Precise Infliximab Exposure and Pharmacodynamic Control

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

July 1, 2023

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2027

Conditions
Crohn Disease
Interventions
DEVICE

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.

DRUG

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."

Trial Locations (11)

19803

RECRUITING

Nemours Children's Health System-Wilmington, Wilmington

23507

RECRUITING

Children's Specialty Group, Norfolk

32207

RECRUITING

Nemours Children's Health System-Jacksonville, Jacksonville

43205

RECRUITING

Nationwide Children's Hospital, Columbus

44106

RECRUITING

Cleveland Clinic Children's Hospital, Cleveland

45229

RECRUITING

Cincinnati Children's Hospital, Cincinnati

46202

RECRUITING

Riley Hospital for Children, Indianapolis

53226

RECRUITING

Medical College of Wisconsin, Children's of Wisconsin, Milwaukee

90027

RECRUITING

Children's Hospital of Los Angeles, Los Angeles

92123

RECRUITING

Rady Children's Hospital San Diego, San Diego

94304

RECRUITING

Lucile Packard Children's Hospital Stanford, Palo Alto

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

lead

Children's Hospital Medical Center, Cincinnati

OTHER