RecruitingNCT05496348

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

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

Sponsor

AbbVie

Enrollment

400 participants

Start Date

Oct 20, 2022

Study Type

OBSERVATIONAL

Conditions

Ulcerative Colitis

Summary

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria2

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

Locations(94)

Kepler Universitaetsklinikum GmbH /ID# 251868

Linz, Upper Austria, Austria

Krankenhaus der Barmherzigen Brueder Wien /ID# 251867

Vienna, Vienna, Austria

Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869

Salzburg, Austria

Universitaetsklinik Heidelberg /ID# 249922

Heidelberg, Baden-Wurttemberg, Germany

Praxis fuer Gastroenterologie /ID# 249917

Heidelberg, Baden-Wurttemberg, Germany

Rems-Murr-Klinikum Winnenden /ID# 278791

Winnenden, Baden-Wurttemberg, Germany

Klinikum Augsburg /ID# 249979

Augsburg, Bavaria, Germany

Medizinisches Versorgunszentrum Dachau /ID# 249945

Dachau, Bavaria, Germany

TUM Klinikum rechts der Isar /ID# 262176

Munich, Bavaria, Germany

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

Brandenburg, Brandenburg, Germany

Praxis Dr. Grümmer /ID# 249925

Potsdam, Brandenburg, Germany

Private Practice - Dr. Kempelmann /ID# 249935

Tostedt, Hamburg, Germany

Klinikum Darmstadt /ID# 267685

Darmstadt, Hesse, Germany

Praxis Dres. Hurst/Simonis /ID# 255421

Darmstadt, Hesse, Germany

Interdisziplinaeres Crohn Colitis Zentrum /ID# 252622

Frankfurt am Main, Hesse, Germany

Bethanien-Krankenhaus /ID# 260865

Frankfurt am Main, Hesse, Germany

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

Kassel, Hesse, Germany

Mueller/Mueller-Ziehm, Hanover /ID# 252617

Hanover, Lower Saxony, Germany

Medizinische Hochschule Hannover /ID# 254980

Hanover, Lower Saxony, Germany

Klinikum Lueneburg /ID# 249948

Lüneburg, Lower Saxony, Germany

Verein für Wissenschaft und Forschung /ID# 249928

Oldenburg, Lower Saxony, Germany

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

Coesfeld, North Rhine-Westphalia, Germany

Evangelisches Krankenhaus Kalk /ID# 249987

Cologne, North Rhine-Westphalia, Germany

Gastroenterologische Gemeinschaftspraxis Herne /ID# 249990

Herne, North Rhine-Westphalia, Germany

Gastroenterologische Gemeinschaftspraxis Minden /ID# 249914

Minden, North Rhine-Westphalia, Germany

Dres. Mallach/Spelter /ID# 270912

Wuppertal, North Rhine-Westphalia, Germany

Benner & Dommermuth /ID# 249896

Koblenz, Rhineland-Palatinate, Germany

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

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Klinikum Worms gGmbH /ID# 269804

