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VeDOlizumab PERsistence in IBD Patients After Switching From Intravenous to Subcutaneous Administration : a Real-life Multicenter Study (DOPER)

NCT05158517 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 349

Last updated 2024-07-22

No results posted yet for this study

Summary

Descriptive : A 12-months multicenter, observational, prospective cohort study. Population : IBD patients under stable clinical and biological remission will be proposed to switch from the IV vedolizumab to the SC vedolizumab as part of routine care. All consecutive IBD 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 DOPER study is to describe SC vedolizumab persistence after switching from IV vedolizumab to SC vedolizumab at month 12.

Conditions

  • Inflammatory Bowel Diseases

Interventions

DRUG

Subcutaneous vedolizumab

Patients will be switched from IV vedolizumab into subcutaneous vedolizumab

Sponsors & Collaborators

  • Takeda

    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
2022-03-20
Primary Completion
2024-03-31
Completion
2025-03-20

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 NCT05158517 on ClinicalTrials.gov