Clinical trial NCT01881191: Th Effects of Aubagio on Brain Pathology in Multiple Sclerosis Studied Over 12 Months
Official title: Effect of Teriflunomide (Aubagio®) on Gray Matter Pathology in Multiple Sclerosis: The 12 Months, Prospective, Observational, Single-blinded, Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
relapsing remitting
MRI
teriflunomide
aubagio
gray matter atrophy
gray matter pathology
Lead sponsor: University at Buffalo
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: baseline, 6 month and 12 month
Secondary outcomes:
measure: 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.
timeFrame: baseline, month 6 and month 12
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Buffalo Neuroimaging Analysis Center
state: New York
Study officials:
affiliation: University at Buffalo
name: Robert Zivadinov, MD,PhD,FAAN
role: PRINCIPAL_INVESTIGATOR
References: