Clinical trial · Observational
Ibd CAncer and seRious Infections in France (I-CARE 2)
NCT06089590CI-TRIAL-00087219I-CARE 2recruitingClinicalTrials.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)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Crohn Disease | — | UNRESOLVED | — |
| IBD | — | UNRESOLVED | — |
| Ulcerative Colitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-interventional | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Group Anti-IL23p19
- description
- Patients treated with anti-IL23p19 (risankizumab, guselkumab, mirikizumab, brazikumab)
- interventionNames
- Other: Non-interventional
- label
- Group Jak inhibitors
- description
- Patient treated with Jak inhibitors (tofacitinib, upadacitinib, filgotinib)
- interventionNames
- Other: Non-interventional
- label
- Group S1P Modulators
- description
- Patient treated with S1P modulators (ozanimod, etrasimod)
- interventionNames
- Other: Non-interventional
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.