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)
|Crohn's Disease||Biological: Infliximab 5 mg/kg body weight infused over 2 hours||Phase 4|
|Study Design:||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)|
- Endoscopic Improvement [ Time Frame: Week 26 ]Mean change in Lewis score between Baseline and Week 26
- Clinical improvement [ Time Frame: Week 26 ]Mean change in Crohn's Disease Activity Index (CDAI) between Baseline and Week 26.
- Early endoscopic improvement [ Time Frame: Week 10 ]Mean change in Lewis score between Baseline and Week 10
- Clinical Improvement [ Time Frame: Week 10 ]Mean change in CDAI between Baseline and Week 10
|Study Start Date:||June 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181765
|Ottawa, Ontario, Canada|
|Toronto, Ontario, Canada|
|Study Director:||Janssen Inc. Clinical Trial||Janssen Inc.|