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)

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.

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).

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis, Relapsing-Remitting

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Study Connect Contact Center http://www.bmsstudyconnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• Italy
  • Isernia, Italy, 86077
    • Recruiting
    • Neuromed Istituto Neurologico Mediterraneo
    • Contact: Diego Centonze, Site 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population is composed of 180 participants 18-55 years with Relapsing Remitting Multiple Sclerosis (RRMS) diagnosed according to 2017 revised McDonald criteria, switching from a first or second line Disease Modifying Therapy (DMT) to ozanimod, and in treatment with ozanimod between 4 and 12 weeks before the enrollment.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort 1

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Ozanimod
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: IM047-1038