NCT06345157

ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients

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: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 379 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	Ofatumumab	This is an observational study. There is no treatment allocation. The decision to initiate treatment with ofatumumab (Kesimpta®) will be based solely on clinical judgement and according to the SmPC and AIFA reimbursement criteria.

Timeline

• Start date: 2024-07-30
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-04-03
• Last updated: 2026-04-13

Locations

31 sites across 1 country: Italy