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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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IBD, Ulcerative Colitis, Crohn Disease

Intervention / Treatment
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* Other: Non-interventional


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group Anti-IL23p19<br>Patients treated with anti-IL23p19 (risankizumab, guselkumab, mirikizumab, brazikumab) | Other: Non-interventional<br>* This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.<br>|
| Group Jak inhibitors<br>Patient treated with Jak inhibitors (tofacitinib, upadacitinib, filgotinib) | Other: Non-interventional<br>* This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.<br>|
| Group S1P Modulators<br>Patient treated with S1P modulators (ozanimod, etrasimod) | Other: Non-interventional<br>* This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.<br>|
| Group Anti TNF<br>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<br>* This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.<br>|
| Group Anti integrins<br>Patient treated with anti-integrins (vedolizumab) | Other: Non-interventional<br>* This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.<br>|
| Group Anti IL12/23<br>Patient treated with anti-IL12/23 (ustekinumab) | Other: Non-interventional<br>* This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 to 7.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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. | 4 to 7.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UC, CD