CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
adalimumab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00517296
NCT00517296Phase 4Completed
CompareCT.gov

EUS Guided Treatment With Humira for Crohn's Perianal Fistulas

Vanderbilt University Medical Center·interventional·Posted Aug 16, 2007·Updated Apr 21, 2017

In Brief

A Phase 4 clinical trial evaluating EUA with seton placement if necessary, adalimumab, and 1 other intervention for Crohn Disease and Rectal Fistula. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease, Rectal Fistula
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 16, 2007
Enrollment StartJan 1, 2008
Primary CompletionDec 1, 2014
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 18.9 years ago

Interventions

EUA with seton placement if necessaryprocedure

Patients randomized to the combination therapy group, the surgeon will have access to EUS findings.

adalimumabdrug

Patients began therapy with adalimumab using clinic standards for dosing.

EUSprocedure

Patients in combination therapy group had an EUS done every 12 weeks to help guide therapy.