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)

April 12, 2022 updated by: Bristol-Myers Squibb

Ozanimod (Zeposia®) In Patients With RRMS: A 5-Year, Multicenter, Prospective, Non-Interventional Study to Document Utilization, Effectiveness and Quality of Life in Clinical Practice in Germany (OZEAN)

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Universitätsklinikum Dresden, MS Ambulanz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 1,300 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 140 specialist study sites (office-based neurologists and clinics) across Germany.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants persistence with therapy
Time Frame: Up to 60 months
Up to 60 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Distribution of participant demographics characteristics: Age
Time Frame: At baseline
At baseline
Distribution of participant demographics characteristics: Sex
Time Frame: At baseline
At baseline
Distribution of participant demographics characteristics: Height
Time Frame: At baseline
At baseline
Distribution of participant demographics characteristics: Body weight
Time Frame: At baseline
At baseline
Distribution of clinical characteristics: Smoking status
Time Frame: At baseline
At baseline
Distribution of clinical characteristics: Multiple Sclerosis (MS) diagnosis
Time Frame: At baseline
At baseline
Distribution of clinical characteristics: MS anamnesis/history
Time Frame: At baseline
At baseline
Distribution of clinical characteristics: Prior diseases
Time Frame: At baseline
At baseline
Distribution of clinical characteristics: Concomitant diseases
Time Frame: At baseline
At baseline
Distribution of clinical characteristics: Concomitant medication
Time Frame: At baseline
At baseline
Distribution of clinical characteristics: Prior MS medication
Time Frame: At baseline
At baseline
Distribution of clinical characteristics: Physical examination
Time Frame: At baseline
At baseline
Distribution of clinical characteristics: Reasons for switch to ozanimod
Time Frame: At baseline
At baseline
Distribution of clinical characteristics: Treatment start with ozanimod
Time Frame: At baseline
At baseline
Distribution of clinical characteristics: Treatment with ozanimod dose interruptions
Time Frame: Up to 60 months
Up to 60 months
Distribution of clinical characteristics: Discontinuation, defined as physician's documentation of a discontinuation of ozanimod treatment
Time Frame: Up to 60 months
Up to 60 months
Distribution of clinical characteristics: Reason for discontinuation
Time Frame: Up to 60 years
Up to 60 years
Distribution of clinical characteristics: Subsequent MS treatment
Time Frame: Up to 68 years
Up to 68 years
Distribution of clinical characteristics: Persistence with therapy
Time Frame: Up to 60 years
Up to 60 years
Distribution of clinical characteristics: Adherence to therapy
Time Frame: Up to 60 years
Up to 60 years
Treatment Satisfaction Questionnaire for Medication (TSQM v1.4)
Time Frame: Up to 68 months
Up to 68 months
Symbol Digit Modalities Test (SDMT)
Time Frame: Up to 68 months
Up to 68 months
Fatigue scale for motor and cognitive functions (FSMC)
Time Frame: Up to 68 months
Up to 68 months
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Time Frame: Up to 68 months
Up to 68 months
United Kingdom Neurological Disability Rating Scale (UNDS)
Time Frame: Up to 68 months
Up to 68 months
Clinical Relapse defined as the annualized relapse rate (ARR)
Time Frame: Up to 68 months
Up to 68 months
Expanded disability status scale (EDSS)
Time Frame: Up to 68 months
Up to 68 months
Work Productivity and Activity Index-Multiple Sclerosis (WPAI-MS German v2.1)
Time Frame: Up to 68 months
Up to 68 months
Multiple Sclerosis Health Resource Survey (MS-HRS 3.0)
Time Frame: Up to 68 months
Up to 68 months
Incidence rate for Adverse Events (AEs)
Time Frame: Up to 60 years
Up to 60 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Anticipated)

March 31, 2029

Study Completion (Anticipated)

November 30, 2029

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPC-1063-MS-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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