Precise Infliximab Exposure and Pharmacodynamic Control (REMODEL-CD)

April 29, 2026 updated by: Children's Hospital Medical Center, Cincinnati

Precise Infliximab Exposure and Pharmacodynamic Control to Achieve Deep Remission in Pediatric Crohn's Disease

Approximately 3 million people in the United States are living with inflammatory bowel disease, which includes Crohn's Disease (CD). There are limited treatment options approved for use in children and adults with Crohn's disease. Physicians need better ways to inform decisions on treatment.

The main reason for this research study is to determine if a computer program that calculates an individualized dose based on a patient's blood testing results (precision dosing) can better achieve the best possible response to infliximab compared to standard dosing (conventional dosing).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label, cluster randomized clinical trial to test whether precision infliximab dosing with a targeted concentration intervention is superior in achieving deep remission (endoscopic healing and clinical remission) compared to patients receiving conventional infliximab dosing.

With recognition that CD patients who achieve the "target" of deep remission with anti-TNF dose optimizations following pharmacodynamic monitoring had a significant reduction in CD-related adverse events, our central hypothesis is precision dosing with infliximab during induction and maintenance will achieve superior rates of deep remission vs. conventional care (control arm)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital of Los Angeles
        • Contact:
          • Mallory Chavannes
        • Principal Investigator:
          • Mallory Chavannes, MD
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Lucile Packard Children's Hospital Stanford
        • Contact:
          • Alka Goyal
        • Principal Investigator:
          • Alka Goyal, MD
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital San Diego
        • Contact:
          • Laura Bauman
        • Principal Investigator:
          • Laura Bauman, MD
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Nemours Children's Health System-Wilmington
        • Contact:
          • Zarela Molle-Rios
        • Principal Investigator:
          • Zarela Molle-Rios, MD
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Nemours Children's Health System-Jacksonville
        • Contact:
          • Jill Dorsey
        • Principal Investigator:
          • Jill Dorsey, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children
        • Contact:
          • Steven Steiner
        • Principal Investigator:
          • Steven Steiner, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital
        • Contact:
        • Principal Investigator:
          • Phillip Minar, MD, MS
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Cleveland Clinic Children's Hospital
        • Contact:
          • Jacob Kurowski
        • Principal Investigator:
          • Jacob Kurowski, MD
      • Columbus, Ohio, United States, 43205
        • Recruiting
        • Nationwide Children's Hospital
        • Contact:
          • Brendan Boyle
        • Principal Investigator:
          • Brendan Boyle
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Children's Specialty Group
        • Contact:
        • Principal Investigator:
          • Rana Ammoury, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin, Children's of Wisconsin
        • Principal Investigator:
          • Joshua Noe, MD
        • Contact:
          • Joshua Noe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Written informed consent from the patient (≥18 years old) or from parent/legal guardian if patient is <18 years old
  2. Written informed assent from patient when age appropriate
  3. Diagnosis of Crohn's disease within the last 90 days (luminal-only or luminal with a perianal fistula or abscess treated with antibiotics for at least 7 days)
  4. ≥6 years to ≤22 years of age, anti-TNF naïve and starting infliximab

  5. Clinical activity and luminal inflammation, defined by both (1) and (2)

    • (1) PCDAI≥10 (<18 years old) or CDAI ≥150 (≥18 years old) in last 60 days before the decision to start infliximab
    • (2) SES-CD>6, or SES-CD>3 for isolated ileal disease (or a report of large intestinal ulcerations)* within the last 60 days or a fecal calprotectin >250 μg/g within last 75 days prior to screening
  6. C-reactive protein >1.0 mg/dL in last 30 days and/or fecal calprotectin >250 μg/g within last 75 days prior to screening
  7. Negative TB (tuberculosis) interferon-gamma release test and a negative urine pregnancy test for female patients (if menstruation has started)

Exclusion Criteria:

