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

Crohn Disease Clinical Trial

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

Status Recruiting

Clinical 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).

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Crohn Disease
• Recurrence

• NCT number: NCT05072782
• Study type: Interventional
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: Pauline riviere
• Phone: 0972576160
• Email: projet@getaid.org
• Status: Recruiting
• Phase: Phase 4
• Start date: December 21, 2021
• Completion date: June 15, 2024