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

NCT05811416 | Active Not Recruiting

• 1 other identifier: IM047-066
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsing-remitting Multiple Sclerosis (RRMS)

Keywords

Ozanimod; Zeposia; Relapsing-remitting multiple sclerosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• 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

Study Arms (1)

Cohort 1

Participants that have initiated ozanimod.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Relapsing-remitting multiple sclerosis (RRMS) diagnosis by 2017 revised McDonald criteria at the treatment start
• Low-to-moderate activity, defined as less than 2 relapses in the previous year before starting the treatment with ozanimod

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Barcelona, 08008, Spain

Location

Related Links

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

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 13, 2023
• Study Start: June 14, 2023
• Primary Completion (Estimated): November 9, 2026
• Study Completion (Estimated): November 9, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

ES (1)