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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University at Buffalo
Sponsor:
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo
ClinicalTrials.gov Identifier:
NCT01881191
First received: June 17, 2013
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Multiple Sclerosis
Other: MRI

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University at Buffalo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum to be retained.


Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881191

Contacts
Contact: Robert Zivadinov, MD,PhD,FAAN 716-859-7031 rzivadinov@bnac.net
Contact: Cheryl L Kennedy, LMSW, MPH 716-859-7068 ckennedy@bnac.net

Locations
United States, New York
Buffalo Neuroimaging Analysis Center Recruiting
Buffalo, New York, United States, 14203
Contact: Cheryl L Kennedy, LMSW, MPH    716-859-7068    ckennedy@bnac.net   
Contact: Rebecca Melia, BS    716-859-7040    rmelia@bnac.net   
Principal Investigator: Robert Zivadinov, MD,PhD, FAAN         
Sponsors and Collaborators
University at Buffalo
Investigators
Principal Investigator: Robert Zivadinov, MD,PhD,FAAN University at Buffalo
  More Information

No publications provided

Responsible Party: Robert Zivadinov, MD, PhD, Director, Buffalo Neuroimaging Analysis Center, Professor, University at Buffalo
ClinicalTrials.gov Identifier: NCT01881191     History of Changes
Other Study ID Numbers: GZ-2013-10958
Study First Received: June 17, 2013
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University at Buffalo:
multiple sclerosis
relapsing remitting
MRI
teriflunomide
aubagio
gray matter atrophy
gray matter pathology

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014