A 12-month Real Life Study of IBD Patients Switched From Adalimumab Originator Humira® to One of Its Biosimilar
NCT ID: NCT04422171
Last Updated: 2020-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2020-06-19
2023-01-31
Brief Summary
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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.
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Detailed Description
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Questionnaires will be done in addition during all usual hospital consultations.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Inactive CD or UC outpatients are defined per clinical assessment as an Harvey Bradshaw Index (HBI) score ≤4 for CD patients and a Partial Mayo Score (PMS) ≤2 with each sub-score of 1 or less for UC and/or according to ECCO classification (Sturm 2019) within previous 3 months, demonstrating an adequate clinical remission to ada originator
* May be receiving the following drugs (but must remain on stable dose for 10 weeks):
* Oral 5-aminosalicylates (ASA) compounds or rectal formulations of 5ASA provided the dose to be stable at least 4 weeks before switching
* Azathioprine, 6-MP or methotrexate provided the dose has been stable for 4 weeks prior to inclusion (dose must remain stable for 10 weeks after switching)
* Non opposition required
Exclusion Criteria
* Current use of another TNF inhibitor included (but not limited to) infliximab, certolizumab, golimumab
* Current use of vedolizumab or ustekinumab
* Current use of JAK inhibitors or S1P modulators
* Current use of oral corticosteroids
* Active flaring CD or UC patients defined as a HBI \> 4 for CD and a PMS\>1 for UC and/or concomitant CS medication
* Pregnancy or breast feeding
* Subject under guardianship or subject deprived of liberty
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Nicolas Mathieu
Role: PRINCIPAL_INVESTIGATOR
CHU Grenoble Alpes
Locations
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Chu Grenoble Alpes
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-A00494-35
Identifier Type: OTHER
Identifier Source: secondary_id
38RC19.379
Identifier Type: -
Identifier Source: org_study_id
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