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Recruiting NCT06089590

Ibd CAncer and seRious Infections in France (I-CARE 2)

Trial Parameters

Condition IBD
Sponsor Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study Type OBSERVATIONAL
Phase N/A
Enrollment 6,000
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-01-25
Completion 2031-03-01
Interventions
Non-interventional

Brief Summary

This is a French prospective longitudinal observational multicentre cohort study. Primary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.

Eligibility Criteria

Inclusion Criteria: * Patient with an established diagnosis of Crohn's disease, ulcerative colitis or IBD unclassified based on usual radiological, endoscopic or histological criteria. * Patient aged 18 and older accepting to sign the informed participating consent form, stating that he accepts to provide personal details (mobile and home phone number, e-mail address), to complete the e-PRO as required and to be contacted by a Study Coordinator and his gastroenterologist for the purpose of the study during the entire study period and during follow up if required. Exclusion Criteria: * Patient unable to sign the informed consent form * Patient with no regular access to internet * Patient refusing to sign the informed consent form * Patient enrolled in a Randomized Clinical Trial (If the investigational product received was blinded, and if the treatment is unknown at time of enrolment in I-CARE 2)

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