A Study Investigating the Utilization, Effectiveness and Quality of Life in Clinical Practice in Germany for Participants With Relapsing-remitting Multiple Sclerosis Treated With Ozanimod (Zeposia®)

NCT05335031 | Completed FDA Drug

• 1 other identifier: RPC-1063-MS-003
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect real-world data and to gain insights about long-term usage of ozanimod (Zeposia ®), its effect on well-defined outcome parameters comprising participant-relevant outcomes, as well as quality of life, effectiveness, and incidence of adverse events.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis; Relapsing-Remitting; Ozanimod; Zeposia®

Outcome Measures

Primary Outcomes (1)

• Proportion of participants persistence with therapy

  Up to 36 months

Secondary Outcomes (29)

• Distribution of participant demographics characteristics: Age

  At baseline

• Distribution of participant demographics characteristics: Sex

  At baseline

• Distribution of participant demographics characteristics: Height

  At baseline

• Distribution of participant demographics characteristics: Body weight

  At baseline

• Distribution of clinical characteristics: Smoking status

  At baseline

Study Arms (1)

Participants with relapsing-remitting multiple sclerosis (RRMS) treated with Ozanimod

Drug: Ozanimod

Interventions

Ozanimod DRUG

As per product label

Participants with relapsing-remitting multiple sclerosis (RRMS) treated with 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

Approximately 450 relapsing-remitting multiple sclerosis (RRMS) adult participants (any gender) who are either newly treated RRMS participants or who switched from other RRMS treatments to ozanimod are planned to be enrolled in up to 100 specialist study sites (office-based neurologists and clinics) across Germany.

You may qualify if:

• Confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS)
• The decision upon treatment with ozanimod must have been made before enrollment and independently of this non-interventional observational study
• All data on ozanimod treatment are collected prospectively. The retrospective documentation of ozanimod therapy and enrollment of participants that are already on ozanimod therapy is not allowed

You may not qualify if:

• Special warnings, precautions and contraindications specified in the current version of the Summary of Product Characteristics (SmPC)
• Hypersensitivity to the active substance(s) or to any of the excipients of ozanimod as specified in the prescribing information must not be enrolled
• Participation in any other clinical studies

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Universitätsklinikum Dresden, MS Ambulanz

Dresden, Saxony, 01307, Germany

Location

Related Publications (1)

• Ziemssen T, Richter S, Maurer M, Buttmann M, Kreusel B, Poehler AM, Lampl M, Linker RA. OzEAN Study to Collect Real-World Evidence of Persistent Use, Effectiveness, and Safety of Ozanimod Over 5 Years in Patients With Relapsing-Remitting Multiple Sclerosis in Germany. Front Neurol. 2022 Jun 27;13:913616. doi: 10.3389/fneur.2022.913616. eCollection 2022.

  PMID: 35832177 BACKGROUND

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

ozanimod

Condition Hierarchy (Ancestors)

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: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: March 3, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)