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

Last updated: March 24, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcers

Colic

Ulcerative Colitis

Treatment

N/A

Clinical Study ID

NCT05496348
P23-430
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Participants with an endoscopically confirmed diagnosis of active moderate to severeUlcerative colitis (UC).

  • Participants initiating Upadacitinib (UPA) at the investigator's discretion as partof their routine clinical care; the decision to administer UPA must be made prior toand independent of documentation for the study and according to the approved locallabel.

  • Participants able to understand and communicate with the investigator and complywith the requirements of the study.

  • Participants willing to continue with study documentation after cessation of UPA.

Exclusion

Exclusion Criteria:

  • Participants with any contraindication to Upadacitinib (UPA).

  • Participants previously exposed to a Janus kinase (JAK) inhibitor.

Study Design

Total Participants: 400
Study Start date:
October 20, 2022
Estimated Completion Date:
August 31, 2027

Connect with a study center

  • Kepler Universitaetsklinikum GmbH /ID# 251868

    Linz, Oberoesterreich 4020
    Austria

    Active - Recruiting

  • Krankenhaus der Barmherzigen Brueder Wien /ID# 251867

    Vienna, Wien 1020
    Austria

    Active - Recruiting

  • Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869

    Salzburg, 5010
    Austria

    Active - Recruiting

  • Praxis fuer Gastroenterologie /ID# 249917

    Heidelberg, Baden-Wuerttemberg 69121
    Germany

    Active - Recruiting

  • Universitaetsklinik Heidelberg /ID# 249922

    Heidelberg, Baden-Wuerttemberg 69120
    Germany

    Active - Recruiting

  • Klinikum Augsburg /ID# 249979

    Augsburg, Bayern 86156
    Germany

    Active - Recruiting

  • Medizinisches Versorgunszentrum Dachau /ID# 249945

    Dachau, Bayern 85221
    Germany

    Active - Recruiting

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

    Brandenburg an der Havel, Brandenburg 14776
    Germany

    Active - Recruiting

  • Praxis Dr. Grümmer /ID# 249925

    Potsdam, Brandenburg 14471
    Germany

    Completed

  • Klinikum Darmstadt /ID# 267685

    Darmstadt, Hessen 64283
    Germany

    Site Not Available

  • Praxis Dres. Hurst/Simonis /ID# 255421

    Darmstadt, Hessen 64293
    Germany

    Active - Recruiting

  • Bethanien-Krankenhaus /ID# 260865

    Frankfurt, Hessen 60389
    Germany

    Active - Recruiting

  • Interdisziplinaeres Crohn Colitis Zentrum /ID# 252622

    Frankfurt, Hessen 60318
    Germany

    Active - Recruiting

  • Universitaetsklinikum Frankfurt /ID# 254079

    Frankfurt am Main, Hessen 60590
    Germany

    Active - Recruiting

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

    Kassel, Hessen 34117
    Germany

    Active - Recruiting

  • Universitaetsmedizin Rostock /ID# 253769

    Rostock, Mecklenburg-Vorpommern 18057
    Germany

    Active - Recruiting

  • Mueller/Mueller-Ziehm, Hanover /ID# 252617

    Hannover, Niedersachsen 30449
    Germany

    Active - Recruiting

  • Klinikum Lueneburg /ID# 249948

    Lueneburg, Niedersachsen 21339
    Germany

    Active - Recruiting

  • Verein für Wissenschaft und Forschung /ID# 249928

    Oldenburg, Niedersachsen 26123
    Germany

    Active - Recruiting

  • Evangelisches Krankenhaus Kalk /ID# 249987

    Cologne, Nordrhein-Westfalen 51103
    Germany

    Active - Recruiting

  • Gastroenterologische Gemeinschaftspraxis Herne /ID# 249990

    Herne, Nordrhein-Westfalen 44623
    Germany

    Active - Recruiting

  • Gastroenterologische Gemeinschaftspraxis Minden /ID# 249914

    Minden, Nordrhein-Westfalen 32423
    Germany

    Active - Recruiting

  • Dres. Mallach/Spelter /ID# 270912

    Wuppertal, Nordrhein-Westfalen 42103
    Germany

    Active - Recruiting

  • Benner & Dommermuth /ID# 249896

    Koblenz, Rheinland-Pfalz 56068
    Germany

    Active - Recruiting

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

    Ludwigshafen am Rhein, Rheinland-Pfalz 67067
    Germany

    Active - Recruiting

  • Klinikum Worms gGmbH /ID# 269804

    Worms, Rheinland-Pfalz 67550
    Germany

    Active - Recruiting

  • Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 249974

    Friedrichsthal, Saarland 66299
    Germany

    Active - Recruiting

  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 249971

    Saarbrücken, Saarland 66111
    Germany

    Active - Recruiting

  • Klinikum Chemnitz gGmbH /ID# 259156

    Chemnitz, Sachsen 09116
    Germany

    Active - Recruiting

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 249989

    Dresden, Sachsen 01307
    Germany

    Active - Recruiting

  • Universitaetsklinikum Leipzig /ID# 254081

    Leipzig, Sachsen 04103
    Germany

    Active - Recruiting

  • Universitaetsklinikum Leipzig /ID# 262612

    Leipzig, Sachsen 04103
    Germany

    Active - Recruiting

  • Praxisgemeinschaft Jerichow Schulze /ID# 262931

    Jerichow, Sachsen-Anhalt 39319
    Germany

    Active - Recruiting

  • Praxis Jessen/Grimm /ID# 249930

    Altenholz, Schleswig-Holstein 24161
    Germany

    Active - Recruiting

  • Praxis S. Tetzlaff /ID# 253770

    Büdelsdorf, Schleswig-Holstein 24782
    Germany

    Active - Recruiting

  • Gastroenterologisch - Hepatologisches MVZ Kiel GmbH /ID# 252623

    Kiel, Schleswig-Holstein 24146
    Germany

    Active - Recruiting

  • Thormann and Bethge /ID# 249897

    Kiel, Schleswig-Holstein 24105
    Germany

    Active - Recruiting

  • Thurman/Bethge /ID# 249897

    Kiel, Schleswig-Holstein 24105
    Germany

    Active - Recruiting

  • Dres. Schmidt/Büning/Bär, Praxis für Gastroenterologie /ID# 249907

    Lübeck, Schleswig-Holstein 23560
    Germany

    Active - Recruiting

  • Praxis fuer Gastroenterologie /ID# 249907

    Lübeck, Schleswig-Holstein 23560
    Germany

    Active - Recruiting

  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249984

    Lübeck, Schleswig-Holstein 23538
    Germany

    Active - Recruiting

  • Friedrich-Ebert-Krankenhaus GmbH /ID# 249973

    Neumuenster, Schleswig-Holstein 24534
    Germany

    Active - Recruiting

  • Universitaetsklinikum Jena /ID# 253768

    Jena, Thueringen 07747
    Germany

    Active - Recruiting

  • Universitaetsklinikum Jena /ID# 254371

    Jena, Thueringen 07747
    Germany

    Active - Recruiting

  • Praxis Dr. Schiffelholz /ID# 252621

    Augsburg, 86150
    Germany

    Active - Recruiting

  • Dres. Schick/Wesenberg /ID# 249977

    Berlin, 10437
    Germany

    Active - Recruiting

  • MVZ Gastro Friedrichshain /ID# 249924

    Berlin, 10249
    Germany

    Active - Recruiting

  • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 249981

    Berlin, 10825
    Germany

    Active - Recruiting

  • Praxis Dr. Berndt /ID# 252067

    Berlin, 10409
    Germany

    Active - Recruiting

  • Praxis Dr. Soellenboehmer /ID# 249985

    Berlin, 14052
    Germany

    Active - Recruiting

  • Praxis Dr. Spitz /ID# 252616

    Berlin, 14163
    Germany

    Active - Recruiting

  • Praxis S. Grüngreiff /ID# 249927

    Berlin, 12683
    Germany

    Active - Recruiting

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

    Berlin, 12559
    Germany

    Active - Recruiting

  • Krankenhaus Waldfriede /ID# 249900

    Berlin-Zehlendorf, 14163
    Germany

    Active - Recruiting

  • Internist. Facharztp. Dr. Palmai /ID# 251821

    Bitterfeld-Wolfen, 06749
    Germany

    Active - Recruiting

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

    Blaubeuren, 89143
    Germany

    Active - Recruiting

  • Dres. Kemper/Dreck /ID# 249916

    Coesfeld, 48653
    Germany

    Active - Recruiting

  • Dr. Janschek /ID# 255092

    Dresden, 01309
    Germany

    Active - Recruiting

  • Frach/Hohaus, Dresden, DE /ID# 254979

    Dresden, 01067
    Germany

    Active - Recruiting

  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 249989

    Dresden, 01307
    Germany

    Active - Recruiting

  • Dres. Ende / Weisflog /ID# 249918

    Erfurt, 99084
    Germany

    Active - Recruiting

  • Dres. Krause/Schiffer /ID# 251727

    Frechen, 50226
    Germany

    Active - Recruiting

  • Dres. Bauer/Doerflinger /ID# 251568

    Freiburg im Breisgau, 79102
    Germany

    Active - Recruiting

  • Internisten in Geldern /ID# 252068

    Geldern, 47608
    Germany

    Active - Recruiting

  • Universitaetsklinikum Halle (Saale) /ID# 254083

    Halle (Saale), 06120
    Germany

    Active - Recruiting

  • Fachinternistische Schwerpunktpraxis Dr. Matthias Eichler, Dr. Matthias Kahl /ID# 249933

    Hamburg, 22041
    Germany

    Active - Recruiting

  • Private Practice - Dr. Matthias Eichler /ID# 249933

    Hamburg, 22041
    Germany

    Active - Recruiting

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

    Hamm, 59065
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover /ID# 254980

    Hannover, 30625
    Germany

    Active - Recruiting

  • Gastroenterologische Gemeinschaftspraxis /ID# 263633

    Heilbronn, 74072
    Germany

    Active - Recruiting

  • Städtisches Kh. Heinsberg GmbH /ID# 252624

    Heinsberg, 52525
    Germany

    Active - Recruiting

  • Praxis Dres. Preiss/Engelke /ID# 249919

    Herne, 44649
    Germany

    Active - Recruiting

  • Praxis Dr. Schwarz /ID# 251819

    Hettstedt, 06333
    Germany

    Active - Recruiting

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

    Iserlohn, 58644
    Germany

    Active - Recruiting

  • Praxis Dr. Weber /ID# 256099

    Jena, 07743
    Germany

    Active - Recruiting

  • Praxis Dr. Schulze /ID# 262931

    Jerichow, 39319
    Germany

    Active - Recruiting

  • Gastroenterologe am Ettlinger Tor /ID# 249982

    Karlsruhe, 76133
    Germany

    Active - Recruiting

  • Gastroenterologie Opernstrasse /ID# 251822

    Kassel, 34117
    Germany

    Active - Recruiting

  • MVZ Doceins West GmbH /ID# 249915

    Koblenz, 56068
    Germany

    Active - Recruiting

  • MVZ Gastroenterologie Leverkusen /ID# 260512

    Leverkusen, 51375
    Germany

    Active - Recruiting

  • Gastropraxis Magdeburg /ID# 249988

    Magdeburg, 39104
    Germany

    Active - Recruiting

  • Gastro Campus Research GbR /ID# 249983

    Muenster, 48159
    Germany

    Active - Recruiting

  • Medizinisches Versorgungszentrum Portal 10 /ID# 249947

    Muenster, 48155
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 262176

    Munich, 81675
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar /ID# 262176

    Munich, 81675
    Germany

    Active - Recruiting

  • Praxis Dr. Burlefinger /ID# 259159

    Munich, 80336
    Germany

    Active - Recruiting

  • Prof-med-stud.de /ID# 255419

    Munich, 80935
    Germany

    Active - Recruiting

  • Praxis Dres Brendel /ID# 254078

    Nuernberg, 90449
    Germany

    Active - Recruiting

  • Medius Klinik Nürtingen /ID# 255420

    Nürtingen, 72622
    Germany

    Completed

  • Pc Docs /Id# 249921

    Pirmasens, 66953
    Germany

    Active - Recruiting

  • Elisabeth Klinikum GmbH /ID# 252264

    Schmalkalden, 98574
    Germany

    Active - Recruiting

  • Praxis fuer Gastroenterologie /ID# 252615

    Schwerin, 19057
    Germany

    Active - Recruiting

  • Dres. Rehbehn/Skusa /ID# 252618

    Solingen, 42651
    Germany

    Active - Recruiting

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

    Stuttgart, 70435
    Germany

    Active - Recruiting

  • Praxis Dr. Kempelmann /ID# 249935

    Tostedt, 21255
    Germany

    Active - Recruiting

  • Dr. Schirin-Sokhan /ID# 259158

    Würselen, 52146
    Germany

    Active - Recruiting

  • University Hospital Zurich /ID# 260966

    Zurich, Zuerich 8006
    Switzerland

    Active - Recruiting

  • Zentrum fur Gastroenterologie und Hepatologie /ID# 260967

    Zurich, Zuerich 8048
    Switzerland

    Active - Recruiting

  • Berner IBD Study Group /ID# 262315

    Bern, 3012
    Switzerland

    Active - Recruiting

  • Inselspital, Universitaetsspital Bern /ID# 260968

    Bern, 3010
    Switzerland

    Active - Recruiting

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