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Completed

NCT Number: NCT05658601

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)

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).

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Isernia, 86077, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Reason for switching treatment

    Time frame: 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

  2. Mode of switching treatment

    Time frame: At baseline

    Wash-out from previous treatment (first/second line DMT) (days), overlapping (days), dosage (first/second line DMT and ozanimod), concomitant treatments

Secondary outcomes

  1. Expanded Disability Status Score (EDSS)

    Time frame: At baseline, week 12, and week 24

    Mean EDSS score in patients enrolled in the study

  2. MRI

    Time frame: At baseline, week 12, and week 24

    Number of new or enlarging T2 lesions and T1 Gadolinium Enhancing Lesions (GdE) lesions.

  3. TSQM

    Time frame: At baseline and week 24

    Treatment Satisfaction Questionnaire for Medication

  4. Lymphocyte sub populations

    Time frame: At baseline, week 12, and week 24

    The pattern of the sub populations of lymphocytes: CD3, CD4, CD8, CD19, CD56.

  5. Incidence of Adverse Events (AEs)

    Time frame: Continuous (Up to 42 months)

    Number of AEs in the study population during the study; AEs will be coded according to MEdDRA.

  6. Incidence of Serious Adverse Events (SAEs)

    Time frame: Continuous (Up to 42 months)

    Number of SAEs in the study population during the study; SAEs will be coded according to MEdDRA.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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.

Acronym: SWITCH - ITA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 21, 2022
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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