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).
Study Type
OBSERVATIONAL
Enrollment
104
Local Institution - 0001
Isernia, Italy
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
Time frame: 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
Time frame: At baseline
Expanded Disability Status Score (EDSS)
Mean EDSS score in patients enrolled in the study
Time frame: At baseline, week 12, and week 24
MRI
Number of new or enlarging T2 lesions and T1 Gadolinium Enhancing Lesions (GdE) lesions.
Time frame: At baseline, week 12, and week 24
TSQM
Treatment Satisfaction Questionnaire for Medication
Time frame: At baseline and week 24
Lymphocyte sub populations
The pattern of the sub populations of lymphocytes: CD3, CD4, CD8, CD19, CD56.
Time frame: 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.
Time frame: Continuous (Up to 42 months)
Incidence of Serious Adverse Events (SAEs)
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Number of SAEs in the study population during the study; SAEs will be coded according to MEdDRA.
Time frame: Continuous (Up to 42 months)