Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.
ClinicalTrials.gov Identifier:
NCT01181765
First received: August 12, 2010
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Janssen Inc.:

Primary Outcome Measures:
  • Endoscopic Improvement [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Mean change in Lewis score between Baseline and Week 26


Secondary Outcome Measures:
  • Clinical improvement [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Mean change in Crohn's Disease Activity Index (CDAI) between Baseline and Week 26.

  • Early endoscopic improvement [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    Mean change in Lewis score between Baseline and Week 10

  • Clinical Improvement [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    Mean change in CDAI between Baseline and Week 10


Enrollment: 1
Study Start Date: June 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181765

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:
No publications provided

Responsible Party: Janssen Inc.
ClinicalTrials.gov Identifier: NCT01181765     History of Changes
Other Study ID Numbers: CR100747, P05088
Study First Received: August 12, 2010
Last Updated: December 13, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Janssen Inc.:
Crohn's Disease
infliximab
capsule endoscopy

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014