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®)

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— OzEAN  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05335031
• Other study ID #: RPC-1063-MS-003
• Status: Recruiting
• Start date: March 3, 2021
• Est. completion date: November 30, 2029

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: November 30, 2029
• Est. primary completion date: March 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Locations

Country	Name	City	State
Germany	Univeritaetsklinikum Dresden	Dresden
Germany	Universitätsklinikum Dresden, MS Ambulanz	Dresden	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

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

External Links

•   BMS Clinical Trial Information