Clinical trial NCT04895202: Swiss Study of the Impact of Mayzent on SPMS Patients in a Long-term Non-interventional Study
Official title: Swiss Study of the Impact of Mayzent (Siponimod) on Secondary Progressive Multiple Sclerosis Patients in a Long-term Non-interventional Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Secondary Progressive Multiple Sclerosis With Inflammatory Disease Activity
Keywords: SPMS
secondary progressive multiple sclerosis
Siponimod
active disease
inflammatory disease activity
disability progression
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SPMS population in Switzerland who are treated with Siponimod as per Swiss label

Brief summary: This study is a national, prospective, multicenter, non-interventional (observational) study with the aim to describe the impact of Siponimod treatment in a real-world SPMS population in Switzerland who are treated with Siponimod as per Swiss label.

Detailed description: Primary data will be collected during an observational period of three years of Siponimod treatment. Additionally, medical history of participants will be collected including EDSS, MRI outcomes, relapses and previous medication to allow the estimation of Siponimod treatment effects on an individual basis. It is planned to include an optional blood draw for a later biomarker analysis.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Adult patients with a documented diagnosis of SPMS with inflammatory disease activity who are going to be treated with Siponimod under routine medical care and in accordance with the Swiss label
3. Patient willing and able to complete the questionnaires

Exclusion Criteria:

1. Patients treated outside of the approved Swiss label for Siponimod
2. Prior treatment or already ongoing treatment with Siponimod
3. Use of investigational drugs during the study, OR within 3 months before enrollment, OR within 5 half-lives of investigational drug before enrollment, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer
4. Subjects who are not able to provide consent due to incapable judgement

Primary outcomes:
measure: Change of expanded disability status scale (EDSS)
timeFrame: Baseline, month 36
Secondary outcomes:
measure: Proportion of patients with six month confirmed disability progression (CDP) by expanded disability status scale (EDSS)
timeFrame: month 36
measure: Proportion of patients with six month confirmed disease progression by symbol digit modalities test (SDMT)
timeFrame: Up to 36 months
measure: Treatment effect of Siponimod on walking speed as measured by the timed 25 foot walk test (T25FWT)
timeFrame: Baseline, up to 36 months
measure: Treatment effect of Siponimod on quality of life based on EQ-5D
timeFrame: Baseline, month 36
measure: Treatment effect of Siponimod on fatigue measured by Fatigue Scale for Motor and Cognitive Functions (FSMC)
timeFrame: Baseline, month 36
measure: Treatment effect of Siponimod on fatigue measured by Beck's depression inventory (BDI)
timeFrame: Baseline, month 36
measure: Treatment effect of Siponimod on fatigue measured by Epworth sleepiness scale (ESS) questionnaire
timeFrame: Baseline, month 36
Other outcomes:
Locations:
city: Zug
country: Switzerland
facility: Novartis Investigative Site
state: ZG
city: Zurich
country: Switzerland
facility: Novartis Investigative Site
state: ZH
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Lugano
country: Switzerland
facility: Novartis Investigative Site
city: Winterthur
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceiticals
role: STUDY_DIRECTOR
References: