Official Title: “EUS Guided Treatment With Humira for Crohn's Perianal Fistulas”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Procedure: Rectal Endoscopic Ultrasound(EUS)
  • Rectal Endoscopic Ultrasound(EUS) performed at screening and every 12 weeks with additional interventions performed as warranted based on the results of the EUS.
• Procedure: Rectal endoscopic ultrasound (EUS)
  • Rectal endoscopic ultrasound(EUS) performed at screening and at study completion

Arms, Groups and Cohorts in this Clinical Trial

• Other: A, Control
  • Group A patients will receive Adalimumab 40 mg subcutaneously every other week for maintenance therapy without any additional interventions being performed.
• Other: B, Intervention
  • Group B patients will receive Adalimumab 40mg every other week for maintenance therapy and will receive additional rectal EUS and appropriate interventions deemed necessary based on results of EUS.

Primary Measures

• Rate of durable fistula healing
  • Time Frame: at week 48
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Vanderbilt University

Overall Clinical Trial Officials and Contacts

David A Schwartz, MD Principal Investigator Vanderbilt University  

Overall Contact: Tonya Givens, BSN 615-936-1745 tonya.givens@vanderbilt.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00517296

Study ID Number: 061178

ClinicalTrials.gov Identifier: NCT00517296

Health Authority: United States: Food and Drug Administration