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

Completed · Not applicable

Conditions studied: Crohns Disease, Fistula, Abscess

In brief

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

Key facts

Study ID

NCT01145365

Run by

Vanderbilt University Medical Center

People needed

21

Starts

2010-12-01

Expected to finish

2015-06-01

Last updated by the study team

2017-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Maryland — Baltimore, Maryland, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.