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

February 11, 2016 updated by: Robert Zivadinov, MD, PhD, University at Buffalo

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • Buffalo Neuroimaging Analysis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: baseline, 6 month and 12 month
baseline, 6 month and 12 month

Secondary Outcome Measures

Outcome 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.
Time Frame: baseline, month 6 and month 12
baseline, month 6 and month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University at Buffalo

Investigators

  • Principal Investigator: Robert Zivadinov, MD,PhD,FAAN, University at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 18, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Estimate)

February 12, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZ-2013-10958

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe