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

Crohn Disease Clinical Trial

Official title:

EUS Guided Treatment With Humira for Crohn's Perianal Fistulas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00517296
• Other study ID #: 061178
• Status: Active, not recruiting
• Phase: N/A
• First received: August 15, 2007
• Last updated: July 14, 2011
• Start date: January 2008
• Est. completion date: December 2011

Study information

• Verified date: July 2011
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Fistula
• Rectal Fistula

Intervention

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.
• Rectal endoscopic ultrasound (EUS)
Rectal endoscopic ultrasound(EUS) performed at screening and at study completion

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of durable fistula healing		at week 48	No