Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07822529). StuddyBuddy aggregates publicly available trial information.