Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
120 participants
OBSERVATIONAL
2018-06-14
2019-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Aubagio
Individuals diagnosed with multiple sclerosis (MS) who have been treated with teriflunomide (Aubagio).
Teriflunomide
Individuals with MS treated with teriflunomide (Aubagio)
Tecfidera
Individuals diagnosed with multiple sclerosis (MS) who have been treated with dimethyl fumarate (Tecfidera) and matched with the teriflunomide (Aubagio) patients on age, sex, disease duration, and disability level
Dimethyl Fumarate
Individuals with MS treated with dimethyl fumarate (Tecfidera)
Interventions
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Dimethyl Fumarate
Individuals with MS treated with dimethyl fumarate (Tecfidera)
Teriflunomide
Individuals with MS treated with teriflunomide (Aubagio)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-65 years
* Relapsing disease course
* Expanded Disability Status Scale (EDSS) score of ≤ 5.5
* MRI obtained at baseline (medication start date), 12 months, and 24 months
* Treated with 14mg of teriflunomide ≥ 3 months or with 240mg of dimethyl fumarate ≥ 3 months to meet inclusion, reflective of recommended dosing on the package label
* Clinical information available over the 24 month follow-up
Exclusion Criteria
* Use of experimental drug or investigational procedure during the study period
* Pregnancy during study period
* Severe hepatic impairment
* Relapse within 30 days prior to any of the 3 MRIs
* Corticosteroid use within 30 days prior to the MRIs
* Teriflunomide patients who have used leflunomide
* Pre-baseline use of alemtuzumab, cladribine, rituximab, or mitoxantrone
* Any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation
18 Years
65 Years
ALL
No
Sponsors
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University at Buffalo
OTHER
Responsible Party
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Robert Zivadinov, MD, PhD
Director, Principal Investigator
Locations
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Buffalo Neuroimaging Analysis Center
Buffalo, New York, United States
Countries
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References
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Zivadinov R, Bergsland N, Carl E, Ramasamy DP, Hagemeier J, Dwyer MG, Lizarraga AA, Kolb C, Hojnacki D, Weinstock-Guttman B. Effect of Teriflunomide and Dimethyl Fumarate on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective, Observational, Case-Control Pilot Study. J Clin Med. 2019 Mar 12;8(3):344. doi: 10.3390/jcm8030344.
Other Identifiers
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STUDY00002359
Identifier Type: -
Identifier Source: org_study_id
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