Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551519
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis FILAXOS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
FILAXOS
Brief Summary:
This is a prospective multicenter observational non-interventional study NIS in patients with Multiple Sclerosis MS and routinely assessed serum neurofilament light sNfL values in Germany
Detailed Description:
Prospective primary data will be collected from patients with sNfL outcomes in the context of switching to ofatumumab or continuing their current therapy Data collection will cover a maximum period of 24 months
The observational period will not be dictated by the protocol Baseline and follow-up visits will take place at a frequency defined as per Investigators discretion following clinical routine The diagnostic or monitoring procedures are only those ordinarily applied to therapeutic strategy and routine clinical care During the observation phase of the study data will be collected according to standard of care as recommended by KKNMS Competence Network Multiple Sclerosis in Germany
Eligible participants for the study are patients who have received treatment with category 1 DMTs and those who have included sNfL into their treatment decision-making process These patients have the option to either continue their current DMT or switch to ofatumumab According to local treatment guidelines DMT category 1 include dimethylfumaratediroximelfumarate glatirameroids Interferon beta and teriflunomide The decision to switch to ofatumumab or to continue the current DMT category 1 therapy must be made by the treating physician independently of the decision to enroll the patient in the study
The observational period will not be dictated by the protocol Baseline and follow-up visits will take place at a frequency defined as per Investigators discretion following clinical routine The diagnostic or monitoring procedures are only those ordinarily applied to therapeutic strategy and routine clinical care During the observation phase of the study data will be collected according to standard of care as recommended by KKNMS Competence Network Multiple Sclerosis in Germany
Eligible participants for the study are patients who have received treatment with category 1 DMTs and those who have included sNfL into their treatment decision-making process These patients have the option to either continue their current DMT or switch to ofatumumab According to local treatment guidelines DMT category 1 include dimethylfumaratediroximelfumarate glatirameroids Interferon beta and teriflunomide The decision to switch to ofatumumab or to continue the current DMT category 1 therapy must be made by the treating physician independently of the decision to enroll the patient in the study
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?: