NCT06089590 Ibd CAncer and seRious Infections in France (I-CARE 2)
| NCT ID | NCT06089590 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
| Condition | IBD |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2024-01-25 |
| Primary Completion | 2031-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,000 participants in total. It began in 2024-01-25 with a primary completion date of 2031-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Julien Kirchgesner
PRINCIPAL INVESTIGATOR
Hôpital Saint Antoine - APHP
Frequently Asked Questions
Who can join the NCT06089590 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying IBD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06089590 currently recruiting?
Yes, NCT06089590 is actively recruiting participants. Contact the research team at mcoisnon@getaid.org for enrollment information.
Where is the NCT06089590 trial being conducted?
This trial is being conducted at Amiens, France, Paris, France.
Who is sponsoring the NCT06089590 clinical trial?
NCT06089590 is sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. The principal investigator is Julien Kirchgesner at Hôpital Saint Antoine - APHP. The trial plans to enroll 6,000 participants.