Study to Assess Change in Disease Activity of Risankizumab Treatment in Adult Participants With Moderate to Severe Ulcerative Colitis

Launched by ABBVIE · Jan 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called risankizumab on adults with moderate to severe ulcerative colitis (UC), a condition that causes inflammation and bleeding in the colon. The goal of the study is to see how well this treatment works in everyday clinical settings. About 200 participants in Germany and Austria who have been prescribed risankizumab by their doctors will take part in the trial, and they will be monitored for up to 52 weeks.

To be eligible for this study, participants must have a confirmed diagnosis of moderate to severe ulcerative colitis and be starting treatment with risankizumab as part of their regular medical care. It's important to note that participants should not have received risankizumab before, and they should not be involved in any other clinical research that requires active treatment. Throughout the study, participants will attend regular visits at their usual healthcare facilities, but there won’t be any extra procedures or tests beyond what they would normally experience for their condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants with an endoscopically confirmed diagnosis of moderate to severe ulcerative colitis.
• • Participants initiating risankizumab at the investigator's discretion as part of their routine clinical care; the decision to administer risankizumab must be made prior to and independent of documentation for the study and according to the approved local label.
• Exclusion Criteria:
• • Participants previously exposed risankizumab
• • Participants who are currently participating in interventional research (not including noninterventional studies, post-marketing observational study (PMOS), or registry participation).