Swiss Study of the Impact of Mayzent on SPMS Patients in a Long-term Non-interventional Study

Novartis Pharmaceuticals8 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Secondary Progressive Multiple Sclerosis With Inflammatory Disease Activity

Interventions

SiponimodOTHER

Prospective observational cohort study. There is no treatment allocation. Patients administered siponimod as by swiss label, that have started before inclusion of the patient into the study will be enrolled.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Novartis Investigative Site

Zug, Canton of Zug, Switzerland

Novartis Investigative Site

Zurich, Canton of Zurich, Switzerland

Novartis Investigative Site

Basel, Switzerland

Novartis Investigative Site

Bern, Switzerland

Outcomes

Primary Outcomes

Change of expanded disability status scale (EDSS)

The EDSS score is a widely used tool for determining the degree of disability in MS at any point in time. The EDSS value is generated based on overall impression and individual scores of the following functional systems: cognition, mood, fatigue, vision, brain stem, upper extremities, lower extremities, bladder and bowel function, sexuality. This results in a scale from 0 (healthy) to 10 (death from MS)

Time frame: Baseline, month 36

Secondary Outcomes

Proportion of patients with six month confirmed disability progression (CDP) by expanded disability status scale (EDSS)

Disability progression based on the EDSS score is defined as a 1 point increase from baseline in patients with a baseline score of ≤ 5, or a 0.5 point increase in patients with a baseline score of ≥5.5. As part of a secondary endpoint to this study, the deterioration of the EDSS of ≥1 point (baseline EDSS ≤ 5) or 0.5 points (baseline EDSS ≥5.5) must be confirmed after 6 months. This is called 6-month confirmed progression (6M-CDPEDSS). EDSS values to confirm progression must not be determined during an attack. The maximum duration of an attack is limited to 90 days

Time frame: month 36

Proportion of patients with six month confirmed disease progression by symbol digit modalities test (SDMT)

The SDMT is a sensitive and specific test for examining attention, concentration and information processing speed, which are typically impaired in cognitively impaired MS patients. The patients receive an SDMT test sheet. At the beginning of this sheet there are 9 numbers paired with 9 associated individual symbols. Below that are further lines with symbols and empty boxes. The patients must now verbally assign the correct numbers to the symbols as quickly as possible. Exercise examples are given at the beginning of the test which are not taken into account when evaluating the test. The number of correctly assigned items within 90 seconds results into the test score. The total duration of the test is about 5 minutes. SDMT: ≥4.0-point confirmed worsening from baseline score sustained for at least 6 months respectively

Data from ClinicalTrials.gov

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