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Comparison of Trough Level- and Clinical-based Spacing of Infliximab Infusions in Patients With IBD in Deep Remission
Sponsor: University Hospital, Montpellier
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
Conditions
Interventions
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.
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