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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00517296
First Posted: August 16, 2007
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Schwartz, Vanderbilt University Medical Center
  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 Phase
Crohn Disease Rectal Fistula Procedure: EUA with seton placement if necessary Drug: adalimumab Procedure: EUS Phase 4

Study Type: Interventional
Study Design: 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.
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 David Schwartz, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Number of Participants With Durable Fistula Healing [ Time Frame: at week 48 ]
    Complete cessation of fistula drainage at 48 weeks


Secondary Outcome Measures:
  • Changes in Disease Activity [ Time Frame: Baseline and 48 Weeks ]
    Changes in Crohn's disease activity using the Harvey Bradshaw Index (HBI) at Week 48 compared to baseline HBI Scores. Higher numbers for the HBI equal more significant disease activity. Range can vary from 0 to 17 plus the number of liquid stools per day.

  • Changes in Perianal Disease Activity Index (PDAI) [ Time Frame: Baseline and 48 Weeks ]
    Changes in Crohn's disease activity at Week 48 compared to baseline based on PDAI Scores- higher numbers equal more significant disease activity. PDAI has a range from 0 to 20.


Enrollment: 21
Study Start Date: January 2008
Study Completion Date: December 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adalimumab with EUS guided therapy
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.
Procedure: EUA with seton placement if necessary
Patients randomized to the combination therapy group, the surgeon will have access to EUS findings.
Drug: adalimumab
Patients began therapy with adalimumab using clinic standards for dosing.
Procedure: EUS
Patients in combination therapy group had an EUS done every 12 weeks to help guide therapy.
Active Comparator: Adalimumab
Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
Procedure: EUA with seton placement if necessary
Patients randomized to the combination therapy group, the surgeon will have access to EUS findings.
Drug: adalimumab
Patients began therapy with adalimumab using clinic standards for dosing.

Detailed 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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517296


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

Responsible Party: David Schwartz, Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00517296     History of Changes
Other Study ID Numbers: 061178
First Submitted: August 15, 2007
First Posted: August 16, 2007
Results First Submitted: August 25, 2016
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents