Assessing the effectiveness of Upadacitinib for adults with Axial Spondyloarthritis

Effectiveness of Upadacitinib in Patients With Axial Spondyloarthritis Suffering From Typical Disease Activity and Pain in a Real-World Setting

This study is testing how well Upadacitinib works for adults with axial spondyloarthritis to see if it helps reduce pain and improve their quality of life.

Quick facts

• Study type: Observational
• Enrollment: 352 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AbbVie (Industry-sponsored)
• Drugs / interventions: upadacitinib, tofacitinib, baricitinib, filgotinib
• Locations: 72 sites (Baden-Baden, Baden-Wurttemberg and 71 other locations)
• Trial ID: NCT05094128 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the real-world effectiveness of Upadacitinib in adult participants diagnosed with axial spondyloarthritis (axSpA). It aims to assess disease activity, pain levels, and patient-reported outcomes in individuals receiving Upadacitinib as prescribed by their physicians. Approximately 352 participants will be enrolled across various locations in Germany, focusing on the impact of treatment on chronic pain and overall quality of life.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with active axial spondyloarthritis who are prescribed Upadacitinib by their physician.

Not a fit: Patients who have previously been treated with any Janus kinase (JAK) inhibitors or those with primary fibromyalgia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of Upadacitinib in managing symptoms and improving the quality of life for patients with axSpA.

How similar studies have performed: While this study focuses on real-world effectiveness, similar studies evaluating Upadacitinib for other conditions have shown promising results.

Eligibility criteria

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.

Where this trial is running

Baden-Baden, Baden-Wurttemberg and 71 other locations

• ACURA Rheumazentrum Baden-Bade /ID# 249751 — Baden-Baden, Baden-Wurttemberg, Germany (Completed)
• Heilig, Heidelberg, DE /ID# 240492 — Heidelberg, Baden-Wurttemberg, Germany (Active_not_recruiting)
• Rheumatologische Schwerpunktpraxis /ID# 245392 — Stuttgart, Baden-Wurttemberg, Germany (Completed)
• Praxis Dr. Haas /ID# 242982 — Tübingen, Baden-Wurttemberg, Germany (Active_not_recruiting)
• Praxis Dr. Rinaldi /ID# 242984 — Ulm, Baden-Wurttemberg, Germany (Active_not_recruiting)
• Praxis K. Pagel /ID# 240490 — Hoppegarten, Brandenburg, Germany (Active_not_recruiting)
• Rheumahaus Studien GbR, Potsdam, DE /ID# 245231 — Potsdam, Brandenburg, Germany (Active_not_recruiting)
• Praxis Dr. Sabine Reckert /ID# 245142 — Potsdam, Brandenburg, Germany (Completed)
• Fachpraxis fuer Rheumatologie und Osteologie /ID# 243358 — Bruchhausen-Vilsen, Lower Saxony, Germany (Active_not_recruiting)
• Stille, Hanover, DE /ID# 252222 — Hanover, Lower Saxony, Germany (Active_not_recruiting)
• Praxis. F. Bigdeli-Wilshusen /ID# 272904 — Hanover, Lower Saxony, Germany (Active_not_recruiting)
• Medizinische Hochschule Hannover /ID# 262814 — Hanover, Lower Saxony, Germany (Active_not_recruiting)
• Rheumatologie Kassel /ID# 275998 — Kassel, Lower Saxony, Germany (Active_not_recruiting)
• Krankenhaus Porz am Rhein /ID# 243765 — Cologne, North Rhine-Westphalia, Germany (Active_not_recruiting)
• Rheumazentrum Ruhrgebiet /ID# 240460 — Herne, North Rhine-Westphalia, Germany (Active_not_recruiting)
• Beyer, Kaiserslautern, DE /ID# 240444 — Kaiserslautern, Rhineland-Palatinate, Germany (Active_not_recruiting)
• Krankenhaus der Barmherzigen Brüder Trier /ID# 240524 — Trier, Rhineland-Palatinate, Germany (Active_not_recruiting)
• Praxis Bernd Mueller /ID# 240488 — Homburg, Saarland, Germany (Completed)
• Rheumapraxis Dr. Prothmann /ID# 240671 — Püttlingen, Saarland, Germany (Active_not_recruiting)
• Medizinischen Versorgungszentrums Agilomed /ID# 240481 — Chemnitz, Saxony, Germany (Completed)
• Rheumatologisches Medizinisches Versorgungszentrum Dresden /ID# 240516 — Dresden, Saxony, Germany (Completed)
• Hamann & Teich & Boche,Leipzig /ID# 240445 — Leipzig, Saxony, Germany (Active_not_recruiting)
• Praxis internistische Rheumatologie /ID# 240515 — Leipzig, Saxony, Germany (Active_not_recruiting)
• Praxis Dr. Liebhaber /ID# 240480 — Halle, Saxony-Anhalt, Germany (Completed)
• Aurich & Sieburg, Magdeburg /ID# 240518 — Magdeburg, Saxony-Anhalt, Germany (Active_not_recruiting)
• Rheumatologische Facharztpraxis - Naumburg (Saale) /ID# 240477 — Naumburg, Saxony-Anhalt, Germany (Active_not_recruiting)
• Rheumatologische Praxis Dr. Jochen Walter /ID# 250263 — Rendsburg, Schleswig-Holstein, Germany (Active_not_recruiting)
• MVZ Ambulantes Rheumazentrum Erfurt /ID# 244448 — Erfurt, Thuringia, Germany (Active_not_recruiting)
• Rheumapraxis Weimar /ID# 268387 — Weimar, Thuringia, Germany (Active_not_recruiting)
• Kupka & Kupka, Altenburg, DE /ID# 240479 — Altenburg, Germany (Active_not_recruiting)
• Marycz, Amberg, DE /ID# 240483 — Amberg, Germany (Active_not_recruiting)
• Rheumapraxis am Webereck /ID# 240454 — Augsburg, Germany (Active_not_recruiting)
• Praxis S. Bresgulewski /ID# 240662 — Bad Bertrich, Germany (Active_not_recruiting)
• Kerckhoff Klinik /ID# 252219 — Bad Nauheim, Germany (Active_not_recruiting)
• Rheumapraxis Berlin /ID# 242987 — Berlin, Germany (Active_not_recruiting)
• Praxis Dr. med. Angela Seifert /ID# 245107 — Berlin, Germany (Completed)
• Praxis Dr. Silke Zinke /ID# 240526 — Berlin, Germany (Active_not_recruiting)
• Krankenhaus Waldfriede /ID# 268389 — Berlin, Germany (Completed)
• Eisterhues, Braunschweig, DE /ID# 239438 — Braunschweig, Germany (Completed)
• MVZ Herzogin Elisabeth Hospital /ID# 267983 — Braunschweig, Germany (Active_not_recruiting)
• Dr. Walberer /ID# 249752 — Burglengenfeld, Germany (Active_not_recruiting)
• Private Practice - Dr. Sebastian Schuh /ID# 240498 — Coburg, Germany (Completed)
• Dres. Karger/Baerlecken /ID# 240442 — Cologne, Germany (Active_not_recruiting)
• MVZ-Medizinisches Versorgungszentrum Daun GmbH /ID# 254839 — Daun, Germany (Completed)
• Kreiskrankenhaus Demmin /ID# 240451 — Demmin, Germany (Active_not_recruiting)
• Praxis Dilltal /ID# 240520 — Ehringshausen, Germany (Active_not_recruiting)
• Private Practice - Dr. Daniel Bestler /ID# 251860 — Erfurt, Germany (Active_not_recruiting)
• Michael Mueller, Freiberg, DE /ID# 240489 — Freiberg, Germany (Active_not_recruiting)
• Praxis Dres. Sensse/Sensse /ID# 240517 — Gifhorn, Germany (Active_not_recruiting)
• Private Practice - Dr. Hauke E. Heintz /ID# 254037 — Hamburg, Germany (Active_not_recruiting)

Study contacts

• Study coordinator: Medical Information Germany

Conditions Axial Spondylarthritis; Upadacitinib; RINVOQ