A 12-month Real Life Study of IBD Patients Switched From Adalimumab Originator Humira to One of Its Biosimilar

  • STATUS
    Recruiting
  • days left to enroll
    6
  • participants needed
    400
  • sponsor
    University Hospital, Grenoble
Updated on 25 January 2021

Summary

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.

Description

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.

Details
Condition IBD Patients, Originator Treatment, Biosimilar, Switch Back, IBD Patients, Originator Treatment, Biosimilar, Switch Back, IBD Patients, Originator Treatment, Biosimilar, Switch Back
Clinical Study IdentifierNCT04422171
SponsorUniversity Hospital, Grenoble
Last Modified on25 January 2021

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