Impact of Mayzent on aSPMS Patients in a Long-term NIS in Italy

Impact of Mayzent (Siponimod) on Active Secondary Progressive Multiple Sclerosis Patients in a Long-term Non-interventional Study in Italy

ClinicalTrials.gov Identifier: NCT05376579

Novartis Reference Number: CBAF312AIT04

Last Update: Feb 08, 2023

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

This is an observational, multicenter, single-arm, prospective study conducted in Italy

Condition

Active Secondary Progressive Multiple Sclerosis

Phase

Not Given

Overall status

Recruiting

Start date

Jun 17, 2022

Completion date

Jun 30, 2026

Gender

All

Age(s)

18 Years - 60 Years (Adult)

Interventions

Other

siponimod

Prospective observational cohort study. There is no treatment allocation. Patients will be invited to participate in the study after the independent decision by physician and patient to start siponimod treatment as routine clinical care.

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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).