Back to resultsStudy to Look at Benefit of Surgical Drainage Before Beginning Medical Therapy for Crohns Perianal Fistulas
Primary Purpose
Crohns Disease, Fistula, Abscess
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exam under anesthesia (EUA)
Sponsored by
About this trial
This is an interventional treatment trial for Crohns Disease focused on measuring Crohns, Fistula, Perianal Abscess, Perianal
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
Sites / Locations
- University of Maryland
- University of Pittsburgh
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Combination Therapy Group
Control Group
Arm Description
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.
Patients in this group will begin medical therapy with Cimzia regardless of status of surgically established drainage.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01145365
First Posted
June 14, 2010
Last Updated
April 1, 2017
Sponsor
Vanderbilt University Medical Center
Collaborators
UCB Pharma
1. Study Identification
Unique Protocol Identification Number
NCT01145365
Brief Title
Study to Look at Benefit of Surgical Drainage Before Beginning Medical Therapy for Crohns Perianal Fistulas
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohns Disease, Fistula, Abscess
Keywords
Crohns, Fistula, Perianal Abscess, Perianal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination Therapy Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients in this group will begin medical therapy with Cimzia regardless of status of surgically established drainage.
Intervention Type
Procedure
Intervention Name(s)
Exam under anesthesia (EUA)
Intervention Description
EUA established drainage of perianal fistulas &/or abscesses will be done before patient begins medical therapy with certolizumab (Cimzia)
Primary Outcome Measure Information:
Title
Surgical drainage of all perianal fistulas & abscesses prior to start of medical tx improves rate of healing & prevents further abscess formation.
Description
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.
Time Frame
54 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-1375
Country
United States
12. IPD Sharing Statement
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Study to Look at Benefit of Surgical Drainage Before Beginning Medical Therapy for Crohns Perianal Fistulas
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