eligibility_summary
Include: 6–22 yrs, anti‑TNF‑naïve, Crohn’s dx ≤90 d, starting infliximab, luminal ± perianal (treated ≥7 d), active disease by PCDAI/CDAI plus ulcers or FCP>250, CRP>1 or FCP>250, TB negative, consent. Exclude: UC/IBD‑U, prior anti‑TNF, recent penetrating/obstructive disease or planned surgery, active infection or hospitalization, MTX/6‑MP during induction, certain autoimmune disease or malignancy, serious infections/immunodeficiency/CNS demyelination/heart failure, pregnancy/breastfeeding, unable to consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05660746 tests two interventions in pediatric Crohn’s disease: 1) Infliximab (Remicade and biosimilars, chimeric IgG1 monoclonal antibody, anti–TNF-α). Mechanism: binds soluble and membrane TNF-α, blocking TNFR1/2 signaling to dampen NF-κB/MAPK pathways, lowering pro‑inflammatory cytokines and leukocyte trafficking, can induce apoptosis of activated T cells/macrophages and promote mucosal healing. 2) RoadMAB clinical decision support (device) using PK model–informed Bayesian estimation to personalize infliximab dosing to target serum concentrations and PD markers (CRP, fecal calprotectin). Targeted cells/pathways: activated T lymphocytes, macrophages, dendritic cells in gut, TNF-α/TNFR signaling axis and downstream NF‑κB–mediated inflammatory cascade.