Actively Recruiting
Ibd CAncer and seRious Infections in France (I-CARE 2)
Led by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Updated on 2025-03-14
6000
Participants Needed
2
Research Sites
370 weeks
Total Duration
On this page
Sponsors
G
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Lead Sponsor
S
Sanoia
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Ibd CAncer and seRious Infections in France (I-CARE 2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
CHU Amiens Picardie
Amiens, France, 80000
Actively Recruiting
2
APHP Hôpital Saint Antoine
Paris, France, 75012
Actively Recruiting
Research Team
M
Marie Coisnon
CONTACT
C
Charlotte Mailhat
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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