Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas

Completed · Phase 4

Conditions studied: Crohn Disease, Rectal Fistula

In brief

This study is to assess whether utilizing endoscopic ultrasound(EUS) to guide treatment can improve durable fistula healing in patients with Crohn's perianal fistulas and to get preliminary information regarding the effectiveness of Adalimumab for Crohn's perianal fistulas.

Key facts

Study ID

NCT00517296

Run by

Vanderbilt University Medical Center

People needed

21

Starts

2008-01-01

Expected to finish

2015-12-01

Last updated by the study team

2017-04-21

Who can join

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

You may qualify if…

• A patient may be considered for study participation if all of the following apply:
• Male and Female aged 18 years or older; and
• A confirmed diagnosis of Crohn's disease and one or more identifiable perianal fistulas.

You may not qualify if…

• A patient will be excluded from the study if one or more of the following apply:
• Females who are pregnant or breast feeding;
• Infliximab received 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 adalimumab;
• 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 carcinoma in-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

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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