Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04808739
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2021-03-17
Brief Title:
Adalimumab Biosimilar in Clinical Practice
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
Retrospective Observational Study to Analyze the Effectiveness of Adalimumab
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
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:
None
Brief Summary:
This is an observational retrospective multicenter and descriptive study of patients treated with adalimumab biosimilar for psoriasis according to clinical practice
Existing data will be collected from the Dermatology Services database of the hospitals participating in the study from the medical histories of all treated patients who meet the inclusion criteria and sign informed consent
The aim of the study is to determine the effectiveness of the different adalimumab biosimilars in clinical practice
Existing data will be collected from the Dermatology Services database of the hospitals participating in the study from the medical histories of all treated patients who meet the inclusion criteria and sign informed consent
The aim of the study is to determine the effectiveness of the different adalimumab biosimilars in clinical practice
Detailed Description:
Adalimumab is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic treatment There are currently several biosimilar drugs Amgevita Imraldi Hyrimoz Idacio Hulio in addition to the reference product Humira
The reduction in the cost of production of biosimilar drugs with respect to reference products has led to their replacement by biosimilar drugs in patients initiating biological therapy but some centers are also switching to adalimumab biosimilar in patients who are controlled with original adalimumab Humira
There are no actual clinical efficacy safety data in our setting on the use of adalimumab biosimilars
There is also no evidence of maintenance response in patients who are switched from adalimumab Humira to biosimilar adalimumab in clinical practice
This retrospective study will collect demographic and disease data of the psoriasis patient treated with the different biosimilars of adalimumab as well as their comorbidities response to treatment and safety In this way data will be available in usual clinical practice to improve the management of the patient with psoriasis treated with biosimilar drugs
The reduction in the cost of production of biosimilar drugs with respect to reference products has led to their replacement by biosimilar drugs in patients initiating biological therapy but some centers are also switching to adalimumab biosimilar in patients who are controlled with original adalimumab Humira
There are no actual clinical efficacy safety data in our setting on the use of adalimumab biosimilars
There is also no evidence of maintenance response in patients who are switched from adalimumab Humira to biosimilar adalimumab in clinical practice
This retrospective study will collect demographic and disease data of the psoriasis patient treated with the different biosimilars of adalimumab as well as their comorbidities response to treatment and safety In this way data will be available in usual clinical practice to improve the management of the patient with psoriasis treated with biosimilar drugs
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