Anoperineal LesionsPéricrohnIRMNCT07152977
Description of the Radiological Response of Anoperineal Fistulizing Lesions of Crohn's Disease
An observational study of Anoperineal Lesions and Crohn's Disease Relapse, run by University Hospital, Rouen at 1 site in France.
Trial summary
The presence of ano-perineal lesions (APL) in Crohn's disease is common and represents a major burden for the patient. More than one-third of patients with Crohn's disease will develop at least one ano-perineal lesion during the course of their disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anoperineal Lesions, Crohn's Disease Relapse
- What is being tested?
- Radiological evolution of ano-perineal lesions by MRI
- Type of treatment
- Injection or infusion
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2019to 31 Jul 2024
- Phase
- Observational
- 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
Study population: Tous les patients majeurs, suivis au CHU de Rouen pour une maladie de Crohn, compliquée de lésion ano-périnéale fistulisante, traités par Biothérapie
Who may be able to join
- All adult patients, monitored at the Rouen University Hospital for Crohn's disease, complicated by fistulizing anoperineal lesion, treated with Biotherapy, having benefited from an MRI at the start of treatment and during follow-up.
Who cannot join
- Minor patients
- Patients with an anoperineal lesion, without Crohn's disease
- Patients who have received surgical treatment with a stoma for perineal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Description of the Radiological Response of Anoperineal Fistulizing Lesions of Crohn's Disease in Patients Treated With Biotherapy
The presence of ano-perineal lesions (APL) in Crohn's disease is common and represents a major burden for the patient. More than one-third of patients with Crohn's disease will develop at least one ano-perineal lesion during the course of their disease. The cumulative incidence of APL is approximately 30% at 10 years and 43% at 20 years, regardless of the type of APL.
The appearance of ano-perineal lesions represents an important phase in the progression of Crohn's disease, but they have been little studied to date. There is little consensus regarding their overall management. Indeed, their management is difficult due to their destructive and recurrent nature, and their significant impact on patients' quality of life, continence, and sexuality is significant. The presence of ano-perineal lesions at the time of diagnosis, especially in young patients, is a poor prognostic factor.
Read the detailed description
Currently, magnetic resonance imaging is the gold standard for diagnosing anoperineal lesions in Crohn's disease. It allows for precise mapping of lesions, and its safety allows for repeated use. MRI is therefore highly effective for diagnosis and can also highlight lesions not identified during clinical examination.
Therapeutic objectives for Crohn's disease are changing, and a new "treat-to-target" strategy is emerging in the guidelines. It consists of closely monitoring clinical symptoms and endoscopic lesions to achieve complete remission. The occurrence of anoperineal lesions has been studied, and relapse is common under anti-TNF alpha therapy. It is conceivable that the treatment of anoperineal lesions could follow the same strategy. However, the role of MRI in monitoring ano-perineal lesions is poorly codified. A Rouen study investigated the feasibility of MRI for the study of ano-perineal lesions and assessed the clinical benefit of anti-TNF treatment in APL due to Crohn's disease, which was associated with a significant improvement in the Van Assche score, particularly T2 hyperintensity, a sign of perineal Crohn's disease activity. The disappearance of contrast enhancement was associated with remission. In 2017, follow-up of these APL patients treated with anti-TNF therapy found twenty-six patients in clinical remission, and 16 of the 26 had a normal MRI, defined by the absence of contrast enhancement or T2 hyperintensity.
The radiological evolution of ano-perineal lesions is also poorly understood. MRI monitoring of anoperineal lesions will be a determining element of the future "Treat-to-target" strategy, in the context of the emergence of new biotherapies and other treatments. Among the anti-TNF agents used in Crohn's disease, only infliximab has been specifically evaluated in anoperineal lesions. (15) Another anti-TNF agent used, adalimumab, has been poorly evaluated.
Data regarding the efficacy of other monoclonal antibodies such as vedolizumab (anti-integrin antibodies) and ustekinumab (anti-IL12 and IL23 antibodies) are currently limited. The main objective of the study is to describe the radiological evolution of patients with Crohn's disease, with fistulizing anoperineal lesion, treated with biotherapy.
- Conditions
- Anoperineal Lesions, Crohn's Disease Relapse
- Being tested
- Radiological evolution of ano-perineal lesions by MRI
- Keywords
- magnetic resonance imaging, anti-TNF treatment, "Treat-to-target" strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiological evolution of ano-perineal lesions by MRIOther
Patients selected retrospectively will have benefited from an MRI at diagnosis and a control MRI during follow-up. They will be selected during a follow-up consultation or a biotherapy injection in a day hospital. Patients selected consecutively are monitored at the Rouen University Hospital for perineal Cohn's disease, treated with Biotherapy: Infliximab, Adalimumab, Ustekinumab, Vedolizumab.
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological evolution of patients
The main objective of the study is to describe the radiological evolution of patients with Crohn's disease, with fistulizing anoperineal lesion, treated with biotherapy. For patients selected retrospectively, they must have had an MRI at the diagnosis of the fistulizing anoperineal lesion and a control MRI during follow-up (at 1 year and at 3 years). The fistulizing ano-perineal lesion is defined radiologically by T2 hyperintensity on the initial MRI.
Measured: at the enrollment visit, at the 1-year visit and at the 3-year visit
Secondary outcomes (3)
Clinical course of patients with APL
Describe the evolution of fecal calprotectin in patients with APL by biological analysis of stools and quantitative data collected
Measured: at the enrollment visit, at the 1-year visit and at the 3-year visit
Activity of the fistulizing anoperineal lesion
Describe the evolution of the activity score of the fistulizing anoperineal lesion by the PDAI score. The PDAI Score is collected during follow-up, at 1 year in patients treated with biotherapy: it focuses on 5 items: type of lesion, degree of induration, discharge, sexual impact and pain; each item is subdivided into 5 severity scores ranging from 0 to 4.
Measured: at the 1-year visit and at the 3-year visit
Factors associated with radiological response
Describe the factors associated with radiological response by assessment of the use of surgical management
Measured: at the 1-year visit and at the 3-year visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start31 Jul 2019
- Primary completion31 Jan 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anoperineal LesionsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152977
- Sponsor's protocol ID
- 2018/396/OB
- Other IDs
- 2018-A03187-48
- Acronym
- PéricrohnIRM
- Status last verified
- Jan 2025
- First submitted
- 25 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Radiological Response of Anoperineal Fistulizing Lesions of Crohn's Disease in Patients Treated With Biotherapy
- ClinicalTrials.gov ID
- NCT07152977
- Acronym / sponsor ID
- PéricrohnIRM / 2018/396/OB
- Conditions
- Anoperineal Lesions, Crohn's Disease Relapse
- Keywords
- magnetic resonance imaging, anti-TNF treatment, "Treat-to-target" strategy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 3 Sep 2025 (actual)
- 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.
The presence of ano-perineal lesions (APL) in Crohn's disease is common and represents a major burden for the patient. More than one-third of patients with Crohn's disease will develop at least one ano-perineal lesion during the course of their disease. The cumulative incidence of APL is approximately 30% at 10 years and 43% at 20 years, regardless of the type of APL.
The appearance of ano-perineal lesions represents an important phase in the progression of Crohn's disease, but they have been little studied to date. There is little consensus regarding their overall management. Indeed, their management is difficult due to their destructive and recurrent nature, and their significant impact on patients' quality of life, continence, and sexuality is significant. The presence of ano-perineal lesions at the time of diagnosis, especially in young patients, is a poor prognostic factor.
Detailed description
Currently, magnetic resonance imaging is the gold standard for diagnosing anoperineal lesions in Crohn's disease. It allows for precise mapping of lesions, and its safety allows for repeated use. MRI is therefore highly effective for diagnosis and can also highlight lesions not identified during clinical examination.
Therapeutic objectives for Crohn's disease are changing, and a new "treat-to-target" strategy is emerging in the guidelines. It consists of closely monitoring clinical symptoms and endoscopic lesions to achieve complete remission. The occurrence of anoperineal lesions has been studied, and relapse is common under anti-TNF alpha therapy. It is conceivable that the treatment of anoperineal lesions could follow the same strategy. However, the role of MRI in monitoring ano-perineal lesions is poorly codified. A Rouen study investigated the feasibility of MRI for the study of ano-perineal lesions and assessed the clinical benefit of anti-TNF treatment in APL due to Crohn's disease, which was associated with a significant improvement in the Van Assche score, particularly T2 hyperintensity, a sign of perineal Crohn's disease activity. The disappearance of contrast enhancement was associated with remission. In 2017, follow-up of these APL patients treated with anti-TNF therapy found twenty-six patients in clinical remission, and 16 of the 26 had a normal MRI, defined by the absence of contrast enhancement or T2 hyperintensity.
The radiological evolution of ano-perineal lesions is also poorly understood. MRI monitoring of anoperineal lesions will be a determining element of the future "Treat-to-target" strategy, in the context of the emergence of new biotherapies and other treatments. Among the anti-TNF agents used in Crohn's disease, only infliximab has been specifically evaluated in anoperineal lesions. (15) Another anti-TNF agent used, adalimumab, has been poorly evaluated.
Data regarding the efficacy of other monoclonal antibodies such as vedolizumab (anti-integrin antibodies) and ustekinumab (anti-IL12 and IL23 antibodies) are currently limited. The main objective of the study is to describe the radiological evolution of patients with Crohn's disease, with fistulizing anoperineal lesion, treated with biotherapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tous les patients majeurs, suivis au CHU de Rouen pour une maladie de Crohn, compliquée de lésion ano-périnéale fistulisante, traités par Biothérapie
Key inclusion criteria (1 listed)
- All adult patients, monitored at the Rouen University Hospital for Crohn's disease, complicated by fistulizing anoperineal lesion, treated with Biotherapy, having benefited from an MRI at the start of treatment and during follow-up.
Key exclusion criteria (3 listed)
- Minor patients
- Patients with an anoperineal lesion, without Crohn's disease
- Patients who have received surgical treatment with a stoma for perineal 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 |
|---|---|---|
| Radiological evolution of ano-perineal lesions by MRIPatients selected retrospectively will have benefited from an MRI at diagnosis and a control MRI during follow-up. They will be selected during a follow-up consultation or a biotherapy injection in a day hospital. Patients selected consecutively are monitored at the Rouen University Hospital for perineal Cohn's disease, treated with Biotherapy: Infliximab, Adalimumab, Ustekinumab, Vedolizumab. | Other | – |
Primary outcome
Radiological evolution of patients
Time frame: at the enrollment visit, at the 1-year visit and at the 3-year visit
The main objective of the study is to describe the radiological evolution of patients with Crohn's disease, with fistulizing anoperineal lesion, treated with biotherapy. For patients selected retrospectively, they must have had an MRI at the diagnosis of the fistulizing anoperineal lesion and a control MRI during follow-up (at 1 year and at 3 years). The fistulizing ano-perineal lesion is defined radiologically by T2 hyperintensity on the initial MRI.
3 secondary outcomes
Clinical course of patients with APL
Time frame: at the enrollment visit, at the 1-year visit and at the 3-year visit
Activity of the fistulizing anoperineal lesion
Time frame: at the 1-year visit and at the 3-year visit
Factors associated with radiological response
Time frame: at the 1-year visit and at the 3-year visit
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 3 Sep 2025.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anoperineal Lesions and Crohn's Disease Relapse, run by University Hospital, Rouen at 1 site in 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 1 inclusion and 3 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 3 Sep 2025. 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 France. 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?
Radiological evolution of patients (time frame: at the enrollment visit, at the 1-year visit and at the 3-year visit). 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 3 Sep 2025.