Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486779
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-27
Brief Title:
Kesimpta Ofatumumab in Greek Multiple Sclerosis Patients - an Observational Study
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Non-interventional multiCenter Observational Study to Evaluate tHe Effectiveness and Patient-Reported Outcomes of Ofatumumab Kesimpta in patieNts With Relapsing Multiple sclerOsis Treated in Routine Care Settings in Greece CHRONOS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
CHRONOS
Brief Summary:
This study is a single-country non-interventional multicenter observational study mainly based on primary data collection to assess the effect of ofatumumab on clinical parameters of Multiple Sclerosis MS in a routine medical care setting as compared to the standard of care SoC arm of a closely monitored phase-IIIb study STHENOS which includes glatiramer acetate interferons teriflunomide or dimethyl fumarate
Detailed Description:
Primary data from MS adult patients who initiate ofatumumab early in their disease course will be collected over a period of two years and will be compared to the ofatumumab and Standard of Care SoC arms of the STHENOS trial a closely monitored phase-IIIb trial Eligible patients are those with Relapsing Multiple Sclerosis RMS diagnosis within 3 years and those who have been on treatment with ofatumumab for at least 3 months but not longer than 6 months prior to inclusion in the study The overall study duration is expected to be 48 months including a recruitment period and a per-patient observation period of 24 months each Follow-up visit frequency will be determined by the treating physician however study-related data will be collected at study enrollment and at 6- 12- 18- and 24-month data collection timepoints post with an allowable time window of 1 month for all data collection timepoints NEDA-3 status MS Relapse EDSS MRI PROs questionnaires MSIS-29 SDMT Adherence and persistence AEs eill be assessed during 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?: