eligibility_summary
Adults ≥18 with ECCO-defined moderate–severe UC/CD ≥3 months, inadequate response to standard therapy, objective active disease, starting infliximab CT‑P13, CD anal suppuration allowed. Consent and social security required. WOCBP must use approved contraception to 6 months post-dose, non‑childbearing per surgical menopause/postmenopause criteria. Exclude: combo immunomodulators (except with anal suppuration), infliximab/protein allergy, HBV/HCV/HIV, significant/recent infections or positive TB test, NYHA III–IV HF, pregnant/breastfeeding/minors/legally protected/incarcerated/under psychiatric care.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06274294 (PASSPORT): Phase 3 in adults with active Crohn’s disease or ulcerative colitis initiating infliximab. Interventions: CT-P13 (infliximab biosimilar) given as subcutaneous-only induction (fixed dose) vs standard intravenous induction (weight-based), then both switch to subcutaneous every 2 weeks through week 24. Primary aim: non-inferior pharmacokinetics at week 6. Drug/mechanism: CT-P13 is a biologic, chimeric IgG1 monoclonal antibody TNF-alpha inhibitor. It neutralizes soluble and transmembrane TNF-alpha, blocks TNFR1/TNFR2 signaling, can mediate ADCC/CDC and apoptosis of TNF-expressing immune cells, and downregulates NF-kB–driven cytokines, chemokines, and adhesion molecules. Target cells/pathways: activated T cells, monocytes/macrophages, dendritic cells, and gut endothelial/epithelial cells, TNF-alpha/NF-kB inflammatory cascade and leukocyte recruitment.