Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas
Condition: Crohn Disease; Rectal Fistula
MeSH terms: Crohn Disease; Rectal Fistula; Fistula
Intervention: EUA with seton placement if necessary; adalimumab; EUS
Intervention description: Patients randomized to the combination therapy group, the surgeon will have access to EUS findings.; Patients began therapy with adalimumab using clinic standards for dosing.; Patients in combination therapy group had an EUS done every 12 weeks to help guide therapy.
Intervention MeSH terms: Adalimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Masking description: Surgeon did not have access to EUS data for the control group prior to exam under anesthesia (EUA) and surgical intervention.
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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.