Multiple Sclerosis, Relapsing-RemittingOzEANNCT05335031
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®)
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Bristol-Myers Squibb at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Ozanimod
- How many people
- 450 participants
- Where
- 1 siteGermany
- Study dates
- 3 Mar 2021to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Dresden, MS Ambulanz
Dresden, Saxony, 01307
About this study
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)
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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Ozanimod
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Ozanimod, Zeposia®
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzanimodDrug
As per product label
| Study group | Role | What they receive |
|---|---|---|
| Participants with relapsing-remitting multiple sclerosis (RRMS) treated with Ozanimod | Not described Receives: Drug: Ozanimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants persistence with therapy
Measured: Up to 36 months
Secondary outcomes (29)
Distribution of participant demographics characteristics: Age
Measured: At baseline
Distribution of participant demographics characteristics: Sex
Measured: At baseline
Distribution of participant demographics characteristics: Height
Measured: At baseline
Distribution of participant demographics characteristics: Body weight
Measured: At baseline
Distribution of clinical characteristics: Smoking status
Measured: At baseline
Distribution of clinical characteristics: Multiple Sclerosis (MS) diagnosis
Measured: At baseline
Distribution of clinical characteristics: MS anamnesis/history
Measured: At baseline
Distribution of clinical characteristics: Prior diseases
Measured: At baseline
Distribution of clinical characteristics: Concomitant diseases
Measured: At baseline
Distribution of clinical characteristics: Concomitant medication
Measured: At baseline
Distribution of clinical characteristics: Prior MS medication
Measured: At baseline
Distribution of clinical characteristics: Physical examination
Measured: At baseline
Distribution of clinical characteristics: Reasons for switch to ozanimod
Measured: At baseline
Distribution of clinical characteristics: Treatment start with ozanimod
Measured: At baseline
Distribution of clinical characteristics: Discontinuation, defined as physician's documentation of a discontinuation of ozanimod treatment
Measured: Up to 36 months
Distribution of clinical characteristics: Reason for discontinuation
Measured: Up to 36 months
Distribution of clinical characteristics: Subsequent MS treatment
Measured: Up to 44 months
Distribution of clinical characteristics: Persistence with therapy
Measured: Up to 36 months
Distribution of clinical characteristics: Adherence to therapy
Measured: Up to 36 months
Treatment Satisfaction Questionnaire for Medication (TSQM v1.4)
Measured: Up to 44 months
Symbol Digit Modalities Test (SDMT)
Measured: Up to 44 months
Fatigue scale for motor and cognitive functions (FSMC)
Measured: Up to 44 months
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Measured: Up to 44 months
United Kingdom Neurological Disability Rating Scale (UNDS)
Measured: Up to 44 months
Clinical Relapse defined as the annualized relapse rate (ARR)
Measured: Up to 44 months
Expanded disability status scale (EDSS)
Measured: Up to 44 months
Work Productivity and Activity Index-Multiple Sclerosis (WPAI-MS German v2.1)
Measured: Up to 44 months
Multiple Sclerosis Health Resource Survey (MS-HRS 3.0)
Measured: Up to 44 months
Incidence rate for Adverse Events (AEs)
Measured: Up to 44 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start3 Mar 2021
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335031
- Sponsor's protocol ID
- RPC-1063-MS-003
- Acronym
- OzEAN
- Status last verified
- Sep 2025
- First submitted
- 12 Apr 2022
- Last updated
- 8 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35832177
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05335031
- Acronym / sponsor ID
- OzEAN / RPC-1063-MS-003
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Ozanimod, Zeposia®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with relapsing-remitting multiple sclerosis (RRMS) treated with Ozanimod | – | Drug: Ozanimod |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzanimodAs per product label | Drug | Participants with relapsing-remitting multiple sclerosis (RRMS) treated with Ozanimod |
Primary outcome
Proportion of participants persistence with therapy
Time frame: Up to 36 months
29 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
Distribution of clinical characteristics: Prior MS medication
Time frame: At baseline
Distribution of clinical characteristics: Physical examination
Time frame: At baseline
Distribution of clinical characteristics: Reasons for switch to ozanimod
Time frame: At baseline
Distribution of clinical characteristics: Treatment start with ozanimod
Time frame: At baseline
Distribution of clinical characteristics: Discontinuation, defined as physician's documentation of a discontinuation of ozanimod treatment
Time frame: Up to 36 months
Distribution of clinical characteristics: Reason for discontinuation
Time frame: Up to 36 months
Distribution of clinical characteristics: Subsequent MS treatment
Time frame: Up to 44 months
Distribution of clinical characteristics: Persistence with therapy
Time frame: Up to 36 months
Distribution of clinical characteristics: Adherence to therapy
Time frame: Up to 36 months
Treatment Satisfaction Questionnaire for Medication (TSQM v1.4)
Time frame: Up to 44 months
Symbol Digit Modalities Test (SDMT)
Time frame: Up to 44 months
Fatigue scale for motor and cognitive functions (FSMC)
Time frame: Up to 44 months
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Time frame: Up to 44 months
United Kingdom Neurological Disability Rating Scale (UNDS)
Time frame: Up to 44 months
Clinical Relapse defined as the annualized relapse rate (ARR)
Time frame: Up to 44 months
Expanded disability status scale (EDSS)
Time frame: Up to 44 months
Work Productivity and Activity Index-Multiple Sclerosis (WPAI-MS German v2.1)
Time frame: Up to 44 months
Multiple Sclerosis Health Resource Survey (MS-HRS 3.0)
Time frame: Up to 44 months
Incidence rate for Adverse Events (AEs)
Time frame: Up to 44 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 35832177Ziemssen 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.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Bristol-Myers Squibb at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants persistence with therapy (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05335031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.