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

NCT04895202 | Terminated

• 1 other identifier: CBAF312ACH01
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 6

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.

Conditions

Secondary Progressive Multiple Sclerosis With Inflammatory Disease Activity

Keywords

SPMS; secondary progressive multiple sclerosis; Siponimod; active disease; inflammatory disease activity; disability progression

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline, month 36

Secondary Outcomes (7)

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

  month 36

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

  Up to 36 months

• Treatment effect of Siponimod on walking speed as measured by the timed 25 foot walk test (T25FWT)

  Baseline, up to 36 months

• Treatment effect of Siponimod on quality of life based on EQ-5D

  Baseline, month 36

• Treatment effect of Siponimod on fatigue measured by Fatigue Scale for Motor and Cognitive Functions (FSMC)

  Baseline, month 36

Study Arms (1)

Siponimod

Patients administered Siponimod as per Swiss label

Other: Siponimod

Interventions

Siponimod OTHER

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.

Siponimod

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SPMS population in Switzerland who are treated with Siponimod as per Swiss label

You may qualify if:

• Signed informed consent
• 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
• Patient willing and able to complete the questionnaires

You may not qualify if:

• Patients treated outside of the approved Swiss label for Siponimod
• Prior treatment or already ongoing treatment with Siponimod
• 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
• Subjects who are not able to provide consent due to incapable judgement

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Zug, Canton of Zug, 6300, Switzerland

Location

Novartis Investigative Site

Zurich, Canton of Zurich, 8006, Switzerland

Location

Novartis Investigative Site

Basel, 4031, Switzerland

Location

Novartis Investigative Site

Bern, 3010, Switzerland

Location

Novartis Investigative Site

Lugano, 6900, Switzerland

Location

Novartis Investigative Site

Winterthur, 8400, Switzerland

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 Pharmaceiticals

  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 17, 2021
• First Posted: May 20, 2021
• Study Start: November 19, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (6)