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

Crohn's Disease Clinical Trial

— ICE  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181765
• Other study ID #: CR100747
• Secondary ID: P05088
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2010
• Last updated: December 13, 2013
• Start date: June 2012
• Est. completion date: January 2013

Study information

• Verified date: December 2013
• Source: Janssen Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Infliximab 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic Improvement	Mean change in Lewis score between Baseline and Week 26	Week 26	No
Secondary	Clinical improvement	Mean change in Crohn's Disease Activity Index (CDAI) between Baseline and Week 26.	Week 26	No
Secondary	Early endoscopic improvement	Mean change in Lewis score between Baseline and Week 10	Week 10	No
Secondary	Clinical Improvement	Mean change in CDAI between Baseline and Week 10	Week 10	No

External Links

•   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).