Clinical trial NCT00517296: Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas
Official title: EUS Guided Treatment With Humira for Crohn's Perianal Fistulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Crohn Disease
Rectal Fistula
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2007-08-16
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Prospective randomized trial to assess the effectiveness of rectal EUS to guide perianal fistula treatment. Our hypothesis is that using imaging, in this case endoscopic ultrasound (EUS), to initially evaluate and then guide therapy with an anti-TNF agent (adalimumab) for fistulizing disease will lead to better short- and long-term outcomes.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Number of Participants With Durable Fistula Healing
timeFrame: at week 48
Secondary outcomes:
measure: Changes in Disease Activity
timeFrame: Baseline and 48 Weeks
measure: Changes in Perianal Disease Activity Index (PDAI)
timeFrame: Baseline and 48 Weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David A Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References: