eligibility_summary
Phase 1: 6–<18 with suspected CD, infections ruled out. Excl: post‑op Dx/likely resection, recent oral CS or investigational Rx, pregnancy, uncontrolled illness, prior IMM/anti‑TNF, recent other biologic, no MRE. Phase 2: Phase 1 completer with ileal/colonic CD on scope/MRE, MRE near scope, initial CS/IMM/5‑ASA/nutrition/ADA/IFX, start ADA/IFX ≤180 d, biopsy criteria. Excl: capsule‑only, isolated oro/UGI/perianal, internal fistulas, other biologics, no MRE/video, poor f/u, recent resection.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05781152 (CAMEO) in newly diagnosed pediatric Crohn’s disease. Intervention: optimized anti-TNF therapy guided by a clinical decision support tool (therapeutic drug monitoring). Drugs: infliximab (chimeric IgG1 monoclonal antibody) and adalimumab (fully human IgG1 monoclonal antibody), including biosimilars. Mechanism: bind soluble and transmembrane TNF-α to block TNFR1/2 signaling, dampening NF-κB–driven proinflammatory cytokines/chemokines, adhesion molecule expression, and leukocyte trafficking, can induce apoptosis of activated TNF-expressing immune cells. Targets: intestinal immune axis—activated T cells (Th1/Th17), monocytes/macrophages, neutrophil-mediated inflammation—and downstream effects on endothelial/epithelial cells and mucosal/transmural inflammation.