eligibility_summary
Eligible: Patients with Crohn’s disease or ulcerative colitis confirmed per European criteria, starting infliximab (originator or biosimilar), with or without concomitant immunosuppressants/steroids, who consent. Exclude: Not eligible for infliximab per standard screening, prior infliximab exposure, participation in another interventional study, or no French health insurance coverage.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05722353 studies subcutaneous infliximab CT-P13 (Remsima SC) in infliximab-naïve IBD (Crohn’s/UC). Drug/intervention: CT-P13 is a biosimilar chimeric IgG1 monoclonal antibody (anti–TNF-α). Regimen: IV induction (Day 1, Week 2) then switch to SC at Week 6, every 2 weeks to Week 48, blood/stool biocollection for biomarkers and outcomes. Mechanism of action: high-affinity binding to soluble and transmembrane TNF-α, blocking TNFR1/TNFR2 signaling, induces apoptosis and immune clearance of TNF-expressing cells via ADCC/CDC, suppresses NF-κB–mediated inflammation, reduces proinflammatory cytokines (e.g., IL-1, IL-6) and leukocyte trafficking. Cells/pathways targeted: TNF-α axis in intestinal mucosal immunity—activated T cells (Th1/Th17), monocytes/macrophages, dendritic cells, and endothelial activation.