Status:
COMPLETED
Study to Look at Benefit of Surgical Drainage Before Beginning Medical Therapy for Crohns Perianal Fistulas
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
UCB Pharma
Conditions:
Crohns Disease
Fistula
Eligibility:
All Genders
18+ years
Phase:
NA
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 appro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01145365
Start Date
December 1 2010
End Date
June 1 2015
Last Update
April 4 2017
Active Locations (3)
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1
University of Maryland
Baltimore, Maryland, United States, 21201
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
3
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-1375