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

NCT05376579 | Completed

• 1 other identifier: CBAF312AIT04
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 24

Brief Summary

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

Conditions

Active Secondary Progressive Multiple Sclerosis

Keywords

Secondary Progressive Multiple Sclerosis; aSPMS; NIS; Italy; Mayzent; siponimod

Outcome Measures

Primary Outcomes (1)

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

  Confirmed disability progression (CDP) is defined as a ≥1.0-point worsening of Expanded Disability Status Scale (EDSS) score from ≤5.0 baseline or a 0.5-point worsening from \>5.0 baseline for at least 6 months OR a ≥4.0-point confirmed cognitive worsening (CCW) from baseline of Symbol Digit Modalities Test (SDMT) for at least 6 months.

  36 months

Secondary Outcomes (19)

• Annualized relapse rate (ARR)

  Month 12, month 24 and month 36

• Number of new/newly enlarging T2 [neT2] and Gd+T1 lesions

  Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36

• Expanded Disability Status Scale scores

  Month 12, month 24 and month 36

• Expanded Disability Status Scale trend

  Month 12, month 24 and month 36

• Proportion of patients with No Evidence of Disease Activity (NEDA)-3

  Month 12, month 24 and month 36

Study Arms (1)

siponimod

patients treated with siponimod

Other: siponimod

Interventions

siponimod OTHER

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.

Also known as: mayzent

siponimod

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients in Italy with active SPMS treated with siponimod as per label and local clinical practice.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (24)

Novartis Investigative Site

Ancona, AN, 60126, Italy

Location

Novartis Investigative Site

L’Aquila, AQ, 67100, Italy

Location

Novartis Investigative Site

Bergamo, BG, 24127, Italy

Location

Novartis Investigative Site

Bologna, BO, 40124, Italy

Location

Novartis Investigative Site

Brescia, BS, 25123, Italy

Location

Novartis Investigative Site

Como, CO, 22100, Italy

Location

Novartis Investigative Site

Catanzaro, CZ, 88100, Italy

Location

Novartis Investigative Site

Foggia, FG, 71122, Italy

Location

Novartis Investigative Site

Genova, GE, 16132, Italy

Location

Novartis Investigative Site

Messina, ME, 98124, Italy

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

Palermo, PA, 90127, Italy

Location

Novartis Investigative Site

Padua, PD, 35128, Italy

Location

Novartis Investigative Site

Pisa, PI, 56126, Italy

Location

Novartis Investigative Site

Pavia, PV, 27100, Italy

Location

Novartis Investigative Site

Roma, RM, 00133, Italy

Location

Novartis Investigative Site

Roma, RM, 00152, Italy

Location

Novartis Investigative Site

Roma, RM, 00189, Italy

Location

Novartis Investigative Site

Orbassano, TO, 10043, Italy

Location

Novartis Investigative Site

Trieste, TS, 34149, Italy

Location

Novartis Investigative Site

Vicenza, VI, 36100, Italy

Location

Novartis Investigative Site

Naples, 80131, Italy

Location

Novartis Investigative Site

Naples, 80138, Italy

Location

Novartis Investigative Site

Novara, 28100, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

siponimod

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 17, 2022
• Study Start: June 17, 2022
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (24)