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

Recruiting

• Conditions: Ulcerative Colitis

• Registration Number: NCT05496348
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Study Start: 2022-10-20
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-18
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (93)

Kepler Universitaetsklinikum GmbH /ID# 251868; 🇦🇹 Linz, Oberoesterreich, Austria

Krankenhaus der Barmherzigen Brueder Wien /ID# 251867; 🇦🇹 Vienna, Wien, Austria

Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869; 🇦🇹 Salzburg, Austria

Universitaetsklinik Heidelberg /ID# 249922; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany

Praxis fuer Gastroenterologie /ID# 249917; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany

Klinikum Augsburg /ID# 249979; 🇩🇪 Augsburg, Bayern, Germany

Medizinisches Versorgunszentrum Dachau /ID# 249945; 🇩🇪 Dachau, Bayern, Germany

Dr.med. Johannes Behrendt Facharzt für Innere Medizin und Gastroenterologie /ID# 260516; 🇩🇪 Brandenburg an der Havel, Brandenburg, Germany

Praxis Dr. Grümmer /ID# 249925; 🇩🇪 Potsdam, Brandenburg, Germany

Klinikum Darmstadt /ID# 267685; 🇩🇪 Darmstadt, Hessen, Germany

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