eligibility_summary
Inclusion: 19–80, confirmed perianal fistulizing Crohn’s, biologic/IND‑naive, ≥1 draining fistula, failed ≥2 standard therapies, women use contraception during and 6 mo after. Exclusion: no consent, recent/planned bowel surgery, stoma, short bowel, strictures/abscess, non‑perianal fistulas, mAb allergy, steroid‑dependent unless ≤20 mg pred with taper, active/untreated latent TB, HBV/HCV/HIV/C. difficile, severe heart disease, demyelination, recent cancer/infection, transplant, pregnant/lactating, non‑Korean, investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06051253 tests two dosing strategies of infliximab (CT‑P13, Remsima), a chimeric IgG1 monoclonal antibody biologic that neutralizes soluble and transmembrane TNF‑α. Arms: (1) TDM-based IV therapy (5 mg/kg induction at weeks 0,2,6, weeks 14–46 dose escalated to 10 mg/kg if trough <10 μg/mL) vs (2) standard fixed 5 mg/kg IV dosing on the same schedule without TDM-guided adjustments. Mechanism of action: anti‑TNF binds TNF‑α to block TNFR1/2 signaling, reducing downstream NF‑κB/MAPK activation, pro‑inflammatory cytokines (e.g., IL‑1, IL‑6), adhesion molecule expression, and leukocyte trafficking, can induce apoptosis/ADCC of TNF‑expressing cells. Targeted cells/pathways: TNF‑α pathway in activated T lymphocytes, macrophages/monocytes, dendritic cells, neutrophils, and vascular endothelium within inflamed perianal Crohn’s lesions.