Trial Outcomes & Findings for The Use of Small Bowel Ultrasound to Predict Response to Remicade Induction (NCT NCT02488005)

NCT ID: NCT02488005

Last Updated: 2019-05-10

Results Overview

Change in Bowel Wall Thickness at week 14 as compared to baseline, prior to initiating infliximab (IFX 0).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: Baseline and Week 14
• Results posted on: 2019-05-10

Participant Flow

Participant milestones

Measure	Small Bowel Ultrasound Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Small Bowel Ultrasound Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.
Overall Study Lost to Follow-up	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Small Bowel Ultrasound n=15 Participants Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.
Age, Continuous	13 years n=15 Participants
Sex: Female, Male Female	6 Participants n=15 Participants
Sex: Female, Male Male	9 Participants n=15 Participants

PRIMARY outcome

Timeframe: Baseline and Week 14

Change in Bowel Wall Thickness at week 14 as compared to baseline, prior to initiating infliximab (IFX 0).

Outcome measures

Measure	Small Bowel Ultrasound n=13 Participants Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.
Change in Bowel Wall Thickness (BWT) baseline	5 mm Interval 1.0 to 7.0
Change in Bowel Wall Thickness (BWT) week 14	4 mm Interval 2.0 to 7.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Small Bowel Ultrasound n=13 Participants Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.
Change in Weighted Pediatric Crohn's Disease Activity Index (wPCDAI) baseline	17.5 score on a scale Interval 7.5 to 85.0
Change in Weighted Pediatric Crohn's Disease Activity Index (wPCDAI) week 14	0 score on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: Baseline and Week 14

change in fecal calprotectin at week 14 compared to baseline, using a specimen collection kit given to subjects

Outcome measures

Measure	Small Bowel Ultrasound n=13 Participants Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.
Change in Fecal Calprotectin baseline	358 mcg/g Interval 16.0 to 1074.0
Change in Fecal Calprotectin week 14	246 mcg/g Interval 16.0 to 974.0

SECONDARY outcome

Timeframe: 14 weeks

C-Reactive Protein (CRP) blood level

Outcome measures

Measure	Small Bowel Ultrasound n=13 Participants Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.
C-Reactive Protein week 14	2.5 mg/L Interval 0.2 to 23.0
C-Reactive Protein baseline	16.7 mg/L Interval 0.6 to 121.0

SECONDARY outcome

Timeframe: baseline and 14 weeks

Change in Erythrocyte Sedimentation Rate (ESR) blood level at Week 14 from baseline

Outcome measures

Measure	Small Bowel Ultrasound n=13 Participants Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.
Change in Erythrocyte Sedimentation Rate (ESR) baseline	30 mm/hr Interval 3.0 to 81.0
Change in Erythrocyte Sedimentation Rate (ESR) week 14	10 mm/hr Interval 5.0 to 32.0

SECONDARY outcome

Timeframe: Week 14

Infliximab drug (IFX) level at week 14. normal levels are <0.4 µg/mL

Outcome measures

Measure	Small Bowel Ultrasound n=13 Participants Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.
IFX Level	10.8 µg/mL Interval 2.3 to 20.5

SECONDARY outcome

Timeframe: Week 14

Anti-infliximab antibodies at week 14.

Outcome measures

Measure	Small Bowel Ultrasound n=13 Participants Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.
Anti-infliximab Antibodies (ATI)	0 U/mL Interval 0.0 to 8.3

Adverse Events

Small Bowel Ultrasound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Becky Phan

Icahn School of Medicine at Mount Sinai

Phone: 212-824-7785

Email: becky.phan@mssm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee There is an agreement between Principal Investigator and the Sponsor (and its agents) that allows study results to be posted to clinicaltrials.gov, and has limitations regarding PI's rights to publications and presentations.
• Publication restrictions are in place

Restriction type: OTHER