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®)

Bristol-Myers Squibb450 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

450

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

OzanimodDRUG

As per product label

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitätsklinikum Dresden, MS Ambulanz

Dresden, Saxony, Germany

Outcomes

Primary Outcomes

Proportion of participants persistence with therapy

Time frame: Up to 36 months

Secondary Outcomes

Distribution of participant demographics characteristics: Age

Time frame: At baseline

Distribution of participant demographics characteristics: Sex

Time frame: At baseline

Distribution of participant demographics characteristics: Height

Time frame: At baseline

Distribution of participant demographics characteristics: Body weight

Time frame: At baseline

Distribution of clinical characteristics: Smoking status

Time frame: At baseline

Distribution of clinical characteristics: Multiple Sclerosis (MS) diagnosis

Time frame: At baseline

Distribution of clinical characteristics: MS anamnesis/history

Time frame: At baseline

Distribution of clinical characteristics: Prior diseases

Time frame: At baseline

Distribution of clinical characteristics: Concomitant diseases

Time frame: At baseline

Distribution of clinical characteristics: Concomitant medication

Time frame: At baseline

Data from ClinicalTrials.gov

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