Multiple Sclerosis, Relapsing-RemittingORIONNCT05605782
A Post-Authorization, Long-term Study of Ozanimod Real-world Safety
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to determine the rates of adverse events of interest (AEIs) in a real-world population of participants with relapsing remitting multiple sclerosis (RRMS) receiving Ozanimod, sphingosine-1 phosphate (S1P) receptor modulator, compared to the rates of these events in two population of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- How many people
- 9,000 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2021to 26 Jul 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population will include men and women at least 18 years old who have a diagnosis of multiple sclerosis and are new users of ("initiate") treatment with one of three cohort-defining treatments. Participants will be grouped into the following cohorts: * Exposed: Starting ozanimod * Non-exposed: Starting another sphingosine 1-phosphate (S1P) receptor modulator * Non-exposed: Starting a disease modifying treatment other than an S1P receptor modulator
Who may be able to join
- Have a diagnosis of multiple sclerosis (MS) recorded on or before the index prescription
- Have at least 6 months of continuous enrollment in the data source (thereby providing medical and dispensing/prescription history data, along with an operational definition of new use) before the index date
Who cannot join
- Participants with dispensing/prescription of more than one cohort defining drug on the index date
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ORION (Ozanimod Real-World Safety - A Post- Authorisation Multi-National Long-term Non-Interventional Study)
The purpose of this study is to determine the rates of adverse events of interest (AEIs) in a real-world population of participants with relapsing remitting multiple sclerosis (RRMS) receiving Ozanimod, sphingosine-1 phosphate (S1P) receptor modulator, compared to the rates of these events in two population of participants:
- Participants not exposed to ozanimod with RRMS who have received treatment with other S1P-receptor modulators disease modifying treatments (DMTs)
- Participants not exposed to ozanimod with RRMS who have received treatment with other non-S1P-receptor modulators disease modifying treatments (DMTs)
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Relapsing-Remitting Multiple Sclerosis, Ozanimod, Serious opportunistic infections, Serious acute liver injury, Malignancy, Macular edema
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Neoplasms, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants initiating treatment with ozanimod | Not described | |
| Participants initiating an sphingosine-1 phosphate (S1P) modulator | Not described | |
| Participants initiating other non-S1P-receptor modulators disease modifying treatments (DMTs) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse cardiovascular events (MACE)
Measured: Up to 10 years
Incidence of serious opportunistic infection (SOI)
Measured: Up to 10 years
Incidence of serious acute liver injury (SALI)
Measured: Up to 10 years
Incidence of macular edema
Measured: Up to 10 years
Identified rate of malignancies identified based upon the presence of at least 1 international classification of diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code
Measured: Up to approximately 2 years
Secondary outcomes (3)
Incidence of symptomatic bradycardia
Measured: Up to approximately 5 years
Incidence of progressive multifocal leukoencephalopathy (PML)
Measured: Up to approximately 5 years
Incidence of posterior reversible encephalopathy syndrome (PRES)
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start2 Sep 2021
- Primary completion26 Jul 2033 (estimated)
- Study completion26 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 9,000 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
- NCT05605782
- Sponsor's protocol ID
- IM047-009
- Other IDs
- EUPAS44615
- Acronym
- ORION
- Status last verified
- Jun 2025
- First submitted
- 31 Oct 2022
- Last updated
- 26 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORION (Ozanimod Real-World Safety - A Post- Authorisation Multi-National Long-term Non-Interventional Study)
- ClinicalTrials.gov ID
- NCT05605782
- Acronym / sponsor ID
- ORION / IM047-009
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Relapsing-Remitting Multiple Sclerosis, Ozanimod, Serious opportunistic infections, Serious acute liver injury, Malignancy, Macular edema
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 9,000 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 26 Jul 2033 (estimated)
- Study completion
- 26 Jul 2033 (estimated)
- First posted
- 4 Nov 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 determine the rates of adverse events of interest (AEIs) in a real-world population of participants with relapsing remitting multiple sclerosis (RRMS) receiving Ozanimod, sphingosine-1 phosphate (S1P) receptor modulator, compared to the rates of these events in two population of participants:
- Participants not exposed to ozanimod with RRMS who have received treatment with other S1P-receptor modulators disease modifying treatments (DMTs)
- Participants not exposed to ozanimod with RRMS who have received treatment with other non-S1P-receptor modulators disease modifying treatments (DMTs)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants initiating treatment with ozanimod | – | – |
| Participants initiating an sphingosine-1 phosphate (S1P) modulator | – | – |
| Participants initiating other non-S1P-receptor modulators disease modifying treatments (DMTs) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include men and women at least 18 years old who have a diagnosis of multiple sclerosis and are new users of ("initiate") treatment with one of three cohort-defining treatments. Participants will be grouped into the following cohorts: * Exposed: Starting ozanimod * Non-exposed: Starting another sphingosine 1-phosphate (S1P) receptor modulator * Non-exposed: Starting a disease modifying treatment other than an S1P receptor modulator
Key inclusion criteria (2 listed)
- Have a diagnosis of multiple sclerosis (MS) recorded on or before the index prescription
- Have at least 6 months of continuous enrollment in the data source (thereby providing medical and dispensing/prescription history data, along with an operational definition of new use) before the index date
Key exclusion criteria (2 listed)
- Participants with dispensing/prescription of more than one cohort defining drug on the index date
- 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.
Primary outcome
Incidence of major adverse cardiovascular events (MACE)
Time frame: Up to 10 years
Incidence of serious opportunistic infection (SOI)
Time frame: Up to 10 years
Incidence of serious acute liver injury (SALI)
Time frame: Up to 10 years
Incidence of macular edema
Time frame: Up to 10 years
Identified rate of malignancies identified based upon the presence of at least 1 international classification of diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code
Time frame: Up to approximately 2 years
3 secondary outcomes
Incidence of symptomatic bradycardia
Time frame: Up to approximately 5 years
Incidence of progressive multifocal leukoencephalopathy (PML)
Time frame: Up to approximately 5 years
Incidence of posterior reversible encephalopathy syndrome (PRES)
Time frame: Up to approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
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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 United States.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of major adverse cardiovascular events (MACE) (time frame: Up to 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2025.