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

NCT05496348 | Active Not 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

Location

Kepler Universitaetsklinikum GmbH /ID# 251868

Linz, Upper Austria, 4020, Austria

Location

Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869

Salzburg, 5010, Austria

Location

Universitaetsklinik Heidelberg /ID# 249922

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Praxis fuer Gastroenterologie - Heidelberg /ID# 249917

Heidelberg, Baden-Wurttemberg, 69121, Germany

Location

Rems-Murr-Klinikum Winnenden /ID# 278791

Winnenden, Baden-Wurttemberg, 71364, Germany

Location

Klinikum Augsburg /ID# 249979

Augsburg, Bavaria, 86156, Germany

Location

Medizinisches Versorgunszentrum Dachau /ID# 249945

Dachau, Bavaria, 85221, Germany

Location

TUM Klinikum rechts der Isar /ID# 262176

Munich, Bavaria, 81675, Germany

Location

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

Brandenburg an der Havel, Brandenburg, 14776, Germany

Location

Praxis Dr. Grümmer /ID# 249925

Potsdam, Brandenburg, 14471, Germany

Location

Private Practice - Dr. Kempelmann /ID# 249935

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

Location

Klinikum Darmstadt /ID# 267685

Darmstadt, Hesse, 64283, Germany

Location

Praxis Dres. Hurst/Simonis /ID# 255421

Darmstadt, Hesse, 64293, Germany

Location

Interdisziplinaeres Crohn Colitis Zentrum /ID# 252622

Frankfurt am Main, Hesse, 60318, Germany

Location

Bethanien-Krankenhaus /ID# 260865

Frankfurt am Main, Hesse, 60389, Germany

Location

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

Kassel, Hesse, 34117, Germany

Location

Mueller/Mueller-Ziehm, Hanover /ID# 252617

Hanover, Lower Saxony, 30449, Germany

Location

Medizinische Hochschule Hannover /ID# 254980

Hanover, Lower Saxony, 30625, Germany

Location

Klinikum Lueneburg /ID# 249948

Lüneburg, Lower Saxony, 21339, Germany

Location

Verein für Wissenschaft und Forschung /ID# 249928

Oldenburg, Lower Saxony, 26123, Germany

Location

Praxis fuer Gastroenterologie - Schwerin /ID# 252615

Schwerin, Mecklenburg-Vorpommern, 19057, Germany

Location

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

Coesfeld, North Rhine-Westphalia, 48653, Germany

Location

Evangelisches Krankenhaus Kalk /ID# 249987

Cologne, North Rhine-Westphalia, 51103, Germany

Location

Gastroenterologische Gemeinschaftspraxis Herne /ID# 249990

Herne, North Rhine-Westphalia, 44623, Germany

Location

Gastroenterologische Gemeinschaftspraxis Minden /ID# 249914

Minden, North Rhine-Westphalia, 32423, Germany

Location

Dres. Mallach/Spelter /ID# 270912

Wuppertal, North Rhine-Westphalia, 42103, Germany

Location

Benner & Dommermuth /ID# 249896

Koblenz, Rhineland-Palatinate, 56068, Germany

Location

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

Ludwigshafen am Rhein, Rhineland-Palatinate, 67067, Germany

Location

Klinikum Worms gGmbH /ID# 269804

Worms, Rhineland-Palatinate, 67550, Germany

Location

Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 249974

Friedrichsthal, Saarland, 66299, Germany

Location

Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 249971

Saarbrücken, Saarland, 66111, Germany

Location

Klinikum Chemnitz - Flemmingstraße /ID# 259156

Chemnitz, Saxony, 09116, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 249989

Dresden, Saxony, 01307, Germany

Location

Private Practice - Dr. Johannes Janschek /ID# 255092

Dresden, Saxony, 01309, Germany

Location

Universitaetsklinikum Leipzig /ID# 262612

Leipzig, Saxony, 04103, Germany

Location

Gesellschaft für klinische Studien /ID# 254081

Leipzig, Saxony, 04105, Germany

Location

Praxisgemeinschaft Jerichow Schulze /ID# 262931

Jerichow, Saxony-Anhalt, 39319, Germany

Location

Gemeinschaftspraxis im Medicum /ID# 249930

Altenholz, Schleswig-Holstein, 24161, Germany

Location

Praxis S. Tetzlaff /ID# 253770

Buedelsdorf, Schleswig-Holstein, 24782, Germany

Location

Thormann and Bethge /ID# 249897

Kiel, Schleswig-Holstein, 24105, Germany

Location

Gastroenterologisch - Hepatologisches MVZ Kiel GmbH /ID# 252623

Kiel, Schleswig-Holstein, 24146, Germany

Location

Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249984

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Praxis fuer Gastroenterologie - Lubeck /ID# 249907

