This is a European prospective longitudinal observational multicenter cohort study.
The primary objective of I-CARE is to assess prospectively the presence and the extent of safety concerns (cancers (especially lymphoma) and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.
Main inclusion criteria
– Patient with an established diagnosis of Crohn’s disease, ulcerative colitis or IBD-unclassified, made at least 3 months earlier based on usual radiological, endoscopic or histological criteria.
Study duration 4 years; one year inclusion period and three-year follow-up period.
Number of patients needed: 17.000
Patient need to complete an e-Diary on a monthly basis and ePRO questionnaires once a year.