Status:
UNKNOWN
A 12-month Real Life Study of IBD Patients Switched From Adalimumab Originator Humira® to One of Its Biosimilar
Lead Sponsor:
University Hospital, Grenoble
Conditions:
IBD Patients, Originator Treatment, Biosimilar, Switch Back
Eligibility:
All Genders
18-75 years
Brief 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 wit...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2023
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04422171
Start Date
June 19 2020
End Date
January 31 2023
Last Update
September 29 2020
Active Locations (1)
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1
Chu Grenoble Alpes
Grenoble, France, 38043