Th Effects of Aubagio on Brain Pathology in Multiple Sclerosis Studied Over 12 Months

Effect of Teriflunomide (Aubagio®) on Gray Matter Pathology in Multiple Sclerosis: The 12 Months, Prospective, Observational, Single-blinded, Longitudinal Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01881191

Acronym

GZA

Enrollment

Registered

2013-06-19

Start date

2013-06-30

Completion date

2015-10-31

Last updated

2016-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, relapsing remitting, MRI, teriflunomide, aubagio, gray matter atrophy, gray matter pathology

Brief summary

This study will evaluate the effects of Aubagio on changes in the brain using MRI.

Detailed description

Patients who take Aubagio will have an MRI, eye test, have blood taken, and complete a questionnaire on environmental risk factors to evaluate changes in the brain and on disease progression. A healthy control group will also complete the same testing regimen.

Interventions

OTHERMRI

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Subjects aged 18-65 * Clinically definite MS according to the Polman criteria, 52 * Relapsing MS or Healthy Control (no neurological disorders) * Expanded Disability Status Scale (EDSS) scores ≤5.5 * Disease duration \<30 years * Normal kidney function (creatinine clearance \>59 mL/min) (patients only) * Signed informed consent * None of the

Design outcomes

Primary

Measure	Time frame
The primary aim of this study is to define the effect of teriflunomide (Aubagio®) on the development of gray matter (GM) atrophy in patients with relapsing multiple sclerosis (MS) using MRI.	baseline, 6 month and 12 month

Secondary

Measure	Time frame
The secondary objective of this study is to define the effect of teriflunomide on subcortical deep gray matter (SDGM) pathology using MRI over 12 months.	baseline, month 6 and month 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026