Study of Oral Upadacitinib to Assess Change in Disease Activity in Adult Participants With Ulcerative Colitis (EUROPE)

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

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will assess how effective upadacitinib is in treating UC.

Upadacitinib (RINVOQ) is an approved drug for treating UC. Approximately 400 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in Germany, Austria and Switzerland.

Upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. Participants in the study will be followed for up to 2 years.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and only data which are routinely collected during a regular visit will be utilized for this study.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Medical Information Germany; Phone Number: 49 611 1720 1520; Email: medinfo.germany@abbvie.com

Study Locations

• Austria
  • Salzburg, Austria, 5010
    • Active, not recruiting
    • Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869
  • State of Vienna
    • Vienna, State of Vienna, Austria, 1020
      • Active, not recruiting
      • Krankenhaus der Barmherzigen Brueder Wien /ID# 251867
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Active, not recruiting
      • Kepler Universitaetsklinikum GmbH /ID# 251868
• Germany
  • Augsburg, Germany, 86150
    • Completed
    • Praxis Dr. Schiffelholz /ID# 252621
  • Berlin, Germany, 10249
    • Active, not recruiting
    • MVZ Gastro Friedrichshain /ID# 249924
  • Berlin, Germany, 10825
    • Active, not recruiting
    • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 249981
  • Berlin, Germany, 12559
    • Active, not recruiting
    • Zweite Gemeinnuutzige Krankenhaus GmbH DRK Kliniken Berlin Kopenick /ID# 262849
  • Berlin, Germany, 14163
    • Active, not recruiting
    • Praxis Dr. Spitz /ID# 252616
  • Berlin, Germany, 10409
    • Completed
    • Praxis Dr. Berndt /ID# 252067
  • Berlin, Germany, 10437
    • Active, not recruiting
    • Dres. Schick/Wesenberg /ID# 249977
  • Berlin, Germany, 12683
    • Active, not recruiting
    • Praxis S. Grüngreiff /ID# 249927
  • Berlin, Germany, 14052
    • Active, not recruiting
    • Praxis Dr. Soellenboehmer /ID# 249985
  • Berlin-Zehlendorf, Germany, 14163
    • Active, not recruiting
    • Krankenhaus Waldfriede /ID# 249900
  • Bitterfeld-Wolfen, Germany, 06749
    • Active, not recruiting
    • Internist. Facharztp. Dr. Palmai /ID# 251821
  • Blaubeuren Abbey, Germany, 89143
    • Active, not recruiting
    • Alb-Donau Klinikum Blaubeuren, ADK GmbH für Gesundheit und Soziales /ID# 249923
  • Dresden, Germany, 01067
    • Active, not recruiting
    • Frach/Hohaus, Dresden, DE /ID# 254979
  • Frechen, Germany, 50226
    • Active, not recruiting
    • Dres. Krause/Schiffer /ID# 251727
  • Freiburg im Breisgau, Germany, 79102
    • Active, not recruiting
    • Dres. Bauer/Doerflinger /ID# 251568
  • Guelders, Germany, 47608
    • Active, not recruiting
    • Internisten in Geldern /ID# 252068
  • Halle, Germany, 06120
    • Completed
    • Universitaetsklinikum Halle (Saale) /ID# 254083
  • Hamburg, Germany, 22041
    • Active, not recruiting
    • Private Practice - Dr. Matthias Eichler /ID# 249933
  • Hamm, Germany, 59065
    • Active, not recruiting
    • Tappe/Miks/Delker, Hamm, DE /ID# 251729
  • Hanau, Germany, 63452
    • Active, not recruiting
    • Internistische Praxisgemeinschaft Hanau GbR /ID# 254079
  • Heilbronn, Germany, 74072
    • Completed
    • Gastroenterologische Gemeinschaftspraxis /ID# 263633
  • Heinsberg, Germany, 52525
    • Active, not recruiting
    • Städtisches Kh. Heinsberg GmbH /ID# 252624
  • Herne, Germany, 44649
    • Active, not recruiting
    • Praxis Dres. Preiss/Engelke /ID# 249919
  • Hettstedt, Germany, 06333
    • Active, not recruiting
    • Praxis Dr. Schwarz /ID# 251819
  • Iserlohn, Germany, 58644
    • Active, not recruiting
    • MVZ Dres. Al-Kadi & Partner /ID# 249929
  • Jena, Germany, 07743
    • Active, not recruiting
    • Praxis Dr. Weber /ID# 256099
  • Karlsruhe, Germany, 76133
    • Active, not recruiting
    • Gastroenterologe am Ettlinger Tor /ID# 249982
  • Koblenz, Germany, 56068
    • Active, not recruiting
    • MVZ Doceins West GmbH /ID# 249915
  • Leverkusen, Germany, 51375
    • Active, not recruiting
    • MVZ Gastroenterologie Leverkusen /ID# 260512
  • Magdeburg, Germany, 39104
