currently enrolled in another clinical study.

  • Participants who cannot be treated with upadacitinib according to the applicablelocal label.

Study Design

Total Participants: 352
Treatment Group(s): 1
Primary Treatment: Upadacitinib
Phase:
Study Start date:
November 22, 2021
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • ACURA Rheumazentrum Baden-Bade /ID# 249751

    Baden-baden, Baden-Wuerttemberg 76530
    Germany

    Active - Recruiting

  • Heilig, Heidelberg, DE /ID# 240492

    Heidelberg, Baden-Wuerttemberg 69120
    Germany

    Site Not Available

  • Rheumatologische Schwerpunktpraxis /ID# 245392

    Stuttgart, Baden-Wuerttemberg 70372
    Germany

    Active - Recruiting

  • Praxis Dr. Haas /ID# 242982

    Tuebingen, Baden-Wuerttemberg 72072
    Germany

    Site Not Available

  • Praxis Dr. Rinaldi /ID# 242984

    Ulm, Baden-Wuerttemberg 89073
    Germany

    Site Not Available

  • Praxis Dres. Kellerer/Kellerer/Krüger /ID# 240478

    Munich, Bayern 81541
    Germany

    Site Not Available

  • Praxis K. Pagel /ID# 240490

    Hoppegarten, Brandenburg 15366
    Germany

    Site Not Available

  • Praxis Dr. Sabine Reckert /ID# 245142

    Potsdam, Brandenburg 14469
    Germany

    Active - Recruiting

  • Rheumahaus Studien GbR, Potsdam, DE /ID# 245231

    Potsdam, Brandenburg 14467
    Germany

    Site Not Available

  • Internistisches Praxiszentrum /ID# 240491

    Gießen, Hessen 35392
    Germany

    Site Not Available

  • Fachpraxis fuer Rheumatologie und Osteologie /ID# 243358

    Bruchhausen-Vilsen, Niedersachsen 27305
    Germany

    Site Not Available

  • Stille, Hanover, DE /ID# 252222

    Hannover, Niedersachsen 30161
    Germany

    Site Not Available

  • Praxis. F. Bigdeli-Wilshusen /ID# 272904

    Hanover, Niedersachsen 30173
    Germany

    Active - Recruiting

  • Krankenhaus Porz am Rhein /ID# 243765

    Cologne, Nordrhein-Westfalen 51149
    Germany

    Site Not Available

  • Rheumazentrum Ruhrgebiet /ID# 240137

    Herne, Nordrhein-Westfalen 44649
    Germany

    Site Not Available

  • Rheumazentrum Ruhrgebiet /ID# 240460

    Herne, Nordrhein-Westfalen 44649
    Germany

    Site Not Available

  • Beyer, Kaiserslautern, DE /ID# 240444

    Kaiserslautern, Rheinland-Pfalz 67659
    Germany

    Site Not Available

  • Krankenhaus der Barmherzigen Brüder Trier /ID# 240524

    Trier, Rheinland-Pfalz 54292
    Germany

    Site Not Available

  • Praxis Bernd Mueller /ID# 240488

    Homburg, Saarland 66424
    Germany

    Active - Recruiting

  • Rheumapraxis Dr. Prothmann /ID# 240671

    Püttlingen, Saarland 66346
    Germany

    Site Not Available

  • Med Versorgungszentrum AGILOMED /ID# 240481

    Chemnitz, Sachsen 09130
    Germany

    Active - Recruiting

  • Hamann & Teich & Boche,Leipzig /ID# 240445

    Leipzig, Sachsen 04109
    Germany

    Site Not Available

  • Praxis internistische Rheumatologie /ID# 240515

    Leipzig, Sachsen 04129
    Germany

    Site Not Available

  • Praxis Dr. Liebhaber /ID# 240480

    Halle, Sachsen-Anhalt 06128
    Germany

    Active - Recruiting

  • Aurich & Sieburg, Magdeburg /ID# 240518

    Magdeburg, Sachsen-Anhalt 39104
    Germany

    Site Not Available

  • Rheumatologische Praxis Dr. Jochen Walter /ID# 250263

    Rendsburg, Schleswig-Holstein 24768
    Germany

    Site Not Available

  • MVZ Ambulantes Rheumazentrum Erfurt /ID# 244448

    Erfurt, Thueringen 99096
    Germany

    Site Not Available

  • Rheumapraxis Weimar /ID# 268387

    Weimar, Thueringen 99427
    Germany

    Site Not Available

  • Kupka & Kupka, Altenburg, DE /ID# 240479

    Altenburg, 04600
    Germany

    Site Not Available

  • Marycz, Amberg, DE /ID# 240483

    Amberg, 92224
    Germany

    Site Not Available

  • Rheumapraxis am Webereck /ID# 240454

    Augsburg, 86157
    Germany

    Site Not Available

  • Praxis S. Bresgulewski /ID# 240662

    Bad Bertrich, 56864
    Germany

    Site Not Available

  • Kerckhoff Klinik /ID# 252219

    Bad Nauheim, 61231
    Germany

    Site Not Available

  • Rheumapraxis Bad Neuenahr /ID# 240441

    Bad Neuenahr, 53474
    Germany

    Site Not Available

  • MVZ Weserbergland /ID# 240486

    Bad Pyrmont, 31812
    Germany

    Site Not Available

  • ACURA Rheumazentrum Baden-Bade /ID# 240487

    Baden-baden, 76530
    Germany

    Site Not Available

  • Internistische-rheumatologische Praxisgemeinschaft /ID# 240496

    Bayreuth, 95444
    Germany

    Site Not Available

  • Krankenhaus Waldfriede /ID# 268389

    Berlin, 14163
    Germany

    Active - Recruiting

  • MVZ Rheumatologie /ID# 240614

    Berlin, 10117
    Germany

    Site Not Available

  • Praxis Dr. Silke Zinke /ID# 240526

    Berlin, 13055
    Germany

    Site Not Available

  • Praxis Dr. med. Angela Seifert /ID# 245107

    Berlin, 12555
    Germany

    Active - Recruiting

  • Praxis fuer Rheumatologie und Innere Medizin /ID# 240457

    Berlin, 12163
    Germany

    Site Not Available

  • Rheumapraxis Berlin /ID# 242987

    Berlin, 12435
    Germany

    Site Not Available

  • Eisterhues, Braunschweig, DE /ID# 239438

    Braunschweig, 38100
    Germany

    Completed

  • MVZ Herzogin Elisabeth Hospital /ID# 267983

    Brunswick, 38114
    Germany

    Site Not Available

  • Schwerpunktpraxis fuer Rheumat /ID# 240450

    Burghausen, 84489
    Germany

    Site Not Available

  • Dr. Walberer /ID# 249752

    Burglengenfeld, 93133
    Germany

    Site Not Available

  • Dres. Schuh /ID# 240498

    Coburg, 96450
    Germany

    Active - Recruiting

  • Dres. Karger/Baerlecken /ID# 240442

    Cologne, 50996
    Germany

    Site Not Available

  • MVZ-Medizinisches Versorgungszentrum Daun GmbH /ID# 254839

    Daun, 54550
    Germany

    Active - Recruiting

  • Kreiskrankenhaus Demmin /ID# 240451

    Demmin, 17109
    Germany

    Site Not Available

  • Rheumatologisches MVZ Dresden /ID# 240516

    Dresden, 01109
    Germany

    Active - Recruiting

  • Rheumapraxis Düren /ID# 240447

    Düren, 52355
    Germany

    Site Not Available

  • Praxis Dilltal /ID# 240520

    Ehringshausen, 35630
    Germany

    Site Not Available

  • Dr. Bestler /ID# 251860

    Erfurt, 99096
    Germany

    Site Not Available

  • Michael Mueller, Freiberg, DE /ID# 240489

    Freiberg, 09599
    Germany

    Site Not Available

  • Praxis Dres. Sensse/Sensse /ID# 240517

    Gifhorn, 38518
    Germany

    Site Not Available

  • Universitaetsmedizin Goettingen /ID# 240138

    Goettingen, 37075
    Germany

    Site Not Available

  • Dr. Heintz /ID# 254037

    Hamburg, 22391
    Germany

    Site Not Available

  • Dres. Weinhardt/Knobel/Doepfer /ID# 248195

    Hamburg, 22523
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover /ID# 262814

