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

NCT05496348 · AbbVie

Recruiting

In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title

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

About this study

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.

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.

Study design

Enrollment target: 400 participants

Age groups: adult, older_adult

Timeline

Starts: 2022-10-20

Estimated completion: 2027-08

Last updated: 2026-03-24

Primary outcomes

• 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 (Week 52)

Sponsor

AbbVie · industry

Contacts & investigators

ContactMedical Information Germany · contact · medinfo.germany@abbvie.com · 49 611 1720 1520

InvestigatorABBVIE INC. · study_director, AbbVie

All locations (94)

Krankenhaus der Barmherzigen Brueder Wien /ID# 251867Active Not Recruiting

Vienna, State of Vienna, Austria

Kepler Universitaetsklinikum GmbH /ID# 251868Active Not Recruiting

Linz, Upper Austria, Austria

Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869Active Not Recruiting

Salzburg, Austria

Universitaetsklinik Heidelberg /ID# 249922Active Not Recruiting

Heidelberg, Baden-Wurttemberg, Germany

Praxis fuer Gastroenterologie /ID# 249917Active Not Recruiting

Heidelberg, Baden-Wurttemberg, Germany

Rems-Murr-Klinikum Winnenden /ID# 278791Completed

Winnenden, Baden-Wurttemberg, Germany

Klinikum Augsburg /ID# 249979Recruiting

Augsburg, Bavaria, Germany

Medizinisches Versorgunszentrum Dachau /ID# 249945Active Not Recruiting

Dachau, Bavaria, Germany

TUM Klinikum rechts der Isar /ID# 262176Active Not Recruiting

Munich, Bavaria, Germany

Dr.med. Johannes Behrendt Facharzt für Innere Medizin und Gastroenterologie /ID# 260516Recruiting

Brandenburg an der Havel, Brandenburg, Germany

Praxis Dr. Grümmer /ID# 249925Completed

Potsdam, Brandenburg, Germany

Private Practice - Dr. Kempelmann /ID# 249935Active Not Recruiting

Tostedt, Free and Hanseatic City of Hamburg, Germany

Klinikum Darmstadt /ID# 267685Recruiting

Darmstadt, Hesse, Germany

Praxis Dres. Hurst/Simonis /ID# 255421Recruiting

Darmstadt, Hesse, Germany

Interdisziplinaeres Crohn Colitis Zentrum /ID# 252622Recruiting

Frankfurt am Main, Hesse, Germany

Bethanien-Krankenhaus /ID# 260865Active Not Recruiting

Frankfurt am Main, Hesse, Germany

Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 251822Recruiting

Kassel, Hesse, Germany

Mueller/Mueller-Ziehm, Hanover /ID# 252617Active Not Recruiting

Hanover, Lower Saxony, Germany

Medizinische Hochschule Hannover /ID# 254980Active Not Recruiting

Hanover, Lower Saxony, Germany

Klinikum Lueneburg /ID# 249948Active Not Recruiting

Lüneburg, Lower Saxony, Germany

Verein für Wissenschaft und Forschung /ID# 249928Active Not Recruiting

Oldenburg, Lower Saxony, Germany

Private Practice - Dr. Mechthild Kemper & Dr. Markus Dreck /ID# 249916Recruiting

Coesfeld, North Rhine-Westphalia, Germany

Evangelisches Krankenhaus Kalk /ID# 249987Recruiting

Cologne, North Rhine-Westphalia, Germany

Gastroenterologische Gemeinschaftspraxis Herne /ID# 249990Active Not Recruiting

Herne, North Rhine-Westphalia, Germany

Gastroenterologische Gemeinschaftspraxis Minden /ID# 249914Active Not Recruiting

Minden, North Rhine-Westphalia, Germany

Dres. Mallach/Spelter /ID# 270912Recruiting

Wuppertal, North Rhine-Westphalia, Germany

Benner & Dommermuth /ID# 249896Active Not Recruiting

Koblenz, Rhineland-Palatinate, Germany

St. Marien- und St. Annastiftskrankenhaus /ID# 273172Recruiting

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Klinikum Worms gGmbH /ID# 269804Recruiting

Worms, Rhineland-Palatinate, Germany

Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 249974Active Not Recruiting

Friedrichsthal, Saarland, Germany

Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 249971Recruiting

Saarbrücken, Saarland, Germany

Klinikum Chemnitz - Flemmingstraße /ID# 259156Recruiting

Chemnitz, Saxony, Germany

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 249989Recruiting

Dresden, Saxony, Germany

Private Practice - Dr. Johannes Janschek /ID# 255092Recruiting

Dresden, Saxony, Germany

Universitaetsklinikum Leipzig /ID# 262612Recruiting

Leipzig, Saxony, Germany

Gesellschaft für klinische Studien /ID# 254081Recruiting

Leipzig, Saxony, Germany

Praxisgemeinschaft Jerichow Schulze /ID# 262931Active Not Recruiting

Jerichow, Saxony-Anhalt, Germany

Gemeinschaftspraxis im Medicum /ID# 249930Active Not Recruiting

Altenholz, Schleswig-Holstein, Germany

Praxis S. Tetzlaff /ID# 253770Active Not Recruiting

Buedelsdorf, Schleswig-Holstein, Germany

Thormann and Bethge /ID# 249897Active Not Recruiting

Kiel, Schleswig-Holstein, Germany

Gastroenterologisch - Hepatologisches MVZ Kiel GmbH /ID# 252623Recruiting

Kiel, Schleswig-Holstein, Germany

Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249984Completed

Lübeck, Schleswig-Holstein, Germany

Praxis fuer Gastroenterologie /ID# 249907Recruiting

Lübeck, Schleswig-Holstein, Germany

Friedrich-Ebert-Krankenhaus GmbH /ID# 249973Recruiting

Neumünster, Schleswig-Holstein, Germany

Gemeinschaftspraxis Dr. med. Maik Weisflog Dr. med. Katrin Ende /ID# 249918Active Not Recruiting

