Crohn Disease
Precision versus conventional infliximab dosing for young people with Crohn’s
This study asks whether computer-guided, individualized infliximab dosing improves deep-remission rates compared with conventional dosing in people ages 6–22 who were recently diagnosed with Crohn’s disease and are starting infliximab.
Registry title: Precise Infliximab Exposure and Pharmacodynamic Control
11 recruiting U.S. sites ↓Study at a glance
- Age
- 6 Years–22 Years
- Treatment
- RoadMAB or Infliximab
- Design
- Non Randomized
- Central study contact
- Phillip Minar, MD, MS513-636-4415phillip.minar@cchmc.org
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Research question
Does individualized infliximab dosing supported by blood-test results and the RoadMAB decision-support system produce a higher rate of deep remission than conventional infliximab dosing?
Participant snapshot
Who the study is looking for
- The study is looking for people ages 6 through 22.
- The study is looking for people diagnosed with Crohn’s disease within the past 90 days.
- The study is looking for people who have not previously received anti-tumor necrosis factor therapy and are starting infliximab.
- The study is looking for people with specified levels of clinical Crohn’s activity and objective evidence of intestinal inflammation.
Participation overview
What participation may involve
Participants receive infliximab using either conventional dosing or precision dosing supported by RoadMAB. The study compares clinical remission, endoscopic healing, laboratory markers, drug exposure, quality of life, growth, and safety through week 52. What participation may involve: - Receive infliximab doses at weeks 0, 2, and 6, followed by maintenance dosing every 4–8 weeks. - Have infliximab concentrations and disease-related markers assessed to guide or evaluate dosing. - Complete assessments of Crohn’s disease activity, symptoms, quality of life, and adverse events. - Undergo assessment of intestinal healing using endoscopic and, for one outcome, histologic scores at week 52. The dosing schedule includes doses at weeks 0, 2, and 6 and then every 4–8 weeks, but the record does not provide a complete visit schedule or total visit count.
Study interventions
What participants may receive or do
- RoadMAB: RoadMAB is a real-time computer decision-support dashboard that uses a pharmacokinetic model and patient data to suggest individualized infliximab doses at the point of care. It is used only in the precision-dosing arm.
- Infliximab: Participants in both groups receive infliximab. The conventional group uses specified dose ranges and a flat drug-concentration target, while the precision group uses broader dose ranges and individualized pharmacokinetic and disease-marker targets.
Study design
How the comparison works
This is an open-label, parallel-group phase 2/phase 3 trial comparing precision and conventional infliximab-dosing strategies. The record is internally inconsistent about allocation: its detailed description calls the trial cluster randomized, while the structured design field says non-randomized. The registry gives conflicting information: the narrative describes cluster randomization, but the structured allocation field says non-randomized. The study team should explain how sites or participants are assigned. The study is open-label with no masking, so participants and study staff know which dosing strategy is being used. The control group receives conventional infliximab dosing, while the experimental group receives precision dosing supported by RoadMAB. No placebo arm is listed; both study groups receive infliximab.
Reported activities
Procedures and tests
- Blood testing may include infliximab concentrations and C-reactive protein measurements.
- Stool testing includes fecal calprotectin, a marker of intestinal inflammation.
- Crohn’s disease activity is measured with the Pediatric Crohn’s Disease Activity Index for children or the Crohn’s Disease Activity Index for adults.
- Endoscopic scoring is used to assess intestinal healing at week 52.
- Histologic activity scores from ileal or colon tissue are included in the mucosal-healing outcome.
- Participants report stool frequency and abdominal pain for Patient Reported Outcome-2 assessments.
- Quality-of-life and disability questionnaires differ for child and adult participants.
- For participants in Tanner stages I–III, weight and height velocity are assessed.
- Screening requires confirmation of a negative tuberculosis interferon-gamma release test and, when applicable, a negative urine pregnancy test.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Crohn’s disease must have been diagnosed within the last 90 days; permitted disease includes luminal-only disease or luminal disease with a perianal fistula or abscess treated with antibiotics for at least seven days.
- Participants must be 6 through 22 years old, have no prior anti-tumor necrosis factor treatment, and be starting infliximab.
- Clinical activity must have been documented within 60 days before the decision to start infliximab: PCDAI at least 10 for participants under 18 or CDAI at least 150 for adults.
