Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/14/2017 |
| Start Date: | January 2010 |
| End Date: | September 2013 |
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
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.
Crohn's disease. Endoscopic healing is an important endpoint to measure response to
treatment.
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
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