Overview
The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) treated with Guselkumab in a real-world setting, and to assess the clinical effectiveness (how well the treatment works) in the overall population and in different participant subgroups. Furthermore patient-reported outcomes like fatigue, health-related quality of life (HRQoL), sexuality, work productivity and activity as well as treatment satisfaction will be assessed.
Eligibility
Inclusion Criteria:
- 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
- Signed informed consent form is available, allowing data collection and source data verification in accordance with local requirements
- By judgement of the treating physician, the participant is able and willing to complete the patient-reported outcome(s) (PROs) assessments for the duration of the study
Exclusion Criteria:
- Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy
- Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included
- Has had a colectomy and/or a pouch
- Is currently enrolled in an interventional clinical study or another non-interventional study from Janssen or Johnson & Johnson (J&J)