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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with relapsing-remitting multiple sclerosis (RRMS) treated with Ozanimod |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozanimod | Drug | As per product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants persistence with therapy | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of participant demographics characteristics: Age | At baseline | |
| Distribution of participant demographics characteristics: Sex | At baseline | |
| Distribution of participant demographics characteristics: Height |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Dresden, MS Ambulanz | Dresden | Saxony | 01307 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35832177 | Background | 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. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| At baseline |
| Distribution of participant demographics characteristics: Body weight | At baseline |
| Distribution of clinical characteristics: Smoking status | At baseline |
| Distribution of clinical characteristics: Multiple Sclerosis (MS) diagnosis | At baseline |
| Distribution of clinical characteristics: MS anamnesis/history | At baseline |
| Distribution of clinical characteristics: Prior diseases | At baseline |
| Distribution of clinical characteristics: Concomitant diseases | At baseline |
| Distribution of clinical characteristics: Concomitant medication | At baseline |
| Distribution of clinical characteristics: Prior MS medication | At baseline |
| Distribution of clinical characteristics: Physical examination | At baseline |
| Distribution of clinical characteristics: Reasons for switch to ozanimod | At baseline |
| Distribution of clinical characteristics: Treatment start with ozanimod | At baseline |
| Distribution of clinical characteristics: Discontinuation, defined as physician's documentation of a discontinuation of ozanimod treatment | Up to 36 months |
| Distribution of clinical characteristics: Reason for discontinuation | Up to 36 months |
| Distribution of clinical characteristics: Subsequent MS treatment | Up to 44 months |
| Distribution of clinical characteristics: Persistence with therapy | Up to 36 months |
| Distribution of clinical characteristics: Adherence to therapy | Up to 36 months |
| Treatment Satisfaction Questionnaire for Medication (TSQM v1.4) | Up to 44 months |
| Symbol Digit Modalities Test (SDMT) | Up to 44 months |
| Fatigue scale for motor and cognitive functions (FSMC) | Up to 44 months |
| Multiple Sclerosis Quality of Life-54 (MSQOL-54) | Up to 44 months |
| United Kingdom Neurological Disability Rating Scale (UNDS) | Up to 44 months |
| Clinical Relapse defined as the annualized relapse rate (ARR) | Up to 44 months |
| Expanded disability status scale (EDSS) | Up to 44 months |
| Work Productivity and Activity Index-Multiple Sclerosis (WPAI-MS German v2.1) | Up to 44 months |
| Multiple Sclerosis Health Resource Survey (MS-HRS 3.0) | Up to 44 months |
| Incidence rate for Adverse Events (AEs) | Up to 44 months |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000607776 | ozanimod |
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