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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

NCT ID: NCT01181765

Last Updated: 2013-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Crohn's Disease

Keywords

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Crohn's Disease infliximab capsule endoscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Infliximab infusions (5 mg/kg) at weeks 0, 2, 6, 14 and 22

Group Type EXPERIMENTAL

Infliximab 5 mg/kg body weight infused over 2 hours

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Inc. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Inc.

Locations

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Ottawa, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3412&filename=CR100747_CSR.PDF

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).

Other Identifiers

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P05088

Identifier Type: OTHER

Identifier Source: secondary_id

CR100747

Identifier Type: -

Identifier Source: org_study_id