Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL)
NCT ID: NCT05072782
Last Updated: 2022-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
360 participants
INTERVENTIONAL
2021-12-21
2024-06-15
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Status quo arm
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.
Immunosuppressors (Thiopurines or Methotrexate)
Stratification 1 : No treatments
Stratification 2 : Immunosuppressors at 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.
Infliximab CT-P13
Stratification 1: Infliximab-CT-P13
Stratification 2: Infliximab-CT-P13 in combination with immunosuppressors
Interventions
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Infliximab CT-P13
Stratification 1: Infliximab-CT-P13
Stratification 2: Infliximab-CT-P13 in combination with immunosuppressors
Immunosuppressors (Thiopurines or Methotrexate)
Stratification 1 : No treatments
Stratification 2 : Immunosuppressors at same dose
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Celltrion
INDUSTRY
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
OTHER
Responsible Party
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Locations
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GETAID
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GT-2021-01
Identifier Type: -
Identifier Source: org_study_id
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