Clinical trial NCT06089590: Ibd CAncer and seRious Infections in France (I-CARE 2)
Official title: Ibd CAncer and seRious Infections in France (I-CARE 2)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IBD
Ulcerative Colitis
Crohn Disease
Keywords: UC
CD
Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor class: OTHER
Collaborators: name: Sanoia
First posted: 2023-10-18
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IBD patients initiating a biologic treatment.

Brief 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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
timeFrame: 4 to 7.5 years
Secondary outcomes:
measure: Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
timeFrame: 4 to 7.5 years
measure: Treatment impact on IBD natural history
timeFrame: 4 to 7.5 years
measure: ePRO
timeFrame: 4 to 7.5 years
measure: Benefit-risk ratio
timeFrame: 4 to 7.5 years
measure: Number and duration of hospitalization, surgery, endoscopy and other imaging
timeFrame: 4 to 7.5 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Paris
country: France
facility: APHP Hôpital Saint Antoine
Study officials:
affiliation: Hôpital Saint Antoine - APHP
name: Julien Kirchgesner
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens-Picardie
name: Mathurin Fumery
role: PRINCIPAL_INVESTIGATOR
References: