Cure8 trial brief
This registry will track long-term safety and clinical outcomes in children with IBD, with a focus on infliximab (an anti‑TNF biologic) versus non‑biologic therapies. Long follow-up could help identify uncommon or late adverse events and inform care decisions for pediatric IBD.
Pediatric patients with IBD and their families, pediatric gastroenterologists, clinicians prescribing biologics, and researchers studying long-term safety of IBD therapies.
This is a long-term, multicenter observational registry (20 years) enrolling pediatric patients with Crohn's disease, ulcerative colitis, or indeterminate colitis to collect safety, disease status, quality-of-life, and treatment data.
The registry specifically aims to capture safety outcomes associated with infliximab and other prescribed IBD therapies; some participants may join a substudy measuring blood proteins that can form after infliximab treatment. Treatments are determined by treating physicians as part of routine care; no study drugs are administered by the registry sponsor.
This is an observational post‑marketing registry sponsored by Janssen Biotech that collects data from routine clinical care; it does not assign treatments. Some analyses combine data across related protocols (REMICADE studies). Substudy blood testing and therapeutic‑drug monitoring elements are optional and tied to routine blood draws.
Review the original publication for the complete reporting, methods, and context.
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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