    Hannover, 30625
    Germany

    Site Not Available

  • Zentrum fuer Rheumatologie und Schmerzmedizin /ID# 244370

    Hanover, 30159
    Germany

    Site Not Available

  • Wernicke, Hohen Neuendorf, DE /ID# 250626

    Hohen Neuendorf, 16540
    Germany

    Site Not Available

  • Kremers, Juelich, DE /ID# 243357

    Juelich, 52428
    Germany

    Site Not Available

  • Alb-Donau Klinikum, Langenau /ID# 240446

    Langenau, 89129
    Germany

    Site Not Available

  • Dr. Bolze, Ludwigshafen, DE /ID# 251012

    Ludwigshafen, 67069
    Germany

    Site Not Available

  • Praxis Dr. Annekatrin Rossbach /ID# 240495

    Mansfeld / Großörner, 06343
    Germany

    Active - Recruiting

  • Harmuth, Marktredwitz, DE /ID# 240455

    Marktredwitz, 95615
    Germany

    Site Not Available

  • RHIO Forschungsinstitut /ID# 240525

    Meerbusch, 40668
    Germany

    Site Not Available

  • Prof-med-stud.de /ID# 240458

    Munich, 80935
    Germany

    Site Not Available

  • Rheumatologische Facharztpraxis /ID# 240477

    Naumburg (Saale), 06618
    Germany

    Site Not Available

  • Praxis Dr. med Thilo Klopsch /ID# 240461

    Neubrandenburg, 17033
    Germany

    Site Not Available

  • Praxis Hein & Gess /ID# 240456

    Nienburg, 31582
    Germany

    Site Not Available

  • MVZ für Rheumatologie Dr. M. Welcker /ID# 240521

    Planegg, 82152
    Germany

    Site Not Available

  • MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 240521

    Planegg, 82152
    Germany

    Active - Recruiting

  • Baumann & Lang, Plauen, DE /ID# 244369

    Plauen, 08523
    Germany

    Site Not Available

  • Rheumazentrum Ratingen /ID# 240465

    Ratingen, 40882
    Germany

    Active - Recruiting

  • Rheumatologische Gemeinschaftspraxis Schwerin /ID# 240463

    Schwerin, 19053
    Germany

    Site Not Available

  • Melzer, Seesen, DE /ID# 240484

    Seesen, 38723
    Germany

    Site Not Available

  • Rheumapraxis Magdea /ID# 240482

    Stadtoldendorf, 37627
    Germany

    Site Not Available

  • Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 240523

    Straubing, 94315
    Germany

    Site Not Available

  • Rheumatologische Schwerpunktpraxis /ID# 240564

    Stuttgart, 70372
    Germany

    Site Not Available

  • Krankenhaus der Barmherzigen Brueder Trier /ID# 240524

    Trier, 54292
    Germany

    Active - Recruiting

  • Rheumathologie Ulm /ID# 240494

    Ulm, 89073
    Germany

    Active - Recruiting

  • Praxis F. Schattenberg /ID# 257646

    Waren (Müritz), 17192
    Germany

    Site Not Available

  • Krankenhaus St. Josef /ID# 240522

    Wuppertal, 42105
    Germany

    Site Not Available

  • Krankenhaus St. Josef /ID# 249747

    Wuppertal, 42105
    Germany

    Site Not Available

  • Praxis Barmen /ID# 240449

    Wuppertal, 42285
    Germany

    Site Not Available

  • Sprekeler, Zeven, DE /ID# 240519

    Zeven, 27404
    Germany

    Site Not Available

  • Fricke-Wagner, Zwickau, DE /ID# 240452

    Zwickau, 08060
    Germany

    Site Not Available

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