Study Description
Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting. 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.
Interventions
Ofatumumab
Eligibility Criteria
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.
Novartis Investigative Site
Recruiting
Pozzilli,IS,86077,Italy
Novartis Investigative Site
Recruiting
Sassari,SS,07100,Italy
Novartis Investigative Site
Recruiting
Monza,MB,20900,Italy
Novartis Investigative Site
Recruiting
Trento,TN,38100,Italy
Novartis Investigative Site
Recruiting
Palermo,PA,90127,Italy
Novartis Investigative Site
Recruiting
Ancona,AN,60126,Italy
Novartis Investigative Site
Recruiting
Gallarate,VA,21013,Italy
Novartis Investigative Site
Recruiting
Pavia,PV,27100,Italy
Novartis Investigative Site
Recruiting
Cona,FE,44100,Italy
Novartis Investigative Site
Recruiting
Napoli,80131,Italy
Novartis Investigative Site
Recruiting
Ravenna,RA,48100,Italy
Novartis Investigative Site
Recruiting
Foggia,FG,71122,Italy
Novartis Investigative Site
Recruiting
Roma,RM,00168,Italy
Novartis Investigative Site
Recruiting
Firenze,FI,50134,Italy
Novartis Investigative Site
Recruiting
Roma,RM,00189,Italy
Worldwide Contacts
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