Observational Study on Safety and Effects of JAK Inhibitors, Anti-IL23p19, and S1P Modulators in Adults with Crohns Disease and Ulcerative Colitis in France

What this Trial Is About

Researchers are conducting a French prospective longitudinal observational multicentre cohort study called I-CARE 2 to monitor patients with Crohns disease CD, ulcerative colitis UC, or unclassified inflammatory bowel disease IBD. The primary goal is to prospectively assess safety concerns such as cancer, serious infections, and arterial or venous thrombotic events in patients treated with specific therapies including JAK inhibitors, anti-IL23p19 agents, and S1P modulators. Secondary objectives include evaluating these safety concerns individually, examining the treatments impact on disease progression and complications, assessing patient-reported outcomes, and analyzing healthcare costs and benefit-risk ratios. This non-interventional study enrolls patients who are starting treatment as part of their standard care. Participants are grouped based on their treatments, which include anti-IL23p19 drugs risankizumab, guselkumab, mirikizumab, brazikumab, JAK inhibitors tofacitinib, upadacitinib, filgotinib, S1P modulators ozanimod, etrasimod, anti-TNF agents infliximab, adalimumab, golimumab, anti-integrins vedolizumab, and anti-IL1223 therapy ustekinumab. Recruitment will last 3 years and 6 months with at least 6,000 patients and 250 investigators involved. Participants will be observed over 4 to 7.5 years with ongoing collection of safety events such as serious adverse events SAEs including cancer and thrombotic events. Data on disease progression, hospitalizations, surgeries, endoscopies, imaging, and patient-reported outcomes will be gathered regularly. The study also tracks the benefit-risk balance and healthcare resource use. Patients will complete electronic patient-reported outcomes ePROs quarterly and provide personal contact details for follow-up throughout the study period and beyond if needed.

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