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

Relapsing-remitting Multiple Sclerosis (RRMS) Clinical Trial

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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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05811416
• Other study ID #: IM047-066
• Status: Recruiting
• Start date: June 14, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: November 2023
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis (RRMS)
• Sclerosis

Locations

Country	Name	City	State
Spain	Local Institution - 0001	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from ozanimod treatment initiation to ozanimod treatment permanent discontinuation		Up to 24 months
Primary	Percentage of participants on treatment with ozanimod at 24 months		At month 24
Secondary	Percentage of participants with ozanimod treatment at 3 and 12 months		At month 3 and month 12
Secondary	Percentage of participants with ozanimod treatment discontinuation		Up to 24 months
Secondary	Percentage of participants switching to treatment alternative		Up to 24 months
Secondary	Annualized relapse rate at month 12 month and month 24		At month 12 and month 24
Secondary	Proportion of participants with an increase in Symbol Digit Modalities Test (SDMT) score of =4 points		At month 3, 12 and 24
Secondary	Proportion of participants with a decrease SDMT score of =4 points		At month 3, 12 and 24
Secondary	Proportion of participants with a stable SDMT score		At month 3, 12 and 24
Secondary	Change from baseline in SDMT score at month 3, 12 and 24		Baseline, Month 3, 12 and 24
Secondary	Change from baseline in Neurofilament light (NfL) levels at month 6, 12 and 24		Baseline, Month 6, 12 and 24
Secondary	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
Secondary	Change from baseline in EDSS score at Month 3, 12 and 24		Baseline, Month 3, 12 and 24
Secondary	Change from baseline in number of new or enlarging hypointense T1 lesions at month 12 and 24		Baseline, Month 12 and 24
Secondary	Change from baseline in number of new or enlarging hypointense T2 lesions at month 12 and 24		Baseline, Month 12 and 24
Secondary	Change from baseline in number of new or enlarging gadolinium enhancing brain lesions at month 12 and 24		Baseline, Month 12 and 24
Secondary	Number of Participants with at least one Adverse Event (AE)		Up to 24 months
Secondary	Number of Participants with AE that imply discontinuation of ozanimod		Up to 24 months
Secondary	Description of sociodemographic characteristics of participants		Baseline, up to 24 months
Secondary	Description of clinical characteristics of participants		Baseline, up to 24 months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form