NCT06089590

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 6,000 (estimated)
• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• IBD
• Ulcerative Colitis
• Crohn Disease

Interventions

Type	Name	Description
OTHER	Non-interventional	This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.

Timeline

• Start date: 2024-01-25
• Primary completion: 2031-03-01
• Completion: 2031-03-01
• First posted: 2023-10-18
• Last updated: 2025-03-14

Locations

2 sites across 1 country: France