Assessing the effectiveness of Upadacitinib in treating ulcerative colitis

Early therapeUtic RespOnse and Predictivity of Long-term Effectiveness of Upadacitinib in Ulcerative Colitis (EUROPE)

This study is testing how well Upadacitinib works for adults with moderate to severe ulcerative colitis by following their treatment over two years.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AbbVie (Industry-sponsored)
• Drugs / interventions: Upadacitinib
• Locations: 94 sites (Vienna, State of Vienna and 93 other locations)
• Trial ID: NCT05496348 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the effectiveness of Upadacitinib, an approved medication for ulcerative colitis, in adult patients diagnosed with active moderate to severe ulcerative colitis. Approximately 400 participants will be enrolled across Germany, Austria, and Switzerland, and will receive Upadacitinib as part of their routine clinical care. The study will follow participants for up to two years, collecting data during regular hospital or clinic visits without imposing additional burdens. The treatment decision will be made independently by the investigator based on local guidelines.

Who should consider this trial

Good fit: Ideal candidates include adults with an endoscopically confirmed diagnosis of active moderate to severe ulcerative colitis who are initiating treatment with Upadacitinib.

Not a fit: Patients who have contraindications to Upadacitinib or those previously exposed to a Janus kinase (JAK) inhibitor may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Upadacitinib for managing ulcerative colitis, potentially improving patient outcomes.

How similar studies have performed: Other studies have shown positive outcomes with Upadacitinib in treating ulcerative colitis, indicating that this approach is supported by prior evidence.

Eligibility criteria

Inclusion Criteria:

* Participants with an endoscopically confirmed diagnosis of active moderate to severe Ulcerative colitis (UC).
* Participants initiating Upadacitinib (UPA) at the investigator's discretion as part of their routine clinical care; the decision to administer UPA must be made prior to and independent of documentation for the study and according to the approved local label.
* Participants able to understand and communicate with the investigator and comply with the requirements of the study.
* Participants willing to continue with study documentation after cessation of UPA.

Exclusion Criteria:

* Participants with any contraindication to Upadacitinib (UPA).
* Participants previously exposed to a Janus kinase (JAK) inhibitor.

Where this trial is running

Vienna, State of Vienna and 93 other locations

• Krankenhaus der Barmherzigen Brueder Wien /ID# 251867 — Vienna, State of Vienna, Austria (Active_not_recruiting)
• Kepler Universitaetsklinikum GmbH /ID# 251868 — Linz, Upper Austria, Austria (Active_not_recruiting)
• Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869 — Salzburg, Austria (Active_not_recruiting)
• Universitaetsklinik Heidelberg /ID# 249922 — Heidelberg, Baden-Wurttemberg, Germany (Active_not_recruiting)
• Praxis fuer Gastroenterologie /ID# 249917 — Heidelberg, Baden-Wurttemberg, Germany (Active_not_recruiting)
• Rems-Murr-Klinikum Winnenden /ID# 278791 — Winnenden, Baden-Wurttemberg, Germany (Completed)
• Klinikum Augsburg /ID# 249979 — Augsburg, Bavaria, Germany (Recruiting)
• Medizinisches Versorgunszentrum Dachau /ID# 249945 — Dachau, Bavaria, Germany (Active_not_recruiting)
• TUM Klinikum rechts der Isar /ID# 262176 — Munich, Bavaria, Germany (Active_not_recruiting)
• Dr.med. Johannes Behrendt Facharzt für Innere Medizin und Gastroenterologie /ID# 260516 — Brandenburg an der Havel, Brandenburg, Germany (Recruiting)
• Praxis Dr. Grümmer /ID# 249925 — Potsdam, Brandenburg, Germany (Completed)
• Private Practice - Dr. Kempelmann /ID# 249935 — Tostedt, Free and Hanseatic City of Hamburg, Germany (Active_not_recruiting)
• Klinikum Darmstadt /ID# 267685 — Darmstadt, Hesse, Germany (Recruiting)
• Praxis Dres. Hurst/Simonis /ID# 255421 — Darmstadt, Hesse, Germany (Recruiting)
• Interdisziplinaeres Crohn Colitis Zentrum /ID# 252622 — Frankfurt am Main, Hesse, Germany (Recruiting)
• Bethanien-Krankenhaus /ID# 260865 — Frankfurt am Main, Hesse, Germany (Active_not_recruiting)
• Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 251822 — Kassel, Hesse, Germany (Recruiting)
• Mueller/Mueller-Ziehm, Hanover /ID# 252617 — Hanover, Lower Saxony, Germany (Active_not_recruiting)
• Medizinische Hochschule Hannover /ID# 254980 — Hanover, Lower Saxony, Germany (Active_not_recruiting)
• Klinikum Lueneburg /ID# 249948 — Lüneburg, Lower Saxony, Germany (Active_not_recruiting)
• Verein für Wissenschaft und Forschung /ID# 249928 — Oldenburg, Lower Saxony, Germany (Active_not_recruiting)
• Private Practice - Dr. Mechthild Kemper & Dr. Markus Dreck /ID# 249916 — Coesfeld, North Rhine-Westphalia, Germany (Recruiting)
• Evangelisches Krankenhaus Kalk /ID# 249987 — Cologne, North Rhine-Westphalia, Germany (Recruiting)
• Gastroenterologische Gemeinschaftspraxis Herne /ID# 249990 — Herne, North Rhine-Westphalia, Germany (Active_not_recruiting)
• Gastroenterologische Gemeinschaftspraxis Minden /ID# 249914 — Minden, North Rhine-Westphalia, Germany (Active_not_recruiting)
• Dres. Mallach/Spelter /ID# 270912 — Wuppertal, North Rhine-Westphalia, Germany (Recruiting)
• Benner & Dommermuth /ID# 249896 — Koblenz, Rhineland-Palatinate, Germany (Active_not_recruiting)
• St. Marien- und St. Annastiftskrankenhaus /ID# 273172 — Ludwigshafen am Rhein, Rhineland-Palatinate, Germany (Recruiting)
• Klinikum Worms gGmbH /ID# 269804 — Worms, Rhineland-Palatinate, Germany (Recruiting)
• Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 249974 — Friedrichsthal, Saarland, Germany (Active_not_recruiting)
• Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 249971 — Saarbrücken, Saarland, Germany (Recruiting)
• Klinikum Chemnitz - Flemmingstraße /ID# 259156 — Chemnitz, Saxony, Germany (Recruiting)
• Universitaetsklinikum Carl Gustav Carus Dresden /ID# 249989 — Dresden, Saxony, Germany (Recruiting)
• Private Practice - Dr. Johannes Janschek /ID# 255092 — Dresden, Saxony, Germany (Recruiting)
• Universitaetsklinikum Leipzig /ID# 262612 — Leipzig, Saxony, Germany (Recruiting)
• Gesellschaft für klinische Studien /ID# 254081 — Leipzig, Saxony, Germany (Recruiting)
• Praxisgemeinschaft Jerichow Schulze /ID# 262931 — Jerichow, Saxony-Anhalt, Germany (Active_not_recruiting)
• Gemeinschaftspraxis im Medicum /ID# 249930 — Altenholz, Schleswig-Holstein, Germany (Active_not_recruiting)
• Praxis S. Tetzlaff /ID# 253770 — Buedelsdorf, Schleswig-Holstein, Germany (Active_not_recruiting)
• Thormann and Bethge /ID# 249897 — Kiel, Schleswig-Holstein, Germany (Active_not_recruiting)
• Gastroenterologisch - Hepatologisches MVZ Kiel GmbH /ID# 252623 — Kiel, Schleswig-Holstein, Germany (Recruiting)
• Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249984 — Lübeck, Schleswig-Holstein, Germany (Completed)
• Praxis fuer Gastroenterologie /ID# 249907 — Lübeck, Schleswig-Holstein, Germany (Recruiting)
• Friedrich-Ebert-Krankenhaus GmbH /ID# 249973 — Neumünster, Schleswig-Holstein, Germany (Recruiting)
• Gemeinschaftspraxis Dr. med. Maik Weisflog Dr. med. Katrin Ende /ID# 249918 — Erfurt, Thuringia, Germany (Active_not_recruiting)
• Universitaetsklinikum Jena /ID# 253768 — Jena, Thuringia, Germany (Active_not_recruiting)
• Universitaetsklinikum Jena /ID# 254371 — Jena, Thuringia, Germany (Recruiting)
• Praxis Dr. Schiffelholz /ID# 252621 — Augsburg, Germany (Recruiting)
• MVZ Gastro Friedrichshain /ID# 249924 — Berlin, Germany (Active_not_recruiting)
• Praxis Dr. Berndt /ID# 252067 — Berlin, Germany (Recruiting)

Study contacts

• Study coordinator: Medical Information Germany

Conditions Ulcerative Colitis; Ulcerative colitis; UC; Upadacitinib; UPA; RINVOQ