Personalized Infliximab Induction Strategy With Model-informed Dosing in Patients With Crohn's Di… (NCT04974099) | Clinical Trial Compass
TerminatedPhase 2/3
Personalized Infliximab Induction Strategy With Model-informed Dosing in Patients With Crohn's Disease
Stopped: This was the Pilot study. The larger, confirmatory study has started
United States6 participantsStarted 2021-10-01
Plain-language summary
Approximately 3 million people in the United States are living with inflammatory bowel disease, which includes Crohn's Disease, with many of those being young children and adolescents. Physicians need better ways to inform decisions on treatment.
The main reason for this research study is to determine if a computer program that formulates a dose based on a patient's blood testing results can better achieve the optimal drug level as compared to standard dosing.
Who can participate
Age range6 Years – 22 Years
SexALL
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Inclusion criteria
✓. Written informed consent form from the patient (≥18 years old) or from parent/legal guardian if patient is \<18 years old.
✓. Written informed assent form from patient ≥11 years old.
✓. Age criteria: ≥6 years to ≤22 years of age.
✓. Diagnosis of Crohn's Disease
✓. Starting infliximab (or biosimilar)
✓. Anti-TNF naïve (never received infliximab, adalimumab, golimumab, certolizumab or anti-TNF biosimilar)
✓. Fecal calprotectin \>250 µg/g or fecal lactoferrin \>10 µg/g (up to 6 weeks prior to starting infliximab) or endoscopic evidence of active Crohn's disease (up to 90 days prior to starting infliximab)
✓. wPCDAI \>12.5 (up to 6 weeks) prior to the first infliximab infusion
Exclusion criteria
✕. Diagnosis of ulcerative colitis or inflammatory bowel disease-unspecified
What they're measuring
1
Obtain Safety Data for Optimal Dosing Strategy and Sample Size Estimation
Timeframe: 10 months
2
Enrollment Feasibility
Timeframe: 10 months
3
Completion Feasibility
Timeframe: 10 months
4
Percentage of Patient Adherence to Stool Sample Collections
Timeframe: 10 months
5
RoadMAB Usability
Timeframe: 10 months
6
RoadMAB Efficacy
Timeframe: weeks 10-16
7
Percentage of Patient Adherence to Blood Sample Collection
Timeframe: 10 months
Trial details
NCT IDNCT04974099
SponsorChildren's Hospital Medical Center, Cincinnati