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

Study Overview
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Brief Summary
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This study will evaluate the effects of Aubagio on changes in the brain using MRI.

Detailed Description
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: MRI


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria Exclusion Criteria: MS patients with hepatic impairment Nursing mothers or pregnant women who will need to undergo 12 months follow-up Women of childbearing potential not using reliable contraception Patients currently treated with leflunomide Serum alanine aminotransferase (ALT) >1.5 times the upper limit of normal A clinically significant infectious or neurological (for HC only) illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to treatment assignment Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol Any other reasons that, in the opinion of the Investigator, indicate that the subject is unsuitable for enrollment into this study Other pathology related to MRI abnormalities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aubagio MRI<br>Patients with relapsing-remitting multiple sclerosis who take Aubagio will have an MRI, eye test, blood drawn, and complete a questionnaire. | Other: MRI<br> <br> |
| Healthy controls<br>Subjects who are otherwise healthy, without neurological disorders will have an MRI, eye test, blood drawn, and complete a questionnaire. | Other: MRI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, relapsing remitting, MRI, teriflunomide, aubagio, gray matter atrophy, gray matter pathology