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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT00517296
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 31, 2008
Status verified
Mar 2017
Primary completion
Dec 31, 2014
Completion
Dec 31, 2015

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab with EUS guided therapy
    Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
  • Active Comparator: Adalimumab
    Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232-

Find similar trials in Nashville, TN

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Vanderbilt University Medical Center· Nashville, TN

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