NCT05660746

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
11mo left

Started Jul 2023

Typical duration for phase_2

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jul 2023Mar 2027

First Submitted

Initial submission to the registry

November 29, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

November 29, 2022

Last Update Submit

April 29, 2026

Conditions

Crohn Disease

Keywords

Crohn's

Outcome Measures

Primary Outcomes (1)

  • Rate of Deep Remission

    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 Outcomes (31)

  • Rate of Steroid-free Clinical Remission

    Week 14 and Week 52

  • Rate of Clinical Response

    Week 14 and Week 52

  • Rate of Primary Clinical Nonresponse

    Week 16

  • Rate of Primary Biologic Nonresponse

    Week 16

  • Rate of Sustained Steroid-free Remission

    Week 22 - Week 52

  • +26 more secondary outcomes

Study Arms (2)

Conventional dosing

ACTIVE COMPARATOR

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

Precision dosing

EXPERIMENTAL

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.

Device: RoadMABDrug: Infliximab

Interventions

RoadMABDEVICE

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.

Precision dosing
InfliximabDRUG

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.

Also known as: Avsola, Inflectra, Ixifi, Remicade, Renflexis
Conventional dosingPrecision dosing

Eligibility Criteria

Age6 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Written informed consent from the patient (≥18 years old) or from parent/legal guardian if patient is \<18 years old
  • Written informed assent from patient when age appropriate
  • 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)
  • ≥6 years to ≤22 years of age, anti-TNF naïve and starting infliximab
  • 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
  • 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
  • Negative TB (tuberculosis) interferon-gamma release test and a negative urine pregnancy test for female patients (if menstruation has started)

You may not qualify if:

  • Diagnosis of ulcerative colitis or inflammatory bowel disease-unspecified
  • Prior use of anti-TNF therapy (infliximab, adalimumab, certolizumab pegol, or golimumab)
  • Internal (abdominal/pelvic) penetrating fistula(e) in last 180 days
  • Intra-abdominal abscess/phlegmon/inflammatory mass in the last 180 days
  • Active perianal abscess (receiving oral antibiotics for \<7 days)
  • Intestinal stricture (luminal narrowing with pre-stenotic dilation \>3 cm) and surgery planned in the next 90 days
  • 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.
  • Current hospitalization for complications of severe Crohn's disease
  • Planned use of methotrexate or 6-mercaptopurine (azathioprine) during the induction (first 3 doses of infliximab) phase
  • Current ileostomy, colostomy, ileoanal pouch, and/or previous extensive small bowel resection (\>35 cm) or any CD surgery planned within the next 90 days
  • History of autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, or juvenile idiopathic arthritis
  • Treatment with another investigational drug in the last four weeks
  • History of malignancy (including lymphoma or leukemia)
  • Currently receiving treatment for histoplasmosis
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

RECRUITING

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

RECRUITING

Nemours Children's Health System-Wilmington

Wilmington, Delaware, 19803, United States

RECRUITING

Nemours Children's Health System-Jacksonville

Jacksonville, Florida, 32207, United States

RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

RECRUITING

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

RECRUITING

Cleveland Clinic Children's Hospital

Cleveland, Ohio, 44106, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Children's Specialty Group

Norfolk, Virginia, 23507, United States

RECRUITING

Medical College of Wisconsin, Children's of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (1)

  • Minar PP, Colman RJ, Zhang N, Mizuno T, Vinks AA. Precise infliximab exposure and pharmacodynamic control to achieve deep remission in paediatric Crohn's disease (REMODEL-CD): study protocol for a multicentre, open-label, pragmatic clinical trial in the USA. BMJ Open. 2024 Mar 25;14(3):e077193. doi: 10.1136/bmjopen-2023-077193.

    PMID: 38531570DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Phillip Minar, MD,MS

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Phillip Minar, MD, MS

CONTACT

513-636-4415phillip.minar@cchmc.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients newly diagnosed with Crohn's disease (ages 6-22 years inclusive) within the last 90 days AND starting infliximab
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 21, 2022

Study Start

July 1, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(11)