Observing Real-World Long-Term Use of Guselkumab for Moderate-to-Severe Crohns Disease and Ulcerative Colitis

What this Trial Is About

Researchers are evaluating the long-term use of guselkumab in adults with moderate to severe Crohns disease CD or ulcerative colitis UC, two types of inflammatory bowel disease affecting the colon and small intestine. This observational study focuses on how long guselkumab remains in use in real-world clinical settings without providing the drug as part of the study. Participants with confirmed moderate-to-severe UC or CD who are already receiving guselkumab as part of their standard care will be enrolled. The study collects data from medical records and routine clinical practice only, without administering any study drug. Key periods of observation include assessments up to 96 weeks to track drug persistence and clinical responses using various disease activity scores and patient-reported outcomes. During the study, participants health and disease activity will be monitored through medical record reviews and various measurements such as clinical response scores, laboratory tests, quality of life questionnaires, and safety events up to week 96. The study team will evaluate multiple outcomes including corticosteroid-free remission, endoscopic improvements, and health-related quality of life changes, all while participants continue their usual medical care. The total participation duration can last up to approximately three years.

A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab