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

First Received on January 19, 2010. Last Updated on July 19, 2011 History of Changes

Sponsor:	Shafran Gastroenterology Center
Collaborator:	UCB, Inc.
Information provided by:	Shafran Gastroenterology Center
ClinicalTrials.gov Identifier:	NCT01053559

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:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Endoscopy

Drug Information available for: Certolizumab pegol

U.S. FDA Resources

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:

Practice Website This link exits the ClinicalTrials.gov site

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 May 23, 2012