Study to Look at Benefit of Surgical Drainage Before Beginning Medical Therapy for Crohns Perianal Fistulas

Study Overview
=================
Brief Summary
-----------------
This study is looking at the advantage of establishing surgical drainage for Crohn's fistulas and abscesses prior to starting medical therapy.

Detailed Description
-----------------
Currently the importance of surgically established drainage of Crohn's perianal fistulas prior to medical therapy is controversial. Several retrospective studies have suggested a benefit to this approach. (1, 2) However, there have been no prospective studies performed to answer this important question. This study aims to definitively answer this question. Our hypothesis is that by establishing surgical drainage of all perianal fistulas and abscesses prior to initiation of medical therapy, further abscess formation will be prevented and the rate of durable fistula healing will improve.

Official Title
-----------------
A Prospective Multicenter Trial Evaluating the Benefit of INitial Surgically Established Drainage Prior to Medical Therapy for the Treatment for Crohn's Perianal Fistulas

Conditions
-----------------
Crohns Disease, Fistula, Abscess

Intervention / Treatment
-----------------
* Procedure: Exam under anesthesia (EUA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female aged 18 years or older; A confirmed diagnosis of Crohn's disease and one or more identifiable perianal fistulas; Patient's standard of care treatment plan includes the following options: a) surgical intervention with an exam under anesthesia (EUA) by colorectal surgeon, seton placement and drainage of fistula prior to initiating Certolizumab or b) initiating Certolizumab without surgical intervention; Patient has had recent colonoscopy to determine disease activity and extent; and Patient has had either rectal EUS or pelvic MRI (type of test based on investigator site preference) which has identified one or more perianal fistulas. Exclusion Criteria: Any of Inclusion Criteria is not met; Females who are pregnant or breast feeding; Anti-TNF use 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 certolizumab; 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 carcinomain-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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Combination Therapy Group<br>Patients in this arm will have surgically established drainage of their Crohns perianal fistulas and/or abscesses (exam under anesthesia (EUA)) done BEFORE beginning medical therapy with Cimzia. | Procedure: Exam under anesthesia (EUA)<br>* EUA established drainage of perianal fistulas &/or abscesses will be done before patient begins medical therapy with certolizumab (Cimzia)<br>|
| No Intervention: Control Group<br>Patients in this group will begin medical therapy with Cimzia regardless of status of surgically established drainage. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical drainage of all perianal fistulas & abscesses prior to start of medical tx improves rate of healing & prevents further abscess formation. | Our hypothesis is that by establishing surgical drainage of all perianal fistulas and abscesses prior to initiation of medical therapy, further abscess formation will be prevented and the rate of durable fistula healing will improve. | 54 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohns, Fistula, Perianal Abscess, Perianal