Observational study on safety concerns in IBD patients treated with specific therapies in France
Ibd CAncer and seRious Infections in France (I-CARE 2)
This study is trying to see if certain treatments for Crohn's disease and ulcerative colitis are safe and if they affect patients' health and costs over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives Academic / other |
| Locations | 2 sites (Amiens and 1 other locations) |
| Trial ID | NCT06089590 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of Crohn's disease or ulcerative colitis.
Not a fit: Patients unable to provide informed consent or without regular internet access may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety and efficacy of new treatment strategies for IBD patients.
How similar studies have performed: While this study builds on existing knowledge, it focuses on a specific cohort and treatment strategies, making it a novel approach in the context of IBD safety assessments.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Amiens and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.