- Luminal inflammation must meet the specified endoscopy or fecal-calprotectin threshold within its stated time window.
- C-reactive protein above 1.0 mg/dL within 30 days and/or fecal calprotectin above 250 μg/g within 75 days before screening is required.
- A negative tuberculosis interferon-gamma release test is required, along with a negative urine pregnancy test for participants who menstruate.
- Written consent is required from adult participants or a parent or legal guardian for minors, with age-appropriate assent from the participant.
Possible reasons someone may not be able to join
- People diagnosed with ulcerative colitis or inflammatory bowel disease-unspecified are excluded.
- Any prior use of infliximab, adalimumab, certolizumab pegol, or golimumab is excluded.
- An internal abdominal or pelvic penetrating fistula, intra-abdominal abscess, phlegmon, or inflammatory mass within the last 180 days is excluded.
- An active perianal abscess is excluded when oral antibiotics have been taken for fewer than seven days.
- An intestinal stricture with more than 3 cm of pre-stenotic dilation is excluded when surgery is planned within 90 days.
- A positive test for Clostridium difficile toxin or another intestinal pathogen within 14 days of screening is excluded unless repeat testing is negative and there are no signs of ongoing infection.
- Current hospitalization for complications of severe Crohn’s disease is excluded.
- Planned methotrexate or 6-mercaptopurine, including azathioprine, during the first three infliximab doses is excluded.
- A current ileostomy, colostomy, ileoanal pouch, previous small-bowel resection longer than 35 cm, or planned Crohn’s surgery within 90 days is excluded.
- Pregnancy, breastfeeding, or plans to become pregnant within the next year are excluded.
Important unknowns
What the record does not make clear
- The narrative calls the study cluster randomized, while the structured design field identifies allocation as non-randomized.
- Infliximab dosing intervals and several assessment timepoints are reported, but the complete visit schedule and total number of visits are not.
- Outcomes are measured through week 52, but the record does not explicitly state each participant’s total participation duration.
- The record excludes planned methotrexate or thiopurine use during induction but does not fully describe which other Crohn’s medicines may continue or change.
- The record does not describe rescue treatment or what happens if Crohn’s disease worsens or does not respond.
- The study evaluates endoscopic healing at week 52, but the record does not explain the number of endoscopies, preparation, sedation, biopsy requirements, or whether existing results can be used.
- The record does not explain which treatment, tests, procedures, or related medical care are paid by the study or billed to insurance.
- The record does not state whether participants are compensated.
- The record does not describe reimbursement or support for travel, lodging, meals, parking, or childcare.
- The record does not say whether any visits, questionnaires, or monitoring can be completed remotely or through a local clinician.
- The record does not describe access to the precision-dosing approach or RoadMAB after study participation ends.
- The registry lists multiple recruiting locations, but current availability for a particular age group or dosing cohort should be confirmed directly.
Before contacting the site
Questions for the study team
- How are sites or participants assigned to the conventional- and precision-dosing groups?
- What is the complete schedule of in-person visits, blood draws, stool samples, questionnaires, and infliximab doses?
- Which endoscopies and biopsies are required for research, and how are preparation and sedation handled?
- Which existing Crohn’s treatments may continue, and what treatment is offered if symptoms worsen or infliximab does not work?
- Which costs are covered, which may be billed to insurance, and is compensation or travel support available?
- Can any activities be completed remotely or coordinated with a local gastroenterologist?
- Is the appropriate age group and study cohort currently open at the location I would use?
Before changing care
Questions for your gastroenterologist
- How would either study dosing strategy affect the infliximab plan you would otherwise recommend?
- Are the disease-activity, endoscopy, and biomarker findings required by this study consistent with the current clinical picture?
- What approved treatment alternatives should be considered alongside this trial’s infliximab strategies?
- How should your office and the research team coordinate laboratory monitoring, endoscopy, medication changes, and care if the disease worsens?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
Approximately 3 million people in the United States are living with inflammatory bowel disease, which includes Crohn's Disease (CD). There are limited treatment options approved for use in children and adults with Crohn's disease. Physicians need better ways to inform decisions on treatment. The main reason for this research study is to determine if a computer program that calculates an individualized dose based on a patient's blood testing results (precision dosing) can better achieve the best possible response to infliximab compared to standard dosing (conventional dosing).
