Ignite Creation Date:
2024-05-06 @ 2:46 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04422171
Status:
UNKNOWN
Last Update Posted:
2020-09-29
First Post:
2020-06-04
Brief Title:
A 12-month Real Life Study of IBD Patients Switched From Adalimumab Originator Humira to One of Its Biosimilar
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
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 AmgevitaHulioHyrimoz or Imraldi
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Rhoneswitch
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 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 patients 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
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 patients 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
Detailed Description:
The subject will be include during usual hospital consultation after reviewing inclusionexclusion 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
Questionnaires will be done in addition during all usual hospital consultations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A00494-35 | OTHER | ID RCB | None |