180
Participants
Start Date
July 1, 2023
Primary Completion Date
March 31, 2027
Study Completion Date
March 31, 2027
RoadMAB
The RoadMAB Dashboard is a real-time decision support system that incorporates PK model-informed Bayesian estimation to provide precision dosing at the point of care.
Infliximab
"Conventional dosing. Induction: 5-7.5 mg/kg at 0, 2, and 6 weeks. Maintenance: 5-10 mg/kg at every 4-8 weeks based on results of drug concentration monitoring for a flat target of 5-10 μg/mL.~Precision dosing. Induction: 5-12.5 mg/kg at 0, 2, and 6 weeks to target a week6 concentration of 18-24 μg/mL with dosing support provided by the RoadMABTM clinical decision support tool. Maintenance: 5-15 mg/kg every 4-8 weeks to achieve apriori pharmacokinetic and pharmacodynamic targets (CRP, disease activity scores and fecal calprotectin) with dosing support provided by the RoadMABTM clinical decision support tool."
RECRUITING
Nemours Children's Health System-Wilmington, Wilmington
RECRUITING
Children's Specialty Group, Norfolk
RECRUITING
Nemours Children's Health System-Jacksonville, Jacksonville
RECRUITING
Nationwide Children's Hospital, Columbus
RECRUITING
Cleveland Clinic Children's Hospital, Cleveland
RECRUITING
Cincinnati Children's Hospital, Cincinnati
RECRUITING
Riley Hospital for Children, Indianapolis
RECRUITING
Medical College of Wisconsin, Children's of Wisconsin, Milwaukee
RECRUITING
Children's Hospital of Los Angeles, Los Angeles
RECRUITING
Rady Children's Hospital San Diego, San Diego
RECRUITING
Lucile Packard Children's Hospital Stanford, Palo Alto
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Janssen Scientific Affairs, LLC
INDUSTRY
Children's Hospital Medical Center, Cincinnati
OTHER