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

Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study ID
NCT06089590
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Non-interventional — OTHER
    This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.

Study Details

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.

Key Dates

First listed
Oct 18, 2023
Start date
Jan 25, 2024
Status verified
Mar 2025
Primary completion
Mar 1, 2031
Completion
Mar 1, 2031

Study Design

Enrollment
6,000 participants (estimated)

Arms

  • Arm: Group Anti-IL23p19
    Patients treated with anti-IL23p19 (risankizumab, guselkumab, mirikizumab, brazikumab)
  • Arm: Group Jak inhibitors
    Patient treated with Jak inhibitors (tofacitinib, upadacitinib, filgotinib)
  • Arm: Group S1P Modulators
    Patient treated with S1P modulators (ozanimod, etrasimod)
  • Arm: 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))
  • Arm: Group Anti integrins
    Patient treated with anti-integrins (vedolizumab)
  • Arm: Group Anti IL12/23
    Patient treated with anti-IL12/23 (ustekinumab)

Primary Outcome Measure

Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events) [ Time Frame: 4 to 7.5 years ]

Central Contacts

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