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Crohn DiseasePhase 2/3REMODELNCT04974099

Personalized Infliximab Induction Strategy With Model-informed Dosing in Patients With Crohn's Disease

A Phase 2/3 study testing RoadMAB precision dashboard and Infliximab precision dosing in people with Crohn Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 22 years
Conditions the study is for
Crohn Disease
What is being tested?
RoadMAB precision dashboard and Infliximab precision dosing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
1 Oct 2021to 1 Aug 2024
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 22 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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
  • Negative urine pregnancy test for ALL female subjects
  • Negative TB (tuberculosis) blood test

Who cannot join

  • Diagnosis of ulcerative colitis or inflammatory bowel disease-unspecified
  • Prior treatment with infliximab, adalimumab, certolizumab or golimumab (or anti-TNF biosimilar)
  • Active or prior evidence in past 12 months of internal (abdominal/pelvic) penetrating fistula(e)
  • Active intestinal stricture (luminal narrowing with pre-stenotic dilation >3mm), intra-abdominal abscess or perianal abscess
  • Active Clostridium difficile infection or other known bacterial/viral gastroenteritis in last two weeks
  • Current ileostomy, colostomy, ileoanal pouch, and/or previous extensive small bowel resection leading to short bowel syndrome
Show all 14Show fewer
  • History of autoimmune disease (including autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, psoriasis or juvenile idiopathic arthritis)
  • Treatment with another investigational drug within four weeks.
  • Treatment with intravenous antibiotics within four weeks.
  • Planned continuation of 6-mercaptopurine or azathioprine (Imuran) during study.
  • Planned continuation of methotrexate during study.
  • Treatment with intravenous corticosteroids within two weeks.
  • Currently pregnant, breast feeding or plans in next 12 months to become pregnant
  • Inability or failure to provide informed assent/consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

Other trials in United States

About this study

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.

Read the detailed description

This is a Pilot study to evaluate safety, feasibility and efficacy of utilizing pharmacokinetic modeling to provide an individualized infliximab induction regimen in children and young adults with moderate to severe Crohn's disease. This clinical study is designed with the hypothesis that treatment regimens that account for individual (patient) drug clearance (pharmacokinetic modeling) will not only be safe and cost-effective, but also more effective in reducing intestinal inflammation than as-labeled dosing (ALD) regimens.

Conditions
Crohn Disease
Being tested
RoadMAB precision dashboard, Infliximab precision dosing
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RoadMAB precision dashboardDevice

    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 precision dosingDrug

    The trial is testing whether precision dosing can more reliably achieve the targeted trough concentrations compared to standard dosing

Study groups in NCT04974099
Study groupRoleWhat they receive
Interventional arm with precision dosingExperimentalThe intervention includes utilizing Clinical and Patient Decision Support Software (RoadMABTM) that will guide the selection of the first infliximab dose followed by subsequent infliximab dose and dosing interval during the maintenance phase. During induction, three infusions will occur at 0, 2 and 6 weeks, respectively. The RoadMABTM dashboard will utilize PK modeling software to provide an infliximab starting dose recommendation (range of 5-12 mg/kg) based on the patients biochemical profile. As noted, dosing frequency (weeks) during induction will not be altered during this study. Following the first three doses, the clinician will be informed of their patients PK profile within the RoadMABTM program and with a shared document (paper). RoadMABTM will provide additional dosing recommendations after each infusion (based on the latest drug concentration measures and blood biomarkers) with the final dose and interval selected by the treating physician.
Receives: Device: RoadMAB precision dashboard; Drug: Infliximab precision dosing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Obtain Safety Data for Optimal Dosing Strategy and Sample Size Estimation

