eligibility_summary
Incl: Adults ≥18, moderate–severe CD (CDAI 220–450), ileo/colonic disease meeting SES‑CD+ulcer, FCP ≥250 or CRP ≥0.5, biologic‑naïve, failed/intolerant/contraindicated to conventional therapy, consent. Excl: hypersensitivity, steroids <8 wks, symptomatic strictures, untreated abscess, GI surgery <6 mo or expected, active/untreated TB or LTBI tx <4 wks, HBV/HCV/HIV, NYHA III/IV, active infection, recent cancer/dysplasia, pregnancy/lactation, inadequate contraception 6 mo, investigator decision. Allowed: post‑drainage abscess (≥4–8 wks), cured TB.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Infliximab-dyyb (CT-P13, Remsima)—a chimeric IgG1 anti–TNF-α monoclonal antibody biosimilar—used as subcutaneous (120 mg every 2 weeks) vs intravenous (5 mg/kg or 10 mg/kg every 8 weeks) maintenance with switching between SC and IV. Mechanism of action: Binds soluble and transmembrane TNF-α, blocking TNFR1/2 signaling and downstream NF-κB/MAPK pathways, lowers proinflammatory cytokines (e.g., IL-1, IL-6) and adhesion molecules, can induce apoptosis and Fc-mediated cytotoxicity of TNF-expressing immune cells. Target cells/pathways: TNF-α pathway in intestinal inflammation, activated macrophages/monocytes, Th1/Th17 T cells, dendritic cells, reduces leukocyte recruitment and mucosal inflammation. Aim: assess non-inferiority of SC vs IV for deep remission at week 54 in Crohn’s disease.