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

NCT ID: NCT01145365

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-06-30

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.

Conditions

Crohns Disease; Fistula; Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination Therapy Group

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.

Group Type: ACTIVE_COMPARATOR

Exam under anesthesia (EUA)

Intervention Type: PROCEDURE

EUA established drainage of perianal fistulas \&/or abscesses will be done before patient begins medical therapy with certolizumab (Cimzia)

Control Group

Patients in this group will begin medical therapy with Cimzia regardless of status of surgically established drainage.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exam under anesthesia (EUA)

EUA established drainage of perianal fistulas \&/or abscesses will be done before patient begins medical therapy with certolizumab (Cimzia)

Intervention Type: PROCEDURE

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.

• 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

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

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: collaborator

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

University of Maryland

Baltimore, Maryland, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

100063

Identifier Type: -

Identifier Source: org_study_id