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)

Bristol-Myers Squibb1 site in 1 country450 target enrollmentMarch 3, 2021

ConditionsMultiple Sclerosis, Relapsing-Remitting

InterventionsOzanimod

DrugsOzanimod

Overview

Phase: Not Applicable
Intervention: Ozanimod
Conditions: Multiple Sclerosis, Relapsing-Remitting
Sponsor: Bristol-Myers Squibb
Enrollment: 450
Locations: 1
Primary Endpoint: Proportion of participants persistence with therapy
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 3, 2021

End Date

June 30, 2025

Last Updated

7 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

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

Intervention: Ozanimod

Outcomes

Primary Outcomes

Proportion of participants persistence with therapy

Time Frame: Up to 36 months

Secondary Outcomes

Distribution of clinical characteristics: Prior diseases(At baseline)
Distribution of clinical characteristics: Concomitant medication(At baseline)
Symbol Digit Modalities Test (SDMT)(Up to 44 months)
Distribution of participant demographics characteristics: Age(At baseline)
Distribution of participant demographics characteristics: Height(At baseline)
Distribution of clinical characteristics: MS anamnesis/history(At baseline)
Distribution of clinical characteristics: Smoking status(At baseline)
Distribution of clinical characteristics: Concomitant diseases(At baseline)
Distribution of clinical characteristics: Prior MS medication(At baseline)
Distribution of clinical characteristics: Physical examination(At baseline)
Distribution of clinical characteristics: Treatment start with ozanimod(At baseline)
Distribution of participant demographics characteristics: Sex(At baseline)
Distribution of participant demographics characteristics: Body weight(At baseline)
Distribution of clinical characteristics: Multiple Sclerosis (MS) diagnosis(At baseline)
Distribution of clinical characteristics: Adherence to therapy(Up to 36 months)
Treatment Satisfaction Questionnaire for Medication (TSQM v1.4)(Up to 44 months)
Distribution of clinical characteristics: Reasons for switch to ozanimod(At baseline)
Distribution of clinical characteristics: Persistence with therapy(Up to 36 months)
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)
Clinical Relapse defined as the annualized relapse rate (ARR)(Up to 44 months)
Expanded disability status scale (EDSS)(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)
Fatigue scale for motor and cognitive functions (FSMC)(Up to 44 months)
Multiple Sclerosis Quality of Life-54 (MSQOL-54)(Up to 44 months)
Work Productivity and Activity Index-Multiple Sclerosis (WPAI-MS German v2.1)(Up to 44 months)
United Kingdom Neurological Disability Rating Scale (UNDS)(Up to 44 months)