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

Completed · Not applicable

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT02488005

Run by

Icahn School of Medicine at Mount Sinai

People needed

15

Starts

2016-04-01

Expected to finish

2017-08-17

Last updated by the study team

2019-05-10

Who can join

Age: 6 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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