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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbVie

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 the change in disease activity of risankizumab treatment in adult participants with moderate to severe UC in real-world clinical practice.

Risankizumab is an approved drug for treating participants with ulcerative colitis. Approximately 200 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately multiple sites across Germany and Austria.

Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 52 weeks.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Participants previously exposed risankizumab

Participants who are currently participating in interventional research (not including noninterventional studies, post-marketing observational study (PMOS), or registry participation).

Trial population

Adult participants with moderate to severe ulcerative colitis being treated with risankizumab.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Risankizumab

Trial outcomes

Primary outcomes

1

Percentage of Participants Achieving Symptomatic Remission Responder Per Partial Adapted Mayo Score

Symptomatic remission is defined as stool frequency (SFS) \<=1 and rectal bleeding subscore (RBS)=0

Time frame
Up to approximately 52 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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