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

Phase 4

Completed

Interventions: Procedure: EUA with seton placement if necessary
Drug: adalimumab
Procedure: EUS

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Adalimumab with EUS guided therapy	EUA with seton placement if necessary	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.
Adalimumab with EUS guided therapy	adalimumab	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.
Adalimumab with EUS guided therapy	EUS	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.
Adalimumab	EUA with seton placement if necessary	Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
Adalimumab	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 Measures

Name	Time	Method
Number of Participants With Durable Fistula Healing	at week 48	Complete cessation of fistula drainage at 48 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in Disease Activity	Baseline and 48 Weeks	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)	Baseline and 48 Weeks	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.