Generation of Real-world Evidence of Guselkumab in Inflammatory Bowel Disease Evaluating Effectiveness, Early Outcomes and Patient Relevant Aspects

What this Trial Is About

Researchers are evaluating the use of Guselkumab in adults with moderate-to-severe Crohn's Disease (CD) or Ulcerative Colitis (UC) in a real-world setting. This observational study aims to understand how well Guselkumab works in treating these inflammatory bowel diseases and how it affects different groups of patients. Important patient-reported outcomes such as fatigue, quality of life, sexuality, work productivity, activity, and treatment satisfaction will also be assessed. Participants with confirmed moderate-to-severe UC or CD who begin treatment with Guselkumab according to usual clinical practice will be included. Data will be collected during routine clinical visits at several time points: baseline (week 0), and weeks 4, 8, 12, 24, 48, 72, and 96 after starting Guselkumab. The study does not involve administering treatment but observes patients receiving Guselkumab as prescribed by their doctors. During the study, researchers will collect information from clinical records and patient questionnaires to monitor disease activity and response to treatment. They will measure clinical remission using scores specific to CD and UC at week 48, along with various other outcomes up to week 96, such as changes in symptoms, laboratory markers, quality of life, and work productivity. Safety events will be tracked up to week 108. Participants will be followed for up to four years from the start of treatment, with data collected at regular intervals based on routine care.

A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany