eligibility_summary
Eligibility: Children 6–17 with moderate–severe active Crohn’s (PCDAI ≥30) initiating first infliximab, informed consent required. Exclude: contraindications to infliximab (e.g., severe infection, active TB, malignancy), moderate–severe heart failure, allergy to murine proteins/infliximab, prior/other biologics, planned live vaccines within 3 months or during therapy, participation in other trials within 3 months, or if deemed unsuitable by investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 4, single-arm, multicenter post-marketing registry in China enrolling ~30 pediatric Crohn’s patients (ages 6–17) treated with infliximab and followed for 102 weeks to assess real-world effectiveness and safety. Intervention: Infliximab (CMAB008) — a chimeric IgG1 monoclonal antibody biologic (immunotherapy) targeting TNF-α. Mechanism of action: Binds soluble and transmembrane TNF-α, neutralizing its activity and blocking TNFR1/TNFR2 signaling, downregulates NF-κB–mediated inflammatory cascades (e.g., IL-1, IL-6, adhesion molecules), reduces leukocyte trafficking, and can induce apoptosis of activated immune cells, may engage ADCC/CDC. Cells/pathways targeted: TNF-α/NF-κB pathway, effector T cells (Th1/Th17), macrophages/monocytes, dendritic cells, and intestinal endothelial/epithelial cells implicated in gut inflammation and mucosal injury.