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Evaluation of the Safety and Effectiveness of Switching From Humira® to Imraldi® in Flanders

NCT04045782 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-04-27

No results posted yet for this study

Summary

This is a multicentre, phase IV, prospective, interventional cohort study to evaluate the safety and effectiveness of switching from Originator (Humira®) to Biosimilar (Imraldi®) adalimumab in routine clinical practice. The study will include approximately 170 patients (100 patients treated in OLV Aalst and 70 patients treated in AZ Maria Middelares Gent). The study collects baseline clinical characteristics and assessment of parameters regarding switch and overall satisfaction. For patients who are willing to switch, there is a 12-month follow-up (study) period. During the follow-up (study) period patients will continue their treatment with adalimumab, i.e. Imraldi®, except if good clinical practice for the patient would oblige the treating physician to change treatment regimen.

Conditions

  • Inflammatory Bowel Diseases

Interventions

DRUG

single arm

switch from originator (Humira) to biosimilar (Imraldi)

Sponsors & Collaborators

  • Pieter Dewint, MD PhD

    lead OTHER

Principal Investigators

  • Pieter Dewint, MD, PhD · AZ Maria Middelares Gent

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-19
Primary Completion
2021-01-29
Completion
2021-01-29

Countries

  • Belgium

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 NCT04045782 on ClinicalTrials.gov