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

Study Overview
=================
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.

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)

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Biological: Infliximab 5 mg/kg body weight infused over 2 hours


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infliximab infusions (5 mg/kg) at weeks 0, 2, 6, 14 and 22<br> | Biological: Infliximab 5 mg/kg body weight infused over 2 hours<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic Improvement | Mean change in Lewis score between Baseline and Week 26 | Week 26 | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's Disease, infliximab, capsule endoscopy