Crohns DiseaseNCT01145365
Study to Look at Benefit of Surgical Drainage Before Beginning Medical Therapy for Crohns Perianal Fistulas
A study testing Exam under anesthesia (EUA) in people with Crohns Disease and Fistula, run by Vanderbilt University Medical Center at 3 sites in United States.
Trial summary
This study is looking at the advantage of establishing surgical drainage for Crohn's fistulas and abscesses prior to starting medical therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohns Disease, Fistula, Abscess
- What is being tested?
- Exam under anesthesia (EUA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2010to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland
Baltimore, Maryland, 21201
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-1375
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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
This study is looking at the advantage of establishing surgical drainage for Crohn's fistulas and abscesses prior to starting medical therapy.
Read the 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.
- Conditions
- Crohns Disease, Fistula, Abscess
- Being tested
- Exam under anesthesia (EUA)
- Keywords
- Crohns, Fistula, Perianal Abscess, Perianal
- Medical subject headings
- Crohn Disease, Fistula, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exam under anesthesia (EUA)Procedure or surgery
EUA established drainage of perianal fistulas \&/or abscesses will be done before patient begins medical therapy with certolizumab (Cimzia)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohns DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Principal investigator, David Schwartz, Vanderbilt University Medical Center
- Investigators
- David A Schwartz, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145365
- Sponsor's protocol ID
- 100063
- Status last verified
- Apr 2017
- First submitted
- 14 Jun 2010
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01145365
- Acronym / sponsor ID
- 100063
- Conditions
- Crohns Disease, Fistula, Abscess
- Keywords
- Crohns, Fistula, Perianal Abscess, Perianal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Dec 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is looking at the advantage of establishing surgical drainage for Crohn's fistulas and abscesses prior to starting medical therapy.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy Group | Active comparator | Procedure: Exam under anesthesia (EUA)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. |
| Control Group | No intervention | –Patients in this group will begin medical therapy with Cimzia regardless of status of surgically established drainage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exam under anesthesia (EUA)EUA established drainage of perianal fistulas \&/or abscesses will be done before patient begins medical therapy with certolizumab (Cimzia) | Procedure or surgery | Combination Therapy Group |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Schwartz, MD principal investigator
Vanderbilt University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exam under anesthesia (EUA) in people with Crohns Disease and Fistula, run by Vanderbilt University Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.