NCT01145365

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 4, 2017

Status Verified

April 1, 2017

Enrollment Period

4.5 years

First QC Date

June 14, 2010

Last Update Submit

April 1, 2017

Conditions

Crohns DiseaseFistulaAbscess

Keywords

CrohnsFistulaPerianal AbscessPerianal

Outcome Measures

Primary Outcomes (1)

  • Surgical drainage of all perianal fistulas & abscesses prior to start of medical tx improves rate of healing & prevents further abscess formation.

    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.

    54 weeks

Study Arms (2)

Combination Therapy Group

ACTIVE COMPARATOR

Patients in this arm will have surgically established drainage of their Crohns perianal fistulas and/or abscesses (exam under anesthesia (EUA)) done BEFORE beginning medical therapy with Cimzia.

Procedure: Exam under anesthesia (EUA)

Control Group

NO INTERVENTION

Patients in this group will begin medical therapy with Cimzia regardless of status of surgically established drainage.

Interventions

Exam under anesthesia (EUA)PROCEDURE

EUA established drainage of perianal fistulas \&/or abscesses will be done before patient begins medical therapy with certolizumab (Cimzia)

Combination Therapy Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-1375, United States

Location

MeSH Terms

Conditions

Crohn DiseaseFistulaAbscess

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSuppurationInfectionsInflammationPathologic Processes

Study Officials

  • David A Schwartz, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 16, 2010

Study Start

December 1, 2010

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 4, 2017

Record last verified: 2017-04

Locations

US(3)