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

Swiss Study of the Impact of Mayzent (Siponimod) on Secondary Progressive Multiple Sclerosis Patients in a Long-term Non-interventional Study

ClinicalTrials.gov Identifier: NCT04895202

Novartis Reference Number: CBAF312ACH01

Last Update: May 17, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Secondary Progressive Multiple Sclerosis With Inflammatory Disease Activity
Phase 
Not Given
Overall status 
Recruiting
Start date 
Nov 19, 2021
Completion date 
Aug 25, 2025
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Other
Siponimod
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 Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Locations

Switzerland
Novartis Investigative Site
Recruiting
Baden, 5405
Aargau
Switzerland
Novartis Investigative Site
Recruiting
Valens, 7317
CH
Switzerland
Novartis Investigative Site
Recruiting
Zug, 6300
ZG
Switzerland
Novartis Investigative Site
Recruiting
Zurich, 8006
ZH
Switzerland
Novartis Investigative Site
Recruiting
Basel, 4031
-
Switzerland
Novartis Investigative Site
Recruiting
Bern, 3010
-
Switzerland
Novartis Investigative Site
Recruiting
Lugano, 6900
-
Switzerland
Novartis Investigative Site
Recruiting
Luzern, 6004
-
Switzerland
Novartis Investigative Site
Recruiting
Winterthur, 8400
-
Switzerland

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]