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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06345157
• Other study ID #: COMB157GIT02
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Ofatumumab
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	Baseline, month 6, month 12
Secondary	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).	Baseline, month 3, month 6 and month 12
Secondary	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.	Baseline, 12 months
Secondary	Treatment satisfaction assessed by TSQM-9	Treatment Satisfaction Questionnaire for Multiple Sclerosis (TSQM-9). The TSQM-9 is a validated tool, widely used, to measure treatment satisfaction that will be applied in the context of this study regarding Ofatumumab. The TSQM-9 uses nine of the 14 TSQM Version 1.4 items, not including five questions related to side effects of medication, and comprises three scales: the effectiveness scale, the convenience scale and the global scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.	Month 6, month 12
Secondary	Expanded Disability Status Scale (EDSS)	Proportion of patients with an improved, stable or worsened EDSS. For patients with a baseline EDSS of 0 to 1.5, no disability improvement was possible based on the protocol definition of an improvement; for patients with a baseline EDSS of =2 to 6 or =6.5 to 9.5, the criterion for disability improvement was a decrease in EDSS of =1 or =0.5, respectively For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of =1.5, for patients with a baseline EDSS of 1 to 5 or =5.5, the criterion for disability worsening was an increase in EDSS of =1 or =0.5, respectively.	Baseline, month 12 months
Secondary	Variation of NfL in plasma	Variation of Neurofilaments (NfL) in plasma of the patients	Baseline, month 6 and month 12
Secondary	Adverse Events (AEs)	Exposure-adjusted proportion of patients with adverse events (AE) or serious adverse events (SAE) per 100 subject-years.	12 months
Secondary	Discontinuation rates due to AE and/or other reasons	Discontinuation rates due to AE and/or other reasons	12 months