eligibility_summary
Eligible: anti-TNF–naïve children 1–15 yrs with Crohn’s per Porto, starting infliximab due to ECCO-ESPGHAN indications (non-response to EEN/steroids/immunomodulators, severe growth delay, extensive or stricturing/penetrating disease, ± perianal), per physician judgment. Exclude: monogenic IBD, UC/IBD-U, active fistulizing/perianal disease, severe comorbidity, urgent surgery, severe/opp infections, TB+, malignancy, pregnancy, prior biologics, steroids/mesalazine or EEN <2 wks pre-IFX.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drug/intervention: Infliximab (IFX), an IV chimeric IgG1 monoclonal antibody biologic targeting tumor necrosis factor-α (TNF-α). Regimen: intensified induction 10 mg/kg at week 0, then 5 mg/kg at weeks 2, 4, and 8, maintenance every 6 weeks from week 12. Mechanism of action: binds soluble and transmembrane TNF-α, blocking TNFR1/2 signaling, thereby suppressing NF-κB–driven inflammation, adhesion molecule expression, and downstream cytokines (e.g., IL‑1, IL‑6), can induce apoptosis of activated T cells/monocytes and promotes mucosal healing. Cells/pathways targeted: TNF‑α pathway in innate and adaptive immune cells (macrophages/monocytes, T cells, dendritic cells) and intestinal endothelium/epithelium, reducing leukocyte recruitment and gut inflammation. Primary goal: achieve week‑12 IFX trough ≥5 µg/mL without treatment escalation, also assess remission, anti-drug antibodies (ATI), and safety.