Evaluation of the Safety and Effectiveness of Switching From Humira® to Imraldi® in Flanders
Status:
Completed
Trial end date:
2021-01-29
Target enrollment:
Participant gender:
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.