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

NCT04422171 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2020-09-29

No results posted yet for this study

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.

Conditions

  • IBD Patients, Originator Treatment, Biosimilar, Switch Back

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Nicolas Mathieu · CHU Grenoble Alpes

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-19
Primary Completion
2021-06-18
Completion
2023-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04422171 on ClinicalTrials.gov