The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy

The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy (the ICE Study)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01181765

Acronym

ICE

Enrollment

Registered

2010-08-13

Start date

2012-06-30

Completion date

2013-01-31

Last updated

2013-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's Disease, infliximab, capsule endoscopy

Brief summary

This is a pilot study to estimate the efficacy of infliximab in inducing and maintaining healing of lesions in the mucosa of subjects with Crohn's disease involving their small bowel.

Detailed description

Landmark trials in Crohn's disease demonstrated the efficacy of infliximab in inducing and maintaining clinical remission. Furthermore, the endoscopic sub-studies within these trials demonstrated the ability of infliximab to rapidly induce and maintain mucosal healing as evidenced by the complete absence of mucosal breaks in the colon and terminal ileum. Unfortunately, conventional colonoscopy does not allow intestinal exploration beyond a very restricted portion of the small bowel (at most 10-15 cm of the terminal ileum). A study that systematically examines the changes in the small bowel mucosa during Crohn's disease symptomatic improvement is clearly needed. This study consists of 20 subjects and 30 weeks of follow up. All subjects will undergo wireless camera endoscopy at three (3) visits, namely: at Screening, at Week 10 and at Week 26. Infliximab is administered at (5) visits, namely: at Baseline (week 0), Week 2, Week 6, Week 14 and Week 22. In some subjects, an ileal-colonoscopy may be performed at Week 26.

Interventions

BIOLOGICALInfliximab 5 mg/kg body weight infused over 2 hours

Subjects will receive IV Infusion of infliximab 5 mg/kg body weight at Week 0, Week 2, Week 6, Week 14 and Week 22 as per the approved Canadian product monograph of infliximab.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years old * Established diagnosis of Crohn's disease and evidence of small bowel involvement * CDAI score between 220 and 450 inclusively * Lewis score of at least 790 at Screening * Colonoscopy within the last 6 months * Successful excretion of the intact patency capsule

Exclusion criteria

* Contraindications to anti-TNF therapy (TB, cardiac impairment, etc.) * Prior bowel resection * Prior anti-TNF exposure

Design outcomes

Primary

Measure	Time frame	Description
Endoscopic Improvement	Week 26	Mean change in Lewis score between Baseline and Week 26

Secondary

Measure	Time frame	Description
Clinical improvement	Week 26	Mean change in Crohn's Disease Activity Index (CDAI) between Baseline and Week 26.
Early endoscopic improvement	Week 10	Mean change in Lewis score between Baseline and Week 10
Clinical Improvement	Week 10	Mean change in CDAI between Baseline and Week 10

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026