Status:
COMPLETED
Evaluation of the Safety and Effectiveness of Switching From Humira® to Imraldi® in Flanders
Lead Sponsor:
Pieter Dewint, MD PhD
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
The physicians and IBD nurses working with IBD patients in the participating centres will be informed by the Principal Investigator (PI) with up-to-date information regarding this trial and regarding ...
Eligibility Criteria
Inclusion
- 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
- Currently included in an interventional study.
- Pregnant or breastfeeding.
Key Trial Info
Start Date :
August 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2021
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04045782
Start Date
August 19 2019
End Date
January 29 2021
Last Update
April 27 2021
Active Locations (2)
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1
OLV Aalst
Aalst, Oost-Vlaanderen, Belgium, 9300
2
AZ Maria Middelares Gent
Ghent, Oost-Vlaanderen, Belgium, 9000