    • Active, not recruiting
    • Gastropraxis Magdeburg /ID# 249988
  • Munich, Germany, 80336
    • Active, not recruiting
    • Praxis Dr. Burlefinger /ID# 259159
  • Munich, Germany, 80935
    • Completed
    • Prof-med-stud.de /ID# 255419
  • Münster, Germany, 48155
    • Active, not recruiting
    • Medizinisches Versorgungszentrum Portal 10 /ID# 249947
  • Münster, Germany, 48159
    • Completed
    • Gastro Campus Research GbR /ID# 249983
  • Nuremberg, Germany, 90449
    • Completed
    • Praxis Dres Brendel /ID# 254078
  • Nürtingen, Germany, 72622
    • Completed
    • Medius Klinik Nürtingen /ID# 255420
  • Pirmasens, Germany, 66953
    • Active, not recruiting
    • Pc Docs /Id# 249921
  • Schmalkalden, Germany, 98574
    • Active, not recruiting
    • Elisabeth Klinikum GmbH /ID# 252264
  • Solingen, Germany, 42651
    • Active, not recruiting
    • Dres. Rehbehn/Skusa /ID# 252618
  • Stuttgart, Germany, 70435
    • Completed
    • bauchraum Gastroenterologisches Zentrum Dres. F. Kuehl, C. Hartmann, T. Klag BAG /ID# 251567
  • Würselen, Germany, 52146
    • Active, not recruiting
    • Dr. Schirin-Sokhan /ID# 259158
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • Active, not recruiting
      • Universitaetsklinik Heidelberg /ID# 249922
    • Heidelberg, Baden-Wurttemberg, Germany, 69121
      • Active, not recruiting
      • Praxis fuer Gastroenterologie - Heidelberg /ID# 249917
    • Winnenden, Baden-Wurttemberg, Germany, 71364
      • Completed
      • Rems-Murr-Klinikum Winnenden /ID# 278791
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Completed
      • Klinikum Augsburg /ID# 249979
    • Dachau, Bavaria, Germany, 85221
      • Active, not recruiting
      • Medizinisches Versorgunszentrum Dachau /ID# 249945
    • Munich, Bavaria, Germany, 81675
      • Active, not recruiting
      • TUM Klinikum rechts der Isar /ID# 262176
  • Brandenburg
    • Brandenburg an der Havel, Brandenburg, Germany, 14776
      • Completed
      • Dr.med. Johannes Behrendt Facharzt für Innere Medizin und Gastroenterologie /ID# 260516
    • Potsdam, Brandenburg, Germany, 14471
      • Completed
      • Praxis Dr. Grümmer /ID# 249925
  • Free and Hanseatic City of Hamburg
    • Tostedt, Free and Hanseatic City of Hamburg, Germany, 21255
      • Active, not recruiting
      • Private Practice - Dr. Kempelmann /ID# 249935
  • Hesse
    • Darmstadt, Hesse, Germany, 64283
      • Completed
      • Klinikum Darmstadt /ID# 267685
    • Darmstadt, Hesse, Germany, 64293
      • Active, not recruiting
      • Praxis Dres. Hurst/Simonis /ID# 255421
    • Frankfurt am Main, Hesse, Germany, 60389
      • Active, not recruiting
      • Bethanien-Krankenhaus /ID# 260865
    • Frankfurt am Main, Hesse, Germany, 60318
      • Active, not recruiting
      • Interdisziplinaeres Crohn Colitis Zentrum /ID# 252622
    • Kassel, Hesse, Germany, 34117
      • Active, not recruiting
      • Gastroenterologie Opernstrasse Private Practice - Dr. Falk and Krause and Kuhn /ID# 251822
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30449
      • Active, not recruiting
      • Mueller/Mueller-Ziehm, Hanover /ID# 252617
    • Hanover, Lower Saxony, Germany, 30625
      • Active, not recruiting
      • Medizinische Hochschule Hannover /ID# 254980
    • Lüneburg, Lower Saxony, Germany, 21339
      • Active, not recruiting
      • Klinikum Lueneburg /ID# 249948
    • Oldenburg, Lower Saxony, Germany, 26123
      • Active, not recruiting
      • Verein für Wissenschaft und Forschung /ID# 249928
  • Mecklenburg-Vorpommern
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19057
      • Active, not recruiting
      • Praxis fuer Gastroenterologie - Schwerin /ID# 252615
  • North Rhine-Westphalia
    • Coesfeld, North Rhine-Westphalia, Germany, 48653
      • Active, not recruiting
      • Private Practice - Dr. Mechthild Kemper and Dr. Markus Dreck /ID# 249916
    • Cologne, North Rhine-Westphalia, Germany, 51103
      • Active, not recruiting
      • Evangelisches Krankenhaus Kalk /ID# 249987
    • Herne, North Rhine-Westphalia, Germany, 44623
      • Active, not recruiting
      • Gastroenterologische Gemeinschaftspraxis Herne /ID# 249990
    • Minden, North Rhine-Westphalia, Germany, 32423
      • Active, not recruiting
      • Gastroenterologische Gemeinschaftspraxis Minden /ID# 249914
    • Wuppertal, North Rhine-Westphalia, Germany, 42103
      • Completed
