Clinical Trial: Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: EUS Guided Treatment With Humira for Crohn's Perianal Fistulas

Brief Summary: This study is to assess whether utilizing endoscopic ultrasound(EUS) to guide treatment can improve durable fistula healing in patients with Crohn's perianal fistulas and to get preliminary information regarding the effectiveness of Adalimumab for Crohn's perianal fistulas.

Detailed Summary: Prospective randomized trial to assess the effectiveness of rectal EUS to guide perianal fistula treatment. Our hypothesis is that using imaging, in this case endoscopic ultrasound (EUS), to initially evaluate and then guide therapy with an anti-TNF agent (adalimumab) for fistulizing disease will lead to better short- and long-term outcomes.
Sponsor: Vanderbilt University Medical Center

Current Primary Outcome: Number of Participants With Durable Fistula Healing [ Time Frame: at week 48 ]

Complete cessation of fistula drainage at 48 weeks


Original Primary Outcome: Rate of durable fistula healing [ Time Frame: at week 48 ]

Current Secondary Outcome:

  • Changes in Disease Activity [ Time Frame: Baseline and 48 Weeks ]
    Changes in Crohn's disease activity using the Harvey Bradshaw Index (HBI) at Week 48 compared to baseline HBI Scores. Higher numbers for the HBI equal more significant disease activity. Range can vary from 0 to 17 plus the number of liquid stools per day.
  • Changes in Perianal Disease Activity Index (PDAI) [ Time Frame: Baseline and 48 Weeks ]
    Changes in Crohn's disease activity at Week 48 compared to baseline based on PDAI Scores- higher numbers equal more significant disease activity. PDAI has a range from 0 to 20.


Original Secondary Outcome:

Information By: Vanderbilt University Medical Center

Dates:
Date Received: August 15, 2007
Date Started: January 2008
Date Completion:
Last Updated: March 10, 2017
Last Verified: March 2017