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teriflunomide HMR1726 · TERI-DYNAMIC

Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis

Ensayo de Sanofi en Esclerosis multiple.

Más ensayos de: Esclerosis múltiple.

Fase

Fase 3

Estado

Completado

Participantes

70

previstos

Centros

10

Fin del objetivo primario

ene 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en oct 2013.

Qué mide

Change from baseline in Lymphocyte subset parameters as measured by flow cytometry (At 12 weeks and 24 weeks) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing forms of multiple sclerosis as compared with baseline values and those of a reference population of untreated healthy subjects. Secondary Objectives: To assess if Teriflunomide treatment results in biased T cell clonal diversity. To assess the effect of Teriflunomide on the function of peripheral blood mononuclear cells (proliferation and cytokine production in situ). To assess the circulating cytokines profile in the serum of Relapsing Multiple Sclerosis (RMS) patients during a 24-week treatment versus baseline and healthy controls. To assess the reversibility of all parameter changes in patients who discontinue treatment after accelerated elimination procedure with cholestyramine or activated charcoal.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01863888), actualizada en mar 2015.