Lübeck, Schleswig-Holstein, 23560, Germany

Location

Friedrich-Ebert-Krankenhaus GmbH /ID# 249973

Neumünster, Schleswig-Holstein, 24534, Germany

Location

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

Erfurt, Thuringia, 99084, Germany

Location

Universitaetsklinikum Jena /ID# 253768

Jena, Thuringia, 07747, Germany

Location

Universitaetsklinikum Jena /ID# 254371

Jena, Thuringia, 07747, Germany

Location

Praxis Dr. Schiffelholz /ID# 252621

Augsburg, 86150, Germany

Location

MVZ Gastro Friedrichshain /ID# 249924

Berlin, 10249, Germany

Location

Praxis Dr. Berndt /ID# 252067

Berlin, 10409, Germany

Location

Dres. Schick/Wesenberg /ID# 249977

Berlin, 10437, Germany

Location

MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 249981

Berlin, 10825, Germany

Location

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

Berlin, 12559, Germany

Location

Praxis S. Grüngreiff /ID# 249927

Berlin, 12683, Germany

Location

Praxis Dr. Soellenboehmer /ID# 249985

Berlin, 14052, Germany

Location

Praxis Dr. Spitz /ID# 252616

Berlin, 14163, Germany

Location

Krankenhaus Waldfriede /ID# 249900

Berlin-Zehlendorf, 14163, Germany

Location

Internist. Facharztp. Dr. Palmai /ID# 251821

Bitterfeld-Wolfen, 06749, Germany

Location

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

Blaubeuren Abbey, 89143, Germany

Location

Frach/Hohaus, Dresden, DE /ID# 254979

Dresden, 01067, Germany

Location

Dres. Krause/Schiffer /ID# 251727

Frechen, 50226, Germany

Location

Dres. Bauer/Doerflinger /ID# 251568

Freiburg im Breisgau, 79102, Germany

Location

Internisten in Geldern /ID# 252068

Guelders, 47608, Germany

Location

Universitaetsklinikum Halle (Saale) /ID# 254083

Halle, 06120, Germany

Location

Private Practice - Dr. Matthias Eichler /ID# 249933

Hamburg, 22041, Germany

Location

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

Hamm, 59065, Germany

Location

Internistische Praxisgemeinschaft Hanau GbR /ID# 254079

Hanau, 63452, Germany

Location

Gastroenterologische Gemeinschaftspraxis /ID# 263633

Heilbronn, 74072, Germany

Location

Städtisches Kh. Heinsberg GmbH /ID# 252624

Heinsberg, 52525, Germany

Location

Praxis Dres. Preiss/Engelke /ID# 249919

Herne, 44649, Germany

Location

Praxis Dr. Schwarz /ID# 251819

Hettstedt, 06333, Germany

Location

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

Iserlohn, 58644, Germany

Location

Praxis Dr. Weber /ID# 256099

Jena, 07743, Germany

Location

Gastroenterologe am Ettlinger Tor /ID# 249982

Karlsruhe, 76133, Germany

Location

MVZ Doceins West GmbH /ID# 249915

Koblenz, 56068, Germany

Location

MVZ Gastroenterologie Leverkusen /ID# 260512

Leverkusen, 51375, Germany

Location

Gastropraxis Magdeburg /ID# 249988

Magdeburg, 39104, Germany

Location

Praxis Dr. Burlefinger /ID# 259159

Munich, 80336, Germany

Location

Prof-med-stud.de /ID# 255419

Munich, 80935, Germany

Location

Medizinisches Versorgungszentrum Portal 10 /ID# 249947

Münster, 48155, Germany

Location

Gastro Campus Research GbR /ID# 249983

Münster, 48159, Germany

Location

Praxis Dres Brendel /ID# 254078

Nuremberg, 90449, Germany

Location

Medius Klinik Nürtingen /ID# 255420

Nürtingen, 72622, Germany

Location

Pc Docs /Id# 249921

Pirmasens, 66953, Germany

Location

Elisabeth Klinikum GmbH /ID# 252264

Schmalkalden, 98574, Germany

Location

Dres. Rehbehn/Skusa /ID# 252618

Solingen, 42651, Germany

Location

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

Stuttgart, 70435, Germany

Location

Dr. Schirin-Sokhan /ID# 259158

Würselen, 52146, Germany

Location

Zentrum fur Gastroenterologie und Hepatologie /ID# 260967

Zurich, Canton of Zurich, 8048, Switzerland

Location

University Hospital Zurich /ID# 260966

Zurich, Canton of Zurich, 8091, Switzerland

Location

EOC Ospedale Regionale Lugano /ID# 277165

Lugano, Canton Ticino, 6900, Switzerland

Location

Inselspital, Universitaetsspital Bern /ID# 260968

Bern, 3010, Switzerland

Location

Berner IBD Study Group /ID# 262315

Bern, 3012, Switzerland

Location

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

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: July 16, 2026

Record last verified: 2026-07

Locations

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