EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB Treatment

• Status: Terminated
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to assess perianal and perirectal fistula healing (complete closure) based on endoscopic ultrasound (EUS) evaluation at 3 months and by PDAI (Pouchitis Disease Activity Index) and Fistula Drainage assessment by 6 months, showing no fistula (new or recurrence) in treatment of Crohn's' disease patient with Certolizumab (Cimzia).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: UCB Pharma
• Treatments: Certolizumab Pegol

Criteria

Inclusion Criteria:

• Conventional therapy here indicates non-biologic therapy. Study subjects would have failed conventional and standard regimens of treatment such as immunomodulators (azathioprine, 6-mercaptopurine, methotrexate) or mesalamines or corticosteroids. Certolizumab is actually an approved regimen of treatment for Crohn's disease as patients with perianal fistulas fall under those with moderately to severely active disease. It is not an off-label indication, therefore would not require an IND. The study goal is to look at EUS as a tool to determine how fistula healing occurs with the use of certolizumab which is one of the biologic therapies used to treat fistulizing Crohn's disease. Crohn's disease patients with peri-anal or peri-rectal fistulizing disease. Moderate to severe Crohn's disease patients between the ages of 18 and 70 years with active peri-anal or peri-rectal fistula.

Exclusion Criteria:

• Pre-existing fistula improving on current medical therapy. Contraindication to certolizumab use. Prior use of anti-TNF-alpha.