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 range
6 Years – 22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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