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 (ICE)

• ClinicalTrials.gov Identifier: NCT01181765
• Recruitment Status: Completed
• First Posted: August 13, 2010
• Last Update Posted: December 16, 2013
• Sponsor: Janssen Inc.
• Information provided by (Responsible Party): Janssen Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Crohn's Disease	Biological: Infliximab 5 mg/kg body weight infused over 2 hours	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Study Start Date: June 2012
• Actual Primary Completion Date: January 2013
• Actual Study Completion Date: January 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Infliximab infusions (5 mg/kg) at weeks 0, 2, 6, 14 and 22	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.

Outcome Measures

Primary Outcome Measures :

1. Endoscopic Improvement [ Time Frame: Week 26 ]
   Mean change in Lewis score between Baseline and Week 26

Secondary Outcome Measures :

1. Clinical improvement [ Time Frame: Week 26 ]
   Mean change in Crohn's Disease Activity Index (CDAI) between Baseline and Week 26.
2. Early endoscopic improvement [ Time Frame: Week 10 ]
   Mean change in Lewis score between Baseline and Week 10
3. Clinical Improvement [ Time Frame: Week 10 ]
   Mean change in CDAI between Baseline and Week 10

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Ontario

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Sponsors and Collaborators

Janssen Inc.

Investigators

• Study Director: Janssen Inc. Clinical Trial; Janssen Inc.

More Information

Additional Information:

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). 

• Responsible Party: Janssen Inc.
• ClinicalTrials.gov Identifier: NCT01181765
• Other Study ID Numbers: CR100747; P05088 ( Other Identifier: Janssen Inc. )
• First Posted: August 13, 2010
• Last Update Posted: December 16, 2013
• Last Verified: December 2013

Keywords provided by Janssen Inc.:

Crohn's Disease; infliximab; capsule endoscopy

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Infliximab; Dermatologic Agents; Gastrointestinal Agents; Antirheumatic Agents