ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients
What it found
No result yet.
What was tested
Treatment tested
- Ofatumumab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
Annualized relapse rate (ARR)
1 year
Relapses
Other measures (8)
Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test)
Baseline, month 6, month 12
Thinking and memoryFatigue Severity Scale [FSS]
Baseline, month 3, month 6 and month 12
FatigueQuality of life parameters assessed by EQ-5D-3L
Baseline, 12 months
Walking and mobilityPainMood and sleepQuality of life (reported by participants)Treatment satisfaction assessed by TSQM-9
Month 6, month 12
Quality of life (reported by participants)SafetyExpanded Disability Status Scale (EDSS)
Baseline, month 12 months
Disability progressionVariation of NfL in plasma
Baseline, month 6 and month 12
Blood or spinal fluid markersAdverse Events (AEs)
12 months
SafetyDiscontinuation rates due to AE and/or other reasons
12 months
Who could take part
Relapsing MS · 18 to 99
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting.
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History
Started
Jul 2024
Main results due
Jun 2026
Finished
Jun 2026
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