EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB Treatment
Stopped early
Conditions studied: Crohns Disease
In brief
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).
Key facts
- Study ID
- NCT01582568
- Run by
- Baylor College of Medicine
- People needed
- 1
- Starts
- 2011-06-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2016-02-19
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Pre-existing fistula improving on current medical therapy. Contraindication to certolizumab use. Prior use of anti-TNF-alpha.
Where it is running
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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