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

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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