A study to evaluate specific unmet needs in the current clinical practice of multiple sclerosis

Percentage of participants with treatment failure as determined by the occurrence of first confirmed relapse or Expanded Disability Status Scale (EDSS) progression (increase by ≥1.5 EDSS Points if the initial EDSS is 0, increase by ≥1.0 EDSS Point if the initial EDSS is ≥0.5 ≤5.5, increase by ≥0.5 EDSS points if the initial EDSS is > 5.5) or magnetic resonance imaging (MRI) activity (new T2 or Gadolinium (Gd) enhancing lesion in spinal or cerebral MRI) or treatment change, whichever occurs first by 48 weeks

1. Time to first confirmed relapse during the study (up to 12 months). A relapse is defined as an episode of neurological symptoms that happens at least 30 days after any previous episode began, lasts at least 24 hours and is not attributable to another cause and occurs in the absence of an infection or fever. Changes in neurological examination or an increase in the EDSS Score after confirmation by the treating physician is defined as a confirmed relapse.
2. Percentage of relapse-free participants at the end of study (month 12) where relapse is defined as an episode of neurological symptoms that happens at least 30 days after any previous episode began, lasts at least 24 hours and is not attributable to another cause and occurs in the absence of an infection or fever., and is confirmed by the treating physician through e.g. changes in neurological examination or an increase in the EDSS score the relapse is called a confirmed relapse
3. Change from Baseline in measure of disability and disease progression using the EDSS score around months 6 and 12
4. Time to EDSS progression during the study (up to 12 months). EDSS progression is defined as an increase by ≥1.5 EDSS points if the initial EDSS is 0, increase by ≥1.0 EDSS points if the initial EDSS is ≥ 0.5 ≤ 5.5, increase by ≥0.5 EDSS points if the initial EDSS is >5.5
5. Percentage of participants with treatment change and the type of treatments from baseline up to month 12. Treatment change is defined as any change of the actual treatment status at baseline i.e., due to ongoing disease activity, actual or theoretical safety concerns, low treatment satisfaction, or low quality of life (Qol)
6. Change from Baseline in global impression on the disease course measured using the adapted Clinical Global Impression (CGI) as reported by participant and physician around months 6 and 12
7. Change from baseline in quality of life and participant-reported treatment satisfaction as measured by Health-Related Quality of Life (HR-Qol) at months 6 and 12
8. Change from baseline in quality of life and participant-reported treatment satisfaction as measured by Multiple Sclerosis Impact Scale-29 Version 2 (MSIS-29 v2) at months 6 and 12. The MSIS-29 is a 29-item participant-reported measure of the physical and psychological impacts of MS
9. Change from baseline in quality of life and participant-reported treatment satisfaction as measured by TSQM at months 6 and 12. The TSQM questionnaire covers three dimensions (effectiveness, side effects, and convenience) obtaining four different scores: effectiveness score, side effects score, convenience score, and global satisfaction score
10. Change from baseline in MS signs and symptoms (including mobility, cognition, fatigue) as measured by 2 minutes (min) walking test (2 MWT) at months 6 and 12. 2 MWT allows evaluation of the endurance of the participant assessing the walking distance over 2 minutes
11. Change from baseline in MS signs and symptoms (including mobility, cognition, fatigue) as measured by Symbol Digit Modalities Test (SDMT) at months 6 and 12. SDMT is a brief screening tool for cognitive dysfunction and processing speed in MS
12. Change from baseline in MS signs and symptoms (including mobility, cognition, fatigue) as measured by Fatigue Scale for Motor and Cognitive Functions (FSMC) at months 6 and 12. Fatigue is rated using this self-administered FSMC questionnaire that evaluates both motor fatigue and cognitive fatigue in MS
13. Change from baseline in MS signs and symptoms (including mobility, cognition, fatigue) as measured by the Hospital Anxiety and Depression Scale (HADS) at months 6 and 12. HADS is a common depression and anxiety measurement instrument used in MS. The minimum score is 0 and the maximum score is 21
14. Percentage of participants with adverse events (AEs) and serious adverse events (SAEs) collected prospectively from study start-up to month 12 for participants of cohorts 1 to 3 and in participants of cohorts 4 and 5 in case DMT is started during the study
15. Percentage of participants with adverse events of special interests (AESIs) and pregnancies collected prospectively from study start-up to month 12 for participants of cohorts 1 to 3 and in participants of cohorts 4 and 5 in case DMT is started during the study
16. Percentage of participants with severity of AEs, SAEs and AESIs as per physician’s assessment using National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) collected prospectively from study start up to month 12 for participants of cohorts 1 to 3 and in participants of cohorts 4 and 5 in case DMT is started during the study
17. Percentage of participants with adverse drug reactions (ADRs) and serious adverse drug reaction (SADRs) of DMTs extracted from participant charts (secondary data use) retrospectively for 12 months before start of the study for participants in cohort 2 only (recorded at baseline)
18. Percentage of participants with and severity of ADRs and SADRs of DMTs as per physician’s assessment using NCI CTCAE v4.0 extracted from participant charts (secondary data use) retrospectively for 12 months before start of the study for participants in cohort 2 only (recorded at baseline)