    Percentage of total patients adverse and/or serious adverse events

    Measured: 10 months

  2. Enrollment Feasibility

    Number of patients consented for 10 month study

    Measured: 10 months

  3. Completion Feasibility

    Percentage of patients that complete the study

    Measured: 10 months

  4. Percentage of Patient Adherence to Stool Sample Collections

    Percentage of patients that collected a stool sample for the study

    Measured: 10 months

  5. RoadMAB Usability

    Evaluate rate of physician adherence to the Dashboard

    Measured: 10 months

  6. RoadMAB Efficacy

    Percentage of patients achieving infus3 (Visit 4) infliximab concentration between >16 μg/ml as a dichotomous outcome

    Measured: weeks 10-16

  7. Percentage of Patient Adherence to Blood Sample Collection

    Percentage of patients who provided blood sample collections.

    Measured: 10 months

Secondary outcomes (13)

  1. Evaluate Accuracy of Infliximab Concentration Targets - Median Difference Infusion 3

    Median difference of infusion 3 (Visit 4) levels between cases and controls

    Measured: Weeks 4-8

  2. Evaluate Accuracy of Infliximab Concentration Targets - Incidence

    Incidence of achieving infus2 (Visit 3) level between target range of >26 μg/ml as a dichotomous outcome

    Measured: Weeks 2-3

  3. Evaluate Accuracy of Infliximab Concentration Targets - Median Difference infus2

    Median difference of infus2 (Visit 3) levels between cases and controls

    Measured: Weeks 2-3

  4. Evaluate Accuracy of Infliximab Concentration Targets - Maintenance

    Percentage of achieving maintenance targets infus4-6 (Visits 5-7) >5 μg/ml

    Measured: week2 10-30

  5. Evaluate Accuracy of Infliximab Concentration Targets

    Rate of development of anti-infliximab antibodies at any infusion between cases and controls

    Measured: 6 months

  6. Infus4 (Visit 5) and infus6 (Visit 7): Clinical Response

    Percent of patients that had an improvement in baseline wPCDAI by >17.5 or a wPCDAI<12.5

    Measured: Weeks 10-30

  7. Infus4 (Visit 5): Clinical Remission

    Percentage of patients who had a wPCDAI <12.5 and off corticosteroids

    Measured: Weeks 10-16

  8. Sustained Remission

    Percentage of patients with a wPCDAI <12.5 and off prednisone for all visits from infus4 (Visit 5) to infus6 (Visit 7)

    Measured: Weeks 10-30

  9. Infus4 (Visit 5): Fecal Biochemical Response

    Percentage of patients with a ≥50% improvement in fecal calprotectin

    Measured: Weeks 10-16

  10. Infus4 (Visit 5): Fecal Biochemical Remission

    Percentage of patients with a fecal calprotectin <250 μg/g

    Measured: Week 10-16

  11. Infus6 (Visit 7): Rate of Transmural Ileal

    ileum subscore stage 0 (score = 0)

    Measured: Weeks 18-30

  12. Infus6 (Visit 7): Rate of Colonic Healing

    all segments of colon subscore stage 0 (score = 0)

    Measured: Weeks 18-30

  13. Infus6 (Visit 7): Rate of Total Bowel Healing

    total ileum and colonic subscore is not greater than stage 0 on either individual score

    Measured: Weeks 10-30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2021
  2. Study start1 Oct 2021
  3. Primary completion1 Aug 2024
  4. Study completion1 Aug 2024

Why it stopped: This was the Pilot study. The larger, confirmatory study has started

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
The intervention cohort includes patients, age 6-22 years old who have been diagnosed with CD, are naïve to anti-TNF medications and are scheduled to start infliximab (or infliximab biosimilar).
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04974099
Sponsor's protocol ID
2020-0282
Acronym
REMODEL
Status last verified
Feb 2026
First submitted
29 Jun 2021
Last updated
11 Mar 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing RoadMAB precision dashboard and Infliximab precision dosing in people with Crohn Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Obtain Safety Data for Optimal Dosing Strategy and Sample Size Estimation (time frame: 10 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04974099.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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