Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345157
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-03-27
Brief Title:
ITAKOS - Italian Observation Multicenter Prospective Study of Ofatumumab in RRMS Patients
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An ITAlian Observational Multicenter 12-month Single-arm Study to Evaluate the Effectiveness and Safety of Treatment With Ofatumumab Kesimpta in a pOpulation of RRMS Patients in a Real-world Setting - the ITAKOS Study
Status:
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:
None
Brief Summary:
Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting
Detailed Description:
Prospective real-world data on ofatumumab is still very limited For this reason the main aim of this study is to investigate the impact of ofatumumab in a population of Italian RRMS patients in routine clinical practice to evaluate if ofatumumab is able in these conditions to provide relevant clinical benefits that comprehensively encompass anti-inflammatory activity relapses disability accumulation cognitive impairment fatigue symptoms and quality of life
This is an observational multicenter single-arm prospective study Prospective data will be collected on patients newly treated with ofatumumab over an observational period of 12 months
This is an observational multicenter single-arm prospective study Prospective data will be collected on patients newly treated with ofatumumab over an observational period of 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None