A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen-Cilag G.m.b.H
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Not listed
Trial groups
500 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov