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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01881191
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : February 12, 2016
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo

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

Condition or disease Intervention/treatment
Multiple Sclerosis Other: 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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Teriflunomide (Aubagio®) on Gray Matter Pathology in Multiple Sclerosis: The 12 Months, Prospective, Observational, Single-blinded, Longitudinal Study
Study Start Date : June 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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. [ Time Frame: baseline, 6 month and 12 month ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: baseline, month 6 and month 12 ]

Biospecimen Retention:   Samples With DNA
Serum to be retained.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

MS patients from the Baird MS Center, The Jacobs Neurological Institute, Department of Neurology, State University at Buffalo, NY, USA who are also taking Aubagio as their disease modifying therapy.

Healthy controls from the general population.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01881191

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United States, New York
Buffalo Neuroimaging Analysis Center
Buffalo, New York, United States, 14203
Sponsors and Collaborators
University at Buffalo
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Principal Investigator: Robert Zivadinov, MD,PhD,FAAN University at Buffalo

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Responsible Party: Robert Zivadinov, MD, PhD, Director, Buffalo Neuroimaging Analysis Center, Professor, University at Buffalo Identifier: NCT01881191    
Other Study ID Numbers: GZ-2013-10958
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016
Keywords provided by Robert Zivadinov, MD, PhD, University at Buffalo:
multiple sclerosis
relapsing remitting
gray matter atrophy
gray matter pathology
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases