Status:
COMPLETED
Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Secondary Progressive Multiple Sclerosis
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
The purpose of this study was to understand whether participants could mount an immune response to SARS-CoV-2 modRNA vaccines administered either during continuous siponimod treatment or during a trea...
Detailed Description
This was a three cohort, multicenter, open-label, study of 60 planned (optionally up to 90) multiple sclerosis (MS) patients who were on treatment with siponimod or a first-line disease modifying ther...
Eligibility Criteria
Inclusion
- Secondary Progressive Multiple Sclerosis (SPMS) diagnosis or with Relapsing Remitting Multiple Sclerosis (RRMS) at risk to develop SPMS (at the discretion of the treating physician)
- on stable MS treatment (Siponimod, dimethylfumarate, glatirameracetate, interferon, teriflunomode) or no current treatment
- no recent treatment changes
Exclusion
- prior or current COVID-19 disease
- SARS-CoV-2 antibodies at screening Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2022
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04792567
Start Date
April 19 2021
End Date
August 15 2022
Last Update
June 20 2024
Active Locations (10)
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1
Novartis Investigative Site
Mittweida, Saxony, Germany, 09648
2
Novartis Investigative Site
Bogen, Germany, 94327
3
Novartis Investigative Site
Chemnitz, Germany, 09117
4
Novartis Investigative Site
Dresden, Germany, 01307