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

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

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 Overview

• Status: Recruiting
• Conditions: Relapsing-remitting Multiple Sclerosis (RRMS)

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

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

Study Locations

• Spain
  • Barcelona, Spain, 08008
    • Recruiting
    • Local Institution - 0001
    • Contact: Site 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort 1; Participants that have initiated ozanimod.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

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
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Ozanimod; Relapsing-remitting multiple sclerosis; Zeposia
• 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: IM047-066