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

Launched by GROUPE D'ETUDE THERAPEUTIQUE DES AFFECTIONS INFLAMMATOIRES DIGESTIVES · Oct 13, 2023

Keywords

ClinConnect Summary

The I-CARE 2 trial is a research study taking place in France that aims to understand the safety concerns related to certain treatments for inflammatory bowel disease (IBD), which includes conditions like Crohn's disease and ulcerative colitis. Specifically, the study will look at the risks of cancer, serious infections, and blood clots in patients receiving specific medications called JAK inhibitors, anti-IL23p19 therapies, and S1P modulators.

To be eligible for this study, participants must be at least 18 years old and have a confirmed diagnosis of Crohn's disease, ulcerative colitis, or an unclassified form of IBD. They also need to be willing to provide personal contact information and actively participate in the study by completing online questionnaires. Participants can expect to be involved for the duration of the study and may be contacted by study coordinators or their doctors for follow-up. It's important to note that individuals who cannot provide consent, do not have regular internet access, or are already participating in another clinical trial may not be eligible. This study is currently recruiting participants, and your involvement could help improve our understanding of treatment safety for IBD.

Gender

ALL

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)