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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
REMODEL-CD Trial 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.Check my eligibility
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.See study design
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.
REMODEL-CD Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Deep Remission
Secondary outcome measures
Correlation between infliximab induction exposure and deep remission
Correlation between infliximab induction exposure and endoscopic remission
PK Model Bias
+28 moreREMODEL-CD 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
~3280
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,411 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,412 Total Patients Enrolled
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,338 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or will have surgery related to my digestive system soon.I have had an internal fistula in the last 6 months.I have previously used anti-TNF medications.I am unable to understand or sign the consent form.I have had an abdominal infection or inflammation in the last 6 months.I have a narrowed intestine with plans for surgery within 3 months.I have had cancer, lymphoma, or leukemia before.I am currently being treated for histoplasmosis.I have been diagnosed with ulcerative colitis or an unspecified inflammatory bowel disease.I was diagnosed with Crohn's disease in the last 3 months.I am between 6 and 22 years old and have never taken anti-TNF drugs but am starting infliximab.I have given my written agreement to participate.I am currently hospitalized due to severe Crohn's disease complications.I have a history of certain autoimmune diseases.I am currently taking oral antibiotics for a perianal abscess for less than 7 days.I tested positive for a gut infection but am now clear or have no ongoing symptoms.I will be taking methotrexate or azathioprine during the first 3 doses of infliximab.I have given or my guardian has given written consent for me to participate.I have a history of TB, HIV, immune issues, nerve disease, heart failure, or recent IV antibiotics.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional dosing
- Group 2: Precision dosing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research protocol accept individuals aged 35 and over?
"This research requires participants to be within 6 and 22 years of age."
Answered by AI
Is the protocol for this research project still admitting new participants?
"As confirmed on clinicaltrials.gov, this medical study is no longer soliciting participants as it was first posted in February 1st 2023 and most recently updated December 19th 2022. However, 259 other trials are currently recruiting patients."
Answered by AI
How many healthcare settings are offering this trial to their patients?
"At this time, the trial is available at 10 distinct medical centres. Three of these are located in Palo Alto, San Diego and Wilmington with 7 additional sites elsewhere. Should you choose to join, it would be prudent to pick a site close by so that travel needs can be minimised."
Answered by AI
Am I eligible to participate in this research endeavor?
"The qualified participants of this ileocolitis clinical trial must be aged between 6 and 22, with a diagnosis made in the last 90 days. Furthermore, written informed consent from either the patient (if over 18) or legal guardian is necessary for enrolment. The participant should also have had anti-TNF treatment within the past 60 days, as well as having tested negative for TB interferon-gamma release test and urine pregnancy tests if female and menstruating. As an additional criteria, entrants need to present both a PCDAI ≥10 (under 18 years old), CDAI≥150 (over 18 years old"
Answered by AI
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