Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL) (POMEROL)

  • STATUS
    Recruiting
  • End date
    Jun 15, 2024
  • participants needed
    360
  • sponsor
    Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Updated on 9 August 2022
methotrexate
endoscopy
infliximab
crohn's disease
thiopurines
bowel resection

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).

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.

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

Details
Condition Crohn Disease
Treatment Infliximab CT-P13, Immunosuppressors (Thiopurines or Methotrexate)
Clinical Study IdentifierNCT05072782
SponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Last Modified on9 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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