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

N/AActive Not RecruitingNCT06345157

Novartis Pharmaceuticals379 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

379

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

OfatumumabDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (31)

Outcomes

Primary Outcomes

Annualized relapse rate (ARR)

Annualized relapse rate (ARR) after a maximum observation period of 12 months of ofatumumab treatment. ARR is the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study.

Time frame: 1 year

Secondary Outcomes

Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test)

To evaluate absolute and relative frequencies of patients with an improvement in SDMT (Symbol Digit Modality Test). An improvement is defined as an increase in the score of 4 or more points from baseline. The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution. Higher scores indicate better performance.

Time frame: Baseline, month 6, month 12

Fatigue Severity Scale [FSS]

Proportion of patients passing from "fatigued" (F) to "not fatigued" (NF), according to the Fatigue Severity Scale \[FSS\]. FSS is a 9-statement interview with a 7-point scale response per statement, with higher scores indicating more fatigue. Patients with a mean FSS score ≥ 4 are considered fatigued (F), while those with a mean FSS score \< 4 not fatigued (NF).

Time frame: Baseline, month 3, month 6 and month 12

Quality of life parameters assessed by EQ-5D-3L

EQ-5D-3L is a descriptive questionnaire comprising five dimensions regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three response levels of severity: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level of each of the five dimensions.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.