Worms, Rhineland-Palatinate, Germany

Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 249974

Friedrichsthal, Saarland, Germany

Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 249971

Saarbrücken, Saarland, Germany

Klinikum Chemnitz - Flemmingstraße /ID# 259156

Chemnitz, Saxony, Germany

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 249989

Dresden, Saxony, Germany

Private Practice - Dr. Johannes Janschek /ID# 255092

Dresden, Saxony, Germany

Universitaetsklinikum Leipzig /ID# 262612

Leipzig, Saxony, Germany

Gesellschaft für klinische Studien /ID# 254081

Leipzig, Saxony, Germany

Praxisgemeinschaft Jerichow Schulze /ID# 262931

Jerichow, Saxony-Anhalt, Germany

Gemeinschaftspraxis im Medicum /ID# 249930

Altenholz, Schleswig-Holstein, Germany

Praxis S. Tetzlaff /ID# 253770

Buedelsdorf, Schleswig-Holstein, Germany

Thormann and Bethge /ID# 249897

Kiel, Schleswig-Holstein, Germany

Gastroenterologisch - Hepatologisches MVZ Kiel GmbH /ID# 252623

Kiel, Schleswig-Holstein, Germany

Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249984

Lübeck, Schleswig-Holstein, Germany

Praxis fuer Gastroenterologie /ID# 249907

Lübeck, Schleswig-Holstein, Germany

Friedrich-Ebert-Krankenhaus GmbH /ID# 249973

Neumünster, Schleswig-Holstein, Germany

Gemeinschaftspraxis Dr. med. Maik Weisflog Dr. med. Katrin Ende /ID# 249918

Erfurt, Thuringia, Germany

Universitaetsklinikum Jena /ID# 253768

Jena, Thuringia, Germany

Universitaetsklinikum Jena /ID# 254371

Jena, Thuringia, Germany

Praxis Dr. Schiffelholz /ID# 252621

Augsburg, Germany

MVZ Gastro Friedrichshain /ID# 249924

Berlin, Germany

Praxis Dr. Berndt /ID# 252067

Berlin, Germany

Dres. Schick/Wesenberg /ID# 249977

Berlin, Germany

MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 249981

Berlin, Germany

Zweite Gemeinnuutzige Krankenhaus GmbH DRK Kliniken Berlin Kopenick /ID# 262849

Berlin, Germany

Praxis S. Grüngreiff /ID# 249927

Berlin, Germany

Praxis Dr. Soellenboehmer /ID# 249985

Berlin, Germany

Praxis Dr. Spitz /ID# 252616

Berlin, Germany

Krankenhaus Waldfriede /ID# 249900

Berlin-Zehlendorf, Germany

Internist. Facharztp. Dr. Palmai /ID# 251821

Bitterfeld-Wolfen, Germany

Alb-Donau Klinikum Blaubeuren, ADK GmbH für Gesundheit und Soziales /ID# 249923

Blaubeuren Abbey, Germany

Frach/Hohaus, Dresden, DE /ID# 254979

Dresden, Germany

Dres. Krause/Schiffer /ID# 251727

Frechen, Germany

Dres. Bauer/Doerflinger /ID# 251568

Freiburg im Breisgau, Germany

Internisten in Geldern /ID# 252068

Guelders, Germany

Universitaetsklinikum Halle (Saale) /ID# 254083

Halle, Germany

Private Practice - Dr. Matthias Eichler /ID# 249933

Hamburg, Germany

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

Hamm, Germany

Internistische Praxisgemeinschaft Hanau GbR /ID# 254079

Hanau, Germany

Gastroenterologische Gemeinschaftspraxis /ID# 263633

Heilbronn, Germany

Städtisches Kh. Heinsberg GmbH /ID# 252624

Heinsberg, Germany

Praxis Dres. Preiss/Engelke /ID# 249919

Herne, Germany

Praxis Dr. Schwarz /ID# 251819

Hettstedt, Germany

MVZ Dres. Al-Kadi & Partner /ID# 249929

Iserlohn, Germany

Praxis Dr. Weber /ID# 256099

Jena, Germany

Gastroenterologe am Ettlinger Tor /ID# 249982

Karlsruhe, Germany

MVZ Doceins West GmbH /ID# 249915

Koblenz, Germany

MVZ Gastroenterologie Leverkusen /ID# 260512

Leverkusen, Germany

Gastropraxis Magdeburg /ID# 249988

Magdeburg, Germany

Praxis Dr. Burlefinger /ID# 259159

Munich, Germany

Prof-med-stud.de /ID# 255419

Munich, Germany

Medizinisches Versorgungszentrum Portal 10 /ID# 249947

Münster, Germany

Gastro Campus Research GbR /ID# 249983

Münster, Germany

Praxis Dres Brendel /ID# 254078

Nuremberg, Germany

Medius Klinik Nürtingen /ID# 255420

Nürtingen, Germany

Pc Docs /Id# 249921

Pirmasens, Germany

Elisabeth Klinikum GmbH /ID# 252264

Schmalkalden, Germany

Praxis fuer Gastroenterologie /ID# 252615

Schwerin, Germany

Dres. Rehbehn/Skusa /ID# 252618

Solingen, Germany

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

Stuttgart, Germany

Dr. Schirin-Sokhan /ID# 259158

Würselen, Germany

Zentrum fur Gastroenterologie und Hepatologie /ID# 260967

Zurich, Canton of Zurich, Switzerland

University Hospital Zurich /ID# 260966

Zurich, Canton of Zurich, Switzerland

EOC Ospedale Regionale Lugano /ID# 277165

Lugano, Canton Ticino, Switzerland

Inselspital, Universitaetsspital Bern /ID# 260968

Bern, Switzerland

Berner IBD Study Group /ID# 262315

Bern, Switzerland

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NCT05496348

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