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

NCT ID: NCT05094128

Last Updated: 2025-08-05

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

352 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-22

Study Completion Date

2026-06-30

Brief Summary

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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 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.

Detailed Description

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Conditions

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Axial Spondylarthritis (r-axSpA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants Receiving Upadacitinib.

Upadacitinib

Intervention Type DRUG

Tablet; Oral

Interventions

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Upadacitinib

Tablet; Oral

Intervention Type DRUG

Other Intervention Names

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RINVOQ

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of axSpA upon physician's judgement.
* Physician decision on participant treatment with upadacitinib must have been reached prior to and independently of recruitment in the study.
* Upadacitinib prescribed in accordance with the local label.

Exclusion Criteria

* Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib).
* Participants with primary fibromyalgia (upon physician´s judgement)
* Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days or five half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study.
* Participants who cannot be treated with upadacitinib according to the applicable local label.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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ACURA Rheumazentrum Baden-Bade /ID# 249751

Baden-Baden, Baden-Wurttemberg, Germany

Site Status RECRUITING

Heilig, Heidelberg, DE /ID# 240492

Heidelberg, Baden-Wurttemberg, Germany

Site Status ACTIVE_NOT_RECRUITING

Rheumatologische Schwerpunktpraxis /ID# 245392

Stuttgart, Baden-Wurttemberg, Germany

Site Status RECRUITING

Praxis Dr. Haas /ID# 242982

Tübingen, Baden-Wurttemberg, Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Dr. Rinaldi /ID# 242984

Ulm, Baden-Wurttemberg, Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis K. Pagel /ID# 240490

Hoppegarten, Brandenburg, Germany

Site Status ACTIVE_NOT_RECRUITING

Rheumahaus Studien GbR, Potsdam, DE /ID# 245231

Potsdam, Brandenburg, Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Dr. Sabine Reckert /ID# 245142

Potsdam, Brandenburg, Germany

Site Status RECRUITING

Fachpraxis fuer Rheumatologie und Osteologie /ID# 243358

Bruchhausen-Vilsen, Lower Saxony, Germany

Site Status ACTIVE_NOT_RECRUITING

Stille, Hanover, DE /ID# 252222

Hanover, Lower Saxony, Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis. F. Bigdeli-Wilshusen /ID# 272904

Hanover, Lower Saxony, Germany

Site Status RECRUITING

Medizinische Hochschule Hannover /ID# 262814

Hanover, Lower Saxony, Germany

Site Status ACTIVE_NOT_RECRUITING

Rheumatologie Kassel /ID# 275998

Kassel, Lower Saxony, Germany

Site Status RECRUITING

Krankenhaus Porz am Rhein /ID# 243765

Cologne, North Rhine-Westphalia, Germany

Site Status ACTIVE_NOT_RECRUITING

Rheumazentrum Ruhrgebiet /ID# 240460

Herne, North Rhine-Westphalia, Germany

Site Status ACTIVE_NOT_RECRUITING

Beyer, Kaiserslautern, DE /ID# 240444

Kaiserslautern, Rhineland-Palatinate, Germany

Site Status ACTIVE_NOT_RECRUITING

Krankenhaus der Barmherzigen Brüder Trier /ID# 240524

Trier, Rhineland-Palatinate, Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Bernd Mueller /ID# 240488

Homburg, Saarland, Germany

Site Status RECRUITING

Rheumapraxis Dr. Prothmann /ID# 240671

Püttlingen, Saarland, Germany

Site Status ACTIVE_NOT_RECRUITING

Medizinischen Versorgungszentrums Agilomed /ID# 240481

Chemnitz, Saxony, Germany

Site Status RECRUITING

Hamann & Teich & Boche,Leipzig /ID# 240445

Leipzig, Saxony, Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis internistische Rheumatologie /ID# 240515

Leipzig, Saxony, Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Dr. Liebhaber /ID# 240480

Halle, Saxony-Anhalt, Germany

Site Status RECRUITING

Aurich & Sieburg, Magdeburg /ID# 240518

Magdeburg, Saxony-Anhalt, Germany

Site Status ACTIVE_NOT_RECRUITING

Rheumatologische Praxis Dr. Jochen Walter /ID# 250263

Rendsburg, Schleswig-Holstein, Germany

Site Status ACTIVE_NOT_RECRUITING

MVZ Ambulantes Rheumazentrum Erfurt /ID# 244448

Erfurt, Thuringia, Germany

Site Status ACTIVE_NOT_RECRUITING

Rheumapraxis Weimar /ID# 268387

Weimar, Thuringia, Germany

Site Status ACTIVE_NOT_RECRUITING

Kupka & Kupka, Altenburg, DE /ID# 240479

Altenburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Marycz, Amberg, DE /ID# 240483

Amberg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Rheumapraxis am Webereck /ID# 240454

Augsburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis S. Bresgulewski /ID# 240662

Bad Bertrich, , Germany

Site Status ACTIVE_NOT_RECRUITING

Kerckhoff Klinik /ID# 252219

Bad Nauheim, , Germany

Site Status ACTIVE_NOT_RECRUITING

Rheumapraxis Berlin /ID# 242987

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Dr. med. Angela Seifert /ID# 245107

Berlin, , Germany

Site Status RECRUITING

Praxis Dr. Silke Zinke /ID# 240526

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Krankenhaus Waldfriede /ID# 268389

Berlin, , Germany

Site Status RECRUITING

Eisterhues, Braunschweig, DE /ID# 239438

Braunschweig, , Germany

Site Status COMPLETED

MVZ Herzogin Elisabeth Hospital /ID# 267983

Braunschweig, , Germany

Site Status ACTIVE_NOT_RECRUITING

Dr. Walberer /ID# 249752

Burglengenfeld, , Germany

Site Status ACTIVE_NOT_RECRUITING

Private Practice - Dr. Sebastian Schuh /ID# 240498

Coburg, , Germany

Site Status RECRUITING

Dres. Karger/Baerlecken /ID# 240442

Cologne, , Germany

Site Status ACTIVE_NOT_RECRUITING

MVZ-Medizinisches Versorgungszentrum Daun GmbH /ID# 254839

Daun, , Germany

Site Status RECRUITING

Kreiskrankenhaus Demmin /ID# 240451

Demmin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Rheumatologisches MVZ Dresden /ID# 240516

Dresden, , Germany

Site Status RECRUITING

Praxis Dilltal /ID# 240520

Ehringshausen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Private Practice - Dr. Daniel Bestler /ID# 251860

Erfurt, , Germany

Site Status ACTIVE_NOT_RECRUITING

Michael Mueller, Freiberg, DE /ID# 240489

Freiberg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Dres. Sensse/Sensse /ID# 240517

Gifhorn, , Germany

Site Status ACTIVE_NOT_RECRUITING

Dr. Heintz /ID# 254037

Hamburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Dres. Weinhardt/Knobel/Doepfer /ID# 248195

Hamburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Zentrum fuer Rheumatologie und Schmerzmedizin /ID# 244370

Hanover, , Germany

Site Status ACTIVE_NOT_RECRUITING

Wernicke, Hohen Neuendorf, DE /ID# 250626

Hohen Neuendorf, , Germany

Site Status ACTIVE_NOT_RECRUITING

Kremers, Juelich, DE /ID# 243357

Jülich, , Germany

Site Status ACTIVE_NOT_RECRUITING

Dr. Bolze, Ludwigshafen, DE /ID# 251012

Ludwigshafen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Dr. Annekatrin Rossbach /ID# 240495

Mansfeld / Großörner, , Germany

Site Status RECRUITING

Harmuth, Marktredwitz, DE /ID# 240455

Marktredwitz, , Germany

Site Status ACTIVE_NOT_RECRUITING

RHIO Forschungsinstitut /ID# 240525

Meerbusch, , Germany

Site Status ACTIVE_NOT_RECRUITING

Prof-med-stud.de /ID# 240458

Munich, , Germany

Site Status ACTIVE_NOT_RECRUITING

Rheumatologische Facharztpraxis /ID# 240477

Naumburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Dr. med Thilo Klopsch /ID# 240461

Neubrandenburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Hein & Gess /ID# 240456

Nienburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

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

Planegg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Baumann & Lang, Plauen, DE /ID# 244369

Plauen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Rheumazentrum Ratingen /ID# 240465

Ratingen, , Germany

Site Status RECRUITING

Melzer, Seesen, DE /ID# 240484

Seesen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 240523

Straubing, , Germany

Site Status ACTIVE_NOT_RECRUITING

Rheumathologie Ulm /ID# 240494

Ulm, , Germany

Site Status RECRUITING

Praxis F. Schattenberg /ID# 257646

Waren (Müritz), , Germany

Site Status ACTIVE_NOT_RECRUITING

Krankenhaus St. Josef /ID# 249747

Wuppertal, , Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Barmen /ID# 240449

Wuppertal, , Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Barmen /ID# 277515

Wuppertal, , Germany

Site Status RECRUITING

Fricke-Wagner, Zwickau, DE /ID# 240452

Zwickau, , Germany

Site Status ACTIVE_NOT_RECRUITING

Countries

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Germany

Central Contacts

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Medical Information Germany

Role: CONTACT

49 611 1720 1520

Related Links

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https://www.rxabbvie.com/

This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Other Identifiers

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P21-007

Identifier Type: -

Identifier Source: org_study_id

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