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

Primary Purpose

Crohn Disease

Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Infliximab CT-P13
Immunosuppressors (Thiopurines or Methotrexate)
Sponsored by
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Crohn's Disease, Rutgeerts score i2, Infliximab CT-P13, Postoperative reccurrence, Ileocolonic resection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GETAIDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Status quo arm

Therapy escalation arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of patients with an i0-i1 modified Rutgeerts score at 12 months.
Number of patients with an i0-i1 modified Rutgeerts score at 12 months.

Secondary Outcome Measures

Number of patients with an i3-i4 modified Rutgeerts score at 12 months
Number 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 i2b-i3-i4 modified Rutgeerts score at 12 months
Proportion of patients with an i0 modified Rutgeerts score at 12 months
Proportion of patients with an i0 modified Rutgeerts score at 12 months
Patient Reporting Outcome score at 12 months.
Patient Reporting Outcome score at 12 months will be assessed for the evaluation of disease activity (clinical remission).
Clinical postoperative recurrence
Clinical postoperative recurrence within 12 months defined by : Average daily Stool Frequency ≥ 3.5 and average daily Abdominal Pain 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 Average daily Stool frequency, average daily Abdominal Pain score, CRP and Calprotectin feacal will be combined to report the clinical postoperative recurrence (this outcome is is expressed without units)
Surgical recurrence within 12 months
Surgical recurrence within 12 months defined by need for a new ileocolonic resection. Proportion of surgical recurrence within 12 months
Endoscopic dilatation within 12 months
Endoscopic dilatation within 12 months defined by a 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 Proportion of endoscopic dilatation within 12 months
Time to clinical postoperative recurrence will be assessed
Time to clinical postoperative recurrence will be assessed
Serious adverse events
Occurence of Serious Adverse Events
Quality of life: EQ5D-5L questionnaires
Quality of life will be assessed with the EQ5D-5L questionnaire
Work productivity and activity impairement questionnaires
Work productivity and activity impairement will be assessed with work productivity and activity impairement questionnaires

Full Information

First Posted
August 18, 2021
Last Updated
August 2, 2022
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborators
Celltrion
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1. Study Identification

Unique Protocol Identification Number
NCT05072782
Brief Title
Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL)
Acronym
POMEROL
Official Title
Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborators
Celltrion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Crohn's Disease, Rutgeerts score i2, Infliximab CT-P13, Postoperative reccurrence, Ileocolonic resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Status quo arm
Arm Type
Other
Arm Description
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.
Arm Title
Therapy escalation arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Infliximab CT-P13
Other Intervention Name(s)
Remsima
Intervention Description
Stratification 1: Infliximab-CT-P13 Stratification 2: Infliximab-CT-P13 in combination with immunosuppressors
Intervention Type
Drug
Intervention Name(s)
Immunosuppressors (Thiopurines or Methotrexate)
Intervention Description
Stratification 1 : No treatments Stratification 2 : Immunosuppressors at same dose
Primary Outcome Measure Information:
Title
Number of patients with an i0-i1 modified Rutgeerts score at 12 months.
Description
Number of patients with an i0-i1 modified Rutgeerts score at 12 months.
Time Frame
Month12
Secondary Outcome Measure Information:
Title
Number of patients with an i3-i4 modified Rutgeerts score at 12 months
Description
Number of patients with an i3-i4 modified Rutgeerts score at 12 months
Time Frame
Month 12
Title
Proportion of patients with an i2b-i3-i4 modified Rutgeerts score at 12 months
Description
Proportion of patients with an i2b-i3-i4 modified Rutgeerts score at 12 months
Time Frame
Month 12
Title
Proportion of patients with an i0 modified Rutgeerts score at 12 months
Description
Proportion of patients with an i0 modified Rutgeerts score at 12 months
Time Frame
Month 12
Title
Patient Reporting Outcome score at 12 months.
Description
Patient Reporting Outcome score at 12 months will be assessed for the evaluation of disease activity (clinical remission).
Time Frame
Screening, Baseline, week 2, week 6, Month 4, Month 8, Month 12
Title
Clinical postoperative recurrence
Description
Clinical postoperative recurrence within 12 months defined by : Average daily Stool Frequency ≥ 3.5 and average daily Abdominal Pain 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 Average daily Stool frequency, average daily Abdominal Pain score, CRP and Calprotectin feacal will be combined to report the clinical postoperative recurrence (this outcome is is expressed without units)
Time Frame
Baseline, Month 4, Month 8, Month 12
Title
Surgical recurrence within 12 months
Description
Surgical recurrence within 12 months defined by need for a new ileocolonic resection. Proportion of surgical recurrence within 12 months
Time Frame
Baseline, Month 4, Month 8, Month 12
Title
Endoscopic dilatation within 12 months
Description
Endoscopic dilatation within 12 months defined by a 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 Proportion of endoscopic dilatation within 12 months
Time Frame
Baseline, Month 4, Month 8, Month 12
Title
Time to clinical postoperative recurrence will be assessed
Description
Time to clinical postoperative recurrence will be assessed
Time Frame
Baseline, Month 4, Month 8, Month 12
Title
Serious adverse events
Description
Occurence of Serious Adverse Events
Time Frame
Screening, Baseline, Month 4, Month 8, Month 12
Title
Quality of life: EQ5D-5L questionnaires
Description
Quality of life will be assessed with the EQ5D-5L questionnaire
Time Frame
Baseline, week 2, week 6, Month 4, Month 8, Month 12
Title
Work productivity and activity impairement questionnaires
Description
Work productivity and activity impairement will be assessed with work productivity and activity impairement questionnaires
Time Frame
Baseline, week 2, week 6, Month 4, Month 8, Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline riviere
Phone
0972576160
Email
projet@getaid.org
First Name & Middle Initial & Last Name or Official Title & Degree
Marie COISNON
Phone
0972576160
Email
mcoisnon@getaid.org
Facility Information:
Facility Name
GETAID
City
Paris
ZIP/Postal Code
75009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie COISNON
Email
mcoisnon@getaid.org
First Name & Middle Initial & Last Name & Degree
Charlotte Mailhat
Email
projet@getaid.org

12. IPD Sharing Statement

Learn more about this trial

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

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