Real-world Study of Guselkumab Effectiveness in Adults with Moderate-to-Severe Ulcerative Colitis or Crohns Disease in Germany

What this Trial Is About

Researchers are studying people with Crohns Disease and Ulcerative Colitis who are treated with guselkumab in usual care settings to understand how well this treatment works in real life. The study aims to assess clinical effectiveness in the overall group and various subgroups, as well as patient-reported outcomes such as fatigue, quality of life, sexuality, work productivity, activity, and treatment satisfaction. Participants with confirmed moderate-to-severe Crohns Disease or Ulcerative Colitis starting guselkumab treatment as part of their normal care will be included. Data will be collected during routine clinical visits at baseline week 0, and at weeks 4, 8, 12, 24, 48, 72, and 96, based on the first dose of guselkumab. No additional treatments or interventions are assigned by the study it observes real-world treatment use. During the study, participant data including clinical assessments, patient questionnaires, laboratory tests, and reports of adverse events will be gathered. The main outcomes include clinical remission rates at week 48 measured by disease-specific scores, with additional measures up to week 96 covering symptom changes, biomarker levels, quality of life, fatigue, work productivity, sexuality, and treatment satisfaction. Safety data will be collected up to week 108. Participants may be followed for up to about 4 years total.

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