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

NCT04974099 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 2020-0282
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (7)

• Obtain Safety Data for Optimal Dosing Strategy and Sample Size Estimation

  Percentage of total patients adverse and/or serious adverse events

  10 months

• Enrollment Feasibility

  Number of patients consented for 10 month study

  10 months

• Completion Feasibility

  Percentage of patients that complete the study

  10 months

• Percentage of Patient Adherence to Stool Sample Collections

  Percentage of patients that collected a stool sample for the study

  10 months

• RoadMAB Usability

  Evaluate rate of physician adherence to the Dashboard

  10 months

• RoadMAB Efficacy

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

  weeks 10-16

• Percentage of Patient Adherence to Blood Sample Collection

  Percentage of patients who provided blood sample collections.

  10 months

Secondary Outcomes (13)

• Evaluate Accuracy of Infliximab Concentration Targets - Median Difference Infusion 3

  Weeks 4-8

• Evaluate Accuracy of Infliximab Concentration Targets - Incidence

  Weeks 2-3

• Evaluate Accuracy of Infliximab Concentration Targets - Median Difference infus2

  Weeks 2-3

• Evaluate Accuracy of Infliximab Concentration Targets - Maintenance

  week2 10-30

• Evaluate Accuracy of Infliximab Concentration Targets

  6 months

Study Arms (1)

Interventional arm with precision dosing

EXPERIMENTAL

The 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.

Device: RoadMAB precision dashboard; Drug: Infliximab precision dosing

Interventions

RoadMAB precision dashboard DEVICE

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.

Interventional arm with precision dosing

Infliximab precision dosing DRUG

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

Interventional arm with precision dosing

Eligibility Criteria

• Age: 6 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Negative urine pregnancy test for ALL female subjects
• Negative TB (tuberculosis) blood test

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Crohn's and Colitis Foundation: collaborator
• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Limitations and Caveats

Limitations of the trial. This was the pilot study. The larger, confirmatory clinical trial (REMODEL-CD, NCT05660746) has started and is ongoing.

Results Point of Contact

• Title: Phillip Minar, MD, MS
• Organization: Cincinnati Children's Hospital Medical Center

phillip.minar@cchmc.org

5136364415

Study Officials

• Phillip Minar, MD, MS

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 23, 2021
• Study Start: October 1, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)