Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)

PHASE4CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

April 19, 2021

Primary Completion Date

September 6, 2021

Study Completion Date

August 15, 2022

Conditions
Secondary Progressive Multiple Sclerosis
Interventions
DRUG

BAF312

taken orally once per day (dose depends on CYP2C9 genotype)

DRUG

Baseline disease modifying therapies (DMTs)

DMTs: Dimethylfumarate, glatirameracetate, interferon, teriflunomode according to respective SmPC

BIOLOGICAL

BNT162

Administerd according to the respective EU SmPC at the discretion of the treating physician independent of AMA-VACC. If suggested by local regulations and performed as part of clinical routine any type of booster/refresher vaccination (e.g. mRNA, vector, peptide) was allowed in this study.

BIOLOGICAL

mRNA-1273

Administerd according to the respective EU SmPC at the discretion of the treating physician independent of AMA-VACC. If suggested by local regulations and performed as part of clinical routine any type of booster/refresher vaccination (e.g. mRNA, vector, peptide) was allowed in this study

Trial Locations (10)

40211

Novartis Investigative Site, Düsseldorf

75172

Novartis Investigative Site, Pforzheim

76761

Novartis Investigative Site, Rülzheim

86633

Novartis Investigative Site, Neuburg an der Donau

89073

Novartis Investigative Site, Ulm

93059

Novartis Investigative Site, Regensburg

94327

Novartis Investigative Site, Bogen

09648

Novartis Investigative Site, Mittweida

09117

Novartis Investigative Site, Chemnitz

01307

Novartis Investigative Site, Dresden

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY

NCT04792567 - Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC) | Biotech Hunter | Biotech Hunter