Clinical trial NCT05496348: Study of Oral Upadacitinib to Assess Change in Disease Activity in Adult Participants With Ulcerative Colitis
Official title: Early therapeUtic RespOnse and Predictivity of Long-term Effectiveness of Upadacitinib in Ulcerative Colitis (EUROPE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
UC
Upadacitinib
UPA
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-08-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with Ulcerative colitis (UC)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitaetsklinikum GmbH /ID# 251868
state: Oberoesterreich
city: Vienna
country: Austria
facility: Krankenhaus der Barmherzigen Brueder Wien /ID# 251867
state: Wien
city: Salzburg
country: Austria
facility: Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869
city: Heidelberg
country: Germany
facility: Universitaetsklinik Heidelberg /ID# 249922
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: Praxis fuer Gastroenterologie /ID# 249917
state: Baden-Wuerttemberg
city: Augsburg
country: Germany
facility: Klinikum Augsburg /ID# 249979
state: Bayern
city: Dachau
country: Germany
facility: Medizinisches Versorgunszentrum Dachau /ID# 249945
state: Bayern
city: Brandenburg an der Havel
country: Germany
facility: Dr.med. Johannes Behrendt Facharzt für Innere Medizin und Gastroenterologie /ID# 260516
state: Brandenburg
city: Potsdam
country: Germany
facility: Praxis Dr. Grümmer /ID# 249925
state: Brandenburg
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt /ID# 267685
state: Hessen
city: Darmstadt
country: Germany
facility: Praxis Dres. Hurst/Simonis /ID# 255421
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt /ID# 254079
state: Hessen
city: Frankfurt
country: Germany
facility: Interdisziplinaeres Crohn Colitis Zentrum /ID# 252622
state: Hessen
city: Frankfurt
country: Germany
facility: Bethanien-Krankenhaus /ID# 260865
state: Hessen
city: Kassel
country: Germany
facility: Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 251822
state: Hessen
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock /ID# 253769
state: Mecklenburg-Vorpommern
city: Hannover
country: Germany
facility: Mueller/Mueller-Ziehm, Hanover /ID# 252617
state: Niedersachsen
city: Lueneburg
country: Germany
facility: Klinikum Lueneburg /ID# 249948
state: Niedersachsen
city: Oldenburg
country: Germany
facility: Verein für Wissenschaft und Forschung /ID# 249928
state: Niedersachsen
city: Cologne
country: Germany
facility: Evangelisches Krankenhaus Kalk /ID# 249987
state: Nordrhein-Westfalen
city: Herne
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Herne /ID# 249990
state: Nordrhein-Westfalen
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden /ID# 249914
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
facility: Dres. Mallach/Spelter /ID# 270912
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: Benner & Dommermuth /ID# 249896
state: Rheinland-Pfalz
city: Ludwigshafen am Rhein
country: Germany
facility: St. Marien- und St. Annastiftskrankenhaus /ID# 273172
state: Rheinland-Pfalz
city: Worms
country: Germany
facility: Klinikum Worms gGmbH /ID# 269804
state: Rheinland-Pfalz
city: Friedrichsthal
country: Germany
facility: Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 249974
state: Saarland
city: Saarbrücken
country: Germany
facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 249971
state: Saarland
city: Jerichow
country: Germany
facility: Praxisgemeinschaft Jerichow Schulze /ID# 262931
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH /ID# 259156
state: Sachsen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden /ID# 249989
state: Sachsen
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig /ID# 254081
state: Sachsen
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig /ID# 262612
state: Sachsen
city: Altenholz
country: Germany
facility: Praxis Jessen/Grimm /ID# 249930
state: Schleswig-Holstein
city: Büdelsdorf
country: Germany
facility: Praxis S. Tetzlaff /ID# 253770
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: Thormann and Bethge /ID# 249897
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: Gastroenterologisch - Hepatologisches MVZ Kiel GmbH /ID# 252623
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249984
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Praxis fuer Gastroenterologie /ID# 249907
state: Schleswig-Holstein
city: Neumuenster
country: Germany
facility: Friedrich-Ebert-Krankenhaus GmbH /ID# 249973
state: Schleswig-Holstein
city: Jena
country: Germany
facility: Universitaetsklinikum Jena /ID# 253768
state: Thueringen
city: Jena
country: Germany
facility: Universitaetsklinikum Jena /ID# 254371
state: Thueringen
city: Augsburg
country: Germany
facility: Praxis Dr. Schiffelholz /ID# 252621
city: Berlin-Zehlendorf
country: Germany
facility: Krankenhaus Waldfriede /ID# 249900
city: Berlin
country: Germany
facility: MVZ Gastro Friedrichshain /ID# 249924
city: Berlin
country: Germany
facility: Praxis Dr. Berndt /ID# 252067
city: Berlin
country: Germany
facility: Dres. Schick/Wesenberg /ID# 249977
city: Berlin
country: Germany
facility: MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 249981
city: Berlin
country: Germany
facility: Zweite Gemeinnuutzige Krankenhaus GmbH DRK Kliniken Berlin Kopenick /ID# 262849
city: Berlin
country: Germany
facility: Praxis S. Grüngreiff /ID# 249927
city: Berlin
country: Germany
facility: Praxis Dr. Soellenboehmer /ID# 249985
city: Berlin
country: Germany
facility: Praxis Dr. Spitz /ID# 252616
city: Bitterfeld-Wolfen
country: Germany
facility: Internist. Facharztp. Dr. Palmai /ID# 251821
city: Blaubeuren
country: Germany
facility: Alb-Donau Klinikum Blaubeuren, ADK GmbH für Gesundheit und Soziales /ID# 249923
city: Coesfeld
country: Germany
facility: Dres. Kemper/Dreck /ID# 249916
city: Dresden
country: Germany
facility: Frach/Hohaus, Dresden, DE /ID# 254979
city: Dresden
country: Germany
facility: Dr. Janschek /ID# 255092
city: Erfurt
country: Germany
facility: Dres. Ende / Weisflog /ID# 249918
city: Frechen
country: Germany
facility: Dres. Krause/Schiffer /ID# 251727
city: Freiburg im Breisgau
country: Germany
facility: Dres. Bauer/Doerflinger /ID# 251568
city: Geldern
country: Germany
facility: Internisten in Geldern /ID# 252068
city: Halle (Saale)
country: Germany
facility: Universitaetsklinikum Halle (Saale) /ID# 254083
city: Hamburg
country: Germany
facility: Private Practice - Dr. Matthias Eichler /ID# 249933
city: Hamm
country: Germany
facility: Tappe/Miks/Delker, Hamm, DE /ID# 251729
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover /ID# 254980
city: Heilbronn
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis /ID# 263633
city: Heinsberg
country: Germany
facility: Städtisches Kh. Heinsberg GmbH /ID# 252624
city: Herne
country: Germany
facility: Praxis Dres. Preiss/Engelke /ID# 249919
city: Hettstedt
country: Germany
facility: Praxis Dr. Schwarz /ID# 251819
city: Iserlohn
country: Germany
facility: MVZ Dres. Al-Kadi & Partner /ID# 249929
city: Jena
country: Germany
facility: Praxis Dr. Weber /ID# 256099
city: Karlsruhe
country: Germany
facility: Gastroenterologe am Ettlinger Tor /ID# 249982
city: Koblenz
country: Germany
facility: MVZ Doceins West GmbH /ID# 249915
city: Leverkusen
country: Germany
facility: MVZ Gastroenterologie Leverkusen /ID# 260512
city: Magdeburg
country: Germany
facility: Gastropraxis Magdeburg /ID# 249988
city: Muenster
country: Germany
facility: Medizinisches Versorgungszentrum Portal 10 /ID# 249947
city: Muenster
country: Germany
facility: Gastro Campus Research GbR /ID# 249983
city: Munich
country: Germany
facility: Praxis Dr. Burlefinger /ID# 259159
city: Munich
country: Germany
facility: Prof-med-stud.de /ID# 255419
city: Munich
country: Germany
facility: Klinikum rechts der Isar /ID# 262176
city: Nuernberg
country: Germany
facility: Praxis Dres Brendel /ID# 254078
city: Nürtingen
country: Germany
facility: Medius Klinik Nürtingen /ID# 255420
city: Pirmasens
country: Germany
facility: Pc Docs /Id# 249921
city: Schmalkalden
country: Germany
facility: Elisabeth Klinikum GmbH /ID# 252264
city: Schwerin
country: Germany
facility: Praxis fuer Gastroenterologie /ID# 252615
city: Solingen
country: Germany
facility: Dres. Rehbehn/Skusa /ID# 252618
city: Stuttgart
country: Germany
facility: bauchraum Gastroenterologisches Zentrum Dres. F. Kuehl, C. Hartmann, T. Klag BAG /ID# 251567
city: Tostedt
country: Germany
facility: Praxis Dr. Kempelmann /ID# 249935
city: Würselen
country: Germany
facility: Dr. Schirin-Sokhan /ID# 259158
city: Zurich
country: Switzerland
facility: University Hospital Zurich /ID# 260966
state: Zuerich
city: Zurich
country: Switzerland
facility: Zentrum fur Gastroenterologie und Hepatologie /ID# 260967
state: Zuerich
city: Bern
country: Switzerland
facility: Inselspital, Universitaetsspital Bern /ID# 260968
city: Bern
country: Switzerland
facility: Berner IBD Study Group /ID# 262315
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: