TerminatedNot Applicable

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

Stopped: Insufficient patient recruitment

Switzerland8 participantsStarted 2021-11-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Change of expanded disability status scale (EDSS)

Timeframe: Baseline, month 36

Trial details

NCT IDNCT04895202

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-12-20

View on ClinicalTrials.gov More Secondary Progressive Multiple Sclerosis With Inflammatory Disease Activity trials