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

This study has been completed.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
Ira Shafran M.D., Shafran Gastroenterology Center
ClinicalTrials.gov Identifier:
NCT01053559
First received: January 19, 2010
Last updated: April 23, 2014
Last verified: April 2014
  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: 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:
  • C-Reactive Protein (CRP) Level [ Time Frame: 180 Days ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: January 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (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, congestive heart failure [CHF], cytopenia)
  • Small bowel obstruction, stricture, or any contraindication for capsule endoscopy
  • Previous treatment with certolizumab pegol
  • Are pregnant or lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053559

Locations
United States, Florida
Shafran Gastroenterology Center
Winter Park, Florida, United States, 32789
Sponsors and Collaborators
Shafran Gastroenterology Center
UCB, Inc.
Investigators
Principal Investigator: Ira Shafran, M.D. Shafran Gastroenterology Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ira Shafran M.D., Principal Investigator, Shafran Gastroenterology Center
ClinicalTrials.gov Identifier: NCT01053559     History of Changes
Other Study ID Numbers: Exempt IND
Study First Received: January 19, 2010
Last Updated: April 23, 2014
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
Certolizumab pegol
Immunoglobulin Fab Fragments
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014