A Study of Continued Use of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen Sciences Ireland UC

About this trial

The purpose of this study is to find out how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.

Eligibility criteria

Qualifiers

Participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of the drug

Participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records

Participant must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

Disqualifiers

Contraindicated to guselkumab per the label

Is currently enrolled in an interventional clinical study

Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya (guselkumab), Skyrizi (risankizumab) and Omvoh (mirikizumab). As an exception, participants with history of Ustekinumab exposure may be included

History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

35 Participants
are grouped into 1 trial group

Locations

This trial has no locations

Sponsors and collaborators