relapsing-remitting multiple sclerosis and active secondary progressive multiple sclerosis
Conditions
Interventions
None listed
Sponsors
Sugimoto Toshiya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients must provide written consent to participate in this study before the start of treatment with Kesimpta 2.Patients using Kesimpta for the first time for the following indication Indication: prevention of relapses and and prevention of physical disability progression in the following patients -Relapsing-remitting MS -Active SPMS
Exclusion criteria
Exclusion criteria: 1.Patients with a history of treatment with a drug containing the same ingredient as Kesimpta (investigational drug or post-marketing clinical study drug) 2.Patients with a history of hypersensitivity to any of the Kesimpta ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Incidence of adverse events between the start of treatment with Kesimpta administration and 24 months on Kesimpta 2.Incidence of serious adverse events between the start of treatment with Kesimpta administration and 24 months on Kesimpta 3.Incidence of adverse reactions between the start of treatment with Kesimpta administration and 24 months on Kesimpta | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Physician's Global Assessment at 12 months and 24 months from the start of treatment with Kesimpta 2.Confirmed disability worsening on EDSS continuing for >=3 months and >=6 months (3mCDW, 6mCDW) 3.Confirmed improvement on EDSS continuing for >=6 months (6mCDI) 4.Number of gadolinium (Gd)-enhancing lesions on MRI 5.Annual relapse rate 6.NEDA-3 | — |
Contacts
Public ContactNovartis Direct
Novartis Pharma. K.K.
Outcome results
None listed