Observational, Multicenter Study to Describe the Persistence in Relapsing Remitting Multiple Sclerosis Naive Patients With Low-moderate Activity Treated With Ozanimod (Zeposia®) in Clinical Practice in Spain

Bristol-Myers Squibb1 site in 1 country200 target enrollmentJune 14, 2023

ConditionsRelapsing-remitting Multiple Sclerosis (RRMS)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Relapsing-remitting Multiple Sclerosis (RRMS)
Sponsor: Bristol-Myers Squibb
Enrollment: 200
Locations: 1
Primary Endpoint: Time from ozanimod treatment initiation to ozanimod treatment permanent discontinuation
Status: Active, not recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to collect clinical data on the persistence with ozanimod treatment, as well as to describe its effects on participant-relevant outcome parameters in treatment-naïve participants with RRMS.

Registry

clinicaltrials.gov

Start Date

June 14, 2023

End Date

November 9, 2026

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Relapsing-remitting multiple sclerosis (RRMS) diagnosis by 2017 revised McDonald criteria at the treatment start
•Participant who started treatment with ozanimod for the first time 3 months (+/- 2 weeks) before inclusion, according to European Union (EU) Summary of Product Characteristics (SmPC) and/or Spanish therapeutic positioning report (TPR) recommendation and following routine clinical practice of the participating hospital
•Low-to-moderate activity, defined as less than 2 relapses in the previous year before starting the treatment with ozanimod

Exclusion Criteria

•Prior exposure to ozanimod or any other disease modifier treatment (DMT) for RRMS before starting treatment with ozanimod subject of this study
•Participant who has started ozanimod within a clinical trial
•Note: Other protocol-defined inclusion/exclusion criteria apply

Outcomes

Primary Outcomes

Time from ozanimod treatment initiation to ozanimod treatment permanent discontinuation

Time Frame: Up to 24 months

Percentage of participants on treatment with ozanimod at 24 months

Time Frame: At month 24

Secondary Outcomes

Percentage of participants with ozanimod treatment discontinuation(Up to 24 months)
Proportion of participants with a decrease SDMT score of ≥4 points(At month 3, 12 and 24)
Proportion of participants with a stable SDMT score(At month 3, 12 and 24)
Proportion of participants with change of ≥1.0 point from baseline in expanded disability status scale (EDSS) score at Month 3, 12 and 24(Baseline, Month 3, 12 and 24)
Change from baseline in number of new or enlarging gadolinium enhancing brain lesions at month 12 and 24(Baseline, Month 12 and 24)
Percentage of participants with ozanimod treatment at 3 and 12 months(At month 3 and month 12)
Change from baseline in SDMT score at month 3, 12 and 24(Baseline, Month 3, 12 and 24)
Number of Participants with at least one Adverse Event (AE)(Up to 24 months)
Description of sociodemographic characteristics of participants(Baseline, up to 24 months)
Annualized relapse rate at month 12 month and month 24(At month 12 and month 24)
Change from baseline in Neurofilament light (NfL) levels at month 6, 12 and 24(Baseline, Month 6, 12 and 24)
Percentage of participants switching to treatment alternative(Up to 24 months)
Proportion of participants with an increase in Symbol Digit Modalities Test (SDMT) score of ≥4 points(At month 3, 12 and 24)
Change from baseline in EDSS score at Month 3, 12 and 24(Baseline, Month 3, 12 and 24)
Number of Participants with AE that imply discontinuation of ozanimod(Up to 24 months)
Change from baseline in number of new or enlarging hypointense T1 lesions at month 12 and 24(Baseline, Month 12 and 24)
Change from baseline in number of new or enlarging hypointense T2 lesions at month 12 and 24(Baseline, Month 12 and 24)
Description of clinical characteristics of participants(Baseline, up to 24 months)