Crohn DiseasePhase 4POMEROLNCT05072782
Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL)
A Phase 4 study testing Infliximab CT-P13 and Immunosuppressors (Thiopurines or Methotrexate) in people with Crohn Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 1 site in France.
Trial summary
Study type : A 30 months, multicentre, open-label strategic randomized controlled trial Population : Chron's Disease (CD) patients with an i2 endoscopic postoperative recurrence in the year following ileocolonic resection (6-12months after ileocolonic resection). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Infliximab CT-P13 and Immunosuppressors (Thiopurines or Methotrexate)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2021to 15 Oct 2026
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Crohn's disease diagnosed according usual criteria
- Bowel resection with ileocolonic anastomosis performed removing all inflammatory lesions
- Postoperative endoscopy performed between 6 and 12 months after ileocolonic anastomosis reaching the neoterminal ileum (patients who underwent a two stage surgical procedure are also eligible if the endoscopic evaluation is performed 6-12 months after restoration of the fecal stream)
- Moderate endoscopic postoperative recurrence classified i2 according to the Rutgeerts score at 6-12 months, validated by a blinded central reading
Who cannot join
- Patients with an ostomy
- Ulcerative colitis or IBD type unclassified
- Ileorectal or ileal pouch-anal anastomosis
- Symptoms defined as average daily SF ≥ 3.5 and average daily AP score ≥ 1.5 having started after a free interval without symptoms of at least one month after surgery
- Patients with obstructive symptoms of CD defined by a CDOS > 4
- Patients exposed to infliximab before index surgery with a primary non-response (no clinical effect after 2 infusions at the discretion of the treating gastroenterologist) or history of infusion reactions to infliximab or history of detectable anti-infliximab antibodies
Show all 15Show fewer
- Patients treated with biological therapy (except for intraocular injections) or an investigational medical product after index surgery
- Patients having started thiopurines or methotrexate more than 6 weeks after ileocolonic anastomosis with restoration of the fecal stream
- Patients in whom not all inflammatory lesions have been removed at index surgery
- Patients with active perianal Crohn's disease
- Patients with a contraindication to infliximab: cancer in the 5 years prior to inclusion excluding non-melanoma skin cancer, active tuberculosis or untreated latent tuberculosis, moderate or severe heart failure, HIV or HBV infection (serology < 6 months), recent live vaccination (within 4 weeks of baseline)
- Pregnant women
- Patients under legal protection or unable to express their consent.
- Patients not affiliated to a health insurance system.
- Patients deprived of liberty by judiciary or administrative decision or hospitalized without consent or admitted in a sanitary or social institution for another reason than research.
Trial locations and contacts
1 site in 1 country.
About this study
Study type : A 30 months, multicentre, open-label strategic randomized controlled trial
Population : Chron's Disease (CD) patients with an i2 endoscopic postoperative recurrence in the year following ileocolonic resection (6-12months after ileocolonic resection).
Read more
Treatments :
Stratification at inclusion according to prophylactic therapy.
Patients randomized in 2 arms:
- Status quo arm: if the patient received no prophylactic therapy, no treatment will be started; if the patient received a prophylactic therapy, the same will be continued at the same dose.
- Therapy escalation arm: infliximab-CT-P13 will be started with two intravenous infusions of 5 mg per kg bodyweight at week 0 and week 2 and subcutaneous injections of 120 mg every 2 weeks from week 6 onwards.
Main objective : To evaluate the proportion of CD patients without endoscopic postoperative recurrence (i0-i1) at 12 months in the arm receiving therapy escalation compared to status quo arm in patients having an i2 endoscopic postoperative recurrence 6-12months after ileocolonic anastomosis with restoration of faecal stream.
Read the detailed description
Number of patients : 360 patients in approximatively 25 sites in France.
Recruitement period : The trial duration for each patients will be 12 months from radomization (18 to 24 months from screening (ie : post-operatively))
Endpoints:
Primary endpoints: Proportion of patients with an i0-i1 modified Rutgeerts score at 12 months.
Secondary endpoints:
- Proportion of patients with an i3-i4 modified Rutgeerts score at 12 months
- Proportion of patients with an i2b-i3-i4 modified Rutgeerts score at 12 months
- Proportion of patients with an i0 modified Rutgeerts score at 12 months
- PRO2 score at 12 months
- Clinical postoperative recurrence within 12 months: average daily SF ≥ 3.5 and average daily AP score ≥ 1.5, AND
- increased CRP compared to inclusion, at least + 10 mg/l
- OR increased fecal calprotectin compared to inclusion, at least + 250 μg/g
- Surgical recurrence within 12 months: need for a new ileocolonic resection
- Endoscopic dilatation within 12 months: need for a balloon insufflation at the ileocolonic anastomosis during an ileocolonoscopy when a non-passable stenosis was present in patient having obstructive symptoms (CDOS > 4) before endoscopy
- Time to clinical postoperative recurrence
- Serious adverse events
- Quality of life: EQ5D-5L questionnaire
- Work productivity: Work Productivity and Activity Impairment questionnaire
- Conditions
- Crohn Disease
- Being tested
- Infliximab CT-P13, Immunosuppressors (Thiopurines or Methotrexate)
- Keywords
- Crohn's Disease, Rutgeerts score i2, Infliximab CT-P13, Postoperative reccurrence, Ileocolonic resection
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infliximab CT-P13Drug
Also called Remsima
Stratification 1: Infliximab-CT-P13
Stratification 2: Infliximab-CT-P13 in combination with immunosuppressors
Immunosuppressors (Thiopurines or Methotrexate)Drug
Stratification 1 : No treatments
Stratification 2 : Immunosuppressors at same dose
| Study group | Role | What they receive |
|---|---|---|
| Status quo arm | Other | If the patient received no prophylactic therapy after resection, no treatments will be started.
If the patient received a prophylactic therapy after resection, the same will be continued at the same dose. Receives: Drug: Immunosuppressors (Thiopurines or Methotrexate) |
| Therapy escalation arm | Experimental | Infliximab-CT-P13 will be started with two intravenous infusions of 5 mg per kg bodyweight at week 0 and week 2 and subcutaneous injections of 120 mg every 2 weeks from week 6 onwards. Receives: Drug: Infliximab CT-P13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with an i0-i1 modified Rutgeerts score at 12 months.
Number of patients with an i0-i1 modified Rutgeerts score at 12 months.
Measured: Month12
Secondary outcomes (11)
Number of patients with an i3-i4 modified Rutgeerts score at 12 months
Number of patients with an i3-i4 modified Rutgeerts score at 12 months
Measured: Month 12
Proportion of patients with an i2b-i3-i4 modified Rutgeerts score at 12 months
Proportion of patients with an i2b-i3-i4 modified Rutgeerts score at 12 months
Measured: Month 12
Proportion of patients with an i0 modified Rutgeerts score at 12 months
Proportion of patients with an i0 modified Rutgeerts score at 12 months
Measured: Month 12
Patient Reporting Outcome score at 12 months.
Patient Reporting Outcome score at 12 months will be assessed for the evaluation of disease activity (clinical remission).
Measured: Screening, Baseline, week 2, week 6, Month 4, Month 8, Month 12
Clinical postoperative recurrence
Clinical postoperative recurrence within 12 months defined by : Average daily Stool Frequency ≥ 3.5 and average daily Abdominal Pain score ≥ 1.5, AND
- increased CRP compared to inclusion, at least + 10 mg/l
- OR increased fecal calprotectin compared to inclusion, at least + 250 μg/g
Average daily Stool frequency, average daily Abdominal Pain score, CRP and Calprotectin feacal will be combined to report the clinical postoperative recurrence (this outcome is is expressed without units)
Measured: Baseline, Month 4, Month 8, Month 12
Surgical recurrence within 12 months
Surgical recurrence within 12 months defined by need for a new ileocolonic resection. Proportion of surgical recurrence within 12 months
Measured: Baseline, Month 4, Month 8, Month 12
Endoscopic dilatation within 12 months
Endoscopic dilatation within 12 months defined by a need for a balloon insufflation at the ileocolonic anastomosis during an ileocolonoscopy when a non-passable stenosis was present in patient having obstructive symptoms (CDOS > 4) before endoscopy Proportion of endoscopic dilatation within 12 months
Measured: Baseline, Month 4, Month 8, Month 12
Time to clinical postoperative recurrence will be assessed
Time to clinical postoperative recurrence will be assessed
Measured: Baseline, Month 4, Month 8, Month 12
Serious adverse events
Occurence of Serious Adverse Events
Measured: Screening, Baseline, Month 4, Month 8, Month 12
Quality of life: EQ5D-5L questionnaires
Quality of life will be assessed with the EQ5D-5L questionnaire
Measured: Baseline, week 2, week 6, Month 4, Month 8, Month 12
Work productivity and activity impairement questionnaires
Work productivity and activity impairement will be assessed with work productivity and activity impairement questionnaires
Measured: Baseline, week 2, week 6, Month 4, Month 8, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start21 Dec 2021
- Primary completion15 Oct 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- 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
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Collaborators
- Celltrion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072782
- Sponsor's protocol ID
- GT-2021-01
- Acronym
- POMEROL
- Status last verified
- Nov 2026
- First submitted
- 18 Aug 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL)
- ClinicalTrials.gov ID
- NCT05072782
- Acronym / sponsor ID
- POMEROL / GT-2021-01
- Conditions
- Crohn Disease
- Keywords
- Crohn's Disease, Rutgeerts score i2, Infliximab CT-P13, Postoperative reccurrence, Ileocolonic resection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Collaborators
- Celltrion
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 15 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 11 Oct 2021 (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.
Study type : A 30 months, multicentre, open-label strategic randomized controlled trial
Population : Chron's Disease (CD) patients with an i2 endoscopic postoperative recurrence in the year following ileocolonic resection (6-12months after ileocolonic resection).
Treatments :
Stratification at inclusion according to prophylactic therapy.
Patients randomized in 2 arms:
- Status quo arm: if the patient received no prophylactic therapy, no treatment will be started; if the patient received a prophylactic therapy, the same will be continued at the same dose.
- Therapy escalation arm: infliximab-CT-P13 will be started with two intravenous infusions of 5 mg per kg bodyweight at week 0 and week 2 and subcutaneous injections of 120 mg every 2 weeks from week 6 onwards.
Main objective : To evaluate the proportion of CD patients without endoscopic postoperative recurrence (i0-i1) at 12 months in the arm receiving therapy escalation compared to status quo arm in patients having an i2 endoscopic postoperative recurrence 6-12months after ileocolonic anastomosis with restoration of faecal stream.
Detailed description
Number of patients : 360 patients in approximatively 25 sites in France.
Recruitement period : The trial duration for each patients will be 12 months from radomization (18 to 24 months from screening (ie : post-operatively))
Endpoints:
Primary endpoints: Proportion of patients with an i0-i1 modified Rutgeerts score at 12 months.
Secondary endpoints:
- Proportion of patients with an i3-i4 modified Rutgeerts score at 12 months
- Proportion of patients with an i2b-i3-i4 modified Rutgeerts score at 12 months
- Proportion of patients with an i0 modified Rutgeerts score at 12 months
- PRO2 score at 12 months
- Clinical postoperative recurrence within 12 months: average daily SF ≥ 3.5 and average daily AP score ≥ 1.5, AND
- increased CRP compared to inclusion, at least + 10 mg/l
- OR increased fecal calprotectin compared to inclusion, at least + 250 μg/g
- Surgical recurrence within 12 months: need for a new ileocolonic resection
- Endoscopic dilatation within 12 months: need for a balloon insufflation at the ileocolonic anastomosis during an ileocolonoscopy when a non-passable stenosis was present in patient having obstructive symptoms (CDOS > 4) before endoscopy
- Time to clinical postoperative recurrence
- Serious adverse events
- Quality of life: EQ5D-5L questionnaire
- Work productivity: Work Productivity and Activity Impairment questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Status quo arm | Other | Drug: Immunosuppressors (Thiopurines or Methotrexate)If the patient received no prophylactic therapy after resection, no treatments will be started. If the patient received a prophylactic therapy after resection, the same will be continued at the same dose. |
| Therapy escalation arm | Experimental | Drug: Infliximab CT-P13Infliximab-CT-P13 will be started with two intravenous infusions of 5 mg per kg bodyweight at week 0 and week 2 and subcutaneous injections of 120 mg every 2 weeks from week 6 onwards. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Crohn's disease diagnosed according usual criteria
- Bowel resection with ileocolonic anastomosis performed removing all inflammatory lesions
- Postoperative endoscopy performed between 6 and 12 months after ileocolonic anastomosis reaching the neoterminal ileum (patients who underwent a two stage surgical procedure are also eligible if the endoscopic evaluation is performed 6-12 months after restoration of the fecal stream)
- Moderate endoscopic postoperative recurrence classified i2 according to the Rutgeerts score at 6-12 months, validated by a blinded central reading
Key exclusion criteria (15 listed)
- Patients with an ostomy
- Ulcerative colitis or IBD type unclassified
- Ileorectal or ileal pouch-anal anastomosis
- Symptoms defined as average daily SF ≥ 3.5 and average daily AP score ≥ 1.5 having started after a free interval without symptoms of at least one month after surgery
- Patients with obstructive symptoms of CD defined by a CDOS > 4
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 |
|---|---|---|
| Infliximab CT-P13Also: RemsimaStratification 1: Infliximab-CT-P13 Stratification 2: Infliximab-CT-P13 in combination with immunosuppressors | Drug | Therapy escalation arm |
| Immunosuppressors (Thiopurines or Methotrexate)Stratification 1 : No treatments Stratification 2 : Immunosuppressors at same dose | Drug | Status quo arm |
Primary outcome
Number of patients with an i0-i1 modified Rutgeerts score at 12 months.
Time frame: Month12
Number of patients with an i0-i1 modified Rutgeerts score at 12 months.
11 secondary outcomes
Number of patients with an i3-i4 modified Rutgeerts score at 12 months
Time frame: Month 12
Proportion of patients with an i2b-i3-i4 modified Rutgeerts score at 12 months
Time frame: Month 12
Proportion of patients with an i0 modified Rutgeerts score at 12 months
Time frame: Month 12
Patient Reporting Outcome score at 12 months.
Time frame: Screening, Baseline, week 2, week 6, Month 4, Month 8, Month 12
Clinical postoperative recurrence
Time frame: Baseline, Month 4, Month 8, Month 12
Surgical recurrence within 12 months
Time frame: Baseline, Month 4, Month 8, Month 12
Endoscopic dilatation within 12 months
Time frame: Baseline, Month 4, Month 8, Month 12
Time to clinical postoperative recurrence will be assessed
Time frame: Baseline, Month 4, Month 8, Month 12
Serious adverse events
Time frame: Screening, Baseline, Month 4, Month 8, Month 12
Quality of life: EQ5D-5L questionnaires
Time frame: Baseline, week 2, week 6, Month 4, Month 8, Month 12
Work productivity and activity impairement questionnaires
Time frame: Baseline, week 2, week 6, Month 4, Month 8, Month 12
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 6 Nov 2026.
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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.
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?
A Phase 4 study testing Infliximab CT-P13 and Immunosuppressors (Thiopurines or Methotrexate) in people with Crohn Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives 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 4 inclusion and 15 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 6 Nov 2026. 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.
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?
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?
Number of patients with an i0-i1 modified Rutgeerts score at 12 months. (time frame: Month12). 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 6 Nov 2026.