A Study to Describe the Persistence With Ozanimod Treatment in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants

N/AActive Not RecruitingNCT05811416

Bristol-Myers Squibb200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Relapsing-remitting Multiple Sclerosis (RRMS)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution - 0001

Barcelona, Spain

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 at 3 and 12 months

Time frame: At month 3 and month 12

Percentage of participants with ozanimod treatment discontinuation

Time frame: Up to 24 months

Percentage of participants switching to treatment alternative

Time frame: Up to 24 months

Annualized relapse rate at month 12 month and month 24

Time frame: At month 12 and month 24

Proportion of participants with an increase in Symbol Digit Modalities Test (SDMT) score of ≥4 points

Time frame: At month 3, 12 and 24

Proportion of participants with a decrease SDMT score of ≥4 points

Time frame: At month 3, 12 and 24

Proportion of participants with a stable SDMT score

Time frame: At month 3, 12 and 24

Change from baseline in SDMT score at month 3, 12 and 24

Time frame: Baseline, Month 3, 12 and 24

Change from baseline in Neurofilament light (NfL) levels at month 6, 12 and 24

Data from ClinicalTrials.gov

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