eligibility_summary
Eligibility: Adults (≥18) with confirmed CD/UC/IBDU in steroid‑free clinical remission and biological remission (CRP<10 mg/L, fecal calprotectin <250 µg/g), on IV infliximab ≥26 weeks with stable regimen ≥20 weeks (avg q8w dose >8–≤22 mg/kg), Dutch/French/English fluent. Exclude: ileorectal/IPAA/ostomy, interventional trial, prior SC infliximab, active perianal fistulas, microscopic colitis.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 4, randomized, open-label study in IBD (Crohn’s disease/ulcerative colitis) switching from optimized IV infliximab to subcutaneous (SC) infliximab. Interventions: 120 mg SC infliximab weekly vs 120 mg SC every 2 weeks, comparator: continue optimized IV infliximab. Drug/mechanism: Infliximab (including SC biosimilar CT‑P13) is a chimeric IgG1 monoclonal antibody (biologic) that binds soluble and transmembrane TNF‑α, blocking TNFR1/TNFR2 signaling, suppressing NF‑κB–mediated pro‑inflammatory cytokines, it can induce apoptosis and CDC/ADCC of TNF‑expressing cells. Targets: TNF‑α pathway, activated T cells (Th1/Th17), monocytes/macrophages, dendritic and endothelial cells in gut mucosa, downstream mediators (e.g., IL‑1, IL‑6), chemokines, and adhesion molecules involved in leukocyte recruitment.