Trial | NCT01053559  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    15
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.
Study Started
Jan 31
2010
Primary Completion
Sep 30
2013
Study Completion
Sep 30
2013
Last Update
Apr 24
2014
Estimate

Drug certolizumab pegol

400mg subcutaneous injections at week 0, week 2, week 4, then every 4 weeks thereafter

  • Other names: Cimzia

certolizumab pegol Other

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.

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
No Results Posted