      • Dres. Mallach/Spelter /ID# 270912
  • Rhineland-Palatinate
    • Koblenz, Rhineland-Palatinate, Germany, 56068
      • Active, not recruiting
      • Benner & Dommermuth /ID# 249896
    • Ludwigshafen am Rhein, Rhineland-Palatinate, Germany, 67067
      • Active, not recruiting
      • St. Marien- und St. Annastiftskrankenhaus /ID# 273172
    • Worms, Rhineland-Palatinate, Germany, 67550
      • Active, not recruiting
      • Klinikum Worms gGmbH /ID# 269804
  • Saarland
    • Friedrichsthal, Saarland, Germany, 66299
      • Active, not recruiting
      • Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 249974
    • Saarbrücken, Saarland, Germany, 66111
      • Active, not recruiting
      • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 249971
  • Saxony
    • Chemnitz, Saxony, Germany, 09116
      • Active, not recruiting
      • Klinikum Chemnitz - Flemmingstraße /ID# 259156
    • Dresden, Saxony, Germany, 01307
      • Active, not recruiting
      • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 249989
    • Dresden, Saxony, Germany, 01309
      • Active, not recruiting
      • Private Practice - Dr. Johannes Janschek /ID# 255092
    • Leipzig, Saxony, Germany, 04105
      • Active, not recruiting
      • Gesellschaft für klinische Studien /ID# 254081
    • Leipzig, Saxony, Germany, 04103
      • Active, not recruiting
      • Universitaetsklinikum Leipzig /ID# 262612
  • Saxony-Anhalt
    • Jerichow, Saxony-Anhalt, Germany, 39319
      • Active, not recruiting
      • Praxisgemeinschaft Jerichow Schulze /ID# 262931
  • Schleswig-Holstein
    • Altenholz, Schleswig-Holstein, Germany, 24161
      • Active, not recruiting
      • Gemeinschaftspraxis im Medicum /ID# 249930
    • Buedelsdorf, Schleswig-Holstein, Germany, 24782
      • Active, not recruiting
      • Praxis S. Tetzlaff /ID# 253770
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Active, not recruiting
      • Thormann and Bethge /ID# 249897
    • Kiel, Schleswig-Holstein, Germany, 24146
      • Active, not recruiting
      • Gastroenterologisch - Hepatologisches MVZ Kiel GmbH /ID# 252623
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Completed
      • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249984
    • Lübeck, Schleswig-Holstein, Germany, 23560
      • Active, not recruiting
      • Praxis fuer Gastroenterologie - Lubeck /ID# 249907
    • Neumünster, Schleswig-Holstein, Germany, 24534
      • Active, not recruiting
      • Friedrich-Ebert-Krankenhaus GmbH /ID# 249973
  • Thuringia
    • Erfurt, Thuringia, Germany, 99084
      • Active, not recruiting
      • Gemeinschaftspraxis Dr. med. Maik Weisflog Dr. med. Katrin Ende /ID# 249918
    • Jena, Thuringia, Germany, 07747
      • Active, not recruiting
      • Universitaetsklinikum Jena /ID# 253768
    • Jena, Thuringia, Germany, 07747
      • Completed
      • Universitaetsklinikum Jena /ID# 254371
• Switzerland
  • Bern, Switzerland, 3010
    • Active, not recruiting
    • Inselspital, Universitaetsspital Bern /ID# 260968
  • Bern, Switzerland, 3012
    • Active, not recruiting
    • Berner IBD Study Group /ID# 262315
  • Canton Ticino
    • Lugano, Canton Ticino, Switzerland, 6900
      • Active, not recruiting
      • EOC Ospedale Regionale Lugano /ID# 277165
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8048
      • Recruiting
      • Zentrum fur Gastroenterologie und Hepatologie /ID# 260967
    • Zurich, Canton of Zurich, Switzerland, 8091
      • Active, not recruiting
      • University Hospital Zurich /ID# 260966

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with Ulcerative colitis (UC)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Upadacitinib; Participants will receive upadacitinib as prescribed by their physician according to local label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants achieving symptomatic remission per partial adapted Mayo score among those who achieved clinical response and/or intestinal ultrasound (IUS) response at week 8 of upadacitinib (UPA) induction	Symptomatic remission per partial adapted Mayo score is defined as stool frequency (SF)=0/1 and rectal bleeding score (RBS) =0.	Week 52

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: UPA; Upadacitinib; Ulcerative colitis; UC; RINVOQ
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: P23-430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No