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

Recruiting

• Conditions: Ulcerative Colitis

• Registration Number: NCT05496348
• Lead Sponsor: AbbVie

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Study Start: 2022-10-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Symptomatic remission per partial adapted Mayo score is defined as stool frequency (SF)=0/1 and rectal bleeding score (RBS) =0.

Trial Locations

Locations (93)

Praxis Dr. Weber /ID# 256099; 🇩🇪 Jena, Germany

Prof-med-stud.de /ID# 255419; 🇩🇪 Munich, Germany

Dr. Schirin-Sokhan /ID# 259158; 🇩🇪 Würselen, Germany

Dres. Bauer/Doerflinger /ID# 251568; 🇩🇪 Freiburg im Breisgau, Germany

Kepler Universitaetsklinikum GmbH /ID# 251868; 🇦🇹 Linz, Oberoesterreich, Austria

Krankenhaus der Barmherzigen Brueder Wien /ID# 251867; 🇦🇹 Vienna, Wien, Austria

Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869; 🇦🇹 Salzburg, Austria

Universitaetsklinik Heidelberg /ID# 249922; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany

Praxis fuer Gastroenterologie /ID# 249917; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany

Klinikum Augsburg /ID# 249979; 🇩🇪 Augsburg, Bayern, Germany

Medizinisches Versorgunszentrum Dachau /ID# 249945; 🇩🇪 Dachau, Bayern, Germany

Dr.med. Johannes Behrendt Facharzt für Innere Medizin und Gastroenterologie /ID# 260516; 🇩🇪 Brandenburg an der Havel, Brandenburg, Germany

Praxis Dr. Grümmer /ID# 249925; 🇩🇪 Potsdam, Brandenburg, Germany

Klinikum Darmstadt /ID# 267685; 🇩🇪 Darmstadt, Hessen, Germany

Praxis Dres. Hurst/Simonis /ID# 255421; 🇩🇪 Darmstadt, Hessen, Germany

Universitaetsklinikum Frankfurt /ID# 254079; 🇩🇪 Frankfurt am Main, Hessen, Germany

Interdisziplinaeres Crohn Colitis Zentrum /ID# 252622; 🇩🇪 Frankfurt, Hessen, Germany

Bethanien-Krankenhaus /ID# 260865; 🇩🇪 Frankfurt, Hessen, Germany

Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 251822; 🇩🇪 Kassel, Hessen, Germany

Universitaetsmedizin Rostock /ID# 253769; 🇩🇪 Rostock, Mecklenburg-Vorpommern, Germany

Mueller/Mueller-Ziehm, Hanover /ID# 252617; 🇩🇪 Hannover, Niedersachsen, Germany

Klinikum Lueneburg /ID# 249948; 🇩🇪 Lueneburg, Niedersachsen, Germany

Verein für Wissenschaft und Forschung /ID# 249928; 🇩🇪 Oldenburg, Niedersachsen, Germany

Evangelisches Krankenhaus Kalk /ID# 249987; 🇩🇪 Cologne, Nordrhein-Westfalen, Germany

Gastroenterologische Gemeinschaftspraxis Herne /ID# 249990; 🇩🇪 Herne, Nordrhein-Westfalen, Germany

Gastroenterologische Gemeinschaftspraxis Minden /ID# 249914; 🇩🇪 Minden, Nordrhein-Westfalen, Germany

Dres. Mallach/Spelter /ID# 270912; 🇩🇪 Wuppertal, Nordrhein-Westfalen, Germany

Benner & Dommermuth /ID# 249896; 🇩🇪 Koblenz, Rheinland-Pfalz, Germany

St. Marien- und St. Annastiftskrankenhaus /ID# 273172; 🇩🇪 Ludwigshafen am Rhein, Rheinland-Pfalz, Germany

Klinikum Worms gGmbH /ID# 269804; 🇩🇪 Worms, Rheinland-Pfalz, Germany

Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 249974; 🇩🇪 Friedrichsthal, Saarland, Germany

Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 249971; 🇩🇪 Saarbrücken, Saarland, Germany

Praxisgemeinschaft Jerichow Schulze /ID# 262931; 🇩🇪 Jerichow, Sachsen-Anhalt, Germany

Klinikum Chemnitz gGmbH /ID# 259156; 🇩🇪 Chemnitz, Sachsen, Germany

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 249989; 🇩🇪 Dresden, Sachsen, Germany

Universitaetsklinikum Leipzig /ID# 254081; 🇩🇪 Leipzig, Sachsen, Germany

Universitaetsklinikum Leipzig /ID# 262612; 🇩🇪 Leipzig, Sachsen, Germany

Praxis Jessen/Grimm /ID# 249930; 🇩🇪 Altenholz, Schleswig-Holstein, Germany

Praxis S. Tetzlaff /ID# 253770; 🇩🇪 Büdelsdorf, 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; 🇩🇪 Neumuenster, Schleswig-Holstein, Germany

Universitaetsklinikum Jena /ID# 253768; 🇩🇪 Jena, Thueringen, Germany

Universitaetsklinikum Jena /ID# 254371; 🇩🇪 Jena, Thueringen, Germany

Praxis Dr. Schiffelholz /ID# 252621; 🇩🇪 Augsburg, Germany

Krankenhaus Waldfriede /ID# 249900; 🇩🇪 Berlin-Zehlendorf, 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

Internist. Facharztp. Dr. Palmai /ID# 251821; 🇩🇪 Bitterfeld-Wolfen, Germany

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

Dres. Kemper/Dreck /ID# 249916; 🇩🇪 Coesfeld, Germany

Frach/Hohaus, Dresden, DE /ID# 254979; 🇩🇪 Dresden, Germany

Dr. Janschek /ID# 255092; 🇩🇪 Dresden, Germany

Dres. Ende / Weisflog /ID# 249918; 🇩🇪 Erfurt, Germany

Dres. Krause/Schiffer /ID# 251727; 🇩🇪 Frechen, Germany

Internisten in Geldern /ID# 252068; 🇩🇪 Geldern, Germany

Universitaetsklinikum Halle (Saale) /ID# 254083; 🇩🇪 Halle (Saale), Germany

Private Practice - Dr. Matthias Eichler /ID# 249933; 🇩🇪 Hamburg, Germany

Tappe/Miks/Delker, Hamm, DE /ID# 251729; 🇩🇪 Hamm, Germany

Medizinische Hochschule Hannover /ID# 254980; 🇩🇪 Hannover, 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

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

Medizinisches Versorgungszentrum Portal 10 /ID# 249947; 🇩🇪 Muenster, Germany

Gastro Campus Research GbR /ID# 249983; 🇩🇪 Muenster, Germany

Praxis Dr. Burlefinger /ID# 259159; 🇩🇪 Munich, Germany

Klinikum rechts der Isar /ID# 262176; 🇩🇪 Munich, Germany

Praxis Dres Brendel /ID# 254078; 🇩🇪 Nuernberg, 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

Praxis Dr. Kempelmann /ID# 249935; 🇩🇪 Tostedt, Germany

University Hospital Zurich /ID# 260966; 🇨🇭 Zurich, Zuerich, Switzerland

Zentrum fur Gastroenterologie und Hepatologie /ID# 260967; 🇨🇭 Zurich, Zuerich, Switzerland

Inselspital, Universitaetsspital Bern /ID# 260968; 🇨🇭 Bern, Switzerland

Berner IBD Study Group /ID# 262315; 🇨🇭 Bern, Switzerland