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

Novartis

Status: Active, not recruiting

Conditions: Active Secondary Progressive Multiple Sclerosis

Treatments: Other: siponimod

Study type: Observational

Funder types: Industry

Identifiers

NCT05376579

CBAF312AIT04

Details and patient eligibility

About

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

Full 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 the effects of siponimod treatment on an individual basis.

Enrollment: 134 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent: patient must provide written informed consent before any study assessment is performed.
2. Male/female participants aged between 18 and 60.
3. Documented diagnosis of active SPMS.
4. 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

1. Patients treated outside the approved siponimod label or with any controindication indicated in the SmPC.
2. Pregnant or lactating women.
3. 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.
4. Current participation in an interventional trial.
5. Treatment with siponimod prior to inclusion in this study (siponimod can be started not more than 7 days before baseline visit).

Trial design

134 participants in 1 patient group

siponimod

Description:

patients treated with siponimod

Treatment:

Other: siponimod