CompletedNot Applicable

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

Italy134 participantsStarted 2022-06-17

Plain-language summary

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

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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).

Proportion of patients with six-month CDP during 36 months of treatment

Timeframe: 36 months

NCT IDNCT05376579

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-07-22

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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).