Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Secondary Progressive Multiple Sclerosis
Type
Interventional
Phase
Phase 4
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 100 years
Gender
Both males and females

Description

This is a three cohort, multicenter, open-label, prospective study of 60 (optionally up to 90) multiple sclerosis (MS) patients currently treated with siponimod or a first-line disease modifying therapy (DMT) or without MS treatment in clinical routine planning to undergo a SARS-CoV-2 modRNA vaccina...

This is a three cohort, multicenter, open-label, prospective study of 60 (optionally up to 90) multiple sclerosis (MS) patients currently treated with siponimod or a first-line disease modifying therapy (DMT) or without MS treatment in clinical routine planning to undergo a SARS-CoV-2 modRNA vaccination as part of clinical routine. The maximal duration of the study for an individual patient is 14 months. The first cohort in this study will be participants not interrupting their current siponimod therapy for the purpose of a SARS-CoV-2 modRNA vaccination. The second cohort will be participants interrupting their current siponimod therapy for the purpose of a SARS-CoV-2 modRNA vaccination for approximately 2-3 months. The third cohort will be participants receiving modRNA vaccine while on treatment with the following first-line DMTs (dimethylfumarate, glatirameracetate, interferons, teriflunomide) or no current treatment in clinical routine. The study will investigate the development of functional anti-SARS-CoV-2 antibodies and T-cell titers for six months after the participants' vaccination.

Tracking Information

NCT #
NCT04792567
Collaborators
Not Provided
Investigators
Not Provided
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