Clinical trial NCT06345157: ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis,
Relapsing-Remitting,
RRMS,
ofatumumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-04-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 300 RRMS patients newly treated with ofatumumab.

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.

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.

Primary outcomes:
measure: Annualized relapse rate (ARR)
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test)
timeFrame: Baseline, month 6, month 12
measure: Fatigue Severity Scale [FSS]
timeFrame: Baseline, month 3, month 6 and month 12
measure: Quality of life parameters assessed by EQ-5D-3L
timeFrame: Baseline, 12 months
measure: Treatment satisfaction assessed by TSQM-9
timeFrame: Month 6, month 12
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Baseline, month 12 months
measure: Variation of NfL in plasma
timeFrame: Baseline, month 6 and month 12
measure: Adverse Events (AEs)
timeFrame: 12 months
measure: Discontinuation rates due to AE and/or other reasons
timeFrame: 12 months
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Novartis Investigative Site
state: AN
city: L Aquila
country: Italy
facility: Novartis Investigative Site
state: AQ
city: Bari
country: Italy
facility: Novartis Investigative Site
state: BA
city: Bergamo
country: Italy
facility: Novartis Investigative Site
state: BG
city: Chieti
country: Italy
facility: Novartis Investigative Site
state: CH
city: Catanzaro
country: Italy
facility: Novartis Investigative Site
state: CZ
city: Cona
country: Italy
facility: Novartis Investigative Site
state: FE
city: Foggia
country: Italy
facility: Novartis Investigative Site
state: FG
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Pozzilli
country: Italy
facility: Novartis Investigative Site
state: IS
city: Monza
country: Italy
facility: Novartis Investigative Site
state: MB
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Ravenna
country: Italy
facility: Novartis Investigative Site
state: RA
city: Reggio Calabria
country: Italy
facility: Novartis Investigative Site
state: RC
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Sassari
country: Italy
facility: Novartis Investigative Site
state: SS
city: Trento
country: Italy
facility: Novartis Investigative Site
state: TN
city: Orbassano
country: Italy
facility: Novartis Investigative Site
state: TO
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Gallarate
country: Italy
facility: Novartis Investigative Site
state: VA
city: Vicenza
country: Italy
facility: Novartis Investigative Site
state: VI
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Novara
country: Italy
facility: Novartis Investigative Site
Study officials:
References: