Crohn DiseasePhase 2/3REMODEL-CDNCT05660746
Precise Infliximab Exposure and Pharmacodynamic Control
A Phase 2/3 study testing RoadMAB and Infliximab in people with Crohn Disease, run by Children's Hospital Medical Center, Cincinnati at 11 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 22 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- RoadMAB and Infliximab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Jul 2023to 31 Mar 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Written informed consent from the patient (≥18 years old) or from parent/legal guardian if patient is <18 years old
- Written informed assent from patient when age appropriate
- 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)
- ≥6 years to ≤22 years of age, anti-TNF naïve and starting infliximab
- Clinical activity and luminal inflammation, defined by both (1) and (2)
- (1) PCDAI≥10 (<18 years old) or CDAI ≥150 (≥18 years old) in last 60 days before the decision to start infliximab
Show all 9Show fewer
- (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 screening
- C-reactive protein >1.0 mg/dL in last 30 days and/or fecal calprotectin >250 μg/g within last 75 days prior to screening
- Negative TB (tuberculosis) interferon-gamma release test and a negative urine pregnancy test for female patients (if menstruation has started)
Who cannot join
- Diagnosis of ulcerative colitis or inflammatory bowel disease-unspecified
- Prior use of anti-TNF therapy (infliximab, adalimumab, certolizumab pegol, or golimumab)
- Internal (abdominal/pelvic) penetrating fistula(e) in last 180 days
- Intra-abdominal abscess/phlegmon/inflammatory mass in the last 180 days
- Active perianal abscess (receiving oral antibiotics for <7 days)
- Intestinal stricture (luminal narrowing with pre-stenotic dilation >3 cm) and surgery planned in the next 90 days
Show all 18Show fewer
- 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.
- Current hospitalization for complications of severe Crohn's disease
- Planned use of methotrexate or 6-mercaptopurine (azathioprine) during the induction (first 3 doses of infliximab) phase
- Current ileostomy, colostomy, ileoanal pouch, and/or previous extensive small bowel resection (>35 cm) or any CD surgery planned within the next 90 days
- History of autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, or juvenile idiopathic arthritis
- Treatment with another investigational drug in the last four weeks
- History of malignancy (including lymphoma or leukemia)
- Currently receiving treatment for histoplasmosis
- 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 infection
- Currently pregnant, breast feeding or plans to become pregnant in the next 1 year
- Inability or failure to provide informed assent/consent
- Any developmental disabilities that would impede providing assent/consent
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Kimberly Jackson, kimberly.jackson@cchmc.org
Phillip Minar, MD, MS
- Recruiting
Cleveland Clinic Children's Hospital
Cleveland, Ohio, 44106
Jacob Kurowski
Jacob Kurowski, MD
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Brendan Boyle
Brendan Boyle
- Recruiting
Riley Hospital for Children
Indianapolis, Indiana, 46202
Steven Steiner
Steven Steiner, MD
- Recruiting
Nemours Children's Health System-Jacksonville
Jacksonville, Florida, 32207
Jill Dorsey
Jill Dorsey, MD
- Recruiting
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Mallory Chavannes
Mallory Chavannes, MD
- Recruiting
Medical College of Wisconsin, Children's of Wisconsin
Milwaukee, Wisconsin, 53226
Joshua Noe
Joshua Noe, MD
- Recruiting
Children's Specialty Group
Norfolk, Virginia, 23507
Amy Quinn, Amy.quinn@chkd.org
Rana Ammoury, MD
- Recruiting
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
Alka Goyal
Alka Goyal, MD
- Recruiting
Rady Children's Hospital San Diego
San Diego, California, 92123
Laura Bauman
Laura Bauman, MD
- Recruiting
Nemours Children's Health System-Wilmington
Wilmington, Delaware, 19803
Zarela Molle-Rios
Zarela Molle-Rios, MD
About this study
Official title: Precise Infliximab Exposure and Pharmacodynamic Control to Achieve Deep Remission in Pediatric Crohn's Disease
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).
Read the detailed description
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)
- Conditions
- Crohn Disease
- Being tested
- RoadMAB, Infliximab
- Keywords
- Crohn's
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoadMABDevice
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.
InfliximabDrug
Also called Avsola, Inflectra, Ixifi, Remicade
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional dosing | Active comparator | 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. Receives: Drug: Infliximab |
| Precision dosing | Experimental | 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. Receives: Device: RoadMAB; Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Deep Remission
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
Measured: Week 52
Secondary outcomes (31)
Rate of Steroid-free Clinical Remission
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
Measured: Week 14 and Week 52
Rate of Clinical Response
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)
Measured: Week 14 and Week 52
Rate of Primary Clinical Nonresponse
On prednisone >16 consecutive weeks from start of infliximab or a PCDAI>30 or CDAI>220 for first four infusions
Measured: Week 16
Rate of Primary Biologic Nonresponse
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)
Measured: Week 16
Rate of Sustained Steroid-free Remission
PCDAI<10 (child) or CDAI<150 (adult) at dose5 to week52 and off prednisone/budesonide from week 22-52
Measured: Week 22 - Week 52
Rate of Steroid-free Remission -biomarker composite
PCDAI<10 (child) or CDAI<150 (adult), off prednisone/budesonide for ≥4 weeks, CRP≤0.5 mg/dL and fecal calprotectin <250 μg/g
Measured: Week 14 and Week 52
Rate of Endoscopic Healing
Simple endoscopic score-Crohn's disease (SES-CD) ≤2
Measured: Week 52
Rate of Complete Endoscopic Healing
SES-CD=0
Measured: Week 52
Rate of Endoscopic Remission
SES-CD<4
Measured: Week 52
Rate of Mucosal Healing
SES-CD≤2 and Ileal Global Histologic Activity Score (GHAS)/ Colon Global Histologic Activity Score (CGHAS) ≤2
Measured: Week 52
PK Model Bias
Model predicted vs. actual infliximab concentration. Bias: mean predictive error (MPE)
Measured: Week 0 - Week 52
PK Model Precision
Model predicted vs. actual infliximab concentration. Precision: root mean squared error (RMSE)
Measured: Week 0 - Week 52
Rate of IBD related event - Fistula
Occurrence of fistula and presence of antibody to infliximab >200 ng/mL
Measured: Week 0 - Week 52
Rate of IBD related - Hospitalization
Occurrence of Crohn's disease related hospitalization
Measured: Week 0 - Week 52
Rate of IBD related event - Surgery
Occurrence of Crohn's disease related surgery
Measured: Week 0 - Week 52
Rate of IBD related event - Intestinal stricture
Occurrence of Crohn's disease related intestinal stricture
Measured: Week 0 - Week 52
Rate of IBD related event - Starting corticosteroids
Occurrence of subjects starting a corticosteroid after week20
Measured: Week 0 - Week 52
Rate of IBD related event - Antibodies to infliximab
Occurrence of antibodies to infliximab defined as >200 ng/mL
Measured: Week 0 - Week 52
Rate of Growth Restoration - Weight change
In Tanner stage I-III subjects: change in baseline weight (kg) by gender and age group
Measured: Week 14 - Week 52
Rate of Growth Restoration- Height velocity
In Tanner stage I-III subjects: change in height velocity (z-score) by gender
Measured: Week 14 - Week 52
PK of infliximab in pediatric patients
Measured infliximab clearance at baseline and at week52
Measured: Week 0 - Week 52
Correlation between infliximab induction exposure and endoscopic remission
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.
Measured: Exposure Week 0 - Week 14, Efficacy Week 52
Correlation between infliximab induction exposure and deep remission
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.
Measured: Exposure Week 0 - Week 14, Efficacy Week 52
Patient Reported Outcome-2 (PRO2) Response
>50% improvement in total score from baseline
Measured: Week 6, Week 14, Week 26, Week 52
Patient Reported Outcome-2 (PRO2) Remission
Stool frequency ≤3.0 and abdominal pain ≤1.0 (from baseline)
Measured: Week 6, Week 14, Week 26, Week 52
Quality of Life & Disability -IMPACT-III score
Total IMPACT-III (child) score
Measured: Week 52
Quality of Life & Disability - Inflammatory Bowel Disease Disk score
Total Inflammatory Bowel Disease Disk (without sexual function assessment) score
Measured: Week 52
Quality of Life & Disability - Short Inflammatory Bowel Disease score
Total Short IBD Questionnaire (adult) score
Measured: Week 52
Process Evaluation -Usability of Decision Support Tool
Total System Usability Scale score
Measured: Week 0 - Week 52
Rate of Adverse events
Number of Adverse Events
Measured: Week 0 - Week 52
Rate of Serious Adverse events
Number of Serious Adverse Events
Measured: Week 0 - Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Jul 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients newly diagnosed with Crohn's disease (ages 6-22 years inclusive) within the last 90 days AND starting infliximab
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Phillip Minar, MD,MS, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660746
- Sponsor's protocol ID
- 2022-0071
- Other IDs
- R01DK132408-01
- Acronym
- REMODEL-CD
- Status last verified
- Apr 2026
- First submitted
- 29 Nov 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Minar PP, Colman RJ, Zhang N, Mizuno T, Vinks AA. Precise infliximab exposure and pharmacodynamic control to achieve deep remission in paediatric Crohn's disease (REMODEL-CD): study protocol for a multicentre, open-label, pragmatic clinical trial in the USA. BMJ Open. 2024 Mar 25;14(3):e077193. doi: 10.1136/bmjopen-2023-077193.
