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The purpose of this study is to describe the reasons, therapy, and/or disease for changing first or second line Disease Modifying Therapy (DMT) to ozanimod in participants with Relapsing Remitting Multiple Sclerosis (RRMS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Reason for switching treatment | Reason for switching the previous treatment: Lack of efficacy, Poor safety/tolerability, Difficulty in administration, Poor compliance, Patient's request, or other reasons | At baseline |
| Mode of switching treatment | Wash-out from previous treatment (first/second line DMT) (days), overlapping (days), dosage (first/second line DMT and ozanimod), concomitant treatments | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Expanded Disability Status Score (EDSS) | Mean EDSS score in patients enrolled in the study | At baseline, week 12, and week 24 |
| MRI | Number of new or enlarging T2 lesions and T1 Gadolinium Enhancing Lesions (GdE) lesions. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria apply.
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The study population is composed of 180 participants 18-55 years with Relapsing Remitting Multiple Sclerosis (RRMS) diagnosed according to 2017 revised McDonald criteria, switching from a first or second line Disease Modifying Therapy (DMT) to ozanimod, and in treatment with ozanimod between 4 and 12 weeks before the enrollment.
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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 | Isernia | 86077 | Italy |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| At baseline, week 12, and week 24 |
| TSQM | Treatment Satisfaction Questionnaire for Medication | At baseline and week 24 |
| Lymphocyte sub populations | The pattern of the sub populations of lymphocytes: CD3, CD4, CD8, CD19, CD56. | At baseline, week 12, and week 24 |
| Incidence of Adverse Events (AEs) | Number of AEs in the study population during the study; AEs will be coded according to MEdDRA. | Continuous (Up to 42 months) |
| Incidence of Serious Adverse Events (SAEs) | Number of SAEs in the study population during the study; SAEs will be coded according to MEdDRA. | Continuous (Up to 42 months) |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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