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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
certolizumab pegol
Sponsored by
Shafran Gastroenterology Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's, Inflammatory Bowel Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shafran Gastroenterology Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

certolizumab pegol

Arm Description

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.

Outcomes

Primary Outcome Measures

Mucosal Healing

Secondary Outcome Measures

C-Reactive Protein (CRP) Level

Full Information

First Posted
January 19, 2010
Last Updated
April 23, 2014
Sponsor
Shafran Gastroenterology Center
Collaborators
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01053559
Brief Title
Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy
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 Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shafran Gastroenterology Center
Collaborators
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's, Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
certolizumab pegol
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
certolizumab pegol
Other Intervention Name(s)
Cimzia
Intervention Description
400mg subcutaneous injections at week 0, week 2, week 4, then every 4 weeks thereafter
Primary Outcome Measure Information:
Title
Mucosal Healing
Time Frame
180 Days
Secondary Outcome Measure Information:
Title
C-Reactive Protein (CRP) Level
Time Frame
180 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira Shafran, M.D.
Organizational Affiliation
Shafran Gastroenterology Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.shafran.net
Description
Practice Website

Learn more about this trial

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

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