Anal FistulaFISTULENCT02883296
Long-term Follow-up of Anal Fistulae in Crohn's Disease Treated With Anti-TNFalpha and Interest of New MRI Sequences
A study testing Pelvis Magnetic resonance imaging in people with Anal Fistula and Crohn's Disease, run by Central Hospital, Nancy, France.
Trial summary
Main purposes of this study are : Analysis of relapse risk of anal fistulae with prospective follow-up of patients undergoing pelvic MRI every 6 months for one year. This monitoring also determines if the presence of path of fistulae visible on MRI during inclusion visit is associated to increased risk of perianal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula, Crohn's Disease
- What is being tested?
- Pelvis Magnetic resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Jun 2014
- 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
- Aware and cooperative, giving written consent
- Crohn's disease diagnosed with clinical, biological, endoscopic and/or radiologic criteria
- Patient treated with infliximab or adalimumab for perianal fistulizing Crohn's disease since at least one year
- Absence of drainage seton at inclusion
- Absence of active perianal lesions at inclusion: absence of suggestive symptoms and normal proctologic clinical examination without general anesthesia
- Patient with MRI monitoring for perianal fistulizing Crohn's disease
Who cannot join
- Patient under juridical protection or without affiliation to social security
- Refusal or impossibility of giving informed consent
- Patient not followed-up by MRI or having a contraindication for MRI, especially the presence of cardiac stimulators or implantable defibrillators, cochlear implants, neurosurgical clips, intra-orbital or encephalic metallic foreign bodies, endo-prostheses placed since at least 4 weeks or osteosynthesis material placed since less than 6 weeks or gadolinium intolerance history
- Surgery for Crohn's disease already planned at inclusion visit, individual participating to another study evaluating efficacy and/or tolerance of medical or surgical treatment for perianal fistulae of Crohn's disease
- Patient treated with anti-TNF for luminal Crohn's disease
- Patient having active perineal lesions
About this study
Main purposes of this study are :
- Analysis of relapse risk of anal fistulae with prospective follow-up of patients undergoing pelvic MRI every 6 months for one year. This monitoring also determines if the presence of path of fistulae visible on MRI during inclusion visit is associated to increased risk of perianal abscess under infliximab or adalimumab treatment.
- Evaluation of interest of new magnetic resonance imaging sequences for detection of persistent anal fistulae under infliximab or adalimumab treatment.
Read more
Secondary purposes are:
- Description of patients with one or more paths of fistulae visible with MRI after at least one year of treatment with infliximab or adalimumab administered for anal fistulae and showing a complete healing of fistulae at clinical examination of inclusion visit.
- Identification of predictive factors (included the presence of paths of fistulae visible with MRI during inclusion visit) of relapse of anal fistulae during the 1-year-follow-up after inclusion visit.
- Conditions
- Anal Fistula, Crohn's Disease
- Being tested
- Pelvis Magnetic resonance imaging
- Medical subject headings
- Rectal Fistula, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvis Magnetic resonance imagingOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with perianal fistulizing Crohn's disease | Experimental | Not described Receives: Other: Pelvis Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of severity of Crohn's disease with Van Assche MRI score
Measured: day 0
Evaluation of severity of Crohn's disease with Van Assche MRI score
Measured: 6 months
Evaluation of severity of Crohn's disease with Van Assche MRI score
Measured: 1 year
Secondary outcomes (6)
Evaluation of activity of Crohn's disease with CDAI score
Measured: day 0
Evaluation of activity of Crohn's disease with CDAI score
Measured: 6 months
Evaluation of activity of Crohn's disease with CDAI score
Measured: 1 year
Evaluation of severity of perianal injury with PDAI score
Measured: day 0
Evaluation of severity of perianal injury with PDAI score
Measured: 6 months
Evaluation of severity of perianal injury with PDAI score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startApr 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Peyrin-Biroulet, Pr, Principal investigator, Service d'Hépato Gastro-entérologie Hôpital BRABOIS- CHU de NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883296
- Sponsor's protocol ID
- 2010-A00588-31
- Acronym
- FISTULE
- Status last verified
- Aug 2016
- First submitted
- 23 Aug 2016
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Anal Fistulae in Crohn's Disease Treated With Anti-TNFalpha and Interest of New MRI Sequences
- ClinicalTrials.gov ID
- NCT02883296
- Acronym / sponsor ID
- FISTULE / 2010-A00588-31
- Conditions
- Anal Fistula, Crohn's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Aug 2016 (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.
Main purposes of this study are :
- Analysis of relapse risk of anal fistulae with prospective follow-up of patients undergoing pelvic MRI every 6 months for one year. This monitoring also determines if the presence of path of fistulae visible on MRI during inclusion visit is associated to increased risk of perianal abscess under infliximab or adalimumab treatment.
- Evaluation of interest of new magnetic resonance imaging sequences for detection of persistent anal fistulae under infliximab or adalimumab treatment.
Secondary purposes are:
- Description of patients with one or more paths of fistulae visible with MRI after at least one year of treatment with infliximab or adalimumab administered for anal fistulae and showing a complete healing of fistulae at clinical examination of inclusion visit.
- Identification of predictive factors (included the presence of paths of fistulae visible with MRI during inclusion visit) of relapse of anal fistulae during the 1-year-follow-up after inclusion visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with perianal fistulizing Crohn's disease | Experimental | Other: Pelvis Magnetic resonance imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aware and cooperative, giving written consent
- Crohn's disease diagnosed with clinical, biological, endoscopic and/or radiologic criteria
- Patient treated with infliximab or adalimumab for perianal fistulizing Crohn's disease since at least one year
- Absence of drainage seton at inclusion
- Absence of active perianal lesions at inclusion: absence of suggestive symptoms and normal proctologic clinical examination without general anesthesia
Key exclusion criteria (6 listed)
- Patient under juridical protection or without affiliation to social security
- Refusal or impossibility of giving informed consent
- Patient not followed-up by MRI or having a contraindication for MRI, especially the presence of cardiac stimulators or implantable defibrillators, cochlear implants, neurosurgical clips, intra-orbital or encephalic metallic foreign bodies, endo-prostheses placed since at least 4 weeks or osteosynthesis material placed since less than 6 weeks or gadolinium intolerance history
- Surgery for Crohn's disease already planned at inclusion visit, individual participating to another study evaluating efficacy and/or tolerance of medical or surgical treatment for perianal fistulae of Crohn's disease
- Patient treated with anti-TNF for luminal Crohn's disease
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 |
|---|---|---|
| Pelvis Magnetic resonance imaging | Other | Patients with perianal fistulizing Crohn's disease |
Primary outcome
Evaluation of severity of Crohn's disease with Van Assche MRI score
Time frame: day 0
Evaluation of severity of Crohn's disease with Van Assche MRI score
Time frame: 6 months
Evaluation of severity of Crohn's disease with Van Assche MRI score
Time frame: 1 year
6 secondary outcomes
Evaluation of activity of Crohn's disease with CDAI score
Time frame: day 0
Evaluation of activity of Crohn's disease with CDAI score
Time frame: 6 months
Evaluation of activity of Crohn's disease with CDAI score
Time frame: 1 year
Evaluation of severity of perianal injury with PDAI score
Time frame: day 0
Evaluation of severity of perianal injury with PDAI score
Time frame: 6 months
Evaluation of severity of perianal injury with PDAI score
Time frame: 1 year
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 28 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Laurent Peyrin-Biroulet, Pr principal investigator
Service d'Hépato Gastro-entérologie Hôpital BRABOIS- CHU de NANCY
Questions about this trial
What is this clinical trial studying?
A study testing Pelvis Magnetic resonance imaging in people with Anal Fistula and Crohn's Disease, run by Central Hospital, Nancy, France.
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 6 inclusion and 6 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluation of severity of Crohn's disease with Van Assche MRI score (time frame: day 0). The study lists 3 primary outcomes in all. 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 28 Apr 2021.