Status:
TERMINATED
Swiss Study of the Impact of Mayzent on SPMS Patients in a Long-term Non-interventional Study
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Secondary Progressive Multiple Sclerosis With Inflammatory Disease Activity
Eligibility:
All Genders
18+ years
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 w...
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, relap...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 20 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04895202
Start Date
November 19 2021
End Date
December 20 2022
Last Update
August 29 2023
Active Locations (6)
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1
Novartis Investigative Site
Zug, Canton of Zug, Switzerland, 6300
2
Novartis Investigative Site
Zurich, Canton of Zurich, Switzerland, 8006
3
Novartis Investigative Site
Basel, Switzerland, 4031
4
Novartis Investigative Site
Bern, Switzerland, 3010