Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626945
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
AZAHAR Study To Describe Anifrolumab in a Real-World Setting
Sponsor:
None
Organization:
None
Study Overview
Official Title:
AZAHAR Study Observational Retrospective Study To Describe Characteristics And Clinical Outcomes of Patients With Systemic Lupus Erythematosus Initiating Saphnelo Anifrolumab in a Real-World Setting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AZAHAR
Brief Summary:
AZAHAR is an observational retrospective and longitudinal study with adults patients with SLE who initiated treatment with anifrolumab from June 1 2023 to May 31 2024
The overall objective is to describe the characteristics and clinical outcomes of patients with SLE that initiated anifrolumab during its first year of commercialization in Spain
The overall objective is to describe the characteristics and clinical outcomes of patients with SLE that initiated anifrolumab during its first year of commercialization in Spain
Detailed Description:
Systemic lupus erythematosus SLE is a chronic autoimmune disease characterized by altered immune response with excessive cytokines and antibodies production Immune response activation and maintained inflammatory status promote a multisystemic dysfunction affecting numerous organs
Anifrolumab a monoclonal antibody that binds to type 1 IFN which it is involved in pathways altered in SLE blocks its effects In clinical trials showed beneficial effects controlling the disease activity in patients with moderate and severe SLE compared to standard of care This biologic treatment was marketed in Spain on June 1 2023 This study aims to describe real world evidence of anifrolumab in Spain since its commercialization
The primary objective is to describe disease activity including low disease activity state LLDAS and clinical remission at the initiation with anifrolumab and every 6 months up to 18 months after anifrolumab initiation
The secondary objectives are
1 To estimate the flare incidence rate overall and considering severe flares only during the previous 12 months before anifrolumab initiation and every 6 months up to 18 months after anifrolumab initiation
2 To describe SLE treatment especially the use of corticosteroids CS during the previous 12 months before anifrolumab initiation and every 6 months up to 18 months after anifrolumab initiation
3 To describe anifrolumab persistence and adherence rate over time during treatment with anifrolumab
4 To describe healthcare resources utilization HRU for SLE during the previous 12 months before anifrolumab initiation and every 6 months up to 18 months after anifrolumab initiation
The exploratory objectives are
1 To describe skin manifestations at the anifrolumab initiation and every 6 months up to 18 months after anifrolumab initiation
2 To describe organ damage at the anifrolumab initiation and every 6 months up to 18 months after anifrolumab initiation
This is an observational retrospective and longitudinal chart review study including adults patients with moderate-severe SLE who initiated treatment with anifrolumab Baseline data 12 months prior to anifrolumab treatment will be collected and since anifrolumab initiation participants will be followed-up until the closest available data to the end of the study December 31st 2024
This study is based exclusively on secondary data collection from outpatient electronic medical records EMRs Therefore it will rely on already existing data from patients by the time of data collection
The expected sample size is around 120 patients from 20 hospitals in Spain
Anifrolumab a monoclonal antibody that binds to type 1 IFN which it is involved in pathways altered in SLE blocks its effects In clinical trials showed beneficial effects controlling the disease activity in patients with moderate and severe SLE compared to standard of care This biologic treatment was marketed in Spain on June 1 2023 This study aims to describe real world evidence of anifrolumab in Spain since its commercialization
The primary objective is to describe disease activity including low disease activity state LLDAS and clinical remission at the initiation with anifrolumab and every 6 months up to 18 months after anifrolumab initiation
The secondary objectives are
1 To estimate the flare incidence rate overall and considering severe flares only during the previous 12 months before anifrolumab initiation and every 6 months up to 18 months after anifrolumab initiation
2 To describe SLE treatment especially the use of corticosteroids CS during the previous 12 months before anifrolumab initiation and every 6 months up to 18 months after anifrolumab initiation
3 To describe anifrolumab persistence and adherence rate over time during treatment with anifrolumab
4 To describe healthcare resources utilization HRU for SLE during the previous 12 months before anifrolumab initiation and every 6 months up to 18 months after anifrolumab initiation
The exploratory objectives are
1 To describe skin manifestations at the anifrolumab initiation and every 6 months up to 18 months after anifrolumab initiation
2 To describe organ damage at the anifrolumab initiation and every 6 months up to 18 months after anifrolumab initiation
This is an observational retrospective and longitudinal chart review study including adults patients with moderate-severe SLE who initiated treatment with anifrolumab Baseline data 12 months prior to anifrolumab treatment will be collected and since anifrolumab initiation participants will be followed-up until the closest available data to the end of the study December 31st 2024
This study is based exclusively on secondary data collection from outpatient electronic medical records EMRs Therefore it will rely on already existing data from patients by the time of data collection
The expected sample size is around 120 patients from 20 hospitals in Spain
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: