Secondary Progressive Multiple Sclerosis (SPMS)
Conditions
Keywords
Secondary Progressive Multiple Sclerosis, SPMS, Mayzent, Siponimod, Japan
Brief summary
This study is a single cohort, central registration system, all-case, open-label, multicenter observational study in patients using Mayzent for the indication of secondary progressive multiple sclerosis.
Detailed description
This is a non-interventional study, and as such there is no binding treatment strategy, diagnosis/treatment procedures or visit schedule. The investigator should administer Mayzent as labelled. Routine medical practice will apply to visit frequency and evaluation variables, and only these data will be collected by the sponsor as part of the study procedures. The investigator should record data in the applicable CRFs at every visit if possible.
Interventions
DRUGMayzent
There is no treatment allocation. Patients administered Mayzent by prescription that have started before inclusion of the patient into the study will be enrolled.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients prescribed Mayzent for prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions | 24 months | A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal. An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Mayzent or whose causality is not recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annual relapse rate | 24 months | Annual relapse rate will be calculated |
| Physician's Global Assessment (PGA) of disease activity | month 12 and month 24 | Secondary Progressive Multiple Sclerosis (SPMS) symptom changes will be assessed an rated as very much improved, improved, unchanged, worsening or not assessable in comparison with the symptoms at the start of Mayzent administration |
| Changes over time in Expanded Disability Status Scale (EDSS) score | Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21 and month 24 | EDSS assesses disability. An overall score ranging from 0 (normal) to 10 (death due to MS) will be calculated. |
| Time to confirmed disability progression continuing for ≥ 3 months from the start of administration as assessed by the EDSS | 24 months | Disability progression is defined as an increase of 1.5 points or more in patients with an EDSS score of 0 at baseline, an increase of 1 point or more in patients with an EDSS score of 0.5 to 5 at baseline and an increase of 0.5 points or more in patients with an EDSS score of 5.5 or more at baseline. |
| Time to confirmed disability progression continuing for ≥ 6 months from the start of administration as assessed by the EDSS | 24 months | Disability progression is defined as an increase of 1.5 points or more in patients with an EDSS score of 0 at baseline, an increase of 1 point or more in patients with an EDSS score of 0.5 to 5 at baseline and an increase of 0.5 points or more in patients with an EDSS score of 5.5 or more at baseline. |
Countries
Japan
Outcome results
None listed