Ibd CAncer and seRious Infections in France (I-CARE 2)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
IBD patients initiating a biologic treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-interventional
Other interventionThis study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.
Treatment groups
6,000 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Group Anti-IL23p191 intervention
Group B: Group Jak inhibitors1 intervention
Group C: Group S1P Modulators1 intervention
Group D: Group Anti TNF1 intervention
Group E: Group Anti integrins1 intervention
Group F: Group Anti IL12/231 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
4 to 7.5 yearsSecondary outcomes
1
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
Time frame
4 to 7.5 years2
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
Time frame
4 to 7.5 years3
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
Time frame
4 to 7.5 years4
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
Time frame
4 to 7.5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov