Crohn DiseasePhase 4NCT00517296

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

A Phase 4 study testing EUA with seton placement if necessary, adalimumab and EUS in people with Crohn Disease and Rectal Fistula, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Crohn Disease, Rectal Fistula
What is being tested?: EUA with seton placement if necessary, adalimumab and EUS
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Jan 2008to Dec 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: EUS Guided Treatment With Humira for Crohn's Perianal Fistulas

Read the 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.

Conditions: Crohn Disease, Rectal Fistula
Being tested: EUA with seton placement if necessary, adalimumab, EUS
Medical subject headings: Crohn Disease, Rectal Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EUA with seton placement if necessaryProcedure or surgery
Patients randomized to the combination therapy group, the surgeon will have access to EUS findings.
adalimumabDrug
Patients began therapy with adalimumab using clinic standards for dosing.
EUSProcedure or surgery
Patients in combination therapy group had an EUS done every 12 weeks to help guide therapy.

Study groups in NCT00517296
Study group	Role	What they receive
Adalimumab with EUS guided therapy	Experimental	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. Receives: Procedure: EUA with seton placement if necessary; Drug: adalimumab; Procedure: EUS
Adalimumab	Active comparator	Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement. Receives: Procedure: EUA with seton placement if necessary; Drug: adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Durable Fistula Healing
Complete cessation of fistula drainage at 48 weeks
Measured: at week 48

Secondary outcomes (2)

Changes in Disease Activity
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.
Measured: Baseline and 48 Weeks
Changes in Perianal Disease Activity Index (PDAI)
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.
Measured: Baseline and 48 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Dec 2015

First posted16 Aug 2007 (estimated)
Study startJan 2008
Primary completionDec 2014
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Crohn 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Care provider
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00517296
Sponsor's protocol ID: 061178
Status last verified: Mar 2017
First submitted: 15 Aug 2007
Last updated: 21 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Crohn Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EUS Guided Treatment With Humira for Crohn's Perianal Fistulas
ClinicalTrials.gov ID: NCT00517296
Acronym / sponsor ID: 061178
Conditions: Crohn Disease, Rectal Fistula
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Study start: Jan 2008
Primary completion: Dec 2014 (actual)
Study completion: Dec 2015 (actual)
First posted: 16 Aug 2007 (estimated)
Results: Posted 21 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2

Arm	Type	Receives
Adalimumab with EUS guided therapy	Experimental	Procedure: EUA with seton placement if necessary, Drug: adalimumab, Procedure: EUSPatients 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.
Adalimumab	Active comparator	Procedure: EUA with seton placement if necessary, Drug: adalimumabPatients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male and Female aged 18 years or older; and
A confirmed diagnosis of Crohn's disease and one or more identifiable perianal fistulas.

Key exclusion criteria (14 listed)

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;

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
EUA with seton placement if necessaryPatients randomized to the combination therapy group, the surgeon will have access to EUS findings.	Procedure or surgery	Adalimumab, Adalimumab with EUS guided therapy
adalimumabPatients began therapy with adalimumab using clinic standards for dosing.	Drug	Adalimumab, Adalimumab with EUS guided therapy
EUSPatients in combination therapy group had an EUS done every 12 weeks to help guide therapy.	Procedure or surgery	Adalimumab with EUS guided therapy

Primary outcome

Number of Participants With Durable Fistula Healing
Time frame: at week 48
Complete cessation of fistula drainage at 48 weeks

2 secondary outcomes

Changes in Disease Activity
Time frame: Baseline and 48 Weeks
Changes in Perianal Disease Activity Index (PDAI)
Time frame: Baseline and 48 Weeks

Results and safety

Results posted to the registry on 21 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adalimumab With EUS Guided Therapy	10	9
Adalimumab	11	11

Primary outcome: Number of Participants With Durable Fistula Healing

Time frame: at week 48. Number. Unit: participants

Measure	Adalimumab With EUS Guided Therapy n = 9	Adalimumab n = 11
Value	7	8

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were captured beginning with date of consent and continuing through final study visit (week 48). If an adverse event was ongoing at the time of study completion, the event was followed until resolved.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A, Combination Therapy Group	0 of 9 (0%)	3 of 9 (33.3%)	Not reported
B, Control Arm	0 of 11 (0%)	1 of 11 (9.1%)	Not reported

Limitations and caveats (from the sponsor): Small sample size which increases the chance of type II error.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Crohn Disease

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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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 21 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 1 site 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Durable Fistula Healing (time frame: at week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00517296.

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 21 Apr 2017.