ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Children starting infliximab for Crohn’s disease could benefit from blood-based biomarkers that predict who will have a durable response, helping personalize treatment and avoid ineffective exposure to biologics.
Who Should Pay Attention
Pediatric Crohn's patients and their caregivers, clinicians who prescribe biologics, researchers studying IBD biomarkers, and teams developing predictive tests for biologic response.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment107 participants
Study statusCompleted
Source depthTrial registry record
What To Know
The study prospectively collected blood at baseline and at scheduled visits (including week 14 and week 54) for RNA and serum banking and ran SOMAscan proteomic assays to discover pretreatment and longitudinal protein biomarkers. Planned analyses include developing predictor models from baseline serum and monitoring changes over the first year of treatment.
The cohort was pediatric (ages 3–20) and allowed concurrent standard IBD therapies; patients on home infusions or with major prior bowel surgery were excluded.
Practical point: These data are aimed at personalized medicine — identifying minimally invasive blood-based tests that could someday help decide which children will have lasting benefit from infliximab and when treatment is failing.
The record is a trial registry entry (completed observational study) and does not in itself report validated clinical tests or clinical outcome results.
Keep In Mind
This is a ClinicalTrials.gov record for a completed observational discovery study using SOMAscan proteomics; registry entries describe study design and planned analyses but do not constitute peer-reviewed results. Any predictive biomarker models would need independent validation and regulatory review before clinical use.
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
SponsorMassachusetts General Hospital
Trial IDNCT04655729
Study typeObservational
Enrollment107 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedOct 28, 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.
Pharmacometric Targets During Anti-TNF Induction and Their Association with Deep Remission in Pediatric Crohn’s Disease
The study identifies specific induction exposure targets and biomarkers tied to higher chances of deep remission at 12 months in children on anti-TNF therapy, which could inform earlier dose optimization to improve...
Circulating microRNAs as biomarkers of disease activity and treatment response in Crohn’s disease patients receiving infliximab or vedolizumab: a longitudinal cohort study
If validated, blood microRNAs could become noninvasive biomarkers to help track inflammation and predict biochemical response to infliximab or vedolizumab in Crohn’s disease, complementing CRP and fecal calprotectin.
Oncostatin M as a key predictive factor for anti-TNF-α response in inflammatory bowel disease
A blood biomarker that predicts anti-TNF response could help people with IBD and their clinicians choose the right biologic sooner, avoiding ineffective treatment. This study reports that lower baseline serum oncostatin...