Clinical trial · Observational
IBD Cancer and Serious Infection in Europe
NCT02377258CI-TRIAL-00060073I-CAREcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of I-CARE is to assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients. We will stratify the risk of cancers and serious infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| IBD | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non Interventional | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- 1
- description
- without previous or ongoing exposure to IS or biologics, (5ASA and Steroids are allowed)
- interventionNames
- Other: Non Interventional
- label
- 2
- description
- with on-going anti-TNF monotherapy
- interventionNames
- Other: Non Interventional
- label
- 3
- description
- with thiopurines monotherapy
- interventionNames
- Other: Non Interventional
- label
- 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * CD or UC * Capable to complete eDiary on a regular basis, and have access to smartphone or internet * Accepted to participate and provide personal information (name, phone and email) for contact * Accepted to be contacted by study coordinators on a regular basis for follow up with missing information Exclusion Criteria: * Unable to sign consent * Unable to access internet or use smartphone * Refused to sign consent or to provide personal identification information
References
Publications (3)
- DERIVEDKirchgesner J, Beaugerie L, Baumann C, Baert F, Rahier JF, Bergemalm D, Canete F, Caron B, Cossignani M, Dias S, Farkas K, Girod P, Goren I, Holvoet T, Krasz S, Kumar A, Rimmer P, Sheridan J, Thut J, Uzzan M, Viazis N, Weimers P, Zagorowicz E, Buisson A, Avedano L, Rousseau H, Peyrin-Biroulet L, Sebastian S; I-CARE Collaborator Group. Building a Robust Investigator-Initiated Platform: The I-CARE Experience. Clin Pharmacol Ther. 2026 Jun;119(6):1537-1546. doi: 10.1002/cpt.70231. Epub 2026 Feb 15. PMID 41693257
- DERIVEDPeyrin-Biroulet L, Nazar M, Sheahan A, Geldhof A, Azzabi A, Baert F, Mailhat C, Rousseau H, Rahier JF, Beaugerie L. Long-term safety of ustekinumab in Crohn's disease: Descriptive analysis from an observational post-authorisation safety study using I-CARE cohort data. Dig Liver Dis. 2026 Jan;58(1):74-81. doi: 10.1016/j.dld.2025.09.026. Epub 2025 Oct 25. PMID 41139534
- DERIVEDPeyrin-Biroulet L, Rahier JF, Kirchgesner J, Abitbol V, Shaji S, Armuzzi A, Karmiris K, Gisbert JP, Bossuyt P, Helwig U, Burisch J, Yanai H, Doherty GA, Magro F, Molnar T, Lowenberg M, Halfvarson J, Zagorowicz E, Rousseau H, Baumann C, Baert F, Beaugerie L; I-CARE Collaborator Group. I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2023 Mar;21(3):771-788.e10. doi: 10.1016/j.cgh.2022.09.018. Epub 2022 Sep 22. PMID 36152897