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

NCT ID: NCT05496348

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-20

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Upadacitinib

Participants will receive upadacitinib as prescribed by their physician according to local label

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Kepler Universitaetsklinikum GmbH /ID# 251868

Linz, Upper Austria, Austria

Site Status RECRUITING

Krankenhaus der Barmherzigen Brueder Wien /ID# 251867

Vienna, Vienna, Austria

Site Status RECRUITING

Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869

Salzburg, , Austria

Site Status RECRUITING

Universitaetsklinik Heidelberg /ID# 249922

Heidelberg, Baden-Wurttemberg, Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis fuer Gastroenterologie /ID# 249917

Heidelberg, Baden-Wurttemberg, Germany

Site Status ACTIVE_NOT_RECRUITING

Rems-Murr-Klinikum Winnenden /ID# 278791

Winnenden, Baden-Wurttemberg, Germany

Site Status COMPLETED

Klinikum Augsburg /ID# 249979

Augsburg, Bavaria, Germany

Site Status RECRUITING

Medizinisches Versorgunszentrum Dachau /ID# 249945

Dachau, Bavaria, Germany

Site Status ACTIVE_NOT_RECRUITING

Klinikum rechts der Isar /ID# 262176

Munich, Bavaria, Germany

Site Status ACTIVE_NOT_RECRUITING

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

Brandenburg, Brandenburg, Germany

Site Status RECRUITING

Praxis Dr. Grümmer /ID# 249925

Potsdam, Brandenburg, Germany

Site Status COMPLETED

Private Practice - Dr. Kempelmann /ID# 249935

Tostedt, Hamburg, Germany

Site Status ACTIVE_NOT_RECRUITING

Klinikum Darmstadt /ID# 267685

Darmstadt, Hesse, Germany

Site Status RECRUITING

Praxis Dres. Hurst/Simonis /ID# 255421

Darmstadt, Hesse, Germany

Site Status RECRUITING

Interdisziplinaeres Crohn Colitis Zentrum /ID# 252622

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Bethanien-Krankenhaus /ID# 260865

Frankfurt am Main, Hesse, Germany

Site Status ACTIVE_NOT_RECRUITING

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

Kassel, Hesse, Germany

Site Status RECRUITING

Mueller/Mueller-Ziehm, Hanover /ID# 252617

Hanover, Lower Saxony, Germany

Site Status ACTIVE_NOT_RECRUITING

Medizinische Hochschule Hannover /ID# 254980

Hanover, Lower Saxony, Germany

Site Status ACTIVE_NOT_RECRUITING

Klinikum Lueneburg /ID# 249948

Lüneburg, Lower Saxony, Germany

Site Status ACTIVE_NOT_RECRUITING

Verein für Wissenschaft und Forschung /ID# 249928

Oldenburg, Lower Saxony, Germany

Site Status ACTIVE_NOT_RECRUITING

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

Coesfeld, North Rhine-Westphalia, Germany

Site Status RECRUITING

Evangelisches Krankenhaus Kalk /ID# 249987

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Gastroenterologische Gemeinschaftspraxis Herne /ID# 249990

Herne, North Rhine-Westphalia, Germany

Site Status ACTIVE_NOT_RECRUITING

Gastroenterologische Gemeinschaftspraxis Minden /ID# 249914

Minden, North Rhine-Westphalia, Germany

Site Status ACTIVE_NOT_RECRUITING

Dres. Mallach/Spelter /ID# 270912

Wuppertal, North Rhine-Westphalia, Germany

Site Status RECRUITING

Benner & Dommermuth /ID# 249896

Koblenz, Rhineland-Palatinate, Germany

Site Status ACTIVE_NOT_RECRUITING

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

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Site Status RECRUITING

Klinikum Worms gGmbH /ID# 269804

Worms, Rhineland-Palatinate, Germany

Site Status RECRUITING

Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 249974

Friedrichsthal, Saarland, Germany

Site Status ACTIVE_NOT_RECRUITING

Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 249971

Saarbrücken, Saarland, Germany

Site Status RECRUITING

Klinikum Chemnitz - Flemmingstraße /ID# 259156

Chemnitz, Saxony, Germany

Site Status RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 249989

Dresden, Saxony, Germany

Site Status RECRUITING

Private Practice - Dr. Johannes Janschek /ID# 255092

Dresden, Saxony, Germany

Site Status RECRUITING

Universitaetsklinikum Leipzig /ID# 262612

Leipzig, Saxony, Germany

Site Status RECRUITING

Gesellschaft für klinische Studien /ID# 254081

Leipzig, Saxony, Germany

Site Status RECRUITING

Praxisgemeinschaft Jerichow Schulze /ID# 262931

Jerichow, Saxony-Anhalt, Germany

Site Status ACTIVE_NOT_RECRUITING

Gemeinschaftspraxis im Medicum /ID# 249930

Altenholz, Schleswig-Holstein, Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis S. Tetzlaff /ID# 253770

Buedelsdorf, Schleswig-Holstein, Germany

Site Status ACTIVE_NOT_RECRUITING

Thormann and Bethge /ID# 249897

Kiel, Schleswig-Holstein, Germany

Site Status ACTIVE_NOT_RECRUITING

Gastroenterologisch - Hepatologisches MVZ Kiel GmbH /ID# 252623

Kiel, Schleswig-Holstein, Germany

Site Status RECRUITING

Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249984

Lübeck, Schleswig-Holstein, Germany

Site Status RECRUITING

Praxis fuer Gastroenterologie /ID# 249907

Lübeck, Schleswig-Holstein, Germany

Site Status RECRUITING

Friedrich-Ebert-Krankenhaus GmbH /ID# 249973

Neumünster, Schleswig-Holstein, Germany

Site Status RECRUITING

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

Erfurt, Thuringia, Germany

Site Status ACTIVE_NOT_RECRUITING

Universitaetsklinikum Jena /ID# 253768

Jena, Thuringia, Germany

Site Status ACTIVE_NOT_RECRUITING

Universitaetsklinikum Jena /ID# 254371

Jena, Thuringia, Germany

Site Status RECRUITING

Praxis Dr. Schiffelholz /ID# 252621

Augsburg, , Germany

Site Status RECRUITING

MVZ Gastro Friedrichshain /ID# 249924

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Dr. Berndt /ID# 252067

Berlin, , Germany

Site Status RECRUITING

Dres. Schick/Wesenberg /ID# 249977

Berlin, , Germany

Site Status RECRUITING

MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 249981

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

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

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis S. Grüngreiff /ID# 249927

Berlin, , Germany

Site Status RECRUITING

Praxis Dr. Soellenboehmer /ID# 249985

Berlin, , Germany

Site Status RECRUITING

Praxis Dr. Spitz /ID# 252616

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Krankenhaus Waldfriede /ID# 249900

Berlin-Zehlendorf, , Germany

Site Status RECRUITING

Internist. Facharztp. Dr. Palmai /ID# 251821

Bitterfeld-Wolfen, , Germany

Site Status ACTIVE_NOT_RECRUITING

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

Blaubeuren Abbey, , Germany

Site Status ACTIVE_NOT_RECRUITING

Frach/Hohaus, Dresden, DE /ID# 254979

Dresden, , Germany

Site Status RECRUITING

Dres. Krause/Schiffer /ID# 251727

Frechen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Dres. Bauer/Doerflinger /ID# 251568

Freiburg im Breisgau, , Germany

Site Status ACTIVE_NOT_RECRUITING

Internisten in Geldern /ID# 252068

Guelders, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitaetsklinikum Halle (Saale) /ID# 254083

Halle, , Germany

Site Status RECRUITING

Private Practice - Dr. Matthias Eichler /ID# 249933

Hamburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

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

Hamm, , Germany

Site Status RECRUITING

Internistische Praxisgemeinschaft Hanau GbR /ID# 254079

Hanau, , Germany

Site Status RECRUITING

Gastroenterologische Gemeinschaftspraxis /ID# 263633

Heilbronn, , Germany

Site Status RECRUITING

Städtisches Kh. Heinsberg GmbH /ID# 252624

Heinsberg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Dres. Preiss/Engelke /ID# 249919

Herne, , Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Dr. Schwarz /ID# 251819

Hettstedt, , Germany

Site Status ACTIVE_NOT_RECRUITING

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

Iserlohn, , Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Dr. Weber /ID# 256099

Jena, , Germany

Site Status RECRUITING

Gastroenterologe am Ettlinger Tor /ID# 249982

Karlsruhe, , Germany

Site Status RECRUITING

MVZ Doceins West GmbH /ID# 249915

Koblenz, , Germany

Site Status RECRUITING

MVZ Gastroenterologie Leverkusen /ID# 260512

Leverkusen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Gastropraxis Magdeburg /ID# 249988

Magdeburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis Dr. Burlefinger /ID# 259159

Munich, , Germany

Site Status RECRUITING

Prof-med-stud.de /ID# 255419

Munich, , Germany

Site Status RECRUITING

Medizinisches Versorgungszentrum Portal 10 /ID# 249947

Münster, , Germany

Site Status RECRUITING

Gastro Campus Research GbR /ID# 249983

Münster, , Germany

Site Status RECRUITING

Praxis Dres Brendel /ID# 254078

Nuremberg, , Germany

Site Status RECRUITING

Medius Klinik Nürtingen /ID# 255420

Nürtingen, , Germany

Site Status COMPLETED

Pc Docs /Id# 249921

Pirmasens, , Germany

Site Status ACTIVE_NOT_RECRUITING

Elisabeth Klinikum GmbH /ID# 252264

Schmalkalden, , Germany

Site Status RECRUITING

Praxis fuer Gastroenterologie /ID# 252615

Schwerin, , Germany

Site Status RECRUITING

Dres. Rehbehn/Skusa /ID# 252618

Solingen, , Germany

Site Status ACTIVE_NOT_RECRUITING

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

Stuttgart, , Germany

Site Status RECRUITING

Dr. Schirin-Sokhan /ID# 259158

Würselen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Zentrum fur Gastroenterologie und Hepatologie /ID# 260967

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

University Hospital Zurich /ID# 260966

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

EOC Ospedale Regionale Lugano /ID# 277165

Lugano, Canton Ticino, Switzerland

Site Status RECRUITING

Inselspital, Universitaetsspital Bern /ID# 260968

Bern, , Switzerland

Site Status RECRUITING

Berner IBD Study Group /ID# 262315

Bern, , Switzerland

Site Status RECRUITING

Countries

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Austria Germany Switzerland

Central Contacts

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Medical Information Germany

Role: CONTACT

49 611 1720 1520

Related Links

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Other Identifiers

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P23-430

Identifier Type: -

Identifier Source: org_study_id

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