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TERMINATED
NCT03841942
NA

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2019-06-26

Completion Date

2023-10-31

Last Updated

2026-06-22

Healthy Volunteers

No

Interventions

OTHER

clinically-based spacing strategy

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.

OTHER

Trough level-based strategy

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.

Locations (16)

Amiens University Hospital

Amiens, France

Besançon University Hospital

Besançon, France

Bordeaux University Hospital

Bordeaux, France

Caen University Hospital

Caen, France

Clermont-Ferrand University Hospital

Clermont-Ferrand, France

Lille University Hospital

Lille, France

Pineton de Chambrun

Montpellier, France

CHRU Nancy - Hôpitaux de Brabois

Nancy, France

Nantes University Hospital

Nantes, France

Nice University Hospital

Nice, France

Nîmes University Hospital

Nîmes, France

APHP Beaujon Hospital

Paris, France

APHP Paris Cochin

Paris, France

Rennes University Hospital

Rennes, France

Saint Etienne University Hospital

Saint-Etienne, France

Toulouse University Hospital

Toulouse, France