IBD Cancer and Serious Infection in Europe (I-CARE)

August 2, 2022 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

13262

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre Les Nancy, France, 54500
        • Chu Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

17600 patients in 17 European countries, enrolled by 800 investigators (22 subjects per investigator)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

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.
Time Frame: 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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease modification
Time Frame: 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
3 Years
ePRO
Time Frame: 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
3 Years
Benefit-Risk
Time Frame: 3 Years
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
Time Frame: 3 Years
To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Investigators

  • Principal Investigator: Laurent Peyrin-Biroulet, MD, PhD, Head of IBD Unit Inserm U954 Nancy University Hospital FRANCE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2016

Primary Completion (Actual)

May 16, 2022

Study Completion (Actual)

May 16, 2022

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

February 26, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETAID 2015-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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