NCT00517296

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

EUS Guided Treatment With Humira for Crohn's Perianal Fistulas

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Crohn Disease
• Rectal Fistula

Interventions

Type	Name	Description
PROCEDURE	EUA with seton placement if necessary	Patients randomized to the combination therapy group, the surgeon will have access to EUS findings.
DRUG	adalimumab	Patients began therapy with adalimumab using clinic standards for dosing.
PROCEDURE	EUS	Patients in combination therapy group had an EUS done every 12 weeks to help guide therapy.

Timeline

• Start date: 2008-01-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2007-08-16
• Last updated: 2017-04-21
• Results posted: 2017-04-21

Locations

1 site across 1 country: United States