Ibd CAncer and SeRious Infections in France (I-CARE 2)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 6,000
- Locations
- 2
- Primary Endpoint
- Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
Study Overview
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.
Detailed Description
Number of patients : 6 000 at least Participating investigators : 250 at least
Recruitment period : 3 years 6 months
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.
Secondary objectives :
- To assess the presence and the extent of safety concerns in patients treated with JAKi, anti-IL23p19, and S1p modulators for each outcome of interest separately (cancer, serious infections, arterial thrombotic events, venous thrombotic events)
- To investigate prospectively the impact of JAKi, anti-IL23p19 and S1p modulators strategies on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalizations
- To assess the evolution of ePROs on a trimester basis and the impact of JAKi, anti-IL23p19, and S1p modulators on ePROs in IBD
- To evaluate the benefit-risk ratio of strategies based on a wider use of JAKi, anti-IL23p19, and S1p modulators therapy for IBD
- To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
Time Frame: 4 to 7.5 years
The primary objective of I-CARE 2 is 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. The risk of cancers, serious infections and vascular events will be stratified according to IBD phenotype, disease activity (clinical, radiologic and endoscopic) and main comorbidities at baseline.
Secondary Outcomes
- Treatment impact on IBD natural history(4 to 7.5 years)
- ePRO(4 to 7.5 years)
- Number and duration of hospitalization, surgery, endoscopy and other imaging(4 to 7.5 years)
- Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)(4 to 7.5 years)
- Benefit-risk ratio(4 to 7.5 years)