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Study to Look at Benefit of Surgical Drainage Before Beginning Medical Therapy for Crohns Perianal Fistulas

This study is currently recruiting participants.
Verified July 2011 by Vanderbilt University
Sponsor:
Collaborator:
UCB, Inc.
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01145365
First received: June 14, 2010
Last updated: July 14, 2011
Last verified: July 2011
History of Changes
  Purpose

This study is looking at the advantage of establishing surgical drainage for Crohn's fistulas and abscesses prior to starting medical therapy.


Condition Intervention
Crohns Disease
Fistula
Abscess
 Other: Surgically established drainage of perianal fistulas &/or abscesses BEFORE medical tx

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Trial Evaluating the Benefit of INitial Surgically Established Drainage Prior to Medical Therapy for the Treatment for Crohn's Perianal Fistulas

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Surgical drainage of all perianal fistulas & abscesses prior to start of medical tx improves rate of healing & prevents further abscess formation. [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
    Our hypothesis is that by establishing surgical drainage of all perianal fistulas and abscesses prior to initiation of medical therapy, further abscess formation will be prevented and the rate of durable fistula healing will improve.


Estimated Enrollment: 80
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Combination Therapy Group
Patients in this arm will have surgically established drainage of their Crohns perianal fistulas and/or abscesses done BEFORE beginning medical therapy with Cimzia.
 Other: Surgically established drainage of perianal fistulas &/or abscesses BEFORE medical tx
Surgical established drainage of perianal fistulas &/or abscesses will be done BEFORE patient begins medical therapy with Cimzia
Other Names:
  • Cimzia
  • Certolizumab pegol
No Intervention: Control Group
Patients in this group will begin medical therapy with Cimzia regardless of status of surgically established drainage.

Detailed Description:

Currently the importance of surgically established drainage of Crohn's perianal fistulas prior to medical therapy is controversial. Several retrospective studies have suggested a benefit to this approach. (1, 2) However, there have been no prospective studies performed to answer this important question. This study aims to definitively answer this question. Our hypothesis is that by establishing surgical drainage of all perianal fistulas and abscesses prior to initiation of medical therapy, further abscess formation will be prevented and the rate of durable fistula healing will improve.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and Female aged 18 years or older;
  • A confirmed diagnosis of Crohn's disease and one or more identifiable perianal fistulas;
  • Patient's standard of care treatment plan includes the following options: a) surgical intervention with an exam under anesthesia (EUA) by colorectal surgeon, seton placement and drainage of fistula prior to initiating Certolizumab or b) initiating Certolizumab without surgical intervention;
  • Patient has had recent colonoscopy to determine disease activity and extent; and
  • Patient has had either rectal EUS or pelvic MRI (type of test based on investigator site preference) which has identified one or more perianal fistulas.

Exclusion Criteria:

  • Any of Inclusion Criteria is not met;
  • Females who are pregnant or breast feeding;
  • Anti-TNF use 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 certolizumab;
  • 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 carcinomain-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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145365

Contacts
Contact: Tonya F Givens, RN BSN CCRP 615-936-1745 tonya.givens@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232-1375
Contact: Tonya F Givens, RN BSN CCRP     615-936-1745     tonya.givens@vanderbilt.edu    
Principal Investigator: David A Schwartz, MD            
Sub-Investigator: Dawn Beaulieu, MD            
Sub-Investigator: Paul Wise, MD            
Sub-Investigator: Julianne Wagnon, NP            
Sub-Investigator: Caroline Duley, NP            
Sponsors and Collaborators
Vanderbilt University
UCB, Inc.
Investigators
Principal Investigator: David A Schwartz, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: David A. Schwartz, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01145365     History of Changes
Other Study ID Numbers: 100063
Study First Received: June 14, 2010
Last Updated: July 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Crohns
Fistula
Perianal Abscess
Perianal

Additional relevant MeSH terms:
Abscess
Crohn Disease
Fistula
Suppuration
Infection
Inflammation
Pathologic Processes
 Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013