Swiss Study of the Impact of Mayzent on SPMS Patients in a Long-term Non-interventional Study (SWISSMASIA)
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
8 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Novartis Pharmaceuticals; Novartis Pharmaceuticals
Data sourced from clinicaltrials.gov
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