Informations générales (source: ClinicalTrials.gov)
Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL) (POMEROL)
Interventional
Phase 4
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives (Voir sur ClinicalTrials)
décembre 2021
juin 2024
19 octobre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Mathias VIDON | 29/03/2024 01:30:26 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| GETAID - 75009 - Paris - France | Marie COISNON | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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.