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

NCT ID: NCT00517296

Last Updated: 2017-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2015-12-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

EUA with seton placement if necessary

Intervention Type: PROCEDURE

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

adalimumab

Intervention Type: DRUG

Patients began therapy with adalimumab using clinic standards for dosing.

EUS

Intervention Type: PROCEDURE

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

Adalimumab

Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.

Group Type: ACTIVE_COMPARATOR

EUA with seton placement if necessary

Intervention Type: PROCEDURE

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

adalimumab

Intervention Type: DRUG

Patients began therapy with adalimumab using clinic standards for dosing.

Interventions

EUA with seton placement if necessary

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

Intervention Type: PROCEDURE

adalimumab

Patients began therapy with adalimumab using clinic standards for dosing.

Intervention Type: DRUG

EUS

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

A patient may be considered for study participation if all of the following apply:

• Male and Female aged 18 years or older; and
• A confirmed diagnosis of Crohn's disease and one or more identifiable perianal fistulas.

Exclusion Criteria

A patient will be excluded from the study if one or more of the following apply:

• Females who are pregnant or breast feeding;
• Infliximab received within 6 weeks prior to study entry;
• Patients who cannot take, or refuse to take concomitant immunosuppressive therapy with either azathioprine, 6-mercaptopurine, or methotrexate; Unless patient has been intolerant of these therapies in the past or is contraindicated as determined by the investigator;
• Patients who cannot take, or refuse to take concomitant antibiotic therapy;
• Patients with severe anal stenosis or tenderness which would preclude colonoscopy and / or rectal EUS;
• Patients who cannot take or refuse to take adalimumab;
• Patients with active or latent tuberculosis;
• Patients who have had systemic antibiotic, antiviral or antifungal treatment(s) within 3 weeks prior to Screening for all non-Crohn's related infections;
• Patients concurrently taking anakinra (Kineret);
• Patients with a history of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma in-situ of the cervix;
• Patients with chronic hematologic problems such as bleeding dyscrasias;
• Patients with a history of demyelinating disease (i.e. multiple sclerosis); and
• Patients with congestive heart failure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Schwartz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David A Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

061178

Identifier Type: -

Identifier Source: org_study_id