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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shafran Gastroenterology Center
• Collaborator: UCB Pharma
• Treatments: Certolizumab Pegol

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