Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT05368818
Status:
COMPLETED
Last Update Posted:
2022-07-01
First Post:
2022-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Analysis of the Improvement and Quality of Life Trends for UK/ROI Patients Treated With Cosentyx (Secukinumab) in a Retrospective Analysis of the BADBIR Data Source
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
An Analysis of the Improvement and Quality of Life Trends for UK/ROI Patients Treated With Cosentyx (Secukinumab) in a Retrospective Analysis of the BADBIR Data Source
Status:
COMPLETED
Status Verified Date:
2022-06
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 was a retrospective, observational study of psoriasis patients treated with secukinumab, using secondary data from BADBIR. BADBIR is a UK/ROI pharmacovigilance registry that was initiated in 2007 to monitor the long-term safety of biologic drugs used to treat psoriasis. The study used longitudinal data within the registry to track the trends relating to the disease. For the analysis of improvement and patient reported QoL, patients with a minimum of one follow-up visit were included. The index date was defined as the date of initiation of secukinumab treatment, and follow-up visits were at 6-, 12-, 18-, \& 24-months post-index.
Detailed Description:
The BADBIR data was current up until the 31st August 2019 for this analysis.
Study period: From 1st July 2015, as secukinumab was included in BADBIR in January 2016 and patients backdated 6 months, to 31st August 2019.
Identification period: From 1st July 2015 to 31st August 2019 was used to identify applicable patients for analysis.
Index date: Initiation of secukinumab treatment within the BADBIR database.
Study period: From 1st July 2015, as secukinumab was included in BADBIR in January 2016 and patients backdated 6 months, to 31st August 2019.
Identification period: From 1st July 2015 to 31st August 2019 was used to identify applicable patients for analysis.
Index date: Initiation of secukinumab treatment within the BADBIR database.
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?: