eligibility_summary
Eligibility: Adults (≥18) with Crohn’s disease per Beijing 2018, CDAI 220–450, meeting infliximab (IFX) indications, able to consent. Exclude: NUDT15 CT/TT, prior IFX/anti-TNF, pregnancy/breastfeeding within 12 months, intolerance/contraindication to immunosuppressants, serious comorbidities, active infections (e.g., TB), malignancy (e.g., lymphoma, GI), significant labs/conditions per investigator, inability/refusal to follow protocol.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Infliximab (anti‑TNF‑α chimeric monoclonal antibody, IgG1) monotherapy vs infliximab + azathioprine (purine antimetabolite immunosuppressant, 6‑mercaptopurine prodrug). Mechanisms: Infliximab neutralizes soluble/transmembrane TNF‑α, blocking TNFR→NF‑κB signaling and inflammatory cytokine/adhesion cascades, can induce apoptosis of activated T cells/macrophages and dampen Th1/Th17‑driven gut inflammation. Azathioprine inhibits de novo purine synthesis, suppressing proliferating T and B lymphocytes and reducing anti‑drug antibody (ADA) formation to lower anti‑TNF immunogenicity. Targets/cells: TNF‑α/TNFR pathway in intestinal immune cells (T cells, macrophages, dendritic cells) and B‑cell–mediated ADA responses. Trial evaluates how HLADQA105 genotype (linked to higher anti‑TNF immunogenicity) affects efficacy of infliximab ± azathioprine in Chinese Crohn’s disease.