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This was the Pilot study. The larger, confirmatory study has started
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| Name | Class |
|---|---|
| Crohn's and Colitis Foundation | OTHER |
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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.
This is a Pilot study to evaluate safety, feasibility and efficacy of utilizing pharmacokinetic modeling to provide an individualized infliximab induction regimen in children and young adults with moderate to severe Crohn's disease. This clinical study is designed with the hypothesis that treatment regimens that account for individual (patient) drug clearance (pharmacokinetic modeling) will not only be safe and cost-effective, but also more effective in reducing intestinal inflammation than as-labeled dosing (ALD) regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Accuracy of Infliximab Concentration Targets - Median Difference Infusion 3 | Median difference of infusion 3 (Visit 4) levels between cases and controls | Weeks 4-8 |
| Evaluate Accuracy of Infliximab Concentration Targets - Incidence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Minar, MD, MS | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interventional Arm With Precision Dosing | 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 (weight, serum albumin level, sedimentation rate [ESR], neutrophil CD64 activity ratio [nCD64] and prednisone exposure). As noted, dosing frequency (weeks) during induction will not be altered during this study. For dose selections following induction (maintenance phase), we have found therapeutic targets are more reliably achieved when all covariates (weight, nCD64, serum albumin and presence of drug antibodies) are available. RoadMABTM, however, utilizes only available data to formulate a dose recommendation (it does not impute missing data). 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | RoadMAB Dashboard System | Single-arm study. Number of patients that received the intervention. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Obtain Safety Data for Optimal Dosing Strategy and Sample Size Estimation | Percentage of total patients adverse and/or serious adverse events | Posted | Number | percentage of participants | 10 months |
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10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RoadMAB Dashboard System | Single-arm study. Number of patients that received the intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
Limitations of the trial. This was the pilot study. The larger, confirmatory clinical trial (REMODEL-CD, NCT05660746) has started and is ongoing.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip Minar, MD, MS | Cincinnati Children's Hospital Medical Center | 5136364415 | phillip.minar@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2022 | Jul 30, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 8, 2021 | Jul 30, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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).
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| Infliximab precision dosing | Drug | The trial is testing whether precision dosing can more reliably achieve the targeted trough concentrations compared to standard dosing |
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Incidence of achieving infus2 (Visit 3) level between target range of >26 μg/ml as a dichotomous outcome
| Weeks 2-3 |
| Evaluate Accuracy of Infliximab Concentration Targets - Median Difference infus2 | Median difference of infus2 (Visit 3) levels between cases and controls | Weeks 2-3 |
| Evaluate Accuracy of Infliximab Concentration Targets - Maintenance | Percentage of achieving maintenance targets infus4-6 (Visits 5-7) >5 μg/ml | week2 10-30 |
| Evaluate Accuracy of Infliximab Concentration Targets | Rate of development of anti-infliximab antibodies at any infusion between cases and controls | 6 months |
| Infus4 (Visit 5) and infus6 (Visit 7): Clinical Response | Percent of patients that had an improvement in baseline wPCDAI by >17.5 or a wPCDAI<12.5 | Weeks 10-30 |
| Infus4 (Visit 5): Clinical Remission | Percentage of patients who had a wPCDAI <12.5 and off corticosteroids | Weeks 10-16 |
| Sustained Remission | Percentage of patients with a wPCDAI <12.5 and off prednisone for all visits from infus4 (Visit 5) to infus6 (Visit 7) | Weeks 10-30 |
| Infus4 (Visit 5): Fecal Biochemical Response | Percentage of patients with a ≥50% improvement in fecal calprotectin | Weeks 10-16 |
| Infus4 (Visit 5): Fecal Biochemical Remission | Percentage of patients with a fecal calprotectin <250 μg/g | Week 10-16 |
| Infus6 (Visit 7): Rate of Transmural Ileal | ileum subscore stage 0 (score = 0) | Weeks 18-30 |
| Infus6 (Visit 7): Rate of Colonic Healing | all segments of colon subscore stage 0 (score = 0) | Weeks 18-30 |
| Infus6 (Visit 7): Rate of Total Bowel Healing | total ileum and colonic subscore is not greater than stage 0 on either individual score | Weeks 10-30 |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Crohn's disease | Count of Participants | Participants |
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| Primary | Enrollment Feasibility | Number of patients consented for 10 month study | Posted | Number | participants | 10 months |
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| Primary | Completion Feasibility | Percentage of patients that complete the study | Posted | Number | percentage of participants | 10 months |
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| Primary | Percentage of Patient Adherence to Stool Sample Collections | Percentage of patients that collected a stool sample for the study | Posted | Number | percentage of participants | 10 months |
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| Primary | RoadMAB Usability | Evaluate rate of physician adherence to the Dashboard | Posted | Number | percentage of physicians | 10 months |
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| Primary | RoadMAB Efficacy | Percentage of patients achieving infus3 (Visit 4) infliximab concentration between >16 μg/ml as a dichotomous outcome | Posted | Number | percentage of those achieving this goal | weeks 10-16 |
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| Primary | Percentage of Patient Adherence to Blood Sample Collection | Percentage of patients who provided blood sample collections. | Posted | Number | percentage of participants | 10 months |
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| Secondary | Evaluate Accuracy of Infliximab Concentration Targets - Median Difference Infusion 3 | Median difference of infusion 3 (Visit 4) levels between cases and controls | All 6 of the cases received the intervention, but there were no controls enrolled so the median difference between the two groups could not be calculated. | Posted | Median | Inter-Quartile Range | mcg/mL | Weeks 4-8 |
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| Secondary | Evaluate Accuracy of Infliximab Concentration Targets - Incidence | Incidence of achieving infus2 (Visit 3) level between target range of >26 μg/ml as a dichotomous outcome | Posted | Number | percentage of patients | Weeks 2-3 |
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| Secondary | Evaluate Accuracy of Infliximab Concentration Targets - Median Difference infus2 | Median difference of infus2 (Visit 3) levels between cases and controls | All 6 received the intervention, but there were no controls enrolled so the median difference between the two groups could not be calculated. | Posted | Median | Inter-Quartile Range | mcg/mL | Weeks 2-3 |
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| Secondary | Evaluate Accuracy of Infliximab Concentration Targets - Maintenance | Percentage of achieving maintenance targets infus4-6 (Visits 5-7) >5 μg/ml | Posted | Number | percentage of patients | week2 10-30 |
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| Secondary | Evaluate Accuracy of Infliximab Concentration Targets | Rate of development of anti-infliximab antibodies at any infusion between cases and controls | All 6 received the intervention, but there were no controls enrolled so the median difference between the two groups could not be calculated. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Infus4 (Visit 5) and infus6 (Visit 7): Clinical Response | Percent of patients that had an improvement in baseline wPCDAI by >17.5 or a wPCDAI<12.5 | Posted | Number | percentage of patients | Weeks 10-30 |
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| Secondary | Infus4 (Visit 5): Clinical Remission | Percentage of patients who had a wPCDAI <12.5 and off corticosteroids | Posted | Number | percentage of patients | Weeks 10-16 |
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| Secondary | Sustained Remission | Percentage of patients with a wPCDAI <12.5 and off prednisone for all visits from infus4 (Visit 5) to infus6 (Visit 7) | Posted | Number | percentage of patients | Weeks 10-30 |
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| Secondary | Infus4 (Visit 5): Fecal Biochemical Response | Percentage of patients with a ≥50% improvement in fecal calprotectin | Posted | Number | percentage of patients | Weeks 10-16 |
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| Secondary | Infus4 (Visit 5): Fecal Biochemical Remission | Percentage of patients with a fecal calprotectin <250 μg/g | Posted | Number | percentage of patients | Week 10-16 |
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| Secondary | Infus6 (Visit 7): Rate of Transmural Ileal | ileum subscore stage 0 (score = 0) | Assessment of transmural (ileum) healing was not assessed during the study. Although the MRI and this assessment was planned for this study, the study team chose not to have the participants undergo the research MRI assessment due to the high cost of a research-only MRI. The research team had limited availability of research funds to pay for the MRI exam. This could only have been measured by the MRI results and therefore not able to be reported as the MRI was not performed for this study | Posted | Number | participants | Weeks 18-30 |
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| Secondary | Infus6 (Visit 7): Rate of Colonic Healing | all segments of colon subscore stage 0 (score = 0) | Assessment of colonic healing was not assessed during the study. Although the MRI and this assessment was planned for this study, the study team chose not to have the participants undergo the research MRI assessment due to the high cost of a research-only MRI. The research team had limited availability of research funds to pay for the MRI exam. This could only have been measured by the MRI results and therefore not able to be reported as the MRI was not performed for this study. | Posted | Number | participants | Weeks 18-30 |
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| Secondary | Infus6 (Visit 7): Rate of Total Bowel Healing | total ileum and colonic subscore is not greater than stage 0 on either individual score | Assessment of total bowel healing was not assessed during the study. Although the MRI and this assessment was planned for this study, the study team chose not to have the participants undergo the research MRI assessment due to the high cost of a research-only MRI. The research team had limited availability of research funds to pay for the MRI exam. This could only have been measured by the MRI results and therefore not able to be reported as the MRI was not performed for this study | Posted | Number | participants | Weeks 10-30 |
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| 0 |
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Alanine aminotransferase increase | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment | increase in liver enzymes |
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| Vertigo | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Hot Flush | Endocrine disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Swelling of feet | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment | bilateral feet were swollen |
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| D007410 | Intestinal Diseases |