This is an open-label, cluster randomized clinical trial to test whether precision infliximab dosing with a targeted concentration intervention is superior in achieving deep remission (endoscopic healing and clinical remission) compared to patients receiving conventional infliximab dosing. With recognition that CD patients who achieve the "target" of deep remission with anti-TNF dose optimizations following pharmacodynamic monitoring had a significant reduction in CD-related adverse events, our central hypothesis is precision dosing with infliximab during induction and maintenance will achieve superior rates of deep remission vs. conventional care (control arm)
Study design and administration
- Organization
- Children's Hospital Medical Center, Cincinnati
- Organization class
- Other
- Organization study ID
- 2022-0071
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Non Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Child, Adult
Study arms
Active Comparator
Conventional dosing
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.
Interventions: Drug: Infliximab
Experimental
Precision dosing
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.
Interventions: Device: RoadMAB, Drug: Infliximab
Interventions
Device
RoadMAB
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.
Drug
Infliximab
Conventional dosing. Induction: 5-7.5 mg/kg at 0, 2, and 6 weeks. Maintenance: 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. Precision dosing. 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.
Eligibility
6 Years–22 Years
All
Not accepted
Inclusion criteria (9)
- Written informed consent from the patient (≥18 years old) or from parent/legal guardian if patient is \<18 years oldRegistry-derived · unreviewed
- Written informed assent from patient when age appropriateRegistry-derived · unreviewed
- Diagnosis of Crohn's disease within the last 90 days (luminal-only or luminal with a perianal fistula or abscess treated with antibiotics for at least 7 days)Registry-derived · unreviewed
- ≥6 years to ≤22 years of age, anti-TNF naïve and starting infliximabRegistry-derived · unreviewed
- Clinical activity and luminal inflammation, defined by both (1) and (2)Registry-derived · unreviewed
- (1) PCDAI≥10 (\<18 years old) or CDAI ≥150 (≥18 years old) in last 60 days before the decision to start infliximabRegistry-derived · unreviewed
- (2) SES-CD\>6, or SES-CD\>3 for isolated ileal disease (or a report of large intestinal ulcerations)\* within the last 60 days or a fecal calprotectin \>250 μg/g within last 75 days prior to screeningRegistry-derived · unreviewed
- C-reactive protein \>1.0 mg/dL in last 30 days and/or fecal calprotectin \>250 μg/g within last 75 days prior to screeningRegistry-derived · unreviewed
- Negative TB (tuberculosis) interferon-gamma release test and a negative urine pregnancy test for female patients (if menstruation has started)Registry-derived · unreviewed
Exclusion criteria (18)
- Diagnosis of ulcerative colitis or inflammatory bowel disease-unspecifiedRegistry-derived · unreviewed
- Prior use of anti-TNF therapy (infliximab, adalimumab, certolizumab pegol, or golimumab)Registry-derived · unreviewed
- Internal (abdominal/pelvic) penetrating fistula(e) in last 180 daysRegistry-derived · unreviewed
- Intra-abdominal abscess/phlegmon/inflammatory mass in the last 180 daysRegistry-derived · unreviewed
- Active perianal abscess (receiving oral antibiotics for \<7 days)Registry-derived · unreviewed
- Intestinal stricture (luminal narrowing with pre-stenotic dilation \>3 cm) and surgery planned in the next 90 daysRegistry-derived · unreviewed
- Have tested positive for Clostridium difficile toxin (stool assay) or other intestinal pathogens within 14 days of screening unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen.Registry-derived · unreviewed
- Current hospitalization for complications of severe Crohn's diseaseRegistry-derived · unreviewed
- Planned use of methotrexate or 6-mercaptopurine (azathioprine) during the induction (first 3 doses of infliximab) phaseRegistry-derived · unreviewed
- Current ileostomy, colostomy, ileoanal pouch, and/or previous extensive small bowel resection (\>35 cm) or any CD surgery planned within the next 90 daysRegistry-derived · unreviewed
- History of autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, or juvenile idiopathic arthritisRegistry-derived · unreviewed
- Treatment with another investigational drug in the last four weeksRegistry-derived · unreviewed
- History of malignancy (including lymphoma or leukemia)Registry-derived · unreviewed
- Currently receiving treatment for histoplasmosisRegistry-derived · unreviewed
- History of TB, human immunodeficiency virus (HIV), an immunodeficiency syndrome, a central nervous system demyelinating disease, history of heart failure or receiving intravenous antibiotics in last 14 days for any infectionRegistry-derived · unreviewed
- Currently pregnant, breast feeding or plans to become pregnant in the next 1 yearRegistry-derived · unreviewed
- Inability or failure to provide informed assent/consentRegistry-derived · unreviewed
- Any developmental disabilities that would impede providing assent/consentRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Rate of Deep Remission
Time frame: Week 52
Pediatric Crohn's disease activity index (PCDAI) \<10 (child) or Crohn's disease activity index\<150 (adult), off prednisone/budesonide for \>8 weeks and Simple Endoscopic Scorer Crohn's Disease (SES-CD) SES-CD≤2
Secondary outcome
Rate of Steroid-free Clinical Remission
Time frame: Week 14 and Week 52
Pediatric Crohn's disease activity index (PCDAI) \<10 (child) or Crohn's disease activity index(CDAI)\<150 (adult) and off prednisone/budesonide for ≥4 weeks
Secondary outcome
Rate of Clinical Response
Time frame: Week 14 and Week 52
Decrease from baseline PCDAI of at least 12.5 points \& total PCDAI\<30 or a PCDAI\<10 (child) or a reduction of CDAI\>70 from baseline or CDAI\<150 (adult)
Secondary outcome
Rate of Primary Clinical Nonresponse
Time frame: Week 16
On prednisone \>16 consecutive weeks from start of infliximab or a PCDAI\>30 or CDAI\>220 for first four infusions
Secondary outcome
Rate of Primary Biologic Nonresponse
Time frame: Week 16
Failure to improve baseline fecal calprotectin by \>100 μg/g (limited to patients with a baseline fecal calprotectin \>250 μg/g) or Failure to improve baseline c-reactive protein ≥0.5 mg/dL (limited to patients with a baseline c-reactive protein \>1.0 mg/dL)
Secondary outcome
Rate of Sustained Steroid-free Remission
Time frame: Week 22 - Week 52
PCDAI\<10 (child) or CDAI\<150 (adult) at dose5 to week52 and off prednisone/budesonide from week 22-52
Secondary outcome
Rate of Steroid-free Remission -biomarker composite
Time frame: Week 14 and Week 52
PCDAI\<10 (child) or CDAI\<150 (adult), off prednisone/budesonide for ≥4 weeks, CRP≤0.5 mg/dL and fecal calprotectin \<250 μg/g
Secondary outcome
Rate of Endoscopic Healing
Time frame: Week 52
Simple endoscopic score-Crohn's disease (SES-CD) ≤2
Secondary outcome
Rate of Complete Endoscopic Healing
Time frame: Week 52
SES-CD=0
Secondary outcome
Rate of Endoscopic Remission
Time frame: Week 52
SES-CD\<4
Secondary outcome
Rate of Mucosal Healing
Time frame: Week 52
SES-CD≤2 and Ileal Global Histologic Activity Score (GHAS)/ Colon Global Histologic Activity Score (CGHAS) ≤2
Secondary outcome
PK Model Bias
Time frame: Week 0 - Week 52
Model predicted vs. actual infliximab concentration. Bias: mean predictive error (MPE)
Secondary outcome
PK Model Precision
Time frame: Week 0 - Week 52
Model predicted vs. actual infliximab concentration. Precision: root mean squared error (RMSE)
Secondary outcome
Rate of IBD related event - Fistula
Time frame: Week 0 - Week 52
Occurrence of fistula and presence of antibody to infliximab \>200 ng/mL
Secondary outcome
Rate of IBD related - Hospitalization
Time frame: Week 0 - Week 52
Occurrence of Crohn's disease related hospitalization
Secondary outcome
Rate of IBD related event - Surgery
Time frame: Week 0 - Week 52
Occurrence of Crohn's disease related surgery
Secondary outcome
Rate of IBD related event - Intestinal stricture
Time frame: Week 0 - Week 52
Occurrence of Crohn's disease related intestinal stricture
Secondary outcome
Rate of IBD related event - Starting corticosteroids
Time frame: Week 0 - Week 52
Occurrence of subjects starting a corticosteroid after week20
Secondary outcome
Rate of IBD related event - Antibodies to infliximab
Time frame: Week 0 - Week 52
Occurrence of antibodies to infliximab defined as \>200 ng/mL
Secondary outcome
Rate of Growth Restoration - Weight change
Time frame: Week 14 - Week 52
In Tanner stage I-III subjects: change in baseline weight (kg) by gender and age group
Secondary outcome
Rate of Growth Restoration- Height velocity
Time frame: Week 14 - Week 52
In Tanner stage I-III subjects: change in height velocity (z-score) by gender
Secondary outcome
PK of infliximab in pediatric patients
Time frame: Week 0 - Week 52
Measured infliximab clearance at baseline and at week52
Secondary outcome
Correlation between infliximab induction exposure and endoscopic remission
Time frame: Exposure Week 0 - Week 14, Efficacy Week 52
The correlation analysis to be performed for the total area under the curve (infliximab exposure, μg\*h/mL from week0-week14) and patients achieving endoscopic remission. Endoscopic remission is defined as a SES-CD≤2.
