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NCT01053559 Clinical Trial

Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy

Crohn's Disease Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01053559
Other study ID # Exempt IND
Secondary ID
Status Completed
Phase N/A
First received January 19, 2010
Last updated April 23, 2014
Start date January 2010
Est. completion date September 2013

Study information
Verified date April 2014
Source Shafran Gastroenterology Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• certolizumab pegol
400mg subcutaneous injections at week 0, week 2, week 4, then every 4 weeks thereafter

Locations
Country Name City State
United States Shafran Gastroenterology Center Winter Park Florida

Sponsors (2)
Lead Sponsor Collaborator
Shafran Gastroenterology Center UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mucosal Healing 180 Days
Secondary C-Reactive Protein (CRP) Level 180 Days
See also
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