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®) (OzEAN)

Bristol-Myers Squibb (BMS)

Status: Active, not recruiting

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: Ozanimod

Study type: Observational

Funder types: Industry

Identifiers

NCT05335031

RPC-1063-MS-003

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Other protocol-defined inclusion/exclusion criteria apply

Trial design

450 participants in 1 patient group

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

Treatment:

Drug: Ozanimod