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

NCT05496348 | Recruiting

• 1 other identifier: P23-430
• Study Type: observational
• Target: 400
• Locations: 3 countries
• Sites: 94

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; UC; Upadacitinib; UPA; RINVOQ

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Upadacitinib

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with Ulcerative colitis (UC)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (94)

Krankenhaus der Barmherzigen Brueder Wien /ID# 251867

Vienna, State of Vienna, 1020, Austria

ACTIVE NOT RECRUITING

Kepler Universitaetsklinikum GmbH /ID# 251868

Linz, Upper Austria, 4020, Austria

ACTIVE NOT RECRUITING

Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869

Salzburg, 5010, Austria

ACTIVE NOT RECRUITING

Universitaetsklinik Heidelberg /ID# 249922

Heidelberg, Baden-Wurttemberg, 69120, Germany

ACTIVE NOT RECRUITING

Praxis fuer Gastroenterologie - Heidelberg /ID# 249917

Heidelberg, Baden-Wurttemberg, 69121, Germany

ACTIVE NOT RECRUITING

Rems-Murr-Klinikum Winnenden /ID# 278791

Winnenden, Baden-Wurttemberg, 71364, Germany

COMPLETED

Klinikum Augsburg /ID# 249979

Augsburg, Bavaria, 86156, Germany

COMPLETED

Medizinisches Versorgunszentrum Dachau /ID# 249945

Dachau, Bavaria, 85221, Germany

ACTIVE NOT RECRUITING

TUM Klinikum rechts der Isar /ID# 262176

Munich, Bavaria, 81675, Germany

ACTIVE NOT RECRUITING

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

Brandenburg an der Havel, Brandenburg, 14776, Germany

COMPLETED

Praxis Dr. Grümmer /ID# 249925

Potsdam, Brandenburg, 14471, Germany

COMPLETED

Private Practice - Dr. Kempelmann /ID# 249935

Tostedt, Free and Hanseatic City of Hamburg, 21255, Germany

ACTIVE NOT RECRUITING

Klinikum Darmstadt /ID# 267685

Darmstadt, Hesse, 64283, Germany

COMPLETED

Praxis Dres. Hurst/Simonis /ID# 255421

Darmstadt, Hesse, 64293, Germany

ACTIVE NOT RECRUITING

Interdisziplinaeres Crohn Colitis Zentrum /ID# 252622

Frankfurt am Main, Hesse, 60318, Germany

ACTIVE NOT RECRUITING

Bethanien-Krankenhaus /ID# 260865

Frankfurt am Main, Hesse, 60389, Germany

ACTIVE NOT RECRUITING

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

Kassel, Hesse, 34117, Germany

ACTIVE NOT RECRUITING

Mueller/Mueller-Ziehm, Hanover /ID# 252617

Hanover, Lower Saxony, 30449, Germany

ACTIVE NOT RECRUITING

Medizinische Hochschule Hannover /ID# 254980

Hanover, Lower Saxony, 30625, Germany

ACTIVE NOT RECRUITING

Klinikum Lueneburg /ID# 249948

Lüneburg, Lower Saxony, 21339, Germany

ACTIVE NOT RECRUITING

Verein für Wissenschaft und Forschung /ID# 249928

Oldenburg, Lower Saxony, 26123, Germany

ACTIVE NOT RECRUITING

Praxis fuer Gastroenterologie - Schwerin /ID# 252615

Schwerin, Mecklenburg-Vorpommern, 19057, Germany

ACTIVE NOT RECRUITING

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

Coesfeld, North Rhine-Westphalia, 48653, Germany

ACTIVE NOT RECRUITING

Evangelisches Krankenhaus Kalk /ID# 249987

Cologne, North Rhine-Westphalia, 51103, Germany

ACTIVE NOT RECRUITING

Gastroenterologische Gemeinschaftspraxis Herne /ID# 249990

Herne, North Rhine-Westphalia, 44623, Germany

ACTIVE NOT RECRUITING

Gastroenterologische Gemeinschaftspraxis Minden /ID# 249914

Minden, North Rhine-Westphalia, 32423, Germany

ACTIVE NOT RECRUITING

Dres. Mallach/Spelter /ID# 270912

Wuppertal, North Rhine-Westphalia, 42103, Germany

COMPLETED

Benner & Dommermuth /ID# 249896

Koblenz, Rhineland-Palatinate, 56068, Germany

ACTIVE NOT RECRUITING

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

Ludwigshafen am Rhein, Rhineland-Palatinate, 67067, Germany

ACTIVE NOT RECRUITING

Klinikum Worms gGmbH /ID# 269804

Worms, Rhineland-Palatinate, 67550, Germany

ACTIVE NOT RECRUITING

Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 249974

Friedrichsthal, Saarland, 66299, Germany

ACTIVE NOT RECRUITING

Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 249971

Saarbrücken, Saarland, 66111, Germany

ACTIVE NOT RECRUITING

Klinikum Chemnitz - Flemmingstraße /ID# 259156

Chemnitz, Saxony, 09116, Germany

ACTIVE NOT RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 249989

Dresden, Saxony, 01307, Germany

ACTIVE NOT RECRUITING

Private Practice - Dr. Johannes Janschek /ID# 255092

Dresden, Saxony, 01309, Germany

ACTIVE NOT RECRUITING

Universitaetsklinikum Leipzig /ID# 262612

Leipzig, Saxony, 04103, Germany

ACTIVE NOT RECRUITING

Gesellschaft für klinische Studien /ID# 254081

Leipzig, Saxony, 04105, Germany

ACTIVE NOT RECRUITING

Praxisgemeinschaft Jerichow Schulze /ID# 262931

Jerichow, Saxony-Anhalt, 39319, Germany

ACTIVE NOT RECRUITING

Gemeinschaftspraxis im Medicum /ID# 249930

Altenholz, Schleswig-Holstein, 24161, Germany

ACTIVE NOT RECRUITING

Praxis S. Tetzlaff /ID# 253770

Buedelsdorf, Schleswig-Holstein, 24782, Germany

ACTIVE NOT RECRUITING

Thormann and Bethge /ID# 249897

Kiel, Schleswig-Holstein, 24105, Germany

ACTIVE NOT RECRUITING

Gastroenterologisch - Hepatologisches MVZ Kiel GmbH /ID# 252623

Kiel, Schleswig-Holstein, 24146, Germany

ACTIVE NOT RECRUITING

Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249984

Lübeck, Schleswig-Holstein, 23538, Germany

COMPLETED

Praxis fuer Gastroenterologie - Lubeck /ID# 249907

Lübeck, Schleswig-Holstein, 23560, Germany

ACTIVE NOT RECRUITING

Friedrich-Ebert-Krankenhaus GmbH /ID# 249973

Neumünster, Schleswig-Holstein, 24534, Germany

ACTIVE NOT RECRUITING

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

Erfurt, Thuringia, 99084, Germany

ACTIVE NOT RECRUITING

Universitaetsklinikum Jena /ID# 253768

Jena, Thuringia, 07747, Germany

ACTIVE NOT RECRUITING

Universitaetsklinikum Jena /ID# 254371

Jena, Thuringia, 07747, Germany

COMPLETED

Praxis Dr. Schiffelholz /ID# 252621

Augsburg, 86150, Germany

COMPLETED

MVZ Gastro Friedrichshain /ID# 249924

Berlin, 10249, Germany

ACTIVE NOT RECRUITING

Praxis Dr. Berndt /ID# 252067

Berlin, 10409, Germany

COMPLETED

Dres. Schick/Wesenberg /ID# 249977

Berlin, 10437, Germany

ACTIVE NOT RECRUITING

MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 249981

Berlin, 10825, Germany

ACTIVE NOT RECRUITING

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

Berlin, 12559, Germany

ACTIVE NOT RECRUITING

Praxis S. Grüngreiff /ID# 249927

Berlin, 12683, Germany

ACTIVE NOT RECRUITING

Praxis Dr. Soellenboehmer /ID# 249985

Berlin, 14052, Germany

ACTIVE NOT RECRUITING

Praxis Dr. Spitz /ID# 252616

Berlin, 14163, Germany

ACTIVE NOT RECRUITING

Krankenhaus Waldfriede /ID# 249900

Berlin-Zehlendorf, 14163, Germany

ACTIVE NOT RECRUITING

Internist. Facharztp. Dr. Palmai /ID# 251821

Bitterfeld-Wolfen, 06749, Germany

ACTIVE NOT RECRUITING

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

