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New study follows 400 patients on upadacitinib for ulcerative colitis

NCT ID NCT05496348

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study follows 400 adults with moderate to severe ulcerative colitis who are already prescribed upadacitinib (RINVOQ) by their doctor. Researchers will track how well the drug controls symptoms like diarrhea and rectal bleeding over two years. The goal is to see if early improvement predicts long-term success. Participants attend regular clinic visits, and no extra tests are needed beyond standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
upadacitinib (RINVOQ)
What this could lead to
If successful, this study could confirm that upadacitinib effectively controls ulcerative colitis symptoms early on and maintains that control long-term.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. Upadacitinib is already approved, so this study aims to refine its use rather than prove a new breakthrough.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult participants with Ulcerative colitis (UC)

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Blaubeuren Abbey, 89143, Germany

  • Benner & Dommermuth /ID# 249896

    Koblenz, Rhineland-Palatinate, 56068, Germany

  • Berner IBD Study Group /ID# 262315

    Bern, 3012, Switzerland

  • Bethanien-Krankenhaus /ID# 260865

    Frankfurt am Main, Hesse, 60389, Germany

  • Dr. Schirin-Sokhan /ID# 259158

    Würselen, 52146, Germany

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

    Brandenburg an der Havel, Brandenburg, 14776, Germany

  • Dres. Bauer/Doerflinger /ID# 251568

    Freiburg im Breisgau, 79102, Germany

  • Dres. Krause/Schiffer /ID# 251727

    Frechen, 50226, Germany

  • Dres. Mallach/Spelter /ID# 270912

    Wuppertal, North Rhine-Westphalia, 42103, Germany

  • Dres. Rehbehn/Skusa /ID# 252618

    Solingen, 42651, Germany

  • Dres. Schick/Wesenberg /ID# 249977

    Berlin, 10437, Germany

  • EOC Ospedale Regionale Lugano /ID# 277165

    Lugano, Canton Ticino, 6900, Switzerland

  • Elisabeth Klinikum GmbH /ID# 252264

    Schmalkalden, 98574, Germany

  • Evangelisches Krankenhaus Kalk /ID# 249987

    Cologne, North Rhine-Westphalia, 51103, Germany

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

    Dresden, 01067, Germany

  • Friedrich-Ebert-Krankenhaus GmbH /ID# 249973

    Neumünster, Schleswig-Holstein, 24534, Germany

  • Gastro Campus Research GbR /ID# 249983

    Münster, 48159, Germany

  • Gastroenterologe am Ettlinger Tor /ID# 249982

    Karlsruhe, 76133, Germany

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

    Kassel, Hesse, 34117, Germany

  • Gastroenterologisch - Hepatologisches MVZ Kiel GmbH /ID# 252623

    Kiel, Schleswig-Holstein, 24146, Germany

  • Gastroenterologische Gemeinschaftspraxis /ID# 263633

    Heilbronn, 74072, Germany

  • Gastroenterologische Gemeinschaftspraxis Herne /ID# 249990

    Herne, North Rhine-Westphalia, 44623, Germany

  • Gastroenterologische Gemeinschaftspraxis Minden /ID# 249914

    Minden, North Rhine-Westphalia, 32423, Germany

  • Gastropraxis Magdeburg /ID# 249988

    Magdeburg, 39104, Germany

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

    Erfurt, Thuringia, 99084, Germany

  • Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 249974

    Friedrichsthal, Saarland, 66299, Germany

  • Gemeinschaftspraxis im Medicum /ID# 249930

    Altenholz, Schleswig-Holstein, 24161, Germany

  • Gesellschaft für klinische Studien /ID# 254081

    Leipzig, Saxony, 04105, Germany

  • Inselspital, Universitaetsspital Bern /ID# 260968

    Bern, 3010, Switzerland

  • Interdisziplinaeres Crohn Colitis Zentrum /ID# 252622

    Frankfurt am Main, Hesse, 60318, Germany

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

    Bitterfeld-Wolfen, 06749, Germany

  • Internisten in Geldern /ID# 252068

    Guelders, 47608, Germany

  • Internistische Praxisgemeinschaft Hanau GbR /ID# 254079

    Hanau, 63452, Germany

  • Kepler Universitaetsklinikum GmbH /ID# 251868

    Linz, Upper Austria, 4020, Austria

  • Klinikum Augsburg /ID# 249979

    Augsburg, Bavaria, 86156, Germany

  • Klinikum Chemnitz - Flemmingstraße /ID# 259156

    Chemnitz, Saxony, 09116, Germany

  • Klinikum Darmstadt /ID# 267685

    Darmstadt, Hesse, 64283, Germany

  • Klinikum Lueneburg /ID# 249948

    Lüneburg, Lower Saxony, 21339, Germany

  • Klinikum Worms gGmbH /ID# 269804

    Worms, Rhineland-Palatinate, 67550, Germany

  • Krankenhaus Waldfriede /ID# 249900

    Berlin-Zehlendorf, 14163, Germany

  • Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869

    Salzburg, 5010, Austria

  • Krankenhaus der Barmherzigen Brueder Wien /ID# 251867

    Vienna, State of Vienna, 1020, Austria

  • MVZ Doceins West GmbH /ID# 249915

    Koblenz, 56068, Germany

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

    Iserlohn, 58644, Germany

  • MVZ Gastro Friedrichshain /ID# 249924

    Berlin, 10249, Germany

  • MVZ Gastroenterologie Leverkusen /ID# 260512

    Leverkusen, 51375, Germany

  • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 249981

    Berlin, 10825, Germany

  • Medius Klinik Nürtingen /ID# 255420

    Nürtingen, 72622, Germany

  • Medizinische Hochschule Hannover /ID# 254980

    Hanover, Lower Saxony, 30625, Germany

  • Medizinisches Versorgungszentrum Portal 10 /ID# 249947

    Münster, 48155, Germany

  • Medizinisches Versorgunszentrum Dachau /ID# 249945

    Dachau, Bavaria, 85221, Germany

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

    Hanover, Lower Saxony, 30449, Germany

  • Pc Docs /Id# 249921

    Pirmasens, 66953, Germany

  • Praxis Dr. Berndt /ID# 252067

    Berlin, 10409, Germany

  • Praxis Dr. Burlefinger /ID# 259159

    Munich, 80336, Germany

  • Praxis Dr. Grümmer /ID# 249925

    Potsdam, Brandenburg, 14471, Germany

  • Praxis Dr. Schiffelholz /ID# 252621

    Augsburg, 86150, Germany

  • Praxis Dr. Schwarz /ID# 251819

    Hettstedt, 06333, Germany

  • Praxis Dr. Soellenboehmer /ID# 249985

    Berlin, 14052, Germany

  • Praxis Dr. Spitz /ID# 252616

    Berlin, 14163, Germany

  • Praxis Dr. Weber /ID# 256099

    Jena, 07743, Germany

  • Praxis Dres Brendel /ID# 254078

    Nuremberg, 90449, Germany

  • Praxis Dres. Hurst/Simonis /ID# 255421

    Darmstadt, Hesse, 64293, Germany

  • Praxis Dres. Preiss/Engelke /ID# 249919

    Herne, 44649, Germany

  • Praxis S. Grüngreiff /ID# 249927

    Berlin, 12683, Germany

  • Praxis S. Tetzlaff /ID# 253770

    Buedelsdorf, Schleswig-Holstein, 24782, Germany

  • Praxis fuer Gastroenterologie - Heidelberg /ID# 249917

    Heidelberg, Baden-Wurttemberg, 69121, Germany

  • Praxis fuer Gastroenterologie - Lubeck /ID# 249907

    Lübeck, Schleswig-Holstein, 23560, Germany

  • Praxis fuer Gastroenterologie - Schwerin /ID# 252615

    Schwerin, Mecklenburg-Vorpommern, 19057, Germany

  • Praxisgemeinschaft Jerichow Schulze /ID# 262931

    Jerichow, Saxony-Anhalt, 39319, Germany

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

    Dresden, Saxony, 01309, Germany

  • Private Practice - Dr. Kempelmann /ID# 249935

    Tostedt, Free and Hanseatic City of Hamburg, 21255, Germany

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

    Hamburg, 22041, Germany

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

    Coesfeld, North Rhine-Westphalia, 48653, Germany

  • Prof-med-stud.de /ID# 255419

    Munich, 80935, Germany

  • Rems-Murr-Klinikum Winnenden /ID# 278791

    Winnenden, Baden-Wurttemberg, 71364, Germany

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

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67067, Germany

  • Städtisches Kh. Heinsberg GmbH /ID# 252624

    Heinsberg, 52525, Germany

  • TUM Klinikum rechts der Isar /ID# 262176

    Munich, Bavaria, 81675, Germany

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

    Hamm, 59065, Germany

  • Thormann and Bethge /ID# 249897

    Kiel, Schleswig-Holstein, 24105, Germany

  • Universitaetsklinik Heidelberg /ID# 249922

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 249989

    Dresden, Saxony, 01307, Germany

  • Universitaetsklinikum Halle (Saale) /ID# 254083

    Halle, 06120, Germany

  • Universitaetsklinikum Jena /ID# 253768

    Jena, Thuringia, 07747, Germany

  • Universitaetsklinikum Jena /ID# 254371

    Jena, Thuringia, 07747, Germany

  • Universitaetsklinikum Leipzig /ID# 262612

    Leipzig, Saxony, 04103, Germany

  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249984

    Lübeck, Schleswig-Holstein, 23538, Germany

  • University Hospital Zurich /ID# 260966

    Zurich, Canton of Zurich, 8091, Switzerland

  • Verein für Wissenschaft und Forschung /ID# 249928

    Oldenburg, Lower Saxony, 26123, Germany

  • Zentrum fur Gastroenterologie und Hepatologie /ID# 260967

    Zurich, Canton of Zurich, 8048, Switzerland

  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 249971

    Saarbrücken, Saarland, 66111, Germany

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

    Berlin, 12559, Germany

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

    Stuttgart, 70435, Germany

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