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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00517296
First received: August 15, 2007
Last updated: July 14, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Crohn Disease
Rectal Fistula
Procedure: Rectal Endoscopic Ultrasound(EUS)
Procedure: Rectal endoscopic ultrasound (EUS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EUS Guided Treatment With Humira for Crohn's Perianal Fistulas

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Rate of durable fistula healing [ Time Frame: at week 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A, Control
Group A patients will receive Adalimumab 40 mg subcutaneously every other week for maintenance therapy without any additional interventions being performed.
Procedure: Rectal endoscopic ultrasound (EUS)
Rectal endoscopic ultrasound(EUS) performed at screening and at study completion
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517296

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: David A Schwartz, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: David A. Schwartz MD / Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00517296     History of Changes
Other Study ID Numbers: 061178
Study First Received: August 15, 2007
Last Updated: July 14, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Fistula
Rectal Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Rectal Diseases

ClinicalTrials.gov processed this record on July 22, 2014