IBD Patients, Originator Treatment, Biosimilar, Switch Back Clinical Trial
Official title:
A 12-month Real Life Study of IBD Patients Under Stable Steroid Free Clinical and Biological Remission Switched From Adalimumab Originator Humira® to One of Its Biosimilar: Amgevita®,Hulio®,Hyrimoz® or Imraldi®.
Biosimilars represent great potential in cost saving and reinvestment opportunities in
healthcare. Biosimilars of adalimumab appear to be clinically equivalent to the reference
product in patients with rheumatoid arthritis and psoriasis. No data are currently available
in IBD patients. Real-life data are needed.
Minimizing the switch back is another clinical challenge in the current area of biosimilars.
The primary objective of Rhoneswitch is to describe the magnitude of patient's switch back
defined as a deterioration of symptoms without objective identification of disease activity,
12 months after the switch from ada originator Humira®.
The primary endpoint is to assess the percentage of patients who switch back to originator
therapy Humira® 12 months after switching from ada Humira® to ada Bs: Amgevita® ,Hulio®,
Hyrimoz® or Imraldi® in IBD patients without any objective markers of inflammation.
The subject will be include during usual hospital consultation after reviewing
inclusion/exclusion criteria and obtain non opposition. Data will be collected during 3 usual
hospital consultations: at month 3, month 6, and month 12. The end of study will be at month
12 or at premature termination.
Questionnaires will be done in addition during all usual hospital consultations.
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