Observing Outcomes of Guselkumab Treatment for Adults with Moderate-to-Severe Ulcerative Colitis or Crohns Disease in the UK

What this Trial Is About

Researchers are evaluating the real-world effectiveness of the drug Guselkumab in adults with moderately to severely active Ulcerative Colitis UC or Crohns Disease CD, both types of inflammatory bowel disease affecting the colon and small intestine. The study aims to understand how well Guselkumab works across different treatment histories and patient subgroups. Participants with confirmed moderate-to-severe UC or CD who are prescribed Guselkumab as part of their usual care will be observed. No study drug is provided instead, data from routine clinical practice and medical records will be collected. The study will follow participants for up to 96 weeks to assess treatment outcomes. Participants will have their health status monitored through clinical scores like the Harvey-Bradshaw Index for CD and Partial Mayo Score for UC, along with patient-reported outcomes, lab tests, and quality of life questionnaires. Researchers will track remission rates, corticosteroid-free responses, inflammatory markers, adverse events, and healthcare utilization. The study is led by Janssen-Cilag Ltd. and will continue until March 2029.

A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)