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Clinical Trials in Italy / NCT06345157
Active, not recruiting Observational

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

NCT06345157 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-07-30
Last updated
2026-04-13

Condition(s) studied

Multiple Sclerosis, Relapsing-Remitting

Investigational drug(s) / intervention(s)

Ofatumumab →

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (31)

FacilityCityRegionStatus
Novartis Investigative Site Ancona AN
Novartis Investigative Site L’Aquila AQ
Novartis Investigative Site Bari BA
Novartis Investigative Site Bergamo BG
Novartis Investigative Site Chieti CH
Novartis Investigative Site Catania CT
Novartis Investigative Site Catanzaro CZ
Novartis Investigative Site Cona FE
Novartis Investigative Site Foggia FG
Novartis Investigative Site Florence FI
Novartis Investigative Site Genova GE
Novartis Investigative Site Pozzilli IS
Novartis Investigative Site Monza MB
Novartis Investigative Site Palermo PA
Novartis Investigative Site Pavia PV
Novartis Investigative Site Ravenna RA
Novartis Investigative Site Reggio Calabria RC
Novartis Investigative Site Roma RM
Novartis Investigative Site Roma RM
Novartis Investigative Site Siena SI
Novartis Investigative Site Sassari SS
Novartis Investigative Site Trento TN
Novartis Investigative Site Orbassano TO
Novartis Investigative Site Torino TO
Novartis Investigative Site Treviso TV
Novartis Investigative Site Udine UD
Novartis Investigative Site Gallarate VA
Novartis Investigative Site Vicenza VI
Novartis Investigative Site Naples Italy
Novartis Investigative Site Naples Italy
Novartis Investigative Site Novara Italy

More Novartis Pharmaceuticals trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06345157 on ClinicalTrials.gov ↗ ← All trials in Italy