Ibd CAncer and seRious Infections in France (I-CARE 2)
Recruiting · NCT06089590 · Observational (researchers observe without assigning treatment) · Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
View the official record on ClinicalTrials.gov →Interventions studied
Non-interventional
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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)
Where it is running
4 locations listed.
- CHU Amiens Picardie - Amiens, France
- CHU Amiens Picardie - Amiens, France
- APHP Hôpital Saint Antoine - Paris, France
- APHP Hôpital Saint Antoine - Paris, France