ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Patients and clinicians often want long-term, real-world safety data for newer IBD drug classes. This large French cohort aims to compare major safety risks and longer-term disease impacts across modern therapies, which could inform future treatment decisions and guideline updates.
Who Should Pay Attention
Clinicians treating IBD, researchers studying IBD drug safety or outcomes, adult patients considering or receiving biologics/JAK inhibitors/S1P modulators, and policymakers interested in health-economics of IBD therapies.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment6,000 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
I-CARE 2 will enroll adults starting real-world treatments and follow them for several years to measure rates of major safety events and to compare outcomes across modern IBD drug classes. It is observational (non-interventional): treatments are given as part of routine care, not assigned by the study.
The registry includes specific drug examples listed by class (anti-IL23p19: risankizumab, guselkumab, mirikizumab, brazikumab; JAK inhibitors: tofacitinib, upadacitinib, filgotinib; S1P modulators: ozanimod, etrasimod; anti-TNF: infliximab, adalimumab, golimumab; anti-integrin: vedolizumab).
The primary endpoints are serious adverse events reported by patients (cancer, serious infections, arterial/venous thrombotic events) over a multi-year follow-up. Enrollment is planned in multiple French centers with electronic patient-reported outcome collection; certain exclusions apply (e.g., inability to consent or lack of internet access).
Keep In Mind
This is an observational, non-randomized registry following routine-care treatment starts; it will measure associations rather than prove causation. The trial record lists planned drug groups and outcomes but does not report results. Follow-up duration is multi-year and enrollment is ongoing.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Trial IDNCT06089590
Study typeObservational
Enrollment6,000 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedNov 6, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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