Observational study on safety concerns in IBD patients treated with specific therapies in France

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective longitudinal observational multicentre cohort study involving at least 6,000 patients with Crohn's disease and ulcerative colitis across 250 participating centers in France. The primary objective is to assess the safety concerns, including cancer and serious infections, in patients treated with JAK inhibitors, anti-IL23p19, and S1P modulators. Secondary objectives include evaluating the impact of these treatments on the natural history of IBD, healthcare costs, and patient-reported outcomes over a period of 3 years and 6 months.

Why it matters

Who can join: the full rules

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's running

• CHU Amiens Picardie
  Amiens, France Recruiting
• APHP Hôpital Saint Antoine
  Paris, France Recruiting

Study contacts

• Principal investigator: Julien Kirchgesner — Hôpital Saint Antoine - APHP
• Study coordinator: Marie Coisnon
• Email: mcoisnon@getaid.org
• Phone: 09 72 57 61 60

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.