CompletedPhase 4

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

Germany41 participantsStarted 2021-04-19

Plain-language 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 treatment break versus while on treatment with first-line DMTS or no current MS treatment..

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * prior or current COVID-19 disease * SARS-CoV-2 antibodies at screening Other protocol-defined inclusion/exclusion criteria may apply

What they're measuring

Percentage of Participants Achieving Seroconversion One Week After Receiving Second Vaccine (EAS)

Timeframe: At 1 week after vaccination period (defined as 1 week after second dose of vaccine)

Trial details

NCT IDNCT04792567

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-06

Results submitted2023-08-01

View on ClinicalTrials.gov More Secondary Progressive Multiple Sclerosis trials