Status:
COMPLETED
Impact of Mayzent on aSPMS Patients in a Long-term NIS in Italy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Active Secondary Progressive Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Brief Summary
This is an observational, multicenter, single-arm, prospective study conducted in Italy
Detailed Description
Primary data will be collected over a period of three years. Medical history of participants will be collected including EDSS, MRI outcomes, relapses and previous medication to allow the estimation of...
Eligibility Criteria
Inclusion
- Signed informed consent: patient must provide written informed consent before any study assessment is performed.
- Male/female participants aged between 18 and 60.
- Documented diagnosis of active SPMS.
- Siponimod treatment as routine medical care: patients newly treated with siponimod (starting not more than 7 days before baseline visit), for whom the decision to start treatment has already been taken independently of study inclusion based on clinical practice and according to SmPC and AIFA criteria, and who successfully qualified for treatment with siponimod (i.e. passed the screening procedure mandated by the SmPC and Risk Management Plan (RMP) for this treatment, including genotyping for CYP2C9 to determine CYP2C9 metaboliser status).
Exclusion
- Patients treated outside the approved siponimod label or with any controindication indicated in the SmPC.
- Pregnant or lactating women.
- Patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on the investigator's judgement.
- Current participation in an interventional trial.
- Treatment with siponimod prior to inclusion in this study (siponimod can be started not more than 7 days before baseline visit).
Key Trial Info
Start Date :
June 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 22 2025
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT05376579
Start Date
June 17 2022
End Date
July 22 2025
Last Update
December 18 2025
Active Locations (24)
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1
Novartis Investigative Site
Ancona, AN, Italy, 60126
2
Novartis Investigative Site
L’Aquila, AQ, Italy, 67100
3
Novartis Investigative Site
Bergamo, BG, Italy, 24127
4
Novartis Investigative Site
Bologna, BO, Italy, 40124