We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01053559
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : April 24, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Crohn's Disease Drug: certolizumab pegol

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2010
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Mucosal Healing [ Time Frame: 180 Days ]

Secondary Outcome Measures :
  1. C-Reactive Protein (CRP) Level [ Time Frame: 180 Days ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053559


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

Additional Information:
Responsible Party: Ira Shafran M.D., Principal Investigator, Shafran Gastroenterology Center
ClinicalTrials.gov Identifier: NCT01053559     History of Changes
Other Study ID Numbers: Exempt IND
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: April 24, 2014
Last Verified: April 2014

Keywords provided by Ira Shafran M.D., 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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents