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

March 12, 2025 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

6000

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80000
      • Paris, France, 75012

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

IBD patients initiating a biologic treatment.

Description

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)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
Time Frame: 4 to 7.5 years

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)
Time Frame: 4 to 7.5 years

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
Time Frame: 4 to 7.5 years
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
Time Frame: 4 to 7.5 years
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
Time Frame: 4 to 7.5 years
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
Time Frame: 4 to 7.5 years
To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD.
4 to 7.5 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

Collaborators

Sanoia

Investigators

  • Principal Investigator: Julien Kirchgesner, Hôpital Saint Antoine - APHP
  • Principal Investigator: Mathurin Fumery, CHU Amiens-Picardie

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)

January 25, 2024

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETAID-2022-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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