Relapsing-remitting Multiple Sclerosis (RRMS)AppreZiateNCT05811416
A Study to Describe the Persistence With Ozanimod Treatment in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants
An observational study of Relapsing-remitting Multiple Sclerosis (RRMS), run by Bristol-Myers Squibb at 1 site in Spain.
Trial summary
The purpose of the study is to collect clinical data on the persistence with ozanimod treatment, as well as to describe its effects on participant-relevant outcome parameters in treatment-naïve participants with RRMS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis (RRMS)
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jun 2023to 20 Jan 2027
- 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: Candidates will be adult treatment-naïve participants diagnosed with RRMS who attend to a regular follow up visit at a Spanish participating hospital and who started treatment with ozanimod for the first time 3 months (+/- 2 weeks) before inclusion.
Who may be able to join
- Relapsing-remitting multiple sclerosis (RRMS) diagnosis by 2017 revised McDonald criteria at the treatment start
- Participant who started treatment with ozanimod for the first time 3 months (+/- 2 weeks) before inclusion, according to European Union (EU) Summary of Product Characteristics (SmPC) and/or Spanish therapeutic positioning report (TPR) recommendation and following routine clinical practice of the participating hospital
- Low-to-moderate activity, defined as less than 2 relapses in the previous year before starting the treatment with ozanimod
Who cannot join
- Prior exposure to ozanimod or any other disease modifier treatment (DMT) for RRMS before starting treatment with ozanimod subject of this study
- Participant who has started ozanimod within a clinical trial
- Note: Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational, Multicenter Study to Describe the Persistence in Relapsing Remitting Multiple Sclerosis Naive Patients With Low-moderate Activity Treated With Ozanimod (Zeposia®) in Clinical Practice in Spain
The purpose of the study is to collect clinical data on the persistence with ozanimod treatment, as well as to describe its effects on participant-relevant outcome parameters in treatment-naïve participants with RRMS.
- Keywords
- Ozanimod, Zeposia, Relapsing-remitting multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
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 |
|---|---|---|
| Cohort 1 | Participants that have initiated ozanimod. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from ozanimod treatment initiation to ozanimod treatment permanent discontinuation
Measured: Up to 24 months
Percentage of participants on treatment with ozanimod at 24 months
Measured: At month 24
Secondary outcomes (18)
Percentage of participants with ozanimod treatment at 3 and 12 months
Measured: At month 3 and month 12
Percentage of participants with ozanimod treatment discontinuation
Measured: Up to 24 months
Percentage of participants switching to treatment alternative
Measured: Up to 24 months
Annualized relapse rate at month 12 month and month 24
Measured: At month 12 and month 24
Proportion of participants with an increase in Symbol Digit Modalities Test (SDMT) score of ≥4 points
Measured: At month 3, 12 and 24
Proportion of participants with a decrease SDMT score of ≥4 points
Measured: At month 3, 12 and 24
Proportion of participants with a stable SDMT score
Measured: At month 3, 12 and 24
Change from baseline in SDMT score at month 3, 12 and 24
Measured: Baseline, Month 3, 12 and 24
Change from baseline in Neurofilament light (NfL) levels at month 6, 12 and 24
Measured: Baseline, Month 6, 12 and 24
Proportion of participants with change of ≥1.0 point from baseline in expanded disability status scale (EDSS) score at Month 3, 12 and 24
Measured: Baseline, Month 3, 12 and 24
Change from baseline in EDSS score at Month 3, 12 and 24
Measured: Baseline, Month 3, 12 and 24
Change from baseline in number of new or enlarging hypointense T1 lesions at month 12 and 24
Measured: Baseline, Month 12 and 24
Change from baseline in number of new or enlarging hypointense T2 lesions at month 12 and 24
Measured: Baseline, Month 12 and 24
Change from baseline in number of new or enlarging gadolinium enhancing brain lesions at month 12 and 24
Measured: Baseline, Month 12 and 24
Number of Participants with at least one Adverse Event (AE)
Measured: Up to 24 months
Number of Participants with AE that imply discontinuation of ozanimod
Measured: Up to 24 months
Description of sociodemographic characteristics of participants
Measured: Baseline, up to 24 months
Description of clinical characteristics of participants
Measured: Baseline, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start14 Jun 2023
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-remitting Multiple Sclerosis (RRMS)Studies 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
- 200 participants (estimated)
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
- NCT05811416
- Sponsor's protocol ID
- IM047-066
- Acronym
- AppreZiate
- Status last verified
- May 2026
- First submitted
- 15 Mar 2023
- Last updated
- 29 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Multicenter Study to Describe the Persistence in Relapsing Remitting Multiple Sclerosis Naive Patients With Low-moderate Activity Treated With Ozanimod (Zeposia®) in Clinical Practice in Spain
- ClinicalTrials.gov ID
- NCT05811416
- Acronym / sponsor ID
- AppreZiate / IM047-066
- Keywords
- Ozanimod, Zeposia, Relapsing-remitting multiple sclerosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 13 Apr 2023 (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 the study is to collect clinical data on the persistence with ozanimod treatment, as well as to describe its effects on participant-relevant outcome parameters in treatment-naïve participants with RRMS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants that have initiated ozanimod. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Candidates will be adult treatment-naïve participants diagnosed with RRMS who attend to a regular follow up visit at a Spanish participating hospital and who started treatment with ozanimod for the first time 3 months (+/- 2 weeks) before inclusion.
Key inclusion criteria (3 listed)
- Relapsing-remitting multiple sclerosis (RRMS) diagnosis by 2017 revised McDonald criteria at the treatment start
Key exclusion criteria (3 listed)
- Prior exposure to ozanimod or any other disease modifier treatment (DMT) for RRMS before starting treatment with ozanimod subject of this study
- Participant who has started ozanimod within a clinical trial
- Note: 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
Time from ozanimod treatment initiation to ozanimod treatment permanent discontinuation
Time frame: Up to 24 months
Percentage of participants on treatment with ozanimod at 24 months
Time frame: At month 24
18 secondary outcomes
Percentage of participants with ozanimod treatment at 3 and 12 months
Time frame: At month 3 and month 12
Percentage of participants with ozanimod treatment discontinuation
Time frame: Up to 24 months
Percentage of participants switching to treatment alternative
Time frame: Up to 24 months
Annualized relapse rate at month 12 month and month 24
Time frame: At month 12 and month 24
Proportion of participants with an increase in Symbol Digit Modalities Test (SDMT) score of ≥4 points
Time frame: At month 3, 12 and 24
Proportion of participants with a decrease SDMT score of ≥4 points
Time frame: At month 3, 12 and 24
Proportion of participants with a stable SDMT score
Time frame: At month 3, 12 and 24
Change from baseline in SDMT score at month 3, 12 and 24
Time frame: Baseline, Month 3, 12 and 24
Change from baseline in Neurofilament light (NfL) levels at month 6, 12 and 24
Time frame: Baseline, Month 6, 12 and 24
Proportion of participants with change of ≥1.0 point from baseline in expanded disability status scale (EDSS) score at Month 3, 12 and 24
Time frame: Baseline, Month 3, 12 and 24
Change from baseline in EDSS score at Month 3, 12 and 24
Time frame: Baseline, Month 3, 12 and 24
Change from baseline in number of new or enlarging hypointense T1 lesions at month 12 and 24
Time frame: Baseline, Month 12 and 24
Change from baseline in number of new or enlarging hypointense T2 lesions at month 12 and 24
Time frame: Baseline, Month 12 and 24
Change from baseline in number of new or enlarging gadolinium enhancing brain lesions at month 12 and 24
Time frame: Baseline, Month 12 and 24
Number of Participants with at least one Adverse Event (AE)
Time frame: Up to 24 months
Number of Participants with AE that imply discontinuation of ozanimod
Time frame: Up to 24 months
Description of sociodemographic characteristics of participants
Time frame: Baseline, up to 24 months
Description of clinical characteristics of participants
Time frame: Baseline, up to 24 months
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 29 May 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink 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 Relapsing-remitting Multiple Sclerosis (RRMS), run by Bristol-Myers Squibb at 1 site in Spain.
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 3 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 29 May 2026. 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 Spain. 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?
Time from ozanimod treatment initiation to ozanimod treatment permanent discontinuation (time frame: Up to 24 months). The study lists 2 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 29 May 2026.