IBDI-CARE 2NCT06089590
Ibd CAncer and seRious Infections in France (I-CARE 2)
An observational study of IBD and Ulcerative Colitis, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IBD, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Non-interventional
- How many people
- 6,000 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Jan 2024to 1 Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: IBD patients initiating a biologic treatment.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, 80000
Mathurin FUMERY, PHD, Fumery.Mathurin@chu-amiens.fr
Mathurin FUMERY, PHD
- Recruiting
APHP Hôpital Saint Antoine
Paris, 75012
Julien Kirchgesner, julien.kirchgesner@aphp.fr
Julien Kirchgesner
About this study
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.
Read the 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.
- Conditions
- IBD, Ulcerative Colitis, Crohn Disease
- Being tested
- Non-interventional
- Keywords
- UC, CD
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.
| Study group | Role | What they receive |
|---|---|---|
| Group Anti-IL23p19 | Patients treated with anti-IL23p19 (risankizumab, guselkumab, mirikizumab, brazikumab) Receives: Other: Non-interventional | |
| Group Jak inhibitors | Patient treated with Jak inhibitors (tofacitinib, upadacitinib, filgotinib) Receives: Other: Non-interventional | |
| Group S1P Modulators | Patient treated with S1P modulators (ozanimod, etrasimod) Receives: Other: Non-interventional | |
| 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)) Receives: Other: Non-interventional | |
| Group Anti integrins | Patient treated with anti-integrins (vedolizumab) Receives: Other: Non-interventional | |
| Group Anti IL12/23 | Patient treated with anti-IL12/23 (ustekinumab) Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 to 7.5 years
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 4 to 7.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start25 Jan 2024
- Primary completion1 Mar 2031 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Collaborators
- Sanoia
- Responsible party
- Sponsor
- Investigators
- Julien Kirchgesner, Principal investigator, Hôpital Saint Antoine - APHPMathurin Fumery, Principal investigator, CHU Amiens-Picardie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089590
- Sponsor's protocol ID
- GETAID-2022-02
- Acronym
- I-CARE 2
- Status last verified
- Nov 2026
- First submitted
- 11 Sep 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibd CAncer and seRious Infections in France (I-CARE 2)
- ClinicalTrials.gov ID
- NCT06089590
- Acronym / sponsor ID
- I-CARE 2 / GETAID-2022-02
- Conditions
- IBD, Ulcerative Colitis, Crohn Disease
- Keywords
- UC, CD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Collaborators
- Sanoia
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 1 Mar 2031 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group Anti-IL23p19 | – | Other: Non-interventionalPatients treated with anti-IL23p19 (risankizumab, guselkumab, mirikizumab, brazikumab) |
| Group Jak inhibitors | – | Other: Non-interventionalPatient treated with Jak inhibitors (tofacitinib, upadacitinib, filgotinib) |
| Group S1P Modulators | – | Other: Non-interventionalPatient treated with S1P modulators (ozanimod, etrasimod) |
| Group Anti TNF | – | Other: Non-interventionalPatient 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)) |
| Group Anti integrins | – | Other: Non-interventionalPatient treated with anti-integrins (vedolizumab) |
| Group Anti IL12/23 | – | Other: Non-interventionalPatient treated with anti-IL12/23 (ustekinumab) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- IBD patients initiating a biologic treatment.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalThis study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures. | Other | Group Anti IL12/23, Group Anti TNF, Group Anti integrins, Group Anti-IL23p19, Group Jak inhibitors, Group S1P Modulators |
Primary outcome
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.
5 secondary outcomes
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
Time frame: 4 to 7.5 years
Treatment impact on IBD natural history
Time frame: 4 to 7.5 years
ePRO
Time frame: 4 to 7.5 years
Benefit-risk ratio
Time frame: 4 to 7.5 years
Number and duration of hospitalization, surgery, endoscopy and other imaging
Time frame: 4 to 7.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julien Kirchgesner principal investigator
Hôpital Saint Antoine - APHP
Mathurin Fumery principal investigator
CHU Amiens-Picardie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD and Ulcerative Colitis, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Coisnon (09 72 57 61 60, mcoisnon@getaid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events) (time frame: 4 to 7.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.