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

Study Overview
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Brief Summary
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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
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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.

Official Title
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EUS Guided Treatment With Humira for Crohn's Perianal Fistulas

Conditions
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Crohn Disease, Rectal Fistula

Intervention / Treatment
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* Procedure: EUA with seton placement if necessary
* Drug: adalimumab
* Procedure: EUS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adalimumab with EUS guided therapy<br>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. | Procedure: EUA with seton placement if necessary<br>* Patients randomized to the combination therapy group, the surgeon will have access to EUS findings.<br>Drug: adalimumab<br>* Patients began therapy with adalimumab using clinic standards for dosing.<br>Procedure: EUS<br>* Patients in combination therapy group had an EUS done every 12 weeks to help guide therapy.<br>|
| Active Comparator: Adalimumab<br>Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement. | Procedure: EUA with seton placement if necessary<br>* Patients randomized to the combination therapy group, the surgeon will have access to EUS findings.<br>Drug: adalimumab<br>* Patients began therapy with adalimumab using clinic standards for dosing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Durable Fistula Healing | Complete cessation of fistula drainage at 48 weeks | at week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 48 Weeks | 
| 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. | Baseline and 48 Weeks |