Erfurt, Thuringia, Germany

Universitaetsklinikum Jena /ID# 253768Active Not Recruiting

Jena, Thuringia, Germany

Universitaetsklinikum Jena /ID# 254371Recruiting

Jena, Thuringia, Germany

Praxis Dr. Schiffelholz /ID# 252621Recruiting

Augsburg, Germany

MVZ Gastro Friedrichshain /ID# 249924Active Not Recruiting

Berlin, Germany

Praxis Dr. Berndt /ID# 252067Recruiting

Berlin, Germany

Dres. Schick/Wesenberg /ID# 249977Recruiting

Berlin, Germany

MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 249981Active Not Recruiting

Berlin, Germany

Zweite Gemeinnuutzige Krankenhaus GmbH DRK Kliniken Berlin Kopenick /ID# 262849Active Not Recruiting

Berlin, Germany

Praxis S. Grüngreiff /ID# 249927Recruiting

Berlin, Germany

Praxis Dr. Soellenboehmer /ID# 249985Recruiting

Berlin, Germany

Praxis Dr. Spitz /ID# 252616Active Not Recruiting

Berlin, Germany

Krankenhaus Waldfriede /ID# 249900Recruiting

Berlin-Zehlendorf, Germany

Internist. Facharztp. Dr. Palmai /ID# 251821Active Not Recruiting

Bitterfeld-Wolfen, Germany

Alb-Donau Klinikum Blaubeuren, ADK GmbH für Gesundheit und Soziales /ID# 249923Active Not Recruiting

Blaubeuren Abbey, Germany

Frach/Hohaus, Dresden, DE /ID# 254979Recruiting

Dresden, Germany

Dres. Krause/Schiffer /ID# 251727Active Not Recruiting

Frechen, Germany

Dres. Bauer/Doerflinger /ID# 251568Active Not Recruiting

Freiburg im Breisgau, Germany

Internisten in Geldern /ID# 252068Active Not Recruiting

Guelders, Germany

Universitaetsklinikum Halle (Saale) /ID# 254083Recruiting

Halle, Germany

Private Practice - Dr. Matthias Eichler /ID# 249933Active Not Recruiting

Hamburg, Germany

Tappe/Miks/Delker, Hamm, DE /ID# 251729Recruiting

Hamm, Germany

Internistische Praxisgemeinschaft Hanau GbR /ID# 254079Recruiting

Hanau, Germany

Gastroenterologische Gemeinschaftspraxis /ID# 263633Recruiting

Heilbronn, Germany

Städtisches Kh. Heinsberg GmbH /ID# 252624Active Not Recruiting

Heinsberg, Germany

Praxis Dres. Preiss/Engelke /ID# 249919Active Not Recruiting

Herne, Germany

Praxis Dr. Schwarz /ID# 251819Active Not Recruiting

Hettstedt, Germany

MVZ Dres. Al-Kadi & Partner /ID# 249929Active Not Recruiting

Iserlohn, Germany

Praxis Dr. Weber /ID# 256099Recruiting

Jena, Germany

Gastroenterologe am Ettlinger Tor /ID# 249982Recruiting

Karlsruhe, Germany

MVZ Doceins West GmbH /ID# 249915Recruiting

Koblenz, Germany

MVZ Gastroenterologie Leverkusen /ID# 260512Active Not Recruiting

Leverkusen, Germany

Gastropraxis Magdeburg /ID# 249988Active Not Recruiting

Magdeburg, Germany

Praxis Dr. Burlefinger /ID# 259159Recruiting

Munich, Germany

Prof-med-stud.de /ID# 255419Recruiting

Munich, Germany

Medizinisches Versorgungszentrum Portal 10 /ID# 249947Recruiting

Münster, Germany

Gastro Campus Research GbR /ID# 249983Recruiting

Münster, Germany

Praxis Dres Brendel /ID# 254078Recruiting

Nuremberg, Germany

Medius Klinik Nürtingen /ID# 255420Completed

Nürtingen, Germany

Pc Docs /Id# 249921Active Not Recruiting

Pirmasens, Germany

Elisabeth Klinikum GmbH /ID# 252264Recruiting

Schmalkalden, Germany

Praxis fuer Gastroenterologie /ID# 252615Recruiting

Schwerin, Germany

Dres. Rehbehn/Skusa /ID# 252618Active Not Recruiting

Solingen, Germany

bauchraum Gastroenterologisches Zentrum Dres. F. Kuehl, C. Hartmann, T. Klag BAG /ID# 251567Recruiting

Stuttgart, Germany

Dr. Schirin-Sokhan /ID# 259158Active Not Recruiting

Würselen, Germany

Zentrum fur Gastroenterologie und Hepatologie /ID# 260967Recruiting

Zurich, Canton of Zurich, Switzerland

University Hospital Zurich /ID# 260966Recruiting

Zurich, Canton of Zurich, Switzerland

EOC Ospedale Regionale Lugano /ID# 277165Recruiting

Lugano, Canton Ticino, Switzerland

Inselspital, Universitaetsspital Bern /ID# 260968Recruiting

Bern, Switzerland

Berner IBD Study Group /ID# 262315Recruiting

Bern, Switzerland

View on ClinicalTrials.gov ↗Find similar trials