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A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC

NCT04990258 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 444

Last updated 2024-01-24

No results posted yet for this study

Summary

Descriptive: A 24-month multicentre, observational, prospective cohort study. Population: IBD Patients under stable clinical and biological remission Study treatments: Patients who will be proposed to switch, or who have just switched, from the intravenous originator Remicade® or one of its biosimilars to the subcutaneous infliximab Remsima®SC as part of routine care. All consecutive patients in IBD centers participating in the study will be proposed to participate in the study during their regular outpatients' visits.

Objectives:The primary objective of PEREM study is to determine the rate of persistence of subcutaneous infliximab at 48 weeks after switching from IV infliximab to subcutaneous infliximab Remsima®SC.

Conditions

  • Inflammatory Bowel Diseases

Interventions

DRUG

Subcutaneous infliximab CT-P13 Remsima®SC

Patients will be switched from IV infliximab into subcutaneous infliximab Remsima®SC 120 mg.

Sponsors & Collaborators

  • Celltrion

    collaborator INDUSTRY

  • Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-06
Primary Completion
2024-06-30
Completion
2024-09-30

Countries

  • France

Study Locations

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Entities

Companies

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 NCT04990258 on ClinicalTrials.gov