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

Primary Purpose

Crohn Disease, Rectal Fistula

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

EUA with seton placement if necessary

adalimumab

EUS

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adalimumab with EUS guided therapy

Adalimumab

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Number of Participants With Durable Fistula Healing

Complete cessation of fistula drainage at 48 weeks

Secondary Outcome Measures

Changes in Disease Activity

Changes in Crohn's disease activity using the Harvey Bradshaw Index (HBI) at Week 48 compared to baseline HBI Scores. Higher numbers for the HBI equal more significant disease activity. Range can vary from 0 to 17 plus the number of liquid stools per day.

Changes in Perianal Disease Activity Index (PDAI)

Changes in Crohn's disease activity at Week 48 compared to baseline based on PDAI Scores- higher numbers equal more significant disease activity. PDAI has a range from 0 to 20.

Full Information

NCT ID

NCT00517296

First Posted

August 15, 2007

Last Updated

March 10, 2017

Sponsor

Vanderbilt University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00517296

Brief Title

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

Official Title

EUS Guided Treatment With Humira for Crohn's Perianal Fistulas

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease, Rectal Fistula

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Masking Description

Surgeon did not have access to EUS data for the control group prior to exam under anesthesia (EUA) and surgical intervention.

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adalimumab with EUS guided therapy

Arm Type

Experimental

Arm Description

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.

Arm Title

Adalimumab

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

EUA with seton placement if necessary

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

adalimumab

Intervention Description

Patients began therapy with adalimumab using clinic standards for dosing.

Intervention Type

Procedure

Intervention Name(s)

EUS

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Durable Fistula Healing

Description

Complete cessation of fistula drainage at 48 weeks

Time Frame

at week 48

Secondary Outcome Measure Information:

Title

Changes in Disease Activity

Description

Time Frame

Baseline and 48 Weeks

Title

Changes in Perianal Disease Activity Index (PDAI)

Description

Changes in Crohn's disease activity at Week 48 compared to baseline based on PDAI Scores- higher numbers equal more significant disease activity. PDAI has a range from 0 to 20.

Time Frame

Baseline and 48 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David A Schwartz, MD

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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