Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy
This study is currently recruiting participants.
Verified July 2011 by Shafran Gastroenterology Center
Sponsor:
Shafran Gastroenterology Center
Collaborator:
UCB, Inc.
Information provided by:
Shafran Gastroenterology Center
ClinicalTrials.gov Identifier:
NCT01053559
First received: January 19, 2010
Last updated: July 19, 2011
Last verified: July 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 19, 2010 | ||||||||
| Last Updated Date | July 19, 2011 | ||||||||
| Start Date ICMJE | January 2010 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Mucosal Healing [ Time Frame: 180 Days ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01053559 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
CRP Level [ Time Frame: 180 Days ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy | ||||||||
| Official Title ICMJE | Open Label Investigator Initiated, Single Site Study of Mucosal Healing in Patients With Small Bowel Crohn's Disease Treated With Certolizumab Pegol (Cimzia) Assessed by Wireless Capsule Endoscopy | ||||||||
| Brief Summary | Wireless Capsule Endoscopy has been the most reliable diagnostic standard for small bowel Crohn's disease. Endoscopic healing is an important endpoint to measure response to treatment. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Crohn's Disease | ||||||||
| Intervention ICMJE | Drug: certolizumab pegol
400mg subcutaneous injections at week 0, week 2, week 4, then every 4 weeks thereafter
Other Name: Cimzia |
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| Study Arm (s) | certolizumab pegol
Subjects will receive FDA approved Cimzia injections as indicated on the product label. Subjects will undergo 3 wireless capsule endoscopies, one at screening,Day 84 and Day 168 as well as monthly bloodwork.
Intervention: Drug: certolizumab pegol |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 5 | ||||||||
| Estimated Completion Date | September 2012 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01053559 | ||||||||
| Other Study ID Numbers ICMJE | Exempt IND | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Ira Shafran M.D., Shafran Gastroenterology Center | ||||||||
| Study Sponsor ICMJE | Shafran Gastroenterology Center | ||||||||
| Collaborators ICMJE | UCB, Inc. | ||||||||
| Investigators ICMJE |
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| Information Provided By | Shafran Gastroenterology Center | ||||||||
| Verification Date | July 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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