ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients
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
1 other identifier
observational
379
1 country
31
Brief Summary
Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2024
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2024
CompletedFirst Posted
Study publicly available on registry
April 3, 2024
CompletedStudy Start
First participant enrolled
July 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
April 13, 2026
April 1, 2026
1.9 years
March 27, 2024
April 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test)
Baseline, month 6, month 12
Fatigue Severity Scale [FSS]
Baseline, month 3, month 6 and month 12
Quality of life parameters assessed by EQ-5D-3L
Baseline, 12 months
Treatment satisfaction assessed by TSQM-9
Month 6, month 12
Expanded Disability Status Scale (EDSS)
Baseline, month 12 months
- +3 more secondary outcomes
Study Arms (1)
Ofatumumab
Patients treated with Ofatumumab
Interventions
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 Criteria
300 RRMS patients newly treated with ofatumumab.
You may qualify if:
- Male or female outpatients ≥18 years old.
- Patients diagnosed with RRMS (McDonald criteria 2017).
- Patient or a legal representative of the patient must provide written informed consent before any study assessment is performed.
You may not qualify if:
- Patients outside the approved label of ofatumumab.
- Pregnant and lactating women.
- 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.
- Patients cannot participate in this non-interventional study if they also participate in an interventional trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Novartis Investigative Site
Ancona, AN, 60126, Italy
Novartis Investigative Site
L’Aquila, AQ, 67100, Italy
Novartis Investigative Site
Bari, BA, 70124, Italy
Novartis Investigative Site
Bergamo, BG, 24127, Italy
Novartis Investigative Site
Chieti, CH, 66100, Italy
Novartis Investigative Site
Catania, CT, 95123, Italy
Novartis Investigative Site
Catanzaro, CZ, 88100, Italy
Novartis Investigative Site
Cona, FE, 44124, Italy
Novartis Investigative Site
Foggia, FG, 71122, Italy
Novartis Investigative Site
Florence, FI, 50134, Italy
Novartis Investigative Site
Genova, GE, 16132, Italy
Novartis Investigative Site
Pozzilli, IS, 86077, Italy
Novartis Investigative Site
Monza, MB, 20900, Italy
Novartis Investigative Site
Palermo, PA, 90127, Italy
Novartis Investigative Site
Pavia, PV, 27100, Italy
Novartis Investigative Site
Ravenna, RA, 48100, Italy
Novartis Investigative Site
Reggio Calabria, RC, 89124, Italy
Novartis Investigative Site
Roma, RM, 00168, Italy
Novartis Investigative Site
Roma, RM, 00189, Italy
Novartis Investigative Site
Siena, SI, 53100, Italy
Novartis Investigative Site
Sassari, SS, 07100, Italy
Novartis Investigative Site
Trento, TN, 38122, Italy
Novartis Investigative Site
Orbassano, TO, 10043, Italy
Novartis Investigative Site
Torino, TO, 10126, Italy
Novartis Investigative Site
Treviso, TV, 31100, Italy
Novartis Investigative Site
Udine, UD, 33100, Italy
Novartis Investigative Site
Gallarate, VA, 21013, Italy
Novartis Investigative Site
Vicenza, VI, 36100, Italy
Novartis Investigative Site
Naples, 80131, Italy
Novartis Investigative Site
Naples, 80138, Italy
Novartis Investigative Site
Novara, 28100, Italy
Biospecimen
Sample of whole blood to evaluate KREC, TREC and B and T cells subset. Sample of Serum to evaluate NfL.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2024
First Posted
April 3, 2024
Study Start
July 30, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04