RECRUITINGOBSERVATIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - Participants with any contraindication to Upadacitinib (UPA). - Participants previously exposed to a Janus kinase (JAK) inhibitor. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Locations (20)

Kepler Universitaetsklinikum GmbH /ID# 251868

Linz, Upper Austria, Austria

Krankenhaus der Barmherzigen Brueder Wien /ID# 251867

Vienna, Vienna, Austria

Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869

Salzburg, Austria

Universitaetsklinik Heidelberg /ID# 249922

Heidelberg, Baden-Wurttemberg, Germany

Praxis fuer Gastroenterologie /ID# 249917

Heidelberg, Baden-Wurttemberg, Germany

Rems-Murr-Klinikum Winnenden /ID# 278791

Winnenden, Baden-Wurttemberg, Germany

Klinikum Augsburg /ID# 249979

Augsburg, Bavaria, Germany

Medizinisches Versorgunszentrum Dachau /ID# 249945

Dachau, Bavaria, Germany

TUM Klinikum rechts der Isar /ID# 262176

Munich, Bavaria, Germany

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

Brandenburg, Brandenburg, Germany

Praxis Dr. Grümmer /ID# 249925

Potsdam, Brandenburg, Germany

Private Practice - Dr. Kempelmann /ID# 249935

Tostedt, Hamburg, Germany

Klinikum Darmstadt /ID# 267685

Darmstadt, Hesse, Germany

Praxis Dres. Hurst/Simonis /ID# 255421

Darmstadt, Hesse, Germany

Interdisziplinaeres Crohn Colitis Zentrum /ID# 252622

Frankfurt am Main, Hesse, Germany

Bethanien-Krankenhaus /ID# 260865

Frankfurt am Main, Hesse, Germany

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

Kassel, Hesse, Germany

Mueller/Mueller-Ziehm, Hanover /ID# 252617

Hanover, Lower Saxony, Germany

Medizinische Hochschule Hannover /ID# 254980

Hanover, Lower Saxony, Germany

Klinikum Lueneburg /ID# 249948

Lüneburg, Lower Saxony, Germany