  1. Diagnosis of ulcerative colitis or inflammatory bowel disease-unspecified
  2. Prior use of anti-TNF therapy (infliximab, adalimumab, certolizumab pegol, or golimumab)
  3. Internal (abdominal/pelvic) penetrating fistula(e) in last 180 days
  4. Intra-abdominal abscess/phlegmon/inflammatory mass in the last 180 days
  5. Active perianal abscess (receiving oral antibiotics for <7 days)
  6. Intestinal stricture (luminal narrowing with pre-stenotic dilation >3 cm) and surgery planned in the next 90 days
  7. Have tested positive for Clostridium difficile toxin (stool assay) or other intestinal pathogens within 14 days of screening unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen.
  8. Current hospitalization for complications of severe Crohn's disease
  9. Planned use of methotrexate or 6-mercaptopurine (azathioprine) during the induction (first 3 doses of infliximab) phase
  10. Current ileostomy, colostomy, ileoanal pouch, and/or previous extensive small bowel resection (>35 cm) or any CD surgery planned within the next 90 days
  11. History of autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, or juvenile idiopathic arthritis
  12. Treatment with another investigational drug in the last four weeks
  13. History of malignancy (including lymphoma or leukemia)
  14. Currently receiving treatment for histoplasmosis
  15. History of TB, human immunodeficiency virus (HIV), an immunodeficiency syndrome, a central nervous system demyelinating disease, history of heart failure or receiving intravenous antibiotics in last 14 days for any infection
  16. Currently pregnant, breast feeding or plans to become pregnant in the next 1 year
  17. Inability or failure to provide informed assent/consent
  18. Any developmental disabilities that would impede providing assent/consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional dosing
Induction Phase: 5-7.5 mg/kg at 0, 2, and 6 weeks. Maintenance Phase : 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.
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.

Other Names:
  • Remicade
  • Avsola
  • Inflectra
  • Ixifi
  • Renflexis
Experimental: 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.
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.

Other Names:
  • Remicade
  • Avsola
  • Inflectra
  • Ixifi
  • Renflexis
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Deep Remission
Time Frame: Week 52
Pediatric Crohn's disease activity index (PCDAI) <10 (child) or Crohn's disease activity index<150 (adult), off prednisone/budesonide for >8 weeks and Simple Endoscopic Scorer Crohn's Disease (SES-CD) SES-CD≤2
Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Primary Biologic Nonresponse
Time Frame: Week 16
Failure to improve baseline fecal calprotectin by >100 μg/g (limited to patients with a baseline fecal calprotectin >250 μg/g) or Failure to improve baseline c-reactive protein ≥0.5 mg/dL (limited to patients with a baseline c-reactive protein >1.0 mg/dL)
Week 16
Rate of IBD related event - Fistula
Time Frame: Week 0 - Week 52
Occurrence of fistula and presence of antibody to infliximab >200 ng/mL
Week 0 - Week 52
Rate of IBD related - Hospitalization
Time Frame: Week 0 - Week 52
Occurrence of Crohn's disease related hospitalization
Week 0 - Week 52
Rate of IBD related event - Intestinal stricture
Time Frame: Week 0 - Week 52
Occurrence of Crohn's disease related intestinal stricture
Week 0 - Week 52
Rate of IBD related event - Starting corticosteroids
Time Frame: Week 0 - Week 52
Occurrence of subjects starting a corticosteroid after week20
Week 0 - Week 52
Rate of IBD related event - Antibodies to infliximab
Time Frame: Week 0 - Week 52
Occurrence of antibodies to infliximab defined as >200 ng/mL
Week 0 - Week 52
Rate of Growth Restoration - Weight change
Time Frame: Week 14 - Week 52
In Tanner stage I-III subjects: change in baseline weight (kg) by gender and age group
Week 14 - Week 52
PK of infliximab in pediatric patients
Time Frame: Week 0 - Week 52
Measured infliximab clearance at baseline and at week52
Week 0 - Week 52
Quality of Life & Disability -IMPACT-III score
Time Frame: Week 52
Total IMPACT-III (child) score
Week 52
Quality of Life & Disability - Inflammatory Bowel Disease Disk score
Time Frame: Week 52
Total Inflammatory Bowel Disease Disk (without sexual function assessment) score
Week 52
Quality of Life & Disability - Short Inflammatory Bowel Disease score
Time Frame: Week 52
Total Short IBD Questionnaire (adult) score
Week 52
Process Evaluation -Usability of Decision Support Tool
Time Frame: Week 0 - Week 52
Total System Usability Scale score
Week 0 - Week 52
Rate of Adverse events
Time Frame: Week 0 - Week 52
Number of Adverse Events
Week 0 - Week 52
Rate of Serious Adverse events
Time Frame: Week 0 - Week 52
Number of Serious Adverse Events
Week 0 - Week 52
Rate of Steroid-free Clinical Remission
Time Frame: Week 14 and Week 52
Pediatric Crohn's disease activity index (PCDAI) <10 (child) or Crohn's disease activity index(CDAI)<150 (adult) and off prednisone/budesonide for ≥4 weeks
Week 14 and Week 52
Rate of Clinical Response
Time Frame: Week 14 and Week 52
Decrease from baseline PCDAI of at least 12.5 points & total PCDAI<30 or a PCDAI<10 (child) or a reduction of CDAI>70 from baseline or CDAI<150 (adult)
Week 14 and Week 52
Rate of Primary Clinical Nonresponse
Time Frame: Week 16
On prednisone >16 consecutive weeks from start of infliximab or a PCDAI>30 or CDAI>220 for first four infusions
Week 16
Rate of Sustained Steroid-free Remission
Time Frame: Week 22 - Week 52
PCDAI<10 (child) or CDAI<150 (adult) at dose5 to week52 and off prednisone/budesonide from week 22-52
Week 22 - Week 52
Rate of Steroid-free Remission -biomarker composite
Time Frame: Week 14 and Week 52
PCDAI<10 (child) or CDAI<150 (adult), off prednisone/budesonide for ≥4 weeks, CRP≤0.5 mg/dL and fecal calprotectin <250 μg/g
Week 14 and Week 52
Rate of Endoscopic Healing
Time Frame: Week 52
Simple endoscopic score-Crohn's disease (SES-CD) ≤2
Week 52
Rate of Complete Endoscopic Healing
Time Frame: Week 52
SES-CD=0
Week 52
Rate of Endoscopic Remission
Time Frame: Week 52
SES-CD<4
Week 52
Rate of Mucosal Healing
Time Frame: Week 52
SES-CD≤2 and Ileal Global Histologic Activity Score (GHAS)/ Colon Global Histologic Activity Score (CGHAS) ≤2
Week 52
PK Model Bias
Time Frame: Week 0 - Week 52
Model predicted vs. actual infliximab concentration. Bias: mean predictive error (MPE)
Week 0 - Week 52
PK Model Precision
Time Frame: Week 0 - Week 52
Model predicted vs. actual infliximab concentration. Precision: root mean squared error (RMSE)
Week 0 - Week 52
Rate of IBD related event - Surgery
Time Frame: Week 0 - Week 52
Occurrence of Crohn's disease related surgery
Week 0 - Week 52
Rate of Growth Restoration- Height velocity
Time Frame: Week 14 - Week 52
In Tanner stage I-III subjects: change in height velocity (z-score) by gender
Week 14 - Week 52
Correlation between infliximab induction exposure and endoscopic remission
Time Frame: Exposure Week 0 - Week 14, Efficacy Week 52
The correlation analysis to be performed for the total area under the curve (infliximab exposure, μg*h/mL from week0-week14) and patients achieving endoscopic remission. Endoscopic remission is defined as a SES-CD≤2.
Exposure Week 0 - Week 14, Efficacy Week 52
Correlation between infliximab induction exposure and deep remission
Time Frame: Exposure Week 0 - Week 14, Efficacy Week 52
The correlation analysis to be performed for the total area under the curve (infliximab exposure, μg*h/mL from week0-week14) and patients in deep remission. Deep remission is defined as a PCDAI<10 (child) or CDAI<150 (adult), off prednisone/budesonide for >8 weeks and a SES-CD≤2.
Exposure Week 0 - Week 14, Efficacy Week 52
Patient Reported Outcome-2 (PRO2) Response
Time Frame: Week 6, Week 14, Week 26, Week 52
>50% improvement in total score from baseline
Week 6, Week 14, Week 26, Week 52
Patient Reported Outcome-2 (PRO2) Remission
Time Frame: Week 6, Week 14, Week 26, Week 52
Stool frequency ≤3.0 and abdominal pain ≤1.0 (from baseline)
Week 6, Week 14, Week 26, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital Medical Center, Cincinnati

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Janssen Scientific Affairs, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Phillip Minar, MD,MS, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-0071
  • R01DK132408-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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