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

Novartis

Status: Active, not recruiting

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: Ofatumumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06345157

COMB157GIT02

Details and patient eligibility

About

Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting.

Full 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.

Enrollment: 378 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female outpatients ≥18 years old.
2. Patients diagnosed with RRMS (McDonald criteria 2017).
3. Patients newly treated with ofatumumab, for whom the decision to start treatment with the drug has already been taken independently from study inclusion, based on clinical practice and according to the SmPC and to AIFA reimbursement criteria and who already successfully qualified for treatment with ofatumumab (i.e., passed the screening procedure mandated by the SmPC and the Risk Management Plan (RMP) for this treatment).
4. Patient or a legal representative of the patient must provide written informed consent before any study assessment is performed.

Exclusion criteria

1. Patients outside the approved label of ofatumumab.
2. Pregnant and lactating women.
3. Patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on investigator's judgement.
4. Patients cannot participate in this non-interventional study if they also participate in an interventional trial.
5. Treatment with ofatumumab prior to inclusion in this study or after 7 days from baseline visit.

Trial design

378 participants in 1 patient group

Ofatumumab

Description:

Patients treated with Ofatumumab

Treatment:

Drug: Ofatumumab