Clinical trial NCT02833714: Teriflunomide's Therapeutic Mechanisms of Action in Patients With Relapsing Remitting Multiple Sclerosis.
Official title: Characterization of Teriflunomide's Therapeutic Mechanisms of Action in Patients With Relapsing Remitting Multiple Sclerosis.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: RELAPSING REMITTING MULTIPLE SCLEROSIS
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2016-07-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurology/MS clinic: patients with Relapsing Remitting MS "Treatment naïve Relapsing Remitting MS patients will be recruited to provide samples for the in vitro tests. In addition, Relapsing Remitting MS patients who are already receiving treatment with teriflunomide as a part of their routine care will be recruited to obtain blood samples for the in vivo testing."

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Inhibition of activated/memory B-cells derived from RRMS patients.
timeFrame: 1 year
Secondary outcomes:
measure: Change in Cytokine Secretion Profile of T-cells stimulated by teriflunomide treatment
timeFrame: 1 year
measure: Measure the effect of oral teriflunomide on the cytokine secretion as measured in the ex-vivo obtained longitudinal samples from the treated patients.
timeFrame: 1 year
measure: Measure the effect of oral teriflunomide on the B cell activation as measured in the ex-vivo obtained longitudinal samples from the treated patients.
timeFrame: 1 year
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: Universtiy of North Carolina at Chapel Hill
name: Silva MarkovicPlese, MD
role: PRINCIPAL_INVESTIGATOR
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