Summary

Eligibility
for people ages 6-17 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Sofia Verstraete, MD, MAS
Headshot of Sofia Verstraete
Sofia Verstraete

Description

Summary

Details

Study Sites: Approximately 27 pediatric clinical centers in North America Study Period: Planned enrollment period - 3 years Planned duration of the study: 5 years Primary Study Objective: Identify clinical, radiologic, genomic, immune, microbial and transcriptomic factors associated with complete intestinal healing (CH) in the context of optimized anti-TNF therapy in children with newly diagnosed CD Secondary Study Objective: Identify clinical, radiologic, genomic, immune, microbial and transcriptomic factors associated with endoscopic healing only, transmural healing by MRE only, endoscopic response only, transmural response only, clinical remission, fecal calprotectin normalization, in the context of optimized anti-TNF therapy in children with newly diagnosed CD Study Design: Prospective multicenter open label single arm clinical trial with 2-phase enrollment Sample Size: Phase 1: 900; Phase 2: 550

Keywords

Crohn Disease, children, pediatric, anti-TNF therapy, therapeutic drug monitoring, intestinal microbiome, inflammatory bowel disease, gene expression, genomic DNA, Infliximab, Anti-tumor necrosis factor (TNF)

Eligibility

Locations

  • UCSF Benioff Children's Hospitals accepting new patients
    San Francisco California 94158 United States
  • Cedars-Sinai accepting new patients
    Los Angeles California 90048 United States

Lead Scientist at UCSF

  • Sofia Verstraete, MD, MAS
    Associate Professor, Pediatrics, School of Medicine. Authored (or co-authored) 29 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Connecticut Children's Medical Center
Links
CAMEO Study Website
ID
NCT05781152
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 900 study participants
Last Updated