drugset / Trial / NCT01863888

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

NCT01863888

Phase 3 Completed 70 enrolled Sanofi
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Primary 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.

Timeline

Start
2013-10
Primary completion
2015-01
Completion
2015-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Teriflunomide Small molecule 14 mg Oral
Background Cholestyramine Other / unclassified Oral
Background charcoal Unknown Oral

Indications