IBD Cancer and Serious Infection in Europe

Completed

• Conditions: IBD
• Interventions: Other: Non Interventional

• Registration Number: NCT02377258
• Lead Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Brief Summary

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

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)

Study Timeline

• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-03-03
• Study Start: 2016-03-04
• Primary Completion: 2022-05-16
• Study Completion: 2022-05-16
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13262

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	Non Interventional	with on-going anti-TNF monotherapy
4	Non Interventional	with on-going combination therapy
3	Non Interventional	with thiopurines monotherapy
5	Non Interventional	patients on vedolizumab (1 on vedolizumab alone and 1 on combination therapy)
6	Non Interventional	patients on ustekinumab (alone or on combination therapy)
1	Non Interventional	without previous or ongoing exposure to IS or biologics, (5ASA and Steroids are allowed)

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chu Nancy; 🇫🇷 Vandoeuvre Les Nancy, France