Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients (Prevention of Relapses and Delay of Progression of Physical Disability in Secondary Progressive Multiple Sclerosis)

Conditions
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Secondary Progressive Multiple Sclerosis (SPMS)

Intervention / Treatment
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* Drug: Mayzent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients prescribed Mayzent for prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis Exclusion Criteria: -

Ages Eligible for Study
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Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mayzent<br>Patients administered Mayzent by prescription | Drug: Mayzent<br>* There is no treatment allocation. Patients administered Mayzent by prescription that have started before inclusion of the patient into the study will be enrolled.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions | 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's Global Assessment (PGA) of disease activity | 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 | month 12 and month 24 | 
| Changes over time in Expanded Disability Status Scale (EDSS) score | EDSS assesses disability. An overall score ranging from 0 (normal) to 10 (death due to MS) will be calculated. | Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21 and month 24 | 
| Time to confirmed disability progression continuing for ≥ 3 months from the start of administration as assessed by the EDSS | 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. | 24 months | 
| Time to confirmed disability progression continuing for ≥ 6 months from the start of administration as assessed by the EDSS | 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. | 24 months | 
| Annual relapse rate | Annual relapse rate will be calculated | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary Progressive Multiple Sclerosis, SPMS, Mayzent, Siponimod, Japan