Ibd CAncer and seRious Infections in France (I-CARE 2)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives
About this trial
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
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Non-interventional
Treatment groups
6,000 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov