Clinical trial NCT05376579: Impact of Mayzent on aSPMS Patients in a Long-term NIS in Italy
Official title: Impact of Mayzent (Siponimod) on Active Secondary Progressive Multiple Sclerosis Patients in a Long-term Non-interventional Study in Italy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Active Secondary Progressive Multiple Sclerosis
Keywords: Secondary Progressive Multiple Sclerosis
aSPMS
NIS
Italy
Mayzent
siponimod
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients in Italy with active SPMS treated with siponimod as per label and local clinical practice.

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

Detailed 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.

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).

Primary outcomes:
measure: Proportion of patients with six-month CDP during 36 months of treatment
timeFrame: 36 months
Secondary outcomes:
measure: Annualized relapse rate (ARR)
timeFrame: Month 12, month 24 and month 36
measure: Number of new/newly enlarging T2 [neT2] and Gd+T1 lesions
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36
measure: Expanded Disability Status Scale scores
timeFrame: Month 12, month 24 and month 36
measure: Expanded Disability Status Scale trend
timeFrame: Month 12, month 24 and month 36
measure: Proportion of patients with No Evidence of Disease Activity (NEDA)-3
timeFrame: Month 12, month 24 and month 36
measure: UK Neurological Disability Scale (UKNDS)
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36
measure: Fatigue Scale for Motor and Cognitive Functions (FSMC)
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36
measure: Symbol Digit Modality test (SDMT)
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36
measure: Clinical Global Impression (CGI)
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36
measure: MS activity status (MS-AS) - number of relapse
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36
measure: MS activity status (MS-AS) - Number of patients with presence of symptoms
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36
measure: T25-foot-walk
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36
measure: 9-Hole peg test
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36
measure: EQ-5D: EuroQol five-dimensional
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36
measure: TSQM-9: Treatment Satisfaction Questionnaire for Medication
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36
measure: Exposure adjusted proportion of patients with adverse event (AE) or serious adverse event (SAE) per 100 subject-years
timeFrame: Up to 36 months
measure: Discontinuation rates due to AE or other reasons
timeFrame: Up to 36 months
measure: Proportion of patient who required FDO when starting siponimod and the reason why
timeFrame: Baseline
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Novartis Investigative Site
state: AN
city: L Aquila
country: Italy
facility: Novartis Investigative Site
state: AQ
city: Bergamo
country: Italy
facility: Novartis Investigative Site
state: BG
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: BO
city: Brescia
country: Italy
facility: Novartis Investigative Site
state: BS
city: Como
country: Italy
facility: Novartis Investigative Site
state: CO
city: Catanzaro
country: Italy
facility: Novartis Investigative Site
state: CZ
city: Foggia
country: Italy
facility: Novartis Investigative Site
state: FG
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Messina
country: Italy
facility: Novartis Investigative Site
state: ME
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Orbassano
country: Italy
facility: Novartis Investigative Site
state: TO
city: Trieste
country: Italy
facility: Novartis Investigative Site
state: TS
city: Vicenza
country: Italy
facility: Novartis Investigative Site
state: VI
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Novara
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: