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

NCT00517296 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-04-21

Study results available
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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.

Conditions

  • Crohn Disease
  • Rectal Fistula

Interventions

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.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • David A Schwartz, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00517296 on ClinicalTrials.gov