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Evaluating Ofatumumab in Italian Patients with Relapsing-Remitting Multiple Sclerosis

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

Observational Novartis · NCT06345157

This study is testing how well ofatumumab works for people in Italy with relapsing-remitting multiple sclerosis by looking at their health over a year after starting the treatment.

Quick facts

Study typeObservational
Enrollment300 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsofatumumab
Locations27 sites (Ancona, AN and 26 other locations)
Trial IDNCT06345157 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather real-world data on the effectiveness of ofatumumab in patients with relapsing-remitting multiple sclerosis (RRMS) in Italy. It will involve collecting prospective data from patients who are newly treated with ofatumumab over a 12-month period. The study will assess various clinical outcomes, including relapse rates, disability progression, cognitive function, fatigue, and overall quality of life. By focusing on routine clinical practice, the study seeks to provide insights into the drug's impact in a real-life setting.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been newly diagnosed with relapsing-remitting multiple sclerosis and are starting treatment with ofatumumab.

Not a fit: Patients who are pregnant, lactating, or have conditions that interfere with their ability to comply with study procedures will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable evidence on the clinical benefits of ofatumumab for patients with RRMS, potentially improving treatment strategies.

How similar studies have performed: While this study focuses on real-world data for ofatumumab, similar studies have shown promising results for other treatments in RRMS, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Ancona, AN and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis,Relapsing-Remitting,RRMS,ofatumumab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.