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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01053559 |
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Date of registration:
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19/01/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy
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Scientific title:
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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 |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01053559 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Ira Shafran, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shafran Gastroenterology Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adults aged 18-70 with confirmed Crohn's disease that includes small bowel disease
- Moderately to severely active disease (CDAI score >220 and < 450)
- Stable doses of steroids, 5-ASA, antibiotics, Immunosuppressants
Exclusion Criteria:
- Any and all contraindications to the use of certolizumab pegol (including but not
limited to hepatitis, infection, abscess, malignancy, congestive heart failure [CHF],
cytopenia)
- Small bowel obstruction, stricture, or any contraindication for capsule endoscopy
- Previous treatment with certolizumab pegol
- Are pregnant or lactating
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: certolizumab pegol
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Primary Outcome(s)
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Mucosal Healing
[Time Frame: 180 Days]
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Secondary Outcome(s)
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C-Reactive Protein (CRP) Level
[Time Frame: 180 Days]
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Secondary ID(s)
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Exempt IND
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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