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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants that have initiated ozanimod. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time from ozanimod treatment initiation to ozanimod treatment permanent discontinuation | Up to 24 months | |
| Percentage of participants on treatment with ozanimod at 24 months | At month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with ozanimod treatment at 3 and 12 months | At month 3 and month 12 | |
| Percentage of participants with ozanimod treatment discontinuation | Up to 24 months | |
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Inclusion Criteria:
Relapsing-remitting multiple sclerosis (RRMS) diagnosis by 2017 revised McDonald criteria at the treatment start
Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria apply
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Barcelona | 08008 | Spain |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| Percentage of participants switching to treatment alternative |
| Up to 24 months |
| Annualized relapse rate at month 12 month and month 24 | At month 12 and month 24 |
| Proportion of participants with an increase in Symbol Digit Modalities Test (SDMT) score of ≥4 points | At month 3, 12 and 24 |
| Proportion of participants with a decrease SDMT score of ≥4 points | At month 3, 12 and 24 |
| Proportion of participants with a stable SDMT score | At month 3, 12 and 24 |
| Change from baseline in SDMT score at month 3, 12 and 24 | Baseline, Month 3, 12 and 24 |
| Change from baseline in Neurofilament light (NfL) levels at month 6, 12 and 24 | 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 | Baseline, Month 3, 12 and 24 |
| Change from baseline in EDSS score at Month 3, 12 and 24 | Baseline, Month 3, 12 and 24 |
| Change from baseline in number of new or enlarging hypointense T1 lesions at month 12 and 24 | Baseline, Month 12 and 24 |
| Change from baseline in number of new or enlarging hypointense T2 lesions at month 12 and 24 | Baseline, Month 12 and 24 |
| Change from baseline in number of new or enlarging gadolinium enhancing brain lesions at month 12 and 24 | Baseline, Month 12 and 24 |
| Number of Participants with at least one Adverse Event (AE) | Up to 24 months |
| Number of Participants with AE that imply discontinuation of ozanimod | Up to 24 months |
| Description of sociodemographic characteristics of participants | Baseline, up to 24 months |
| Description of clinical characteristics of participants | Baseline, up to 24 months |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |