NCT05072782

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Infliximab CT-P13	Stratification 1: Infliximab-CT-P13 Stratification 2: Infliximab-CT-P13 in combination with immunosuppressors
DRUG	Immunosuppressors (Thiopurines or Methotrexate)	Stratification 1 : No treatments Stratification 2 : Immunosuppressors at same dose

Timeline

• Start date: 2021-12-21
• Primary completion: 2023-06-30
• Completion: 2024-06-15
• First posted: 2021-10-11
• Last updated: 2022-08-04

Locations

1 site across 1 country: France