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Recruiting
NCT07822529
A Study of Long Term Persistency of Guselkumab in Adult Participants With Inflammatory Bowel Disease
Conditions: Inflammatory Bowel Diseases
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 400
Sponsor: Janssen Research & Development, LLC
Location: CHU Amiens Picardie Amiens
Summary
The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) 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
Inclusion criteria:
* Must be greater than or equal to (\>=) 18 years old
* 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. Decision to prescribe must solely be made by the treating physician. Enrolment must take place before or on the day of the first administration (but after treatment decision by physician)
* Must have a confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative Colitis (UC) recorded in their medical records
* Participant has received the information note/given his/her oral agreement and has not objected to the collection of their data
Exclusion criteria:
* 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 a prior history of Stelara (ustekinumab) and biosimilars exposure, may be included
* History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
Source: ClinicalTrials.gov (NCT07822529). StuddyBuddy aggregates publicly available trial information.