Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444087
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-05-30
Brief Title:
Patients Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Patients Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation a French Multicentric Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-07
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:
SPECTRA
Brief Summary:
The primary objective of this non-interventional study is to describe the evolution of Hidradenitis suppurativa HS symptoms 12 months after secukinumab initiation based on the patients assessment of pain oozing and bad smell
Detailed Description:
This study is a prospective primary data national descriptive non-interventional multicentre study conducted by medical practice and hospital-based dermatologists across different geographical regions in France
This real-world study does not change the physician-patient relationship or patient management or follow-up Physicians remain free with their prescriptions and patient follow-up procedures In fact secukinumab initiation and all treatment decisions will be made according to routine medical care and independently of study participation
Recruited patients will be longitudinally followed-up for the duration of the study up to 24 months 3 months after secukinumab initiation or secukinumab treatment discontinuation before the end of the 24 months of follow-up early discontinuation
This real-world study does not change the physician-patient relationship or patient management or follow-up Physicians remain free with their prescriptions and patient follow-up procedures In fact secukinumab initiation and all treatment decisions will be made according to routine medical care and independently of study participation
Recruited patients will be longitudinally followed-up for the duration of the study up to 24 months 3 months after secukinumab initiation or secukinumab treatment discontinuation before the end of the 24 months of follow-up early discontinuation
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