PubMed 38531570
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise Infliximab Exposure and Pharmacodynamic Control to Achieve Deep Remission in Pediatric Crohn's Disease
- ClinicalTrials.gov ID
- NCT05660746
- Acronym / sponsor ID
- REMODEL-CD / 2022-0071
- Conditions
- Crohn Disease
- Keywords
- Crohn's
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Janssen Scientific Affairs, LLC
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients newly diagnosed with Crohn's disease (ages 6-22 years inclusive) within the last 90 days AND starting infliximab
| Arm | Type | Receives |
|---|---|---|
| Conventional dosing | Active comparator | Drug: InfliximabInduction 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. |
| Precision dosing | Experimental | Device: RoadMAB, Drug: InfliximabInduction: 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. |
Who may qualify
- Ages
- 6 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Written informed consent from the patient (≥18 years old) or from parent/legal guardian if patient is <18 years old
- Written informed assent from patient when age appropriate
- 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)
- ≥6 years to ≤22 years of age, anti-TNF naïve and starting infliximab
- Clinical activity and luminal inflammation, defined by both (1) and (2)
Key exclusion criteria (18 listed)
- Diagnosis of ulcerative colitis or inflammatory bowel disease-unspecified
- Prior use of anti-TNF therapy (infliximab, adalimumab, certolizumab pegol, or golimumab)
- Internal (abdominal/pelvic) penetrating fistula(e) in last 180 days
- Intra-abdominal abscess/phlegmon/inflammatory mass in the last 180 days
- Active perianal abscess (receiving oral antibiotics for <7 days)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoadMABThe 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. | Device | Precision dosing |
| InfliximabAlso: Avsola, Inflectra, Ixifi, RemicadeConventional 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. | Drug | Conventional dosing, Precision dosing |
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
31 secondary outcomes
Rate of Steroid-free Clinical Remission
Time frame: Week 14 and Week 52
Rate of Clinical Response
Time frame: Week 14 and Week 52
Rate of Primary Clinical Nonresponse
Time frame: Week 16
Rate of Primary Biologic Nonresponse
Time frame: Week 16
Rate of Sustained Steroid-free Remission
Time frame: Week 22 - Week 52
Rate of Steroid-free Remission -biomarker composite
Time frame: Week 14 and Week 52
Rate of Endoscopic Healing
Time frame: Week 52
Rate of Complete Endoscopic Healing
Time frame: Week 52
Rate of Endoscopic Remission
Time frame: Week 52
Rate of Mucosal Healing
Time frame: Week 52
PK Model Bias
Time frame: Week 0 - Week 52
PK Model Precision
Time frame: Week 0 - Week 52
Rate of IBD related event - Fistula
Time frame: Week 0 - Week 52
Rate of IBD related - Hospitalization
Time frame: Week 0 - Week 52
Rate of IBD related event - Surgery
Time frame: Week 0 - Week 52
Rate of IBD related event - Intestinal stricture
Time frame: Week 0 - Week 52
Rate of IBD related event - Starting corticosteroids
Time frame: Week 0 - Week 52
Rate of IBD related event - Antibodies to infliximab
Time frame: Week 0 - Week 52
Rate of Growth Restoration - Weight change
Time frame: Week 14 - Week 52
Rate of Growth Restoration- Height velocity
Time frame: Week 14 - Week 52
PK of infliximab in pediatric patients
Time frame: Week 0 - Week 52
Correlation between infliximab induction exposure and endoscopic remission
Time frame: Exposure Week 0 - Week 14, Efficacy Week 52
Correlation between infliximab induction exposure and deep remission
Time frame: Exposure Week 0 - Week 14, Efficacy Week 52
Patient Reported Outcome-2 (PRO2) Response
Time frame: Week 6, Week 14, Week 26, Week 52
Patient Reported Outcome-2 (PRO2) Remission
Time frame: Week 6, Week 14, Week 26, Week 52
Quality of Life & Disability -IMPACT-III score
Time frame: Week 52
Quality of Life & Disability - Inflammatory Bowel Disease Disk score
Time frame: Week 52
Quality of Life & Disability - Short Inflammatory Bowel Disease score
Time frame: Week 52
Process Evaluation -Usability of Decision Support Tool
Time frame: Week 0 - Week 52
Rate of Adverse events
Time frame: Week 0 - Week 52
Rate of Serious Adverse events
Time frame: Week 0 - Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 38531570Minar PP, Colman RJ, Zhang N, Mizuno T, Vinks AA. Precise infliximab exposure and pharmacodynamic control to achieve deep remission in paediatric Crohn's disease (REMODEL-CD): study protocol for a multicentre, open-label, pragmatic clinical trial in the USA. BMJ Open. 2024 Mar 25;14(3):e077193. doi: 10.1136/bmjopen-2023-077193.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Phillip Minar, MD,MS principal investigator
Children's Hospital Medical Center, Cincinnati
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RoadMAB and Infliximab in people with Crohn Disease, run by Children's Hospital Medical Center, Cincinnati at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phillip Minar, MD, MS (513-636-4415, phillip.minar@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Deep Remission (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05660746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 3 Nov 2026.