Clinical trial NCT05811416: A Study to Describe the Persistence With Ozanimod Treatment in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Relapsing-remitting Multiple Sclerosis (RRMS)
Keywords: Ozanimod
Zeposia
Relapsing-remitting multiple sclerosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-04-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Candidates will be adult treatment-naïve participants diagnosed with RRMS who attend to a regular follow up visit at a Spanish participating hospital and who started treatment with ozanimod for the first time 3 months (+/- 2 weeks) before inclusion.

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.


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

Primary outcomes:
measure: Time from ozanimod treatment initiation to ozanimod treatment permanent discontinuation
timeFrame: Up to 24 months
measure: Percentage of participants on treatment with ozanimod at 24 months
timeFrame: At month 24
Secondary outcomes:
measure: Percentage of participants with ozanimod treatment at 3 and 12 months
timeFrame: At month 3 and month 12
measure: Percentage of participants with ozanimod treatment discontinuation
timeFrame: Up to 24 months
measure: Percentage of participants switching to treatment alternative
timeFrame: Up to 24 months
measure: Annualized relapse rate at month 12 month and month 24
timeFrame: At month 12 and month 24
measure: Proportion of participants with an increase in Symbol Digit Modalities Test (SDMT) score of ≥4 points
timeFrame: At month 3, 12 and 24
measure: Proportion of participants with a decrease SDMT score of ≥4 points
timeFrame: At month 3, 12 and 24
measure: Proportion of participants with a stable SDMT score
timeFrame: At month 3, 12 and 24
measure: Change from baseline in SDMT score at month 3, 12 and 24
timeFrame: Baseline, Month 3, 12 and 24
measure: Change from baseline in Neurofilament light (NfL) levels at month 6, 12 and 24
timeFrame: Baseline, Month 6, 12 and 24
measure: Proportion of participants with change of ≥1.0 point from baseline in expanded disability status scale (EDSS) score at Month 3, 12 and 24
timeFrame: Baseline, Month 3, 12 and 24
measure: Change from baseline in EDSS score at Month 3, 12 and 24
timeFrame: Baseline, Month 3, 12 and 24
measure: Change from baseline in number of new or enlarging hypointense T1 lesions at month 12 and 24
timeFrame: Baseline, Month 12 and 24
measure: Change from baseline in number of new or enlarging hypointense T2 lesions at month 12 and 24
timeFrame: Baseline, Month 12 and 24
measure: Change from baseline in number of new or enlarging gadolinium enhancing brain lesions at month 12 and 24
timeFrame: Baseline, Month 12 and 24
measure: Number of Participants with at least one Adverse Event (AE)
timeFrame: Up to 24 months
measure: Number of Participants with AE that imply discontinuation of ozanimod
timeFrame: Up to 24 months
measure: Description of sociodemographic characteristics of participants
timeFrame: Baseline, up to 24 months
measure: Description of clinical characteristics of participants
timeFrame: Baseline, up to 24 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: