An observational study in IBD, Ulcerative Colitis and Crohn Disease, sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Recruiting at 2 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Observational
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.
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 :
IBD patients initiating a biologic treatment.
Exclusion Criteria:
Patients treated with anti-IL23p19 (risankizumab, guselkumab, mirikizumab, brazikumab)
Other: Non-interventional
Patient treated with Jak inhibitors (tofacitinib, upadacitinib, filgotinib)
Other: Non-interventional
Patient treated with S1P modulators (ozanimod, etrasimod)
Other: Non-interventional
Patient treated with anti-TNF (infliximab, adalimumab, golimumab) (with a maximal proportion of 25% as 1st first line biologic after conventional treatment (aminosalicylates, corticosteroids, thiopurines, methotrexate))
Other: Non-interventional
Patient treated with anti-integrins (vedolizumab)
Other: Non-interventional
Patient treated with anti-IL12/23 (ustekinumab)
Other: Non-interventional
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
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.
Time frame: 4 to 7.5 years
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
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
Time frame: 4 to 7.5 years
Treatment impact on IBD natural history
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
Time frame: 4 to 7.5 years
ePRO
To assess the evolution of ePROs on a trimester basis and the impact of JAKi, anti-IL23p19, and S1p modulators on ePROs in IBD
Time frame: 4 to 7.5 years
Benefit-risk ratio
To evaluate the benefit-risk ratio of strategies based on a wider use of JAKi, anti-IL23p19, and S1p modulators therapy for IBD
Time frame: 4 to 7.5 years
Number and duration of hospitalization, surgery, endoscopy and other imaging
To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD.
Time frame: 4 to 7.5 years
Plan to share: No
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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives