Teriflunomide's Therapeutic Mechanisms of Action in Patients With Relapsing Remitting Multiple Sclerosis.
Terminated
- Conditions
- RELAPSING REMITTING MULTIPLE SCLEROSIS
- Registration Number
- NCT02833714
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent Inhibition of activated/memory B-cells derived from RRMS patients. 1 year
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States