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

NCT05376579

CompletedN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Active Secondary Progressive Multiple Sclerosis

Interventions: siponimod

Countries: Italy

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

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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).
Locations (24)
  • Ancona, AN, Italy
  • L’Aquila, AQ, Italy
  • Bergamo, BG, Italy
  • Bologna, BO, Italy
  • Brescia, BS, Italy
  • Como, CO, Italy
  • Catanzaro, CZ, Italy
  • Foggia, FG, Italy
  • Genova, GE, Italy
  • Messina, ME, Italy
  • Milan, MI, Italy
  • Palermo, PA, Italy
  • Padova, PD, Italy
  • Pisa, PI, Italy
  • Pavia, PV, Italy
  • Roma, RM, Italy
  • Roma, RM, Italy
  • Roma, RM, Italy
  • Orbassano, TO, Italy
  • Trieste, TS, Italy
  • Vicenza, VI, Italy
  • Naples, Italy
  • Naples, Italy
  • Novara, Italy