Ulcerative Colitis Clinical Trial
— EUROPEOfficial title:
Early therapeUtic RespOnse and Predictivity of Long-term Effectiveness of Upadacitinib in Ulcerative Colitis (EUROPE)
| NCT number | NCT05496348 |
| Other study ID # | P23-430 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 20, 2022 |
| Est. completion date | August 16, 2027 |
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.
| Status | Recruiting |
| Enrollment | 400 |
| Est. completion date | August 16, 2027 |
| Est. primary completion date | August 16, 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Kepler Universitaetsklinikum GmbH /ID# 251868 | Linz | Oberoesterreich |
| Austria | Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869 | Salzburg | |
| Austria | Krankenhaus der Barmherzigen Brueder Wien /ID# 251867 | Vienna | Wien |
| Germany | Praxis Jessen/Grimm /ID# 249930 | Altenholz | Schleswig-Holstein |
| Germany | Praxis Dr. Schiffelholz /ID# 252621 | Augsburg | |
| Germany | Dres. Schick/Wesenberg /ID# 249977 | Berlin | |
| Germany | MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 249981 | Berlin | |
| Germany | MVZ Gastro Friedrichshain /ID# 249924 | Berlin | |
| Germany | Praxis Dr. Berndt /ID# 252067 | Berlin | |
| Germany | Praxis Dr. Soellenboehmer /ID# 249985 | Berlin | |
| Germany | Praxis Dr. Spitz /ID# 252616 | Berlin | |
| Germany | Praxis S. Grüngreiff /ID# 249927 | Berlin | |
| Germany | Zweite Gemeinnuutzige Krankenhaus GmbH DRK Kliniken Berlin Kopenick /ID# 262849 | Berlin | |
| Germany | Krankenhaus Waldfriede /ID# 249900 | Berlin-Zehlendorf | |
| Germany | Internist. Facharztp. Dr. Palmai /ID# 251821 | Bitterfeld-Wolfen | |
| Germany | Alb-Donau Klinikum Blaubeuren, ADK GmbH für Gesundheit und Soziales /ID# 249923 | Blaubeuren | |
| Germany | Dr.med. Johannes Behrendt Facharzt für Innere Medizin und Gastroenterologie /ID# 260516 | Brandenburg an der Havel | Brandenburg |
| Germany | Praxis S. Tetzlaff /ID# 253770 | Büdelsdorf | Schleswig-Holstein |
| Germany | Klinikum Chemnitz gGmbH /ID# 259156 | Chemnitz | |
| Germany | Dres. Kemper/Dreck /ID# 249916 | Coesfeld | |
| Germany | Evangelisches Krankenhaus Kalk /ID# 249987 | Cologne | Nordrhein-Westfalen |
| Germany | Medizinisches Versorgunszentrum Dachau /ID# 249945 | Dachau | |
| Germany | Praxis Dres. Hurst/Simonis /ID# 255421 | Darmstadt | |
| Germany | Dr. Janschek /ID# 255092 | Dresden | |
| Germany | Frach/Hohaus, Dresden, DE /ID# 254979 | Dresden | |
| Germany | Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 249989 | Dresden | |
| Germany | Dres. Ende / Weisflog /ID# 249918 | Erfurt | |
| Germany | Bethanien-Krankenhaus /ID# 260865 | Frankfurt | |
| Germany | Interdisziplinaeres Crohn Colitis Zentrum /ID# 252622 | Frankfurt | |
| Germany | Universitaetsklinikum Frankfurt /ID# 254079 | Frankfurt am Main | Hessen |
| Germany | Dres. Krause/Schiffer /ID# 251727 | Frechen | |
| Germany | Dres. Bauer/Doerflinger /ID# 251568 | Freiburg im Breisgau | |
| Germany | Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 249974 | Friedrichsthal | Saarland |
| Germany | Internisten in Geldern /ID# 252068 | Geldern | |
| Germany | Universitaetsklinikum Halle (Saale) /ID# 254083 | Halle (Saale) | |
| Germany | Fachinternistische Schwerpunktpraxis Dr. Matthias Eichler, Dr. Matthias Kahl /ID# 249933 | Hamburg | |
| Germany | Tappe/Miks/Delker, Hamm, DE /ID# 251729 | Hamm | |
| Germany | Medizinische Hochschule Hannover /ID# 254980 | Hannover | |
| Germany | Mueller/Mueller-Ziehm, Hanover /ID# 252617 | Hannover | |
| Germany | Praxis fuer Gastroenterologie /ID# 249917 | Heidelberg | Baden-Wuerttemberg |
| Germany | Universitaetsklinik Heidelberg /ID# 249922 | Heidelberg | Baden-Wuerttemberg |
| Germany | Gastroenterologische Gemeinschaftspraxis /ID# 263633 | Heilbronn | |
| Germany | Städtisches Kh. Heinsberg GmbH /ID# 252624 | Heinsberg | |
| Germany | Gastroenterologische Gemeinschaftspraxis Herne /ID# 249990 | Herne | Nordrhein-Westfalen |
| 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 | Praxis Dr. Weber /ID# 256099 | Jena | |
| Germany | Universitaetsklinikum Jena /ID# 253768 | Jena | Thueringen |
| Germany | Universitaetsklinikum Jena /ID# 254371 | Jena | Thueringen |
| Germany | Praxis Dr. Schulze /ID# 262931 | Jerichow | |
| Germany | Gastroenterologe am Ettlinger Tor /ID# 249982 | Karlsruhe | |
| Germany | Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 251822 | Kassel | |
| Germany | Gastroenterologisch - Hepatologisches MVZ Kiel GmbH /ID# 252623 | Kiel | |
| Germany | Thurman/Bethge /ID# 249897 | Kiel | |
| Germany | Benner & Dommermuth /ID# 249896 | Koblenz | |
| Germany | MVZ Doceins West GmbH /ID# 249915 | Koblenz | |
| Germany | Universitaetsklinikum Leipzig /ID# 254081 | Leipzig | Sachsen |
| Germany | Universitaetsklinikum Leipzig /ID# 262612 | Leipzig | Sachsen |
| Germany | MVZ Gastroenterologie Leverkusen /ID# 260512 | Leverkusen | |
| Germany | Dres. Schmidt/Büning/Bär, Praxis für Gastroenterologie /ID# 249907 | Lübeck | Schleswig-Holstein |
| Germany | Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249984 | Lübeck | Schleswig-Holstein |
| Germany | Klinikum Lueneburg /ID# 249948 | Lueneburg | |
| Germany | Gastropraxis Magdeburg /ID# 249988 | Magdeburg | |
| Germany | Gastroenterologische Gemeinschaftspraxis Minden /ID# 249914 | Minden | |
| Germany | Gastro Campus Research GbR /ID# 249983 | Muenster | |
| Germany | Medizinisches Versorgungszentrum Portal 10 /ID# 249947 | Muenster | |
| Germany | Klinikum rechts der Isar /ID# 262176 | Munich | |
| Germany | Praxis Dr. Burlefinger /ID# 259159 | Munich | |
| Germany | Prof-med-stud.de /ID# 255419 | Munich | |
| Germany | Friedrich-Ebert-Krankenhaus GmbH /ID# 249973 | Neumuenster | Schleswig-Holstein |
| Germany | Praxis Dres Brendel /ID# 254078 | Nuernberg | |
| Germany | Medius Klinik Nürtingen /ID# 255420 | Nürtingen | |
| Germany | Verein für Wissenschaft und Forschung /ID# 249928 | Oldenburg | |
| Germany | Pc Docs /Id# 249921 | Pirmasens | |
| Germany | Praxis Dr. Grümmer /ID# 249925 | Potsdam | Brandenburg |
| Germany | Universitaetsmedizin Rostock /ID# 253769 | Rostock | Mecklenburg-Vorpommern |
| Germany | Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 249971 | Saarbrücken | Saarland |
| 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 | Dr. Schirin-Sokhan /ID# 259158 | Würselen |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
Austria, Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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