RELAPSING REMITTING MULTIPLE SCLEROSIS
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Genzyme, a Sanofi Company
University of North Carolina, Chapel Hill
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Inhibition of activated/memory B-cells derived from RRMS patients. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Change in Cytokine Secretion Profile of T-cells stimulated by teriflunomide treatment | 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. | 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. | 1 year |
Countries
United States
Outcome results
None listed