ClinicalTrials.gov
Cure8 trial brief
Why This Matters
The study focuses on children newly diagnosed with Crohn's disease who start anti-TNF treatment and aims to identify biological and clinical markers tied to complete intestinal healing after one year; results could help personalize pediatric IBD care.
Who Should Pay Attention
Pediatric patients newly diagnosed with Crohn's disease and their caregivers, pediatric gastroenterologists, and researchers interested in biologic therapy response, biomarkers, and pediatric IBD outcomes.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 4
Enrollment1,270 participants
Study statusActive_not_recruiting
Source depthTrial registry record
What To Know
The study will follow children starting anti-TNF drugs (infliximab or adalimumab) and use colonoscopy and MRE before treatment and at 52 weeks to measure healing of the intestinal lining and wall. Investigators will collect blood, stool, genomic, immune, microbial, and transcriptomic data and use therapeutic drug monitoring (ROADMAB™ CDST) to guide dosing.
The trial is large (planned ~1,270 participants across ~27 North American pediatric centers) and designed to identify clinical, radiologic, genomic, microbial, and immune markers linked to full healing, endoscopic healing, transmural healing, fecal calprotectin normalization, and clinical remission.
If you or a child is newly diagnosed and likely to start anti-TNF therapy soon, this study is aimed at understanding who achieves deep healing and why, which could inform more personalized treatment in the future.
Keep In Mind
This is a registered interventional phase 4 multicenter trial (ACTIVE_NOT_RECRUITING) using optimized anti-TNF therapy guided by a therapeutic-drug-monitoring tool. As a trial record, this describes planned study design and objectives rather than published results.
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
SponsorConnecticut Children's Medical Center
Trial IDNCT05781152
Study typeInterventional
Trial phasePhase 4
Enrollment1,270 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedOct 20, 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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