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teriflunomide · TERIVA

Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide

Ensayo de Sanofi en Esclerosis multiple.

Fase: Fase 2
Estado: Completado
Participantes: 128
Centros: 14
Fin del objetivo primario: ene 2012

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en sep 2011.

Qué mide

Percentage of Participants With Antibody Titer ≥40 at 28 Days Post Vaccination (28 days post vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: Assess the antibody response to influenza vaccine in patients with relapsing form of multiple sclerosis (RMS) treated with teriflunomide compared to a reference population. Secondary Objectives: * Assess the effect of teriflunomide on immunoglobulin levels; * Assess the safety of influenza vaccination in patients with RMS treated with teriflunomide. The reference population was defined as multiple sclerosis (MS) patients with a stable treatment with interferon-β-1. Antibody response was measured using hemagglutination inhibition assay (HIA) and the hemagglutinin antigens representing the stains of H3N2, H1N1, and B as present in the influenza vaccine used.

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Ficha completa en ClinicalTrials.gov (NCT01403376), actualizada en ene 2016.