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

NCT03841942 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-06-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Guillaume Pineton de Chambrun · CHU of Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-26
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03841942 on ClinicalTrials.gov