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

Vanderbilt University Medical Center

Status and phase: Completed; Phase 4

Conditions: Rectal Fistula; Crohn Disease

Treatments: Procedure: EUS; Procedure: EUA with seton placement if necessary; Drug: adalimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00517296

061178

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

21 participants in 2 patient groups

Adalimumab with EUS guided therapy

Experimental group

Description:

Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.

Treatment:

Procedure: EUS

Drug: adalimumab

Procedure: EUA with seton placement if necessary

Adalimumab

Active Comparator group

Description:

Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.

Treatment:

Drug: adalimumab

Procedure: EUA with seton placement if necessary