NCT06089590Recruiting
Ibd CAncer and seRious Infections in France (I-CARE 2)
Source: ClinicalTrials.gov · Last updated 14 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 6000 (estimated)
- First submitted
- 11 Sept 2023
- Start date
- 25 Jan 2024
- Primary completion date
- 1 Mar 2031
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06089590
What you commit to
- Study type: Observational
- Planned participants: 6000
- From 25 Jan 2024 to the primary completion date, 1 Mar 2031
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other
- Patient unable to sign the informed consent form
- Patient with no regular access to internet
- Patient refusing to sign the informed consent form
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Amiens Picardie Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| APHP - Hôpital Saint Antoine Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.