A 12-month Real Life Study of IBD Patients Switched From Adalimumab Originator Humira® to One of Its Biosimilar (Rhoneswitch)
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.
Study Overview
Status
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: NICOLAS MATHIEU
- Phone Number: + 33 4 76 76 55 97
- Email: nmathieu@chu-grenoble.fr
Study Contact Backup
- Name: Laure Bordy
- Phone Number: + 33 4 76 76 61 50
- Email: lbordy@chu-grenoble.fr
Study Locations
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Grenoble Cedex 9, France, 38043
- Recruiting
- Chu Grenoble Alpes
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Contact:
- Nicolas MATTHIEU
- Email: NMathieu@chu-grenoble.fr
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Principal Investigator:
- Nicolas MATHIEU
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
INCLUSION CRITERIA
- Documented diagnosis of CD or UC established on the basis of standard clinical, endoscopic and histological criteria at least 3 months prior to inclusion.
- 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
- Diagnosis of indeterminate colitis, ischaemic colitis, fulminant colitis
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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®.
Time Frame: 12 months
|
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.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicolas Mathieu, Chu Grenoble Alpes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 38RC19.379
- 2020-A00494-35 (Other Identifier: ID RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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