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Ulcerative ColitisEUROPENCT05496348

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

An observational study of Ulcerative Colitis, run by AbbVie at 94 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
How many people
400 participants
Where
94 sitesin 3 countries
Study dates
20 Oct 2022to Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult participants with Ulcerative colitis (UC)

Who may be able to join

  • 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.

Who cannot join

  • Participants with any contraindication to Upadacitinib (UPA).
  • Participants previously exposed to a Janus kinase (JAK) inhibitor.

Trial locations and contacts

94 sites in 3 countries.

94 sites in 3 countries

Germany86 sites

  • Gemeinschaftspraxis im Medicum /ID# 249930

    Altenholz, Schleswig-Holstein, 24161

  • Klinikum Augsburg /ID# 249979

    Augsburg, Bavaria, 86156

  • Praxis Dr. Schiffelholz /ID# 252621

    Augsburg, 86150

  • MVZ Gastro Friedrichshain /ID# 249924

    Berlin, 10249

  • Praxis Dr. Berndt /ID# 252067

    Berlin, 10409

  • Dres. Schick/Wesenberg /ID# 249977

    Berlin, 10437

  • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 249981

    Berlin, 10825

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

    Berlin, 12559

  • Praxis S. Grüngreiff /ID# 249927

    Berlin, 12683

  • Praxis Dr. Soellenboehmer /ID# 249985

    Berlin, 14052

  • Praxis Dr. Spitz /ID# 252616

    Berlin, 14163

  • Krankenhaus Waldfriede /ID# 249900

    Berlin-Zehlendorf, 14163

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

    Bitterfeld-Wolfen, 06749

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

    Blaubeuren Abbey, 89143

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

    Brandenburg an der Havel, Brandenburg, 14776

  • Praxis S. Tetzlaff /ID# 253770

    Buedelsdorf, Schleswig-Holstein, 24782

  • Klinikum Chemnitz - Flemmingstraße /ID# 259156

    Chemnitz, Saxony, 09116

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

    Coesfeld, North Rhine-Westphalia, 48653

  • Evangelisches Krankenhaus Kalk /ID# 249987

    Cologne, North Rhine-Westphalia, 51103

  • Medizinisches Versorgunszentrum Dachau /ID# 249945

    Dachau, Bavaria, 85221

  • Klinikum Darmstadt /ID# 267685

    Darmstadt, Hesse, 64283

  • Praxis Dres. Hurst/Simonis /ID# 255421

    Darmstadt, Hesse, 64293

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 249989

    Dresden, Saxony, 01307

  • Private Practice - Dr. Johannes Janschek /ID# 255092

    Dresden, Saxony, 01309

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

    Dresden, 01067

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

    Erfurt, Thuringia, 99084

  • Interdisziplinaeres Crohn Colitis Zentrum /ID# 252622

    Frankfurt am Main, Hesse, 60318

  • Bethanien-Krankenhaus /ID# 260865

    Frankfurt am Main, Hesse, 60389

  • Dres. Krause/Schiffer /ID# 251727

    Frechen, 50226

  • Dres. Bauer/Doerflinger /ID# 251568

    Freiburg im Breisgau, 79102

  • Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 249974

    Friedrichsthal, Saarland, 66299

  • Internisten in Geldern /ID# 252068

    Guelders, 47608

  • Universitaetsklinikum Halle (Saale) /ID# 254083

    Halle, 06120

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

    Hamburg, 22041

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

    Hamm, 59065

  • Internistische Praxisgemeinschaft Hanau GbR /ID# 254079

    Hanau, 63452

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

    Hanover, Lower Saxony, 30449

  • Medizinische Hochschule Hannover /ID# 254980

    Hanover, Lower Saxony, 30625

  • Universitaetsklinik Heidelberg /ID# 249922

    Heidelberg, Baden-Wurttemberg, 69120

  • Praxis fuer Gastroenterologie - Heidelberg /ID# 249917

    Heidelberg, Baden-Wurttemberg, 69121

  • Gastroenterologische Gemeinschaftspraxis /ID# 263633

    Heilbronn, 74072

  • Städtisches Kh. Heinsberg GmbH /ID# 252624

    Heinsberg, 52525

  • Gastroenterologische Gemeinschaftspraxis Herne /ID# 249990

    Herne, North Rhine-Westphalia, 44623

  • Praxis Dres. Preiss/Engelke /ID# 249919

    Herne, 44649

  • Praxis Dr. Schwarz /ID# 251819

    Hettstedt, 06333

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

    Iserlohn, 58644

  • Universitaetsklinikum Jena /ID# 253768

    Jena, Thuringia, 07747

  • Universitaetsklinikum Jena /ID# 254371

    Jena, Thuringia, 07747

  • Praxis Dr. Weber /ID# 256099

    Jena, 07743

  • Praxisgemeinschaft Jerichow Schulze /ID# 262931

    Jerichow, Saxony-Anhalt, 39319

  • Gastroenterologe am Ettlinger Tor /ID# 249982

    Karlsruhe, 76133

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

    Kassel, Hesse, 34117

  • Thormann and Bethge /ID# 249897

    Kiel, Schleswig-Holstein, 24105

  • Gastroenterologisch - Hepatologisches MVZ Kiel GmbH /ID# 252623

    Kiel, Schleswig-Holstein, 24146

  • Benner & Dommermuth /ID# 249896

    Koblenz, Rhineland-Palatinate, 56068

  • MVZ Doceins West GmbH /ID# 249915

    Koblenz, 56068

  • Universitaetsklinikum Leipzig /ID# 262612

    Leipzig, Saxony, 04103

  • Gesellschaft für klinische Studien /ID# 254081

    Leipzig, Saxony, 04105

  • MVZ Gastroenterologie Leverkusen /ID# 260512

    Leverkusen, 51375

  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249984

    Lübeck, Schleswig-Holstein, 23538

  • Praxis fuer Gastroenterologie - Lubeck /ID# 249907

    Lübeck, Schleswig-Holstein, 23560

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

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67067

  • Klinikum Lueneburg /ID# 249948

    Lüneburg, Lower Saxony, 21339

  • Gastropraxis Magdeburg /ID# 249988

    Magdeburg, 39104

  • Gastroenterologische Gemeinschaftspraxis Minden /ID# 249914

    Minden, North Rhine-Westphalia, 32423

  • TUM Klinikum rechts der Isar /ID# 262176

    Munich, Bavaria, 81675

  • Praxis Dr. Burlefinger /ID# 259159

    Munich, 80336

  • Prof-med-stud.de /ID# 255419

    Munich, 80935

  • Medizinisches Versorgungszentrum Portal 10 /ID# 249947

    Münster, 48155

  • Gastro Campus Research GbR /ID# 249983

    Münster, 48159

  • Friedrich-Ebert-Krankenhaus GmbH /ID# 249973

    Neumünster, Schleswig-Holstein, 24534

  • Praxis Dres Brendel /ID# 254078

    Nuremberg, 90449

  • Medius Klinik Nürtingen /ID# 255420

    Nürtingen, 72622

  • Verein für Wissenschaft und Forschung /ID# 249928

    Oldenburg, Lower Saxony, 26123

  • Pc Docs /Id# 249921

    Pirmasens, 66953

  • Praxis Dr. Grümmer /ID# 249925

    Potsdam, Brandenburg, 14471

  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 249971

    Saarbrücken, Saarland, 66111

  • Elisabeth Klinikum GmbH /ID# 252264

    Schmalkalden, 98574

  • Praxis fuer Gastroenterologie - Schwerin /ID# 252615

    Schwerin, Mecklenburg-Vorpommern, 19057

  • Dres. Rehbehn/Skusa /ID# 252618

    Solingen, 42651

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

    Stuttgart, 70435

  • Private Practice - Dr. Kempelmann /ID# 249935

    Tostedt, Free and Hanseatic City of Hamburg, 21255

  • Rems-Murr-Klinikum Winnenden /ID# 278791

    Winnenden, Baden-Wurttemberg, 71364

  • Klinikum Worms gGmbH /ID# 269804

    Worms, Rhineland-Palatinate, 67550

  • Dres. Mallach/Spelter /ID# 270912

    Wuppertal, North Rhine-Westphalia, 42103

  • Dr. Schirin-Sokhan /ID# 259158

    Würselen, 52146

Other trials in Germany

Switzerland5 sites

  • Inselspital, Universitaetsspital Bern /ID# 260968

    Bern, 3010

  • Berner IBD Study Group /ID# 262315

    Bern, 3012

  • EOC Ospedale Regionale Lugano /ID# 277165

    Lugano, Canton Ticino, 6900

  • Zentrum fur Gastroenterologie und Hepatologie /ID# 260967

    Zurich, Canton of Zurich, 8048

  • University Hospital Zurich /ID# 260966

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Austria3 sites

  • Kepler Universitaetsklinikum GmbH /ID# 251868

    Linz, Upper Austria, 4020

  • Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869

    Salzburg, 5010

  • Krankenhaus der Barmherzigen Brueder Wien /ID# 251867

    Vienna, State of Vienna, 1020

Other trials in Austria

About this study

Official title: Early therapeUtic RespOnse and Predictivity of Long-term Effectiveness of Upadacitinib in Ulcerative Colitis (EUROPE)

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.

Read more

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.

Keywords
Ulcerative colitis, UC, Upadacitinib, UPA, RINVOQ
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05496348
Study groupRoleWhat they receive
UpadacitinibParticipants will receive upadacitinib as prescribed by their physician according to local label

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2022
  2. Study start20 Oct 2022
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05496348
Sponsor's protocol ID
P23-430
Acronym
EUROPE
Status last verified
Jul 2026
First submitted
9 Aug 2022
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, run by AbbVie at 94 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in Germany, Switzerland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05496348.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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