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

ClinicalTrials.gov ID

NCT06089590

Lead Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

6,000Estimated

Last Update Posted

Mar 14, 2025Actual

Start Date

Jan 25, 2024Actual

Primary Completion Date

Mar 1, 2031Estimated

Completion Date

Mar 1, 2031Estimated

Official Title

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

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.

• IBD
• Ulcerative Colitis
• Crohn Disease

• Non-interventional

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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)

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesOTHER

Collaborators

SanoiaOTHER

julien.kirchgesner@aphp.fr

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