eligibility_summary
Eligible: adults 18–75 with confirmed IBD on stable IV infliximab 5–10 mg/kg q6–8w for ≥16 wks, no IFX side effects, in remission ≥16 wks (CD HBI<4, UC partial Mayo<2) with fecal calprotectin <250 µg/g and CRP<10 mg/L, no systemic steroids in prior 16 wks, stable AZA/6‑MP/TG/MTX ≥12 wks allowed, consent. Exclude: <18, CT‑P13 excipient allergy, active perianal fistula, other autoimmune disease, other mAb, new IFX contraindications, pregnancy/lactation/plans, serious comorbidity/psychiatric risk, deemed unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Switch from intravenous infliximab to subcutaneous CT-P13 (biosimilar infliximab). Drug type: chimeric IgG1 monoclonal antibody (biologic) against tumor necrosis factor-α (TNF-α). Mechanism of action: Binds soluble and transmembrane TNF-α, blocking TNFR1/2 signaling (e.g., NF-κB/MAPK), reducing pro‑inflammatory cytokines and adhesion molecules, and inducing apoptosis of TNF‑expressing activated T cells and macrophages, may mediate ADCC/CDC. Concomitant meds (subset): thiopurines (azathioprine, 6‑MP, thioguanine, purine antimetabolites causing T‑cell apoptosis via Rac1 and impaired DNA synthesis) and methotrexate (antifolate, inhibits DHFR/AICAR-T, increases adenosine, suppresses lymphocyte proliferation). Targets/cells/pathways: TNF‑α pathway, activated T lymphocytes, macrophages/monocytes, dendritic cells, and vascular endothelium in the gut inflammatory cascade in Crohn’s disease and ulcerative colitis.