Trial Outcomes & Findings for Personalized Infliximab Induction Strategy With Model-informed Dosing in Patients With Crohn's Disease (NCT NCT04974099)
NCT ID: NCT04974099
Last Updated: 2026-03-11
Results Overview
Percentage of total patients adverse and/or serious adverse events
TERMINATED
PHASE2/PHASE3
6 participants
10 months
2026-03-11
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Personalized Infliximab Induction Strategy With Model-informed Dosing in Patients With Crohn's Disease
Baseline characteristics by cohort
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
13 years
STANDARD_DEVIATION 3.3 • n=9 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=9 Participants
|
|
Crohn's disease
|
6 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 10 monthsPercentage of total patients adverse and/or serious adverse events
Outcome measures
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Obtain Safety Data for Optimal Dosing Strategy and Sample Size Estimation
|
50 percentage of participants
|
PRIMARY outcome
Timeframe: 10 monthsNumber of patients consented for 10 month study
Outcome measures
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Enrollment Feasibility
|
6 participants
|
PRIMARY outcome
Timeframe: 10 monthsPercentage of patients that complete the study
Outcome measures
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Completion Feasibility
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: 10 monthsPercentage of patients that collected a stool sample for the study
Outcome measures
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Percentage of Patient Adherence to Stool Sample Collections
|
92 percentage of participants
|
PRIMARY outcome
Timeframe: 10 monthsEvaluate rate of physician adherence to the Dashboard
Outcome measures
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
RoadMAB Usability
|
100 percentage of physicians
|
PRIMARY outcome
Timeframe: weeks 10-16Percentage of patients achieving infus3 (Visit 4) infliximab concentration between \>16 μg/ml as a dichotomous outcome
Outcome measures
| Measure |
RoadMAB Dashboard System
n=5 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
RoadMAB Efficacy
|
100 percentage of those achieving this goal
|
PRIMARY outcome
Timeframe: 10 monthsPercentage of patients who provided blood sample collections.
Outcome measures
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Percentage of Patient Adherence to Blood Sample Collection
|
81 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4-8Population: 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.
Median difference of infusion 3 (Visit 4) levels between cases and controls
Outcome measures
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Evaluate Accuracy of Infliximab Concentration Targets - Median Difference Infusion 3
|
41 mcg/mL
Interval 24.8 to 52.5
|
SECONDARY outcome
Timeframe: Weeks 2-3Incidence of achieving infus2 (Visit 3) level between target range of \>26 μg/ml as a dichotomous outcome
Outcome measures
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Evaluate Accuracy of Infliximab Concentration Targets - Incidence
|
83.3 percentage of patients
|
SECONDARY outcome
Timeframe: Weeks 2-3Population: All 6 received the intervention, but there were no controls enrolled so the median difference between the two groups could not be calculated.
Median difference of infus2 (Visit 3) levels between cases and controls
Outcome measures
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Evaluate Accuracy of Infliximab Concentration Targets - Median Difference infus2
|
51 mcg/mL
Interval 33.8 to 60.8
|
SECONDARY outcome
Timeframe: week2 10-30Percentage of achieving maintenance targets infus4-6 (Visits 5-7) \>5 μg/ml
Outcome measures
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Evaluate Accuracy of Infliximab Concentration Targets - Maintenance
|
83.3 percentage of patients
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All 6 received the intervention, but there were no controls enrolled so the median difference between the two groups could not be calculated.
Rate of development of anti-infliximab antibodies at any infusion between cases and controls
Outcome measures
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Evaluate Accuracy of Infliximab Concentration Targets
|
2 Participants
|
SECONDARY outcome
Timeframe: Weeks 10-30Percent of patients that had an improvement in baseline wPCDAI by \>17.5 or a wPCDAI\<12.5
Outcome measures
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Infus4 (Visit 5) and infus6 (Visit 7): Clinical Response
Infusion4
|
100 percentage of patients
|
|
Infus4 (Visit 5) and infus6 (Visit 7): Clinical Response
Infusion6
|
80 percentage of patients
|
SECONDARY outcome
Timeframe: Weeks 10-16Percentage of patients who had a wPCDAI \<12.5 and off corticosteroids
Outcome measures
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Infus4 (Visit 5): Clinical Remission
|
83 percentage of patients
|
SECONDARY outcome
Timeframe: Weeks 10-30Percentage of patients with a wPCDAI \<12.5 and off prednisone for all visits from infus4 (Visit 5) to infus6 (Visit 7)
Outcome measures
| Measure |
RoadMAB Dashboard System
n=5 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Sustained Remission
|
20 percentage of patients
|
SECONDARY outcome
Timeframe: Weeks 10-16Percentage of patients with a ≥50% improvement in fecal calprotectin
Outcome measures
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Infus4 (Visit 5): Fecal Biochemical Response
|
83 percentage of patients
|
SECONDARY outcome
Timeframe: Week 10-16Percentage of patients with a fecal calprotectin \<250 μg/g
Outcome measures
| Measure |
RoadMAB Dashboard System
n=6 Participants
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Infus4 (Visit 5): Fecal Biochemical Remission
|
67 percentage of patients
|
SECONDARY outcome
Timeframe: Weeks 18-30Population: 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
ileum subscore stage 0 (score = 0)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 18-30Population: 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.
all segments of colon subscore stage 0 (score = 0)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 10-30Population: 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
total ileum and colonic subscore is not greater than stage 0 on either individual score
Outcome measures
Outcome data not reported
Adverse Events
RoadMAB Dashboard System
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RoadMAB Dashboard System
n=6 participants at risk
Single-arm study. Number of patients that received the intervention.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • 10 months
|
|
Hepatobiliary disorders
Alanine aminotransferase increase
|
16.7%
1/6 • Number of events 1 • 10 months
|
|
Nervous system disorders
Vertigo
|
16.7%
1/6 • Number of events 1 • 10 months
|
|
Endocrine disorders
Hot Flush
|
16.7%
1/6 • Number of events 1 • 10 months
|
|
Musculoskeletal and connective tissue disorders
Swelling of feet
|
16.7%
1/6 • Number of events 1 • 10 months
|
Additional Information
Phillip Minar, MD, MS
Cincinnati Children's Hospital Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place