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®)
- Registration Number
- NCT05335031
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with relapsing-remitting multiple sclerosis (RRMS) treated with Ozanimod Ozanimod -
- Primary Outcome Measures
Name Time Method Proportion of participants persistence with therapy Up to 36 months
- Secondary Outcome Measures
Name Time Method Expanded disability status scale (EDSS) Up to 44 months 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: Prior diseases At baseline Distribution of clinical characteristics: Concomitant medication 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: 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 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 Distribution of clinical characteristics: Reasons for switch to ozanimod At baseline Multiple Sclerosis Health Resource Survey (MS-HRS 3.0) Up to 44 months
Trial Locations
- Locations (1)
Universitätsklinikum Dresden, MS Ambulanz
🇩🇪Dresden, Saxony, Germany
Universitätsklinikum Dresden, MS Ambulanz🇩🇪Dresden, Saxony, Germany