Secondary outcome
Correlation between infliximab induction exposure and deep remission
Time frame: Exposure Week 0 - Week 14, Efficacy Week 52
The correlation analysis to be performed for the total area under the curve (infliximab exposure, μg\*h/mL from week0-week14) and patients in deep remission. Deep remission is defined as a PCDAI\<10 (child) or CDAI\<150 (adult), off prednisone/budesonide for \>8 weeks and a SES-CD≤2.
Secondary outcome
Patient Reported Outcome-2 (PRO2) Response
Time frame: Week 6, Week 14, Week 26, Week 52
\>50% improvement in total score from baseline
Secondary outcome
Patient Reported Outcome-2 (PRO2) Remission
Time frame: Week 6, Week 14, Week 26, Week 52
Stool frequency ≤3.0 and abdominal pain ≤1.0 (from baseline)
Secondary outcome
Quality of Life & Disability -IMPACT-III score
Time frame: Week 52
Total IMPACT-III (child) score
Secondary outcome
Quality of Life & Disability - Inflammatory Bowel Disease Disk score
Time frame: Week 52
Total Inflammatory Bowel Disease Disk (without sexual function assessment) score
Secondary outcome
Quality of Life & Disability - Short Inflammatory Bowel Disease score
Time frame: Week 52
Total Short IBD Questionnaire (adult) score
Secondary outcome
Process Evaluation -Usability of Decision Support Tool
Time frame: Week 0 - Week 52
Total System Usability Scale score
Secondary outcome
Rate of Adverse events
Time frame: Week 0 - Week 52
Number of Adverse Events
Secondary outcome
Rate of Serious Adverse events
Time frame: Week 0 - Week 52
Number of Serious Adverse Events
Recruiting locations in the United States
Children's Hospital of Los Angeles
RecruitingLos Angeles, California, 90027, United States
Mallory Chavannes
Mallory Chavannes, MD
Lucile Packard Children's Hospital Stanford
RecruitingPalo Alto, California, 94304, United States
Alka Goyal
Alka Goyal, MD
Rady Children's Hospital San Diego
RecruitingSan Diego, California, 92123, United States
Laura Bauman
Laura Bauman, MD
Nemours Children's Health System-Wilmington
RecruitingWilmington, Delaware, 19803, United States
Zarela Molle-Rios
Zarela Molle-Rios, MD
Nemours Children's Health System-Jacksonville
RecruitingJacksonville, Florida, 32207, United States
Jill Dorsey
Jill Dorsey, MD
Riley Hospital for Children
RecruitingIndianapolis, Indiana, 46202, United States
Steven Steiner
Steven Steiner, MD
Cincinnati Children's Hospital
RecruitingCincinnati, Ohio, 45229, United States
Kimberly Jacksonkimberly.jackson@cchmc.org
Phillip Minar, MD, MS
Cleveland Clinic Children's Hospital
RecruitingCleveland, Ohio, 44106, United States
Jacob Kurowski
Jacob Kurowski, MD
Nationwide Children's Hospital
RecruitingColumbus, Ohio, 43205, United States
Brendan Boyle
Brendan Boyle
Children's Specialty Group
RecruitingNorfolk, Virginia, 23507, United States
Amy QuinnAmy.quinn@chkd.org
Rana Ammoury, MD
Medical College of Wisconsin, Children's of Wisconsin
RecruitingMilwaukee, Wisconsin, 53226, United States
Joshua Noe
Joshua Noe, MD
Central study contacts
Registry dates
- First posted
- Dec 21, 2022
- Primary completion
- Mar 31, 2027
- Overall completion
- Mar 31, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.