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

NCT05496348 · tracked via the Priya Life Science Germany tracker

Sponsor

AbbVie

Phase

Observational

Started

2022-10-20

Last updated

2026-07-16

Condition(s) studied

Ulcerative Colitis

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

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 — Week 52
Symptomatic remission per partial adapted Mayo score is defined as stool frequency (SF)=0/1 and rectal bleeding score (RBS) =0.

Trial sites (94)

Facility	City	Region
Krankenhaus der Barmherzigen Brueder Wien /ID# 251867	Vienna	State of Vienna
Kepler Universitaetsklinikum GmbH /ID# 251868	Linz	Upper Austria
Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869	Salzburg	Austria
Universitaetsklinik Heidelberg /ID# 249922	Heidelberg	Baden-Wurttemberg
Praxis fuer Gastroenterologie - Heidelberg /ID# 249917	Heidelberg	Baden-Wurttemberg
Rems-Murr-Klinikum Winnenden /ID# 278791	Winnenden	Baden-Wurttemberg
Klinikum Augsburg /ID# 249979	Augsburg	Bavaria
Medizinisches Versorgunszentrum Dachau /ID# 249945	Dachau	Bavaria
TUM Klinikum rechts der Isar /ID# 262176	Munich	Bavaria
Dr.med. Johannes Behrendt Facharzt für Innere Medizin und Gastroenterologie /ID# 260516	Brandenburg an der Havel	Brandenburg
Praxis Dr. Grümmer /ID# 249925	Potsdam	Brandenburg
Private Practice - Dr. Kempelmann /ID# 249935	Tostedt	Free and Hanseatic City of Hamburg
Klinikum Darmstadt /ID# 267685	Darmstadt	Hesse
Praxis Dres. Hurst/Simonis /ID# 255421	Darmstadt	Hesse
Interdisziplinaeres Crohn Colitis Zentrum /ID# 252622	Frankfurt am Main	Hesse
Bethanien-Krankenhaus /ID# 260865	Frankfurt am Main	Hesse
Gastroenterologie Opernstrasse Private Practice - Dr. Falk and Krause and Kuhn /ID# 251822	Kassel	Hesse
Mueller/Mueller-Ziehm, Hanover /ID# 252617	Hanover	Lower Saxony
Medizinische Hochschule Hannover /ID# 254980	Hanover	Lower Saxony
Klinikum Lueneburg /ID# 249948	Lüneburg	Lower Saxony
Verein für Wissenschaft und Forschung /ID# 249928	Oldenburg	Lower Saxony
Praxis fuer Gastroenterologie - Schwerin /ID# 252615	Schwerin	Mecklenburg-Vorpommern
Private Practice - Dr. Mechthild Kemper and Dr. Markus Dreck /ID# 249916	Coesfeld	North Rhine-Westphalia
Evangelisches Krankenhaus Kalk /ID# 249987	Cologne	North Rhine-Westphalia
Gastroenterologische Gemeinschaftspraxis Herne /ID# 249990	Herne	North Rhine-Westphalia
Gastroenterologische Gemeinschaftspraxis Minden /ID# 249914	Minden	North Rhine-Westphalia
Dres. Mallach/Spelter /ID# 270912	Wuppertal	North Rhine-Westphalia
Benner & Dommermuth /ID# 249896	Koblenz	Rhineland-Palatinate
St. Marien- und St. Annastiftskrankenhaus /ID# 273172	Ludwigshafen am Rhein	Rhineland-Palatinate
Klinikum Worms gGmbH /ID# 269804	Worms	Rhineland-Palatinate
Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 249974	Friedrichsthal	Saarland
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 249971	Saarbrücken	Saarland
Klinikum Chemnitz - Flemmingstraße /ID# 259156	Chemnitz	Saxony
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 249989	Dresden	Saxony
Private Practice - Dr. Johannes Janschek /ID# 255092	Dresden	Saxony
Universitaetsklinikum Leipzig /ID# 262612	Leipzig	Saxony
Gesellschaft für klinische Studien /ID# 254081	Leipzig	Saxony
Praxisgemeinschaft Jerichow Schulze /ID# 262931	Jerichow	Saxony-Anhalt
Gemeinschaftspraxis im Medicum /ID# 249930	Altenholz	Schleswig-Holstein
Praxis S. Tetzlaff /ID# 253770	Buedelsdorf	Schleswig-Holstein

+ 54 more sites — see the full list on the official registry below.

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Other trials for the same condition

Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis Active, not recruiting

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis Recruiting

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis Recruiting

ABTECT - Maintenance Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05496348 on ClinicalTrials.gov ↗ ← All trials in Germany