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
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