Cure8 trial brief
This registry will gather real-world safety and effectiveness data on infliximab in Chinese children with moderate-to-severe Crohn's disease, which can help clinicians and families understand how the drug performs outside tightly controlled trials.
Pediatric Crohn's disease patients and their caregivers in China; pediatric gastroenterologists; researchers tracking post-marketing biologic safety and effectiveness.
This is a prospective, multicenter, interventional registry open to children aged 6–17 with moderate to severe active Crohn's disease (PCDAI ≥30).
The study plans to enroll about 30 participants treated with infliximab and follow them for 102 weeks, with a registered primary outcome of clinical response at 14 weeks (PCDAI decrease ≥15 points and total PCDAI ≤30).
The trial excludes patients with contraindications to infliximab, prior biologic anti–TNF use, recent live vaccination, or recent participation in other clinical studies. The study is registered as Phase 4 and recruiting at Beijing Children's Hospital (Capital Medical University).
Because this is a registry/post-marketing study, its aim is to observe real-world safety and effectiveness rather than to establish initial efficacy.
This is a Phase 4, post-marketing registry (recruiting) and does not present study results. Planned enrollment is ~30 children and follow-up is 102 weeks; findings will be observational and may have limited statistical power.
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.
The 5-year PROFILE follow-up is presented as strong evidence that early, effective therapy (in this case infliximab plus an immunomodulator) can change the long-term course of Crohn’s disease by lowering surgery rates...
The study suggests starting anti-TNF therapy with an immunomodulator at diagnosis may reduce surgery, hospital stays, and progression to complicated Crohn’s over 5 years — outcomes that matter to patients and clinicians...
Early “top-down” infliximab plus an immunomodulator was linked to much lower 5-year risk of abdominal surgery, disease progression, and hospitalization versus a step-up approach. This could influence treatment planning...
