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

Completed · Not applicable

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT01053559

Run by

Shafran Gastroenterology Center

People needed

15

Starts

2010-01-01

Expected to finish

2013-09-01

Last updated by the study team

2014-04-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Shafran Gastroenterology Center — Winter Park, Florida, United States

Full record on ClinicalTrials.gov

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