The Use of Small Bowel Ultrasound to Predict Response to Remicade Induction

April 19, 2019 updated by: Icahn School of Medicine at Mount Sinai
Small bowel ultrasound (SBUS) is emerging as a well tolerated, non-invasive, radiation free, low cost measure to assess inflammatory bowel disease (IBD), and is being used as first-line imaging in Europe. SBUS findings have been shown to correlate with endoscopic findings, and a small number of recent studies have looked at change in bowel wall thickness (BWT) in response to anti-tumor necrosis factor (anti-TNF) therapy. However, the use of SBUS to detect response to anti-TNF therapy has not been tested in pediatric patients. The purpose of this study is to apply the use of SBUS to pediatric patients with Crohn's disease and to assess response to treatment with infliximab. The investigators will also measure C-reactive protein and fecal calprotectin at baseline, and additionally measuring IFX levels and anti-infliximab antibodies (ATI) at week 14 to assess change in biochemical response to infliximab treatment, as well as correlation between these markers with changes in patient reported outcomes via a weighted pediatric Crohn's disease activity questionnaire (wPCDAI) and changes in BWT. This study is novel in that it will be the first study in pediatric patients to use SBUS to assess response to IFX therapy, and will also be the first study to correlate SBUS findings with therapeutic drug monitoring (TDM). This study has the potential to propagate the use of SBUS in the pediatric population, as the use of TDM in concert with small bowel imaging post-induction will allow the investigators to tailor therapy early in the treatment course.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pediatric inflammatory bowel disease (IBD) patients are at increased risk for high ionizing radiation exposure in the assessment of their condition. Small bowel ultrasound (SBUS) is emerging as a well tolerated, non-invasive, radiation free, low cost measure to assess inflammatory bowel disease, and is being used as first-line imaging in Europe. SBUS findings have been shown to correlate with endoscopic findings, and a small number of recent studies have looked at change in bowel wall thickness (BWT), in response to anti-TNF therapy.

The use of SBUS to detect response to anti-TNF therapy has not been tested in pediatric patients. In addition, these studies frequently use Crohn's Disease Activity Index (CDAI) as a measure of clinical activity, yet it is known from multiple studies including the SONIC trial that CDAI is not a reliable or accurate measure to predict mucosal healing. A weighted PCDAI will be used instead, which has been shown to perform better than the original PCDAI and is more feasible, especially considering the study spans 14 weeks and scoring items such as height velocity from the full PCDAI will be irrelevant.

The goal of this study is to measure bowel wall thickness (BWT) prior to initiating infliximab (IFX 0) and at week 14 and to look at the correlation between change in BWT (delta BWT) with change in clinical disease activity (delta wPCDAI) between these two time points. The research team will measure fecal calprotectin at baseline and at week 14 with stool collected the day prior to the visit using a specimen collection kit given to subjects. The research team will also collect results from routine laboratories (including C-Reactive Protein, Erythrocyte Sedimentation Rate, Complete Blood Count, and Albumin) done before each infusion, and IFX levels and anti-infliximab antibodies (ATI) at week 14 to assess change in biochemical response to infliximab treatment, as well as correlation between these markers with changes in patient reported outcomes (via a wPCDAI questionnaire) and changes in BWT.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No infliximab therapy previously initiated
  • Infliximab indicated for treatment of IBD
  • Patient consent/assent and/or parent/guardian consent
  • Ability to remain in follow-up for 14 weeks from start of study

Exclusion Criteria:

  • Lack of small bowel disease
  • Inability to give consent or adhere to study protocol
  • Infliximab-experienced
  • Presence of active infections
  • Presence of abscess or strictures
  • Current or planned Pregnancy for the 14 week study duration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Small Bowel Ultrasound
Subjects will receive a small bowel ultrasound to measure bowel wall thickness at Week 0 and Week 14
Device: Ultrasound
An ultrasound of the small bowel will be done by a radiologist or ultrasound technician. Subject should not eat or drink anything (i.e. no food and no water/beverages) for 8 hours prior to their ultrasound appointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bowel Wall Thickness (BWT)
Time Frame: Baseline and Week 14
Change in Bowel Wall Thickness at week 14 as compared to baseline, prior to initiating infliximab (IFX 0).
Baseline and Week 14
Change in Weighted Pediatric Crohn's Disease Activity Index (wPCDAI)
Time Frame: Baseline and Week 14
wPCDAI at week 14 as compared to baseline. PCDAI includes three history items (abdominal pain, number of liquid stools, general wellbeing), five physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and three laboratory tests (hematocrit, albumin, erythrocyte sedimentation rate). Items are scored on a three-point scale (zero, 5, or 10 points) except for hematocrit and erythrocyte sedimentation rate which are scored as zero, 2.5 or 5 points. PCDAI scores can range from zero to 125 with higher scores indicating more active disease.
Baseline and Week 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fecal Calprotectin
Time Frame: Baseline and Week 14
change in fecal calprotectin at week 14 compared to baseline, using a specimen collection kit given to subjects
Baseline and Week 14
C-Reactive Protein
Time Frame: 14 weeks
C-Reactive Protein (CRP) blood level
14 weeks
Change in Erythrocyte Sedimentation Rate (ESR)
Time Frame: baseline and 14 weeks
Change in Erythrocyte Sedimentation Rate (ESR) blood level at Week 14 from baseline
baseline and 14 weeks
IFX Level
Time Frame: Week 14
Infliximab drug (IFX) level at week 14. normal levels are <0.4 µg/mL
Week 14
Anti-infliximab Antibodies (ATI)
Time Frame: Week 14
Anti-infliximab antibodies at week 14.
Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Janssen Scientific Affairs, LLC

Investigators

  • Principal Investigator: Marla C. Dubinsky, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

August 17, 2017

Study Completion (Actual)

August 17, 2017

Study Registration Dates

First Submitted

June 29, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Actual)

May 10, 2019

Last Update Submitted That Met QC Criteria

April 19, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 15-0878

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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