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)

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05658601

Acronym

SWITCH - ITA

Enrollment

104

Registered

2022-12-21

Start date

2023-07-14

Completion date

2025-07-03

Last updated

2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis, Ozanimod

Brief summary

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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/

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results