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

Launched by NOVARTIS PHARMACEUTICALS · Mar 27, 2024

Keywords

ClinConnect Summary

The ITAKOS trial is a study looking at how well a medication called ofatumumab works for patients in Italy who have been diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS). This study aims to understand the effectiveness of ofatumumab in real-life situations, meaning how it helps people outside of a controlled clinical setting. Currently, the trial is recruiting participants aged 18 and older who are starting treatment with ofatumumab for the first time. It's important that potential participants have already been evaluated and approved to use this medication based on standard medical guidelines.

To be eligible for the study, participants must be diagnosed with RRMS and provide written consent to join. However, some people may not qualify, including those who are pregnant, have certain health conditions that could affect their participation, or have received ofatumumab treatment in the past. For those who do join, they can expect to contribute to understanding how this drug works in everyday practice, which could help improve treatment options for future patients with RRMS.

Gender

ALL

Eligibility 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.