Blaubeuren Abbey, 89143, Germany

ACTIVE NOT RECRUITING

Frach/Hohaus, Dresden, DE /ID# 254979

Dresden, 01067, Germany

ACTIVE NOT RECRUITING

Dres. Krause/Schiffer /ID# 251727

Frechen, 50226, Germany

ACTIVE NOT RECRUITING

Dres. Bauer/Doerflinger /ID# 251568

Freiburg im Breisgau, 79102, Germany

ACTIVE NOT RECRUITING

Internisten in Geldern /ID# 252068

Guelders, 47608, Germany

ACTIVE NOT RECRUITING

Universitaetsklinikum Halle (Saale) /ID# 254083

Halle, 06120, Germany

COMPLETED

Private Practice - Dr. Matthias Eichler /ID# 249933

Hamburg, 22041, Germany

ACTIVE NOT RECRUITING

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

Hamm, 59065, Germany

ACTIVE NOT RECRUITING

Internistische Praxisgemeinschaft Hanau GbR /ID# 254079

Hanau, 63452, Germany

ACTIVE NOT RECRUITING

Gastroenterologische Gemeinschaftspraxis /ID# 263633

Heilbronn, 74072, Germany

COMPLETED

Städtisches Kh. Heinsberg GmbH /ID# 252624

Heinsberg, 52525, Germany

ACTIVE NOT RECRUITING

Praxis Dres. Preiss/Engelke /ID# 249919

Herne, 44649, Germany

ACTIVE NOT RECRUITING

Praxis Dr. Schwarz /ID# 251819

Hettstedt, 06333, Germany

ACTIVE NOT RECRUITING

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

Iserlohn, 58644, Germany

ACTIVE NOT RECRUITING

Praxis Dr. Weber /ID# 256099

Jena, 07743, Germany

ACTIVE NOT RECRUITING

Gastroenterologe am Ettlinger Tor /ID# 249982

Karlsruhe, 76133, Germany

ACTIVE NOT RECRUITING

MVZ Doceins West GmbH /ID# 249915

Koblenz, 56068, Germany

ACTIVE NOT RECRUITING

MVZ Gastroenterologie Leverkusen /ID# 260512

Leverkusen, 51375, Germany

ACTIVE NOT RECRUITING

Gastropraxis Magdeburg /ID# 249988

Magdeburg, 39104, Germany

ACTIVE NOT RECRUITING

Praxis Dr. Burlefinger /ID# 259159

Munich, 80336, Germany

ACTIVE NOT RECRUITING

Prof-med-stud.de /ID# 255419

Munich, 80935, Germany

COMPLETED

Medizinisches Versorgungszentrum Portal 10 /ID# 249947

Münster, 48155, Germany

ACTIVE NOT RECRUITING

Gastro Campus Research GbR /ID# 249983

Münster, 48159, Germany

COMPLETED

Praxis Dres Brendel /ID# 254078

Nuremberg, 90449, Germany

COMPLETED

Medius Klinik Nürtingen /ID# 255420

Nürtingen, 72622, Germany

COMPLETED

Pc Docs /Id# 249921

Pirmasens, 66953, Germany

ACTIVE NOT RECRUITING

Elisabeth Klinikum GmbH /ID# 252264

Schmalkalden, 98574, Germany

ACTIVE NOT RECRUITING

Dres. Rehbehn/Skusa /ID# 252618

Solingen, 42651, Germany

ACTIVE NOT RECRUITING

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

Stuttgart, 70435, Germany

COMPLETED

Dr. Schirin-Sokhan /ID# 259158

Würselen, 52146, Germany

ACTIVE NOT RECRUITING

Zentrum fur Gastroenterologie und Hepatologie /ID# 260967

Zurich, Canton of Zurich, 8048, Switzerland

RECRUITING

University Hospital Zurich /ID# 260966

Zurich, Canton of Zurich, 8091, Switzerland

ACTIVE NOT RECRUITING

EOC Ospedale Regionale Lugano /ID# 277165

Lugano, Canton Ticino, 6900, Switzerland

ACTIVE NOT RECRUITING

Inselspital, Universitaetsspital Bern /ID# 260968

Bern, 3010, Switzerland

ACTIVE NOT RECRUITING

Berner IBD Study Group /ID# 262315

Bern, 3012, Switzerland

ACTIVE NOT RECRUITING

Related Links

• Related info

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

Medical Information Germany

CONTACT

49 611 1720 1520; medinfo.germany@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: October 20, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

CH (5); DE (86); AU (3)