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

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Status

Enrolling

Conditions

Ulcerative Colitis

IBD

Crohn Disease

Treatments

Other: Non-interventional

Study type

Observational

Funder types

Other

Identifiers

NCT06089590

GETAID-2022-02

Details and patient eligibility

About

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.

Full description

Number of patients : 6 000 at least Participating investigators : 250 at least

Recruitment period : 3 years 6 months

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.

Enrollment

6,000 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)

Trial design

6,000 participants in 6 patient groups

Group Anti-IL23p19

Description:

Patients treated with anti-IL23p19 (risankizumab, guselkumab, mirikizumab, brazikumab)

Treatment:

Other: Non-interventional

Group Jak inhibitors

Description:

Patient treated with Jak inhibitors (tofacitinib, upadacitinib, filgotinib)

Treatment:

Other: Non-interventional

Group S1P Modulators

Description:

Patient treated with S1P modulators (ozanimod, etrasimod)

Treatment:

Other: Non-interventional

Group Anti TNF

Description:

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))

Treatment:

Other: Non-interventional

Group Anti integrins

Description:

Patient treated with anti-integrins (vedolizumab)

Treatment:

Other: Non-interventional

Group Anti IL12/23

Description:

Patient treated with anti-IL12/23 (ustekinumab)

Treatment:

Other: Non-interventional