Clinical trial NCT05335031: 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®)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
Relapsing-Remitting
Ozanimod
Zeposia®
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-04-19
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 450 relapsing-remitting multiple sclerosis (RRMS) adult participants (any gender) who are either newly treated RRMS participants or who switched from other RRMS treatments to ozanimod are planned to be enrolled in up to 100 specialist study sites (office-based neurologists and clinics) across Germany.

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.


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

Primary outcomes:
measure: Proportion of participants persistence with therapy
timeFrame: Up to 36 months
Secondary outcomes:
measure: Distribution of participant demographics characteristics: Age
timeFrame: At baseline
measure: Distribution of participant demographics characteristics: Sex
timeFrame: At baseline
measure: Distribution of participant demographics characteristics: Height
timeFrame: At baseline
measure: Distribution of participant demographics characteristics: Body weight
timeFrame: At baseline
measure: Distribution of clinical characteristics: Smoking status
timeFrame: At baseline
measure: Distribution of clinical characteristics: Multiple Sclerosis (MS) diagnosis
timeFrame: At baseline
measure: Distribution of clinical characteristics: MS anamnesis/history
timeFrame: At baseline
measure: Distribution of clinical characteristics: Prior diseases
timeFrame: At baseline
measure: Distribution of clinical characteristics: Concomitant diseases
timeFrame: At baseline
measure: Distribution of clinical characteristics: Concomitant medication
timeFrame: At baseline
measure: Distribution of clinical characteristics: Prior MS medication
timeFrame: At baseline
measure: Distribution of clinical characteristics: Physical examination
timeFrame: At baseline
measure: Distribution of clinical characteristics: Reasons for switch to ozanimod
timeFrame: At baseline
measure: Distribution of clinical characteristics: Treatment start with ozanimod
timeFrame: At baseline
measure: Distribution of clinical characteristics: Discontinuation, defined as physician's documentation of a discontinuation of ozanimod treatment
timeFrame: Up to 36 months
measure: Distribution of clinical characteristics: Reason for discontinuation
timeFrame: Up to 36 months
measure: Distribution of clinical characteristics: Subsequent MS treatment
timeFrame: Up to 44 months
measure: Distribution of clinical characteristics: Persistence with therapy
timeFrame: Up to 36 months
measure: Distribution of clinical characteristics: Adherence to therapy
timeFrame: Up to 36 months
measure: Treatment Satisfaction Questionnaire for Medication (TSQM v1.4)
timeFrame: Up to 44 months
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Up to 44 months
measure: Fatigue scale for motor and cognitive functions (FSMC)
timeFrame: Up to 44 months
measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54)
timeFrame: Up to 44 months
measure: United Kingdom Neurological Disability Rating Scale (UNDS)
timeFrame: Up to 44 months
measure: Clinical Relapse defined as the annualized relapse rate (ARR)
timeFrame: Up to 44 months
measure: Expanded disability status scale (EDSS)
timeFrame: Up to 44 months
measure: Work Productivity and Activity Index-Multiple Sclerosis (WPAI-MS German v2.1)
timeFrame: Up to 44 months
measure: Multiple Sclerosis Health Resource Survey (MS-HRS 3.0)
timeFrame: Up to 44 months
measure: Incidence rate for Adverse Events (AEs)
timeFrame: Up to 44 months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden, MS Ambulanz
state: Saxony
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Ziemssen T, Richter S, Maurer M, Buttmann M, Kreusel B, Poehler AM, Lampl M, Linker RA. OzEAN Study to Collect Real-World Evidence of Persistent Use, Effectiveness, and Safety of Ozanimod Over 5 Years in Patients With Relapsing-Remitting Multiple Sclerosis in Germany. Front Neurol. 2022 Jun 27;13:913616. doi: 10.3389/fneur.2022.913616. eCollection 2022.