Trial record 2 of 3 for:    cimzia and fistula

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

June 14, 2010
July 14, 2011
December 2010
June 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01145365 on ClinicalTrials.gov Archive Site
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Study to Look at Benefit of Surgical Drainage Before Beginning Medical Therapy for Crohns Perianal Fistulas
A Prospective Multicenter Trial Evaluating the Benefit of INitial Surgically Established Drainage Prior to Medical Therapy for the Treatment for Crohn's Perianal Fistulas

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Crohns Disease
  • Fistula
  • Abscess
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
  • 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.
    Intervention: Other: Surgically established drainage of perianal fistulas &/or abscesses BEFORE medical tx
  • No Intervention: Control Group
    Patients in this group will begin medical therapy with Cimzia regardless of status of surgically established drainage.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Tonya F Givens, RN BSN CCRP 615-936-1745 tonya.givens@vanderbilt.edu
United States
 
NCT01145365
100063
No
David A. Schwartz, MD, Vanderbilt University Medical Center
Vanderbilt University
UCB, Inc.
Principal Investigator: David A Schwartz, MD Vanderbilt University
Vanderbilt University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP