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)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05496348

Acronym

EUROPE

Enrollment

400

Registered

2022-08-11

Start date

2022-10-20

Completion date

2027-08-01

Last updated

2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis, UC, Upadacitinib, UPA, RINVOQ

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Austria, Germany, Switzerland

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results