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

• Status: Completed
• Trial end date: 2021-01-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pieter Dewint, MD PhD
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Adult (≥ 18 years of age).

• Ulcerative Colitis or Crohn's disease diagnosis.

• Maintenance therapy with Humira® for at least 8 weeks prior to switch to Imraldi®.

• Able to communicate in Flemish or French or English.

• Able and willing to voluntarily participate in the study and to provide signed informed consent.

Exclusion Criteria:

• Currently included in an interventional study.

• Pregnant or breastfeeding.