The Use of Small Bowel Ultrasound to Predict Response to Remicade Induction
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Ultrasound
Intervention type(s): Device
Intervention description(s): 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
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Inflammatory Bowel Disease; Small Bowel; Crohn's Disease; Small Bowel Ultrasound