eligibility_summary
Adults (>=18) with confirmed IBD (Crohn’s, UC, indeterminate) on IV vedolizumab/infliximab or switched to SC (2–8 wks prospective, >8 wks retrospective), in steroid-free remission >=12 wks (HBI<5 or PMS<2) at switch, able to consent and attend visits. Exclude: diet/med changes, colectomy/ostomy, planned hospitalization/surgery, other interventional trials, poor adherence, contraindicating conditions, or refusal to consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: BIOES is a 24‑month observational cohort evaluating clinical effectiveness and tolerance after switching IBD patients in stable remission from intravenous (IV) to subcutaneous (SC) biologics. Interventions: IV vs SC vedolizumab and infliximab (switch done per clinical practice). Drug types and mechanisms: Infliximab—chimeric IgG1 monoclonal antibody against TNF‑α, neutralizes soluble and transmembrane TNF‑α, can induce apoptosis of activated effector T cells/monocytes and suppress NF‑κB–driven cytokines. Vedolizumab—humanized IgG1 monoclonal antibody against α4β7 integrin, blocks α4β7–MAdCAM‑1 binding, reducing gut‑homing lymphocyte trafficking (gut‑selective). Target cells/pathways: TNF‑α inflammatory pathway in macrophages/monocytes/T cells, α4β7+ CD4+ T lymphocytes mediating gut-specific trafficking. Population: adults with Crohn’s disease/ulcerative colitis in steroid‑free remission.