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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05811416

Collaborator

(none)

200

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsing-remitting Multiple Sclerosis (RRMS)

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

May 31, 2023

Anticipated Primary Completion Date :

Mar 31, 2026

Anticipated Study Completion Date :

Mar 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Participants that have initiated ozanimod.

Outcome Measures

Primary Outcome Measures

Time from ozanimod treatment initiation to ozanimod treatment permanent discontinuation [Up to 24 months]
Percentage of participants on treatment with ozanimod at 24 months [At month 24]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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