Comparison of Trough Level- and Clinical-based Spacing of Infliximab Infusions in Patients With IBD in Deep Remission

NCT03841942 | Terminated

• 1 other identifier: RECHMPL18_0024 7596
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 16

Brief Summary

Comparison of trough level-based spacing and clinical-based spacing of infliximab infusions in patients with inflammatory bowel disease in deep remission A prospective, multicenter, open-label, randomized, controlled Study

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (2)

• Rate of loss of clinical remission

  mucosal Healing

  12 months

• Rate of loss of biological remission

  antidrug antibodies with detectable IFX trough levels

  12 months

Study Arms (2)

clinically-based spacing

OTHER

All patients (as there are free from symptoms) after inclusion will have a spacing of their infliximab infusion interval which will be maintained until the end of the study.

Other: clinically-based spacing strategy

Trough level-based spacing

OTHER

Only patients with a baseline infliximab trough level ≥ 7 ug/ml will have a spacing of their infliximab infusion interval which will be maintained until the end of the study. Patients with a baseline infliximab trough level \< 7 ug/ml will keep their baseline infliximab infusion interval until the end of the study.

Other: Trough level-based strategy

Interventions

clinically-based spacing strategy OTHER

All patients (as there are free from symptoms) will have a first step of a 2 weeks spacing of their infliximab infusion interval. Then, at the next infliximab infusion, if clinical remission is maintained (CDAI \< 150 for CD, Partial Mayo score \< 3 for UC), patients will have a second step of a 2 weeks infliximab infusion spacing which will be maintained until the end of the study.

clinically-based spacing

Trough level-based strategy OTHER

patients will have at inclusion a determination of the infliximab trough level. According to this dosage, only patients with a trough level ≥ 7 µg/ml will have a first step of a 2 weeks spacing of their infliximab infusion interval. Then, at the next infliximab infusion, if clinical remission (CDAI \< 150 for CD, Partial Mayo score \< 3 for UC) is maintained and if infliximab trough level is still ≥ 7 ug/ml, patients will have a second step of 2 weeks infliximab spacing until the end of the study. Patients with a baseline infliximab trough level \< 7 ug/ml will keep their baseline infliximab infusion interval until the end of the study.

Trough level-based spacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years
• Patients with a diagnosis of Crohn's disease or ulcerative colitis according to clinical, biological, morphological and endoscopic criteria defined by the ECCO guidelines22, 23
• Patients in deep remission since at least 6 months17:
• CDAI \< 150 for CD, Partial Mayo score \< 3 for UC
• CRP (C reactive protein) \< 10 mg/l
• CDEIS \< 6 (\<3 in each segment) for CD, Mayo endoscopic subscore of 0 or 1 for UC
• For CD patients with small bowel disease: No ulceration on MRI, only asymptomatic fibrotic stenosis without inflammation and retro dilatation. No ulceration on wireless capsule endoscopy if feasible
• For patients with perianal disease: No active draining fistula, or perianal abscess on clinical exam and MRI
• Treatment with infliximab at stable dose (5mg/kg) with a stable interval for at least 4 months
• Infliximab trough level \> 3 ug/ml
• No change in other IBD therapies in the past 4 months
• Signed informed consent form
• Subjects must be able to attend all scheduled visits and to comply with all trial procedures
• Subjects must be covered by public health insurance

You may not qualify if:

• Subject unable to read or/and write
• Planned longer stay outside the region that prevents compliance with the visit plan
• Subject who are in a dependency or employment with the sponsor or the investigator
• Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date
• Previous withdrawal or spacing over 8 weeks of infliximab therapy
• Infliximab therapy at 10 mg/kg
• Patients who have presented a severe acute or delayed reaction to infliximab.
• Patients with ostomy or ileoanal pouch
• Pregnancy or planned pregnancy during the study
• Inability to follow study procedures as judged by the investigator
• Steroid use ≤3 months prior to screening

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (16)

Amiens University Hospital

Amiens, France

Location

Besançon University Hospital

Besançon, France

Location

Bordeaux University Hospital

Bordeaux, France

Location

Caen University Hospital

Caen, France

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, France

Location

Lille University Hospital

Lille, France

Location

Pineton de Chambrun

Montpellier, 34000, France

Location

CHRU Nancy - Hôpitaux de Brabois

Nancy, France

Location

Nantes University Hospital

Nantes, France

Location

Nice University Hospital

Nice, France

Location

Nîmes University Hospital

Nîmes, France

Location

APHP Beaujon Hospital

Paris, France

Location

APHP Paris Cochin

Paris, France

Location

Rennes University Hospital

Rennes, France

Location

Saint Etienne University Hospital

Saint-Etienne, France

Location

Toulouse University Hospital

Toulouse, France

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Guillaume Pineton de Chambrun

  CHU of Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 15, 2019
• Study Start: June 26, 2019
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (16)