Teriflunomide's Therapeutic Mechanisms of Action in Patients With Relapsing Remitting Multiple Sclerosis.

University of North Carolina, Chapel Hill26 enrolled

Overview

The purpose of this research is to characterize the effect of teriflunomide on the activation of B-cells, as well as its capacity to modify B-cell cytokine secretion. The in-vitro identified effects of teriflunomide on the expression of B-cell activation markers, costimulatory and antigen presenting molecules, as well as on cytokine secretion, will then be confirmed in a cohort of Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with this medication.

Study Type

OBSERVATIONAL

Enrollment

Conditions

RELAPSING REMITTING MULTIPLE SCLEROSIS

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * confirmed diagnosis of RRMS according to McDonald's diagnostic criteria, * age 18-55, * an extended disability status score (EDSS) of 1.5-5.5. Exclusion Criteria: \- Previous treatment with DMT.

Locations (1)

University of North Carolina

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Percent Inhibition of activated/memory B-cells derived from RRMS patients.

Time frame: 1 year

Secondary Outcomes

Change in Cytokine Secretion Profile of T-cells stimulated by teriflunomide treatment

Time frame: 1 year

Measure the effect of oral teriflunomide on the cytokine secretion as measured in the ex-vivo obtained longitudinal samples from the treated patients.

Time frame: 1 year

Measure the effect of oral teriflunomide on the B cell activation as measured in the ex-vivo obtained longitudinal samples from the treated patients.

Time frame: 1 year

Data from ClinicalTrials.gov

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