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Monoclonal Antibodies

Individualized Infliximab Dosing for Crohn's Disease (REMODEL-CD Trial)

Phase 2 & 3

Recruiting

Led By Phillip Minar, MD,MS

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6, week 14, week 26, week 52

Awards & highlights

No Placebo-Only Group

Summary

This trial studies if individualizing doses of a common Crohn's disease drug based on blood tests can help patients better respond to treatment.

Who is the study for?

This trial is for children and adults aged 6 to 22 with Crohn's Disease who are new to anti-TNF therapy and about to start infliximab. They must have active disease, confirmed diagnosis within the last 90 days, no recent severe infections or surgeries planned, not be hospitalized for severe CD complications, and not pregnant. Consent is required.

What is being tested?

The study tests if precision dosing of Infliximab using a computer program based on blood tests can lead to better treatment outcomes compared to standard dosing in patients with Crohn's Disease. The goal is personalized medication management.

What are the potential side effects?

Infliximab may cause side effects like increased risk of infection, allergic reactions during infusion, headache, stomach pain, nausea and potential long-term risks such as liver damage or heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6, week 14, week 26, week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6, week 14, week 26, week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6, week 14, week 26, week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Deep Remission

Secondary study objectives

Correlation between infliximab induction exposure and deep remission

Correlation between infliximab induction exposure and endoscopic remission

PK Model Bias

+28 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Precision dosingExperimental Treatment2 Interventions

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.

Group II: Conventional dosingActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Infliximab

2017

Completed Phase 4

~3350

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