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Anti-TNF-alpha Monoclonal Antibody

RoadMAB for Crohn's Disease (REMODEL Trial)

Q: What is the total number of participants for this clinical experiment?

Indeed, the data on clinicaltrials.gov displays that this trial is actively recruiting individuals. This study was initially advertised on October 1st 2021 and has since been edited as of October 19th 2021. 20 participants are required to be enrolled from a single medical site.

Q: For what type of participant is this clinical trial most suitable?

This research project is open to 20 individuals between the ages of 6 and 22 suffering from ileocolitis. Essential requirements for participation include having never been exposed to anti-TNF treatments such as infliximab, adalimumab, golimumab, certolizumab or a biosimilar thereof; plus obtaining written consent from patients aged 11 years or older.

Q: Is the age criteria for entry into this research trial beyond twenty years?

In line with the eligibility requirements, minors age 6 to 22 can be incorporated into this clinical 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

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)

Starting infliximab (or biosimilar)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

REMODEL Trial Summary

This trial is testing a computer program that creates dosing plans for patients with Crohn's Disease based on their blood test results. The goal is to see if this is more effective than the standard dosing methods.

Who is the study for?

This trial is for children and young adults aged 6 to 22 with Crohn's Disease who haven't used anti-TNF drugs like infliximab. They must have active disease signs, no recent infections or surgeries affecting the gut, not be pregnant, and agree to specific testing. Those with other autoimmune diseases or using certain medications can't join.Check my eligibility

What is being tested?

The study tests a personalized dosing strategy using RoadMAB and a computer program that decides on drug doses based on blood test results. It aims to see if this method reaches optimal drug levels better than standard dosing in treating Crohn's Disease.See study design

What are the potential side effects?

While the trial doesn't specify side effects of RoadMAB, similar treatments may cause immune system changes, risk of infection, allergic reactions during infusion, headaches, stomach issues and potential impact on liver function.

REMODEL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have recent tests showing active Crohn's disease.

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I am starting treatment with infliximab or a similar medication.

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I have never been treated with anti-TNF drugs.

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I have been diagnosed with Crohn's Disease.

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I am between 6 and 22 years old.

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I am not pregnant.

REMODEL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Completion feasibility

Enrollment feasibility

Obtain safety data for optimal dosing strategy and sample size estimation

+3 more

Secondary outcome measures

Evaluate accuracy of infliximab concentration targets

Evaluate accuracy of infliximab concentration targets - Incidence

Evaluate accuracy of infliximab concentration targets - Maintenance

+10 more

REMODEL Trial Design

1Treatment groups

Experimental Treatment

Group I: RoadMAB dashboard systemExperimental Treatment2 Interventions

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.

0 / 6Eligibility criteria met

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Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,576 Total Patients Enrolled

Crohn's and Colitis FoundationOTHER

43 Previous Clinical Trials

27,877 Total Patients Enrolled

Phillip Minar, MD, MSPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

1 Previous Clinical Trials

239 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently available to recruits?

"Affirmative. Information on clinicaltrials.gov confirms that this medical study, which was first published on October 1st 2021, is actively recruiting for 20 patients across a single location."

Answered by AI

What aims has this research endeavor set out to attain?

"This long-term trial, expected to span two years of observation, is primarily focused on the feasibility of sample collection. Secondary goals encompass sustained remission (where wPCDAI <12.5 and prednisone use ceases from infus4 to infus6), accuracy assessment for infliximab concentration targets at Visit 3, and evaluation of transmural ileal stage 0 score at Visit 7."

Answered by AI

What is the total number of participants for this clinical experiment?

"Indeed, the data on clinicaltrials.gov displays that this trial is actively recruiting individuals. This study was initially advertised on October 1st 2021 and has since been edited as of October 19th 2021. 20 participants are required to be enrolled from a single medical site."

Answered by AI

For what type of participant is this clinical trial most suitable?

"This research project is open to 20 individuals between the ages of 6 and 22 suffering from ileocolitis. Essential requirements for participation include having never been exposed to anti-TNF treatments such as infliximab, adalimumab, golimumab, certolizumab or a biosimilar thereof; plus obtaining written consent from patients aged 11 years or older."

Answered by AI