Status:
COMPLETED
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
Lead Sponsor:
Janssen Inc.
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01181765
Start Date
June 1 2012
End Date
January 1 2013
Last Update
December 16 2013
Active Locations (2)
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1
Ottawa, Ontario, Canada
2
Toronto, Ontario, Canada