Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy
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
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 19, 2010
CompletedFirst Posted
Study publicly available on registry
January 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedApril 24, 2014
April 1, 2014
3.7 years
January 19, 2010
April 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mucosal Healing
180 Days
Secondary Outcomes (1)
C-Reactive Protein (CRP) Level
180 Days
Study Arms (1)
certolizumab pegol
OTHERSubjects 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.
Interventions
400mg subcutaneous injections at week 0, week 2, week 4, then every 4 weeks thereafter
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shafran Gastroenterology Centerlead
- UCB Pharmacollaborator
Study Sites (1)
Shafran Gastroenterology Center
Winter Park, Florida, 32789, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ira Shafran, M.D.
Shafran Gastroenterology Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 19, 2010
First Posted
January 21, 2010
Study Start
January 1, 2010
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
April 24, 2014
Record last verified: 2014-04