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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Amiens Picardie
RECRUITING
Amiens
APHP Hôpital Saint Antoine
RECRUITING
Paris
Contact Information
Primary
Marie Coisnon
mcoisnon@getaid.org
09 72 57 61 60
Backup
Charlotte Mailhat
cmailhat@getaid.org
09 72 57 61 60
Time Frame
Start Date: 2024-01-25
Estimated Completion Date: 2031-03-01
Participants
Target number of participants: 6000
Treatments
Group Anti-IL23p19
Patients treated with anti-IL23p19 (risankizumab, guselkumab, mirikizumab, brazikumab)
Group Jak inhibitors
Patient treated with Jak inhibitors (tofacitinib, upadacitinib, filgotinib)
Group S1P Modulators
Patient treated with S1P modulators (ozanimod, etrasimod)
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))
Group Anti integrins
Patient treated with anti-integrins (vedolizumab)
Group Anti IL12/23
Patient treated with anti-IL12/23 (ustekinumab)
Sponsors
Collaborators: Sanoia
Leads: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

This content was sourced from clinicaltrials.gov