IBD Cancer and Serious Infection in Europe

Study Overview
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Brief Summary
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The primary objective of I-CARE is to assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients. We will stratify the risk of cancers and serious infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic).

Detailed Description
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The four main secondary objectives of the I-CARE project are: To investigate prospectively the impact of anti-TNF based 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 Patient Reported Outcome (ePRO) on a yearly basis and the impact of anti-TNF agents on ePRO in IBD To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF therapy for IBD To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD 5-ASA and Steroids across Europe At least 5000 IBD patients treated with 5-ASA or Steroids and FU for 3 years use of 5-ASA and efficacy (persistence, switch, mucosal healing etc.) chemoprevention of CRC: first study that will specifically and accurately address this question use of budesonide mmx and efficacy (clinical efficacy, mucosal healing and potential for disease modification) safety of steroids (infections etc) STUDY DESIGN: 22 patients per investigator. Each Investigator will recruit and enrol 20 patients with imposed treatment stratification : Group 1: 5 without previous or ongoing exposure to IS or biologics, (5 ASA and Steroids are allowed) Group 2: 5 with on-going anti-TNF monotherapy Group 3: 5 with thiopurines monotherapy Group 4: 5 with on-going combination therapy Group 5: 2 patients on vedolizumab (on vedolizumab alone and 1 on combination therapy) (optionnal) Group 6: 5 patients treated with ustekinumab with or without any concomitant medications. (optional)

Official Title
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IBD Cancer and Serious Infection in Europe

Conditions
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IBD

Intervention / Treatment
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* Other: Non Interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CD or UC Capable to complete eDiary on a regular basis, and have access to smartphone or internet Accepted to participate and provide personal information (name, phone and email) for contact Accepted to be contacted by study coordinators on a regular basis for follow up with missing information Exclusion Criteria: Unable to sign consent Unable to access internet or use smartphone Refused to sign consent or to provide personal identification information

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| 1<br>without previous or ongoing exposure to IS or biologics, (5ASA and Steroids are allowed) | Other: Non Interventional<br> <br> |
| 2<br>with on-going anti-TNF monotherapy | Other: Non Interventional<br> <br> |
| 3<br>with thiopurines monotherapy | Other: Non Interventional<br> <br> |
| 4<br>with on-going combination therapy | Other: Non Interventional<br> <br> |
| 5<br>patients on vedolizumab (1 on vedolizumab alone and 1 on combination therapy) | Other: Non Interventional<br> <br> |
| 6<br>patients on ustekinumab (alone or on combination therapy) | Other: Non Interventional<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients. | assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease modification | To investigate prospectively the impact of anti-TNF based 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 hospitalisations | 3 Years | 
| ePRO | To assess the evolution of Patient Reported Outcome (ePRO) on a yearly basis and the impact of anti-TNF agents on ePRO in IBD | 3 Years | 
| Benefit-Risk | To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF therapy for IBD | 3 Years | 
| Cost Efficacy | To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD | 3 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, safety, biologic therapies