NCT05072782

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 21, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

August 4, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

August 18, 2021

Last Update Submit

August 2, 2022

Conditions

Crohn Disease

Keywords

Crohn's DiseaseRutgeerts score i2Infliximab CT-P13Postoperative reccurrenceIleocolonic resection

Outcome Measures

Primary Outcomes (1)

  • 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.

    Month12

Secondary Outcomes (11)

  • Number of patients with an i3-i4 modified Rutgeerts score at 12 months

    Month 12

  • Proportion of patients with an i2b-i3-i4 modified Rutgeerts score at 12 months

    Month 12

  • Proportion of patients with an i0 modified Rutgeerts score at 12 months

    Month 12

  • Patient Reporting Outcome score at 12 months.

    Screening, Baseline, week 2, week 6, Month 4, Month 8, Month 12

  • Clinical postoperative recurrence

    Baseline, Month 4, Month 8, Month 12

  • +6 more secondary outcomes

Study Arms (2)

Status quo arm

OTHER

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.

Drug: Immunosuppressors (Thiopurines or Methotrexate)

Therapy escalation arm

EXPERIMENTAL

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.

Drug: Infliximab CT-P13

Interventions

Infliximab CT-P13DRUG

Stratification 1: Infliximab-CT-P13 Stratification 2: Infliximab-CT-P13 in combination with immunosuppressors

Also known as: Remsima
Therapy escalation arm
Immunosuppressors (Thiopurines or Methotrexate)DRUG

Stratification 1 : No treatments Stratification 2 : Immunosuppressors at same dose

Status quo arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GETAID

Paris, 75009, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

CT-P132-mercaptopurineMethotrexate

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Pauline riviere

CONTACT

0972576160projet@getaid.org

Marie COISNON

CONTACT

0972576160mcoisnon@getaid.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2021

First Posted

October 11, 2021

Study Start

December 21, 2021

Primary Completion

June 30, 2023

Study Completion

June 15, 2024

Last Updated

August 4, 2022

Record last verified: 2022-05

Locations

FR(1)