Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
Multiple Sclerosis, Relapsing-Remitting, Ozanimod, Zeposia®
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.
Interventions
DRUGOzanimod
As per product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants persistence with therapy | Up to 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Relapse defined as the annualized relapse rate (ARR) | Up to 44 months |
| Expanded disability status scale (EDSS) | Up to 44 months |
| Work Productivity and Activity Index-Multiple Sclerosis (WPAI-MS German v2.1) | 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 |
| Distribution of participant demographics characteristics: Age | At baseline |
| Distribution of participant demographics characteristics: Sex | At baseline |
| Distribution of participant demographics characteristics: Height | At baseline |
| Distribution of participant demographics characteristics: Body weight | At baseline |
| Distribution of clinical characteristics: Smoking status | At baseline |
| Distribution of clinical characteristics: Multiple Sclerosis (MS) diagnosis | At baseline |
| Distribution of clinical characteristics: MS anamnesis/history | At baseline |
| Distribution of clinical characteristics: Prior diseases | At baseline |
| Distribution of clinical characteristics: Concomitant diseases | At baseline |
| Distribution of clinical characteristics: Concomitant medication | At baseline |
| Distribution of clinical characteristics: Prior MS medication | At baseline |
| Distribution of clinical characteristics: Physical examination | At baseline |
| Distribution of clinical characteristics: Reasons for switch to ozanimod | At baseline |
| Distribution of clinical characteristics: Treatment start with ozanimod | At baseline |
| 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 |
| Distribution of clinical characteristics: Persistence with therapy | Up to 36 months |
| Distribution of clinical characteristics: Adherence to therapy | Up to 36 months |
| Treatment Satisfaction Questionnaire for Medication (TSQM v1.4) | Up to 44 months |
| Symbol Digit Modalities Test (SDMT) | 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 |
| United Kingdom Neurological Disability Rating Scale (UNDS) | Up to 44 months |
Countries
Germany
Outcome results
None listed