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

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.