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.
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.
Study Type
OBSERVATIONAL
Enrollment
451
There is no treatment allocation. Patients administered Mayzent by prescription that have started before inclusion of the patient into the study will be enrolled.
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
Time frame: 24 months
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Anjo, Aichi-ken, Japan
Novartis Investigative Site
Hekinan, Aichi-ken, Japan
Novartis Investigative Site
Ichinomiya, Aichi-ken, Japan
Novartis Investigative Site
Kariya, Aichi-ken, Japan
Novartis Investigative Site
Kasugai, Aichi-ken, Japan
Novartis Investigative Site
Nagakute, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
...and 164 more locations
Time frame: 24 months
Annual relapse rate
Annual relapse rate will be calculated
Time frame: 24 months