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Completed

NCT Number: NCT05335031

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®)

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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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Dresden, MS Ambulanz

Dresden, Saxony, 01307, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ozanimod

Drug

As per product label

Primary outcomes

  1. Proportion of participants persistence with therapy

    Time frame: Up to 36 months

Secondary outcomes

  1. Distribution of participant demographics characteristics: Age

    Time frame: At baseline

  2. Distribution of participant demographics characteristics: Sex

    Time frame: At baseline

  3. Distribution of participant demographics characteristics: Height

    Time frame: At baseline

  4. Distribution of participant demographics characteristics: Body weight

    Time frame: At baseline

  5. Distribution of clinical characteristics: Smoking status

    Time frame: At baseline

  6. Distribution of clinical characteristics: Multiple Sclerosis (MS) diagnosis

    Time frame: At baseline

  7. Distribution of clinical characteristics: MS anamnesis/history

    Time frame: At baseline

  8. Distribution of clinical characteristics: Prior diseases

    Time frame: At baseline

  9. Distribution of clinical characteristics: Concomitant diseases

    Time frame: At baseline

  10. Distribution of clinical characteristics: Concomitant medication

    Time frame: At baseline

  11. Distribution of clinical characteristics: Prior MS medication

    Time frame: At baseline

  12. Distribution of clinical characteristics: Physical examination

    Time frame: At baseline

  13. Distribution of clinical characteristics: Reasons for switch to ozanimod

    Time frame: At baseline

  14. Distribution of clinical characteristics: Treatment start with ozanimod

    Time frame: At baseline

  15. Distribution of clinical characteristics: Discontinuation, defined as physician's documentation of a discontinuation of ozanimod treatment

    Time frame: Up to 36 months

  16. Distribution of clinical characteristics: Reason for discontinuation

    Time frame: Up to 36 months

  17. Distribution of clinical characteristics: Subsequent MS treatment

    Time frame: Up to 44 months

  18. Distribution of clinical characteristics: Persistence with therapy

    Time frame: Up to 36 months

  19. Distribution of clinical characteristics: Adherence to therapy

    Time frame: Up to 36 months

  20. Treatment Satisfaction Questionnaire for Medication (TSQM v1.4)

    Time frame: Up to 44 months

  21. Symbol Digit Modalities Test (SDMT)

    Time frame: Up to 44 months

  22. Fatigue scale for motor and cognitive functions (FSMC)

    Time frame: Up to 44 months

  23. Multiple Sclerosis Quality of Life-54 (MSQOL-54)

    Time frame: Up to 44 months

  24. United Kingdom Neurological Disability Rating Scale (UNDS)

    Time frame: Up to 44 months

  25. Clinical Relapse defined as the annualized relapse rate (ARR)

    Time frame: Up to 44 months

  26. Expanded disability status scale (EDSS)

    Time frame: Up to 44 months

  27. Work Productivity and Activity Index-Multiple Sclerosis (WPAI-MS German v2.1)

    Time frame: Up to 44 months

  28. Multiple Sclerosis Health Resource Survey (MS-HRS 3.0)

    Time frame: Up to 44 months

  29. Incidence rate for Adverse Events (AEs)

    Time frame: Up to 44 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Ozanimod (Zeposia®) In Patients With RRMS: A 3-Year, Multicenter, Prospective, Non-Interventional Study to Document Utilization, Effectiveness and Quality of Life in Clinical Practice in Germany (OZEAN)

Acronym: OzEAN

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 19, 2022
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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