RecruitingNCT06089590

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

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Enrollment

6,000 participants

Start Date

Jan 25, 2024

Study Type

OBSERVATIONAL

Conditions

Crohn Disease Ulcerative Colitis IBD

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

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 Criteria4

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)