A Study to Describe the Switching From a First- or Second-line Disease Modifying Therapy (DMT) to Ozanimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

Study Overview
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Brief Summary
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The purpose of this study is to describe the reasons, therapy, and/or disease for changing first or second line Disease Modifying Therapy (DMT) to ozanimod in participants with Relapsing Remitting Multiple Sclerosis (RRMS).

Official Title
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SWITCH - ITA A Multicentre, Single Country, Prospective Non Interventional Observational Study to Describe the Switching From a First- or Second-line Disease Modifying Therapy (DMT) to Ozanimod, in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated According to Clinical Practice.

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with RRMS according to 2017 revised McDonald criteria Patients who switched a previous first or second line DMT to ozanimod between 4 and 12 weeks before the enrollment Patient with a MRI performed within three months before the enrollment Patient eligible to ozanimod according to SmPC Exclusion Criteria: Patients with clinical forms of MS other than RRMS Patients unable to participate for various reasons Patients participating in another clinical study with an investigational product if the study considers the switching behavior as an endpoint or objective Contraindications to ozanimod according to SmPC Other protocol-defined Inclusion/Exclusion Criteria apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reason for switching treatment | Reason for switching the previous treatment: Lack of efficacy, Poor safety/tolerability, Difficulty in administration, Poor compliance, Patient's request, or other reasons | At baseline | 
| Mode of switching treatment | Wash-out from previous treatment (first/second line DMT) (days), overlapping (days), dosage (first/second line DMT and ozanimod), concomitant treatments | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expanded Disability Status Score (EDSS) | Mean EDSS score in patients enrolled in the study | At baseline, week 12, and week 24 | 
| MRI | Number of new or enlarging T2 lesions and T1 Gadolinium Enhancing Lesions (GdE) lesions. | At baseline, week 12, and week 24 | 
| TSQM | Treatment Satisfaction Questionnaire for Medication | At baseline and week 24 | 
| Lymphocyte sub populations | The pattern of the sub populations of lymphocytes: CD3, CD4, CD8, CD19, CD56. | At baseline, week 12, and week 24 | 
| Incidence of Adverse Events (AEs) | Number of AEs in the study population during the study; AEs will be coded according to MEdDRA. | Continuous (Up to 42 months) | 
| Incidence of Serious Adverse Events (SAEs) | Number of SAEs in the study population during the study; SAEs will be coded according to MEdDRA. | Continuous (Up to 42 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Ozanimod