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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Shafran Gastroenterology Center.
Recruitment status was  Recruiting
Sponsor:
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
  Purpose

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.


Condition Intervention
Crohn's Disease
Drug: certolizumab pegol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shafran Gastroenterology Center:

Primary Outcome Measures:
  • Mucosal Healing [ Time Frame: 180 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CRP Level [ Time Frame: 180 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: January 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: certolizumab pegol
400mg subcutaneous injections at week 0, week 2, week 4, then every 4 weeks thereafter
Other Name: Cimzia

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, CHF, cytopenia)
  • Small bowel obstruction, stricture, or any contraindication for capsule endoscopy
  • Previous treatment with certolizumab pegol
  • Are pregnant or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053559

Contacts
Contact: Peggy A Galvis, RN 4076298121 peggaL7@aol.com
Contact: Patricia M. Burgunder, ARNP 4076298121 pburgunder@me.com

Locations
United States, Florida
Shafran Gastroenterology Center Recruiting
Winter Park, Florida, United States, 32789
Principal Investigator: Ira Shafran, M.D.         
Sub-Investigator: Patricia M Burgunder, ARNP         
Sponsors and Collaborators
Shafran Gastroenterology Center
UCB, Inc.
Investigators
Principal Investigator: Ira Shafran, MD Shafran Gastroenterology Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ira Shafran M.D., Shafran Gastroenterology Center
ClinicalTrials.gov Identifier: NCT01053559     History of Changes
Other Study ID Numbers: Exempt IND
Study First Received: January 19, 2010
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Shafran Gastroenterology Center:
Crohn's
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014