Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy
- Registration Number
- NCT01053559
- Lead Sponsor
- Shafran Gastroenterology Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description certolizumab pegol 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.
- Primary Outcome Measures
Name Time Method Mucosal Healing 180 Days
- Secondary Outcome Measures
Name Time Method C-Reactive Protein (CRP) Level 180 Days
Trial Locations
- Locations (1)
Shafran Gastroenterology Center
🇺🇸Winter Park, Florida, United States